European Biotech Act – Removing Barriers to the Development of Biologics in Europe

The European Commission’s regulatory initiative

In light of the above mentioned findings set out in the Draghi report, the European Commission has published a proposal for a regulation aimed at supporting development and strengthening the competitiveness of the pharmaceutical biotechnology sector in Europe.

This regulatory initiative seeks to encourage companies to relocate their R&D, clinical development and manufacturing activities to Europe, in particular by:

• introducing new funding and investment mechanisms;
• accelerating the clinical development of innovative biological medicines and biosimilars through the streamlining the regulatory framework;
• facilitating the use and sharing of health data, notably through the integration of AI-based solutions.

1-year extension of SPC protection for biologics (5+1)

With respect to industrial property aspects, the Commission proposes to extend by one year the duration of protection conferred by a Supplementary Protection Certificate (SPC), thereby increasing such protection to six years, for best-in-class human-use biologics, subject to certain conditions.

The introduction of such incentives appears justified, as biologics generally require significantly longer development timeframes than small-molecule medicines derived from synthetic chemistry and therefore benefit from a shorter effective period of protection by IP titles.

Eligible products

To be eligible to such 1-year extension, the pharmaceutical product must be derived from biotechnological processes based on recombinant technologies, or on the controlled expression of genes encoding biologically active proteins. Advanced Therapy Medicinal Products (ATMPs) are also covered, namely gene therapies, somatic cell therapies such as CAR-T cells, and tissue-engineered products.

Cumulative conditions

In order to benefit from this extension of protection, the draft regulation provides for four cumulative conditions:

1. the pharmaceutical product must contain a new active substance that is “significantly different” from that of any other medicinal product authorised in the EU;
2. the pharmaceutical product must have a mechanism of action that is “significantly different” from that of any other medicinal product authorised in the EU and must demonstrate at least an equivalent level of safety and efficacy;
3. the clinical trials supporting the marketing authorisation must have been conducted in at least two EU Member States;
4. at least one stage of the manufacturing process (excluding packaging and quality control) must be carried out within the EU.

Veterinary medicinal products

It should be noted that a 12-month extension is also proposed for SPCs covering veterinary biologics products intended for the diagnosis, treatment or prevention of zoonoses (diseases transmissible between animals and humans), under similar conditions.

Legislative process

This draft regulation will follow the ordinary European legislative procedure and may evolve during the successive readings before the European Parliament and the Council.