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Juliusz Krzyżanowski

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Political compromise raises questions around feasibility implementation and EU’s innovation edge After nearly two years of negotiations, the Council of the EU has adopted its negotiating position on the proposed revision of the pharmaceutical legislation on 4 June 2025. This milestone reached under the Polish presidency follows intense debate and numerous concessions among Member States. The most divisive issues of access to medicines and incentives for pharmaceutical innovation are likely to remain a balancing act…

In brief 1 November 2023 marked the entry into force of the largest amendment to the Polish Act on the Reimbursement (Amendment) since it came into force in 2012. As reported in this blog, the Commission’s Proposal to reform the EU General Pharmaceutical legislation includes a measure whereby  marketing authorisation holders (MAHs) would be expected to ensure patient access in all the EU Member States within two (or in exceptional cases, three) years as of…