The US government is stepping up on TRIPS plus pressure through bilateral forums based on a US law that passed under Obama to strengthen IPR enforcement and the 301 process. Countries targeted include India, Indonesia, China, Thailand, Ukraine in Asia and Argentina, Chile and Venezuela in Latin America.
Most likely this will be public when USTR sends a report to congress (potentially this month). Indonesia and Argentina are already being made aware of the list of demands by USTR.
Already China’s FDA is undertaking a policy revision on data exclusivity and patent linkage, which is likely to have been triggered by US pressure.
This pressure from the US government comes less than a year after the United Nations Secretary-General’s High Level Panel on Access to Medicines put out a comprehensive report that highlighted that access to medicines, vaccines, diagnostics and medical devices, which are currently priced out-of-reach of patients and governments alike – has become a matter of concern for rich and poor countries – and proposed solutions to address the incoherence between the right to health, intellectual property and trade rules.
Even as these countries face access barriers and exorbitant prices for medicines, particularly for HCV and cancer, the US government is making a renewed effort to pressure these countries into agreeing to its demands that will further undermine compulsory licensing, push for stringent IP enforcement and introduce new IP barriers to block generic competition.
These concerns about heightened pressure are also confirmed by a news article in Kaiser Health News which is based on a six page document outlining the draft provisions or objectives of a proposed Presidential Executive Order (EO) which clearly includes “Extending the patent life of drugs in foreign markets to provide for protection and enforcement of intellectual property rights.”
See Exclusive: White House Task Force Echoes Pharma Proposalshttp://khn.org/news/exclusive-white-house-task-force-echoes-pharma-proposals/
The article analyses the documents prepared for an executive order on the cost of pharmaceuticals and reveals behind-the-scenes discussions influenced by the pharmaceutical industry. Joe Grogan, associate director of health programs for the Office of Management and Budget (OMB), has led Trump’s “Drug Pricing and Innovation Working Group. Until March, Grogan served as a lobbyist for Gilead Sciences, the pharmaceutical company that priced its hepatitis C drugs at $1,000 per pill. To solve the crisis of high drug prices, the group discussed “strengthening the monopoly rights of pharmaceuticals overseas….”
A follow on article authored by Jamie Love is worth a read and is available https://medium.com/@jamie_love/the-trump-eo-on-drug-prices-not-what-was-promised-or-needed-not-consistent-with-access-fairness-231a36aebbd
Jamie Love – Director, Knowledge Ecology International – points out that the “Trump EO will probably not stop at patent extensions, and will also continue to press countries to lower standards for granting patents (so more patents can be granted on the same drug), restrict the use of compulsory licenses, press for extended test data protection, including 12 years for biologic drugs, and attack the efforts of countries to negotiate lower prices”.