12
What Is Complementary/Alternative Health Care? Complementary/alternative health care is also referred to as complementary and alternative medi- cine or CAM. CAM includes all health systems and therapies based on theories about the causes and treatment of ill health that are different from “con- ventional” medicine: examples include Ayurvedic medicine, Traditional Chinese Medicine, and some Aboriginal healing traditions, which rest on differ- ent systems of belief and understanding about ill- ness and health. CAM also includes therapies that may work in a fashion that can be explained by basic principles of conventional medicine, but which haven’t been val- idated by conventional scientific methods. For example, if a given herbal mixture or natural sub- stance is used to treat cancer, the chemical effects of the substance could be described, but perhaps conventional science either can’t explain how the substance could help in treating cancer, or perhaps the evidence doesn’t show that the substance is effective. Because CAM includes a wide range of therapies and health systems, it’s important to avoid general- izations. As with conventional medicine, some CAM has been shown to be safe and effective for some purposes, while some therapies or practices are known to be harmful and/or ineffective. For many, there isn’t enough evidence to make any firm evaluation of safety or effectiveness. Categories of CAM The National Center for Complementary and Alternative Medicine at the US National Institutes of Health has identified five categories for classify- ing CAM: alternative medical systems (eg, traditional Chinese medicine, Ayurveda, Aboriginal sys- tems, homeopathy, naturopathy); mind–body interventions (eg, meditation, hyp- nosis, art therapy, prayer, and mental healing); biologically based therapies (eg, herbal thera- pies, special diet therapies, animal substances); manipulative and body-based methods (eg, chi- ropractic, osteopathic manipulation, massage therapy); and energy therapies (Qi gong, reiki, therapeutic touch). Some say these categories are artificial, or irrelevant to a “holistic” perspective that underlies many CAM therapies, and that such a breakdown is root- ed in a “biomedical” understanding of illness and health. What is Complementary/ Alternative Medicine? Who Uses it and Why? This info sheet reviews what is known about how commonly people use complementary/alternative health care, and the reasons people use it. This is one of a series of 5 info sheets on complementary/alternative health care and HIV/AIDS. 1.What is CAM? Who Uses it and Why? 2. Ethical Issues and the Use of CAM 3. Natural Health Products: Regulatory Issues 4. Regulating CAM Practices and Practitioners 5. Key Resources Complementary/ Alternative Health Care and HIV/AIDS 1

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Page 1: Complimentary Alternative Healthcare and HIV/AIDS€¢ energy therapies (Qi gong, reiki, therapeutic touch). Some say these categories are artificial, or irrelevant to a “holistic”

What Is Complementary/AlternativeHealth Care?Complementary/alternative health care is alsoreferred to as complementary and alternative medi-cine or CAM. CAM includes all health systems andtherapies based on theories about the causes andtreatment of ill health that are different from “con-ventional” medicine: examples include Ayurvedicmedicine, Traditional Chinese Medicine, and someAboriginal healing traditions, which rest on differ-ent systems of belief and understanding about ill-ness and health.

CAM also includes therapies that maywork in afashion that can be explained by basic principles ofconventional medicine, but which haven’t been val-idated by conventional scientific methods. Forexample, if a given herbal mixture or natural sub-stance is used to treat cancer, the chemical effectsof the substance could be described, but perhapsconventional science either can’t explain how thesubstance could help in treating cancer, or perhapsthe evidence doesn’t show that the substance iseffective.

Because CAM includes a wide range of therapiesand health systems, it’s important to avoid general-izations. As with conventional medicine, someCAM has been shown to be safe and effective forsome purposes, while some therapies or practicesare known to be harmful and/or ineffective. Formany, there isn’t enough evidence to make anyfirm evaluation of safety or effectiveness.

Categories of CAMThe National Center for Complementary andAlternative Medicine at the US National Institutesof Health has identified five categories for classify-ing CAM:

• alternative medical systems (eg, traditionalChinese medicine, Ayurveda, Aboriginal sys-tems, homeopathy, naturopathy);

• mind–body interventions (eg, meditation, hyp-nosis, art therapy, prayer, and mental healing);

• biologically based therapies (eg, herbal thera-pies, special diet therapies, animal substances);

• manipulative and body-based methods (eg, chi-ropractic, osteopathic manipulation, massagetherapy); and

• energy therapies (Qi gong, reiki, therapeutictouch).

Some say these categories are artificial, or irrelevantto a “holistic” perspective that underlies manyCAM therapies, and that such a breakdown is root-ed in a “biomedical” understanding of illness andhealth.

What isComplementary/

AlternativeMedicine?

Who Uses it and Why?

This info sheet reviews what is known about how commonly people use complementary/alternative health care,

and the reasons people use it.

This is one of a series of 5 info sheets on

complementary/alternative health care and HIV/AIDS.

1.What is CAM? Who Uses it and Why?

2. Ethical Issues and the Use of CAM

3. Natural Health Products: Regulatory Issues

4. Regulating CAM Practices and Practitioners

5. Key Resources

Complementary/AlternativeHealth Care

and HIV/AIDS

1

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Use of CAM by CanadiansResearch has shown that a significant and rapidlyincreasing number of Canadians have used CAM. Themost recent, comprehensive information availablecomes from a study undertaken in 1997 (Ramsey et al,1999). It shows that 73% of Canadians had used someform of CAM at least once, and 50% had used CAMin the past year. The researchers estimated that in 1997Canadians spent about $1.8 billion on visits to CAMproviders and another $2 billion on products such asherbal medicines, vitamins, diet programs, and relatedbooks.

Use of CAM by People with HIV/AIDSThere are only a few studies into the use of CAM bypeople with HIV/AIDS in Canada. Some conclusionscan be drawn: (1) There is a high variation in overalluse of CAM among people with HIV/AIDS. Studiesdone in BC and Ontario showed rates of roughly 40%and 80%, respectively; (2) It appears that womenliving with HIV use CAM more frequently than men;(3) People with HIV/AIDS most commonly use mas-sage, acupuncture, vitamins, supplements, and herbalproducts; (4) Overall, many people with HIV/AIDSsay that using CAM has made them feel better.

