United Nations General Assembly

Agenda:

Improving and Ensuring Access to Life-saving Drugs

for LDCs and Developing nations.

NOTE FROM THE EXECUTIVE BOARD

Greetings Delegates!

Welcome to the General Assembly at the NUJS Model United Nations 2015. I,

Mimansa Ambastha, will serve as your Chairperson with Kirti Misra as your Vice-

Chair.

This background guide is merely a glimpse at the agenda at hand, and serves the

purpose of sketching out the key aspects that should be covered within the committee

during the conference. Your real research lies beyond this guide and we hope to see

some strong content and debate come our way.

An agenda relating to access to essential drugs has very rarely been discussed on

student platforms, much less Model UNs. However, the opportunity to discuss the

same will give us a chance to move beyond the realm of comfortable agenda-setting

and instead learn about new ones. This agenda particularly caught my eye as it so

greatly affects each one of us. It is not about a conflict in a far off place of the world or

about some financial hurricane toppling over Wall Street, but about something as

basic and essential as medicines which we consume on a regular basis. Thus,

increasing barriers to their access leads to a great cause for worry.

The agenda at hand is both vast and complex, and a successful discussion on it would

entail the collective participation of all of you. It shall be your prerogative to decide the

direction in which you want to take this committee. We hope to see a great level of

effort and enthusiasm from you all, so that we all can take back a great experience.

Happy researching!

INTRODUCTION

Over the last three decades, medical technologies have transformed many previously

untreatable diseases such as HIV/AIDS into manageable long-term conditions.

However, as the global disease burden evolves there is a continuing need to develop new

and more effective medicines. The challenge for policymakers is to establish an

environment that stimulates health innovation while ensuring widespread access to new,

more effective products to address unmet global health needs.

Target 6A of the Millennium

Development Goals1 acknowledges the

dire need to improve the availability of

Several countries have made considerable

strides towards increasing access to

necessary medicines and treatments to fight HIV/AIDS, malaria and tuberculosis,

however, the current stage of access to essential medicines in developing countries is not

nearly enough.

In countries for which there is information, the availability of medicines in the public

sector is only one third, while private sector availability is about two thirds, and the prices

people pay for lowest-priced generic medicines vary from 2.5 times to 6.5 times

international reference prices (IRPs) in these two sectors, respectively.2

Recent progress in a number of countries shows that access to essential medicines can be

improved through stronger partnership among governments, pharmaceutical companies

and civil society, including consumers, working together to ensure universal access to

essential medicines. The role of pharmaceutical companies, ranging from multinationals

to generic manufacturers to national distributors, is critical in this effort.

1 http://www.un.org/millenniumgoals/ 2 http://www.who.int/medicines/mdg/MDG08ChapterEMedsEn.pdf

The issues of innovation and access are inevitably

intertwined, cutting across distinct policy areas, in

particular, public health, intellectual property (IP) and

international trade. Finding the right balance between

health, trade and IP policies to sustain innovation and

ensure widespread access to life-saving technologies is one

of the primary public policy challenges of our time.

The third sustainable development goal (SDG)3

promote w ambitious goal which, like every other

SDG, has been broken down into various sub-goals. From child and maternal mortality to

epidemic diseases being all the way down to road traffic accidents, every area of human

mortality is covered.

sub goals offers us the following encouraging targets:

-care services,

including for family planning, information and education, and the integration of

reproductive health into national strategies and programmes.

3.8 Achieve universal health coverage, including financial risk protection, access to quality

essential health-care services and access to safe, effective, quality and affordable essential

3.c Substantially increase health financing and the recruitment, development, training and

retention of the health workforce in developing countries, especially in least developed

countries and small island developing States

3.d Strengthen the capacity of all countries, in particular developing countries, for early

warning, risk reduction and management of national and glo

The medicines themselves are categorised into many: reproductive, basic health

provision, epidemic resilience, medicament pricing and insurance, all of whom are

covered within the SDG. Although the indicators used to measure progress on these

targets and Goals have not yet been developed there is already a lot of political work to

be done.4

3 http://www.un.org/sustainabledevelopment/sustainable-development-goals/ 4 http://www.wipo.int/wipo_magazine/en/2013/05/article_0002.html

UNDERSTANDING LIFE SAVING DRUGS

What are life saving drugs?

