An international publication dealing with medicolegal issues. articles, court decisions and legislation on:Medical law, forensic medicine, sexology and law, psychiatry and law, psychology and law, dentistry and law, nursing law, pharmaceutical law, medical ethics, clinical criminology, drugs, alcohol, child abuse, medical experimentation, genetic engineering, organ transplantation, abortion, contraception, sterilization, euthanasia, religion, AIDS etc.

© PROBOOK 2014

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WORLD ASSOCIATION FOR MEDICAL LAW

Board of GovernorsPresident

Prof. Thomas T. Noguchi (United States)

Vice PresidentsBerna Arda (Turkey)Kenneth Berger (Canada)Eduardo Dantas (Brazil)Muh Nasser (Indonesia)Chongqi Wu (China)

Executive CommitteeOren Asman (Israel)Roy G. Beran (Australia)Thomas T. Noguchi (United States)Andre G. Dias Pereira (Portugal)

Executive Vice PresidentOren Asman (Israel)

Secretary GeneralRoy G. Beran (Australia)

TreasurerAndre G. Dias Pereira (Portugal)

Board of GovernorsBerna Arda (Turkey)Oren Asman (Israel)Roy G. Beran (Australia)Kenneth Berger (Canada)David Collins (New Zealand)Eduardo Dantas (Brazil)Sanjin Dekovic (Bosnia and Herzegovina)Anne-Marie Duguet (France)Terhi Hermanson (Finland)Radmyla Hrevtsova (Ukraine)

Mitsuyasu Kurosu (Japan)Natalia Lojko (Poland)Vugar Mammadov (Azerbaijan)Muh Nasser (Indonesia)Thomas T. Noguchi (United States)Herman Nys (Belgium)Andre G. Dias Pereira (Portugal)Yuriy Sergeyev (Russian Federation)Chongqi Wu (China)

Members of Honor

R. DierkensWAML Medalion (2002)Hon. Secretary General and Founder (2004)

Koichi BaiWAML Medalion (2006)

Arthur LewisHonorary Governor (2004)

SonderlandHonorary Governor (2004)

Antonio PigaHonorary Governor (2006)

Jose Pinto De CostaHonorary Governor (2006)

Amnon CarmiHonorary President (2010)

Bernard DickensHonorary Vice President (2010)

Ethics: Submission of a manuscript for publication in this Journal confirms that allstandard ethics procedures were conducted; such as but not restricted to, voluntaryinformed consent of research participants when applicable and approval of theresponsible Research Ethics Board(s).

LIST OF CONTENTSTHEME ISSUE

VOLUME 33 NUMBER 1

Gianluca Montanari Vergallo 2Negligence and Embryo Protection: a New Frontier for Medical Law?

Marshall B. Kapp 14I’m Getting Turned Off: Emerging Consensus on Deactivating Cardiac Implantable Electronic Devices

Ernest Owusu-Dapaa 22The Historical Development of the Health Care Law and Bioethics in England and Wales: A Symbiotic Relationship?

Nikola Tupanceski and Dragana Kiprijanovska 40Medicine, Law and Human Rights – A Symbiotic Relationship

Vina Vaswani* and Ravi Vaswani 64Perceptions of People Living with HIV/AIDS Regarding Access to Health Care

Index 74

Med Law (2014) 33:2- Medicine and Law

©PROBOOK 2014

2

NEGLIGENCE AND EMBRYO PROTECTION: A NEW FRONTIER FOR MEDICAL LAW?

Gianluca Montanari Vergallo*

Abstract: In early 2012, many embryos were destroyed in a Roman hospital because of the breakdown of the freezing machine. In such cases the biological damage, for instance by ovarian hyper-stimulation, and the pecuniary damage, i.e. the costs of treatments, can be compensated if the plaintiff demonstrates that subsequent fertility treatments would not have been performed if the embryos had not been destroyed. The damage for pain and suffering can be compensated regardless of what would have been the outcome of the implant. Indeed, even in the case where the implant of cryopreserved embryos would not have been successful, the loss of embryos is suitable to cause pain and suffering because it violates the right to become a parent. Nevertheless, the proof of such damage is difficult to achieve. In order to impede that the negligent loss of embryos would remain without consequences it seems to be possible and appropriate to provide a crime to punish those who cause the death of embryos by negligence.

Keywords: Loss of Embryos; Civil Liability; Causal Nexus; Pecuniary Damages; Non-Pecuniary Damages; Legal Value of the Embryo; Introduction of a New Offense.

1. INTRODUCTION

The topic of embryo safeguard has been mainly debated paying attention on the moral and juridical acceptability of the assisted fertilization techniques that, on the one hand, protect the rights of the couples or the collective interest in scientific research but, on the other hand, entail the loss of many embryos.

* Institute of Legal Medicine, Department of Anatomical, Histological, Medico-legal and Orthopaedic Sciences, University of Rome “Sapienza” 50, Via Catania, 00161 Rome, Italy. Tel.:0039-06-64465419. Fax: 0039-06-4452726. Email: gianluca.montanarivergallo@uniroma1.it

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3Medicine and Law

However, the survival of embryos may also be threatened by negligent conducts, as occurred in early 2012 in one of the main hospitals in Rome, where the breakdown of the freezing machine caused the loss of many embryos.

This paper focuses on analyzing, on the one hand, whether and under what conditions damages for loss of frozen embryos are recoverable and, on the other hand, whether it is appropriate and possible to reform penal law introducing an autonomous offense for such an eventuality.

The protection of stored embryos is an actual issue also in Italy, since the Constitutional Court has stated that the law n. 40/2004 on medically assisted procreation is inconsistent with the Italian Constitution because it prohibits the cryopreservation and binds the woman to implant immediately all the produced1 embryos. Therefore, being cryopreservation no longer forbidden, the number of stored embryos is increasing in Italy as well.

2. CIVIL LIABILITY IN CASES OF NEGLIGENT LOSS OF EMBRYOS

The facilities that deal exclusively with cryopreservation are not the only ones required to prevent the loss of stored embryo. This obligation is also binding on hospitals in which assisted reproduction treatments are performed. Indeed, conservation is necessary to ride out the reproductive problems of the couple. Thus, even apart from the moral status of the embryo, all health facilities have an obligation to protect his life because this is the only way to protect the couple’s right to procreate2.

On the contrary, the other elements of medical liability are much more controversial3.

1 Italian Constitutional Court, 1 April 2009, n. 151, available at www.giurcost.org. Last access: 28 May 2013.

2 KENNEDY, I. & GRUBB, A. (1998) Principles of Medical Law. Oxford: Oxford Univ. Press, p. 583, argue the possibility to bring an action for civil liability for breach of the Human Embryo Fertilization Act of 1990. Such legislation clearly identifies suppliers of gametes as the persons who have to be protected from license-holders.

3 REICH, J.B. & SWINK D. (2010) You Can’t Put The Genie Back In The Bottle: Potential Rights And Obligations Of Egg Donors In The Cyber-procreation Era. Alb. L.J. Sci. & Tech. 20 (1). p. 1-66, at p. 58, available at http://www.albanylawjournal.org/Documents/Articles/20.1.1-Reich.pdf. Last access: 18 June 2013.

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In fact, according to both Italian and common law, causal nexus is established when the damage would not have occurred but for the physician’s negligence. This assessment is based on a more likely than not criterion4.

Consequently, in order to prove causation it is firstly necessary that the embryos were still implantable and suitable to grow up with the ability to survive outside the womb.

Moreover, it is also essential that the circumstances of the case lead to believe that the couple would have implanted those embryos were not they had been destroyed.

In addition, when the health conditions of the couple do not support the view that the implantation of embryos would have led to the birth of a child, the couple would have had to undergo further fertility treatment anyhow, even if the embryos had not died. Thus, pecuniary and non-pecuniary damages due to such treatments could not be compensated.

On the contrary, if the birth of the child was more likely than not, the loss of cryopreserved embryos would force the patient to undergo once again assisted fertilization procedure.

Therefore, the damage caused by such treatments should be compensated by the health facility where the embryos were cryopreserved, unless it demonstrates force majeure, responsibility of the manufacturer of the freezing machine or unforeseeable circumstances that prevented the physicians from freezing the embryos.

As for pecuniary damages, the compensation should include, as well as any loss of earnings, both the financial costs of creating the embryos5 and the cost of all subsequent cycles of in vitro fertilization (IVF) actually performed and not just one. This conclusion undoubtedly applies in cases where an abortion

4 Miller v. Minister of Pensions (1947) 2 All ER 372; Italian Supreme Court, united civil sections, 11 January 2008, n. 576, available at www.cortedicassazione.it. Last access: 22 May 2013.

5 RUSSO, L. (2009) “Microscopic Americans?” A new conception of the right to recover for the loss of a pre-embryo in tort law. Mich. St. L. Rev. p. 789-816, at p. 815, available at http://msulawreview.org/wp-content/uploads/2012/10/2009-3-Russo.pdf. Last access: 1 July 2013.

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carelessly performed determines the sterility of the patient6. However, it can also be extended to cases where the embryos are thawed negligently. In fact, the loss of cryopreserved embryos is a necessary condition not only for the IVF cycle immediately following to the breakdown of the freezing machine, but also for any additional cycles.

Even if subsequent cycles were futile, this circumstance would not constitute a supervening cause. In fact, the uselessness of successive cycles does, in no way, constitute an exceptional occurrence. Indeed, it is part of the risk created by the negligent loss of cryopreserved embryos.

So, all damages due to these IVF cycles are caused by the thawing of the embryos.

As for the non-pecuniary damage, such situations could cause a temporary or permanent biological damage, particularly for the injurious consequences of hormonal stimulation required for the production of eggs to be fertilized.

However, functional limitations cannot be compensated when they are typically temporary and ordinarily related to embryo implantation and gestation. Such damage, in fact, would have occurred even if the cryopreserved embryos had not died, because the patient, in order to become a mother, would have had to implant them anyhow.

This applies to the first implant following the loss of such embryos. On the contrary, even the temporary damages related to the successive implants are compensated when, as mentioned, (more probably than not) the first implant would have led to the birth of the child.

As stated in Frisina v. Women and Infants Hosp. of R.I., also damages for pain and suffering, called moral damages in some civil law jurisdictions7, are recoverable in the event of loss of embryos8. Unlike the biological

6 SCHRIER, N. (2011) Wisconsin Medical Malpractice Law Fails To Fully Compensate For Negligently Performed Abortions. Wis. J. L. Gender & Soc’y. 26 (1). p. 141-165, at p. 163, available at http://hosted.law.wisc.edu/wjlgs/issues/2011_spring/schrier.pdf. Last access: 28 May 2013. See also WEVERS, K. (2010) Prenatal Torts and Pre-implantation Genetic Diagnosis. Harv. J. L. & Tech. 24 (1). p. 257-280, at p. 275, available at http://jolt.law.harvard.edu/articles/pdf/v24/24HarvJLTech257.pdf. Last access: 28 May 2013.

7 van Dam, C. (2013) European Tort Law, 2nd ed., Oxford: Oxford Univ. Press 346-3938 Damages for emotional distress due to the loss of an embryo stored in a hospital have

been awarded in Frisina v. Women and Infants Hosp. of R.I., No. CIV. A. 95-4037, CIV. A. 95-4469, CIV. A. 95-5827, 2002 WL 1288784, at p. 10, available at http://law.justia.com/cases/rhode-island/superior-court/2002/95-4037.html. Last access: 10 May 2013.

6 Medicine and Law

damage, the damage for pain and suffering can be compensated regardless of what would have been the outcome of the implant. Indeed, even in the case where (more probably than not) the implant of cryopreserved embryos would not have been successful, the loss of embryos is suitable to cause pain and suffering.

Nonetheless, the plaintiff must ride out evidentiary difficulties, in particular with regard to proof of damage. In order to prove the pain and suffering it is necessary to demonstrate the intention of the couple to implant the embryos would they had not died.

Wherefore, for instance, adoption of a child after implant failure, or a long period of couple crisis, may induce to believe that the loss of embryo did not cause any recoverable pain or suffering because in those circumstances it is probable that the couple would not want a child any more.

The loss of cryopreserved embryos not only affects the emotional serenity and psychophysical health of the couple, but also violates the right to become parents.

Such right is relevant not only in Italy, where the Constitution safeguards human right (section2) and supports the formation of families and protects motherhood and childhood (section 31)9, but also to the common law where the right to procreate is one of the “basic civil rights”10 and “a vital part of an individual’s right to privacy”11.

Although the Italian Constitution safeguards the right to become parents, it does not seem that violating this right is itself considered as a separate damage. In fact, the loss of cryopreserved embryos infringes upon the right of procreation, at least in terms of chance and, consequently, may cause pain and suffering. Thus, the violation of the right to procreate is not a compensable damage in itself, but is part of the causation of the emotional distress.

Consequently, the amount of the concrete chances of becoming a parent should be considered in quantifying moral damage, not an autonomous type

9 ZANCHETTI, M. (2003) L. 22 maggio 1978, n. 194. In: Palazzo, F.C. & Paliero, C.E. (eds) Commentario breve alle leggi penali complementari. Padova: Cedam, p. 1241.

10 Skinner v. Oklahoma, 316 U.S. 535 (1942), available at http://www.law.cornell.edu/supct/html/historics/USSC_CR_0316_0535_ZS.html. Last access: 12 May 2013.

11 Davis v. Davis, 842 S.W.2d 588, p. 600 (Tenn. 1992), available at http://biotech.law.lsu.edu/cases/cloning/davis_v_davis.htm. Last access: 13 May 2013.

7Medicine and Law

of damage. Indeed, even when there is no certainty that the couple would have implanted the stored embryos, their loss violates the right of couples to become parents because it eliminates the possibility of having a child through the implantation of those embryos. The greater the possibility that the cryopreserved embryos would have been implanted and would have led to the birth of a child the more the breach of the right to become a parent is serious and the compensation for moral damages should increase.

3. INTRODUCTION OF AN OFFENSE TO PUNISH THE NEGLIGENT LOSS OF EMBRYOS

Besides the rights of the couple, the status of the embryos needs also to be examined in order to evaluate the opportunity to introduce specific sanctions to whom causes their loss by negligence, independently of the compensation to the couple.

The legal value of the embryo is a very controversial issue.

In York v. Jones it has been argued that embryos are properties of the parents since they are the owners of the gametes that constitute them12. Contrariwise, in Davis v. Davis it has been held that since it possesses human nature, the embryo needs to be protected exactly as a human being13.

An additional approach sustains that the cryopreserved embryos cannot be considered as actual human life because, in their state, they are not vital14. Consequently, embryos have only a potential for human life that is anyway sufficient to entitle them to special respect15.

12 York v. Jones, 717 F. Supp. 421,424 (E.D. Va. 1989). 13 Davis v. Davis, No. E-14496, 1989 WL 140495, at *9 (Tenn. Cir. Ct. 1989). HOLLOW-

ELL, K.J. (2002) Defining a Person under the Fourteenth Amendment: A Constitution-ally and Scientifically Based Analysis. Regent U.L. Rev. 14. p. 67-95, at p. 77, available at http://www.regent.edu/acad/schlaw/student_life/studentorgs/lawreview/docs/issues/v14n1/Vol.%2014,%20No.%201,%203%20Hollowell.pdf. Last access: 18 May 2013.

14 LYON, K.W. (2000) Babies on Ice: The Legal Status of Frozen Embryos In-volved in Custody Disputes during Divorce. Whittier L. Rev. 21. p. 695-735, at p. 725.

15 Davis v. Davis, 842 S.W.2d 588, p. 597 (Tenn. 1992), available at http://bio-tech.law.lsu.edu/cases/cloning/davis_v_davis.htm. Last access: 13 May 2013. RAPOSO, V.L. & OSUNA, E. (2007) Embryo dignity: The status and juridical protection of the in vitro embryo. Med. & Law. 26 (4). p. 737-746.

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On the contrary, in Doe v. Irvine Scientific Sales it has been stated that in spite of their potential for human life16, embryos are not entitled to special treatment.

Yet, this debate does not seem to influence the opportunity to introduce an offense in order to punish whoever causes the loss of embryos by negligence.

First, considering the embryos as a property of the parents does not necessarily mean that they can be treated as objects. Rather, as mentioned, the property on the embryo is derived from the ownership over human cells, i.e. gametes, which have formed it. Thus, even this approach confirms that the embryo is not an object but rather it has human nature: if the embryo is composed of human cells, it is difficult to argue that it does not have the same human nature.

The opportunity to sanction careless conducts resulting in the death of human embryos does not seem to be influenced even by the debate about the embryo’s right to live and about the limits to abortion.

The Italian Constitutional Court has affirmed that the safeguard of the conceived has a Constitutional basis and, therefore, it justifies the legislator’s intervention to provide penal sanctions. Consequently, the protection of the conceived may be limited only when it collides with other juridical values protected by the Constitution17.

Moreover, the Italian Supreme Court has stated that the embryo possesses both the right not to be harmed, by commission or omission conduct, negligent or willful, and the right to be provided laws and health facilities suitable to guarantee a healthy birth18. The fact that embryos have the potential for human life leads towards agreement with this statement of the Italian Supreme Court.

In any event, the human nature of embryos is confirmed by the European Court of Human Rights’, in Vo v. France, that states that the common

16 Doe v. Irvine Scientific Sales Co., 7 F. Supp. 2d 737, 742 (E.D. Va. 1998), available at http://www.leagle.com/decision-result/?xmldoc/19987447FSupp2d737_1661.xml/docbase/CSLWAR2-1986-2006. Last access: 20 May 2013.

17 Italian Constitutional Court, 18 February 1975, n. 27, available at www.giurcost.org. Last access: 27 June, 2013; Italian Constitutional Court, 10 February 1997, n. 35, available at www.giurcost.org. Last access: 27 June, 2013.

18 Italian Supreme Court, section III civil, 29 July 2004, n. 14488, available at www.cort-edicassazione.it. Last access: 15 June 2013.

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denominator between States is the belonging to the human species: the embryo’s capacity to become a person must be protected in the name of human dignity, without transforming it into a person with a right to live, under Article 2 of the European Convention on Human Rights19.

Hence, the capacity of an embryo to become person must be protected in the name of its dignity. This seems to mean that the embryo has no right to live, interpreted as right to have birth, but it keeps the right not to be deprived of its capacity to become a person.

Consequently, the introduction of an offense to punish negligent loss of cryopreserved embryos seems possible, provided that the sanction is lower because the embryo is not a person.

The Common Law, traditionally states that the killing of a fetus in the womb does not constitute murder or manslaughter20.

This statement appears comprehensible in the logic that the embryo is not a person, but it still does not seem as an obstacle to the introduction of an autonomous offense to protect stored embryos.

The House of Lords has explained that the fetus, although his survival depends on the mother, “is, from the moment of conception, an organism separate and distinct from the mother”21. Their relation is “one of bond, not of identity (…). The mother and the fetus were two distinct organisms living symbiotically, not a single organism with two aspects”22.

Therefore, the embryo’s autonomous human value from conception recommends the introduction of an offense for negligent loss of stored embryos. The impossibility to apply the offense of manslaughter makes this reform even more necessary.

Furthermore, according to the European Court of Justice in Brüstle C. Greenpeace, every human egg cell since fecundation constitutes a human

19 European Court of Human Rights, sez. Grand Chamber, 8 July 2004, n. 53924, available at http://unipd-centrodirittiumani.it/public/docs/PDU3_2004_D151.pdf. Last access: 29 June 2013.

20 KENNEDY, I. & GRUBB, A. (1998) Principles of Medical Law. Oxford: Oxford Univ. Press, p. 646, quoting Rance v. mid-Downs HA (1991) 1 All ER 801, 817, and House of Lords, Attorney-General’s Reference (No. 3 of 1994) (1997) 3 All ER 936, 948.

