The roadmap for the revision of European pharmaceutical legislation saw the EU Parliament, meeting in plenary session on 10 April, approve by a large majority a series of amendments to the Commission’s initial proposal that, in fact, appear to have largely accommodated the demands of the innovator pharmaceutical companies. The proposal for a directive was approved by 495 votes in favour, 57 against and 45 abstentions, the proposal for a regulation by 488 votes in favour, 67 against and 34 abstentions (link to the proposal for a new code for medicinal products for human use and link to the proposal for a regulation on authorisation procedures for medicinal products).

The proposed amendments had already been approved by the Parliament’s Environment, Public Health and Food Safety (ENVI) Committee on 19 March. The legislative process will now pause, to be resumed by the new members of the EU Parliament after the elections in June. “We hope the Council will take note of our ambition and commitment to create a robust legislative framework, preparing the ground for effective negotiations,” commented the directive’s rapporteur, Danish Pernille Weiss. The rapporteur of the regulation, German Tiemo Wölken, added that “We are strengthening our health infrastructure and increasing our collective resilience in anticipation of future health crises, an important milestone in our pursuit of fairer and more accessible healthcare for all Europeans”.

Seven and a half years of regulatory data protection

Among the most significant changes compared to the initial version of the proposal for a new directive, the text approved by Parliament extends the minimum period of regulatory data protection to seven and a half years (against the six proposed by the Commission). During this period, access to data by other companies, such as generic and biosimilar companies, would be prohibited. Obtaining marketing authorisation would also be linked to a two-year extension of market protection, during which no generic, hybrid or biosimilar versions of products could be marketed. The Parliament also approved a number of extensions of the data protection period upon the occurrence of certain events, but rejected the Commission’s proposal to link this to the simultaneous marketing of the medicinal product in all 27 EU countries. More specifically, pharmaceutical companies could obtain an additional year of data protection for products addressing unmet medical needs. The Parliament also approved a six-month extension in the case of conducting comparative clinical studies, i.e. if a significant part of the R&D on the product was carried out in the EU and at least partly in collaboration with EU research institutions. The maximum period of combined data protection could, in any case, not exceed eight and a half years. At the level of market protection, on the other hand, companies could obtain an additional year of (non-replicable) extension in the case of obtaining a marketing authorisation for an additional indication, and provided that this guarantees significant clinical benefits compared to existing treatments. Market exclusivity could be up to 11 years for orphan drugs suitable for treating rare diseases and addressing ‘high unmet medical need’.

OK for voucher for new antimicrobials

Actions to support the development of new antimicrobial agents include Parliament’s approval of ‘transferable data exclusivity vouchers’, which would benefit companies engaged in the development of priority antimicrobials. The approved scheme provides for the possibility to extend data protection for authorised products for up to 12 months. The voucher would also not be usable for products that have already benefited from the maximum possible period of regulatory data protection, and would only be transferable once to a second MA holder. MEPs also voted in favour of the introduction of market entry rewards and milestone payment reward schemes, based, for example, on early financial support following the achievement of certain R&D goals prior to AIC authorisation. To complement this, and to encourage the development of antimicrobials, the Parliament also envisaged the possibility of a subscription-based model based on voluntary joint procurement agreements.