Life Saving Drugs are those that satisfy the priority health care needs of the population.

They are selected with due regard to disease prevalence, evidence on efficacy and

safety, and comparative cost-effectiveness. These medicines are intended to be

available within the context of functioning health systems at all times in adequate

amounts, in the appropriate dosage forms, with assured quality, and at a price the

individual and the community can afford.5

The Model List of medicines6 is a guide for the development of national and

institutional essential medicine lists. It was not designed as a global standard. However,

for the past 30 years the Model List has led to a global acceptance of the concept of

essential medicines as a powerful means to promote health equity. Most countries have

national lists and some have provincial or state lists as well. National lists of essential

medicines usually relate closely to national guidelines for clinical health care practice

which are used for the training and supervision of health workers.7

Significance of Life Saving Drugs

Warming oceans and a changing climate are resulting in extreme weather patterns which

have brought about an increase of infectious diseases both new and re-emerging. These

extreme weather patterns are creating extended rainy seasons in some areas, and

extended periods of drought in others, as well as introducing new climates to different

regions. These extended seasons are creating climates that are able to sustain vectors for

longer periods of time, allowing them to multiply rapidly, and also creating climates that

are allowing the introduction and survival of new vectors. This has increased the urgency

of adequate disease control.

5 http://www.who.int/medicines/services/essmedicines_def/en/# 6 http://www.who.int/medicines/publications/essentialmedicines/en/ 7 http://www.who.int/selection_medicines/en/

The concept of Life Saving Drugs is forward-looking. It

incorporates the need to regularly update medicines

selections to reflect new therapeutic options and changing

therapeutic needs; the need to ensure drug quality; and the

need for continued development of better medicines, medicines for emerging diseases,

and medicines to meet changing resistance patterns.

Lists of such medicines guide the procurement and supply of medicines in the public

sector, schemes that reimburse medicine costs, medicine donations, and local medicine

production. Many international organizations, including UNICEF, UNHCR and UNFPA as

well as nongovernmental organizations and international non-profit supply agencies, have

adopted the essential medicines concept and base their medicine supply system mainly on

the Model List.

Medicines such as antibiotics and antiretroviral have dramatically improved health

outcomes in the same way that technologies such as medical imaging have transformed

diagnosis and treatment. Developing these complex products is an expensive and risky

business. Unlike other areas of technological development, medical innovation is all the

more challenging because of the ethical dimension of medical research, rigorous

regulatory oversight, liability issues, high costs and high failure rate. This helps explain

why IP protection is so important for companies involved in medical research and

development (R&D)8.

Public sector availability of medicines (given below) is low in all developing country

regions, and is consistently lower than in the private sector. In the 27 developing countries

for which data are available, average public sector availability was only 34.9 per cent.

When medicines are not available in the public sector, patients will have to purchase

medicines from the higher-priced private sector, or forgo treatment altogether. Since

health facilities in the public sector generally provide medicines at low cost or free of

charge, they are especially important for providing access to medicines for the poor. In

8 http://www.wipo.int/wipo_magazine/en/2013/05/article_0002.html

Addressing the root causes of low

public sector availability of medicines

can lead to substantial

improvements.

individual surveys, availability is reported as the percentage of medicine outlets in which

a medicine was found on the day of data collection.

Median

availability is

determined for

the specific list

of medicines in

each survey and

does not account

for alternate

dosage forms of

these products or

therapeutic

alternatives.

Public sector

data may be

limited by the

fact that the list of survey medicines may not correspond to national EMLs where these

exist and some public sector facilities may not be expected to stock all of the survey

medicines. Medicine availability is not guaranteed in private health facilities either. On

average, about one third (36.8 per cent) of private providers in developing countries lacked

availability of essential medicines, but in a sample of six countries in East, South-East and

South Asia the percentage was more than half (55.4 per cent).9

Cost of Manufacturing and Pricing Concerns

The high cost of many life-saving drugs not only keeps

patients from getting treatment, but also discourages

health ministries from improving the quality of patient

9 http://www.who.int/medicines/mdg/

Striking an appropriate balance

between encouraging medical

innovation and enabling access to it

has been a major preoccupation of

policymakers, health activists and the

private sector.

care through the use of newer and better medicines. While the $406 billion-strong drug

industry researches, develops, markets, and prices medicines for the industrialised world,

there is no mechanism to make newer medicines affordable to developing countries.

