New EU pharmaceutical legislation – a win for Sweden and EU patients

“We are pleased that negotiations have been successful and that the countries have joined our position on maintaining data protection. This is a great success for Sweden and patients in the EU. We look forward to the trilogue’s continued work to make the EU more competitive, including on issues related to regulatory market protection and the Bolar exemption,” says Minister for Health Care Acko Ankarberg Johansson.

A priority issue for Sweden has been to safeguard a data protection period of eight years inthe proposal, compared to the Commission’s proposed six years. This creates conditions for companies to be able and willing to research new drugs in Europe and launch new therapies and pharmaceutical products on the European market. In the current legislation, this data protection period is supplemented by two years of regulatory market protection. The new proposal enables the second year of market protection to be granted only on the condition that companies meet certain criteria. Sweden would have liked to keep the current system where such conditions are not a prerequisite, but this proved not be possible. 

The issue of incentives for the development of new priority antibiotics has also been a sticking point for Sweden. Developing pioneering and innovative antibiotics means complex research – at the same time, such products should also be used as little as possible once available, in order to prevent developing resistance. For this reason, developing antibiotics is often not profitable for companies, and for this reason, the public sector needs to help with incentives for companies developing such products. 

Today’s decision includes a completely new incentive, a transferable data exclusivity voucher. Many countries were against a voucher system, but Sweden has fought hard to keep it in the negotiations. To reach a compromise, incentives were supplemented with certain limitations, such as only issuing a maximum of five vouchers and limiting the cost of vouchers in the public sector. Sweden would have liked to create even stronger incentives.

In the negotiations, Sweden also passed a definition of which pharmaceutical products may be eligible for a voucher. This is to enhance opportunities to develop antimicrobial pharmaceuticals against life-threatening conditions – individually and collaboratively.

“The fact that the EU is now establishing a long-term incentives system for new antibiotics speaks for the great success of the negotiations. Predictability and clarity will enable actors to dare to invest in the research and development of new antibiotics, which will be needed to save lives in the future,” says Minister for Social Affairs and Public Health Jakob Forssmed. 

In a previous proposal, the European Commission was able to impose financial penalties if pharmaceutical companies did not push to launch their products in a certain country. This has now been removed from the compromise proposal. Nor will the EU Commission be given a mandate to produce implementing acts that set up criteria for which medicines the countries should have access to. 

The next step in the legislative process is for EU Member States (the Council) to start negotiations with the European Parliament and EU Commission, and once they are in agreement, to then adopt the legislative proposals.