As with Canadians in general, there are many rea-sons why people with HIV/AIDS use CAM. Studiesshow that most use CAM in addition to their conven-tional medical treatment, rather than as an alternative.Some of the most common reasons include: takingactive control over one’s own health care; boostingimmune function; lowering viral load and preventing,delaying, or treating symptoms of HIV disease pro-gression or opportunistic infections; helping with sideeffects of conventional therapy; helping relieve stress,depression, and fatigue, thereby improving generalwell-being; taking a more “holistic” approach to theirhealth.

One small study looked in more detail at the atti-tudes of people with HIV/AIDS toward CAM(Pawluch et al, 1998). Women mentioned additionalreasons for using CAM, such as keeping themselveshealthy to look after family; feeling that conventionalmedicine was neglecting their needs; and feeling thatCAM was “more natural” and “less toxic.”

Aboriginal and black people with HIV/AIDS tendedto be more familiar with CAM and, by using it, some

felt less dependent on medical institutions perceived asinsensitive or racist. Among those with a history ofdrug use, some felt that, unlike conventional medica-tions, CAM therapies were a non-addictive way ofdealing with pain and stress.

Aboriginal People & Traditional HealingMany Aboriginal healing practices that non-Aboriginalpeople may consider “alternative” or “unconventional”are conventional or traditional from their perspective.

Unlike “Western medicine,” which often involvesspecific practices to treat symptoms or disease, tradi-tional Aboriginal healing practices generally see manydimensions to “health,” and aim at restoring balancebetween mind, body, emotion, and spirit.

There is little documented research on the experi-ences of Aboriginal people with HIV/AIDS and theirapproaches to health care. One pressing need identi-fied by the Royal Commission on Aboriginal Peoplesis for “people who can apply Aboriginal knowledge tocurrent health problems and combine traditional healthand healing practices with mainstream approaches tobuild distinctive Aboriginal healing systems.”

Conclusions & Recommendations(1) Many Canadians use CAM as part of their healthcare. There is a need for research and for patient andprovider education. We also need to consider how toregulate the field of CAM to properly balance patients’right to make informed decisions about their healthcare, the use of public money for health care, and theprotection of consumers’ health.

(2) There is a need for research in areas such as: the useof CAM by people with HIV/AIDS; the safety andeffectiveness of those therapies; where and how peoplewith HIV/AIDS get their information about CAM; howto make reliable treatment information accessible; theinterface between how people with HIV/AIDS use con-ventional medicine and CAM; and the barriers (such ascost) that people with HIV/AIDS face in accessingCAM.

(3) Research with and within Aboriginal communitiesmust respect principles of community ownership andcontrol over, and access to, research methods andresults, including enforceable legal protections for tra-ditional knowledge.

The information in this series of info sheets is based on a report prepared by Crouch, Elliott, Lemmens, and Charland for the Canadian HIV/AIDS Legal Network:

Complementary/Alternative Health Care and HIV/AIDS: Legal, Ethical and Policy Issues in Regulation.Additional reading can be found in info sheet 5. Copies of the report and

info sheets are available at www.aidslaw.ca/Maincontent/issues/care-treatment.htm or through the Canadian HIV/AIDS Clearinghouse (email: aids/[email protected]).

Reproduction is encouraged, but copies may not be sold, and the Canadian HIV/AIDS Legal Network must be cited as the source of this information. For further infor-

mation, contact the Network at [email protected]. Ce feuillet d’information est également disponible en français.

Funded by Health Canada under the Canadian Strategy on HIV/AIDS.The views expressed are those of the author and do not necessarily reflectthe views or policies of the Minister of Health.

©Canadian HIV/AIDS Legal Network, 2001

WHAT IS COMPLEMENTARY/ALTERNATIVE MEDICINE?

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Complementary/AlternativeHealth Care

and HIV/AIDS

2Applying Four Ethical Principles toRegulating CAMFour basic ethical principles are helpful in consid-ering the ethical questions raised in regulatingCAM. The principle of non-maleficenceguides usto “do no harm” when our actions can affect others.The principle of beneficencedirects us to bringabout the good of others, whenever possible. Theprinciple of respect for personal autonomyrequiresus to respect the choices and actions of people whenthey act voluntarily and with adequately understoodinformation. Principles of justicerequire a fair dis-tribution of resources or of opportunities to accessresources, as well as fair compensation for harmsand wrongs.

Non-MaleficenceAs with conventional medicines, CAM may carryboth risks and benefits to users.

Some CAM may cause direct physical harm. Anatural substance could be intrinsically harmful tohealth; it could be contaminated with some toxin; itcould be unknown how much is safe to use; it mayprovoke an allergic reaction; or people could beharmed by interactions between herbal productsand conventional medications.

There may also be indirect physical harmas aresult of delaying or avoiding the use of a conven-tional treatment known to be effective.

Harm may also come from financial or emotionalexploitation. Financial exploitation can happen ifan unethical practitioner or manufacturer takesfinancial advantage of patients by misleading themabout a therapy’s safety or effectiveness. Peoplewhose expectations are misleadingly built up, onlyto go unmet when therapy fails, are also harmed byemotionalexploitation.

Ethical implications: (1) Both conventional andCAM health-care practitioners have an ethical dutyto obtain information from their patients about theiruse of CAM and of conventional therapies. Theyneed to become familiar with these therapies andtheir possible interactions, so they can help patientsmake informed decisions and avoid harm. (2) Giventhe widespread use of CAM, safety research intothe most widely used CAM therapies is ethicallyrequired. Priority should be given to researchingthose CAM therapies most widely used by peoplewith HIV/AIDS, or for which there is evidence ofknown or potential negative effects. (3) Qualitycontrol, which is lacking for many CAM therapies,is ethically required to protect users from harm.This includes measures such as “good manufactur-ing practices” for natural health products, and label-ing guidelines. It may require standard-setting forCAM practitioners who are currently not regulated.

