Innovation and Access to Medicines in Europe’s Biotech Framework

The European Biotech Act represents one of the most significant attempts in recent years to strengthen Europe’s position in biotechnology and biomanufacturing. It reflects a growing recognition that Europe must enhance its scientific, industrial and manufacturing capabilities if it wants to remain competitive in a rapidly changing global environment. This objective deserves broad support.

Europe needs stronger biotechnology ecosystems, more investment, greater manufacturing capacity and a regulatory environment capable of attracting research and innovation. The challenge, however, is not simply to generate more innovation. It is to ensure that innovation ultimately benefits patients and healthcare systems.

Too often, the debate is framed as a choice between competitiveness and access. This is a false dichotomy. In healthcare, innovation and access are inseparable. Scientific breakthroughs only generate value when they reach the people who need them.

A biotechnology strategy that succeeds in attracting investment but fails to improve access to medicines cannot be considered a complete success. Likewise, a healthcare system that prioritises affordability but fails to foster innovation will struggle to respond to future health challenges.

The real question is therefore not whether Europe should prioritise innovation or access. The question is how to design a biotechnology framework that delivers both.

Beyond Exclusivities: The Debate on SPC Extension

One of the most debated provisions of the proposed Biotech Act is the extension of Supplementary Protection Certificates (SPCs) for biotechnology products and Advanced Therapy Medicinal Products (ATMPs).

The objective is clear: to encourage investment and development activities within the European Union. Yet there are legitimate reasons to question whether extending exclusivity periods at the end of a product’s lifecycle is the most effective way to achieve this goal.

Additional exclusivity inevitably delays competition. In the case of biological medicines, it postpones the entry of biosimilars that have consistently demonstrated their ability to expand patient access and reduce costs for healthcare systems.

Competition should not be viewed as the enemy of innovation. On the contrary, the transition from monopoly to competitive markets is one of the most important drivers of continuous technological progress. Delaying that transition risks increasing costs while reducing incentives for further innovation.

The question policymakers should ask is not whether innovators deserve incentives. They do. The question is whether extending monopolies after decades of protection is the most efficient and proportionate incentive available.

Better Pull Incentives for European Biotechnology

If Europe wants to strengthen its biotechnology sector, it should consider a broader toolbox.

Market certainty can be as important as intellectual property protection. Joint procurement mechanisms, early access programmes, innovative purchasing models and coordinated European demand signals can provide companies with greater visibility while ensuring that patients benefit from faster access to valuable technologies.

For many innovators, the prospect of predictable uptake within large public healthcare systems may be a stronger incentive than a distant extension of exclusivity whose value remains uncertain at the moment investment decisions are made.

A biotechnology policy focused exclusively on supply-side incentives risks overlooking the importance of demand-side measures that can simultaneously support innovation and access.

Attracting Clinical Development Through Better Framework Conditions

The same logic applies to clinical research.

Europe has rightly identified the need to attract earlier-stage clinical trials and development programmes. However, the factors that influence where companies conduct research are largely immediate rather than distant.

Efficient clinical trial authorisation processes, high-quality research infrastructures, regulatory predictability, rapid patient recruitment and clear pathways to adoption are likely to matter far more than an additional period of exclusivity that may only materialise many years later.

If Europe wants to compete globally for clinical research investment, improving the clinical and regulatory environment is likely to produce greater results than relying primarily on intellectual property incentives.

Biosimilars as a Competitiveness Strategy

One of the paradoxes of the current debate is that biosimilars are often discussed primarily as a cost-containment tool when they should also be recognised as an industrial policy asset.

A strong European biosimilar sector strengthens manufacturing capacity, supports strategic autonomy, creates highly skilled jobs and improves resilience of supply chains.

Most importantly, biosimilars expand access.

Every euro saved through biosimilar competition creates opportunities to finance new innovations and broaden patient access to advanced therapies. Competitiveness and affordability are not opposing objectives in this context; they reinforce one another.

Supporting European biofabrication and biosimilar production should therefore be seen as an essential pillar of the Union’s biotechnology strategy.

Hospital Exemption: Innovation for Forgotten Patients

Perhaps the most important access issue within the biotechnology debate concerns Advanced Therapy Medicinal Products developed under hospital exemption frameworks.

These pathways exist for a reason. Not all patients represent commercially attractive markets.

While therapies targeting large patient populations will often attract private investment and industrial development, many patients with rare, highly specialised or ultra-small conditions depend on public institutions, hospitals and academic centres to develop innovative treatments.

The discussion should not focus exclusively on how rapidly these products can be pushed towards commercial marketing authorisation. The primary objective should remain addressing unmet medical needs. Supporting hospital exemption means supporting innovation for forgotten patients.

Where therapies developed under hospital exemption have broader commercial potential, developers should receive regulatory guidance, business support and appropriate pathways towards commercialisation. But Europe should also preserve space for non-profit and public-interest innovation aimed at patient populations that the market alone cannot adequately serve.

A truly successful biotechnology strategy must create incentives not only for blockbuster products, but also for therapies that address the needs of those who would otherwise have no options.

Europe Must Build Its Own Model

The debate surrounding the Biotech Act ultimately reflects a broader choice about the future of European healthcare innovation.

Some argue that stronger exclusivities and longer monopoly periods are the primary path to competitiveness. Yet the international evidence suggests caution.

The United States has produced remarkable biomedical innovation, but it also combines the highest healthcare spending in the OECD with persistent access barriers and health outcomes that frequently underperform those of many European countries.

Europe should not seek to replicate that model.

Europe’s strength has always been its ability to combine scientific excellence, industrial leadership and social solidarity. The Biotech Act provides an opportunity to reinforce that distinctive approach.

The success of European biotechnology should not be measured solely by investment flows, patent portfolios or manufacturing capacity. It should also be measured by whether patients can access the innovations that Europe’s scientific and industrial ecosystem produces.

In healthcare, innovation achieves its purpose only when it reaches people.

That should remain the guiding principle of Europe’s biotechnology framework.