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…
The Proposal to revise the EU Pharmaceutical legislation has generated unprecedented levels of attention, not only across the industry but also amongst Member States with some countries already positioning themselves in favour or against some of the measures included in the proposed Regulation and Directives. In this article we review some of these positions, which focus mostly on the incentives regime and on the management of shortages. France In March 2023, a month before the…
In brief Reimbursing medicinal products is critical to ensure that treatments are widely available to patients. This is especially true for innovative products and is expected to become even more important with the EU Pharma reform package. Pricing and reimbursement (P&R) is an area regulated at Member State level, and on average the regulatory approach in Hungary has been on the stricter side for new medicinal products causing delay to market access. However recent legal…