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US “Special 301″ Report undermines efforts to lower medicine prices globally: Leena Menghaney


Leena Menghaney, Head-South Asia, Médecins Sans Frontières (MSF), discusses the release of United States Trade Representative (USTR)’s 2019 “Special 301″ Report and its effect on pharma industries in developing nations

The United States Trade Representative (USTR) released its 2019 “Special 301″ Report today. The list included the name of several nations, and has sparked debate in the industry for its controversial nature.

“In the Office of the United States Trade Representative (USTR)’s 2019 Special 301 Report, developing countries like India and Malaysia once again face unfair pressure from the US government over the measures these countries have taken to try to protect access to medicines,” says Leena Menghaney, Head-South Asia, Médecins Sans Frontières (MSF).

The Special 301 report, released annually by USTR, which names countries on “watch lists” may actually cater to the country’s powerful pharmaceutical industry’s demands that call for more stringent intellectual property standards and enforcement in third countries to undermine their competitors, Menghaney opines. Her belief is based on the fact that this year’s report too, like the ones in previous years, names countries making use of public health safeguards in intellectual property laws.

India has been included in the Priority Watch list as well, and Menghaney suspects that it is because of the nation’s policies for patentability criteria, compulsory licensing criteria, the absence of an additional intellectual property monopoly, and data exclusivity.

India’s patent and drug regulatory laws and policies have helped protect price-lowering generic competition globally. Renowned as the “pharmacy of the developing world”, India is known for supplying affordable quality generic medicines to the world at large.

“Such pressure (USTR releasing a “watch list”) violates the integrity and legitimacy of the system of legal rights and flexibility created by the TRIPs Agreement, as reaffirmed by the Doha Declaration for the World Trade Organisation members to meet their rights and public health obligations,” says Menghaney. She adds, “At a time when medicine prices are soaring—including in the U.S., the USTR’s report undermines the efforts of U.S. lawmakers and patient advocates seeking to make medicines more affordable domestically.”

Commenting on the USTR extending its Out-of-Cycle Review of Malaysia and specifically calling it out for compulsory licensing “concerns”, Menghaney states, “MSF urges the Malaysian government to continue to reject any pressure from pharmaceutical corporations or their political allies to reverse the government use licence issued to enable access to an affordable version of the hepatitis C drug sofosbuvir.” She adds that MSF considers compulsory licensing as a much needed and legally permissible tool to overcome patent barriers where necessary.

Menghaney’s prime concern is that USTR’s push for more stringent IP and IP enforcement policies would to keep medicine prices high globally and place lifesaving treatments out of reach for longer in developing countries, like those in which Doctors Without Borders works. She believes that these “unwarranted pressure tactics”, if successful, limit countries’ scope of using internationally agreed public health safeguards, and threaten to undermine their domestic health efforts.

“People all across the globe can’t afford their medicines because pharmaceutical corporations choose to charge unaffordable prices. Considering that people’s health and access to medicines is at stake, developing countries should not capitulate to United States’ pressure at the behest of multinational pharmaceutical corporations against the interest of all people who need access to medicines,” states Menghaney.

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