OPINION
Adrien Samson, EuropaBio; Picture: EuropaBio

The future of health biotech innovation in Europe

The 2023 State of the Union speech saw biotechnology rise as a priority for the European Union. It has been designated as a critical technology for Europe’s economic security. In March 2024, the European Commission presented its biotechnology and biomanufacturing strategy with a clear leadership ambition for Europe’s biotech industries. The Letta Report on the future of the Single Market, published April 2024, proposed a fifth freedom on research and innovation which would directly benefit biotech.

In a sign of how quickly policy priorities change in Brussels, six months before the European Commission published its much-anticipated revision of the EU General Pharmaceutical Legislation (GPL). The proposals make no reference to biotech and the impact on the biotech ecosystem was not specifically assessed. The revision proposed several welcomed improvements, including reducing the assessment periods and the creation of sandboxes for cutting edge products, but also proposed a lower baseline incentives and unpredictable modulation for novel medicines, including for rare diseases that will negatively impact the biotech ecosystem.

Within healthcare, biotech is increasingly the primary source of new therapies, bringing previously untreatable diseases within reach and transitioning from ‘manage’ to ‘cure’ with improvements to quality of life, freeing patients, families, and healthcare systems. Higher risk and long development timelines characterise the translation of biotech into therapies, with smaller companies being the primary vehicle for translation of Europe’s research into development pipelines. The pathway to patients is a highly collaborative ecosystem between companies of all sizes. Innovators, especially emerging and small companies, are highly reliant on a strong and predictable incentives framework to secure early investment for long term programmes.

The GPL is a force for growth in EU biotech innovation and patient benefit. The Commission’s proposals will negatively impact Europe’s biotech ecosystem, with small innovators are at greatest risk and with them the EU’s engine for novel medicines. Biotech companies are strongly inter-dependent for successful development of medicines. Proposed changes negatively impact partnerships and Europe’s healthcare autonomy. Reducing incentives and certainty for early programmes is a barrier to the delivery of innovative medicines through biotech.

Despite the European Parliament having adopted its position on the proposals in record time, it must not be forgotten that GPL is legislation for future innovation and will only become law at the end of the decade. There is still time and opportunity for the Member States in the Council to ensure the GPL is aligned with Europe’s priorities on competitiveness and open strategic autonomy, and delivers a more ambitious vision for the future of biotech innovation.

Adrien Samson is Healthcare Policy Senior Manager at EuropaBio, the European Biotech Industry
Association. He leads the association’s policy work on health biotech issues. He has expertise on EU
pharmaceutical and industrial policies and works with a diverse range of stakeholders, including policymakers, regulators, industry representatives, patient groups, and research organisations, to promote the benefits and potential of biotech for health and society.

This article was originally published in European Biotechnology Magazine Summer 2024.