WHO and UN actions undermine IP and hurt innovation, warns PhRMA

Supranational organisations such as the World Health Organization (WHO) and the United Nations Development Program (UNDP) are promoting acts, policies and practices that prevent biopharmaceutical innovators from securing and maintaining patents.

This is according to the Pharmaceutical Research and Manufacturers of America’s (PhRMA) submission to the US Trade Representative for the “2019 Special 301 Report”, an annually-published review of IP protection and enforcement abroad.

On Wednesday, March 13, PhRMA  announced its submission, encouraging the Trump administration to take a “tough stance in addressing the negative, unfair practices of certain countries”.

“Multilateral organisations that once served as custodians of the international rules-based system increasingly are seeking to undermine and even eliminate IP protections that drive and sustain biopharmaceutical innovation in the US and around the world,” warned PhRMA.

The association, which represents US biopharmaceutical research companies, highlighted the role that some supranational organisations (including the WHO and UNDP) play in “legitimising and facilitating countries’ adoption of policies that undermine IP rights and harm innovation”.

It added: “When the WHO, UNDP or Unitaid advance these policies, often over the objection of the countries that fund them, they jeopardise patient health.”

PhRMA goes on to state that work at the WHO, UNDP and the World Intellectual Property Office (WIPO) can be “inappropriately focused on limitations and exceptions to IP rights, if not actively seeking to undermine and even eliminate the IP protections that drive America’s innovation economy”.

In 2016, UNDP  issued patent examination guidelines which, if followed, would prevent innovators from securing patents on many kinds of biopharmaceutical inventions, claimed PhRMA.

Japan, Canada, Korea and Malaysia were recommended for inclusion on the priority watch list.

Pricing regulations in Japan were allegedly developed with little stakeholder engagement and transparency.

“Last year Japan revised its pricing policies to allow premium pricing based on company criteria that appears to be inherently biased towards domestic companies (eg number of local clinical trials and whether the product was launched first in Japan),” said PhRMA.

PhRMA has also taken issue with the ability to enforce patents in Canada, claiming that it continues to weaken.

“Canada’s current policies discourage and penalise innovators from seeking patent enforcement actions by enabling generic litigants to recover excessive and punitive damage awards,” added the association.

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