India: access to affordable drugs and the right to health

[Guest guest]

India: access to affordable drugs and the right to health

Anand Grover a , Citro a

The Lancet, Volume 377, Issue 9770, Pages 976 - 977, 19 March 2011

Published Online: 11 January 2011

Nearly 2 billion people (a third of the world's population) lack access to

essential medicines.1 In low-income and middle-income countries, drugs account

for 20—60% of health-care costs, and 50—90% of these costs are paid

out-of-pocket by patients.2

Sadly, the median coverage of health insurance is 35% in Latin America, 10% in

Asia, and less than 8% in Africa.3 Many families in India live below the poverty

line due to expenditure on health.4, 5 Cost of drugs is one of the factors

contributing to the problem of access to medicines.

The right to health is a fundamental right in India, judicially recognised under

article 21 of the Constitution.6 Traditionally, the scope of fundamental rights

guaranteed by India's Constitution has been expanded on the basis of

international human rights instruments.

Internationally recognised human rights, including the right to health, are

directly enforceable through domestic courts in the absence of contradictory

domestic law,7 or by virtue of their incorporation into domestic statutory law.8

The right to health is covered by several international human rights

instruments, including article 12 of the International Covenant on Economic,

Social and Cultural Rights.9

Specific obligations are set out by General Comment 14, under which countries

are bound to respect, protect, and fulfil the right to health and make

good-quality services and goods available, accessible, and acceptable. Access to

affordable drugs has been interpreted to be part of the right to health.

Competition from generic companies is the key to affordable drugs.

The absence of patent protection for drugs in India from 1972 to 2005 allowed

drug companies to use alternative non-infringing processes to manufacture

generic drugs. Generic companies in India can therefore produce drugs at prices

that are among the lowest in the world. This cost advantage means more than 89%

of the adult antiretroviral drugs purchased for donor-funded programmes in the

developing world are supplied by companies in India.10 Low prices also allow

India to provide free first-line antiretroviral treatment to 340 000 people with

HIV in the country.

In 2005, India reintroduced patent protections for drugs to comply with its

obligations under the agreement on Trade-Related aspects of Intellectual

Property Rights (TRIPS).11 However, TRIPS allows countries substantial

flexibilities toward protecting public health. India has made use of the

transition period by introducing patent eligibility criteria, disallowing the

patenting of new forms of known substances without clear enhancement of

efficacy.

Procedures for opposition and revocation of compulsory licensing, and

governmental use of patents are also being used to provide space for generic

competition.

The governments of developed nations, under pressure from multinational drug

companies, are employing new ways to thwart competition from generic drugs. The

European Union and India free-trade agreement seeks to introduce TRIPS-plus12

and other measures, such as patent term-extensions, data exclusivity, increased

border and enforcement measures, and investment-protection agreements, all of

which would impede generic competition.

The move to raise global standards in enforcement of intellectual property

rights through the proposed multilateral Anti-Counterfeiting Trade Agreement

(ACTA) will also deter generic competition.13 The agreement, purportedly a

response to the global trade in counterfeit and pirated goods, negates the

flexibilities available to World Trade Organization members under TRIPS with

respect to enforcement of intellectual property rights.

Over the past 4 years alone, six major drug manufacturers in India were bought

out by foreign multinationals at a total cost of US$10•5 billion.14 These

purchases are a cause for concern for the Indian generics industry; the reduced

competition, which is likely to result, will endanger the availability of

low-cost generic drugs in India and the developing world.

India has an obligation under domestic and international law to respect,

protect, and fulfil the right to health of its people. To meet its health-care

obligations India must guarantee the continued domestic production of generic

drugs. International agreements that interfere with India's use of TRIPS

flexibilities and require TRIPS-plus and other measures must, therefore, be

resisted. Foreign investment in the drug industry must also be regulated to

preserve India's fundamental and constitutional right to health for its citizens

and those of the developing world.

AG is the UN Special Rapporteur on the Right to Health. We declare that we have

no conflicts of interest.

References

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http://apps.who.int/medicinedocs/pdf/s5571e/s5571e.pdf. (accessed Nov 30, 2010).

2 WHO. The world medicines situation.

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(accessed Nov 30, 2010).

3 WHO. Equitable access to essential medicines: a framework for collective

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6 Paschim Banga Khet Mazdoor Samity v State of WB (1996) 4 SCC 37; Surjit Singh

v State of Punjab (1996) 2 SCC 336.

7 Vishaka v State of Rajasthan (1997) 6 SCC 241.

8 The National Human Rights Commission. Protection of Human Rights Act, 1993.

http://nhrc.nic.in/Publications/HRActEng.pdf. (accessed Feb 4, 2011).

9 Office of the United Nations High Commissioner for Human Rights. International

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11 The Patents (Amendment) Act, 2005.

http://www.ipindia.nic.in/ipr/patent/patent_2005.PDF. (accessed Feb 18, 2011).

12 Vivas-Eugui D. Regional and bilateral agreements and a TRIPS-plus world: the

free trade area of the Americas (FTAA). Issue Paper.

http://homepages.3-c.coop/tansey/pdfs/ftaa-a4.pdf. (accessed Nov 30, 2010).

13 European Commission. The anti-counterfeiting trade agreement (ACTA) fact

sheet. http://trade.ec.europa.eu/doclib/docs/2009/january/tradoc_142039.pdf.

(accessed Nov 30, 2010).

14 Indian Department of Industrial Policy and Promotion. Discussion paper.

Subject: compulsory licensing.

http://www.dipp.nic.in/ipr-feedback/FeedBack_JyotiMirdha_MP_28September2010.pdf.

(accessed Nov 30, 2010).

a Lawyers Collective HIV/AIDS Unit, Jalaram Kripa, Mumbai 400001, India