21 Attorney-General’s Reference (No 3 of 1994) (1997) 3 WLR 421, 429, 440. 22 Attorney-General’s Reference (No 3 of 1994), at pp. 428-429.

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embryo, so as every non-fecundated human egg cell in which there has been implanted a mature human cell nucleus as well as every non-fecundated human egg cell that, through parthenogenesis, has been inducted to divide and develop23.

It has also been stated that the State has a legitimate and mandatory interest to preserve the embryo’s “potential life”24.

Obviously, in most cases, the freedom of the mother prevails over the public interest to the conservation of the embryo. However, this is irrelevant to the introduction of a separate offense of negligent killing of embryos. Indeed, in cases of loss of cryopreserved embryos, there is no conflict between the interests of the state and the rights of the mother. This autonomous offense, in no way, restricts the rights of potential parents, but solicits health professionals to be more careful.

The need for greater protection of the embryo is even more evident in the Common Law than in the Italian law.

Indeed, being it possible to donate excess embryos for use in stem cell research25 or for adoption26, the survival of the embryos may satisfy the need to guarantee the rights of third parties.

Being the public interest in the survival of embryos clear, it is possible, and appropriate, to provide an offense in order to protect stored embryos from careless conducts.

A step in this direction has been taken from the Illinois Wrongful Death Act, which in 1980 claimed that the state of gestation or development of a

23 European Court of Justice, Grand Chamber, 18 October 2011, n. 34, available at http://www.ippt.eu/files/2011/IPPT20111018_ECJ_Brustle_v_Greenpeace.pdf. Last access: 1 July 2013.

24 Roe v. Wade, 410 U.S. 113, 162-63 (1973), available at http://supreme.justia.com/cases/federal/us/410/113/case.html. Last access: 13 May 2013; Planned Parenthood of Southern Pennsylvania v. Casey, 505 U.S. 846 (1992) seems to be in favor of even more restrictions on the right to have an abortion. See NOONAN, A.M. The Uncertainty of Embryo Disposition Law: How Altera-tions to Roe Could Change Everything. Suffolk U. L. Rev. 40 (2). p. 485-520.

25 National Institutes of Health, Guidelines for Human Stem Cell Research, 74 Fed. Reg. 32170, 32170-71 (July 7, 2009).

26 BIANCHI, D. (2011) The Adoption of Embryos in Malta: Acting in the Interest and Wel-fare of a Child in Embryonic Form. Medical Law Review. 19. p. 401-429.

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human being at the time of his injury or death cannot preclude an action for the protection of the rights deriving from the death of a human being due to negligence or tort (section 2.2)27.

In Miller v. Am. Infertility Group, this provision has been interpreted as referring also to the embryo not yet implanted. Indeed, although the Illinois Wrongful Death Act does not contain the definition of a human being, the Illinois Abortion Law of 197528 has established that the human being has the right to life from conception (section 1) and that conception means fertilization of a human oocyte by a human sperm cell, which occurs when the sperm penetrates the oocyte’s membrane29.

Moreover, since the above-mentioned section 2.2 refers not only to gestation, but also to the development of the human being, this provision is applicable also to the development of the embryo prior to its implant and to pregnancy. In fact, it would be illogical to allow a legal action for the death of a human being after implantation in the uterus and deny it when death occurs before implantation30.

This judgment was overturned on appeal for the following reasons:

First, since section 2.2 introduces an exception to the Common Law, it cannot be extended to situations unrelated to the legislative intent. The latter is to protect the same way the life of the fetus regardless of whether it is viable or not31.

Furthermore, the definition of human being contained in Illinois Abortion Law cannot be applied, because the matter of abortion is different from wrongful death and the two acts have different functions32.

27 740 ILL. COMP. STAT. 180/2.2 (2002). 28 720 ILL. COMP. STAT. 510/1 (2002). 29 Miller v. Am. Infertility Group, No. 02-L-7394, at 6 (Cir. Ct. Cook County, 111. Feb. 4,

2005). 30 Miller, No. 02-L-7394, at p. 8. See DINA, A.N. (2006) Wrongful Death And The Legal

Status Of The Previable Embryo: Why Illinois Is On The Cutting Edge Of Determining A Definitive Standard For Embryonic Legal Rights. Regent U. L. Rev. 19. p. 251-273, at pp. 262-266-267.

31 Miller v. Am. Infertility Group, No. 1-05-3202, (Appeal from Cir. Ct. Cook County, V, Oct. 24, 2008), available at httpwww.state.il.uscourtopinionsAppellateCourt20081stDistrictOctober1053202.pdf, p. 15. Last access: 20 May 2013.

32 Miller v. Am. Infertility Group, No. 1-05-3202, at p. 16.

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In fine, according to the Court of Appeal, within the above mentioned section 2.2, the term gestation refers to the fetus in utero, while development means the fetus born live or the child33.

Consequently, the Illinois Wrongful Death Act could not be applied to punish whoever causes the death of embryos by negligence before they are implanted.

None of these arguments seems to be persuasive.

First, if the legislator had intended to protect in the same way the life of the fetus, regardless of its vitality, he would have used the term fetus instead of the term human being.

In addition, when section 2.2 of the Illinois Wrongful Death Act came into force, in 1980, the notion of human being established from the Illinois Abortion Law was already being applied. Accordingly, since section 2.2 did not introduce a different definition of human being, it has implicitly embraced the definition laid down by the Illinois Abortion Law.

In fine, if the term development used in section 2.2 was interpreted as referring to the developing fetus, such a term would be superfluous, because the fact of protecting the fetus during pregnancy entails that the protection extends to the period after the birth and regardless of the degree of development.

4. CONCLUSIONS

Although the embryo is not unanimously considered as human life, and since the embryo keeps his moral and juridical value, this does not exclude the possibility to sanction careless health professionals.

Indeed, avoiding negligent loss of embryos is necessary to protect the rights of the couple and third parties, as well as the possibility to use them for research of new medical therapies.

In addition, the loss of embryos might remain without compensation, because of lacking of evidence with regard to causation or damage. This risk is even higher in those Common Law jurisdictions, such as Virginia,

33 Miller v. Am. Infertility Group, No. 1-05-3202, at p. 17.

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where the non-pecuniary damage will be compensated only if it results from physical damage34.

In conclusion, it appears clear that in order to protect the rights of the parents and other possibly involved parties, the introduction of such an offense seems, besides the collective interest in research, to be legitimate and appropriate in preventing potential mistakes in the storage of embryos.

34 Naccash v. Burger, 223 Va. 406, 415, 290 S.E. 2d 825, 830 (1982). HEIDE, I.H. (2005) Negligence in the Creation of Healthy Babies: Negligent Infliction of Emotional Distress in Cases of Alternative Reproductive Technology Malprac-tice without Physical Injury. J. Med. & L. 9. p. 55-65.

Med Law (2014) 33:14- Medicine and Law

©PROBOOK 2014

14

I’M GETTING TURNED OFF: EMERGING CONSENSUS ON DEACTIVATING CARDIAC IMPLANTABLE ELECTRONIC DEVICES

Marshall B. Kapp*

Abstract: The surgical insertion of permanent heart rhythm (resynchronization) devices within individuals who have chronic cardiac deficiencies is widespread and increasing. It is predictable that some individuals who have had a permanent heart rhythm device implanted will subsequently reach a point, physically and/or emotionally, at which they (or their surrogates) indicate the desire that their own resynchronization be removed or deactivated. Despite continuing controversy, a professional international consensus has begun to emerge over the past few years, concerning the fundamental legal and ethical principles that ought to guide clinical practice regarding the deactivation of cardiac implantable electrical devices (CIEDs). The central legal and ethical principles of the emerging professional consensus in this sphere are briefly summarized in this article, along with some thoughts about the challenges of translating those principles into clinical practice for specific patients.

Keywords: Medical Jurisprudence; Health Law; Law; Medical Ethics; Cardiac Devices; Pacemakers; Defibrillator; Life-Sustaining Treatment.

Health care professionals involved at the forefront of modern cardiovascular medicine anywhere in the world already regularly confront a host of difficult clinical situations that entail challenging legal and ethical issues, and this situation is likely only to become more complex in the foreseeable future as the scientific, demographic, and financial contexts of healthcare delivery continue to evolve. For example, more than two million inhabitants of the United States alone now have a permanent heart rhythm (resynchronization) device—namely, a pacemaker (PM) that maintains a normal heartbeat for the patient, an implantable cardioverter-defribilator (ICD) that electrically jolts the patient’s heart back to a normal heartbeat from a life-threatening,

* J.D., M.P.H. Director, Florida State University Center for Innovative Collaboration in Medicine & Law; Professor of Geriatrics, FSU College of Medicine; Professor of Medicine and Law, FSU College of Law. 1115 W. Call Street. Tallahassee, FL 32306-4300. Marshall.kapp@med.fsu.edu

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abnormal heartbeat and can additionally serve as a pacemaker, or a left ventricular assist device (LVAD), that helps the heart pump blood throughout the body’s circulatory system. There is substantial evidence that since the first ICD was approved by the U.S. Food and Drug Administration in 19851, these technologies have, due to financial2 and other incentives, frequently been used without adequate medical justification. Nevertheless, when employed judiciously for appropriate candidates, they constitute a tremendous step forward in the management of patients with cardiac disease over the past half century3.

It is predictable that some individuals who have had a permanent heart rhythm device implanted will subsequently reach a point, physically and/or emotionally, at which they (or their surrogates) indicate the desire that their own resynchronization be removed or deactivated. The response of an involved physician and other members of the health care team to such a momentous request must be formulated and carried out within appropriate legal and ethical parameters. The mirror image dilemma of when, if ever, a physician should refuse to maintain a CIED in the face of a patient or surrogate request for such maintenance presents separate legal and ethical issues,4 whose full discussion is beyond the scope of the present article.

EMERGING CONSENSUS

A firm and informed (albeit not universal) professional international consensus has begun to emerge over the past few years concerning the fundamental legal and ethical principles that ought to guide clinical practice regarding the deactivation of cardiac implantable electrical devices (CIEDs). This developing agreement has been manifested and disseminated in the form of several expert consensus statements, enunciated by prestigious organizations including the Heart Rhythm Society [developed in collaboration and endorsed by the American College of Cardiology, American Geriatrics Society, American Academy of Hospice and Palliative

1 Isaac D. Buck, Caring Too Much: Misapplying the False Claims Act to Target Overtreatment, 34 OHIO ST. L.J. 463, 476-77 (2013).

2 Sana M. Al-Khatib, Anne Hellkamp, Jeptha Curtis, Daniel Mark, Eric Peterson, Gillian D. Sanders, Paul A. Heidenreich, Adrian F. Hernandez, Lesley H. Curtis, & Stephen Hammill, Non-Evidence Based ICD Implantations in the United States, 305 JAMA 43 (2011).

3 ROy PORTER, THE GREATEST BENEfIT TO MANkINd: A MEdICAL HISTORy Of HuMANITy 584, 626 (1997).

4 Zaldy S. Tan, The Limits of Life, 60 J. AM. GERIATR.SOC’y 786 (2012).

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Medicine, American Health Association, European Heart Rhythm Association, and the Hospice and Palliative Nurses Association]5 and the European Heart Rhythm Association,6 as well as significant discussions in the medical literature.7,8 The central legal and ethical elements of the emerging professional consensus in this sphere are briefly summarized here.

First, under the ethical principle of autonomy and the legal doctrine of informed consent, any adult patient with present decision-making capacity has the right to refuse, or to request the withdrawal of any medical intervention, regardless of the patient’s medical condition and regardless of whether death will result from the refusal or withdrawal. The patient’s right to choose or refuse medical interventions, moreover, has constitutional dimensions in the United States under the liberty protections of the 14th Amendment Due Process provisions.9 According to the emerging consensus referenced above, this general proposition applies with full force in the CIED arena; put differently, the majority of commentators in this arena have posited no meaningful legal or ethical distinction between proposed or already implanted CIEDs, on one hand, and other, externally applied medical interventions such as respirators or feeding tubes, on the other. In this analysis, the right to refuse or request the withdrawal of treatment does not depend on the characteristics of the particular treatment modality in question.

It must be noted, though, that not every commentator would agree that either the particular patient’s medical condition or the characteristics of the specific medical intervention involved are ethically and legally irrelevant. For instance, Professor Lars Noah explains in the most comprehensive American legal discussion of this set of issues that, regarding “the

5 Heart Rhythm Society, Expert Consensus Statement on the Management of Cardiovascular Implantable Electronic Devices (CIEDs) in Patients Nearing the End of Life or Requesting Withdrawal of Therapy, 7 HEART RHyTHM 1008 (2010).

6 European Heart Rhythm Association/HRS, Expert Consensus Statement, 12 Europace 1480 (2010).

7 Antonio Facciorusso, Seran Michelina, Mario Stanislao, 7 Guido Valle,To Switch Off or Not to Switch Off? Case Report and Ethical Issues on Defibrillator Deactivation in End-of-Life Patients, 2J. CLIN. RESEARCH & BIOETHICS 117(2011).

8 Paul S. Mueller, Sarah M. Jenkins, Katrina A. Bramstedt, & David L. Hayes, Deactivating Implanted Cardiac Devices in Terminally Ill Patients: Practices and Attitudes, 31 PACING ANd CLIN. ELECTROPHySIOL.560 (2008).

9 WILLIAM H. COLBy, uNPLuGGEd: RECLAIMING OuR RIGHT TO dIE IN AMERICA 91 (2006).

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conclusory statement that deactivating CIEDs qualified as the withdrawal of life-sustaining treatment… [t]his strikes me as far from self-evident.”10 Physician/attorney David Orentlicher suggests that what really matters is whether in an actual case the implanted device serves functionally to replace the body’s natural functioning or only to supplement it. In his formulation, when the device replaces the functional capacity of the patient’s own body (the usual situation when an LVAD or partial artificial heart is involved to circulate the blood), such that turning off the device must inevitably and virtually immediately lead to the patient’s death, then we might characterize the deactivation of a vital life function as a form of euthanasia. However, Orentlicher has no similar misgiving about discontinuing the use of a device (such as a pacemaker) that only serves to supplement, but not totally replace, a vital life function of the patient; thus, removal of a pacemaker that only supplemented or assisted the work of the patient’s own heart would not inevitably lead to the patient’s immediate death and therefore is not euthanasia for Orentlicher.11

As a second part of an emerging consensus, for a patient who currently lacks sufficient cognitive and emotional ability to make and express his or her own autonomous choice, the right to assert a medical decision may be exercised by a surrogate decision-maker acting on the patient’s behalf. Moreover, the patient’s wishes regarding the implantation and later withdrawal of a CIED may be expressed, and documented, prospectively through the execution of a valid advance medical directive. Such a directive may take the form of an instruction instrument such as a living will, in which the patient indicates which medical interventions he or she would want to receive or forego in specified future scenarios. The directive also may take the form of a proxy instrument such as a durable or enduring power of attorney for health care, in which the patient (the principle) appoints another person to act as the principle’s decision-making agent. Ideally, the principle and the agent will have communicated prior to the principle having become decisionally incapacitated, so that the decisions asserted by the agent are in accord with the principle’s own authentic values and preferences. Additionally, many proxy directives are written to include general explicit guidance to the agent to assist in making decisions with which the principle would concur if presently capable of doing so.

10 Lars Noah, Turn the Beat Around? Deactivating Implanted Cardiac-Arrest Devices, 39 WM. MITCHELL L.REv.1229, 1265 (2013).

11 David Orentlicher, Deactivating Implanted Cardiac Devices: Euthanasia or the Withdrawal of Treatment? 39 WM. MITCHELL L. REv. 1287 (2013).

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Third, all adults should be afforded a presumption of adequate decision-making capacity. This presumption will not turn out to be factually accurate in every specific case, and thus it may be overcome or rebutted when necessary to best serve the ethical principles of beneficence (doing good) and non-maleficence (avoiding harm) by protecting a decisionally incapacitated person from avoidable injury. However, the existence of the presumption correctly places the burden of proof on the party who is arguing that a particular patient lacks sufficient present decisional capacity and therefore needs a surrogate decision-maker.

Fourth, the consensus view is that there is no relevant legal or ethical difference between a patient or surrogate refusing a CIED intervention in the first place and requesting, at a later time, the withdrawal of a CIED that is already in place. In other words, stopping an existing CIED after a time-limited trial is the moral and legal equivalent of not starting it initially; this is the same principle that is now very widely applied to other forms of life-sustaining medical interventions. Either choice is permissible.

Despite widespread theoretical agreement on the previous points, physicians’ attitudes about patient care can often be influenced as much by emotion, or moral intuition, as by logical reason. Hence, several studies indicate that, notwithstanding the listed abstract legal and ethical principles, a substantial number of physicians are emotionally uncomfortable enough to persist in drawing operational distinctions among different treatment modalities (specifically, among the different types of CIEDs and between CIEDs and other medical interventions) and between foregoing a medical intervention at the outset and discontinuing an intervention that is already in progress.12,13,14 It is important to realize and candidly admit, though, that

12 Nathan E. Goldstein, Davendra Mehta, Ezra Teitelbaum, Elizabeth H. Bradley, & R. Sean Morrison, “It’s Like Crossing a Bridge”: Complexities Preventing Physicians from Discussing Deactivation of Implantable Defibrillators at the End of Life, 23(Suppl. 1) J. GEN. INTERN. MEd. 2 (2008).

13 Suraj Kapa, Paul S. Mueller, David L. Hayes, & Samuel J. Asirvatham, Perspectives on Withdrawing Pacemaker and Implantable Cardioverter-Defibrillator Therapies at End of Life: Results of a Survey of Medical and Legal Professionals and Patients,85 Mayo Clin. Proc. 981 (2010).

14 Daniel B. Kramer, Aaron S. Kesselheim, Dan W. Brock, William H. Maisel , Ethical and Legal Views of Physicians Regarding Deactivation of Cardiac Implantable Electrical Devices: A Quantitative Assessment, 7 HEART RHyTHM 1537 (2010).

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physicians’ persistence in drawing these distinctions has no reasonable legal or ethical foundation, but rather reflects the complicated emotions and family member interpersonal dynamics that frequently come into play and need to be confronted by the physician when patients approach the end of life. Such confrontation might be made more tolerable if real or perceived uncertainties about the lawfulness of physician compliance with patient or surrogate wishes were addressed, as Professor Noah recommends, by clear state legislative attention to this matter.15

A final (although this brief enumeration does not at all purport to be comprehensive) legal and ethical precept pertinent to this discussion is that no clinician should be compelled by the state to carry out an act such as deactivating a patient’s CIED, even when the act is totally permissible legally, if the physician’s participation would violate the physician’s personal ethical values and conscience. A physician may not unilaterally terminate, in a manner that constitutes abandonment, an existing professional relationship with a patient who continues to need care, thereby leaving the patient “high and dry” without access to appropriate medical services. Nonetheless, the physician’s ongoing obligation may be satisfied by timely notifying the patient of the ethical conflict and the physician’s intent, in light of all the circumstances, to terminate the relationship, coupled with reasonable efforts to refer the patient to another adequate source of care that will honor the patient’s or surrogate’s wishes.

PUTTING PRINCIPLES INTO PRACTICE

For decent patient-centered medical care to be available to patients approaching the end of their lives, including patients who are contemplating or have accepted a CIED, the relevant legal and ethical principles need to be effectuated in actual clinical cardiovascular practice. Integration of principles into sound practice with individual patients requires careful attention to a number of details.

