(Forslag) Europaparlaments- og rådsforordning (EU) …/… om det supplerende beskyttelsessertifikat for legemidler (kodifisering) (revisjon)
(Proposal) Regulation (EU) …/… of the European Parliament and of the Council on the supplementary protection certificate for medicinal products (recast)
Dansk departementsnotat offentliggjort 22.9.2023
BAKGRUNN (fra Kommisjonensforslaget)
Supplementary protection certificates (SPCs) are sui generis intellectual property (IP) rights that extend the 20-year term of patents for medicinal or plant protection products (PPPs) by up to 5 years 1 . They aim to offset the loss of effective patent protection due to the compulsory and lengthy testing required in the EU for the regulatory marketing authorisation of these products.
The unitary patent will enter into force on 1 June 2023, allowing for a single patent that covers all participating Member States in a unitary manner 2 .
This proposal aims to simplify the EU’s SPC system as regards national SPCs for medicinal products, as well as improve its transparency and efficiency. This initiative was announced in the Commission work programme for 2022 as initiative number 16 under Annex II (REFIT initiatives) 3 .
Regulation (EC) No 469/2009 provides for SPCs for medicinal products (both human and veterinary medicinal products) to be granted at a national level on the basis of national applications, on a country-by-country basis. Similarly, Regulation (EC) No 1610/96 provides for SPCs for plant protection products. Together these two measures constitute the EU’s SPC regime. As Regulation (EC) No 469/2009 has been amended several times, and since further amendments are to be made, that Regulation should, in the interest of clarity, be recast, which is the first objective of this proposal (and of the parallel proposal on PPPs (COM(2023) 223).
As confirmed by the evaluation carried out in 2020 (SWD(2020)292 final), today’s purely national procedures for granting SPCs involve separate examination proceedings (in parallel or subsequent) in Member States. This entails duplication of work, resulting in high costs and more often discrepancies between Member States in decisions to grant or refuse SPCs including in litigation before national courts. Inconsistency between Member States in decisions to grant or refuse SPCs is the single reason most often cited by national courts for preliminary references to the Court of Justice of the European Union on the application of the EU’s SPC regime. The current purely national procedures, therefore, lead to significant legal uncertainty.
The Commission’s intellectual property action plan of November 2020 (COM(2020) 760 final), which builds on the SPC evaluation, highlighted the need to tackle the remaining fragmentation of the EU’s intellectual property system. The plan noted that, for medicinal products and PPPs, SPC protection is only available at national level. At the same time, there is a centralised procedure for granting European patents and a centralised procedure for obtaining marketing authorisations for medicinal products. In the same vein, the pharmaceutical strategy for Europe (COM(2020) 761 final) emphasised the importance of investing in R&D to create innovative medicines. The strategy stressed, however, that the differences between Member States in the implementation of intellectual property regimes, especially for SPCs, lead to duplications and inefficiencies that affect the competitiveness of the pharmaceutical industry. Both the Council 4 and the European Parliament 5 have called on the Commission to correct these deficiencies.
Therefore, a second objective of this proposal is to introduce a centralised procedure for granting SPCs for medicinal products. This would allow applicants to obtain SPCs in the respective designated Member States subject to marketing authorisations having been granted in/for each of them, by filing a single ‘centralised SPC application’ that would undergo a single centralised examination procedure.
While that examination would be conducted by a centralised authority, the actual grant of SPCs would be done by the respective national offices of the designated Member States, based on a positive opinion from the central examination authority. The opinion of the central examination authority would be binding upon the national offices of the designated Member States.
A parallel proposal (COM(2023) 223), with similar provisions to this one for medicinal products 6 , concerns SPCs for PPPs.
Justis- og beredskapsdepartementet