India 2013 © Sami Siva

LIMA/NEW YORK, MAY 14, 2013—As negotiations for the Trans-Pacific Partnership (TPP) restart in Lima, Peru, tomorrow, countries must prioritize fixing critical flaws in the agreement that could leave millions of people in developing countries with limited access to affordable generic medicines, international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) said today.

“Substantive discussions on access to medicines have languished for more than a year, with negotiating countries and many other groups, including MSF, voicing concerns about the damaging impacts of the proposed rules,” said Judit Rius Sanjuan, U.S. Manager of the MSF Access Campaign. “The Lima round offers a key opportunity for TPP negotiators to remove harmful provisions from this trade agreement before it’s too late.”

Negotiations on the TPP—a far-reaching trade agreement between 11 Pacific Rim countries—continue to be shrouded in secrecy, but leaked copies of the agreement reveal that the United States is demanding the most harmful package of intellectual property protections ever proposed for a trade agreement with developing countries.

These rules would make it extremely difficult for generic competitors to enter the market, keeping prices unaffordably high, with devastating public health consequences. The proposed provisions would, for example, lower patentability standards, making it much easier for pharmaceutical companies to obtain secondary patents and extend product monopolies for existing drugs; prohibit challenges to weak or invalid patents until after they have been granted; and grant backdoor monopolies by locking up clinical data needed to approve generic drugs.

For more information, please refer to MSF’s 2013 TPP Briefing Note, available in English and Spanish at msfaccess.org/tpp.

“The TPP threatens to constrain countries’ ability to limit abusive patenting and to ensure timely access to the affordable generic medicines that are so critically important to treatment providers like MSF,” said Dr. Jonathan Novoa Cain, president of MSF Latin America. “Alarmingly, the TPP is slated to become the ‘gold standard’ for future trade agreements across the globe, which means that unless these provisions are rejected now, they will be replicated and imposed on many more developing countries in the coming years.”

International rules require governments to grant 20-year patents on pharmaceuticals, but they also allow critical flexibilities in controlling the quality of patents, and in determining under what conditions companies can obtain additional patents on existing drugs. Companies have developed a variety of tactics to extend monopoly protection on their drugs beyond the initial 20-year period, a practice commonly referred to as ‘evergreening.’ It is up to governments to prevent evergreening by putting safeguards in place which balance commercial interests with public health needs.

One example is India’s Section 3(d) law, which aims to achieve this balance, and curb evergreening, by prohibiting the granting of secondary patents on existing drugs unless they are substantially more effective than the original drug. Pharmaceutical company Novartis recently lost a seven-year legal battle—which was taken all the way to the Indian Supreme Court—in an attempt to challenge the application of this law. If accepted in its current form, the TPP would take away governments’ ability to implement similar safeguards.

MSF urges governments involved in the TPP negotiations to reject provisions that will harm access to medicines.