To the attention of Mr. Tim Yeend,
Chef de Cabinet and Principle Advisor to Director-General
World Trade Organization

Bruxelles, 16 September 2020

Subject: On the risk of TRIPS to create regulatory barriers to medical innovation

Dear Mr. Tim Yeend,

In light of the “vaccine nationalism” and buy-outs of the broad-spectrum antiviral medication “Remdesivir”, much of the emphasis on intellectual property issues revolved around coronavirus has focused on immunizations and medicines, and we couldn’t stand aside from
this timely discussion.

Earlier this month, South Africa issued a communication titled “Beyond Access to Medicines and Medical Technologies Towards a More Holistic Approach to TRIPS Flexibilities.” It was pointed out that the COVID-19 response required looking beyond patents towards a more “integrated approach to TRIPS flexibilities that include other various types of intellectual property (IP) rights including copyrights, industrial designs and trade secrets” (IP/C/W/666).

“TRIPS flexibilities” that are usually used to refer to exceptions allowing countries to override global IP rules for public health reason have been used mainly in regard to patents. However, as the communication argues, the scope of the flexibilities should also be extended
to other various types of intellectual property (IP) rights including copyrights, industrial designs and trade secrets. As such, the recommendations submitted by South Africa are cross-field as they also touch upon the production and distribution of essential medical devices such as masks, ventilators, and personal protective equipment.

The risk of TRIPS is to create regulatory barriers that go well behind the pharmaceutical industries. Some examples of innovations that are supposed to be shared but face regulatory barriers go beyond pharmaceuticals to AI algorithms for apps and 3D-printed ventilator valves.

As a quick reminder, this can include so-called compulsory licensing when a government authorizes a manufacturer to copy another’s patented medicine. There are other grey areas still to be addressed over compulsory licensing as well as there are many ways to make easier access to vaccines: for example, a mutual recognition of FDA and EMA and other agencies and fast-tracking procedures for some type of medicines.

During tough times, decision-makers are requested to restore certainty to the greatest extent possible. Moreover, this crisis compels us to be one step ahead and anticipate issues.

Looking forward to your swift reaction,
Gianna GANCIA MEP
Anna BONFRISCO MEP
Fulvio MARTUSCIELLO MEP
Massimiliano SALINI MEP
Matteo ADINOLFI MEP
Salvatore DE MEO MEP
Antonio Tajani MEP
Hermann Tertsch MEP
Marlazy Aguilar MEP
Ivan Stefanec MEP
Stefania Zambelli MEP
Fred Roeder, managing director of the Consumer Choice Center