Ethical Issuesand the Use of

CAM

This info sheet reviews four basic ethical principles (non-maleficence, beneficence, respect for personal autonomy, and

justice) in the context of the use of CAM, and discusses implicationsfor research, education/training, and regulation.

This is one of a series of 5 info sheets on

complementary/alternative health care and HIV/AIDS.

1.What is CAM? Who Uses it and Why?

2. Ethical Issues and the Use of CAM

3. Natural Health Products: Regulatory Issues

4. Regulating CAM Practices and Practitioners

5. Key Resources

Page 4: Complimentary Alternative Healthcare and HIV/AIDS€¢ energy therapies (Qi gong, reiki, therapeutic touch). Some say these categories are artificial, or irrelevant to a “holistic”

BeneficenceEthical health-care practice (whether conventional orCAM) requires that patients benefit, or that there be areasonable prospect they will benefit, from a giventherapy. Are the risks adequately balanced by knownbenefits or those that can reasonably be expected?

Assessment is often difficult in the case of CAM forat least two reasons. First, there is reliable evidence ofbenefit in some cases of CAM, but in many cases it isnot available. Second, there are differences betweenCAM therapies and conventional treatments that insome cases make it difficult to assess the effectivenessof CAM therapies using conventional scientificresearch methods. For example, it may be impossibleto do a randomized, placebo-controlled trial for somekinds of CAM, but it may well be possible to developscientifically rigorous research into other forms ofCAM. And research focusing on patient outcomesmay still be useful, even if it does not provide a fully“scientific” explanation for how a therapy works.

Ethical implications: Given that ethical practicerequires benefits to patients, there is an ethical duty toresearch the effectiveness of CAM therapies. Withoutreliable data, practitioners lack an adequate basis fortreatment suggestions, in which case patients cannotexercise their right to informed decision-making.

In evaluating any treatment, it is prudent to adopt amore cautious stance toward risk/benefit analysis andto err on the side of caution. But there should not be adouble-standard: many conventional medical treat-ments are not based on clear results from clinical tri-als, and it would not be in patients’ best interests towithhold access to at least relatively safe therapiesuntil all the scientific evidence is in.

Respect for Personal AutonomySome argue that the unrestricted use of CAM shouldbe permitted because the worry over risks and ques-tionable benefits of many CAM therapies (as withexperimental conventional medications) should notmuch matter,provided thatpeople with HIV/AIDSmake competent, voluntary decisions.

But this is precisely the problem. If we are to respectpersonal autonomy, efforts must be made to ensurethat people have reliable information about the risks

and benefits of alternative therapies. Any claim tounconstrained access to a therapy based on respectingthe individual’s autonomy is weakened where thatperson’s autonomy is weakened because they lack theinformation needed to make an informed choice.

Ethical implications: (1) Information about the risksand benefits of CAM must be given directly to people,through measures such as adequate labeling of natur-al health products or requiring practitioners to discusswhat evidence exists for the safety and effectivenessof a given therapy. (2) Health-care practitioners needto become aware of at least basic information aboutCAM, so they can comply with their ethical duty tosupport the personal autonomy of patients by provid-ing them with information about risks and benefits.

Justice

Distributive justicerequires a fair distribution of bur-dens and benefits in society. It requires, for example,that people with HIV/AIDS don’t disproportionatelybear the burden of health-care expenses by beingdenied public health insurance coverage of medicallynecessary care. This raises the complicated issue ofwhich CAM therapies should be considered “medical-ly necessary” and under what circumstances.

Similarly, distributive justice requires that funds forhealth-care research be distributed so that they standthe best chance of equitably benefiting those in needof care and treatment. Research funding should bebiased in favour of research concerning treatmentsthat address the real health-care needs and wants ofpatients/consumers. A bias by funding agenciesagainst research into CAM per se is unethical.

Compensatory justicerequires that people be compen-sated for the wrongs done to them, and that providersof health-care products and practices be accountableto patients/consumers. Producers must demonstratethat their products meet quality control standards, aresafe, and (if health claims are made or insurance cov-erage of the products is sought) are effective. The statemust ensure mechanisms are in place to guarantee theaccountability of producers. Similar requirementsapply to CAM practitioners.

The information in this series of info sheets is based on a report prepared by Crouch, Elliott, Lemmens, and Charland for the Canadian HIV/AIDS Legal Network:

Complementary/Alternative Health Care and HIV/AIDS: Legal, Ethical and Policy Issues in Regulation.Additional reading can be found in info sheet 5. Copies of the report and

info sheets are available at www.aidslaw.ca/Maincontent/issues/care-treatment.htm or through the Canadian HIV/AIDS Clearinghouse (email: aids/[email protected]).

Reproduction is encouraged, but copies may not be sold, and the Canadian HIV/AIDS Legal Network must be cited as the source of this information. For further infor-

mation, contact the Network at [email protected]. Ce feuillet d’information est également disponible en français.

Funded by Health Canada under the Canadian Strategy on HIV/AIDS.The views expressed are those of the author and do not necessarily reflectthe views or policies of the Minister of Health.

©Canadian HIV/AIDS Legal Network, 2001

ETHICAL ISSUES AND THE USE OF CAM

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Complementary/AlternativeHealth Care

and HIV/AIDS

3What Are Natural Health Products?How Are They Regulated?Until recently, natural health products were legallyclassified as either “foods” or “drugs” under thefederal Food and Drugs Act. How a product wasclassified determined what kinds of health claimscould be made for it. It also determined how care-fully the product was examined before being soldand monitored after being sold. Drugs are morerestricted, and because they make health claims, aremore carefully evaluated than foods.

But it’s been recognized that this classificationsystem often created inappropriate and inconsistentresults, so a new, third category of “natural healthproducts” (NHPs) is now being created inCanadian law. Health Canada’s new Office ofNatural Health Products (ONHP) is responsible fordeveloping and implementing a new regulatoryframework to govern NHPs.

