The European Alliance for Responsible R&D and Affordable Medicines welcomed the opportunity to provide feedback within this European Commission’s consultation on Intellectual property: revised framework for compulsory licensing of patents. Compulsory Licensing (CL) is a crucial public health safeguard to ensure an adequate balance between innovation incentives and access to essential medicines. The creation of a compulsory licensing system in the EU is a unique opportunity to remove the legal obstacles currently hindering the rapid and effective use of compulsory licensing within the EU. 

The COVID-19 pandemic prompted the EU to support the use of compulsory licences in Europe and other countries, including as a purported alternative to a potential temporary waiver of some sections of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. CL is a flexibility allowed under the TRIPS agreements that can be issued under certain requirements in different circumstances, as determined by each country. However, CL has been incorrectly framed as a “last resort” option This persistent yet wrong interpretation of the text and spirit of the TRIPS agreement and the Doha Declaration on the TRIPS and Public Health (2001)  has severely limited the use of CL and constrained access to medical tools worldwide.  

While the EC acknowledges the need to improve the effective use of compulsory licensing, it does not specify concrete actions to adequately improve national legislation on compulsory licensing. The EU legislation on medicinal products also interferes with the effective use of compulsory licensing by Member States because it prohibits the registration of generic equivalents for a defined period, regardless of patent protection. Therefore, EU countries cannot register a generic product during the data/market exclusivity period, even when a medicine is needed The current EU pharmaceuticals legislation has no exception to this rule. 

To restore these flaws, the European Alliance for Responsible R&D and Affordable Medicines recommends:  

  • Remove obstacles to the effective use of CL, by allowing the use of exceptions for data and market exclusivities as well as for SPCs in the form of waivers when applying a CL. These exceptions should also apply to the necessary know-how and trade secrets. 
  • Include broader grounds for a CL beyond public health crisis or pandemic contexts, such as in-country availability or public interest (e.g. to ensure medicine affordability) as well as the right to be requested by any right holder on public interest grounds. 
  • The EU should revisit the decision to opt-out as an importer under Art 31bis of the TRIPS. 
  • The EU should enforce its corresponding obligation under article 66.2 of TRIPS taking measures to expand the transfer of technology to LDCs. 
  • Refrain from exporting EU IP rules (TRIPS+), including on data exclusivity, in bilateral trade agreements with other countries, in particular LMICs.  

Read the Alliance’s full response

See responses to the consultation by Alliance members: