EU PROPOSES RULES ON GENERIC DRUGS FOR DEVELOPING COUNTRIES

On 29 October, the European Commission proposed new regulations to implement the WTO decision of 30 August 2003 allowing manufacturers of generic pharmaceuticals to produce patented medicines for export to developing countries to combat the spread of diseases such as HIV-AIDS, malaria and tuberculosis. The regulations, which must be approved by the bloc's 25 national governments and by the European Parliament, would enable generic medicine companies to apply to national authorities for the grant of a compulsory license from a patent holder who has exclusive rights over the manufacture and sale of the products concerned, thus enabling essential medicines to be exported to developing countries in need. "The WTO decision and the new regulation will help save lives by helping countries in need to acquire affordable medicines without undermining the patent system which is one of the main incentives for the research and development of new medicines," said Internal Market Commissioner Frits Bolkestein. Most national laws in Europe at present do not allow compulsory licences for export because until recently the WTO TRIPS Agreement provided for compulsory licences only "predominantly for the supply of the domestic market". The Doha Declaration on trade and health adopted in November 2001 agreed to address the difficulties raised by this restriction, and in their 30 August 2003 decision WTO Members agreed on a waiver giving these countries access to generics by allowing compulsory licensing for export. Canada was the first country to pass a law implementing the WTO decision in May of this year (see BRIDGES Weekly, 13 October 2004).

"Access to essential medicines," EC, 29 October 2004; "EC Offers Rules to Allow Generic Versions of Patented Drugs to Battle Disease in LDCs," WTO REPORTER, 2 November 2004.

REPORT ON GM MAIZE IN MEXICO MEETS CONTROVERSY

On 8 October, the North American Commission for Environmental Cooperation (CEC) released a report entitled "Maize and Biodiversity: The Effects of Transgenic Maize in Mexico". The report suggests that genetically modified maize imports into Mexico should be restricted so as to preserve genetic diversity given the "significant cultural, symbolic and spiritual value" maize has for most Mexicans. While the report notes that there is "no reason to expect" that a genetically modified organism (GMO) would have a greater or lesser effect upon the genetic diversity of Mexican maize, it suggests that given the fact that Mexico is a centre of origin for maize and that campesinos (smallholder producers in Mexico that make up over two-thirds of the maize producers in the country) "consider the presence of any transgenes in maize as an unacceptable risk to their traditional farming practices, and their cultural, symbolic, and spiritual value of maize," a number of efforts should be made to restrict the spread of GMOs through Mexico. The US Trade Representative condemned the report, calling it "fundamentally flawed and unscientific" and saying that "no economic analysis of their recommendations was conducted, and that many of these recommendations are based solely on socio-cultural considerations" while "failing to consider the potential benefits of biotechnology". The report is the result of a 2002 petition from indigenous communities in Oaxaca, Mexico that asked the CEC to prepare a report on the potential direct and indirect environmental impacts on biodiversity caused by the release of genetically engineered maize in Mexico.

The CEC is an independent body established by Canada, Mexico and the US under the 1994 North American Agreement on Environmental Cooperation (NAAEC), a side agreement under the North American Free Trade Agreement (NAFTA). The NAAEC seeks to foster conservation, protection and enhancement of the North American environment in the context of increasing trade and social links among the countries under NAFTA.

To access the report, visit Internet.

To access the US Trade Representative's reaction, visit Internet.

ICTSD reporting; "U.S. Calls NAFTA Environmental Report 'Flawed, Unscientific,'" USTR, 8 November 2004.

EC APPROVES ANOTHER GM MAIZE VARIETY

On 26 October the EC approved Monsanto's Roundup Ready Maize NK-603 for human consumption and placing on the market. The maize variety, which is tolerant to Monsanto's herbicide glyphosate ("Roundup"), is the second genetically modified (GM) product authorised for food use in the EC since the de facto moratorium on GMO approvals effectively ended in May (see BRIDGES Trade BioRes, 28 May 2004). The decision by the European Commission to put the maize on the market, though not to cultivate it domestically, follows a decision in July to allow the variety to be imported for animal feed, and in August to allow it to be imported and processed. The EC authorisation met with hostility from consumer and environmental groups across the continent. Geert Ritsema, GMO campaigner at Friends of the Earth Europe, said, "despite scientific disagreements over its safety and huge public rejection the Commission decided instead to put the interests of corporate America before the safety of Europeans". Monsanto, on the other hand, applauded the EC decision.

For a detailed account of the approval, see BRIDGES Trade BioRes 3 November 2004.

"Genetically modified NK603 maize authorised for both food and feed," EU, 26 October 2004; "WTO Panel Announces Further Delay In Decision on EU's GMO Restrictions," WTO REPORTER, 8 November 2004.

PUTIN SIGNS OFF ON KYOTO PROTOCOL; GLOBAL EMISSIONS SET TO INCREASE

On 4 November, Russian President Putin signed a bill endorsing Russia's ratification of the Kyoto Protocol to combat climate change. The Russian parliament had voted in favour of ratification on 27 October (see BRIDGES Weekly, 27 October 2004), leaving Putin to complete the process. Russia had been stalling on ratification for over two years, leaving observers to question what the final fate of the Protocol would be. Only Russia could trigger the Protocol's entry into force after the US -- the world's largest greenhouse gas emitter -- pulled out in 2001. Russia's ratification has been linked to EU support for Russia's WTO accession, formalised at a summit in May (see BRIDGES Weekly, 2 June 2004). Once the ratification documents are delivered to the UN, the Kyoto Protocol will enter into force after 90 days.

In related news, projections from the International Energy Agency (IEA) -- released in the "World Energy Assessment 2004" on 26 October -- show that under the status quo, world primary energy demand is set to rise by 59 percent from now until 2030. About 85 percent of the increase is projected to be in the form of carbon-emitting fossil fuels such as coal, oil and natural gas; two-thirds of the new demand would come from developing countries, primarily from China and India. The IEA also provides an alternative scenario based on vigorous government action to steer the world onto a sustainable energy path. Claude Mandil, Executive Director of the IEA, stressed however that ultimately, "achieving a truly sustainable energy system will depend on technological breakthroughs that radically alter how we produce and use energy". This will be a monumental task both for countries that have ratified the Kyoto Protocol, and those that remain outside.

To access the World Energy Assessment 2004 visit Internet.

"Putin clears way for Kyoto pact," CNN, 5 November 2004; "Russia's upper house backs Kyoto," BBC, 27 October 2004; "Russia ratifies Kyoto protocol," ITAR-TASS, 27 October 2004; "Russian Parliament's Kyoto Ratification Underlines Bush Isolation," ONEWORLDUS, 25 October 2004; "IEA Director Releases Latest World Energy Outlook, Says Current Energy Trends Call for Urgent and Decisive Policy Responses", IEA RELEASE, 26 October 2004.