BRUSSELS, Dec 11 (KUNA) -- The European Commission on Thursday welcomed the political agreement reached by the European Council and the European Parliament on updating the legislation governing the pharmaceutical sector in the European Union, following intensive negotiations that continued until last night.
The Commission affirmed that the reform represents a pivotal step to ensure the provision of safe, effective, and accessible medicines for patients across Europe, especially since the current rules are more than 20 years old.
In a press release, the Commission said that the new agreement establishes a more modern, flexible, and competitive framework for the pharmaceutical sector, enabling it to meet the needs of European patients and strengthen its position in global markets.
It added that the reform package will contribute to expanding the availability of medicines and improving their scientific assessment, in addition to accelerating supply chains, reducing bureaucratic procedures for companies, and shortening evaluation periods for new medicines.
The statement pointed out that the reform includes updating the role of the European Medicines Agency (EMA) to ensure faster market entry of new medicines and to facilitate patients' access to treatments, particularly those addressing unmet medical needs.
The new system also provides world-class incentives for innovative products and allows the creation of "regulatory sandboxes" for entirely novel medicines, as well as establishing tailored regulatory frameworks for certain non-standard treatments, such as personalized therapies.
In the same context, the Commission clarified that the reform paves the way for the timely entry of generic medicines into the market by clarifying the application of the "Bolar exemption," which allows certain activities during patent protection without breaching international agreements.
The package also includes establishing a more stringent European framework to monitor medicine shortages, enhancing the coordination role of the EMA, imposing greater obligations on companies to reduce shortages, preparing an EU list of critical medicines, and conducting vulnerability assessments within supply chains.
The Commission stressed that these measures collectively will support a sector that is crucial for the European Union's strategic autonomy, ensuring that EU citizens have access to the best treatments while enhancing the competitiveness and innovation of Europe's healthcare sector. (end) arn.gta