August 22, 2013, Bandar Seri Begawan, Brunei Darussalam – The far-reaching Trans-Pacific Partnership Agreement (TPP) should be a force for improving health outcomes for the more than half a billion people in twelve countries affected by the pact, but instead negotiators are moving towards finalizing a deal that in fact would restrict access to affordable medicines and constrain governments’ ability to protect the health of their citizens, warned Médecins Sans Frontières/Doctors Without Borders (MSF).
“Despite more than 18 months of persistent opposition from its trading partners, the U.S. government has refused to back down from its demands for intellectual property (IP) rules designed to impede timely access to affordable generic medicines,” said Leena Menghaney, MSF Access Campaign Manager, who is attending the negotiations. “The U.S. is keen to block developing country governments from any attempt to control abusive patenting or limit drug patent terms to the internationally-agreed 20 years. These efforts are a repudiation of the U.S. government’s own prior commitments to balance commercial pharmaceutical interests with the public health interests of developing country populations.”
For more details on the U.S. demands, read MSF’s Issue Brief: Trading Away Health
In this 19th round of negotiations, the U.S. may up the ante with a new demand for 12 years of “data exclusivity” protections for biologics, a class of products that includes many lifesaving drugs used to treat conditions such as diabetes, cancer and hepatitis C. Data exclusivity gives companies monopoly rights on drugs by restricting the use of clinical trial data by drug regulators when approving generic drugs or “biosimilar” versions of drugs and vaccines. Data exclusivity therefore creates a new patent-like barrier to accessing medicines and vaccines, even when these products are not protected by patents.
While the data is locked up, competitors with affordable versions of drugs in the pipeline would be forced to repeat clinical trials in order to get them approved – a costly step that is also unethical, as safety and efficacy has already been established by the originator company. The World Health Organization and other UN agencies have warned countries against implementing data exclusivity because of its harmful effects on access to medicines. Furthermore, a twelve-year demand would be at odds with the Obama administration’s own domestic proposal, which would shorten data exclusivity on biologics in the U.S. to seven years.
“Recent victories for patients in India would not have been possible if data exclusivity on medicines had been in force, which would have blocked affordable versions of exorbitantly priced biologic drugs like trastuzumab for breast cancer and pegylated interferon for hepatitis C for years to come, even when the patent has been legally revoked, has expired, or in cases where a compulsory license has been issued,” said Menghaney.
The U.S. proposal represents the most aggressive IP standards ever seen in a trade agreement with developing countries. For example, TPP countries would be bound to grant patents on new uses, new forms and new formulations of existing medicines, effectively “evergreening” pharmaceutical patent monopolies for well beyond 20 years. The practice of repetitive or secondary patenting does not contribute to the development of novel medicines, but instead serves to restrict access to existing and known medicines.
Governments have a responsibility to ensure that the final TPP agreement doesn’t exacerbate the failure of the medical research and development system to deliver affordable medicines that address the health needs of developing countries. As pressure mounts to finalize the TPP pact ahead of the October APEC summit, MSF urges countries to stand firm and reject harmful rules that jeopardize access to medicines.