Foremost, open, honest, timely, and continuous communication is imperative among the various members of the cardiovascular team, with special sensitivity to each individual’s background and role. The same admonition applies to communication between the team and the patient, regarding applicable medical alternatives and their reasonably foreseeable associated

15 Noah, supra Note 10.

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benefits, burdens, and consequences.16 This is a basic matter of respecting the patient’s autonomy and fulfilling the clinicians’ informed consent duties,17 a task often made more difficult by the high level of ignorance among many cardiac patients regarding the legal and ethical options for managing CIEDs near the end of life18 and the reluctance of many of them to discuss this subject.19

When acquiesced to by the patient (as it ordinarily will be) or necessitated because of the patient’s severely impaired decisional capacity, available and interested family members should be thoroughly involved in the ongoing conversation. When multiple family members are involved, effort must be devoted to dealing with the interpersonal dynamics, in a way that optimizes the likelihood of harmony about the best course of medical action (or limitation of action) for the patient; resolving disagreements within the family may require—at the extreme—a significant time and energy investment and entail the assistance of an expanded health care team including clergy, social services, and institutional ethics committees.

Deactivating a CIED entails not just decision-making, but also the logistics of carrying out that decision. Several members of the health care team may be actively involved in the concrete physical steps of either turning off externally or surgically removing the CIED. Institutional providers should formulate and have readily available formal policies and procedures regarding relevant implementation logistics, based on input from all team members (including institutional legal counsel), and should conduct regular

16 Cécile Manaouil, Maxime Gignon, & Sarah Traulle, Cardiovascular Implantable Electronic Devices: Patient Education, Information and Ethical Issues, 31 MEd. & L. 355 (2012).

17 Daniel B. Kramer, Susan L. Mitchell, & Dan W. Brock, Deactivation of Pacemakers and Implantable Cardioverter-Defibrillators, 55 PROG. CARdIOvASC.dIS. 290 (2012).

18 Daniel B. Kramer, Aaron S. Kesselheim, Lisa Salberg, Dan W. Brock, & William H. Maisel, Ethical and Legal Views Regarding Deactivation of Cardiac Implantable Electrical Devices in Patients with Hypertrophic Cardiomyopathy, 107 AM. J. CARdIOL. 1071 (2011).

19 Nathan E. Goldstein, Davendra Mehta, SaimaSiddiqui, Ezra Teitelbaum, Jessica Zeidman, MagdelenaSingson, Elena Pe, Elizabeth H. Bradley, & R. Sean Morrison, “That’s Like an Act of Suicide”: Patients’ Attitudes Toward Deactivation of Implantable Defibrillators, 23 (Suppl. 1) J. GEN. INTERN. MEd. 7 (2008).

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continuing education activities to assure that the institutional policies and procedures are carried out competently and consistently.

The general risks of litigation and legal liability associated with the practice of cardiovascular medicine are not insubstantial, but legal exposure emanating from the health care team’s deactivation of a patient’s CIED based on the informed decision of a mentally capable patient or the patient’s surrogate decision-maker appears, based on experience to date, to be minimal or non-existent.20 Nevertheless, cardiovascular professionals must be prepared to defend their actions in the seemingly improbable event that the propriety of their conduct is subsequently challenged. Therefore, the clinical scenario surrounding the deactivation, including the communication process, action rationale, and conduct undertaken, must be documented in a complete, timely, and accurate manner, directly in the patient’s medical record. It is essential to do the legally and ethically right thing; it is imperative as well to be able to prove after-the-fact that one did the right thing, and documentation is a key in that regard.

CONCLUSION

The future of cardiovascular medicine will certainly be one of increasing satisfaction and potential for doing good for patients, but it will also be one of increasing social complexity and challenge. The more frequently and safely new and improved medical interventions can be done, the more we will need to question whether, when, and for whom we ought to provide those interventions. This article has outlined some of the most salient legal and ethical principles affecting clinical decision-making in one increasingly prevalent area of future cardiovascular practice.

20 William J. Oetgen, P. Divya Parikh, Joseph G. Cacchione, Paul N. Casale, James T. Dove, John G. Harold, Brenda L. Hindle, Michael Maglaras, George P. Rodgers, &Janel S. Wright, Characteristics of Medical Professional Liability Claims in Patients with Cardiovascular Diseases, 105 AM. J. CARdIOL. 745 (2010).

Med Law (2014) 33:22- Medicine and Law

©PROBOOK 2014

22

THE HISTORICAL DEVELOPMENT OF HEALTH CARE LAW AND BIOETHICS IN ENGLAND AND WALES: A SYMBIOTIC RELATIONSHIP?1

Ernest Owusu-Dapaa*

Abstract: The paper explores the backward and forward linkage between HCL and bioethics. Indeed, the relationship between the two is so close that it can be considered one of symbiosis. This is particularly the case when an account is taken of how HCL and bioethics positively benefitted from each other in diverse ways during their development into their present status as discrete disciplines. In the first place, the aftermath of the Second World War, such as the Nuremberg trial and unprecedented medical experiment scandals in the 1960s/70s fuelled the increasing participation of lay scholars in exploring and critiquing medical ethics which culminated in the emergence of bioethics.2 This in turn facilitated the evolution of HCL as a discipline, since academic lawyers involved in early bioethical discourse developed interest in exploring the interface between law and bioethics at the same time that society was waking up to the ethical implications of medical advances. As HCL emerged as a discrete discipline, it consolidated the status of bioethics as a field of inquiry by projecting the relevance of the latter in adjudication of novel cases with significant slippery moral undertones. Thus, the chicken and egg paradox finds a perfect reflection in the emergence of health care law and bioethics in England and Wales.

Keywords: Health Care Law; Medical law; Bioethics; England and Wales; Discrete Body of Law; Field of Law and Medical Ethics.

1 This expression is an adaptation from J. Miola, Medical Ethics and Medical Law : A Symbiotic Relationship (Oxford: Hart Publishing,2007),

2 M. Brazier, S. Ost, Bioethics, Medicine and the Criminal Law- Medicine and Bioethics in the Theatre of the Criminal Process (Cambridge: Cambridge University Press, 2013), p.183.

* Barrister at Law, Lecturer, Faculty of Law, Kwame Nkrumah University of Science and Technology, Ghana and PhD Candidate, Lancaster University School of Law, UK. Email: eodapaa@yahoo.com.

I wish to express my appreciation to Professor Suzanne Ost and Professor SigrunSkoglyof Lancaster University School of Law, for their helpful comments and criticism. I thank my colleagues Alex Murray and Rodrigo Cespedes of Lancaster University for proof reading the draft. I remain solely responsible for all limitations and errors.

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INTRODUCTION

Until four decades ago, health care law (HCL) or medical law and bioethics were not recognised in academic circles as distinct disciplines. The circumstances which gave birth to these two fields of inquiry may be of interest to anyone who is fascinated by how in less than half a century these fields of knowledge have attained the status of a discrete discipline. In this paper, I explore how these disciplines emerged and in particular the extent to which development of each mutually benefit from the other. First, I clarify the taxonomical ambiguities associated with HCL, medical law and bioethics. Second, I attempt to historically contextualise the emergence of each of these disciplines by estimating a symbolic commencement period for each of them. Third, I explore how the development of bioethics accelerated the emergence of HCL as a discrete body in England and Wales. Finally, I explore the extent to which HCL has consolidated the status of bioethics as a discipline.

1. NOMENCLATURE UNCERTAINTIES: DEFINING ‘HEALTH CARE LAW’, AND ‘BIOETHICS’

One major defining characteristic of a specialised field of knowledge is the name or title by which it is identified. The challenge of finding an appropriate name for a discipline is not unique to any particular area of law of field of inquiry.3 HCL and bioethics suffer from nomenclature uncertainties. I propose to first deal with attempts to clarify HCL and then move to consider bioethics.

In the evolution of HCL in England and Wales, different names have been adopted by scholars in referring to this new field. Montgomery4, McHale and Fox5, use the ‘health care law’ label for their works. On the contrary, ‘medical law’ is the preferred description for Kennedy and Grubb,6

3 There are many examples of naming a subject based upon a key aspect of identity and sometimes its existence. These include Tort versus Torts; Conflict of Laws versus Private International Law; Comparative Law versus Law of Comparison. See generally, E. Orucu, The Enigma of Comparative Law Variation on Themes for the Twenty-First Century (Leiden: Martinus Nijhoff Publishers, 2004), pp. 7-18; K. Zweigert & H. Kotz, Introduction to Comparative Law (Oxford: Clarendon Press 1998) P.D. Cruz, Comparative Law in a Changing World (London: Routledge-Cavendish, 2007)

4 J. Montgomery, Health Care Law(Oxford : Oxford University Press, 2003)5 J. MacHale and M. Fox Health Care Law: Text and Materials ( London: Sweet and

Maxwell, 2006)6 I. Kennedy and A. Grubb, Medical Law (London: Butterworths, 2000)

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Hope,7and Brazier.8 Each of the different titles adopted by scholars of this discipline appears to have its underlying assumption regarding the subject matter or core themes of the discipline. Those who adopt the title ‘medical law’ or its variants, such as ‘medical law and ethics’, tend to perceive the core subject matter as the legal enforcement of the ethical dilemmas that arise in the doctor-patient relationship. For example, Kennedy and Grubb have argued that medical law is “essentially concerned with the relationship between health care professionals (particularly doctors and to a lesser extent hospitals or other institutions) and patients.”9This approach to delineating the scope of this field begins from the work of doctors and proceeds outwards. The doctor – patient relationship is thus at the heart of the discipline, and this influences both the content of the subject and its underlying conceptual coherence. Montgomery has criticised such an approach for individualising its focus in the application of ethical principles.10 The conundrum inherent in the Kennedy and Grubb led approach to the field is that by restricting the subject’s scope to issues raised in a clinical or medical context, they potentially exclude a number of important areas of the law. Areas of equal importance that risk exclusion under this paradigm include other health professionals, the health institution that provides platform for delivery of health care, and public health issues.11 It is thus not surprising that some scholars including Sheldon and Thomson12, Hervey and McHale13 and Cruz14 have questioned the suitability of Kennedy and Grubb’s label and definition of the discipline.

In contrast, Montgomery, one of the leading proponents of the title ‘health care law,’ rejects the doctor-patient paradigm. Rather, he contends that the subject ought to be defined in terms of the country’s “international obligation to tackle health problems and ensure that citizens have access

7 R. A. Hope, ‘The Birth of Medical Law’ (1991) 11 Oxford Journal of Legal Studies 247, 253a

8 Brazier, M. and N. Glover, ‘Does Medical Law Have a Future?’ in D. Hayton, ed., Law’s Futures (Oxford: Hart Publishing, 2000), p.371

9 Kennedy, Ian and Grubb, Andrew , n.68 above, p.110 J. Montgomery, Health Care Law (Oxford :Oxford University Press, 2003), p.111 i bid12 S. Sheldon and M. Thomson, Health Care Law and Feminism : A Developing Relationship

in S. Sheldon and M. Thomson, Feminist Perspectives On Health Care Law (London: Cavendish Publishing, 1998), Ch. 1.

13 T.K. Hervey and J.V. McHale, Health Law and European Union (Cambridge: CUP, 2004 ), p.17

14 P. de Cruz , Comparative Healthcare Law (London: Cavendish Publishing Ltd, 2001), p. iv

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to health care that they need.”15 His approach appears attractive, except in one significant respect. By defining the subject from the perspective of the state’s obligation to address health problems as encapsulated in various international instruments, it runs into the problem of being over-ambitious regarding the boundaries of the subject, especially since the elastic nature of the concept of health could result in almost every law and policy in both domestic and international arena being considered as a matter for HCL.

Without prejudice to the above, a broad notion of the subject as contemplated by Montgomery’s approach has “the advantage that it extends beyond those legal measures, to link health law and policy to other social policy fields, such as poverty or social exclusion”.16 Increasingly, a considerable amount of health care for vulnerable groups including the young, the aged and those with disabilities is provided at the interface between social care providers and health care providers. It was in relation to this that Brazier and Glover commented that, to an extent, in the future, HCL might be subsumed under social welfare law.17Despite, the strong case that Montgomery makes to bolster his personal preference for the label ‘health care law’, he concedes that what is in vogue since the emergence of the discipline is the ‘medical law’ label.18 That said, it yetremains a fact that the debate over the most suitable label and definition for the discipline continues.19I preferthe term ofHCL because it provides the discipline with broader focus and truly representative approach of the legal regulation of health care delivery than the narrow focus of doctor-patient relationship as ‘medical law’ suggests.

In their recent contribution to reflection on British Legal Developments in the 21st Century, Brazier and Glover attempted to pronounce verdict on the debate. They remarked as follows:

The difference between these two approaches is more than just nomenclature. Medical law, which focuses on a relationship between doctors and patients, remains in essence a creature of private law. Albeit NHS patients have no

15 Ibid,216 J. McHale and M. Fox Health Care Law: Text and Materials ( London: Sweet and

Maxwell,2006), p.817 M. Brazier and N. Glover, ‘Does Medical Law Have a Future?’ in D. Hayton (ed),Law’s

Futures (Oxford: Hart Publishing, 2000), p.37218 J. Montgomery, ‘Medical Law in the Shadow of Hippocrates’ (1989) 52 Modern

Law Review, 566-576; J. Montgomery, ‘Time for a paradigm shift? Medical law in transition’53(2000)Current Legal Problems, 363 -408

19 J. McHale and M. Fox Health Care Law: Text and Materials ( London: Sweet and Maxwell,2006), p.28

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contractual relationship with their doctors, echoes of contract still haunt their encounters. Health care law is located more firmly in public law. Doctors are shifted to the margins of debate. The needs, and even rights, of individual patients must be viewed within a wider context of protecting health and promoting public goods. A shift from medical law to health care law seems inevitable. We suggest that what we now call medical law will undergo much greater upheaval than simply a change of name. Society’s understanding of illness is in flux. 20

These observations are an accurate assessment of the state of affairs with respect to this discipline, but the suggestion that medical law is a creature of private law and health care law and is located in the realm of public law, is not a complete portrayal of the public/private law dimensions of this discipline. Brazier and Glover argued that medical law is a private law creation because it focuses on doctor-patient relationship, but I do not agree that since emergence of the discipline in 1980s the focus has only been doctor-patient relationship. Indeed, issues of institutional arrangements of health care delivery, resources allocation and public health have equally engaged attention of scholars and lawmakers.21

If the Kennedy and Grubb definition of ‘medical law’ is adopted, it cannot be concluded, as Brazier and Gloverwould have us believe that the discipline is only a private law discipline. The premise of Brazier’s and Glover’s argument is that it is only within the NHS that patients do not have contract with doctors. However, the NHS has been in existence since 1948, long before the emergence of HCL as a distinct discipline in England and Wales. Thus, when Kennedy and Grubb propounded their definition of ‘medical law’, they were not oblivious to the fact that there does not appear to be any contractual nexus between NHS patients and doctors. In my humble opinion, the existence of contractual obligations is not the only evidence in private law. On the contrary, claims founded on tort are other manifestations of private law. Cursory perusal of the law reports will reveal that the majority of the cases that have been litigated upon in connection with health care related to the tort of negligence. HCL is not exclusively public law discipline, as tortious claims could also arise. In my view, whether the discipline is labelled “medical law’’ or “health care law” it generates issues that straddle across private and public law. Having attempted to clarify some

20 M. Brazier, N. Glover. ‘Does Medical Law Have a Future?’ in D. Hayton (ed) Law’s Future(s), (Oxford: Hart Publishing, 2000) 371-389, p.372

21 J. Montgomery, Health Care Law (Oxford: Oxford University Press, 1997), chapters 3,-6

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of the taxonomical complexities associated with HCL, it is pertinent to now unpack the meaning of bioethics. Before exploring the particular aspects of the development of bioethics which impacted on the then evolving HCL, it will be illuminating to unpack the meaning of bioethics. In seeking to explicate bioethics, it is important to note that although bioethics and medical ethics are sometimes used interchangeably, the two are not necessarily uniform in meaning. The term ‘bioethics’ was first used in print in 1970 when Potter, the University of Wisconsin’s oncologist, entitled his article ‘Bioethics, the Science of Survival.’22 Bioethics marks a ‘critical departure’ from the prior tradition of medical ethics, where doctors governed their own conduct through professional codes.23Medical ethics, in a technical sense, connects to the medical (i.e. physician) profession; it ‘governs how a physician, as a professional, should practice- and has traditionally been seen as within the province of the physician only.’24 On the other hand, whilst bioethics encompasses medical ethics within its orbit, it also ‘expands the scope of ethical inquiry to include not only clinical issues but also many more beyond the ‘bedside25 concerns’; for example what happens at the institutional, research, public health and policy levels.’26 Despite the two fields having some kind of distinct identity as a field of inquiry, it is obvious that medical ethics preceded bioethics. Thus, Jonsen has remarked that:

[e]ven though medical ethics, bioethics’ predecessor, was shaken by notable and notorious events, it was a slow accumulation of concerns about the ambiguity of scientific progress that turned the old medical ethics into the new paths [known as bioethics].27

In this regard, it has also been noted that ‘following the emergence of bioethics... many non-physicians played a critical role in developing

22 M.A. Rothstein, ‘The Role of Law in the Development of American Bioethics’ (2009)20(4) Journal of International Bioethics, 73, 74.

23 D. Rothman, Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision-Making (New York : Basic Books, 1991), p.189

24 A.T.Campbell, J.Sicklick, P. Galowitz, R. Randye and S. B. Fleishman, ‘How Bioethics Can Enrich Medical-Legal Collaborations’ (2010) 38 Journal of Legal Medicine and Ethics 847, 852.

25 The phrase ‘bedside’ was used initially in the context of bioethics by D.J. Rothman, Strangers at Bedside: A History of How Law and Bioethics Transformed Medical Decision-Making (New York, Basic Books:1991), 189.

26 A.T.Campbell, J.Sicklick, P. Galowitz, R. Randye and S. B. Fleishman, ‘How Bioethics Can Enrich Medical-Legal Collaborations’(2010) 38 Journal of Legal Medicine and Ethics 847, 852.

27 A.R. Jonsen, The Birth of Bioethics (New York: Oxford University Press, 1998),p.3

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regulatory standards for medicine and the life sciences, and took the lead in publicly defining the ethical issues raised by clinical practice and research.’28 Thus, bioethics can be taken to incorporate interdisciplinary perspectives including philosophy, sociology, law and theology in debating or addressing not only traditional issues of medical ethics, but also the ethical dilemmas generated by advances in medicine, science and biotechnologies. Nevertheless, for the purposes of the inquiry being undertaken in this work, I propose to restrict the meaning of bioethics to aspects which relate mainly to healthcare, rather than the generality of biotechnologies.

2. SYMBOLIC COMMMENCEMENT PERIOD

Before exploring the contributory factors, it is pertinent to define theperiod in which the exploration is situated.

In my view, identifying a precise starting date for the discipline of HCL is rather difficult and not particularly illuminating. This is especially so since, in a broad sense, it can be argued that there had always been some sort of HCL from the very inception of law in society. Nevertheless, in my quest to explore the emergence of HCL as a distinct body of law I consider it helpful to identify an era in which the discipline became visible in academic circles and public discourse.There are differing opinions as to when HCL was ‘born’ or ‘developed’ in England and Wales. The earliest date for which an argument could be made is 1858, when after 20 years of negotiation, the British Medical Association’s (BMA) Medical Reform Committee, successfully secured the passing of the Medical Act 1858.29 The Act established the General Medical Council (GMC) and the Medical Register, which distinguished, for the first time, between qualified and unqualified practitioners.30 When the Act was passed it was a distinctive version of medical reform which was being initiated and ‘MPs were acting to mediate, not just between divergent strands of a still fluidly defined profession, but between professional and lay conceptions of the role of the medical practitioner as well.’31 Thus, if HCL is understood merely as the existence or

28 D. Wilson, ‘Who Guards the Guardians? Ian Kennedy, Bioethics and the ‘Ideology of Accountability’ in British Medicine’ (2012) 25 Social History of Medicine 193

29 M J D Roberts, ‘The Politics of Professionalisation: MPs, Medical Men, and the 1858 Medical Act’ (2009) 53 Medical History 37, 38.

