Update: On Wednesday, 25 November 2020, the European Commission published its IP action plan: Making the most of the EU’s innovative potential – An intellectual property action plan to support the EU’s recovery and resilience. KEI Europe’s President, Dr. Ellen ‘t Hoen provided the following reaction to the European Union’s action plan on intellectual property.
Dr. Ellen ‘t Hoen, President, KEI Europe and Director of Medicines Law & Policy, noted: “I was encouraged to see the Commission’s plan to look ‘into ways to incentivise the rapid pooling of critical IP in times of crisis’. Since we are in a time of crisis, this commitment should translate into action very soon. After all the Commission is spending billions of Euros on IP protected products and should use this as a leverage for sharing IP needed to make C-TAP a success. A big surprise is the Commission’s warm embrace of compulsory licensing. The strategy rightfully points out that this is a matter of national law and calls on members to ensure that their laws allow effective use of the measure. The Commission however should do its part by including a waiver to data exclusivity in its pharmaceutical regulation so products produced under a compulsory license do not run into regulatory barriers to making them available in the EU. A glaring omission is the need to opt back into TRIPS Article 31bis to allow importation of products produced elsewhere under a compulsory license.”
On Friday, 20 November 2020, Politico published an advanced copy of the European Commission’s “intellectual property action plan to support the EU’s recovery and resilience”. This twenty page document is a communication from the European Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions.
In light of multilateral engagement at the World Health Organization (WHO) and the World Trade Organization (WTO) on the COVID-19 response, the action plan’s strategy for “Better tools to share critical IP in times of crisis” is instructive.
The COVID-19 pandemic highlights the importance of an effective IP system, offering strong incentives to innovate, as well as effective tools to share out IP for technologies needed to cope with the crisis. R&D funding as well as IP incentives play a critical role to ensure the rapid development and availability of new technologies, such as vaccines or new treatments. At the same time, we need to ensure that new technologies, once developed, can also be rapidly deployed, not only in Europe but also on a global basis. In addition, access to existing technologies that are critical, such as IP related to existing medicines or protective gear for instance, should be granted when this is needed to secure supplies and cope with shortages, whilst at the same time ensuring a return on investment.(EU IP Action Plan, page 11, November 2020)
The Commission provided the following perspectives on patent pools and voluntary licensing.
“In this context, the Commission supports voluntary pooling and licensing of intellectual property related to COVID-19 therapeutics and vaccines, in line with the recent resolution of the World Health Assembly to promote equitable global access as well as a fair return on investments. Such schemes should be based on a voluntary participation, ensuring equitable access within clear boundaries and allowing IP owners to recoup investments in a balanced way.”
“Building on various experiences with pledges and patent pools, the Commission is working on mechanisms that would enable and incentivise the rapid pooling of critical IP in times of crisis, whilst guaranteeing that such voluntary and temporary pooling preserves strong protection of IP. This would offer interested parties the IP tools they need to quickly ramp up the production of IP-protected technologies, including via repurposing manufacturing.”(Ibid)
In relation to the exigent stress test imposed by the COVID-19 pandemic on the architecture of the TRIPS Agreement, the Commission noted:
“Going forward however, the Commission sees a need to have better tools in place to cope with crisis situations. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) allows states to limit IP protection where necessary to cope with crisis situations. The TRIPS framework is fit for purpose, but can be implemented in a more effective manner.”(Ibid)
Following on from President Ursula von der Leyen’s State of the Union call for the establishment of an EU BARDA, the EU’s IP action anticipated the development of an “effective framework for march-in rights, that should guarantee that publicly funded IP is available in case of critical shortages”. How the European Union designs and implements march-in rights will be crucial.
In relation to compulsory licensing, while the Commission expressed the view that compulsory licensing should be used as a “means of last resort and a safety net when all other efforts to make IP available have failed”, the Commission urged its Member States to establish fast-track procedures to issue compulsory licenses in emergency situations; presumably this would apply to the current COVID-19 pandemic.
Finally, the Commission sees the need to ensure that effective systems for issuing compulsory licenses are in place, to be used as a means of last resort and a safety net, when all other efforts to make IP available have failed. In Europe, compulsory licensing is mainly governed by national law. The Commission calls on the Member States to ensure that the tools they have are as effective as possible, for instance, by putting in place fast-track procedures for issuing compulsory licenses in emergency situations. In addition, it sees a need for a stronger co-ordination in this area, to avoid distortive effects on innovation and trade, but also to ensure that national measures are as effective as possible. Early co-ordination and information sharing between Member States, e.g. on the duration of and royalties on any such licenses, should help secure maximum benefits whilst at the same time avoiding excessive distortions. The Commission will explore with Member States the possibility of creating an emergency co-ordination mechanism, to be triggered at short notice when Member States consider issuing a compulsory license.(EU IP Action Plan, page 12, November 2020)