Shaking up the biotechnology revolution: how can Europe step up the pace?

Shaking up the biotechnology revolution: how can Europe step up the pace?

During a recent event in Brussels, policymakers, industry leaders, and regulatory experts met to discuss what’s needed to avoid falling behind in the biotechnology revolution.

According to a recent report [1], the pace set by the biotechnology sector in Europe is lagging far behind that set by US and Asian counterparts. The so called “Advanced therapy medicinal products” (ATMPs), as well as other innovative medicinal products, form the cornerstone of the biotechnology revolution. They have already proven to be effective and highly relevant, perhaps the most famous example of the latter being the mRNA COVID-19 vaccine.

Stefan Oelrich, (Head of Pharmaceuticals at Bayer AG), kicked-off this event by stressing the need for Europe to capitalise on lessons learnt from the COVID-19 pandemic, to translate research into innovation, and avoid letting the US and China dominate the sector.

Carolina Darias, (Spanish Minister of Health) reminded the audience that whilst more and more innovations are coming to the market, to ensure a sustainable biotech sector in the future, both State actors and a strengthened European pharmaceutical industry are needed to succeed.

Providing an extra-EU perspective, Mark McClellan (director of the Duke-Robert J. Margolis, MD Centre for Health Policy, and former Commissioner of the US FDA), stated that in order for Europe to succeed in the biotech revolution, it should first recognise that the sector is vast, and therefore focus on specific areas (such as mRNA technologies). Secondly, McClellan called for Europe to better manage the downstream impact of ATMPs, (such collecting data on their impact and value over longer periods of time).

Sierk Poetting (Chief Operating Officer, BioNTech), reminded the audience that the research that paved the way for the mRNA vaccine is 35 years old, and that the BioNTech founders have been engaged in this area of research for 20 years.

Pierre Delsaux (Deputy Director General of DG SANTE, European Commission), called for more partnership between public and private actors, such as in the case for COVID-19 vaccines. Delsaux also stated that the European Commission’s new Strategy for Pharmaceuticals aims to provide the framework for innovation, the financial incentives to ensure innovation prospers in Europe, and to reduce the EU’s dependence on third countries.

MEP Ondřej Knotek, (Renew Europe, Czech Republic, and Chair of the TRANSFORM Interest Group on cell and gene therapies), highlighted that knowledge gaps exist on cell and gene therapies with the general public, and policymakers alike. Knotek also called for policymakers to ensure policies and regulation keep pace with advances in new technology, allowing Europe itself to keep pace with other regions of the world.

Capitalising on the lessons learnt from the pandemic, translating research into innovation, and ensuring Europe takes its rightful place as a biotech leader, is a responsibility that all stakeholders bare in the EU health policy ecosystem.

The discussions and lessons learnt from this event form just part of a broader range of activities in European health, pharmaceutical, and biotech policies. Health, particularly thanks to the additional focus provided by the COVID-19 pandemic, has never been higher on the EU’s policy agenda, a timely example of this being the recently adopted European Council Conclusions on COVID-19 [2].

That’s not to mention the ongoing work on an EU regulation on serious cross-border threats to health, establishing the European Health Emergency preparedness and Response Authority (HERA), expanding the mandates of both the European Medicines Agency (EMA), and European Centre for Disease Prevention and Control (ECDC), the launch of Europe’s Beating Cancer Plan, the evaluation of orphan and paediatric medicines, establishing the European Health Data Space, and the upcoming revision of the general pharmaceutical legislation in the EU.

We should be taking advantage of this once in a generation opportunity to shape EU health, pharmaceutical, and biotech policies, and being able to navigate the complex, and multi-dimensional EU legislative, policy, and advocacy ecosystem, is key to effectively achieving this.

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