The European legislature is planning a fundamental reform of European pharmaceutical law. The aim is to promote and protect innovation in pharmaceutical development, to ensure access to medicines and to strengthen Europe as a centre for the pharmaceutical industry. Combating antibiotic resistance is another concern of the proposal.
The European Commission presented the corresponding draft proposals, known as the EU Pharma Package, on 26 April 2023. One year later, on 10 April 2024, the EU Parliament adopted its position on the draft.
The proposal provides far-reaching reforms of pharmaceutical law, such as an adjustment and incentivization of the data protection period, simplifications in the development and authorization of generics and biosimilars, and a – not uncontroversial – transferable data exclusivity voucher for priority antimicrobials.
The Pharma Package is currently on the agenda of the Council’s Working Party on Intellectual Property, so the Council’s 1st reading position should be available in the course of 2025.
Apart from these regulatory proposals, the Commission on 27 April 2023 also published a proposal for the creation of a unitary supplementary protection certificate for medicinal products and plant protection products that can be based on Unitary Patents. This unitary SPC is a unitary right providing uniform protection and having equal effect in all Member States in which the basic Unitary Patent has unitary effect. It requires only one application, is granted by one authority (namely the European Union Intellectual Property Office (EUIPO) in Alicante) and can only be limited, transferred, revoked or lapse in respect of all the UPC Member States where it has effect.
In addition, the Commission plans to recast the existing SPC Regulation and to reform the procedure for ‘classical’ SPCs based on unitary patents or European patents so that these SPCs can be applied for and examined in a single centralized procedure before the EUIPO.
Furthermore, the proposals provide for the possibility for anyone to file an opposition against the grant of a unitary SPC / SPC with suspensive effect, i.e. the SPC will only come into force once the opposition has been decided on, including a possible appeal decision before the Boards of Appeal.
Since the European Parliament provided its position on the Commission’s plans on (unitary) SPCs on 28 February 2024 and the Council discusses the proposal, 2025 promises to be an exciting year for anyone involved in regulatory affairs and patents for medicinal products.
