Doctors Without Borders: Asian Trade Deal Could Restrict Access to Affordable Generics

Regulatory NewsRegulatory News | 21 April 2016 |  By 

The Regional Comprehensive Economic Partnership (RCEP) trade agreement is kicking off another round of negotiations on Sunday in Australia and Doctors Without Borders (MSF) is raising concerns about the tougher intellectual property rights that could restrict access to affordable generic drugs for many in Indonesia, Thailand, Myanmar, Cambodia and Laos.

The Regional Comprehensive Economic Partnership (RCEP) is a proposed free trade agreement (FTA) between the ten member states of the Association of Southeast Asian Nations(ASEAN), which includes Brunei, Burma (Myanmar), Cambodia, Indonesia, Laos, Malaysia, Philippines, Singapore, Thailand, Vietnam, and the six states with which ASEAN has existing FTAs, including Australia, China, India, Japan, South Korea and New Zealand.

A leaked chapter from the negotiations, released this week by the non-governmental organization KEI International, shows that Japan and South Korea have made proposals that extend beyond what international trade rules require and thus undermine access to affordable generic drugs. 

Part of the leaked chapter reads: “Each Party shall prevent applicants for marketing approval for pharmaceutical products which utilize new chemical entities from relying on or from referring to test or other data submitted to its competent authority by the first applicant for a certain period of time counted from the date of approval of that application. As of the date of entry into force of this Agreement, such period of time is stipulated as being no less than five years by the relevant laws of each Party.”

Two thirds of all the drugs MSF purchases to treat HIV, TB and malaria are generic medicines from India and rolling back access to those medicines, particularly under the guise of data exclusivity, could block the entry of more generic medicines to other regional markets, even for drugs that are already off patent, the group says.

 “If the measures in this agreement prevent people from getting the generic medicines they need, the health consequences for any delay or interruption of treatment for many diseases, like HIV, could be serious,” said Dr. Greg Elder, Medical Coordinator for MSF’s Access Campaign. “97% of the HIV medicines MSF uses to treat 230,000 people living with the disease are generics sourced from India. The reality is, without generic medicines, we wouldn’t be able to treat as many people as we do. We urge Indian and ASEAN negotiators to make sure the terms of any trade agreement reached do not impede the supply of generic medicines upon which we and so many people in developing countries rely.”

MSF and KEI also took issue with the biologics data exclusivity provisions from the Trans-Pacific Partnership negotiated late last year.

James Love, KEI Director, said: “The RCEP will be a massive trade agreement and the content of the IP Chapter is important. It will bind India and China, two countries left out of the TPP…Some of the issues that negotiators did not understand in the TPP, such as the damages provisions, are also lurking in this text, creating risks that negotiators will do worse than they think, because the secrecy of the negotiations insulates the negotiators from timely feedback on technically complex issues. Japan and Korea are pushing for test data monopolies, without the same safeguards available to patent monopolies.”

New threat against affordable medicines in trade negotiations with India and ASEAN



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