Geneva Workshop - Health and Patent Flexibilities

The WTO Workshop on TRIPS and Public Health in Geneva earlier this month included participation from 19 officials of developing countries.

Part of the WTO's technical cooperation and capacity-building activities, this workshop was particularly interesting for its emphais on the use of flexibilities in TRIPS for public health purposes.

In particular, the workshop delivered training on the August 2003 and December 2005 decisions, the so-called "paragraph 6 system" of compulsory licensing.

Participants came from including Argentina, Brazil, Cuba, the Gambia, Hong Kong China, India, Indonesia, Iran, Jamaica, Malaysia, Mali, Namibia, Peru, Philippines, Saudi Arabia, Singapore, Turkey, Vietnam and Zambia.

Indonesia, a participant at the workshop, has been at the forefront of recent initiatives in public health. The country is maintaining its stance against participation in the World Health Organisation (WHO) virus-sharing programme, refusing to share bird flu virus samples unless material transfer agreements can place conditions on the subsequent vaccine, including conditions on commercial use, pricing and the creation of intellectual property rights. The New Scientist reports that Jakarta has shared just two specimens this year, both from the tourist resort of Bali.

Public health has been on the agenda for a lot of the WTO's cooperation events recently, including a workshop in the Asia-Pacific in July this year.

Canada - First Notification of Compulsory Licence to Export

On Thursday, Canada became the first country to notify the TRIPS Council of the World Trade Organization (WTO) under Paragraph 2(c) of the Decision of 30 August 2003 on the Implementation of Paragraph 6 of the Doha Declaration of the TRIPS Agreement and Public Health.

The notification follows the earlier notification to import made by Rwanda, 17 July, under paragraph 2(a). This earlier notification informed the WTO of the intention to import 260 000 packs of the fixed-dosed combination treatment for HIV-AIDS, TriAvir. Canada's notification to export the medicine to Rwanda is required under the Decision of 30 August 2003 and, according to the WTO news item, "completes the circle."

Canada's notification under paragraph 2(c) fulfils the requirements under that provision to provide to the TRIPS Council relevant infromation on the compulsory licence. As such, the notification announces the authorisation for the medicine to be produced and exported to Rwanda, the conditions governing the compulsory licence and the medicine covered by the licence. Also required is the website of the company licensed to produce the generic version where posts on quantities and other relevant information are to be published before export occurs.

Future notifications of exports will be published on the WTO's dedicated page. Meanwhile, the UK Intellectual Property Office (IPO) has launched its informal consultation on the proposed changes to the UK Patents Act 1977 to give effect to the Communities' implementation of the Decision on Paragraph 6 on compulsory licences and supplementary protection certificates - Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems (Compulsory Licences Regulation). The deadline for responses is 31 October.

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.