By resolution WHA 59.24, the WHO’s Intergovernmental Working Group on Public Health, Innovation, and Intellectual Property (IGWG) has the goal of producing a Global Strategy and Plan of Action that will implement the CIPIH report recommendations and “secure an enhanced and sustainable basis for needs-driven, essential health research and development relevant to diseases that disproportionately affect developing countries, proposing clear objectives and priorities for research and development, and estimating funding needs in this area.”
In the context of this negotiation, WHO Member States were asked to submit comments to the current draft of the Global Strategy (document A/PHI/IGWG/2/Conf.Paper1/Rev.1) before the second session of the IGWG resumes from 28 April to 3 May 2008.
So far, 16 countries have submitted comments, including the United States, Canada, Brazil, China and India. The Colombian government also has a submission and we have analyzed it with special attention due to the lack of participation of the Colombian government in sub-regional meetings (La Paz, Bolivia in August 2007 and Rio, Brazil in September 2007) that have prepared the Latin American countries for this important negotiation and which resulted in a very important sub-regional consensus known as the Rio Document.
The Colombian submission was prepared by the Minister of Foreign Affairs and it focuses on the parts of the Global Strategy that have not yet been negotiated, parts of elements 5 and 6.
Some of the proposals contained in the submission are problematic, and are quite close to the U.S. government position in this negotiation, for example:
a) Colombia is against the WHO having a greater role in providing technical and policy support on TRIPS flexibilities.
The Colombian submission seeks to minimize the role of WHO in providing technical and policy support to governments in the implementation and use of TRIPS flexibilities, for example in compulsory licenses, appropriate patentability criteria for medical inventions and the Bolar exception. [See comments on elements 5.2, 5.2 (a), 5.2 (c), 5.3 (f), 6.3 (a), 6.3 (d)]
b) Colombia is against health authorities participating in IP negotiations.
The Colombian submission proposes deleting element 5.2 (c) which, as it currently reads, is trying to ensure that the TRIPS flexibilities are fully implemented, which includes a recommendation to ensure the participation of health authorities in intellectual property negotiations.
c) Colombia does not support curbs on TRIPS-plus provisions in bilateral trade agreements and national legislation.
The Colombian submission proposes the deletion of element 5.2 (b) which, as it currently reads, is trying to discourage TRIPS-plus provisions in bilateral trade agreements and/or national legislation in ways that may have a negative impact on access to health products or treatments in developing countries.
d) Colombia is against assessing the public health impact of data-exclusivity regulations.
The Colombian submission proposes deleting element 5.3 (c) which, as it currently reads, proposes the assessment of the impact of data-exclusivity regulations on access to drugs in developing countries.
e) Colombia supports patent-registration linkage.
The Colombian submission proposes deleting the last sentence in element 6.2 (g) which, as it currently reads, calls for clarification of the working relationship between the drug regulatory authorities and patent offices. Recommending this deletion, the Colombian government is trying to avoid the position that patents are private rights that are not enforced by regulatory authorities. Therefore supporting a linkage between patent rights and regulatory approvals that will unnecessarily limit generic competition.