Path clear for the vote in plenary.

CC – 03/2024

MEPs on the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI) adopted their position on the European pharmaceutical reform on 19 March. Both reports were adopted by a large majority. The report by Pernille Weiss (EPP, DK) on the draft directive was adopted with 66 votes in favour, 2 against and 9 abstentions. The report by Tiemo Wölken (S&D, DE) on the draft regulation received the required majority with 67 votes in favour, 6 against and 7 abstentions. With the clear vote, the Health Committee has now adopted its position on the Commission proposals presented in May 2023.

Prior to the vote, there were intense negotiations at the level of the European Parliament's rapporteurs and shadow rapporteurs, particularly on the protection periods for medicinal products and on transferable market exclusivity vouchers.

Protection periods

In order to reward innovation, MEPs want to introduce a minimum regulatory data protection period of seven and a half years and two years of marketing protection. They also want to adjust the scale of incentives. Pharmaceutical manufacturers would be entitled to additional regulatory data protection if the product in question fulfils an unmet medical need (+12 months), if comparator clinical trials are conducted for the product (+6 months) and a significant part of the research and development of the product takes place in the EU and at least partly in cooperation with EU research institutions (+6 months). A one-time extension (+12 months) of the two-year market protection period could be granted if the company receives marketing authorisation for an additional therapeutic indication that offers significant clinical advantages over existing therapies. The delivery obligation within the EU27 provided for in the Commission proposal is to be cancelled.

Antimicrobial resistance

MEPs approve the introduction of a voucher for priority antimicrobials, which provides for additional data protection for a maximum of one year. The Commission proposal was watered down to some extent. For example, the voucher could not be used for a product for which the maximum statutory data protection already applies, and it could only be transferred once to another marketing authorisation holder.

But the vouchers alone are not enough. MEPs emphasise the need to drive forward the research and development of novel antimicrobials. For example, through rewards for market entry or financial support in the early stages of research and development of pharmaceuticals. Member States can also use joint procurement mechanisms on a voluntary basis.

DSV demands balance

The German Social Insurance (DSV) had emphatically put forward its position on pharmaceutical reform in many position papers and statements at European level. The DSV recently calculated the considerable additional costs that the German healthcare system would incur if an additional year of regulatory data protection (RDP) for medicinal products were granted. Every additional year by which the start of generic competition is delayed costs the statutory health insurance system in Germany slightly over one billion euros. Across the EU, the additional costs for each additional year of regulatory data protection amount to just over three billion euros. These figures highlight the need for a balanced position from the European Parliament on the length of the protection periods to ensure the affordability and long-term sustainability of healthcare systems. The position that has now been adopted appears balanced at first glance. 

The plenary of the European Parliament plans to officially approve the two reports on 10 April, thereby adopting its position on the pharmaceutical reform.