Significant costs for healthcare systems, limited contribution to competitiveness.

The proposed extension of the Supplementary Protection Certificate (SPC) is one of the most controversial elements of the European Commission’s proposed Biotech Act. An SPC can extend the protection period of a medicinal product after patent expiry and thereby delay the market entry of more affordable follow-on products. For certain biotechnologically developed medicinal products – including Advanced Therapy Medicinal Products (ATMPs) – this protection period could now be extended by an additional twelve months beyond the current maximum SPC duration of five years. The eligibility of medicinal products for this extension would depend on several conditions laid down in the proposed regulation.

New protection rights for biotech medicines

According to the proposal, medicinal products could benefit from the additional protection period if they meet several requirements. These include containing a new active substance, differing from already authorised therapies in terms of mechanism of action as well as safety and efficacy profile, having conducted clinical trials in more than two Member States, and carrying out at least one relevant manufacturing step within the European Union. Eligible products would include biotechnologically developed medicinal products and ATMPs protected by an SPC or an SPC-eligible patent.

585 million euros annually for the German statutory health insurance system alone

The German Social Insurance (DSV), representing around 75 million people insured under the statutory health insurance system in Germany, strongly opposes the proposed additional SPC extension in its statement. According to DSV calculations, the measure could generate additional costs of approximately €585 million per year for Germany’s statutory health insurance system (GKV) and around €1.7 billion annually across the European Union.

Competition remains essential for affordable access

Strengthening the European biotechnology sector and improving resilience are legitimate political objectives. However, extending monopoly protection rights is not the appropriate instrument to achieve these goals. The Biotech Act should promote innovative and market-ready therapies without weakening competition.

A delayed market entry of biosimilars due to longer protection periods would increase expenditure on high-priced medicinal products and place additional pressure on solidarity-based healthcare systems. At the same time, competition is a key driver of innovation, investment, and affordable access to medicines.

Location decisions are only marginally influenced by SPCs

The DSV explicitly supports the promotion of innovation but rejects blanket extensions of exclusivity periods. In its view, the structural challenges facing the European biotechnology sector relate primarily to production costs, shortages of skilled labour, and limited access to risk capital – not to insufficient monopoly protection. Evaluations by the European Commission itself also show that SPCs have only a limited influence on decisions regarding research and development locations.

At the same time, the proposed SPC extension is, from the DSV’s perspective, neither sufficiently targeted nor evidence-based. The proposed criteria focus mainly on novelty and manufacturing processes rather than on a clear additional clinical benefit. Instead of extending monopoly periods at the expense of public healthcare budgets, the DSV therefore calls for targeted and transparent support instruments to strengthen innovation and competitiveness in Europe.

All eyes on the European Parliament

Attention in the European Parliament is now turning to the upcoming draft report by Vytenis Andriukaitis in the Committee on Public Health (SANT) and Wouter Beke in the Committee on Industry, Research and Energy (ITRE). Both rapporteurs intend to present their joint draft by the end of June, thereby initiating Parliament’s substantive positioning on the Biotech Act.