30 Ibid.31 Ibid.

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creation of statutes to regulate the practice of medicine in order to safeguard the public from hazards of quackery, then 1858 may be a viable proposition as the starting date of HCL. On the other hand, if HCL, as a distinct body, is to be understood as having a well-defined place in the legal academy and in particular having attained most of the defining characteristics identified of a field of law, then 1858 would not be the starting date for the discipline. The defining characteristics of a field of HCL may be restated here as follows: the existence of significant volume of case law and dedicated legislation, teaching of courses relating to the field and the verifiable interest in the field of legal academics.32 HCL was not then taught as a course in the universities, nor did it have a significant volume of dedicated legislation and case law in this jurisdiction.33 Scholarly writing in the area was virtually non-existent compared to the situation post 1980.34

Another possible beginning date for HCL may be 1958, when Glanville Williams published the seminal HCL related book titled ‘The Sanctity of Life and the Criminal Law.’ He presented controversial arguments relating to thought provoking issues such as euthanasia, abortion, contraception, sterilisation and artificial insemination. Undoubtedly, Williams’ work was remarkable for being a pioneering effort by an academic lawyer to engage in analysis of these complex ethical issues that arise in the delivery of health care. However, it did not have a dramatic impact on the evolution of HCL as a discrete subject. A plausible explanation for this is that the major medical advances that were to excite public interest in the legal regulation of bioethical dilemmas had not then crystallised. While literature35 on the interface between law and health care has been published since the nineteenth century, I consider the period between 1980 and 2000 to be a defining moment for HCL as a distinct branch of English law, because it was during those two decades that the discipline became sufficiently visible and effectively met the criteria identified in Chapter 3as a hallmark of a distinct body of law. Having delineated the historical context of the inquiry being

32 M.L.Berman, ‘Defining the Field of Public Health Law’ (September 22, 2012). New England Law | Boston Research Paper No. 12-07, p.5; T. Ruger, ‘Health Law’s Coherence Anxiety (2008) 96 Georgetown Law Journal 625, 630; W. B. Carter, ‘Introduction: What Makes a “Field” a Field?’ (1999) 1 Vanderbilt Journal of Sports& Law 235, 244.

33 See Chapter 3 of this thesis.34 Ibid.35 For example, A. S. Taylor, Elements of Medical Jurisprudence (London: Deacon, 1836);

J.T. Smith, The Laws of England Relating to Public Health(London: S Sweet Ltd, 1848), D. H. Kitchin, Legal Problems in Medical Practice (London: Butler and Tanner Ltd , 1936)

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made in this thesis, I proceed now to consider the factors that accelerated the enhanced visibility of HCL as a field.

3. HOW BIOETHICS ACCELERATED EMERGENCE OF HCL

The increasing visibility of a distinct body of HCL in post 1980England and Wales was in some respect linked to the popularization of bioethics as a field of inquiry in the 1970s.

Within the context of the present historical discussion, my focus then is the extent to which the upsurge in interdisciplinary perspectives on ethical dilemmas in healthcare influenced the emergence of a distinct body of HCL. In this regard, it also becomes important to explore the viability of the hypothesis that patient empowerment and academic interest in medical advances accelerated the development of HCL as a field of law.

(1) development of safer and more successful solid organ transplantation techniques, thereby raising the issue of how to allocate the supply of scarce organs; (2) establishment of hospital ethics committees to deal with organ transplant allocation, end-of-life issues, and other matters; (3) the deinstitutionalization of many individuals with mental illness, often as a result of litigation; (4) debates about the safety of new recombinant DNA technology, including the Asilomar Conference in 197536; and (5) the beginning of medical ethics classes at American medical schools.37

These events had been preceded by some scandals involving healthcare and biomedical science, which aroused public interest and generated calls for having a voice in deliberations relating to healthcare and biomedical research. For example, as a result of controversies over the withholding of syphilis drugs from African Americans in Alabama, and non-consented experiments on institutionalised children in New York, Katz argued that

36 The main goal of the conference was to address the biohazards presented by recombinant DNA technology. According to Paul Berg and Maxine Singer in 1995, the conference marked the beginning of an exceptional era for both science and the public discussion of science policy. http://www.biotech-info.net/asilomar_revisited.html (last visited:18/6/ 2013)

37 D. Wilson, ‘Who Guards the Guardians? Ian Kennedy, Bioethics and the ‘Ideology of Accountability’ in British Medicine’ (2012) 25 Social History of Medicine 193.

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fundamental questions needed to be asked about the nature of authority assigned to physicians.38 He argued for a more active involvement of lay people in research decisions, since doctors were not better placed than the rest of society to be made the sole arbiters of medical ethics. In 1974, President Nixon responded to these controversies by setting up a National Commission for the Protection of Human Subjects in Biomedical and Behavioural Research, which was supposed to have at least six of its eleven members as lay people drawn from philosophy, sociology or the general public.39 The growing influence of bioethics in the USA was confirmed in 1978 when President Carter formed a permanent Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioural Research.40

These developments in the USA had a snowballing effect in England and Wales, which weregoing through social and political change that emphasised accountability and transparency. Politically, Margret Thatcher’s government in the late 1970s had argued that in order to render professions accountable to their end-users, they should be exposed to outside scrutiny.41 It was against the backdrop of this crusade for an audit society, that Ian Kennedy, who had been trained in the USA and followed all the developments in medical ethics and later bioethics, called, during his series of lectures and publications between 1973 and 1981, for an external oversight of medicine.42 Indeed, there was a general crusade for an audit society in the UK at various levels.43 In the social realm, there was a combination of factors that had generated a growing discussion of medical ethics. These included uncertainty over death and transplants, the exposure of birth defects caused by the ‘miraculous’ morning sickness drug, Thalidomide, and the publication of Maurice Pappworth’s Human Guinea Pigs.44 In this publication, Pappworth sought to expose unethical medical and scientific research which was being done

38 J. Katz, ‘Who is to Keep Guard over the Guardians Themselves?’ (1972) 23 Fertility and Sterility, 604.

39 D. Wilson, ‘Who Guards the Guardians? Ian Kennedy, Bioethics and ‘the Ideology of Accountability’ in British Medicine’ (2012), Social History of Medicine, 193, 199.

40 D. Wilson, ‘Who Guards the Guardians?, p.20041 D. Wilson, ‘Who Guards the Guardians?, p.19742 Ibid, p.19743 Ibid.44 . Pappworth, Human Guinea Pigs (London: Routledge and Keegan, 1967); M. Whong-

Barr, ‘Clinical Ethics Education in Britain: A History of the London Medical Group’, 2003 New Review of Bioethics, 73; D. Wilson, ‘Who Guards the Guardians? Above, p.6.

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contrary to the Nuremberg Code. Particularly, he noted that most of the scientific and medical experiments were purely for the career advancement of the researchers rather than for the benefit of the patients as they had been subjected to cardiac catheterization - the insertion of a catheter into a chamber or vessel of the heart - without informed consent.45 According to Pappworth’s biographers, the publication of the book spontaneously provoked a huge storm in British society; its debate attracted massive newspaper and television coverage, as well as questions in Parliament.46 It has been noted that eventually Pappworth’s work ultimately accelerated the introduction of stricter codes of practice for human experimentation and the establishment of research ethics committees, which would have come much later had it not been for his whistleblowing.47 In the wake of these developments, the London Medical Group (LMG) was formedin 1963 by medical students as a forum for discussion of the ethical implications of medical advances and scientific research. The LMG sponsored ‘the extracurricular study of issues raised by the practice of medicine which concern other disciplines, such as the law, moral philosophy, moral theology and the social sciences, in programmes of lectures and symposia on topics identified by students of medicine, nursing and allied disciplines.’48Furthermore, in the 1970s, a small group of academics from law and other disciplines began to discuss the ethical implications of new technologies and clinical practices.49 These were: academic lawyer Ian Kennedy, theologians Alastair Campbell and Gordon Dunstan, and the philosopher Robin Downie. The growth of those ethical discourses around the 1970s culminated in the publication of the Journal of Medical Ethics in 1975. This journal served as a platform for readers and authors who were interested in the rich debates on bioethics taking place in the late 1960s and 1970s and enabled lawyers to contribute legal perspectives.

45 M. Pappworth, n.42 above p. 8.46 B. Harrison(ed.)‘Maurice Henry Pappworth’ Oxford Dictionary of National Biography

(Oxford: Oxford University Press, 2004)47 B. Harrison(ed.)‘Maurice Henry Pappworth’ Oxford Dictionary of National Biography

(Oxford: Oxford University Press, 2004).48 http://www.instituteofmedicalethics.org/website/index.php?option=com_content&vie

w=category&id=1&layout=blog&Itemid=12 (last visited: 20/6/2013); M. Whong-Barr, ‘Clinical Ethics Education in Britain: A History of the London Medical Group’, 2003 New Review of Bioethics, 73.

49 See D. Wilson, Who Guards the Guardians? Above, p.199.

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4. HOW THE EMERGENCE OF HCL CONSOLIDATED THE DISCIPLINARITY OF BIOETHICS

Although Bioethics fuelled the development of HCL as a distinct field of law, it can also be argued that the emergence of HCL in some respects impacts positively on the consolidation of bioethics as a discipline. The teeming interest in HCL among academic lawyers since 1980 did not only result in numerous articles, monographs and textbooks but also contributed towards the thinking of judges in adjudicating medico-legal cases. Articles written in the field of HCL often draw heavily upon bioethical analysis. Thus, when the courts cite HCL literature in their adjudication of medico-legal cases, it implicitly reinforces the relevance of bioethics as a discipline. There have been many instances of the use of opinions of HCL commentators in the writing of court judgments between 1980 and 2000. First in 1984, Ian Kennedy wrote an article entitled ‘The Patient on the Clapham Omnibus’,50 in which he reviewed the trial court’s and the Court of Appeal’s decision in the Sidaway51 case, that the doctor’s obligation in law towards his patient was to give her that information which a reasonable and responsible member of the medical profession would think it proper to give. The House of Lords, by its majority decision in the Sidaway case, rejected the doctrine as not being compatible with English law which had long approved the Bolam test (the reasonable doctor test) as equally encompassing the duty of a physician to disclose information to her patient.52 The House of Lords rejected Mrs.Sidaway’s claim that her doctor’s failure to warn her about an operation’s small risk (one per cent) of damage to her spinal column had been negligent.

However, it is important to note that Lord Scarman openly acknowledged that the common law as at 1984 did not have any cause of action to remedy violation of patient’s right to be informed about inherent risk in a therapy.53Lord Scarman underscored the significance of the Sidawaycase, stating that ‘It raises a question which has never before been considered by your Lordships’ House: has the patient a legal right to know, and is the doctor under a legal duty to disclose, the risk inherent in the treatment which the doctor recommends.’54 Lord Scarman considered it necessary to examine American and Canadian cases which had developed a new of cause of action

50 (1984) 47 The Modern Law Review 454.51 Sidaway v Board of Governors of the Bethlehem Royal Hospital and Maudsley [1985] 1 All ER 643.52 Sidaway v Bethlem Royal Hospital Governors [1985]1 All ER 643.53 Ibid, p. 650.54 Ibid, p.646

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through the recognition of the doctrine of informed consent.55 Although the other Law Lords did not agree with Lord Scarman’s call for an adaptation of the common law to recognise new cause of action based upon the doctrine informed consent, it is significant evidence of the impact of Trans-Atlantic bioethical legal thinking on the emergence of HCL as a discrete subject.

The failure of the court in the Sidawaycase to adopt a position which bioethicists and HCL lawyers think would have advanced patient empowerment did not escape the rigorous critique of leading pioneer scholars in the field. For example, Kennedy contended in his article that the decision was unhelpful as it failed to recognise that the emerging trend of medical practice was a shared partnership which required that the patient begiven all the necessary decision to consent properly.56 When a further appeal in the Sidawaycase was made in 1985to the House of Lords, Lord Scarman acknowledged the assistance he had obtained from the Kennedy’s article aforementioned.57 . Second, an article by Gerald Robertson58 entitled ‘Informed Consent to Medical Treatment’ was extensively relied upon by Lord Scarman in the Sidaway’s case.59 Robertson, having reviewed a long line of English cases from 1950 to 1981, bemoaned the fact that it was judicial policy against expansion of liability of the medical profession which was an obstacle to the recognition of the informed consent doctrine that could meaningfully safeguard patient’s right to self-determination.60 Third, during the House of Lord’s consideration of appeal against Bland’s declaration that it was lawful to withdrawal lifesaving feeding and allow the PVS patient to die, Lord Goff repeatedly cited the article of Ian Kennedy61 entitled ‘ Switching off Life Support Machines: the legal Implications’ to support his vote against the appeal.62 Furthermore, Lord Browne-Wilkinson, in analysing whether removal of nasogastric tube from a PVS patient would constitute a positive act of commission for purposes of offence of homicide,

55 Ibid, p. 652-654.56 n.47 above, p. 459.57 Sidaway, p.652.58 G. Robertson, ‘Informed Consent to Medical Treatment’ (1981) 97 Law Quarterly

Review 102.59 Sidaway, pp.652-653.60 G. Robertson, p.12461 n.48 above, p.351-352. 62 n.42 above, pp.865, 869.

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cited analogous discussion on switching off a ventilator by Skegg63 in his text book.64

Again, the influence of writings of HCL academics on judicial decision-making manifested clearly in the celebrated case of Re A (Children) (Conjoined Twins: Separation) where the Court of Appeal had to decide whether it was appropriate to separate the conjoined twins in order to save the stronger twin’s life, despite the parents refusal to consent to the operation.65 Ward LJ, in paragraph 7.3 of his judgment in considering the legal position on where proposed course of action would terminate life, cited Bland’s case but pointed out that the case has beensubject of much academic scrutiny by Kennedy and Grubb ‘Withdrawal of Artificial Hydration and Nutrition: Incompetent Adult’ (1993) 2 Med L Rev 359; Kennedy and Grubb Medical Law (2nd edn, 1994) ch16; J Finnis ‘Bland, Crossing the Rubicon?’ (1993) 109 LQR 329 and J Keown, ‘Restoring Moral and Intellectual Shape to the Law after Bland’ (1997) 113 LQR 48166This was significant for the influence of bioethical discourse on the emergence of HCL as discrete subject because the acknowledgement of those scholars suggested that academic HCL was making impact on medico-legal litigation. Indeed, in his analysis of the bioethical and legal dilemma inherent in the question of saving life of the stronger baby through separation, Ward LJ extensively drew upon John Keown’s67 analysis that sanctity of life doctrine objects to quality of life because ‘it denies the ineliminable value of each patient and engages in discriminatory judgments, posited on fundamentally arbitrary criteria such as physical or mental disability, about whose lives are ‘worthwhile’ and whose are not.’ The learned judge noted:

When considering the worthwhileness of the treatment, it is legitimate to have regard to the actual condition of each twin and hence the actual balance sheet of advantage and disadvantage which flows from the performance or the non-performance of the proposed treatment. Here it is legitimate, as John Keown demonstrates, and as the cases show, to bear in mind the actual quality of life each child enjoys and may be able to enjoy.68

63 P.D.K. Skegg, Law, Ethics and Medicine: Studies in Medical Law (Oxford: Clarendon Press, 1985), p.169

64 n. 42 above, p. 881.65 [2000] 4 All ER 961.66 Ibid, p. 998.67 J Keown ‘Restoring Moral and Intellectual Shape to the Law after Bland’ (1997) 113 Law

Quarterly Review 481.68 n. 211 above, p.1010.

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The symbiotic relationship between HCL and Bioethics is further demonstrated by the increasing number of research centres that address issues of bioethics and have HCL scholars among the people working in those centres. As early as 1976, the Centre of Medical law and Ethics was established by Ian Kennedy at King’s College London.69 The founder of this Centre became the first Professor of Medical Law and Ethics in England and Wales in 1983.70 In 1986, the Centre for Social Ethics and Policy was established in the University of Manchester with mandate to undertake “research and teaching courses in bioethics and biolaw.”71 In 2005, the Southampton Law School, through the initiative of Jonathan Montgomery,72 established the Health Ethics and Law Network. The Centre for Bioethics and Medical Law, which “promotes high quality interdisciplinary research in bioethics and medical law across a number of disciplines within the University with a clear unifying focus upon the legal and medical dimensions of biomedicine”73has existed, since 2007, in Lancaster University.In the summer of 2011, the University of Birmingham Law School established the Centre for Health Law, Science and Policy as a new interdisciplinary Centre to “foster dialogue and world leading research in this area and also to foster research led teaching through the development of postgraduate courses and doctoral students.”74 It is an inter-disciplinary network exploring the nature of law, its processes of production and impact on society through examining specific examples in HCL and Ethics. In addition, very recently, in December 2011, Durham University School of Law established the Centre for Ethics, Law and Life Sciences to promote research and teaching in the field.75

A special research body worth exploring is the Nuffield Council on Bioethics, which was established in 1991 to examine ethical issues raised by advances in biology and biomedicine.76This Council is, in its origin and funding, independent of government. It seeks to provide advice to assist in the

69 http://www.kcl.ac.uk/law/research/centres/medlawethics/index.aspx (last visited: 6/3/2012).

70 L.O. Gostin, Honouring Ian McColl Kennedy (1997)14 Journal of Contemporary Health Law & Policy, v, xi

71 http://www.law.manchester.ac.uk/research/centres/csep/(last visited: 6/3/2012)72 http://www.southampton.ac.uk/law/research/centres/health_ethics_and_law_network

(last visited: 3/4/2012).73 http://www.lancs.ac.uk/fass/ppr/research/centres/bioethics.htm (last visited: 6/3/2012).74 http://www.birmingham.ac.uk/research/activity/CHLSP/about/index.aspx(last visited :

3/4/2012).75 http://www.dur.ac.uk/cells/ (last visited: 3/4/2012).76 Nuffield Council on Bioethics 1992-99 (London: Nuffield Council on Bioethics, 2000).

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formation of public policy and to foster public understanding. Between 1991 and 1999, the Council has produced five major reports dealing respectively with ethical issues associated with genetic screening, uses of human tissue, xenotransplantation, genetics and mental disorders and genetically modified crops. Because of its independence, as a non-governmental advisory body responsible for biomedicine and biotechnology77the council enjoys more public trust. This is evidenced by the active role the council has played in the process of law making in the field of health care. Few examples can be given from its numerous involvement in advising lawmakers or the government. The Council published a report, ‘Human Tissue: ethical and legal issues’ in 1995 and made pertinent recommendations to government and health authorities, including adoption of Guidelines or Regulations to clarify perceived ethical uncertainties in the existing statutory framework on the removal and use of human tissue.78 Also, the Council’s report on ‘Genetics and human behaviour: the ethical context79’ was extensively quoted in the House of Commons’ Standing Committee on Science and Technology’s Fifth Report on Review of the Human Tissue and Embryology Act of 1990, particularly in exploring the ethical basis for Pre-implantation Genetic Diagnosis.80 Although, Nuffield is a non-governmental research institution, practically it serves a similar purpose as the US Presidential Commission advocated by Kennedy and others in the early 1980s. It is instructive that in 1994, after the Council81 had released its report, the Secretary for Health was questioned in the House of Lords as to when the government was going to respond to the issues raised by the report.82 The significance of this development to HCL is that the Nuffield Council’s research work and recommendations are highly esteemed.

