SPC extension retained – further strengthening of the industrial policy approach

On 15 June, rapporteurs Vytenis Andriukaitis (S&D, SANT) and Wouter Beke (EPP, ITRE) presented their joint draft report on the European Biotech Act. In the explanatory statement, the rapporteurs argue that Europe is losing ground to the United States and China in global competition and must do more to translate its scientific excellence into innovation, manufacturing and economic value creation. In their view, the Biotech Act should therefore go beyond a narrowly defined sectoral instrument and establish a "European biotechnology ecosystem" that combines competitiveness, strategic autonomy and tangible benefits for patients.

Overall, the draft report closely follows the Commission proposal presented in December but introduces additional industrial policy instruments, regulatory incentives and further measures to accelerate regulatory procedures.

Expansion of strategic projects and new industrial policy instruments

A central element of the draft report is the further development of the strategic projects already proposed by the European Commission. These projects are intended to support particularly important biotechnology medicines and technologies that are considered strategically relevant for innovation, manufacturing and security of supply. They would benefit from accelerated authorisation procedures as well as facilitated access to public support and financing.

The rapporteurs propose additional categories for projects of particular strategic importance and the creation of "EU Biotech Flagship Zones" to promote European biotechnology hubs across the entire value chain. They also introduce an "Advanced Biomanufacturing Technology (ABT) Designation" as a new regulatory incentive for innovative manufacturing technologies. At the same time, authorisation procedures for projects of exceptional strategic importance would be further accelerated: for so-called "High-Impact Projects", the maximum authorisation period would be reduced to four months instead of the ten months proposed by the Commission.

Further acceleration of clinical trials

While the European Commission had already proposed shorter timelines for clinical trials, the rapporteurs go a step further by proposing additional deadline reductions and new dedicated procedures for multinational clinical trials. They propose amending the Clinical Trials Regulation (Regulation (EU) No 536/2014) by introducing a specific procedure for multinational clinical trials. The aim is to further centralise and harmonise procedures while reducing approval timelines. In addition, dedicated fast-track procedures are proposed for rare diseases, rare cancers, advanced therapy medicinal products (ATMPs), critical medicines and cross-border health threats. The rapporteurs also call for closer integration of the European Reference Networks (ERNs), registries, biobanks and research infrastructures.

SPC extension remains unchanged

The rapporteurs do not propose any changes to the European Commission's proposal for a one-off twelve-month extension of the Supplementary Protection Certificate (SPC). As a result, one of the most controversial elements of the Biotech Act remains unchanged in the draft report. While the opinion-giving ENVI and JURI Committees recommended deleting the provision entirely, the lead committees SANT and ITRE maintain the principle of granting additional exclusivity rights.

In its statement, the German Social Insurance European Representation (DSV) strongly opposes the proposed SPC extension. According to DSV calculations, the measure could generate additional annual costs of around €585 million for Germany's statutory health insurance system and approximately €1.7 billion per year across the European Union. During the EPSCO Council meeting on 16 June, Poland, Estonia and Malta likewise warned of negative effects on competition, delayed biosimilar market entry, higher healthcare expenditure and reduced affordability of medicines.

A stronger industrial and innovation policy approach

Overall, the rapporteurs pursue a clearly industry- and innovation-oriented approach. In addition to maintaining the SPC extension, they propose new support instruments, privileged project categories and further accelerated procedures. At the same time, they seek to strengthen links between European research, data and healthcare infrastructures, particularly in the field of rare diseases. The draft report therefore reinforces the broader trend of increasingly linking health policy objectives with industrial and competitiveness objectives.

Outlook

Amendments to the draft report may be tabled in the lead ITRE and SANT Committees until 7 July. The committee vote is currently scheduled for 1 December. The opinions already adopted by the associated committees will also feed into the negotiations. The European Parliament is expected to adopt its position in plenary in early 2027. The Council likewise aims to reach its General Approach around the same time.