Newer drugs, which are usually under patent and more expensive than those off-patent,

are expected to become even more expensive with the implementation of the WTO

Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) in all

Members, scheduled to be completed by 2006.

MNCs, emerging International Generic Suppliers and national manufacturer and

distributors constitute the normal private sector, profit driven, market competition basis

through which the vast majority of medicines are provided world-wide. Notwithstanding

the recognition that inadequacies in funding and demand side infrastructures are major

impediments to improving access, the organization of the supply side of the market has

been the subject of considerable criticism.

Over several decades, the capabilities of the major R&D based companies have evolved to

fit the business opportunities in the core developed world markets. Their foremost

strengths, therefore, are innovation through high levels of R&D expenditure and highly

functions. These are strongly oriented to

the demands of regulators and rapid

international diffusion of new products

through marketing. The penalties to the

business of falling foul of the exacting

standards of regulators, by squeezing

manufacturing costs, can be severe. Hence, the resources that make up the key

capabilities of primary and secondary manufacture, process maintenance and

development and quality assurance, tend to be of the highest order. The best up-to-date

Think of the businesses where value-based models are common.

Airlines use it to allocate scarce seats on popular flights.

Manufacturers of luxury goods use it to justify prices for goods

that are out of all proportion to the cost of production. As the

healthcare economist Jack Scannell points out, it is a way of

charging more.

plant and equipment are used and large numbers of top-class scientists and engineers

10

Anger and cynicism towards big pharmaceutical companies and their opaque pricing

policies with regards to essential medicines have been fuelled by reports like this.

Increasing incidents of price mark ups have come under public scrutiny, with increased

debate on how much life saving drugs should cost. While the pharmaceutical industry has

opted for the value-based approach, meaning maximum profits for them, it is very

questionable whether this is the right model for these companies to employ.

While it may be easy to walk away from other non-essential services, that is not the case

with life-saving remedies, especially when alternatives are non-existent or far less

effective. Aggressive value maximization also sits ill with a patent system that suppresses

competition by awarding a drug company a legal monopoly for a time to sell a drug it has

discovered.

Rationing is the ultimate consequence of high drug prices. Unsurprisingly, this is

unpopular and is causing a backlash. In a number of US states, politicians are seeking to

pass legislation forcing drug companies to disclose more information about the cost of

producing their high-priced remedies. There is even talk of capping prices.11

To understand the urgency of addressing price concerns, one only has to glance through

the statistics once. 99% of maternal deaths happen in developing countries because of

lack of funds and access to healthcare. This shows that economic reasons are one of the

major root causes of lack of medical aid access. Sparse affluence in developing countries

means that it is not profitable for big pharmaceutical corporations to sell life saving

medication there. There is much pressure on developing countries to provide for their

citizens and they (governments and local private organisations on the behalf of patients)

are subsequently forced to buy medicine at exceedingly high prices.

10 http://siteresources.worldbank.org/HEALTHNUTRITIONANDPOPULATION/Resources/281627-1095698140167/AttridgeImprovingAccessFinal.pdf 11 http://www.ft.com/cms/s/0/91b0cc8c-43fd-11e5-b3b2-1672f710807b.html#axzz3snYz25yU

Since lifesaving drugs are in high demand, which is unlikely to change with an increase

prices, big pharmaceutical companies have great incentives to set drug prices high in order

to receive a high return on investment for the research and development of a drug.

However, cases of 5,500%12 mark ups have very little justification.13

So how can a balance with regards to price and access be struck? Well, one way to tackle

the question is to look into Equity Pricing14. Another could be to look into working

around the WTO Intellectual property rights framework (discussed further), which has

enabled big companies to get away with exorbitant pricing practises. Newer innovations

by WHO and countries include suggestions of integrating traditional medicines with

drugs15.

BARRIERS TO ACCESS TO LIFE SAVING DRUGS

Apart from steep prices of medicines playing a role in hindering access to medication in

developing countries and intellectual property rights of pharmaceutical companies

allowing them to mark up prices, other barriers also exist to access to drugs.