These HCL research centres have not only been at the forefront of innovative academic research but have provided a home for scholars who have been employed by the state to undertake high profile public enquiries. Kennedy, for example, has been a member of the Medicines Commission and the Department of Health advisory group on AIDS, a chair of children’s heart surgery (1998-2001), a chair of a government inquiry (1997) which gave cautious approval to xenotransplantation (the use of animal-to-human

77 Ibid.78 Human Tissue : Ethical and Legal Issues ( London: Nuffield Council on Bioethics, 1995)79 Genetics and Human Behaviour: The Ethical Context (London: Nuffield Council on

Bioethics, 2002). 80 HC Standing Committee on Science and Technology 14 March 2005, par. 109.81 Genetic Screening : Ethical Issues (London: Nuffield Council on Bioethics, 1993)82 HC Deb 22 February 1994 vol. 238 c205W

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transplants) and a committee (1998) that recommended pet passports.83 Brazier has also been instrumental in the formulation of the state policy on sensitive aspects of health care. She chaired a review into the laws relating to surrogacy (1996–2004),84 the Retained Organs Commission (2001–2004),85 and the Nuffield Council Working Party on Critical Care Decisions in Foetal and Neonatal Medicine (2004–2006).86 The impact of the proliferation of HCL research centres on legal reform and policy initiative in health sector of England and Wales can also be seen in the contributions made to the field by Montgomery. He is the Chair of several important government bodies in the field, including the Human Genetics Commission, which advises the UK Governments on ethical and legal issues relating to that field; the Steering Committee for the UK Brain Banks Network; the Strategy Committee that recommended that the UK Brain Banks should be established and the Advisory Committee on Clinical Excellence Awards which makes recommendations to Ministers for these awards made to senior medical and dental consultants.87 The proliferation of these research centres and the policy roles undertaken by leading HCL academics suggest that HCL has not only matured as an autonomous discipline in its own right, but it is of crucial importance in influencing the policy direction of health sector in our society and is an area of research which attracts funding.88 It further reinforces the relevance of bioethics as a discipline.

CONCLUSION

The paper has unfolded the backward and forward linkage between HCL and bioethics. Indeed, the relationship between the two is so close that it can be considered one of symbiosis. This is a particular case, when an account is taken of how HCL and bioethics positively benefitted from each other in diverse ways during their development into their present status as discrete disciplines. In the first place, the aftermath of the Second World War, such as

83 Gostin, ‘Honouring Ian McColl Kennedy’ 1997,Journal of Contemporary Health Law and Policy, p. v-xii.

84 M. Brazier, A. Campbell and S. Golombok, Surrogacy: Review for Health Ministers of Current Arrangements for Payments and Regulation (Cm. 4068) (HMSO, London 1998).

85 Retained Organ Commission, Remembering the Past – Learning for the Future (NHS, London 2004).

86 Critical Care Decisions in Foetal and Neonatal Medicine (London: Nuffield Council on Bioethics, 2006).

87 http://www.southampton.ac.uk/law/about/staff/jrm.page (last visited: 2/5/2012).88 The centres that I have cited are only some examples of those that currently exist.

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the Nuremberg trial and unprecedented medical experiment scandals in the 1960s/70s fuelled the increasing participation of lay scholars in exploring and critiquing medical ethics which culminated in the emergence of bioethics.89 This, in turn, facilitated the evolution of HCL as a discipline since academic lawyers involved in early bioethical discourse developed interest in exploring the interface between law and bioethics at the same time that society was waking up to the ethical implications of medical advances. As HCL emerged as a discrete discipline, it consolidated the status of bioethics as a field of inquiry by projecting the relevance of the latter in adjudication of novel cases with significant slippery moral undertones. ‘Bioethics perhaps gained credence from judicial acknowledgement of bioethical arguments.’90

89 M. Brazier, S. Ost, Bioethics, Medicine and the Criminal Law- Medicine and Bioethics in the Theatre of the Criminal Process (Cambridge: Cambridge University Press, 2013), p.183.

90 Ibid, p.185.

Med Law (2014) 33:40- Medicine and Law

©PROBOOK 2014

40

MEDICINE, LAW AND HUMAN RIGHTS – A SYMBIOTIC RELATIONSHIP

Nikola Tupanceski, PhD*and Dragana Kiprijanovska, MSc**

Abstract: Law and medicine are separate professions, and attorneys and physicians often see their professions in conflict. There are, however, more similarities than differences between the two professions. And there are areas of mutual concern and overlap that demand the application of both legal and medical knowledge for the good of the society. In the new categorical system of values, which is substantially influenced by the so-called modern or aggressive medicine, clever physicians, researchers, and technicians discover newer and better ways to do things. Often, what science and technology make possible soon becomes permissible and, eventually, normal and expected. Given the rapid advances in technology and medical technology in particular, it is clear that without the reasonable restraints imposed by philosophical but also, legal critique, medicine and its practitioners may unintentionally convert science and medical method into a muddled philosophy of human life’.

Against this background, this paper will handle the questions posed by the extent and protection of human rights and freedoms in terms of application of new biomedical techniques and technologies of treatment toward the development of lnternational human rights law. It also discusses the compatibility of domestic medical law with the normative system of international human rights.

Keywords: The Changing Face of Medicine; Medical Ethics; Medical Law; Bioethics; Medico-Legal Branches; Unlawful Medical Act (s); Human Rights; International Standards From the (bio) Medical Sphere; Macedonian Medical Legislation.

* PhD, Full-time Professor at the Faculty of Law “Iustinianus Primus”, University “Ss. Cyril and Methodius” - Skopje. Teaches Criminal Law, Medical Criminal Law, Law and Public Health, International Criminal Law, Comparative Criminal Law; e-mail: tupanceski@gmail.com.

** Master of Science (PhD candidate), Junior teaching and research fellow, Faculty of Law “Iustinianus Primus”, University “Ss. Cyril and Methodius” Skopje; e-mail: dragana.kiprijanovska@gmail.com.

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1. MEDICINE IN THE LABYRINTH OF SOCIETY VERSUS ETHICS AND LAW

1.1 Introduction

“Medicine can ... try to deal with the diseases which most concern us, but it can also absorb social and personal problems into its own unique sphere of influence”.1

The modernization of medicine (modern, technocratic or aggressive medicine) opened a different professional, ethical and thoughtful process that under new conditions imposed the issue of the scope of protection of human health and the responsibility of the physician and other health care practitioners within the performance of their professional activities.

Necessarily pointed towards the respect of the basic traditional procedures of medical treatment that gain in its complexity or are substituted with newly acknowledged techniques and methods that seek to strengthen the effectiveness and safety of the treatment, medical profession launches new problems and challenges raised as a result of its “contemporary variation(s)”. The growing number of therapeutic and other techniques is based on the everyday development of natural science and the appearance of new methods and technologies that are changing the perspectives of the world and simultaneously penetrate in the essential features of the human itself. Admissibility of their application largely depends on their position on the path from experimental to approved treatment technique and bioethical assessment of compatibility with the prescribed minimum terms and conditions as well as compliance with the basic bioethical principles: respect of the person, beneficence and justice. According to Betke, “the technologisation” of the medicine also has other negative side-phenomenon: it leads to atrophy of the relationship between the physician and the patient as machines interrupt the interpersonal contacts. Devices, however, are neither good nor bad, do not prevent contacts, nor have any effect in terms of strengthening the communication. Crucial is the human factor, which, with or without technology, acts incorrectly, and in most of the cases the physicians are the ones that seek shelter behind technical innovations or they serve as an excuse, so between themselves and the patients they constantly put the apparatus overestimating their role and seeking to hide their own incompetence behind the technique”2.

1 McLean S. Old Law, New Medicine. London: Pandora; 1999; p16.2 Boškovski K. Medicinska etika i deontologija, krivično-pravna odgovornost na lekarot

(Medical ethics and deontology, criminal liability of physicians). Skopje; 2007; p64.

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Multiple technological development produced so far unprecedented power concentrated in the hands of a few, but also concentrated power in the very organization. This in turn increased the probability of occurrence of large-scale damage or causing “illusion of good”. As Michael Freeman remarked in 1988 “...science, in particular but not exclusively biotechnology, has given doctors tools to work miracles, to cause life and to prolong it”3. While in the past, said Belloc, the patients placed their trust to the physicians who took care for their therapy, the latter period is characterized by a different phenomenon. In other words, now we know how to bring people into a state of disease and how to keep them in that condition”4.

In the field of medicine, and in society as a whole, numerous dilemmas and ambivalent situations that implicated need to find a rational and balanced solution, are imposed. This tension does not seem simple at all. The new image of the medicine must not lose from sight the numerous hazards that can have far-reaching consequences in terms of the individual expressed on psychological, legal and economic field. The role of the law as an ethical minimum becomes additionally problematic. It must not become a barrier for medicine preventing her further development, but on the other hand, it must not go too far in setting the threshold of medical tolerance. Hence the necessity of finding a solid basis for setting appropriate permissive or prohibitive norms. Law and ethics however, by their nature are bivalent categories. Often, the evaluation of the ethical and, as a next step, the legal admissibility leads to quite different results. What is considered as ethically justifiable, and even necessary in certain situations, fails the test of law and directly contradicts the established legal criteria, but there are also reversed situations of discrepancy between ethical and legal norms. The request for revision of the existing system of values and return to the philosophical and morally colored views today is greater than ever. However, they are also not able to offer an adequate response, because of the obvious presence of moral skepticism.

1.2 Ethics and Morality of Medicine - A Brief Theoretical Discourse

Having in mind the specific character of the medical activity whose main task is the protection and promotion of human health, an issue of primordial importance in all modern societies, the medical ethics is extremely important

3 Freeman M. Medicine, Ethics and the Law. London: Taylor & Francis; 1988.4 Mackie LJ. Ethics: Inventing Right and Wrong. Penguin Books, Harmondsworth; 1990;

p119.

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because, in the first place, it is intended to physicians and others that have contact with the medical practice in wider sense. As an integral part of professional ethics based on general ethical postulates, the medical ethics has in its center of attention the humans and their supreme values. Its task is to distinguish the good from the bad in different areas of medical practice, in light of philosophical analysis5.

Dunstan determines the medical ethics as duty of a moral character, but at the same time, a regulator of relations in medical practice. Its basic principles have become a benchmark in deciding which in a certain case would be considered as proper, virtuous, and as wrong, which behaviors compose the circle of admissible and which of prohibited actions. According to Veatch, medical ethics represent an analysis of choices in medicine. Medical ethics cover choices made not only by physicians, but also by other health professionals - nurses, pharmacists, hospital chaplains and so forth. More important, it covers choices made by medical lay people - patients, parents, legislators, public officials, and judges6. Ethics in medicine is located somewhere in the middle between health policy and universal human values, thus regulating (and determining) the choice of appropriate solutions complying with the normative principles in society.

It seems that medical ethics is considered to be a conditio sine qua non for the existence of medical practice and the exercise of the medical profession in their eminently humanistic meaning and realization of their fundamental mission. In favor of this view are also many authors that explicitly take the position that the medical or physicians ethics is an essential foundation for successful performance of the functions of the medical profession and, in that sense, the absence of a clear and generally accepted definition of professional (medica l or physicians) ethics7 seems inconceivable. In his efforts to simplify the teaching of morality, Warnock observes it through the priority aim of morality. According to him, morality is a kind of evaluation, certain assessment of human behavior. It must have some special purpose, something concrete t h at should be produced. In the explanation of phenomena, he relies on the general and permanent fixtures on the position

5 Pop-Jordanova N. Medicinska etika (Medical Ethics). Skopje: Kultura; 2003; p11.6 Veatch MR. Medical Ethics. 2nd ed. Jones & Bartlett Learning; 1997; p1.7 See also, Carric k P. Medical Ethics in the Ancient World. Washington: Georgetown

University Press; 2001; p. 71; Engelhardt von D. Sulla sistematica e sulla storia dell’etica medica, Etica e medicina: problemi e scelte della pratica quotidiana. Milano: Edizioni Angelo Guerini e Assoiciati; 1994; p. 341-362; Seidler E. Historische Schwerpunkte der medizinische Ethik, Medizin, Mensch, Gesellschaft; 1980; No. 5; p73-80.

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of human who “by nature can be very miserable and immoral”, in a way that the human desires, needs and interests in significant extent, can be defeated. Among the factors contributing to the inadequate scheduling of things in the natural order of issues there are various limitations: rarity of resources, lack of information and rationality, low level of intelligence, whereby most obvious are the problems of understanding. People sometimes demonstrate open malicious intent towards each other but also out of this environment, they, almost without exception, are obsessed with their egoistic goals “keeping their eyes closed” in front of the duty for mutual assistance. Hence the role of morality which should strengthen trust and understanding among people8. Hume conceives the moral as a kind of emotion, sentiment possessed by and upon which respectable people act. If we reflect this opinion in the field of medical ethics, then we get an image of respectable, kind physician who cherishes “the right opinion”. Such physician will do what he knows that is best for his patients, even though the patient does not even have to understand his actions in a particular situation9. The more modern version of the basic ethical question moves from what represents a character to what is considered as behavior and, instead of the question “what kind of a person should one be”, should be said, “what is needed to be done?” or, which behavior seems to be the best and most appropriate. When it comes to health care professionals the question is: “What should the doctor do”?

This way we approach the study of Kant on concept of duties. Kant’s ethics consists of setting rights and duties, and tends to emphasize the absolute or additional nature of the both10. Hereby are not excluded the conflicting situations that may arise from the position of rights and duties.

Morality, however, does not apply only to the good and the bad, right and the wrong, the virtues and the vices, the rights and the duties. The aforementioned concepts stand in close relation with the selection, conduct of the human that

8 Mackie LJ. 1990; p105-6.9 Pop-Jordanova N. 2003; p12.10 “To find out whether a proposed action is consistent with duty, and morally permissible,

the right question to ask, Kant says, is not,” What are the likely consequences doing (or not doing) this action? “But rather,” Can I, as a rational agent, consistently will that everyone in a similar situation should act this way? “If we convert this question into an imperative, we get” Act always on that maxim that you can consistently will as a principle of action for everyone similarly situated. “Kant calls this rule the” categorical imperative”, and it is the foundation of his ethical system, see Steinbock B, Arras DJ. Ethical issues in modern medicine. London: McGraw-Hill; 2003; p15 etc.

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thrives on a voluntary basis, intention, responsibility and repentance. The moral system cannot be conceived outside the terms that stand in the basics of the human behavior, the choices he makes and the merits. The presented concepts are not simple at all. Therefore it is important, that the analysis of these issues meets the requirement for a clear distinction of the following trouble spots. First is the question whether we can draw a clear borderline between intentional and unintentional, desirable and undesirable actions. Then, in which manner should we assign the moral and legal responsibility, reprimand and confession, and finally, under which circumstances comes the possibility of reward and punishment, in particular, the application of legal penalty11.

In most states, the rules and standards of medical ethics are systemized in a unique Code of professional associations composed by members of the medical profession. In recent times, to the name of these acts not rarely is compounded the term deontology, insisting their common application or even more, substitution of the term medical ethics with the term deontology (Greek deon - duty and logos - science) as a broader term, that besides the ethical principles includes in itself the legal regulations which subject of regulation is the behavior of health professionals while exercising the medical activity. This term was used for the first time by the famous English philosopher Jeremy Bentham in the eponymous work “Deontology” (1834), which deals with the study and determination of the duties of health care professionals12.

This definition appears as a logical consequence of the numerous changes in the relationship between medical ethics and medical law as a normative system in modern societies that increasingly insists on the requirement for establishment of a normative system of rules and standards regulating certain aspects of the medical profession and the person performing medical activity who ones had a purely ethical character, elevating them to the level of legal norms in a way that will allow their mutual co-existence.

While traditional deontological principles basically rely on good, ethically founded medical practice, the emergence of bioethics “attacked” the entire medicine, inputting to the field of its scientific foundation and field of action, certain factors of philosophical, theological, social, political and legal nature, which in their comprehensiveness may have a certain influence

11 Mackie LJ. 1990; p207-8.12 Kaličanin P. Medicinska etika i medicinsko pravo (Medical Ethics and Medical Law).

Beograd: Institut za mentalno zdravlje; 1999; p1.

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on the decisions made by the physician(s)13. There is not a clear definition of the term and the object of bioethics14. This conditions, is however, required by a wealth of issues that take place within its object of study. The bioethicians consider that it deals with ethical issues arising from several fields: medicine, natural sciences, biotechnology, law, philosophy, politics and theology. The issues for determination of the concept and definition of bioethics are often intertwined with those of the medical ethics. Generally

13 Tomašević L. Bioetički izazovi. Izazovi globalne bioetike i biotehnologije (Bio-Ethical Challenges. The Challenges of Global Bio-Ethics & Bio-Technology), Bogoslovska smotra, Vol. 76 No. 2 Kolovoz, 2006, p. 395-415; see also, Beauchamp LT., Childress, FJ., Principles of Biomedical Ethics 4, Oxford, New York: Oxford University Press, 1994

14 Bioethics is a neologism derived from the Greek bios (life) and ethike (ethics), and may be defined as “the systematic study of moral dimensions, including vision, decision, behavior and rules of life sciences and of health care. Reich, in his Encyclopedia of Bioethics has also defined it as “systematic study of moral dimensions - including moral vision, decisions, behaviors and lines guiding it - of life and health sciences, by the use of several methods and with interdisciplinary posture”. Reich WT. Encyclopedia of Bioethics. New York: 2nd Ed, McMilliam; 1995. The concept evolved and in 1995 the Encyclopedia of Bioethics (USA, 199513) defined bioethics as the “systematic study of the moral dimensions - including moral vision, decisions, conduct, and policies of the life sciences and health care, employing a variety of ethical methodologies in an interdisciplinary setting”. Moral dilemmas related to abortion, suspension of artificially supported life, surrogate motherhood, conception of children for the purpose of bone marrow donation, and more recently the use of human stem cells in animal embryos and reproductive cloning, are examples of bioethics typical issues, De Faria LP, editor. Proceedings of the 1st Biennial Seminar in Health Law and Bioethics on The Role of Health Law, Bioethics and Human Rights to Promote a Safer and Healthier World; 2005; Lisbon: 1st Ed, Fundacao Luso-Americana; 2006. p. 15. In schoolbooks, monographies and encyclopedia material there is no accurate data on the occurrence and use of this term for the first time. Namely, it is considered that the neologism, “bioethics” was created by Fritz Jahr in 1927. He, at that time, predicted many of the issues of this area discussed today writing about bioethical imperatives regarding the use of animals and plants in biological research. Others, attributed the main credit for the emergence of the term bioethics to Van Reseller Potter - biochemist and researcher at the University of Wisconsin in the U.S., see Potter VR. Bioethics, the Science of Survival. Perspectives in Biology and Medicine 14, 1970, p127-53. Particular credits for the origin of this discipline goes to Andre Hellegers who uses the bioethics as a mean of resolving moral dilemmas faced by the medicine on its development path. The mentioned author actually advocates the need for establishing appropriate standards and norms that should constitute a major determining factor in terms of the increased scientific impulses in order to determine how far is it possible to go in the artificial creation of human natural features and human life without declining from the natural balance. Among the contemporary bioethicists and philosophers are also the names of Daniel Callahan of the Hastings Center, Peter Singer of Princeton University, Daniel Brock of Harvard University, Albert R. Jonsen University of Washington, Joseph Fins of Cornell University, political economist Francis Fukuyama, attorney Wesley J. Smith and others.

