A deal brokered at the World Trade Organisation on access to medicines is far from perfect, according to advocacy groups, and will continue to create difficulties for countries seeking access to the lowest cost medicines.
The deal, announced on Saturday, will permit countries to issue compulsory licenses for any type of medication, not just the shortlist of infectious diseases drawn up last year at Doha (the so called Paragraph 6 agreement). Europe and the US had originally offered a deal covering a shortlist of diseases including HIV, TB and malaria, but developing countries resisted the move, arguing that they needed to address diseases like diabetes too.
The deal will not be open to use by the US, Canada, Australia, Japan, New Zealand, Norway or any of the countries of the European Union. In addition, the eastern European countries due to join the European Union in 2004 (Czech Republic, Cyprus, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovak Republic and Slovenia) will cesae to use the system once they join the EU, and will use it only for national emergencies in the time remaining before accession.
Hong Kong, Israel, Korea, Kuwait, Macao, Mexico, Qatar, Singapore, Taiwan, Turkey and the United Arab Emirates have promised to use the provisions only in national emergencies.
The deal will allow any country with domestic manufacturing capacity to export unlimited quantities of drugs. Previously the TRIPS agreement restricted countries like India to exporting no more than 49% of total production.
The deal will permit countries that are members of regional trade associations to export drugs to their neighbours, even if those countries are not classified as least developed countries. However, the United States is pressurising Latin American countries to agree to more restrictive patent protection as part of the discussions over the creation of a Free Trade Area of the Americas.
The deal was damned with faint praise by the major advocacy groups involved in lobbying for a more generous deal. Oxfam and Medecins sans Frontieres (MSF) said the deal did little to change the long-term trend in global trade. "What members do not seem to take
into account is that the burdensome system being put in place does nothing
to ensure that generic production will happen in the future," said Celine Charveriat of Oxfam.
developing countries will have little alternative to the high prices and
long-term monopolies of brand-name pharmaceutical companies."
James Love of the Consumer Project on Technology pointed out that the deal gives the WTO Secretariat and the TRIPS Council the right to “oversee the use of compulsory licensing in the most intimate terms.” Far from creating a flexible system, he fears that the deal will allow the WTO, dominated by developed world interests, to argue over interpretation of the deal at every stage.
He argues that public health advocates now need to step up pressure on governments to use the provision.
Countries will have to issue compulsory licenses for every purchase, and it is unclear if global procurement mechanisms, such as the facility being planned by the World Health Organisation, will have to go through time-consuming compulsory licensing procedures for each country that applies for help.
The Pharmaceutical Research and Manufacturers of America welcomed the deal, highlighting no criticisms of the final text in a public statement.
Advocates say that the deal does nothing to address the question of what happens if countries need cheap versions of drugs licensed in the US and Europe after 2005. Under the TRIPS agreement, any drug patented after 2005 cannot be copied by generic manufacturers in India or other major manufacturing nations.
The General Council Chairperson’s statement on the agreement
Implementation of paragraph 6: the final text
The Doha declaration explained (WTO website)
WTO documents on TRIPS and patents
Consumer Project on Technology statement on the WTO agreement
Consumer Project on Technology resources on WTO, access to medicines and patent disputes
MSF and Oxfam joint press release
Financial Times on the future of battles over patent rights and access to medicines - September 3 2003.