Reforming EU medicines law remains a health priority for Belgium in its EU Council Presidency, but Belgium’s efforts to complete the document remain challenged by the complexities of innovation incentives and drug shortages. ing.
The Presidency of the Belgian Health Council focuses on solving two important challenges: discussions on incentives for pharmaceutical innovation and the pressing problem of drug shortages. This commitment is reflected in his 24 planned and three completed work groups dedicated to promoting pharmaceutical packaging.
Each group employs a cluster-based strategy, tackling the “deficit” and “incentive” clusters one after the other. The method involves addressing and clustering articles from both a directive and a regulatory perspective.
“We started with negotiations on the ‘deficit’ cluster. Our goal is to reach a middle compromise. Once this goal is achieved, we will begin negotiations on the ‘incentive’ cluster.” ‘, a Belgian presidential official told Euractic.
The aim is to write a memo outlining some possible compromises on this topic and to better understand the fault lines and common positions of Member States.
“We are taking a cautious approach and proceeding in stages. The first step is to focus the discussion and flesh out our position in an ‘options paper.’”
Concerns remain
Concerns persist over the proposed reduction in Regulatory Data Protection (RDP) from eight to six years, with the European Commission’s proposed adjustment providing a mechanism to readjust the baseline period while allowing for possible extensions. is intended to introduce. In particular, regarding unmet medical needs and the supply of medicines across EU Member States.
In a recent Memorandum of Understanding, Pharma.be, the Belgian R&D-based pharmaceutical industry association, advocates for the maximum protection and strengthening of intellectual property rights at national, European and international level.
IP protection
“Recent proposals to restrict intellectual property rights threaten the innovative activities of our country’s pharmaceutical industry,” the report said.
The association calls on the Belgian government, at national, European and international levels, “to protect and further improve intellectual property, given its importance as the basis for future innovation.”
“Recognizing that the government plays a central role in fostering continued innovation and the prosperity of the pharmaceutical industry in Belgium, it is necessary for the government to take a firm stand on the protection of intellectual property.” the memorandum added.
The stakes are high as Europe grapples with the urgent challenge of remaining competitive in the global pharmaceutical sector. As highlighted by the European Federation of Pharmaceutical Industry Associations (EFPIA), the widening gap in R&D investment between the US and the EU makes it urgent to find practical solutions to strengthen Europe’s position. It highlights that it is a nature.
As the debate unfolds and the debate intensifies, the urgency for compromise that balances industry incentives and patient access to essential medicines is greater than ever.
[By Nicole Verbeeck, edited by Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy Lab]
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