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speaking, it is defined as philosophical teaching on ethical controversies arising from the achievements of biology and medicine15.

Observing the meeting points (as well as divergence points!) between medical ethics as a field of applied ethics and bioethics, it can be noted that it is about philosophical teachings that are very close and overlap in most of the subject of their study. Discrete differences are determined by the fact that while medical ethics is more a form of professional ethics, the bioethics is comprehensive and in itself it synthesizes issues from the field of philosophy, science and biotechnologies. Therefore, it is not accidentally considered that the difference between medical ethics and bioethics is more “a matter of style than professional consensus”.

2. MEDICAL (HEALTH) LAW AS THE GUARANTOR OF MEDICAL PROFESSION

2.1 General Remarks

In modern terms, the Law assumes the role of guarantor of successful performance of the medical profession, seeking to ensure effective control of the area of protection of patients and their rights and appropriate quality of health servic e s. Reinforcing the rational component of deliberation and regulation of the relations, and even more, the danger brought by the contemporary transformation of society and its scientific and technological development of interests, rights and freedoms of the individual, the actions of physicians and other health care professionals should be subject to control whose main objec t ive is to ensure that healthcare professionals, while performing their professional activity, adhere to professional standards and due attention that despite their heterogeneity, are raised to the level of legal norms whose violation activates the possibility of litigation. Despite disciplinary lia b ility, the breach of legal duties provides legal judgment, which, depending on the degree of injury and the damage consequence, is differently assessed in accordance to the criteria of civil and/ or criminal law. In this way, the law gains a special role in the value reconstruction of relations in the modern society as a regulatory mechanism directly associated with the existential, universal human values, whose recognition can not be conditioned by specific historical and social circumstances.

15 Fernando L. Bioethics and animal research. A personal perspective and a note on the contribution of F r itz Jahr, Available from: http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0716-9760 2008000100013 & lng = es & nrm = iso contribution of Fritz Jahr.

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2.2 Medical Law – Conceptual Determination

After this brief review, we come to the next crucial issue that brings us to the conceptual definition of the Medical Law. What is its object of study, course of action and where in fact, is its place in the system of jurisprudence?

The defining could be synthesized in a short explication: a branch of the Law (but legal science also) that deals with the study of manner of performance of medical activity. When the law and the medicine are brought close to each other, immediately arises a limited legal area or set of legal norms regulating the relations between entities while performing medical interventions. The meeting point indicates interest in preserving the basic human values: life and bodily integrity, health and dignity as an extremely important consideration in the field of human rights. Medical Law (Medical Law, Droit Medical, Artzrechts, Derecho medical) is not a closed system of norms systematized in a single legislative act, but a corpus of different ethical norms and legal rules regulating medical activity, position and characteristics of persons who perform that activity, i.e. their relationship with the consumers of health care services. The legal regulations of this kind are a certain guarantee of the right of health, rights of health care and health insurance, determining the rights but also the limits of responsibility of health care professionals and health facilities and organization of the health system as activity of a special social interest16.

According to Kennedy, the basis of medical law is constituted by different aspects of civil, criminal, tort, administrative law, etc..; Medical law marks the next stage of the development of the aforementioned branches of the law17. As Morgan puts it “medical law is indeed not just a subject; it is also a responsibility”. The framing of responses properly lying within medical law is a part of an intellectual responsibility that lies at the heart of the academic obligation which, as John Fleming has otherwise observed, is to be “sensitive to movement and direction being concerned with whence, whither and most important, with why”18.

Medical-legal norms are concentrated on the relationship between the patient and his fundamental rights (the right to health care, i.e. life, health and safety), physician and other health care professionals, the rights and duties of these entities, health care institutions that directly exercise the right

16 Radišić J. Medicinsko pravo (Medical Law). Beograd: Nomos. 2nd ed; 2008; p21.17 De Cruz. Comparative healthcare law. London: Routledge - Cavendish; 2001.18 Derek M. Issues in Medical Law and Ethics. London: Cavendish Publishing; 2001; p3.

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to health care, including the health system as a whole, its regulation and efficient functioning19. Starting from the set definition(s), here should also be mentioned some other terms that are used within the increasingly wider discourse on issues in the field of medicine, ethics and law, and above all, the name “Health Law20” and “Health Care Law21”.

The term Health Law, conceptualized in the new era, emphasizes the interest in defining and applying legal principles in the health care through a common approach with the medical or, in various legal areas22. The study of Health Law normally covers issues such as access to care, health systems organization, patients’ rights, health care professionals’ rights and duties, strict liability, healthcare contracts between institutions and professionals, medical data protection and confidentiality, informed consent and professional secrecy (confidentiality)23. However, several authors believe that this term is much wider than Medical Law, as it includes all rules and regulations connected with health care or health. Furthermore, some authors believe that Health Law is not only wider in scope than Medical Law but that they both deal with a different area of social/ health care activities. The term “Health” is in itself wider and more inclusive than what we consider under the term “Medical”. Health care is a spec i fic form of a very important social activity for all societies, while medicine has its own specific and narrower connotation and

19 Čizmić J. Bioetika i medicinsko pravo (Bioethics and Medical Law). Medicina; 2008; 44(2): 171-185.

20 The Health Law & Justice Program views health law as encompassing not only the law of health care delivery and financing but all areas of study that focus on the intersection between law and health: from the ethics of embryonic stem cell research, to the role of government in preventing child maltreatment, to occupational health and safety regulations, to the laws governing elder care and death. Washington: American University Washington College of Law [Internet]. Health Law and Justice Program [cited 2013 June 10]. Available from: http://www.wcl.american.edu/health/health_law_info.cfm

21 Health care law focuses on the legislative, executive, and judicial rules and regulations that govern the health care industry. The health care industry includes hospitals and hospital systems, public and private insurers, pharmaceutical and device manufacturers, and the individual practitioners who treat patients. Each of these entities functions within a vast complex of laws and regulations, and our curriculum reflects this complexity by offering a variety of courses that focus on specific aspects of health care law, such as fraud and abuse, food and drug law, medical malpractice, and healthcare mergers and acquisitions, Ibid.

22 See Mémeteau G. Cours de droit médical. Bordeaux: Les Études Hospitalières; 2006; p80; Hale Mc, Fox M. Health Care Law, text and materials. London: Sweet & Maxwell; 2007, p719.

23 De Faria LP. Presented paper within the 1st Biennial Seminar in Health Law and Bioethics on The Role of Health Law, Bioethics and Human Rights to Promote a Safer and Healthier World; 2005.

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meaning. This is why some authors believe that Medical Law is only one of the branches of Health Law24. This is the case, for example, in Sweden, where health law, as a more comprehensive concept, in itself integrates also issues that are subject of interest of the medical law, provided that its sources - more than 80% - come from the area of administrative law, and smaller part comes from the field of the civil and criminal law25. In Spain, the medical law has not yet been clearly defined and is often equated with the health law and the legal medicine. Therefore, medical law is only narrowly determined as “part of the legal system pertaining to medicine, in particular the medical profession and in the broader sense with other health care and health care related professions. Contemporary points of view on the Spanish medical law include also the legal implications of the contemporary application of biomedical sciences - genetics, biochemistry, biophysics, etc...26.

A rich plead of terms is used to refer to this specific, complex, and highly topical area which synthesize an infini t e number of issues raised on relation law - medicine. Thus, besides the term Medical Law and Health Law, the following terms are also in use:Legal Medicine27 ,Biolaw28, Law

24 See for more details: De Cruz; 2001; Žnidaršič Skubic V. Medical Law, in International Encyclopedia of Laws. Nys H, editor. (2nd ed). Netherlands: Kluwer Law International BV; 2013; p40-2.

25 Westerhäll L. Medical law. Sweden: Kluwer Law international; 1998; p16-7.26 Romeo-Casabona, Hernandez – Plsencia. Medical Law. Spain: Kluwer Law international;

1994; p29; Kennedy A. Grubb. Medical Law. London: 1989 by Nys H. Medical Law. Belgium: Kluwer Law International; 1997; p38.

27 Legal medicine can be defined as a field of study and accumulation of materials that deals with the application of medical knowledge to the administration of justice, Curran WJ. Titles in the medico-legal field: a proposal for reform. Am J Law Med. 1975; 1:1-11; see also, Sanbar SS. Legal medicine: historical roots and current status, in Legal Medicine. Sander SS, editor. St. Louis: CV Mosby, 2004, p. 3-11.

28 This concept is usually linked to Bioethics as Judith Miller defines Biolaw: “The taking of agreed upon principles and practices of bioethics into law with the sanctions that law engenders. Biolaw includes legislation on bioethical issues, interpretation of such legislation and case law made by judges”. Biolaw must first of all be adaptable to the future developments of scientific knowledge that is always evolving, so its norms must be flexible or risk becoming obsolete. And, secondly, it must reflect the consensus of society and the scientific community or it may create conflicts capable of jeopardizing the applicability of its norms. As an example of the difficulties that surround the making of “bio-norms” we can refer to the French “Lois Bioéthiques”, the first version of which appears in July 1994, and was preceded by almost a decade of public debate including five exhaustive ministerial reports. Rapports Braibant; 1988; Lenoir; 1991, Sérusclat; 1992, Bioulac, 1992 and Mattei, 1993.

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on Physicians29. They however, regulate only certain aspects of a very extensive medico-legal area, hence justifiably some theorists believe that the use of these terms is inappropriate and leads to a restrictive determination of the field of interest of the Medical law. The complexity of the object of observation and emphasized interest on medico-legal area opened the road for the establishment of new scientific disciplines whose sphere of interest form the legal-ethical aspects of the medical activity in its broadest sense. These issues represent an object of consideration of the following (newer) scientific disciplines: Pharmaceutical Law30,

29 The Law on physicians according to some authors, is a synonym for medical law in narrower sense. However, it is increasingly indicated that such beliefs are not completely appropriate because it`s an issue of legal branch whose subject matter is not limited to physicians as the main performers of medical activity, medical law to the greatest extent possible should ensure the achievement of the primary goal - the protection of patients and their best interests. In German legal doctrine the physician`s law exists within the medical law, which incorporates the right of medicines and medical products, the right of transfusion, and the physician`s right is considered to be its central part, Tupanceski N, Deanoska-Trendafilova A, Kiprijanovska D. Medicinsko kazneno pravo (Medical Criminal Law). Štip: 2-ri Avgust S; 2012; p29.

30 Pharmaceutical law is a relatively new scientific discipline that occur as a side-product of the development of the pharmaceutical industry. The starting idea for its establishment is based on the prominent influence of pharmacological revolution which le d to the expansion of “therapeutic weapons”, including new, previously unknown age n ts and other modern discoveries which, in terms of their structure and reaction of the functions of the human body, opened the debate on the responsibility of those directly involved in the “medicamentosa - process” as an integral part of the treatment of the patient. That, in objective sense can be understood as a totality of legal rules governing pharmaceutical activity, determine the characteristics of persons who perform that activ i ty and their relations with the consumers of pharmaceutical services. Unlike the tradi t ional legal disciplines, pharmaceutical law is not specifically codified; it’s about a restricted legal area whose concern is the pharmaceutical profession as well the users of its services. Hence, pharmaceutical law can be determined as “set of diverse legal norms that belong to different branches of law, and their common feature is that they all, in a comprehensive sense regulate relations in the course of the pharmaceutical profession”. Ibid, p30-2.

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Medical Criminal Law31, Medical Civil Law32 and Neurolaw33.

31 The most concise definition of Medical Criminal Law is that this special legal branch (specific subtype of the Criminal Law) governs unlawful medical acts (medical wrongdoing) and sanctions for these offenses. This is Criminal Law which specializes on criminal offences where physicians or other health care personnel in lieu of their medical professions are the perpetrators and (mainly) the patients are the victims. In its wider meaning, Medical Criminal Law encompasses a set of rules which regulate the offenses in order to protect the human freedoms and rights from violations and abuses arising from the application of medical interventions and biomedical techniques and technologies, whether therapeutic or experimental. Medical Criminal law is divided into a general part and a special part. The general part covers the general principles, sources and ethical theories that apply to medical profession, the foundations of the health care professional - patient relationship (the concept of autonomy vs. Medical paternalism), basic standards and elements of the admissibility of therapeutic procedures, the doctrines of criminal liability that contribute to the liability of physicians and other healthcare practitioners and the concept of medical negligence as the predominant theory of liability concerning allegations of medical unlawful acts. The special part of the Medical Criminal Law defines specific medical (and medical assisted) interventions: mercy killing or euthanasia, physician assisted suicide, unlawful abortion, unscrupulous treatment (medical error and its criminal aspects), abandonment of medical help, breach of professional secrecy , quackery, unlawful transplanting of parts of the human body, transmitting an infectious disease, specific (specifically determined) illegal actions in the area of fertilization with bio-medical assistance, cloning, genetic engineering and bioweapons, unscr u pulous performing of a pharmaceutical activity, mentally ill (disordered) offende r s in the criminal justice system, medical expertise and security measures, Tupance s ki N, Deanoska-Trendafilova A, Kiprijanovska D, cited book; p16-9; Korosec D. Medicinsko kazensko pravo (Medical Criminal Law). Ljubljana: Pravna fakulteta and Cankarjeva zalozba; 2004; p27.

32 The Medical civil law deals with the study of contractual aspects of the relationship physician - patient or the medical agreement, the assumptions in terms of compensation, but also, with different types of damage(s) (“lost opportunity” to achieve a better outcome of the treatment, damage that occurred as a result of unwanted birth of a healthy child – “wrongful birth”, damage caused by the birth of a child with severe health damage – “wrongful life”, prenatal damage, liability for damage caused by the use of drugs), the procedure for compensation etc. There is an extensive case law regarding these issues. Medical civil law treats other aspects which, at the same time, constitute the skeleton of the medical criminal law such as biomedical assisted fertilization, transplantation etc.., by which, depending on the level of unlawful act(s) is determined also the application of their mechanisms of protection, although in some cases they register parallel application. N, Deanoska-Trendafilova A, Kiprijanovska D, cited book; p35-6.

33 The interactions between Neuroscience and Law is a relatively new field of study, that in recent years has attracted the international community’s attention thanks to its capacity to involve fundamental concepts as free will, responsibility and individual boundaries. The development of a vivid debate, often called “Neurolaw”, has highlighted various challenges offered by the last neuro-scientific findings to the national legal systems: it has dealt mostly with philosophical questions about free will, and legal enquiries about responsibility and the relationship between brain abnormalities, violence and crime, with special attention to the use of new neuro-techniques before Courts in criminal and civil trials, Bottalico B, Fiorina ML, editors. Neuro & Law. European Center for Law, Science and Technologies. [cited 2013 June, 10]. Available from: http://www.unipv-lawtech.eu/lang1/neuro---law.html.

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3. HUMAN RIGHTS AND (BIO) MEDICINE: THE ROLE OF INTERNATIONAL LAW

3.1 Important International Standards From the (Bio) Medical Sphere

The relevance of international human rights law for health care has become increasingly apparent in recent years. A number of international documents articulate a right to health or to health care. The European Convention on Human Rights in Biomedicine has become an important basis for human rights in health in Europe, for example. A number of scholars in the United States have also argued for greater awareness of international human rights to health, while others have explored its concrete application in specific contexts.

The national legislatives of the states do not share the assessment that instruments for the protection of the human rights in the (bio) medical sphere have played a significant role in shaping the solutions and hence are considered to be one of the main drivers for reform of medical law in the recent years.

The brief review of the corpus of international acts in this area argumentatively enough confirms the logical flow in the ongoing process of creating rules and standards that are considered to be one of the main determinants for the resolution of some major (bio) medical and legal issues. They form a very extensive list of rules (conventions, declarations, protocols, recommendations, resolutions, opinions, strategies, etc..), out of those containing guarantees of the fundamental human rights and freedoms, in that sense, the right to life, physical integrity and protection of the health of each individual34 through the documents that specifically emphasize the rights and duties (as well as responsibility) of health care professionals,

34 The protection of the health primarily and essentially is considered in the context of fundamental human rights established in the most important international instruments on human rights and fundamental freedoms, because the right to health implies a broad and complex set of interrelated issues, in which frame, the health and welfare stand in an unbreakable connection with all the aspects and stages in ones life. These are above all the following international instruments: The Universal Declaration of Human Rights (Art. 25), International Convention on Economic, Social and Cultural Rights (Art. 12), the European Social Charter, the European Convention for the Protection of Human Rights and Fundamental Freedoms (Art. 2, 3, 5, 8, 14), the European Convention for the Prevention of Torture and Inhuman or Humiliating Treatment of the Council of Europe since 1987, Convention on the Elimination of All Forms of Racial Discrimination (Art. 5); Convention on the Elimination of All Forms of Discrimination against Women (Art. 10, 12, 14), the Convention on the Rights of the Child (Art. 24), etc.

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the manner of performing the activity, the need for continuous education, expertise and relation with patients within their professional work (for example, the Declaration on Physician Independence and Professional Freedom35, the Declaration of the World Medical Association for human rights and personal freedoms of health professionals from 198536, the Madrid Declaration on Professional Autonomy and Self-Regulation37, Statement on Medical Malpractice from 199238, Statement on Medical Liability Reform since 200539, then, Statement on Professional Responsibility for Standards of Medical Care (1996)40, Statement on Patient Advocacy and Confidentiality (1993)41, WMA Statement on Access to Health Care (since 1988, additionally revised in 200642), including those documents that contain a minimal list of the patient’s rights such as, for example, the Amsterdam Declaration for promotion of the rights of patients in Europe from 199443, to the later internationally set rules and standards referring to protection of the rights and freedoms of humans concerning applications of new biomedical techniques and technologies of treatment.

35 The Declaration was adopted on 38th Assembly of the World Medical Association in October 1986 in Rancho Mirage, California; official version of the document is available from:

http://www1.umn.edu/humanrts/instree/physicalindependence.html.36 The text of this Declaration was adopted at the 37th Session of the Assembly of the World

Medical Association in Brussels, October 1985 and the focus is placed on the equal rights and opportunities for members of the medical profession.

37 The Declaration was adopted on 39th Assembly of the World Medical Association in 1987, in Madrid, and was revised in 2005 in France. Today, the mentioned document is replaced by a Declaration on Professional Autonomy and Clinical Independence (2008) and the Declaration of Madrid on Professional Regulations (2009). Available from http://www.wma.net/en/30publications/10policies/20archives/a21/index.html.

38 Statement on Malpractice was adopted by the World Medical Association in Marbella September 1992, http://www1.umn.edu/humanrts/instree/malpractice.html.

39 Statement on Medical Liability Reform was adopted by the World Medical Association in Santiago, 2005. It is a very important international instrument which closely regulates the complex issues related to the responsibility of health care practicioners, although in terms of content, it significantly corresponds with the Statement on Malpractice listed above, http://www.wma.net/en/30publications/10policies/l5/index.html.

40 available from: http://www1.umn.edu/humanrts/instree/medcarestandards.html41 Statement on Patient Advocacy and Confidentiality is a document of the World Medical

Association adopted in Budapest in 1993, http://www1.umn.edu/humanrts/instree/patientadvocacy.html.

42 Available from: http://www.wma.net/en/30publications/10policies/a6/index.html.43 The Declaration was adopted by the Regional Office for Europe of the World Health

Organization in 1994 and served as a basis for adopting special laws in several countries in Europe, for the text of the Declaration see http://infodoc.inserm.fr/ethique/ Ethique.nsf/0/901e922bf0f1db42c12566ac00493be8? Open Document.

