After two years of negotiations, EU Member States have reached an agreement on revised pharmaceutical legislation. This process faced significant challenges, particularly regarding data protection and incentives for developing priority antimicrobials.
“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,” said Minister for Health Care Acko Ankarberg Johansson.
Sweden prioritised securing an eight-year data protection period, compared to the Commission’s proposed six-year period. This extended period is crucial for promoting investment in research and the development of new drugs in Europe. While the current legislation offers an additional two years of regulatory market protection, the new proposal stipulates that the second year of protection depends on meeting specific criteria, a condition Sweden preferred to avoid.
Incentives for developing new priority antibiotics remain a critical concern for Sweden. The complex nature of antibiotic development, combined with the need to limit their use to prevent resistance, makes it less financially appealing for companies. The recent decision includes a transferable data exclusivity voucher despite opposition from several countries. Sweden successfully advocated for this system, though it is limited to five vouchers and capped costs for the public sector.
Additionally, Sweden established criteria for pharmaceutical products eligible for the voucher, aiming to promote the development of treatments for life-threatening conditions.
“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,” emphasised Minister for Social Affairs and Public Health Jakob Forssmed.
A prior proposal allowing the European Commission to impose financial penalties on companies for delays in product launches has been removed. The EU Commission will also not have the authority to mandate which medicines member states must provide.
The next step involves EU Member States (the Council) negotiating with the European Parliament and the EU Commission before formally adopting the legislative proposals.
