French snub of EU firefighting aid calls novel scheme into question
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Hoping to support pharmaceutical innovation and competitiveness, Stockholm is advocating for a Unitary Patent System. Sweden is one of eleven EU Member States pushing the Danish Presidency to finalise an EU system for enhanced patent protection for medicines. Supplementary Protection Certificates (SPCs) have been in place for several decades in the European Union. They are an intellectual property right that grants a patentholder an additional five years of patent protection, primarily for medicine patents. So far, each Member State has to implement such protection nationally, resulting in varying outcomes between countries. However, a unitary system was proposed by the EU Commission in 2023. Under this proposal, a unitary SPC would be relevant in the 18 EU states that have currently joined the so-called Unitary Patent System. 'A unitary SPC would be an important piece of the puzzle to finalise the Unitary Patent System and a reform that would boost innovation and competitiveness', Louise Petrelius, a senior advisor at the Swedish Ministry of Justice, told Euractiv. She explains that the system is expected to streamline the extension of patent protection for both medicinal and plant protection products (e.g. pesticides) in the EU by introducing a single, unified procedure across participating member states. 'This aims to simplify the current system, which requires separate applications in each country, reducing costs and administrative burden for applicants.' Longer time to market According to Petrelius, SPCs aim to compensate patent holders for the extra time it takes to bring their products to market, due to the compulsory lengthy testing and clinical trials required prior to obtaining regulatory marketing approval. The protection for patents in the EU is 20 years. An SPC could extend such a patent right for a maximum of five years. As the SPC mechanism extends the market exclusivity of a patented medicine beyond the initial patent term, it could delay the entry of generic or biosimilar competition and maintain higher prices for a longer period in the EU. According to the Swedish Intellectual Property Office (PRV), companies producing generics and biosimilars are only allowed to start manufacturing and storing a medicine during the extra five-year protection period if their products are to be exported outside the EU. Civil society organisations, as Médecins Sans Frontières (MSF), have previously called upon the EU to abolish the SPC mechanism, saying it contributes 'to high drug prices and hinders access to essential medicines by delaying the availability of generic and biosimilar alternatives'. No price analysis Johan Pontén, International Coordinator at the Swedish Dental and Pharmaceutical Benefits Agency (TLV), told Euractiv that 'TLV agrees with the Swedish government that a centralised SPC system creates more uniform and simpler management within the EU, which is positive,' adding, however: 'We have not been tasked with analysing how a changed system could affect the prices of medicines and therefore cannot comment on it'. Meanwhile, according to the Swedish Ministry of Justice, there is no ongoing discussion in the EU that links higher prices to the SPC proposal. 'Since the question of the existence of SPCs is not subject to negotiation, it is not discussed in this project. In general, my view is that Sweden is in favour of a system that promotes innovation and attractiveness on the pharmaceutical side, where intellectual property protection is an important component,' Petter Söderbäck, also a senior legal advisor at the Swedish Ministry of Justice, told Euractiv. Euractiv has requested a comment from the Danish Presidency, but has not received a response so far. [Edited by Vasiliki Angouridi]