1. Regulatory issues: Regulatory authorities are set up to assess the efficacy, quality and

safety of health commodities, provide approval for their distribution and support

authorization for their purchase. However, many low-income countries‟ regulatory

agencies are severely under-resourced, causing delayed registration of life-saving

commodities, a lack of oversight of the quality of products and general inefficiencies that

discourage manufacturers from engaging in the market.

2. Market failures: Another barrier affecting many life-saving commodities is market

failures, where return on investment is not sufficiently high to create incentives for

manufacturers to enter the market or sustain sufficient levels of production.

12 https://www.rt.com/usa/316046-pharma-daraprim-price-hike/ 13 http://globalnews.ca/news/2234578/sticker-shock-how-the-prices-of-life-saving-drugs-skyrocket-overnight/ 14 https://www.wto.org/english/tratop_e/trips_e/hosbjor_presentations_e/15thoen_e.pdf 15 http://apps.who.int/medicinedocs/pdf/whozip16e/whozip16e.pdf

3. User supply and demand challenges: The third main barrier affecting many of the

commodities is user supply and demand challenges such as low demand for the product

by end-users, local delivery and distribution breakdowns and incorrect prescription and

use. There has been an insufficient focus on optimizing innovative approaches to product

formulation, packaging and delivery devices.16

Insurance companies17 have also been accused of making it difficult to gain access to

medical aid. This is especially true in the case of families belonging to the relatively higher

socio-economic strata in society, where they can afford insurance, but may not

necessarily be able to pay full price for medicines.

Furthermore, an irregular supply of drugs may lead to interrupted and hence, ineffective

treatment. For example, In Kyrgyzstan, patients had their methadone doses sharply

reduced or were urged to stop treatment in 2005 due to delays in procurement and

distribution18.

Countries also face issues with corruption and wilfully hindered access to medicines by

law enforcement agencies and the bureaucracies. The public system is also plagued with

lack of adequate medical information to the right authorities, resulting in mistaken and

ignorant steps taken against innocent patients. In Indonesia, organizations report that

they are forbidden to make arrests in the clinic area; as a result, some patients report that

they have become targets for the police because they use other drugs in addition to

methadone19.

To further understand barriers to essential drug access in the case of specific medicines,

you can refer to the table given on the next page.

16 Source: https://www.unfpa.org/sites/default/files/pub pdf/Final%20UN%20Commission%20Report_14sept2012.pdf 17 http://www.sacbee.com/opinion/op-ed/soapbox/article16432784.html 18 https://www.opensocietyfoundations.org/sites/default/files/barriersfootnotes040808.pdf 19 STIGMA Foundation, Indonesia. Personal communication, July 16, 2007. On file at IHRD offices.

20

20 Source: https://www.unfpa.org/sites/default/files/pub-pdf/Final%20UN%20Commission%20Report_14sept2012.pdf

THE HUMAN RIGHT TO HEALTH

The right to health has been established as a fundamental human right of economic and

social nature in a number of international human rights treaties. As soon as 1945, the

United Nations (UN) Charter established the role of the UN as, inter alia

international cooperation in solving international problems of an economic, social, cultural or

humanitarian character, and in promoting and encouraging respect for human rights and for

fundamental freedoms for all without distinction as to race, sex, 21.

22 and

health 23. As an

economic and social right, the right to health is to be achieved progressively, according to

24 However, no treaty clearly defines what the right to

health consists in, what its scope is, and how to evaluate whether a state abides by its

obligations.

The international community seems to have become increasingly aware of its obligation

to guarantee the right to health in the context of development - out of the eight

Millennium Development Goals developed by the United Nations Development

Programme (UNDP) in September 2001, four goals are directly related to health, namely:

a) to reduce maternal mortality

b) to reduce under-5 child mortality,

c) to reverse the spread of HIV/AIDS

d) to ensure environmental sustainability by 2015.25

21 Article 13, United Nations Charter 22 Article 55(a) 23 Article 55(b) 24 International Covenant on Economic, Social and Cultural Rights, Art. 2.1 25 United Nations Development Programme (UNDP), Millennium Development Goals. Available at: http://www.undp.org/mdg/ [Accessed on 1st March 2014]

UNDERSTANDING PATENTING

When a pharmaceutical company first develops a new drug to be used for a disease

exclusive right to exploit it under law. Once the patent is acquired by the company it will

for use by patients). The drug is covered under patent protection, which means that only

the pharmaceutical company that holds the patent is allowed to manufacture, market the

drug and eventually make profit from it.