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The very latest are of great importance for the further development of medical law. Their application solved some important issues regarding the items, i.e. conditions for admissibility of specific (bio) medical procedures. The motives for their adoption are the rapid development of science and technologies requiring a global response to the ethical implications that arise from them, and that should be investigated, starting from the need for respect of the human rights. Such international regulation caused significant repercussions on the national level and had an impact, in terms of expanding the existing legal framework in the (bio) medical area, by adopting new legislation and amending the existing medico-legal solutions set in function of protection of the individual and its fundamental rights and freedoms.

Indeed, it is about an infinite number of regulations that address certain aspects of (bio) medical interventions and their application on human beings. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (April, 4, 1997), also known as the Oviedo Convention’s44 is the leading document for all areas in the biomedical field, amended by the protocols to that on the prohibition of cloning human beings (1998)45, transplantation of organs and tissues of human origin,46 Additional Protocol to the Convention concerning Biomedical Research47 and Additional Protocol concerning Genetic Testing for Health Purposes48. While elaborating the documents of the Council of Europe should also be mentioned the Recommendation no. Rec (2006)

44 The Convention on Human Rights and Biomedicine is in force since 12.01.1999. The Republic of Macedonia has signed it on 04/04/1997, but it was ratified only on 09.03.2009 and entered into force on 01.01.2010, for the text of the Convention. Available from: url: http://conventions.coe.int/treaty/EN/Treaties/Html/ 164.htm.

45 Council of Europe, European Treaty Series - No. 168 1998.46 Protocol on transplantation of organs and tissues of human origin was signed in

Strasbourg, 24.1.2002, and entered into force on 01.05.2006. The Republic of Macedonia signed it on 15.03.2002 and ratified on 03.09/2009, in force from 01.01.2010, http://conventions.coe.int/treats/EH/Treaties/Html/186/htm.

47 Supplementary Protocol on Biomedical Research was signed in Strasbourg on January, 25, 2005 and entered into force on September, 1, 2007. The text of the Protocol see on: Council of Europe, European Treaty Series No.195,2005,http://www.coe.int/t/dg3/healthbioethic/activities/01_oviedo%20convention/195%20Protoco e 20recherche%20biomedicale%20e43.pdf.

48 Protocol addresses the issue of genetic testing for health purposes and was adopted in Strasbourg on 27 November 2008. Not yet entered into force see. the Council of Europe, European Treaty Series - No. 203 2008, http://conventions.coe.int/ Treaty/EN/Treaties/Html/203.htm.

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4 on research of biological materials of human origin49, Recommendation 1100 (1989) of the Parliamentary Assembly of the Council of Europe on the use of human embryos and fetuses in scientific researches50, Recommendation 1046 (1986) 1 on the use of human embryos and fetuses for diagnostic, therapeutic, scientific, industrial and commercial purposes51, Recommendation Rec (2004) 7 of the Committee of Ministers to member states on organ trafficking52, Recommendation 1611 (2003) 1 on Trafficking in organs in Europe53 and Recommendation Rec (2005) 11 of the Committee of Ministers to member states on the role and training of professionals responsible for organ donation (transplant “donor co-ordinators”)54.

Among the documents adopted by the United Nations in particular should be stressed the Universal Declaration on Bioethics and Human Rights adopted by UNESCO in 200555, and among the more significant documents in this area are also included the following: Universal Declaration on the Human Genome and Human Rights56, the International Declaration on Human Genetic Data57 and the Convention on the Prohibition of the Development,

49 The mentioned document was adopted by the Committee of Ministers of the Council of Europe on 958-th Meeting of Deputy Ministers on March 15, 2006 (Council of Europe (2008), 146-153).

50 The text of this Recommendation was adopted at the 40th regular session of the Parliamentary Assembly of the Council of Europe on 2 February 1989 (Council of Europe II (2008), 20-26).

51 http://assembly.coe.int/main.asp?Link=/documents/adoptedtext/ta86/erec1046.htm52 This document was adopted by the Committee of Ministers on 19 May 2004

at the 884th meeting of the Ministers’ Deputies, https://wcd.coe.int/ViewDoc.jsp?id=744621&Lang=en.

53 http://assembly.coe.int/Main.asp?link=/Documents/AdoptedText/ta03/EREC1611.htm.54 Recommendation Rec (2005) 11 of the Committee of Ministers to member states on the

role and training of professionals responsible for organ donation (transplant “donor co-ordinators”) was a adopted by the Committee of Ministers on 15 June 2005 at the 930th meeting of the Ministers’ Deputies,

https://wcd.coe.int/ViewDoc.jsp?id=870643.55 Universal Declaration on Bioethics and Human Rights adopted by the General

Conference of UNESCO in October 2005, url: http://portal.unesco.org/en/ev.php URL_ID=31058&URL_DO=DO_TOPIC&URL_SECTION = 201.html

56 The Declaration was adopted by UNESCO in 1997 and its main idea is the rejection of any doctrine of inequality of men and races.

http://portal.unesco.org/en/ev.php URL_ID=13177&URL_DO=DO_TOPIC&URL_SECTION=201.html

57 Universal Declaration on Human Genetic Data was adopted by acclamation the 32nd General Conference of UNESCO on 16 October 2003.

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Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction58. Certain important issues and principles in the area of the medical profession are incorporated in the following documents: The basic p r inciples of transplantation of human organs from Geneva, 1991., WHO document59, WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects since 1964, amended, on several occasions (1975, 1983, 1989, 1996, 2000 and last, in 2008),60 The Guiding principles of medical ethics and human rights etc61.

3.2 Incorporation of international regulations in the Macedonian medical legislation

In the Republic of Macedonia, the attempts to recognize, mark, and develop the Medical law, as a science, are very modest and its study at the university level is in its very initial phase. However, the regulation of the medical sphere in an increasing number of areas confirms its existence. Individual disciplines that are part of the programs at the Law faculties are the Medical Law, Medical Criminal Law, Bioethics and the Law and the Public health care and the Law.

The macedonian medical law is represented primarily by the following acts: Health Care Law62, Law on Protection of Patients` Rights63, Health Insurance Act64, Law on Biomedical Assisted Insemination65, Law on taking and transplantation of human body parts for the purpose of medical

58 The Convention was signed in London, Moscow and Washington on 10 April 1972, in force on March 26, 1975, the text of the Convention see on url: http://www.opbw.org/ convention / documents / btwctext.pdf.

url:http://portal.unesco.org/en/ev.phpURL_ID=13177&URL_DO=DO_TOPIC&URL_SECTION=201.html.

59 59 http://www1.umn.edu/humanrts/instree/organtransplant.html.60 http://www.wma.net/en/30publications/10policies/b3/17c.pdf.61 Nys H, editor. International Medical Law and Ethics. Boston, Hague-London; 2000;

IB2.I.1.-1; Deanoska-Trendafilova, Kaznenopravni aspekti na genetskite manipulacii, doktorska disertacija (Criminal aspects of genetic manipulation, doctoral dissertation). Skopje: Faculty of Law “Iustinianus Primus; 2010, p129-30.

62 Official Gazette of RM no. 43/12, 145/12 and 87/13.63 Official. Gazette of RM no. 82/08, 12/09 and 53 / 11.64 Official Gazette of RM no. 25/00, 34/00, 96/00, 50/01, 11/02, 31/03, 84/05, 37/06, 18/07,

36/07, 82/08, 98/08, 6 / 09, 67/09, 50/10, 156/10, 53/11, 26/12 and 16/13.65 Official Gazette of RM no. 37/08

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treatment66, Law on Termination of Pregnancy67, Law on protection of the population from infectious diseases68, the Mental Health Act69, and Law on Medicinal Products and Medical Devices70. Numerous implementing regulation acts were passed to support the acts above. These regulations provide a more detailed way of using the legislation in practice and facilitate their implementation. Significant provisions are also contained in the Law on Obligations71 and the Criminal Code72, separating into a special chapter those behaviors that represent the most serious violation to the human health73.

Nobody disputes the fact that in the recent years, national legislation moves towards the reception of solutions embedded in international regulatory instruments in this area (UN documents, CE conventions and the EU documents, hereby including the acts adopted by the international medical bodies). These findings were supported by the adoption of the Biomedical Assisted Insemination Act in 2008; it is in fact, the first Macedonian law which governs the procedure, types, conditions for conducting biomedical fertilization, etc.., and this law is the first that incriminates cloning (Art. 68) in accordance to the international laws and, above all, the Additional Protocol to the Convention on Human Rights and Biomedicine on the prohibition of cloning. In addition, sanctions are prescribed also for some other activities, with respect to the lack of their moral, medical, legal, ethical and social justifiability and admissibility (Art. 69).

Following the example of the modern European state in the same year was adopted the Law on Protection of Patients` Rights. The law provides appropriate mechanisms and precise regulation on defining and protecting concrete rights of the patients regarding therapeutic and experimental

66 Official Gazette of RM no. 47/11. 67 Official Gazette of RM no. 87/13.68 Official Gazette of RM no. 66/04, 139/08 and 99/0969 Official Gazette of RM no. 71/06.70 Official Gazette of RM no. 106/07, 88/10, 36/11, 53/11, 136/11 and 11/12.71 Official Gazette of RM no. 18/01, 4/02, 5/03, 84/2008, 81/09 and 161/09.72 Official Gazette of RM no. 37/96, 80/99, 4/02, 43/03, 19/04, 81/05, 60/06, 73/2006, 7/08,

139/08, 114/09, 51/11, 135/11, 185/2011, 142/12, 166/12, 55/13 and 82/13.73 In the systematics of the special part of the Criminal Code of the Republic of Macedonia

are incorporated totally 13 incriminations which according to the closer object of protection, as well as the threat to a protected object, can appear in several sub-groups, including: acts of violation of health with infectious diseases; physicians criminal acts, “drug-incrimination” and acts of health violation with harmful means for medical treatment and other products.

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procedures on different levels of health care: primary, secondary and tertiary and, at very large scale, corresponds with the principles and content of the international rules and standards, primarily those provided in the Amsterdam Declaration. Moreover, the new Law on transplantation confirms this conclusion, illustrated through the tendency for adoption of modern law in accordance with international standards and comparative experiences. The new Law on transplantation was enacted in 2011 and is the third law in the country regulating these issues - the first one was adopted in 1983 and the second in 1995. This Law specifies the conditions under which parts of human body (organs and tissues) of living or deceased persons can be collected, stored, processed, exchanged, transferred and transplanted for the purpose of treatment, the conditions that should be fulfilled by the health institutions performing the collecting, storing, processing, exchanging, transferring and transplanting parts of human body for the purpose of medical treatment, the organization and implementation of collecting and transplantation of parts of human body, as well as the supervision of the law enforcement. For the purpose of implementation of these principles, and in particular to ensure equitable access for future recipients, a national waiting list (divided by organs) is established in accordance with transparent, objective, ethical and generally accepted medical criteria. The law includes a series of unlawful acts, criminal offenses and misdemeanors, that aim towards filling the gap that appeared with the fact that, on the one hand the transplantation in Macedonia becomes more and more applicable as a therapeutic procedure, and on the other, the new legislation establishes a new, potentially more functional system, with regards to the fact that the only article of the Criminal Code (Article 210: “unlawful transplanting of parts of the human body”) does not meet the modern legal requirements for appropriate prevention and repression in light of the growing organ trafficking and abuse of transplantation procedures that mark the emerging organized forms.

Since 2012 a new Law on health care is in force, and its adoption was imposed as necessary in order to establish an adequate legal basis for the development of the health care system that would follow the modern trends in health care and medicine and will enable proper response towards modern challenges facing the health care system, including justifiably increased demands and expectations of the citizens for quality and admissible health care.

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Indications of the level of development of medical law are also the innovations in the existing framework that regulates issues regarding abortion, i.e. the procedure and conditions for its admissibility. The adoption of the new Abortion Law (June, 17, 2013) caused a serious debate in the Parliament and expert circles and drew the attention of the public. The regulation in this area was established within the former Yugoslavia (1972), by which, during the period of 1995 minor changes were introduced. Such a law did not correspond with the fundaments of the modern health care system and the current methods and principles of medical treatment, which imposed the need to reform the existing legal framework. Serious discussion was caused by Article 6 of the Law where, for the first time, submitting a written request in the form and content determined by the Minister of Health, on behalf of a pregnant woman who decided to have an abortion was envisaged. In addition to the application, the woman has to submit the findings from the completed ultrasonographic examination, as well as the medical and other necessary documents stipulated by the law (Art. 6 Par. 1-2). Pursuant to a direct legislative provision the physician is obliged before terminating the pregnancy to advise the pregnant women about the possible advantages of the continuation of pregnancy as well as the risks of the executing or not executing the intervention for termination of pregnancy with respect to the health and life of the women, the methods for performing termination of pregnancy and familiarization with the possibilities and methods of preventing pregnancy (Par. 3). The content and manner of the advising procedure is prescribed by the Minister of Health with a special act. An additional novelty in the law is the ‘three days - waiting period after the advising, before whose expiration the pregnant woman can not expose herself to the procedure for termination of pregnancy’74. Exceptions are provided only in those situations where a minor, or a woman whose legal capacity has been revoked or limited, are affected, and when there is a justified medical indication, which the physician must duly record in the medical records and documentation (Par. 7). If a pregnant woman, after receiving the information, maintains her request, she is obliged to provide a written statement of consent to accept the execution of the intervention for termination of pregnancy in accordance to the law. Among other issues,

74 The Ministry of Health made a certain attempt to respond to the criticism expressed regarding the novelties in the law concerning the prescribed deadline - waiting period, indicating that the established legal solutions are not new and that they exist in the modern European legislations for a longer period of time. See for more details: Draft Law on Termination of Pregnancy (in shorten procedure), The Ministry of Health. Skopje: May, 2013; available from: http://www.sobranie.mk/ext/materials.aspx.

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amendments were also made regarding the misdemeanor and criminal provisions. Despite the fact that illegal termination of pregnancy was (and still is) sanctioned by the Criminal Code (Art. 129), the new law (Art. 36) incriminates the so-called “unlawful abortion” taken by the physician (delictum proprium). Thus, the provision overlaps with a part of prohibited acts provided in the Criminal Code and inconsistency, also exists in terms of the prescribed penalties - according to the Criminal Code, sentence of imprisonment (Par. 1) is set in a range from three months to three years, and the Law on termination of pregnancy, prescribes imprisonment for a period from six months to three years. Also, the sanctions for the legal entity – the health care institution - may not correspond with the general provisions of the Criminal Code, which regulate the liability of the legal entities and the conditions for imposing appropriate sanctions (Art. 96-c) .Additional legal regulation is also relevant for the issues imposed in, that is the Law on Medical Products and Medical Devices, which is the fundamental legal resource in the pharmaceutical area. The law, adopted in 2007,75 is aimed towards supplementing and clarifying the issues in the area of pharmacy and pharmaceutical law. After its adoption, few changes and amendments were made, where the last ones in 2012, were primarily motivated by the need to strengthen the criminal law protection in the pharmaceutical sphere. In this context, five new incrimination (Article 156-a - 156-d) whose main purpose is to supplement the system of criminal activities in the field of pharmacy were introduced76.

Everything above-mentioned confirms the original thesis that in the recent years there is a remarkably enhanced international and national activity in the process of creating solutions from the medico-legal area. The general impression is that the rapid advances in technology and medical technology in particular, new discoveries in the field of medicine and biology and interest in improving the safety of the patients become one of the major concerns not only in the global framework, but they are slowly penetrating also on a national level. Through the prism of national medical law, a significant progress has been achieved with the modernization of existing legislation through the establishment of new legal solutions that are in line

75 Untill its adoption the central issues from the area of pharmacy and pharmaceutical law were regulated by the Law on drugs, assisting medicines means and medical devices, Official. Gazette of RM No. 21/98.

76 Kiprijanovska D. Kaznenopravni aspekti na farmacevtskata dejnost (Criminal Aspects of Pharmaceutical Profession). Skopje: Legal Journal “Legal Dialogue”. 2012 September; 7:4-20.

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with the international standards and modern European legislation. The medical law is under reform that is to be achieved through the adoption of new regulations and correction of the existing provisions. Perhaps it only seems like that satisfactory level of appropriate consistency and coherence has been achieved. It imposes the need of further review and innovation of solutions embedded in the corresponding medico-legal legal acts in terms of their (additional) specification, harmonization, i.e. avoiding certain overlap with provisions of other laws, thus introducing new legal provisions that will mean strict adherence of the fundamental values of the person. Modifications are needed in more regulations and, above all, in the Law on Protection of Patients` Rights and in the Law on Biomedical Assisted Insemination, including, among other issues, criminal law provisions having in mind that some of the prescribed offenses represent more severe type of unlawful acting and deserve to be raised to the level of criminal law prohibitions. Also, the Law on termination of pregnancy should undergo some corrections because the existing solutions as they are formulated rep r esent serious, flagrant violation of the fundamental rights of the pregnant woman. Along with it, the subject of theoretical debate should also be the issues on the scope of protection of the embryos. On the comparative level, the legal status of the embryo is one of the crucial point around which the physicians, philosophers, moralists and lawyers debate. Different assumptions about the status of an embryo have led to different conclusions about the appropriate protection, both in terms of its starting point and its level. These different arguments have been combined in various ways. As a result of these combinations, different positions on its legal status are defined. In Macedonia, however, these issues remained, for a longer period, unjustifiably outside the focus of the scientific interest. Tabooing certain issues or subjects of science would be a contradiction in itself. We are dealing with a hypersensitive area, not only from the aspect of the consequences but from the point of view of the “subjects” that are affected as well.

The next phase of the reform of the medical legislation must not detour the pharmaceutical law, especially in the part of the provisions that regulate clinical trials of drugs (when it is contrary to the regulations), and the legal descriptions of the criminal acts embedded in the last novel of the law should also be reconsidered. The emphasis should be placed on the provisions positioned in the systematics of the special part of the Criminal Code, i.e. criminal offenses against human health. An issue concerning the necessity of introducing new incriminations in the medical field (unlawful medical acts or medical offenses) and prescribing appropriate sanctions (primarily

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prohibition to perform profession, activity or duty) for the offenders, has been raised. One of the central themes that should be comprised by the next novel should be the one relating to the legal regulation of medical error, thus allowing an outcome of (traditional) vicious circles of repeating mistakes in medicine and also obeying the “law on silence” as well as consistent adherence to the principles of medical solidarity.

One is the issue of codification of this matter, but even greater importance is attached to the monitoring process of its dynamics and compliance with the development and achievements of contemporary medicine and biotehnology and respect of the rights and interests of the patients, which should be of a primary concern when taking any (bio) medical therapeutic, and even more interventions of an experimental character.

Med Law (2014) 33:64- Medicine and Law

©PROBOOK 2014

64

PERCEPTIONS OF PEOPLE LIVING WITH HIV/AIDS REGARDING ACCESS TO HEALTH CARE

Vina Vaswani* and Ravi Vaswani**

Abstract: Although the health care is replete with technology in the present day, it is not freely accessible in a developing country. The situation could be even more compromised in the case of people living with HIV/AIDS, with the added dimension of stigma and discrimination. What are the factors that act as barriers to health care? This study was conducted to look into perceptions of people living with HIV/AIDS with regard to access to health care. The study looked into accessibility of general health vis-à-vis access to antiretroviral therapy. Demographic variables like age, gender, income were studied in relation to factors such as counseling, confidentiality, stigma and discrimination, which are known to influence access to health care. People living with HIV/AIDS perceive general health care as more accessible than care for HIV treatment. Discrimination by health care workers causes a barrier to accessibility.

Keywords: Access to Healthcare; Stigma; Discrimination; People Living with HIV/AIDS.

