The European Parliament has voted through the pharmaceutical reforms as legislation, despite the pharma industry previously claiming they could compromise competitiveness and patient care.
The European Parliament has said that the file will be finalised after the European elections in June 2024.
The new directive and regulation, which include a reduction in the minimum regulatory data protection (RDP) period for new medicines, will be set to seven and a half years, with a further two years of market exclusivity, during which generic or biosimilar products cannot be sold.
Drug developers will be able to extend this to a maximum of eight and a half years if new therapies address an unmet medical need, are tested in comparative clinical trials or have research and development carried out within the EU.
For orphan drugs for rare diseases, drug developers could benefit from up to 11 years of market exclusivity if they address a “high unmet medical need”.
The proposal has previously proved controversial, with members of the European Parliament divided over how best to achieve improved patient access while encouraging innovation.
The pharma industry warned against potential extensions, including an additional two years of data protection when launching a drug in all 27 EU member states, after saying that companies will have no control over the timing of separate national pricing and reimbursement decisions and could cause delays in access when a company is involved in these types of negotiations.
The European Federation of Pharmaceutical Industries and Associations presented results in November 2023 which showed that the European Commission’s proposals will reduce the incentive to invest in medicines by 55% in Europe.
The new proposal has been praised for its introduction to a regulatory ‘sandbox’ and the creation of a transferable exclusivity voucher to provide developers of new antimicrobials with an extra 12 months of RDP.
Despite improvements, “the position adopted in the plenary reduces regulatory data protection by six months,” said Nathalie Moll, director general of the European Federation of Pharmaceutical Industries and Associations.
She continued: “The challenge now is for policymakers to align the next iteration of the pharmaceutical legislation with the recurrent calls by EU leaders to boost EU competitiveness and build a resilient industrial future.”