Submission to the US International Trade Commission

On 17 June 2022, World Trade Organization (WTO) Members adopted a Ministerial Decision outlining flexibilities in the WTO’s Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement that countries could use to access Covid-19 vaccines. A decision on whether and how to extend the scope of the Decision was tabled for 17 December 2023 but subsequently postponed to a later date.

As part of its decision-making process, the US Trade Representative has commissioned a study to determine the case for extending the Decision and invited submissions by interested parties.

Read the full submission by Medicines Law & Policy to the USITC. Below is a summary of the submission.

Medicines Law & Policy recommends an extension to the Decision:

Ensure access to all pandemic countermeasures including vaccines, diagnostics, therapeutics and any other health technologies needed to prevent, address and/or recover from a health crisis.

Ensure preparedness for future pandemics by making the Ministerial Decision applicable to any emerging or declared health emergency in the future.

Ensure an easy pathway for countries to opt back into TRIPS Art. 31bis. In 2003, many countries opted out of using Art. 31bis (compulsory licensing for export). With increasing concentration of pharmaceutical manufacturing, those countries may find themselves in need of this provision, in particular in a crisis situation.

Ensure waivers on market and data exclusivity are available so that effective implementation of a compulsory licence is not delayed by lack of access to information needed for regulatory purposes. 

Since 2001, ML&P has been tracking the use of TRIPS flexibilities for public health in our TRIPS Flexibilities Database (TFD). We see that TRIPS Flexibilities are:

Widely used. The TFD currently documents 172 instances, of which 122 concern compulsory licensing, 3 exceptions to patent rights, 46 the least developed country (LDC) extension and 1 parallel import.

Effective even when not executed. The TFD notes 27 instances between 2001 and 2023 where compulsory licences were proposed but not executed. Of those,16 resulted in an access measure by a company – either a voluntary licence, a price decrease, or a declaration not to enforce rights.

Useful in a pandemic. The TFD shows that since 2020 there have been 10 instances of compulsory licensing that concerned products needed to prevent or treat Covid-19. Five of these instances were in high-income countries and four were executed.

Useful in high-income countries. Of 122 compulsory licence instances in the databases, 23 were for the use in high-income countries.  

TRIPS flexibilities have an important role in ensuring access to medicines in general, and access to countermeasures in the case of public health emergencies in particular. The Ministerial Decision has the opportunity to ease their use to ensure a more effective response to Covid-19 and future pandemics. WTO Members should take the recommendations above to extend the Ministerial Decision and work to incorporate TRIPS flexibilities into their national legislation. They should also seek to avoid actions that make it more difficult to use TRIPS flexibilities, including opting out of Art. 31bis, agreeing to or demanding so-called ‘TRIPS-plus’ provisions, or engaging in political pressure against the use of TRIPS flexibilities. 

Read Medicines Law & Policy’s full submission to the USITC.

Author

  • Ellen 't Hoen

    Ellen ‘t Hoen, LLM PhD, is a lawyer and public health advocate with over 30 years of experience working on pharmaceutical and intellectual property policies.