In most cases, the drug patent is awarded for around twenty years. The lifetime of the

patent varies between countries and also between drugs. Since the company applies for a

patent long before the clinic

the effective patent period after the drug has finally received approval is often around

seven to twelve years.

Once the patent has expired, the drug can be manufactured and sold by other companies.

At this point, the drug is referred to as a generic drug. According to guidelines in most

countries, including those from the US FDA, generic drugs have to be identical to the

branded drug. The company holding the initial patent may, however, renew the patent by

forming a new version of the drug that is significantly changed compared to the original

compound.

Compulsory licensing is when a government allows someone else to produce the

patented product or process without the consent of the patent owner, even before the

the TRIPS (Trade-Related Aspects of

Intellectual Property Rights) Agreement. When such a license is granted it means that the

exclusive monopoly of the patent holder is broken and a competitor can produce the

same drug, generally at more affordable prices. Thus, Compulsory licensing occurs when

a government licenses, or permits a third party to license

to use, manufacture, import or sell its patented invention,

consent.26

as poverty or high incidence of disease. However, signatories that undertake compulsory

lic

Article 31 of the TRIPS agreement states that where WTO member states provide in their

patent legislation for grant of compulsory licenses the following things must be kept in

mind by the deciding authority:

each case must be decided on its own merits;

the applicant for the compulsory licence must have initially made efforts to take a

licence from the patentee on reasonable commercial terms, but the patentee did

not agree;

the scope and duration of the compulsory licence must be limited to the purpose

for which it was granted;

the patentee must be paid adequate remuneration for use under the compulsory

licence;

the decision to grant a compulsory licence and the determination of what is

adequate remuneration shall be subject to judicial review;

TRIPS AGREEMENT

Virtually since the Agreement on Trade-Related Aspects of Intellectual Property Rights

(TRIPs) entered into force as part of the newly created World Trade Organization

(WTO) in 1995, WTO Member States and interested observers have recognized

that significant gaps exist in the agreement with respect to patent protection and

26WORLD TRADE ORG., Glossary Term: Compulsory Licensing, available at

http://www.wto.org/english/thewto_e/glossary_e/compulsory_licensing_e.htm (last visited 27 February 2014).

access to life-saving medicines in developing and least-developed countries (LDCs); but

finding and agreeing on improvements to the system has proven to be a much harder

proposition.

Although multilateral treaties on patents have existed since the late nineteenth century,27

for much of the twentieth century, countries that opposed pharmaceutical product

patents simply disallowed such patents. In the mid-1980s, as many as fifty countries

prohibited pharmaceutical product patents; this list included a few developed countries,

such as Spain and Portugal, but consisted primarily of large middle- and low-income

nations, such as Brazil, India, Mexico and Egypt.28 Around this time, industries across a

variety of sectors in the United States claimed that they were suffering heavy losses

because of the absence of adequate intellectual property protection in foreign markets.

The U.S. International Trade Commission confirmed these claims, estimating that

American firms were losing about $50 billion a year from lack of overseas intellectual

property protection. This led American businesses to call upon their government to seek

greater intellectual property protection in international trade agreements.29

When the Uruguay Round of multinational trade negotiations began in 1986, the United

Stat -Related Aspects of

27 Paris Convention for the Protection of Industrial Property, July 14, 1967, 21 U.S.T. 1583, translated in G.H.C.

BODENHAUSEN, GUIDE TO THE APPLICATION OF THE PARIS CONVENTION FOR THE

PROTECTION OF INDUSTRIAL PROPERTY 17 (1968).

28 Karin Timmermans & Togi Hutadjulu, THE TRIPS AGREEMENT AND PHARMACEUTICALS, REPORT

OF AN ASEAN WORKSHOP ON THE TRIPS AGREEMENT AND ITS IMPACT ON PHARMACEUTICALS,

WORLD HEALTH ORG. 11 (2000).

