Where are Medicines Patentable: international trade and patents in poor nations.

 

The Trade Related Aspects of Intellectual Property Regulation (TRIPS) agreement radically altered the role of international trade law in promoting and enforcing intellectual property protection around the globe.  TRIPS is an international agreement that requires members of the World Trade Organization (WTO) to implement strong intellectual property protections in their domestic law.  Along with this change, patent protection for pharmaceuticals, and the impact that such patent protection is likely to have on access to medicines for the world’s poor, has become a major source of conflict between rich and poor nations.  This chapter discusses TRIPS, and explains why it has become the centre of heated debate.

 

The New Global Intellectual Property Rules

While there have been international agreements on intellectual property and patent protection for over 100 years, such agreements have been largely unenforceable.[1]  Until 1994 countries were largely free to design their own intellectual property regimes.[2]  This meant that countries could choose to provide no patent protection for pharmaceuticals.  In 1994, the countries that founded the WTO approved a package of agreements that all WTO member states must accept and implement in their domestic law.  The TRIPS agreement was one of those treaties.  TRIPS is the first comprehensive multilateral intellectual property agreement that requires the domestic implementation of specific levels of intellectual property protection and enforcement mechanisms for IPRs.[3]  As a WTO agreement, non-compliance with TRIPS can be challenged under the WTO dispute resolution process, leading to trade sanctions against countries that fail to implement the agreement.

 

Under TRIPS all WTO member states must implement 20-year patent protection for all inventions that meet general criteria for patentability.  Countries must also enforce patents equally, regardless of industry, and provide the same protection to all persons, provided they are citizens of, or corporations registered in, a WTO member country.  TRIPS specifies a minimum level of intellectual property protection, and grants countries some latitude in national implementation, but broad exceptions for pharmaceuticals are not possible.[4]

 

By 1994, most developed countries already had patent laws that were largely in compliance with TRIPS.[5]  Developing nations were given until the end of 2005 to bring their legislation into compliance.  In 2002, the world’s Least Developed Counties (LDCs) where given an extension until 2016 to bring their legislation into compliance.[6]  However, by 2002 most developing countries were TRIPS compliant.

 

Poor country governments agreed to TRIPS reluctantly in order to gain other concessions from rich countries, such as the lowering of trade barriers on agricultural products.[7]  As a result, some developing country governments have had trouble implementing the TRIPS agreement.  India, for example, has a vibrant, but non-innovative pharmaceutical industry that has been nurtured by the absence of patent laws on pharmaceuticals.  The Indian Parliament has several times rejected proposed amendments to patent protection laws that would bring the laws in line with the requirements of TRIPS.[8]

 

TRIPS Flexibilities and Access to Medicines

At a result of developing country concerns[9] over the rights of governments to limit TRIPS protection in order to safeguard public health, at the WTO Ministerial Meeting in Doha, Qatar, 2001, the WTO member states issued a the ‘Doha Declaration’ on the TRIPS agreement and public health, stating at paragraph four:

 

We agree that 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.[10]

 

While this declaration suggests that governments can take a number of measures to protect public health, the extent of that power is not well defined.  In particular the Declaration seems to support the position that nations can engage in compulsory licensing in order to facilitate access to medicines, more on compulsory licensing below.  However, the authority of the Declaration is unclear.  Ministerial declarations can provide guidance to tribunals arbitrating trade disputes and interpreting the clauses of WTO agreements.  Ministerial declarations cannot, however, override the text and substance of WTO agreements.[11]  There have been no trade disputes related access to medicines since the Doha Declaration was issued, so the impact that it will have on TRIPS remains unclear.

 

The TRIPS agreement itself provides some recognition that intellectual property rights can be overridden in order to safeguard public health.  Article 8(1) of TRIPS holds that:

 

Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this Agreement.[12]

 

In addition, the two most widely recognized flexibilities allowed under TRIPS, parallel importation (See here for more on parallel importing)[13] and compulsory licensing, may grant countries significant flexibility to override pharmaceutical patents, particularly in light of the Doha Declaration.  There is debate over the circumstances under which, and the obligations that accompany, the issuing of compulsory licenses.  Compulsory licensing occurs where a government grants a license for the use of a patent without the consent of the patent holder.  Debate is even more heated over the provision of an alternative to compulsory licensing for countries that cannot practically issue such licenses because they do not have domestic pharmaceutical manufacturing capacity.  Many developing countries lack the necessary technology and expertise to manufacture generic pharmaceuticals.  Under current international law these countries lack a mechanism for overriding patent protection in order to gain access to needed pharmaceuticals in even the most dire of circumstances.  The Doha Declaration, at paragraph 6, committed WTO member states to resolving this issue by the end of 2002, but to date, no solution has been forthcoming.[14]

 

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[1] The Paris Convention for the Protection on Intellectual Property, 1883, amended 1979 is the most important treaty protecting patent rights prior to the TRIPS agreement.  The Berne Convention for the Protection of Literary and Artistic Works, 1886, amended 1979, is the most important treaty protecting copyright prior to the TRIPS agreement.  Both agreements continue in force.  See the WIPO website for the text of both agreements: http://www.wipo.int.