The ONHP has conducted country-wide consulta-tions about issues such as the legal definition ofNHPs and what kinds of regulations should apply.These regulations will cover things such as: thekind of evidence necessary for getting approval tosell something in Canada as an NHP and to makecertain kinds of claims about its health benefits;how NHPs should be labeled; what “good manu-facturing practices” should be followed by makersof NHPs, etc. The final regulations should be avail-able toward the end of 2001 and become law soonafter.

The definition of “natural health products” willlikely include things such as: herbs on a list pre-pared by the ONHP; homeopathic preparations;substances used as a “traditional medicine”(including in traditional Chinese, Ayurvedic, orNorth American Aboriginal medicine); and miner-als, vitamins, amino acids, essential fatty acids, andother “botanical, animal or micro-organism derivedsubstances.”

Product Licensing: Degree of Risk and Nature of Health Claims

As a basic principle, the regulation of NHPs shouldbe based on the known or reasonably foreseeablerisks of harm they pose. This should apply both atthe stage of review beforethe government licensesa product for sale in Canada (“pre-marketingreview”) and in the approach to monitoring theproduct’s safety after it goes on the market (“post-marketing surveillance”). In addition, the strictnessof pre-marketing review should partly depend onthe claims being made about the product’s healthbenefits. Claims that are supported by evidenceshould be allowed. The stronger the claim, the

Natural HealthProducts:Regulatory

Issues

This info sheet explains what natural health products are and howthey have been regulated, and makes recommendations about

licensing, labeling, and post-approval surveillance.

This is one of a series of 5 info sheets on

complementary/alternative health care and HIV/AIDS.

1.What is CAM? Who Uses it and Why?

2. Ethical Issues and the Use of CAM

3. Natural Health Products: Regulatory Issues

4. Regulating CAM Practices and Practitioners

5. Key Resources

Page 6: Complimentary Alternative Healthcare and HIV/AIDS€¢ energy therapies (Qi gong, reiki, therapeutic touch). Some say these categories are artificial, or irrelevant to a “holistic”

stronger the evidence must be. Otherwise, only gener-alized claims should be permitted.

Labeling RequirementsAs with drugs, labeling requirements for NHPs are keyto helping avoid harm to the consumer and promotinginformed decision-making in using NHPs. A group oforganizations working in HIV/AIDS have recom-mended that the federal government require that alllabels of NHPs sold in Canada:

• be in a standardized format using plain languageand including key information about the safe andrecommended use of the product;

• list the quantities of all contents (and if a product islabeled as a product, it must contain minimumamounts of that product that are specified by law);

• indicate whether the product is synthetic or natur-al, including whether it uses animal sources, andwhether it incorporates genetically modifiedorganisms;

• include directions for use, recommended dosage,warnings and, where known, possible interactionswith drugs or other NHPs;

• advise consumers to tell their health-care providerthat they are using the product, even if it may notseem relevant at the time;

• include a toll-free number and website for infor-mation on how consumers can report a bad reac-tion to the product.

In some cases the physical packaging of a productdoes not allow these things to be included in or on thepackage itself. In such cases, a vendor of the productshould be required to have a product “monograph” (ie,a written description of the product, its proper use, andthe evidence for its health claims) with this informa-tion available for consumers where they purchase theproduct.

Monitoring Safety: Post-MarketingSurveillance of NHPsA system for reporting “adverse events” (ie, negativeeffects) linked to the use of NHPs would allow con-sumers and health-care practitioners to provide input

regarding their observations and experiences usingsuch products. It would also ensure that consumershave easy access to information regarding knownadverse reactions (eg, access through a toll-free num-ber) in addition to the disclosure of such confirmedinformation on product labels (including packageinserts).

Under existing law, manufacturers of products clas-sified as “drugs” have specific obligations to reportadverse events to Health Canada, so that healthauthorities can take necessary steps (which couldinclude removing the drug from the market) to protectthe public’s health. The ONHP and others have pro-posed a similar reporting scheme for NHPs.

The ONHP should establish a post-marketing sur-veillance system for NHPs that, through differentmechanisms, collects information about (1) adverseevents of varying degrees; (2) short-term side effectsand long-term cumulative effects of NHPs; and (3)data regarding consumer use of NHPs.

As part of that system, those licensed to sell NHPs inCanada should be legally required to report any“seri-ous adverse event” regarding their product they knowabout, whether inside or outside Canada, and whetherit was anticipated or “unexpected.” In addition, health-care practitioners should be legally required to reportto the ONHP any seriousadverse event in a patientunder their care that relates to the use of an NHP(whether or not the product is legally sold in Canada).

In addition, the ONHP and pharmacists’ profession-al associations and regulatory bodies should, with theinput of consumer groups, collaborate in developing astandard protocol for pharmacists to encouragepatients to voluntarily disclose serious adverse eventswith NHPs and non-prescription medications they areusing. This information should be kept confidential,but should be tracked by pharmacies to identify possi-ble interactions or safety concerns about the use ofproduct. Such a tracking system would allow pharma-cists to systematically provide this information topatients/consumers and, where appropriate, draw con-cerns to the attention of Health Canada for furtherinvestigation.

The information in this series of info sheets is based on a report prepared by Crouch, Elliott, Lemmens, and Charland for the Canadian HIV/AIDS Legal Network:

Complementary/Alternative Health Care and HIV/AIDS: Legal, Ethical and Policy Issues in Regulation.Additional reading can be found in info sheet 5. Copies of the report and

info sheets are available at www.aidslaw.ca/Maincontent/issues/care-treatment.htm or through the Canadian HIV/AIDS Clearinghouse (email: aids/[email protected]).

Reproduction is encouraged, but copies may not be sold, and the Canadian HIV/AIDS Legal Network must be cited as the source of this information. For further infor-

mation, contact the Network at [email protected]. Ce feuillet d’information est également disponible en français.