29 The American pharmaceutical industry was particularly instrumental in lobbying for greater intellectual property

protections.

On January 1, 1995, the Uruguay Round of negotiations ended with the establishment of

the WTO, whose members were all required to sign on to the new, binding TRIPS

agreement.30

Section 5 of Part II of this agreement covers patents, and Articles 27 and 28, which form

the core of this section, grant pharmaceutical innovators strong patent protections. Article

27 establishes a ceiling for patentability requirements, by requiring that patents be

for any inventions . . . in all fields of technology, provided that they are new, involve an

inventive step and are capable of industrial application 31 The article confirms that TRIPS

requires all its signatories to allow pharmaceutical product patents.

Article 28, which defines the rights conferred by a patent, prohibits third parties from

the consent of the patent holder. It thus prevents generic drug manufacturers from

infringing upon pharmaceutical product patents. Together, Articles 27 and 28 of TRIPS

establish an international patent protection regime for pharmaceutical products. Over

seventy countries signed on to TRIPS at the start of 1995, including Spain, Portugal, Brazil,

India, Mexico and Egypt. Today, with over one hundred and fifty TRIPS signatories,

Articles 27 and 28 enjoy near-universal authority. Signatories that violate these Articles, or

resolution body, which may allow other signatories to impose retaliatory trade

sanctions.32

Contrary to public opinion, TRIPs does not provide for a global system of intellectual

property protection; meaning Members do not automatically recognize other M

patents. Instead, inventors must apply for protection in each Member State in which they

wish to be protected.

30 WORLD TRADE ORG., Overview: The TRIPS Agreement, available at

zttp://www.wto.org/english/tratop_e/trips_e/intel2_e.htm (last visited 27 February 2014).

31 TRIPS, supra note 7, art. 27.

32 Ruth Okediji, TRIPS Dispute Settlement and the Sources of (International) Copyright Law Part II, 49 J. OF COPYRIGHT

SOC. OF THE U.S.A. 585, 595 (2001).

TRIPs also includes a number of transitional provisions, such as granting LDCs until

January 2006 to comply with TRIPs and giving developing countries that have

never legislated on intellectual property rights until January 2000 to apply some

TRIPs provisions, while giving them until January 2005 to apply other provisions,

including several provisions of particular importance to pharmaceuticals. Importantly

(and controversially), TRIPs also includes a number of exceptions to the exclusive rights of

the patent holder. The most important of these exclusions are the general exceptions

provided by Article 30, the compulsory licensing provision of Article 31, and the parallel

importing clauses contained in Articles 28 and 5.

Many developing countries and non-governmental organizations (NGOs) rapidly grew

frustrated waiting for WTO Members to improve the situation of medicinal access in poor

countries, losing the battle against such public health epidemics as tuberculosis, malaria,

and HIV/AIDS and actively campaigned for both structural and operational changes

within the WTO. While those groups succeeded in getting public health issues on the

agenda at the Third Ministerial Conference, held in Seattle in 1999, the process of

resolving several key health issues did not solidify until the Fourth Ministerial

Conference, held in Doha, Qatar in 2001 (Doha Round).

-

The key in evaluating the policy trend of TRIPS in relation to the pharmaceutical industry

is to look through the lens of its Article 7 objective to balance two competing interests:

promoting innovation of new drugs and providing access to these drugs. For example,

nations with weak economies and public health crises want medication for their people

while innovative pharmaceutical companies want to protect their temporary exclusive

rights in order to recoup their investment and maximize profits. At that time, the original

TRIPS agreement took on a utilitarian posture. It placed more emphasis on promoting

innovation than on providing access to essential drugs, thereby favoring member nations

that enjoy the majority of pharmaceutical innovation. Recognizing this inequity, the

WTO decided to place more emphasis on public health.33

In 2001, the WTO Ministerial Conference officially initiated the Doha Agenda with a

declaration [hereinafter Doha Declaration] that acknowledged the need to recognize a

sovereign nation's right to protect public health, even at the expense of intellectual

property rights. Namely, the Doha Declaration affirmed a sovereign nation's authority to

grant compulsory licenses during national emergencies and to define what constitutes a

national emergency. A country that was suffering a major epidemic could compel

licensure for domestic production of patented medication that they could not otherwise

afford.