[2] Some regional trade agreements, such as NAFTA, incorporated IPR protections, but this is a relatively recent trend.

[3] There are a number of treatises and articles discussing the general attributes of TRIPS.  Gervais, Daniel.  “The TRIPS Agreement: Drafting History and Analysis.”  Sweet & Maxwell, London, 1998, [hereinafter “The Trips Agreement.”] provides a comprehensive article-by-article analysis, including drafting history, of the agreement, prefaced by a useful history of the agreement’s negotiation.

[4] Carlos Correa provides an analysis of the flexibilities available to developing nations in the TRIPS agreement in “Integrating Public Health Concerns into Patent Legislation in Developing Countries.”  South Centre, Geneva, 2001.

[5] Even in the run-up to the Uruguay round of trade talks intellectual property exceptions for pharmaceuticals were not unheard of in the developed world.  Canadian patent law only closed compulsory licensing exceptions for pharmaceuticals in 1993, and prior to 1987 had wide intellectual property exceptions for the treatment of pharmaceuticals.  See Jones J.C.H et al. “Patents, brand-generic competition and the pricing of ethical drugs in Canada: some empirical evidence from British Columbia, 1981-1994,” 33 Applied Economics 947, 2001.

[6] See Extension of the transition period under article 66.1 of the trips agreement for least-developed country members for certain obligations with respect to pharmaceutical products.  Decision of the Council for TRIPS of 27 June 2002 for the text of the decision extending until 2016 the deadline for LDCs to implement TRIPS, accessed 2003-08-18, available on the WTO website at http://www.wto.org/english/news_e/pres02_e/pr301_e.htm.

[7] The introduction and first section of Prof. Gervais “The Trips Agreement” contains a description of the negotiations leading up to the TRIPS agreement.  Abbot, FM. “WTO TRIPS Agreement and Its Implications for Access to Medicines in Developing Countries,” British Commission on Intellectual Property Rights, 2002 has a detailed discussion of TRIPS and its implications for access to medicines.

[8] See Cullet, C. “Amended Patents Act and Access to Medicines After Doha,” Economic and Political Weekly, 38(24), p. 2278 available at the International Environmental Law Research Centre website, http://www.ielrc.org/Content/N02051T.html for a discussion of recent changes to India’s patent laws.

[9] Much of the pressure that resulted in the passage of the Doha Declaration resulted from pressure exerted by civil society organizations, in particular, highlighting the high price of drugs to treat HIV/AIDS in Sub-Saharan Africa.  See Tully, Danielle L. “Prospects for Progress: The TRIPS agreement and developing countries after the Doha Conference,” 26 Bost College L Rev 129 at p. 140.  Also, MSF has an extensive website devoted to access to medicine issues at http://www.access-meds.org.  See also www.haiweb.org for information from Health Action International and http://www.oxfam.org/eng/campaigns_camp_cutcost.htm for information of Oxfam’s Cut the Cost Campaign.

[10] “Declaration on the TRIPS agreement and public health.”  Doha 2001 Ministerial Meeting, Adopted 14 November 2001, paragraph 4.  Available at the WTO web site at http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm accessed 2003-08-18.

[11] Sykes, Alan O. “Public Health and International Law: TRIPS, Pharmaceuticals, Developing Countries, and the Doha ‘Solution’,” 3 Chi J Int’l L 47, 2002 at p. 55.

[12] The text of the TRIPS agreement can be found on the WTO website, www.wto.org at http://www.wto.org/english/docs_e/legal_e/legal_e.htm#TRIPs, accessed 2003-08-18.

[13] See here for more on parallel importing.

[14] There is a tremendous amount of academic commentary on this issue.  Haag, Thomas, A.  “TRIPS Since Doha: How far will the WTO go toward modifying the terms for compulsory licensing,” 84 Journal of the Patent and Trademark Office Society 945, 2002 provides a review of the suggestions for resolving the Doha Declaration received from developing nations, the European union and the United States.

 

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