In this post we will discuss the The Doha Declaration on the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement & public health, and how it affects the scope of intellectual property laws set out for the first time in international law for WTO Members by the TRIPS Agreement in 1994.

The need for a clarification of the scope of the TRIPS agreement arose because of the potential conflict of two matters of public interest:

1) The matter of providing incentives to those who innovate solutions which have the potential to improve public health
2) The matter of making available to impoverished populations those public health solutions which exist

In order to provide incentives to innovate, WTO Members ratified the first international intellectual property law in the form of the TRIPS agreement. The TRIPS agreement required that WTO Members’ laws meet minimum standards with respect to protecting intellectual property.

However, developing countries worried that the imposition of these regulations would, in the case of innovations which could potentially help in public health matters, create monopolies for life-saving drugs manufacturers, and make those life-saving drugs unaffordable for the poor of their populations. Life-saving anti-retroviral drugs for AIDS, a pandemic sweeping across much of sub-Saharan Africa, was at the forefront of the minds of people who put this argument forward.

Pressure from civil society led to the introduction of TRIPS flexibilities as part of the Doha Declaration in 2001.

Paragraph 4 of the 2001 Doha Declaration on the TRIPS agreement and public health:
‘The TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all. In this connection, we reaffirm the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.’

Specifically, governments agreed that they would have the right to force patent holders (for example pharmaceutical producers) to grant the use of their patent to others (for example generics drugs manufacturers), and that the governments would have the freedom to determine the grounds upon which such licenses would be granted

‘5. (b) Each Member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted.’

Typically, these grounds implied a national emergency or other circumstances of public health crises, including those relating to HIV/AIDS, tuberculosis, malaria, and other epidemics.

‘5. (c) Each Member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency.’

Recognising that there would be a contradiction in allowing countries which could not manufacture their own generic drugs to import the generics (under compulsory licensing) while forbidding countries from exporting those drugs, the Council for TRIPS was, under the Doha Declaration, to find a solution to this problem.

‘6. We recognize that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002.’

In conformity with Paragraph 6, the Council for TRIPS decided in 2003 that countries could export generics to countries which did not have the capacity to manufacture generics themselves but which imposed the compulsory license.

But in order to give, for example, Indian generic manufacturers an incentive to help sub-Saharan African countries develop the capacity to manufacture generics for themselves, two more conditions were added:

1) Least Developing Countries would not have to conform to patent laws until 2016 (whereas other countries would have to conform by 2006) and
2) Generics manufacturers in LDCs would not have to meet the same rigorous conditions that generics manufactures in non-LDCs would in order to export generics to other LDCs under compulsory licenses

General Council’s Decision, 2003, on the Implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health, Paragraph 6i:
‘where a developing or least-developed country WTO Member is a party to a regional trade agreement [ . . . ] the obligation of that Member under Article 31(f) of the TRIPS Agreement shall be waived to the extent necessary to enable a pharmaceutical product produced or imported under a compulsory licence in that Member to be exported to the markets of those other developing or least developed country parties to the regional trade agreement that share the health problem in question. It is understood that this will not prejudice the territorial nature of the patent rights in question’

A case study of an Indian generic drugs manufacturer investing in a joint venture in a Least Developing Country, Uganda, in order to more easily access LDC markets in sub-Saharan Africa: Quality Chemicals Industries Limited (QCIL)

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Bibliography:

Pills, Bills, and Investing thrills: Foreign Direct Investment in Sub-Saharan Africa’s Pharmaceutical Industry, Tatiana Popa, Master of International Business thesis, The Fletcher School of Law and Diplomacy, Tufts University, April 14, 2010

Integrating Intellectual Property Rights and Development Policy, Commission on Intellectual Property Rights, 2002, Ch. 2

WTO Accepts Rules Limiting Medicine Exports to Poor Countries, John James, September 12, 2003, The Body

Declaration on the TRIPS agreement and public health, adopted on 14 November 2001, WTO

FACT SHEET: TRIPS AND PHARMACEUTICAL PATENTS, Obligations and exceptions, WTO

Implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health, Decision of the General Council of 30 August 2003, WTO