In the early morning of 11 December 2025, the Council and European Parliament reached a political agreement on the overhaul of the general EU pharmaceutical legislation (the “Pharma Package”) consisting of a new Regulation replacing current Regulation (EC) No 726/2004, and a new Directive replacing current Directive 2001/83/EC. This is the first major reform in over 20 years, and it comes nearly three years after the Commission’s initial proposal was published in April 2023. The…
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…
Baker McKenzie has the pleasure of inviting you to an afternoon of conversations on themes ranging from discovery, AI and innovation, EU joint procurement and building resilience in supply chains to latest trends in life science dealmaking in Europe and Benelux.The event will take place at the Cardo Hotel in Brussels on Wednesday, 25 September, and we would be delighted if you could join us for this exclusive afternoon of learning, sharing and networking with…
Hungary has taken over the EU Council’s rotating presidency as of 1 July 2024. Hungary’s EU presidency comes at a time when the European Parliament (EP) has already adopted its position on the EU pharma reform, and the file is now in the Council’s hands. In this article, we review Hungary’s EU presidency program and related press statements to provide a brief overview on what the industry should expect. In more detail Prior to taking…
On 13 December 2023, the German government published a long-awaited strategy outline of intended upcoming legislative measures to counter both the dwindling significance of Germany as a strong hub for pharmaceutical innovation, and threats to supply chain security. The proposed action items fall into 8 chapters, the most significant of which for pharmaceutical companies are briefly summarised below: 1. Strengthening clinical research; a model clinical trial agreement and centralised ethics committee The government intends to…
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…
The European Parliament (EP) has published two draft reports on the Commission’s proposals for a new Pharmaceutical Regulation and Directive. The reports have been drafted by the MEPs assigned as rapporteurs for the Directive (Pernille Weiss, EPP) and for the Regulation (Tiemo Wölken, S&D) and will be debated at the Committee for the Environment, Public Health and Food Safety (ENVI) later this month or beginning of November. The report on the Directive is favourable to…
On June 13, the French Government released a list of 450 medicines considered “essential” to meet patient priority needs and which require specific measures to ensure their availability. Medicines were selected according to shortage criticality combining frequency of use and severity in case of shortage. The current list is available here but is not set in stone. It is intended to be enriched and updated according to changes in the French population’s needs and the…
As already well noted on this blog, on 26 April 2023 the European Commission published a set of proposals for the reform of EU pharmaceutical legislation. A key plank of the reforms comprises measures designed to preserve and protect the supply of medicines across the EU, in particular, critical medicines. Although many member states already have mechanisms in their armoury to protect their own supply chains, this reformatory drive to protect supply chains throughout the…
As previously covered in this blog, on 26 April 2023 the European Commission published a set of proposals for the reform of EU pharmaceutical legislation. One of the most significant aspects of the reforms is that measures to protect the environment are core. For the first time, protection of the environment will be brought to the fore of the pharmaceuticals industry, and are embedded and enshrined throughout the package. Our ESG expert within our Brussels…