Funded by Health Canada under the Canadian Strategy on HIV/AIDS.The views expressed are those of the author and do not necessarily reflectthe views or policies of the Minister of Health.

©Canadian HIV/AIDS Legal Network, 2001

NATURAL HEALTH PRODUCTS: REGULATORY ISSUES

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Complementary/AlternativeHealth Care

and HIV/AIDS

4Statutory Regulation of Health-Care PractitionersIn Canada, the regulation of occupations and pro-fessions (including health-care practitioners) is aprovincial/territorial matter. However, governmentshave largely delegated this responsibility to health-care professions themselves. Usually a “college” or“board” has the legal power to set standards of prac-tice and codes of conduct, and to discipline mem-bers.

Historically, there are three principal forms ofregulation. Under a licensure (or “exclusive scopeof practice”) model, only licensed members of aprofession can do things considered to be withinthat profession’s scope of practice. For example,only licensed physicians can practise “medicine.”Practitioners are usually subject to ongoing profes-sional regulation, and to discipline if they fail tomeet professional standards.

Under a less restrictive certification (or “right totitle”) model, only practitioners who meet certaintraining requirements are allowed to use a givenprofessional title (eg, “registered massage thera-pist”). Other practitioners may offer the same ser-vices, but are not allowed to use the title. This sig-nals to the consumer/patient that the practitionerhas (or lacks) certain qualifications. A certificationsystem does not generally involve possible disci-pline for misconduct.

Least restrictive is the registration model, whichrequires practitioners who provide a certain type ofservice to register on some sort of official registry.There are no particular training standards or otherqualification requirements, and no legally bindingstandards of professional conduct.

In the last decade, several provinces/territorieshave moved to what is called a “controlled acts”model. Rather than establish exclusive areas ofpractice (eg, “medicine”) reserved to only certainprofessionals (eg, physicians), this model focuseson identifying certain acts or practices that pose arisk of harm to patients. These acts are then “con-trolled” by authorizing only certain practitioners toprovide or perform them, based on the level of spe-cialized skill and expertise the acts require. Sosome procedures can be done not only by physi-cians, but also by nurses, osteopaths, chiropractors,etc. As in traditional approaches, a “controlledacts” model usually restricts who can use certainprofessional titles.

Should CAM Practitioners BeRegulated? How?Some practitioners (eg, chiropractors in most juris-dictions) already have the experience of both the

Regulating CAMPractices andPractitioners

Standards of practice are one important way to protect the health ofpatients who use the services of health care providers.This info sheetconsiders the direct regulation of health care practitioners through

legislation and professional codes. It also looks at how the lawindirectly regulates conduct by holding practitioners liable in case ofmalpractice. Both of these issues are considered as they relate to

practice in the field of CAM.

This is one of a series of 5 info sheets on

complementary/alternative health care and HIV/AIDS.

1.What is CAM? Who Uses it and Why?

2. Ethical Issues and the Use of CAM

3. Natural Health Products: Regulatory Issues

4. Regulating CAM Practices and Practitioners

5. Key Resources

Page 8: Complimentary Alternative Healthcare and HIV/AIDS€¢ energy therapies (Qi gong, reiki, therapeutic touch). Some say these categories are artificial, or irrelevant to a “holistic”

benefits and drawbacks of being regulated by law.Others, such as naturopaths, massage therapists, etc,are at different stages.

Opinions vary among CAM practitioners about for-mal professional regulation. There is a history of con-flict between conventional health professions andCAM practitioners, who have sometimes been dis-missed as “quacks.” Some CAM providers are con-cerned that conventional professionals will use regu-lation to restrict CAM practices.

Governments have also historically violated therights of Aboriginal peoples, and even sometimes out-lawed traditional practices. Some healers and commu-nities feel that governments cannot be trusted with theregulation of traditional Aboriginal healers.

But many see regulation as an important step inachieving legitimacy, and as a way to maintain pro-fessional standards, discipline incompetent practition-ers, and protect their profession’s reputation.Regulation could also lead to better integration withother health-care professionals, and increase thechance of insurance coverage.

For CAM practitioners not already regulated by law,voluntary self-regulation may be a first step.Voluntarily grouping together to establish standardsfor training and for competent, ethical practice, andenforcing those standards among members, could bethe basis for getting legal recognition as a self-regu-lating health profession.

Regulating Conventional Practitioners Some conventional health professionals incorporateCAM therapies into their practices, but are also subjectto the rules set out in statutes or by their professionalbodies, some of which have adopted policies on “com-plementary medicine.”

For example, professional rules governing physi-cians in Québec or British Columbia are strictly word-ed. Physicians using many kinds of CAM run the riskof professional discipline. The policy of the BCCollege of Physicians & Surgeons even prohibits the“ethical” physician from associating with alternativepractitioners who recommend “unproven” therapies,and states that physicians must not expose a patient toany degree of risk from a CAM therapy of no provenbenefit. This arguably goes too far.

Less restrictive approaches are possible. Legislationhas been adopted in BC, Alberta, and Ontario that saysthat a physician cannot be found guilty of profession-al misconduct or incompetence merely for using a“non-traditional” or “complementary” therapy unlessit poses a greater risk to the patient than the prevailingmedical practice.

Aboriginal HealersAboriginal communities are discussing how to dealwith individuals who claim to be traditional healers butwho are not aware of, or who do not follow, properteachings. Traditional healers are generally seen asaccountable to the people they assist, but mechanismsor processes for accountability are not as formallydefined as a system of professional regulatory bodies.Accountability is more diffuse, and not based on legalmeasures such as disciplinary proceedings. In someprovinces, legislation governing health professionalsstates that it does not apply to Aboriginal healers pro-viding traditional healing services.

Practitioners’ Liability for MalpracticeCAM practitioners have a legal duty to use reasonablecare and skill, both in obtaining patients’ informedconsent and in “diagnosing” and “treating” the patient.Legally, the practitioner must act as would a “prudentand diligent” practitioner “in the same circumstances.”And a specialist must exercise the skill and knowledgeof an “average specialist” in the field.

