The European Commission has on 26 April 2023 made two proposals for the revision of pharmaceutical legislation – a proposal for a new directive and a new regulation.
According to the Commission, one of the main objectives of the legislative revision is to create a single market for medicines that ensures that all patients across the EU have timely and equitable access to safe, effective, and affordable medicines.
The proposed directive regulates the requirements for authorization, monitoring, labeling and regulatory protection, placing on the market, and a number of authorization procedures for medicinal products authorized at a central and national level. In addition, the Regulation sets specific rules for medicinal products authorized at EU level.
A key change to the existing rules is the proposal to reduce the current regulatory protection period by 2 years to 6 years in total. It will be possible to extend this standard period by 2 years if the medicine is launched in all Member States. There will also be other options for extending the period, for example in the case of special medicines or special patient groups. The Commission is also seeking to simplify the decision-making procedure for authorizing medicinal products in order to reduce processing times, as well as to adjust the structure of the European Medicines Authority (EMA).
As part of the legislative revision, a so-called AMR voucher system will also be introduced to encourage the development of new antimicrobials. The system will provide "transferable data exclusivity vouchers" to developers of 'game-changing' novel antimicrobials. The background to the system is that, according to the Commission, it is currently not profitable to carry out research into the development of these medicines, even though they are considered essential for fighting multidrug-resistant pathogens in the future.
It has been important for the Commission to emphasize that the reform does not (directly) affect the EU's system of intellectual property protection (mainly patents and SPCs). However, reducing the regulatory protection period by 2 years (compared to today) and other measures encouraging early market access of generics and biosimilars are likely to have significant consequences for rights holders and the industry in general. The proposal could make the industry less competitive compared to competitors in, for example, the United States and Asia. The uncertainty that the proposal entails about the possibilities of achieving a regulatory protection period, comparable to the current one, may lead to investments being moved to Asia and the United States and to raising capital in any case becoming more expensive. These effects could significantly affect the innovative power of the industry and undermine the development of innovative treatments in Europe, to the detriment of patients, healthcare, industry, and society broadly.
The proposal for the directive can be read here.
The proposal for the regulation can be read here.
Originally published by 27 April, 2023
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