Specialization in all disciplines of medicine has raised the standard of medical care but has also escalated its cost and placed specialist medical care beyond the means of an average citizen. This has resulted in infringement of basic tenets of socialism and utilitarianism (that is the greatest good of the greatest number) paving way for economic control over medicine. This has dichotomized the human race into the haves and the have-nots.

Health systems are intended to deliver health services through planning, determining, prioritizing, mobilizing and allocating the resources. Over a billion people in developing countries have too low an income to access any kind of health care service1. Specialization has contributed to the decline of

1 Park J and Park K. Park’s Textbook of Preventive and Social Medicine. 2004. 18th Ed Banarsidas

Bhanot Publishers: 28

* Director, Centre for Ethics, Yenepoya University, Mangalore** Professor and Head, Department of Internal Medicine, Yenepoya University,

Mangalore. Address for Correspondence: Director, Centre for Ethics, Yenepoya University, Deralakatte, Mangalore 575018, Karnataka, India . Email: bioethics@yenepoya.edu.in

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the general practice and the general practitioner who was the torchbearer of the medical care system now stands in isolation2.

John Bryant in the introduction to his book “Health and the Developing world” presented the challenges of inequalities in health by pointing that…“Large number of world’s people, perhaps more than half, has no access at all, and for many of the rest, the care they receive does not answer the disease they have”3.

Health is a fundamental human right. This implies that the state is responsible for the health of its people. Health care is an expression of concern for fellow human beings. In many countries, it is largely a government function. Health care is a larger component, which also includes medical care.

In an increasing number of societies, health is no longer accepted as charity, or the privilege of a few, but demanded as a right for all. Right to health care is an implicit right, linked to the right to life, according to Article 21 of the Constitution of India4. For this right to have significant impact, it needs to be made explicit and justiciable. The Universal Declaration of Human Rights (UDHR - 1948); Article 25, states: “Everyone has a right to a standard of living, adequate for the health and well-being of himself and his family”. If this is a fundamental right then there is a presumable duty laid on the governments to implement it5.

As of 2011 an estimated 34 million people were living with HIV worldwide. 95%of people living with HIV/AIDS (PLHAs) live in low- and middle-income countries. An estimated 23 million alone live in sub-Saharan Africa. By the end of 2012, only 9.7 million people had access to antiretroviral therapy. Treatment, for millions, is unavailable or inaccessible. According to the World Health Organization (WHO) global statistics, nearly 26 million are eligible to receive antiretroviral therapy (ART)6.

Human Immunodeficiency Virus (HIV) infection rates have decreased the world over with new infections in 2011 being 20% lesser than in 2001.

2 Noble, John. Primary Care and the Practice of Medicine. 1976. Boston, Little, Brown and Co.

3 Bryant J. Health and the Developing World. Cornell University Press, Ithaca, NY. 1969.4 Austin G. The Indian Constitution: Cornerstone of a nation. 1966, Reprint 1999.

Oxford UniversityPress, New Delhi: 655 http://www.un.org/Overview/rights.html. Adopted and proclaimed by General

Assembly resolution 217 A (III) of 10 December 19486 http://www.who.int/mediacentre/factsheets/fs360/en/index.html

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However, certain pockets have shown undesirable increases. The Middle East and North Africa showed an increase in incidence up 20% from 20017.

As per the National AIDS Control Organization, HIV estimates in India for year 2009 (reported in 2011) is 120,000 new cases, representing a 50% decline from 20018. The National AIDS Control Organization, under the auspices of the Ministry of Health and Family Welfare, updates the HIV estimates for the country every year since 1998 for monitoring the trends and pattern of HIV/AIDS epidemic in the country.

The HIV burden is estimated on the basis of the HIV prevalence observed at designated sentinel surveillance sites for different risk groups. People who have high-risk behavior for HIV infection include those attending STD clinics, MSM (men having sex with men) and FSW (female sex workers) intervention centers and drug de-addiction centers. Antenatal clinics attendees are considered representatives of the general population. Blood samples collected from respective risk groups are tested for HIV following ‘unlinked anonymous’ procedure at regular intervals annually. The data thus compiled is used for epidemiological analysis and estimation purpose.

One of the major barriers to accessing health care for PLHAs is the possibility of stigma and discrimination from society, family and even the health care system. Due to lack of total cure, HIV AIDS disease had evoked fear responses in human beings beyond the realm of natural reaction.

Parker and co-workers narrate that Jonathan Mann, former Director of the WHO Global Program on AIDS, spoke of three stages of the HIV/AIDS epidemic: the HIV epidemic, the AIDS epidemic and the epidemic of stigma and discrimination, and this last one, is as pivotal to the issue of controlling the epidemic as any other9.

7 http:/ /www.unaids.org/en/media/unaids/contentassets/documents/epidemiology/2012/gr2012/20121120_UNAIDS_Global_Report_2012_en.pdf

8 http://www.naconline.orgOfficial Website of the National AIDS Control Organization of India

9 Parker R, Aggleton P, Attawell K, Pulerwitz J, Brown L. HIV AIDS Related Stigma and Discrimination: A conceptual framework and agenda for action. The Population Council. May 2002. http//:pdf.dec.org/pdj_docs/pnacq832.pdf

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Stigma has been defined as “a dynamic process of devaluation that significantly discredits an individual in the eyes of others”10. When stigma is enacted upon, the result is discrimination. From the start of the global HIV/AIDS epidemic, stigma and discrimination have fuelled the transmission of the disease and have greatly increased the associated negative impact. This stigmatization drives the affected population underground resulting in denial of the problem, resistance to voluntary testing and delay in health care delivery. Every now and then the media highlights stories of societal stigma against PLHAs, even till as recently as this year. A national daily reported protest by parents of non-HIV children, when the school admitted 26 HIV positive children11, HIV/AIDS has come to India in a big way and there is significant stigma and discrimination, at societal level, against people living with HIV AIDS.

This study was undertaken to assess the perceptions of People living with HIV AIDS with respect to the accessibility of the health care system and to assess their perceptions about the role of stigma and discrimination in the denial of this access. The research tool was a structured and validated questionnaire that was used to assess responses of PLHAs.

The research methodology involved

♦ Identifying the study population of people living with HIV/AIDS

♦ Informing them about the study

♦ Taking valid consent

♦ Administering the questionnaire

♦ Tabulating the responses on a scale

The subjects for the study were enrolled from a nearby HIV/AIDS Care and Support Center. Ethical clearance was taken for the study.

Informed consent was taken from all the participants and they were given a 15-item questionnaire (n=52). The questions addressed several issues

10 Goffman E. Stigma: Notes on the management of a spoiled identity. 1963. New York. Simon and Schuster

11 http://www.indianexpress.com/news/admission-to-hivpositive-kids-prompts-protest-in-gujarat-village/1138471/

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including the known duration of the disease, awareness of the long term consequences, the issue of counseling, the perception of the participant regarding stigma and discrimination by health care providers and access to health care facilities. Each of the questions required the participant to grade his perceptions on a Likert type scale of 1-4, ranging from negative perceptions “1” to positive perceptions “4”. In the event of the participant being unable to read, the same questions were translated into the individual’s native language and the responses recorded with the help of a medical social worker and counselor. In all, the questionnaires were distributed to 60 people living with HIV/AIDS from which52 completed questionnaires were returned.

RESULTS: 34 were males and 18 females. The youngest was 14 years old and the oldest was 65 years. The bulk of the patients were in the economically fruitful age groups of 21 - 50 years (Table 1; Figure 1). Only five out of the 52 were uneducated and 24 (46%) were educated till primary level (Table 2; Figure 2). Table 3 and figure 3 provide details on the income levels of the participants. The participants were grouped into four groups based on the duration of their illness: <1 year (1). 1 to 3 years (2), 3 to 5 years (3) and>5 years (4). The subjects were roughly equally divided (Table 4; Figure 4)

Pre and post-test counseling are generally not done by physicians or treating doctors. Nor are they referred to a counselor. One person recollected that some years ago, when admitted to a hospital, “…my blood was taken and suddenly a day later, I could perceive open hostility in the doctor and nurse, and I was immediately advised to take discharge and leave the hospital. Much later when I consulted another doctor was I informed that I was HIV positive. The shock was unbearable…..” With the Government starting the Voluntary Counseling and Testing Centers at all the district hospitals, the scene has improved somewhat. Notwithstanding this, our study showed a poor percentage of satisfactorily done pre and post-test counseling (15% and 27% respectively). No pre and/or post-test counseling at all, were reported by 67% and 46% respectively. In the remaining, it was done either cursorily or inadequately (Table 5; Figure 5). Forty percent participants never had their consent taken for HIV testing and only in 29% of the cases a proper informed consent was taken (Table 6; Figure 6). Thirty five percent of the participants reported proper maintenance of confidentiality. In the other cases, confidentiality was breached at varying levels, either to family members, excluding spouse, or to health care worker or both (Table 7; Figure 7).

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This study looked into the issue of discrimination by health care workers as perceived by people living with HIV/AIDS, with respect to doctors, nurses and other health care workers. 24 of the participants (46.15%) reported no perception of discrimination by doctors. The remaining 54% perceived some level of discrimination. In the case of nurses, 21 respondents (40.39%) perceived no discrimination during their previous hospital admissions. Nearly 60% of the responders felt some amount of discrimination by nurses.

Discrimination by family and community are also indirect reasons for PLHAs not accessing health care. The most obvious reason is the lack of support, both physical and financial. This study looked into the perceptions of PLHAs regarding the discrimination done against them by their family and the community.

Perceptions about the degree of discrimination by family members and community were roughly equally divided, with approximately one quarter each perceiving no, little, some or significant discrimination. Four responders perceived unfairness due to loss of job on the knowledge of their HIV positive status. We report high levels of discrimination perceived by the people living with HIV/AIDS, perpetrated by all groups of people concerned with their access to health care (Table 8; Figure 8).

In an attempt to know in which areas of the health care these perceptions of discrimination came through strongest, we tried, in this study, to determine which areas of health care, during their admission to hospital or during attempts to access health care, the participants perceived discrimination. Six participants reported refusal of surgery due to their HIV status. 22 respondents reported discrimination during the admission process and 23 during physical examination. The maximum discrimination (27) was perceived in the hospital stay, during which the PLHAs felt nurses and other health care providers were more hostile and intimidating (Table 9; Figure 9).

This study looked at access to general health care (not involving antiretroviral therapy) under the following parameters: physical access (distance and transport facility), economic access and information access. Physical accessibility proved to be the most notable barrier, while accessibility of information as a barrier ranked the lowest. .

The Government of India, under the aegis of the World Health Organization, has been giving free ART in certain select centers across the country. For logistical reasons these centers have been selected not because of the high

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population of PLHAs, but because of infrastructural and political ease of administration. However, the country is way below the expected target, both in terms of the general population and the prevention of parent to child transmission program12.

The participants in this study, very nearly unanimously reported that antiretroviral therapy, being provided free, was initially physically inaccessible, but has improved in the last few years. They felt that till ART was available only in Bangalore, it was economically inaccessible also, as it entailed staying for a month in Bangalore, with an accompanying person, before receiving a month’s supply and then visiting the state capital once every month. Ever since ART has become available in all district hospitals, all respondents reported that it has become easily accessible, with respect to all parameters.

When asked to rate the overall perception about their experience with regard to accessibility, affordability, awareness and attitudes of health care providers, the response varied from “very bad”(19- 36.54%) to “bad”(21- 40.38%), with not even one responder perceiving the health care system to be easily accessible or the overall perception to be very good (Table 11; Figure 11).

Comparing demographic data (age, sex, education, income and occupation) in the two areas of access to general health and access to ART we see, from Table 12, that before the advent of free ART, income was the most significant demographic parameter that altered the economic and physical accessibility of patients living with HIV/AIDS to both the general health care and antiretroviral therapy. Further, we observe that in the case of access to ART, economic access is affected by gender (males accessed better), occupation level and income level of the subjects. Physical access was also significantly affected by the income status of the PLHA. Income played a significant role in the economic access to both, general healthcare as also ART care, lower incomes were associated with decreased access.

Discussion: This study was carried out in a Comprehensive Care Centre for HIV/AIDS and included 52 adult people living with HIV/AIDS (PLHAs) who filled in a 15-item questionnaire enquiring into their perceptions about the quality of pre and post-test counseling, confidentiality and privacy,

12 Rahangdale L, Bannandur P, Sreenivas A, Turan J, Washington R, Cohen CR. Stigma as experienced by women accessing prevention of parent to child transmission of HIV services in Karnataka, India. AIDS Care. 2010 July; 22(7): 836-42.

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stigma and discrimination. The questionnaire also attempted to evaluate the level of contribution from different members of the health care team and in the different physical areas of the health care facility. Finally, the questionnaire sought to identify the perceptions about barriers to accessing treatment with antiretroviral therapy, before and after the government’s attempts to provide free medications under the WHO scale up program.

Participants were asked about their perceptions on pretest and posttest counseling. 85% reported that either pretest counseling was not done, or was unsatisfactory. 75% participants responded in the same manner, on the issue of posttest counseling. Consent was reported as adequately taken in less than one-third (28.85%). In the remaining 71% patients, it was either not taken at all or the participant was misled or the process was perceived as inadequate. Likewise, confidentiality was respected in only 34% people and in the remaining, the trust and confidence of the patient was breached. Benteyerga and co-workers13 (2004) have reported that many PLHAs in Ethiopia reported poor quality of counseling because health care workers feel it takes up too much time. Mahendra et al14 (2007) found that in India, health care providers commonly did not do pretest counseling for patients suspected to have HIV/AIDS.

We looked into the matter of discrimination, working on the premise that people living with HIV/AIDS would avoid accessing health care services if they perceived that the very people who are supposed to take care of their health are stigmatizing and discriminating against them. Likewise, they would be less likely to access health care if their families and community did the same. Nearly one third of the patients perceived obvious discrimination by doctors (28.85%). The same was the outcome of the perceptions about nurses, family and community. Though the actual figures varied, the broad picture was very obvious and disturbing. Reis et al (2005), report from

13 Banteyerga H, Kidanu A, Nyblade L, MacQuarrie K, Pande R. Exploring HIV AIDS stigma and related

discrimination in Ethiopia: Causes, Manifestations, Consequences and Coping mecha nisms. Miz-Hasab

Research Centre and International Centre for Research on Women. Addis Ababa. 2004 Jan.

14 Mahendra VS, Gilborn L, Bharat S, Mudoi R, Gupta I, George B et al. Understanding and measuring

AIDS-related stigma in health care settings: A developing country perspective. Journal of Social Aspects

of HIV/AIDS. 2007 Aug; 4(2):6-6-25.

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Nigeria that nearly 10% of the doctors who were anonymously interviewed, agreed to have discriminated against PLHAs15.

The area of access to health care was divided into two spheres; to look at perceptions with regard to general health care and also at access to antiretroviral therapy. Three parameters were looked at: physical accessibility, economic accessibility and information accessibility. In gestalt, general health care was perceived as fairly well accessible, with only 10 (19%), 5 (10%) and 3 (6%) people perceiving it as totally inaccessible. When it came to antiretroviral therapy, the first question asked was regarding information access. Little less than two-thirds (32 out of 52) were either totally unaware of, or had a vague idea about antiretroviral therapy being provided free of cost by the government. Next, they were asked about affording ART. When self-sustenance was ruled out, the participants were asked to rate the economic ability to access free ART at Bangalore (at a distance of 350 kilometers). Finally, they were asked how physically accessible they perceived ART (either private or government sponsored) to be, in the days before ART was available locally. 92% of the people felt that antiretroviral therapy, then, was physically and/or economically inaccessible, but after ART was made freely available this was neutralized. Informational access fared comparatively better with roughly 2/3 finding information about ART inaccessible and 1/3 finding it accessible. UNAIDS’ HIV Drug Access Initiative (DAI), aimed at providing wider access to HIV-related drugs in developing countries, was launched in November 1997. Four countries, Chile, Côte d’Ivoire, Uganda and Vietnam, participated. Msellati and colleagues15 (2003) conducted a cross-sectional survey, from December 1999 to February 2000, in the Côte d’Ivoire. The questionnaire included eleven questions dealing with patients’ socio-economic status including variables about their practical conditions of living (such as living in collective housing, an indicator of poverty). Additional questions dealt with the following items: knowledge of HIV status, circumstances of HIV testing and date of HIV diagnosis, sexual behaviours, psychological and health status, quality of life, health

15 Msellati PA; Juillet-Amari AB; Prudhomme JC; Akribi HAD; Coulibaly-Traore DE; Souville MF et al.

Socio-economic and health characteristics of HIV-infected patients seeking care in relation to access to

the Drug Access Initiative and to antiretroviral treatment in Cote d’Ivoire.AIDS. 2003 Jul; 17 (Suppl

3):S63-S68.

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care-seeking behaviour and history of access to HIV care, impact of disease on resources of the household, family and social support, disclosure of HIV sero-status to others, knowledge and beliefs about HIV treatments and awareness of the DAI. Of the 711 respondents, less than one-third (29.6%) knew about the existence of an initiative offering access to ARVs. Although women accounted for 48.9% of the total sample, this proportion was significantly higher among those included in the DAI than in the rest of the sample (55.0 versus 45.8%, p = 0.026). Not being ART treated and not having access to the DAI was significantly related to being a male, not having health care insurance, having a low level of education and living in poor housing conditions. According to the authors, information access was not as widespread as it should have been, since more than 60% of patients in the non-DAI group in their sample had never heard about it. A recent knowledge of HIV status (less than 9 months) was associated with non-access to DAI.

In conclusion, this study brings out the perceptions that after nearly three decades of HIV and despite major advances in the treatment of HIV, many people living with HIV/AIDS still perceive and experience stigma and discrimination from health care workers and this adversely affects their access to health care, which leads to increasing the burden of the disease.

Med Law (2014) 33:74- Medicine and Law

©PROBOOK 2014

74

Index Volume 33 No. 1

AAccess to Healthcare: 64.

BBioethics: 22-3, 27-8, 30-3, 36, 38-40, 45-7,

56-7.

CCardiac Devices: 14. Causal Nexus: 2, 4.Civil Liability: 2-3.

DDefibrillator: 14.Discrete Body of Law: 22. Discrimination: 64, 66-9, 71, 73.

EEngland and Wales: 22-3, 26, 28, 30-1, 36, 38.

FField of Law: 22, 29-30, 33.

HHealth Care Law: 22-6, 49, 57.Health Law: 14, 25, 36, 49-50.Human Rights: 8-9, 40, 48, 53-8, 65.

IInternational Standards From the (bio) Medical Sphere: 40, 53.Introduction of a New Offense: 2.

75Medicine and Law

Index Volume 33 No. 1 (continued)

LLaw: 3-6, 9-12, 14, 22-6, 28-9, 32-7, 39-

42, 46-51, 53, 57-63.Legal Value of the Embryo: 2, 7.Life-Sustaining Treatment: 14, 17.Loss of Embryos: 2-3, 5-8, 12.

MMacedonian Medical Legislation: 40, 57. Medical Ethics: 14, 22, 27-8, 30-2, 39-40, 42-7, 57. Medical Jurisprudence: 14.Medical law: 22-6, 35-6, 40, 45, 48-51, 53, 55,

57, 60-2.Medico-Legal Branches: 40.

NNon-Pecuniary Damages: 2, 4.

PPacemakers: 14.Pecuniary Damages: 2, 4. People Living with HIV/AIDS: 64-5, 67-71, 73.

SStigma: 64, 66-8, 71, 73.

TThe Changing Face of Medicine: 40.

U Unlawful Medical Act (s): 40.

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