Legally, CAM practitioners belonging to an identifi-able profession or “school of practice” should gener-ally be held to the standards of their own school,rather than to standards set by some other school, butin some cases it may be hard to identify a coherentschool with generally accepted protocols or practices.

In the case of conventional professionals using CAMwho are sued for malpractice, the appropriate legalstandard may not be clear, but courts are likely to holdthem to the regulatory standards set by their conven-tional professional body.

While the issue of malpractice and professional stan-dards for some practitioners using CAM remainsuncertain, there is no doubt of the importance of allpractitioners’ ethical and legal duty to ensure patients’informed consent to treatment.

The information in this series of info sheets is based on a report prepared by Crouch, Elliott, Lemmens, and Charland for the Canadian HIV/AIDS Legal Network:

Complementary/Alternative Health Care and HIV/AIDS: Legal, Ethical and Policy Issues in Regulation.Additional reading can be found in info sheet 5. Copies of the report and

info sheets are available at www.aidslaw.ca/Maincontent/issues/care-treatment.htm or through the Canadian HIV/AIDS Clearinghouse (email: aids/[email protected]).

Reproduction is encouraged, but copies may not be sold, and the Canadian HIV/AIDS Legal Network must be cited as the source of this information. For further infor-

mation, contact the Network at [email protected]. Ce feuillet d’information est également disponible en français.

Funded by Health Canada under the Canadian Strategy on HIV/AIDS.The views expressed are those of the author and do not necessarily reflectthe views or policies of the Minister of Health.

©Canadian HIV/AIDS Legal Network, 2001

REGULATING CAM PRACTICES AND PRACTITIONERS

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Complementary/AlternativeHealth Care

and HIV/AIDS

5CAM: General Documents &Resources for Research

Achilles R. Defining Complementary and Alter-native Health Care. Paper prepared for HealthCanada, 10 April 2000. Available at www.hc-sc.gc.ca/hppb/healthcare/cahc/index.html.

Achilles R. Complementary Medicine: A Biblio-graphy. National Network on Environments andWomen’s Health Working Paper Series #1 (August1997). Available at www.yorku.ca/nnewh/english/pubs/workpap1.pdf.

York University Centre for Health Studies.Complementary and Alternative Health Practicesand Therapies: A Canadian Overview. August1999. Available at www.yorku.ca/ychs/data1/publications.html.

Foundation for Integrated Medicine. IntegratedHealthcare. A Way Forward for the Next FiveYears?London: FIM, 2000. Available at www.fimed.org.

National Center for Complementary andAlternative Medicine (US NIH). Factsheet: MajorDomains of Complementary and AlternativeMedicine. Available at http://nccam.nih.gov.

[United Kingdom] House of Lords. Comple-mentary and Alternative Medicine. Sixth Report ofthe House of Lords Select Committee on Scienceand Technology (HL 123): 21 November 2000.Available via www.parliament.the-stationery-office.co.uk.

Use of CAM

“Use of CAM” and “CAM Use by People withHIV/AIDS.” In: Crouch R, Elliott R, Lemmens T,and Charland L. Complementary/AlternativeHealth Care and HIV/AIDS: Legal, Ethical andPolicy Issues in Regulation. Montréal: CanadianHIV/AIDS Legal Network, 2001. Available atwww.aidslaw.ca/Maincontent/issues/care-treatment.htm.

Duggan J et al. Use of complementary and alterna-tive therapies in HIV-infected patients. AIDSPatient Care STDs2001; 15: 159-167.

Eisenberg DM et al. Unconventional medicine inthe United States: prevalence, costs, and patterns ofuse. New England Journal of Medicine1993; 328:246-252.

Eisenberg DM et al. Trends in alternative medicineuse in the United States, 1990-1997: results of afollow-up national survey. Journal of the AmericanMedical Association1998; 280: 1569-1575.

Complementary/AlternativeHealth Care:

Key Resources

There is a vast literature on complementary/alternative health care.This info sheet provides information about a number of selected,

essential resources – articles, books, reports, and websites that providecrucial information on CAM, its use (including by people with

HIV/AIDS), research into CAM, and ethical and regulatory issues.

This is one of a series of 5 info sheets on

complementary/alternative health care and HIV/AIDS.

1.What is CAM? Who Uses it and Why?

2. Ethical Issues and the Use of CAM

3. Natural Health Products: Regulatory Issues

4. Regulating CAM Practices and Practitioners

5. Key Resources

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Ernst E, White A . The BBC survey of complementarymedicine use in the UK. Complementary Therapies inMedicine2000; 8: 32-36.

Fairfield KM et al. Patterns of use, expenditures, andperceived efficacy of complementary and alternativetherapies in HIV-infected patients. Archives ofInternal Medicine1998; 158: 2257-2264.

Pawluch D, Cain R, Gillett J. Approaches toComplementary Therapies: Diverse PerspectivesAmong People with HIV/AIDS. Health Canada,March 1998.

Piscitelli SC. Use of complementary medicines bypatients with HIV: full sail into uncharted waters.Medscape HIV/AIDS2000; 6(3), available viahttp://hiv.medscape.com.

Ramsay C, Walker M, Alexander J. AlternativeMedicine in Canada: Use and Public Attitudes.Vancouver, BC: The Fraser Institute, 1999; alsoreported in Public Policy Sources1999; 21. Availableat www.fraserinstitute.ca/publications/pps/21.

Research into CAM

Ernst E. Complementary AIDS therapies: the good,the bad and the ugly. International Journal of STD &AIDS1997; 8: 281-285.

Nahin RL, Straus SE. Research into complementaryand alternative medicine: problems and potential.British Medical Journal2001; 322: 161-164.

[US] National Center for Complementary andAlternative Medicine. Expanding Horizons ofHealthcare: Five-Year Strategic Plan, 2001-2005.Available via www.nccam.nih.gov.

