Following proposals that will weaken the EU’s intellectual property framework in yesterday’s EU Pharmaceutical Legislation [26 April 2023], today’s release of the patent package proposal provides some positives, but also considerable concerns and uncertainty for companies operating in the region.

EFPIA is encouraged by the move toward simplification and harmonization surrounding the SPC framework and the opportunities for its implementation via the Unitary patent. However, the EC’s proposal for an EU-level compulsory license, which could be used to broadly abrogate the IP rights of innovators, provokes concerns for the stability of the IP regime in Europe and appears to disregard lessons learned from the COVID pandemic response.

On Compulsory licensing

• Compulsory licensing is a last-resort option: it prevents the innovators themselves - who best understand the technology - from choosing the best-positioned, trusted partners to bring a given product to market within the shortest possible time frame, in the interest of patients.
• COVID-19 taught us that voluntary licensing not compulsory licensing enabled the launch of vaccines within a year and the rapid scale-up of manufacturing capacity such that supply quickly exceeded demand.
• Compulsory licensing revokes the rights of an innovator, undermining confidence in the investment stability of a region’s intellectual property system and harms the overall innovation pipeline.

Supplementary Protection Certificate (SPC)

• The implementation of the Unified Patent provides an opportunity for SPC harmonization, permitting greater efficiency, consistency, and legal certainty for this key innovation enabler in Europe.
• The SPC is the key IP protection driving pharmaceutical investment in Europe for over half of innovative products; given the trend for reduction and curtailing of IP and other R&D enablers across recent EU legislative proposals, it is more important than ever to ensure this key protection remains stable and predictable 

Nathalie Moll, Director General, EFPIA, said:

“Strong intellectual property protection is the foundation for medical innovation. Protecting the EU’s intellectual property framework could not be more important if we are to close the investment gap between Europe, the US and increasingly China and continue to offer patients the best possible treatments. Yet we are seeing multiple proposals emerging from the European Commission in the pharmaceutical legislation and patent package which tend towards the opposite.

The introduction of compulsory licensing at the EU level would promulgate the perception of companies and investors that Europe’s intellectual property framework is not predictable or stable. Compulsory licensing also undermines the innovation that we need when a health crisis arises.

Europe’s ability to lead the world in researching, developing and manufacturing vaccines for Covid-19 was built on a solid foundation of strong intellectual property and a diverse eco-system of research- based companies and institutions working tirelessly together. We need to decide if we want a competitive Europe with strong science or to become importers of medical science and accept the risks that come with this.”

EFPIA will continue to work with Members of the European Parliament, Council and other stakeholders to ensure the revised pharmaceutical legislation and patent package both support and boost Europe’s life science potential while meeting the needs of patients, our healthcare systems, Member States.  

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