Tuesday, November 13, 2007

Rwanda and Canada: Leading the Implementation of the August 2003 Decision for Import/Export of Pharmaceuticals Produced Under Compulsory License

The South Centre recently published its third IP Quarterly for 2007. The Quarterly examines the use of the August 2003 Decision for import/export of pharmaceuticals produced under compulsory license by Rwanda and Canada. It concluded that the Rwanda-Canada case demonstrates that the August 2003 Decision is a viable option for improving access to medicines. The Rwanda-Canada use of the August 2003 Decision case so far is a success because of various factors that worked together, namely (1) an offer from a generic manufacturer to produce a new fixed dose combination drugs at no cost, (2) consent for royalty free use of their patents and non-opposition by right holders against the compulsory license, (3) the Rwandan government’s willingness to take the risk of navigating the untested system under the August 2003 Decision in order to address a public health problem, (4) the Canadian government that put in place a law that, at least in the present case, appears to be working, and (5) legal and public support from MSF that assisted the various actors navigating the procedural requirements.

However, it warns on the difficulty of using the system because of additional legal requirements under the implementing legislation in exporting countries. The difference in implementation legislation among exporting countries can also be challenging for importing countries.

It recommends developing countries to cooperate among themselves to facilitate the use of the August 2003 Decision. Furthermore, those developing countries with limited or no pharmaceutical manufacturing capacity, should notify their intention to use the system in accordance with paragraph 1 (b) of the August 2003 Decision. Notification of intention to use of the system does not depend on ratification of the Protocol amending the TRIPS Agreement.

The full article is available at http://www.southcentre.org/info/sccielipquarterly/ipdev2007q3.pdf

The quarterly update also provides an update of major developments at the multilateral, regional and bilateral levels concerning intellectual property rights, innovation and access to knowledge.

2 comments:

Anonymous said...

The article on p. 4 states that “As an LDC benefiting from the transition period for implementation of the TRIPS Agreement, including Article 31 of the agreement, it is not necessary for Rwanda to ratify the Protocol amending the TRIPS Agreement that incorporated the system created under August 2003 Decision.”

The availability of the transition period does not preclude the ratification of the amendment of the Protocol amending Art. 31 of the TRIPS Agreement. If LDCs ratify the Protocol they still maintain the transition period for implementation of the TRIPS Agreement. Since the August 2003 Decisions is simply a waiver, it is in the long-term interest of LDCs to ratify and ensure the entry into force of the Protocol.

Ermais Biadgleng, IAKP, South Centre said...

The comment above is pertinent and very important for LDCs. The August 2003 Decision of the General Council of the WTO provides only interim waivers with regard to the obligations set out in paragraphs (f) and (h) of Article 31 of the TRIPS Agreement. The system created under the interim waiver is incorporated into the TRIPS Agreement as permanent solution by the Protocol Amending the TRIPS Agreement (2005).

LDCs have secured extension of the transition period for the implementation of the TRIPS Agreement, including paragraphs (f) and (h) of Article 31. Such extension facilitates the use of flexibilities provided by the TRIPS Agreement, the August 2003 Decision and the subsequent Protocol amending the TRIPS Agreement. As noted in the article of IP Quarterly Update, the system created by the August 2003 Decision and subseqently made permanent by the amendment of the TRIPS is precisely adopted for the benefit of LDCs, and countries with limited or no pharmaceutical manufacturing capacity.

Currently, the Protocol amending the TRIPS Agreement has not entered into force because of the limited number of ratification. Although LDCs can benefit from the August 2003 Decision, it is legally and politically important to ratify the Protocol to institute the system as a permanent solution. The paragraph on p. 4 of the article quoted above (in the comment) should be read only as encouraging countries to use the system, although they have yet to ratified the Protocol.