Oszoy M, Ernst E. How effective are complementarytherapies for HIV and AIDS? – a systematic review.International Journal of Sexually TransmittedDiseases & AIDS1999; 10: 629-635.

CAM and Aboriginal Peoples

Aboriginal People and Traditional Healing. In:Crouch R, Elliott R, Lemmens T, and Charland L.Complementary/Alternative Health Care andHIV/AIDS: Legal, Ethical and Policy Issues inRegulation. Montréal: Canadian HIV/AIDS LegalNetwork, 2001. Available at www.aidslaw.ca/Maincontent/issues/care-treatment.htm.

Royal Commission on Aboriginal Peoples. People toPeople, Nation to Nation: Highlights from the Reportof the Royal Commission on Aboriginal Peoples.(“Culture and traditional healing.”) Ottawa: Supplyand Services Canada, 1996.

Shestowsky B. Traditional Medicine and PrimaryHealth Care Among Canadian Aboriginal People – ADiscussion Paper with Annotated Bibliography.Ottawa: Aboriginal Nurses Association of Canada,1993.

Use of CAM: Ethical Issues

“Ethical Issues.” In: Crouch R, Elliott R, Lemmens T,and Charland L. Complementary/Alternative HealthCare and HIV/AIDS: Legal, Ethical and Policy Issuesin Regulation. Montréal: Canadian HIV/AIDS LegalNetwork, 2001. Available at www.aidslaw.ca/Maincontent/issues/care-treatment.htm.

Dixon J. Catastrophic Rights: Experimental Drugs &AIDS. Vancouver: New Star Books, 1990.

Ernst E. The ethics of complementary medicine.Journal of Medical Ethics1996; 22: 197-198.

Freedman B. Compassionate access to experimentaldrugs and catastrophic rights. Canadian HIV/AIDSPolicy & Law Newsletter1996; 3(1): 44-46. Availableat www.aidslaw.ca/Maincontent/otherdocs/Newsletter/newsletter.htm.

Lemmens T. Compassionate access to experimentaldrugs: balancing interests and harms. CanadianHIV/AIDS Policy & Law Newsletter1996; 3(1): 43-44. Available at www.aidslaw.ca/Maincontent/otherdocs/Newsletter/newsletter.htm.

Natural Health Products

Advisory Panel on Natural Health Products. FinalReport of the Advisory Panel on Natural HealthProducts: Regulatory Framework for Natural HealthProducts. Ottawa, May 1998.

Canadian Medical Association. CMA Policy: Naturalhealth products (update 2000). Available atwww.cma.ca.

Ernst E. Harmless herbs? A review of the recent liter-ature. American Journal of Medicine1998; 104: 170-178.

Fugh-Berman A. Herb–drug interactions. Lancet2000: 355: 134-138.

Health Canada. Government Response to the Report ofthe Standing Committee on Health. March 1999.Available via www.hc-sc.gc.ca.

Health Canada (Office of Natural Health Products,Transition Team). A Fresh Start. Final Report of theONHP Transition Team. May 2000. Available viawww.hc-sc.gc.ca/hpb/onhp.

COMPLEMENTARY/ALTERNATIVE HEALTH CARE: KEY RESOURCES

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Health Canada (Office of Natural Health Products).(1) Summary report: Natural Health ProductsResearch Priority-Setting Conference (Halifax, 6-8November 1999); (2) Proposed RegulatoryFramework for Natural Health Products (plain-textoverview), March 2001; and (3) “Working Draft” ofNHPs Proposed Regulatory Framework (September2001). All available via www.hc-sc.gc.ca/hpb/onhp.

Standing Committee on Health (House of Commons,Canada). Natural Health Products: A New Vision.November 1998. Available via www.parl.gc.ca.

Regulatory Issues: Legal & Ethical Issues

“Legal and Policy Issues.” In: Crouch R, Elliott R,Lemmens T, and Charland L. Complementary/Alternative Health Care and HIV/AIDS: Legal,Ethical and Policy Issues in Regulation. Montréal:Canadian HIV/AIDS Legal Network, 2001. Availableat www.aidslaw.ca/Maincontent/issues/care-treatment.htm.

Association of Complementary Physicians of BritishColumbia. Consensus Paper on ComplementaryMedicine. November 1999. Available at www.ccmadoctors.ca/acp_consensus.htm.

British Medical Association. Complementary Medi-cine: New Approaches to Good Practice. Oxford Uni-versity Press, 1993.

Canadian Naturopathic Association. “Guide to theEthical Conduct of Naturopathic Doctors” (May1994) and “Standards of Practice” (1999). Availableat www.naturopathicassoc.ca.

Casey J, Picherack F. The Regulation of Comple-mentary and Alternative Health Care Practitioners:Policy Considerations. Prepared for Health Canada,2001. Available at www.hc-sc.gc.ca/hppb/health-care/cahc/index.html.

Cohen MH. Complementary and Alternative Medi-cine: Legal Boundaries and Regulatory Perspectives.Baltimore: Johns Hopkins University Press, 1998.

College of Physicians & Surgeons of BritishColumbia. Policy Manual: “Complementary andAlternative Therapies” (Chapter C-12, June 1999) and“Unproven and Unconventional Treatment” (ChapterU-2, June 1995). Available at www.cpsbc.bc.cawww.cpsbc.bc.ca.

College of Physicians and Surgeons of Ontario.Complementary Medicine: Policy No 1-00, February2000. Available at www.cpso.on.ca.

Feasby C. Determining standard of care in alternativecontexts. Health Law Journal1997; 5: 45-65.

Mills S, Peacock W. Professional Organisation ofComplementary and Alternative Medicine in the UK1997: A Report to the Department of Health.University of Exeter, 1997.

Minnesota Department of Health – Commissioner ofHealth. Complementary Medicine: Final Report to theLegislature. January 1998.

