Friday, July 20, 2007

WTO Paragraph 6 System Used for First Time by Rwanda

[Apologies for cross-posting from my post on IPKat]

Yesterday Rwanda became the first country to notify the World Trade Organisation (WTO) under the 30 August 2003 decision.

The 30 August 2003 decision implemented Paragraph 6 of the Doha Declaration on TRIPS and Public Health. The decision addressed the public health needs of countries with no capacity to manufacture under a compulsory licence. The decision created a mechanism for such countries to import cheaper generics made under compulsory licensing elsewhere - the "Paragraph 6 System" or "Paragraph 6 Solution". A permanent amendment to TRIPS was agreed 6 December 2005 in Article 31 bis, but as yet only 7 countries have accepted the amendment (or just 4.7% of the membership): United States, Switzerland, El Salvador, Republic of Korea, Norway, India and the Philippines.

Rwanda has notified the WTO of the proposed importation of HIV/AIDS medicine manufactured in Canada in yesterday's submission IP/N/9/RWA/1. Under Paragraph 2(a), the details of proposed importation by an eligible country are to be notified:
"Based on Rwanda's present evaluation of its public health needs, we expect to import during the next two years 260,000 packs of TriAvir, a fixed-dose combination of Zidovudine, Lamivudine and Nevirapine manufactured in Canada by Apotex, Inc. However, because it is not possible to predict with certainty the extent of the country's public health needs, we reserve the right to modify the foregoing estimate as necessary or appropriate."
However, as a least-developed country, Rwanda is not obliged to notify the desire to be an "eligible importing member" (Paragraph 1(b)).

The move has been described as "a bold step" amid suggestions that there is reluctance to utilise the flexibility of the Paragraph 6 System because of the restrictive and limited scope of the system.

More information is available on the WTO dedicated web page for the 30 August 2003 decision.


Anonymous said...

I would be grateful if you can let me know why Rwanda had to make a notification. My understanding is that an importing country, when it is a least developing country, is not required to make any notification as per the definition of "importing country" in paragraph 6 decision. The notification has to be made only by developing countries.

Johanna said...

As I mentioned in the original post, Rwanda, as a least-developed country, is not required to issue a notification under para 1(b). However, if a least-developed country ever intends to import the medicines, then it needs to notify the WTO each time under para 2(a) (which is exactly what Rwanda did). This is specific notification, which the importing country is required to provide. And Rwanda made this notification because it was importing 260000 packs of Triavir (a combination drug package for the treatment of HIV-AIDS). It never notified under para 1(b) because it didn't need to do so. However, it is still the only country to notify under para 2(a).