Still, the Doha Declaration fell short of its objective to "promote access to medicines for

all." Even with a compulsory license, many countries with severe health epidemics did

not have the means or capacity to manufacture drugs. Nonetheless, TRIPS required that

the majority of manufacture and sales resulting from compulsory licensing must be

limited within the domestic market. Furthermore, the license was non-assignable; a

country in dire straits could not assign a compulsory license to a nearby country that had

adequate capacity to manufacture and sell generic versions of the drug at an affordable

price. Recognizing these shortcomings, the WTO met again in 2003 to continue

negotiating on the Doha Agenda at the Fifth Ministerial Conference in Cancun.34 There,

they passed the Implementation Decision which extended compulsory licensing

provisions by temporarily removing limitations on exports of drugs under a compulsory

license to countries that could not manufacture drugs themselves.35 This decision was

adopted by the General Council in consideration of the Chairperson's statement, in which

33 http://www.nyulawglobal.org/globalex/TRIPS_Compulsory_Licensing.html#_B._Evolution_and_Trend of TRIPS: Th 34 The accounts of day-to-day discussions and negotiations can be found on the WTO website. WTO

Ministerial Conferences, Cancun 5th Ministerial, at

http://www.wto.org/english/thewto_e/minist_e/min03_e/min03_e.htm

35 WTO General Council Decision, Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, WT/L/540, (Aug. 30, 2003), at http://www.wto.org/english/tratop_e/trips_e/implem_para6_e.htm

he reassured the members that compulsory licensing is to be used in good faith and

stressed the need to prevent diversion of supplied drugs.36

In 2005, during a ministerial conference in Hong Kong, the General Council agreed to

make the Implementation Decision permanent by amending TRIPS. Now, a country that

is eligible for compulsory licensing but lacks sufficient drug manufacturing capacity can

import drugs from an exporting member that is also operating under a compulsory

license, subject to certain conditions.37 That is, the TRIPS Council must be notified before

a cross-border compulsory license can be issued, but approval is not required. However,

remedial measures to resolve conflicts from alleged abuse of the system remain vague.

Thus, the TRIPS Council's sentiment, with respect to their goal of striking a balance

between the competing Article 7 interests, has shifted from favoring IPRs to favoring

wider access to drugs for the benefit of public health. There are, however, uncertainties as

to whether the amendment will achieve its purpose.

Despite the WTO's tremendous efforts to create a diplomatic compulsory licensing

system that improve access to prescription medicine, the latest TRIPS amendment did not

resolve several existing issues and even created some new concerns. Particularly

troublesome are the lack of specific requirements in determining eligibility for compulsory

licensing, risks of arbitrage and production of counterfeit drugs, and whether TRIPS, in its

current construction, will actually help developing countries gain accessory to essential

drugs.

36 WTO Intellectual Property, General Council Chairperson's Statement (30 August 2003), at http://www.wto.org/english/tratop_e/trips_e/gc_stat_30aug03_e.htm 37 The Hong Kong Declaration defined an "exporting member" as a WTO member nation that manufactures drugs under a compulsory license to export to nations that require a compulsory license but lack the capacity to produce drugs domestically.

ISSUES TO ADDRESS

1. How far has your country been successful in meeting the health clauses in MDGs? How can your methods be translated into international action?

2. What is the best way to define a life saving drug? How can the International and National Lists of Life Saving Drugs be reconciled?

3. What role can the public sector play in bettering medical aid access?

4. What problems are faced by your country with regards to access to essential medicines? How have they been addressed? What is the rate of success of these measures?

5. What pricing mechanism can be employed to make the cost of medicines less exorbitant?

6. How does the patenting of drugs effect price of essential drugs? What is the concept of -

7. What can countries do to reconcile their public health needs with the need to grant patent protections to drugs?

AREAS OF RESEARCH

1. Meaning of life saving drugs

2. Past international agreements and obligations relating to life saving drugs

3. Barriers to access to such drugs and remedies for the same

4. Meaning of patents and provisions relating to patents under the TRIPS Agreement of the WTO

5. Suggestions to improve the conflict between patent protection and access to life saving drugs.