Stone J, Matthews J. Complementary Medicine andthe Law. Oxford: Oxford University Press, 1996.

Studdert DM. Legal issues in the delivery of alterna-tive medicine. Journal of the American MedicalWomen’s Association1999; 54(4): 173-176.

Studdert DM et al. Medical malpractice implicationsof alternative medicine. Journal of the AmericanMedical Association1998; 280: 1610-1615.

Health Care Providers and CAM

Cain R, Pawluch D, Gillett J. Practitioner Perspectiveson Complementary Therapy Use Among PeopleLiving with HIV. Health Canada, March 1999.

Goldszmidt M, Levitt C, Duarte-Franco E,Kaczorowski J. Complementary health care services:a survey of general practitioners’ views. CanadianMedical Association Journal1995; 153: 29-35.

Lavalley JW, Verhoef MJ. Integrating complementarymedicine and health care services into practice.Canadian Medical Association Journal1995; 153:45-49.

Ruedy J, Kaufman DM, MacLeod H. Alternative andcomplementary medicine in Canadian medicalschools: a survey. Canadian Medical AssociationJournal1999; 160: 816-817.

Useful WebsitesCanadian AIDS Treatment Information Exchangewww.catie.caCATIE is a Canadian national, non-profit organizationproviding HIV/AIDS treatment information. It operatesa comprehensive website, electronic mailing lists, sev-eral print publications, and a bilingual, toll-free service(1-800-263-1638). It also produces info sheets on com-plementary/alternative therapies and “practical guides”on complementary therapies and herbal products.

CAMlinehttp://camline.orgA Canadian-based database on CAM that includesinformation on various therapies, a list of “best prac-tices” from institutions, and a mechanism for report-ing adverse reactions.

COMPLEMENTARY/ALTERNATIVE HEALTH CARE: KEY RESOURCES

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Canadian Health Network – Alternative Health Centre www.canadian_health_network.ca/1alternative_health.htmlA web-based source of information funded by HealthCanada and created in partnership with the Tzu-ChiInstitute for Complementary and AlternativeMedicine in Vancouver (www.tzu-chi.bc.ca) and theToronto Public Library.

Canadian HIV/AIDS Legal Networkwww.aidslaw.caContains an extensive section on “Legal and EthicalIssues Related to Care, Treatment, and Support for People with HIV/AIDS” at www.aidslaw.ca/Maincontent/issues/care-treatment.htm. IncludesCrouch R, Elliott R, Lemmens T, and Charland L.Complementary/Alternative Health Care and HIV/AIDS: Legal, Ethical and Policy Issues in Regulation.Montréal: Canadian HIV/AIDS Legal Network, 2001,and the series of info sheets on the subject.

Centre for Complementary Health Studies,University of Exeterwww.ex.ac.uk/chsThis leading centre’s website includes general infor-mation about complementary and alternative medi-cine in the UK and Europe. The Centre publishes thejournal FACT – Focus on Alternative and Comple-mentary Therapies: An evidence-based approach.

Foundation for Integrated Medicinewww.fimed.orgThis United Kingdom foundation produces policydocuments relating to the integration of conventionaland complementary/alternative medicine, and in-cludes website news updates.

National Center for Complementary andAlternative MedicineUS National Institutes of Healthhttp://nccam.nih.gov/fcp/clearinghouse/index.htmlThe NCCAM Clearinghouse disseminates informa-tion to the public and healthcare providers about theCenter’s program and research findings through factsheets, information packages, publications and a quar-

terly newsletter distributed to public subscribers. Seealso the Combined Health Information Database(CHID) (http://chid.nih.gov) for a variety of materialsregarding CAM that are not publicly available else-where.

CAM on PubMedvia http://nccam.nih.gov or at www.nlm.nih.gov/nccam/camonpubmed.htmlA partnership between NCCAM and the US NationalLibrary of Medicine, CAM on PubMed allows usersfree access to a database of journal citations on com-plementary/alternative medicine.

Direct Access Alternative Information Resourceswww.daair.orgA members-only, not-for-profit buyers club promoting“self-empowered healing” to help manage illnessthrough the use of scientifically researched nutrients,therapies, and practices.

Research Council on Complementary Medicinewww.rccm.org.uk/This UK charitable organization supports CAMresearch. The website has information on recentresearch, a database with thousands of references onpublished and unpublished research in complemen-tary medicine (searchable for a fee), and a list of pub-lications on CAM research.

Rosenthal Center for CAM, Columbia Universityhttp://cpmcnet.columbia.edu/dept/rosenthalIncludes links to complementary medicine Internetresources, factsheets and databases, as well as infor-mation about the Center for CAM Research inWomen’s Health.

Health Canada’s Office of Natural Health Productswww.hc-sc.gc.ca/hpb/onhpResponsible for overseeing the regulation of naturalhealth products in Canada.

White House Commission on Complementary andAlternative Medicine Policy www.whccamp.hhs.govCharged with reporting to the US President on policyissues relating to CAM.

The information in this series of info sheets is based on a report prepared by Crouch, Elliott, Lemmens, and Charland for the Canadian HIV/AIDS Legal Network:

Complementary/Alternative Health Care and HIV/AIDS: Legal, Ethical and Policy Issues in Regulation.Additional reading can be found in info sheet 5. Copies of the report and

info sheets are available at www.aidslaw.ca/Maincontent/issues/care-treatment.htm or through the Canadian HIV/AIDS Clearinghouse (email: aids/[email protected]).

Reproduction is encouraged, but copies may not be sold, and the Canadian HIV/AIDS Legal Network must be cited as the source of this information. For further infor-

mation, contact the Network at [email protected]. Ce feuillet d’information est également disponible en français.

Funded by Health Canada under the Canadian Strategy on HIV/AIDS.The views expressed are those of the author and do not necessarily reflectthe views or policies of the Minister of Health.

©Canadian HIV/AIDS Legal Network, 2001

COMPLEMENTARY/ALTERNATIVE HEALTH CARE: KEY RESOURCES