Open Letter to Ministers of Trade in Countries Negotiating the US-Andean Free Trade Agreement
September 10, 2004
Dear Ministers of Trade,
US proposals for the chapter on intellectual property rights of the US-Andean free trade agreement have recently been made public.1 Doctors Without Borders/Médecins Sans Frontières (MSF) would like to take the opportunity of the upcoming round of negotiations scheduled to take place in San Juan, Puerto Rico, on September 13-17 to draw your attention to the most harmful of these proposals, which will have consequences for access to medicines in Andean countries concerned (Bolivia, Colombia, Ecuador, and Peru). As you may know, MSF works in all four countries, providing primary health care in urban and rural areas, assisting internally displaced persons in conflict areas, and delivering medical care for people living with HIV/AIDS and Chagas disease.
The US proposals include all of the most restrictive provisions found in other US free trade agreements previously signed. These restrictive provisions will have one major consequence with regard to access to medicines: they will strengthen and extend the monopoly rights of multinational pharmaceutical manufacturers at the expense of patients in Andean countries. More specifically, these provisions all seek to limit, and in some cases completely block, generic competition. Generic competition has proven to be key in lowering the prices of medicines, thereby improving access to medicines.
None of these restrictive provisions are required under the World Trade Organization (WTO) Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS), and this is reaffirmed by the November 2001 Doha Declaration on TRIPS and Public Health. Rather, these proposals are part of a deliberate strategy by the US government to increase the standards of intellectual property protection above the WTO requirements, directly undermining the Doha Declaration, and to ensure that US intellectual property standards become a global norm.
In particular, the US proposals, if adopted, will:
Reduce dramatically the number of inventions that can be excluded from patentability under TRIPS (Art.27.2 and 27.3). The TRIPS Agreement requires WTO Members to grant patents for products and processes in all fields of technology and give some examples of inventions that can be excluded from patentability, such as "diagnostic, therapeutic and surgical methods for the treatment of humans or animals," but it does not expressly limit the kind of inventions that can be excluded from patentability. The US proposal (Art. 8.1 and 8.2) eliminates the freedom of Andean countries not to grant
patents on "diagnostic, therapeutic and surgical methods." It also specifically requires Andean countries to grant
patents on new uses of known compounds (which do not meet the novelty requirement) and prevents countries from excluding certain types of products from patentability (such as essential medicines which used to be excluded from patentability under Andean Community Decision 344).
Eliminate the right of Andean countries to allow
parallel importation of patented products, unless authorized by the patent owner (Art.8.4). This directly contradicts Article 5.d of the Doha Declaration, which expressly acknowledges the "freedom" of WTO Members in this respect.
Eliminate the right of revoking patents in accordance with the Paris Convention, and of allowing oppositions to patents before their granting (Art 8.5).
Limit dramatically the circumstances under which compulsory licenses can be granted (Art.8.7), whereas paragraph 5.b of the Doha Declaration expressly acknowledges "the freedom [of WTO members] to determine the grounds upon which such licences are granted." See the attached MSF briefing note entitled "What to watch out for in free trade agreements with the United States" for further explanation on this point.
Extend the term of patent protection to compensate for "unreasonable delays" in the granting of patents (Art.8.8(a)) or in the drug approval process (Art.8.8(b)(i)). Note that compensation is required even if the patent is granted on the basis of an examination made by a foreign patent office (Art.8.9) or if the medicine is approved on the basis of a foreign prior approval (Art.8.8(b)(ii)).
five years of market exclusivity to manufacturers of new medicines with a new chemical entity (Art.9.1), and three years of market exclusivity to manufacturers of medicines with a known chemical entity (Art.9.2). Such market exclusivity, so called "data exclusivity," is additional to patent rights and would have effect even if the medicine is not protected by any patent, as is the case for many drugs in Andean countries (due to the lack of patent protection before the 1990s). It is particularly relevant for medicines with a known chemical entity, which are less likely to get patent protection, for lack of novelty. See MSF's briefing note entitled "What to watch out for in free trade agreements with the United States" for further explanation on this point.
national drug regulatory authorities (NDRAs) to block registration of generic medicines during the life of the patent. This proposal would have two major consequences: first, it would make the use of compulsory license useless since the generic medicine produced under a
compulsory license could not get marketing approval from the NDRA; second, it would require NDRAs to
help enforce private patent rights (Art.9.4) that may be invalid,2 thereby obliging generic manufacturers to challenge invalid patents first before getting approval, and further delaying patients' access to affordable medicines.
Members of the Andean Community introduced patent protection for medicines in the 1990s as a consequence of TRIPS negotiations, and adopted data exclusivity provisions following the model of North American Free Trade Agreement (NAFTA) in 1993. In 2000, however, data exclusivity was removed from the Common Intellectual Property Regime in full compliance with the TRIPS Agreement. And in 2001, all WTO members agreed to uphold the principles enshrined in the Doha Declaration that member states have the "right to protect public health and to promote access to medicines for all." Introducing new three- or five-year data exclusivity provisions would reverse these important pro-public health measures.
The US, in adopting the Doha Declaration along with all other WTO members in November 2001, made a clear commitment to prioritize public health over private commercial interests. By proposing the measures described above, the US is clearly reneging on this commitment. It is not in the interest of Andean countries to accept restrictive US proposals. These will mainly serve the interests of intellectual property owners from industrialized countries. For patients living in Bolivia, Colombia, Ecuador and Peru, these provisions could have life or death consequences.
We therefore urge you to protect your rights and uphold your obligations under the Doha Declaration by rejecting any intellectual property proposal that goes beyond the requirements of the TRIPS Agreement.
Silvia Moriana, Head of Mission, MSF in Bolivia
Antonio Da Silva, Head of Mission, MSF in Colombia
Marc Bosch, Head of Mission, MSF in Ecuador
Cedric Martin, Head of Mission, MSF in Peru
1 Published in the Colombian daily newspaper La Republica on 27 August 2004.
2 Note that in the US, nearly half of fully litigated patents are declared invalid. J. Allison, M. Lemley, "Empirical Evidence on the Validity of Litigated Patents," AIPLA Quarterly J., vol. 26, p. 185 (1998).
Access to Medicines