The EU Proposal for Reduced Regulatory Protection Could Be a Bombshell for the Innovative Life Sciences Industry
Martin Dræbye, partner at Bech-Bruun, discusses the recent presentation by the European Commission of proposals for a new directive and a new regulation to revise pharmaceutical legislation, their purpose, and the possible repercussions for the industry.
The main objectives of the law revision
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 authorisation, monitoring, labelling and regulatory protection, and placing on the market of medicinal products authorised at a central and national level. In addition, the Regulation sets specific rules for medicinal products authorised at EU level.
The proposal to reduce the current regulatory protection period
A key change to the existing rules is the proposal to reduce the current regulatory protection period by two years to six years in total. It will be possible to extend this standard period by two 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.
“Reducing the regulatory protection period by two years is likely to have significant consequences for rights holders and the industry in general.”
The Commission is also seeking to simplify the decision-making procedure for authorising medicinal products in order to reduce processing times, as well as to adjust the structure of the European Medicines Authority (EMA).
The AMR voucher system
As part of the legislative revision, a so-called antimicrobial resistance (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.
Impact of the proposal
It has been important for the Commission to emphasise that the reform does not (directly) affect the EU’s system of intellectual property protection (mainly patents and supplementary protection certificates). However, reducing the regulatory protection period by two years (compared to today), and other measures encouraging early market access for generics and biosimilars, is 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, regarding 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.
Bech-Bruun
