[KUALA LUMPUR] A proposed free trade agreement among countries bordering the Pacific Ocean will jeopardise the accessibility of affordable generic drugs in member and trade-partner states, says a group of non-governmental organisations and academics.
The group has urged the UN special rapporteur on the right to health to intervene in the agreement's negotiations.
In an open letter, they said that, if accepted, a leaked draft of the US proposal for the intellectual property (IP) chapter of the Trans-Pacific Partnership (TPP) free trade agreement would make it more difficult for cheaper generic drugs to be produced and imported to countries that cannot afford branded medications.
They also said that negotiations on the agreement have been carried out with excessive secrecy and that the United States has been given too much influence.
The group sent a letter to Anand Grover, the UN rapporteur on health, last month (22 March), urging him to appeal to the negotiating governments, which completed the sixth round of negotiations on the TPP last week (28 March–2 April).
The governments involved are Australia, Brunei, Chile, Malaysia, New Zealand, Peru, Singapore, the United States and Vietnam.
The letter said that the United States was expected to propose clauses that would exceed the countries' commitments to respect pharmaceutical patents under the World Trade Organisation's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
For example, Edward Low, director of the Positive Malaysian Treatment Access and Advocacy Group (MTAAG+) and a signatory of the letter, told SciDev.Net that the TRIPS agreement allows companies producing generic drugs to use the clinical data for the branded equivalent when gaining regulatory approval.
But the proposed TPP clauses, such as those giving pharmaceutical companies exclusive rights to drug clinical trial data, would mean generic drug manufacturers registering in the nine countries have to run a completely new trial to prove that the generic drug works.
Ida Madieha Abdul Ghani Azmi, professor of IP law at the International Islamic University of Malaysia, agreed that the data exclusivity clause is "excessive".
However, she said that another contentious clause which seeks to extend the patents of drugs found to have a new function by 20 years is already the law in Malaysia.
A representative from the Malaysian TPP negotiation team told SciDev.Net that Malaysia will ensure diagnostics and surgical procedures cannot be patented; that compulsory licencing of drugs in the interests of public health is maintained; and that clinical trial data will still be made available when necessary.
He added that "decisions on patent-related issues will be driven by the need for greater accessibility of medicines".
The TPP negotiations are expected to undergo another three rounds, with the final one scheduled for 24–28 October in Lima, Peru.
Link to full letter [467kB]