On 14 December 2023, Council and the European Parliament reached a major political agreement on the Substances of Human Origin (SoHO) Regulation. This Regulation will replace the Blood Directive and the Tissues and Cells Directive, combining both legal texts into one. In addition, the Regulation will extend its protection to any SoHO regardless of whether it meets the definition of ‘blood’, ‘tissue’ or ‘cell’ to avoid that certain groups of donors or recipients are left…
On Friday 8 December, after intense negotiations, EU lawmakers reached a major political agreement on the EU Artificial Intelligence (AI) Regulation. This is the bloc’s landmark legislation regulating the development and use of AI in Europe and one of the world’s first comprehensive attempts to regulate the use of AI. More details on this agreement and on the Regulation are available here. In this blog, we have been following the Regulation’s legislative process closely and…
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 22 June 2023, the Court of Justice of the EU (“the Court”) set aside a judgment of the General Court regarding the impartiality of experts involved in the scientific assessment of a marketing authorisation application submitted before the European Medicines Agency (EMA). The case stems from the Commission’s decision to refuse the granting of a marketing authorisation for an orphan designated product intended to treat multiple myeloma. The applicant challenged the refusal before 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…
On 26 April 2023 the European Commission published its Proposals to Reform the EU pharmaceutical legislation.[1] We continue our analysis of the Proposals with this focus upon the changes concerning orphan medicines. 1.The current Orphan Regulation (EC) No 141/2000 will be repealed, and the new orphan provisions will be integrated into the general Regulation laying down the EU procedures for the authorisation and supervision of medicines. 2. The orphan designation criteria remain largely unchanged, meaning…
Today the European Commission has finally published its Proposal to revise the EU Pharmaceutical legislation, the most momentous reform for over 20 years. This is an eagerly anticipated overhaul of the EU’s pharmaceutical system that has generated a lot of debate and concern since earlier leaked documents showed the far-reaching effect of the measures that were being considered and the impact these could have on the industry. The review is part of the EU’s Pharmaceutical…
In brief The amendment to the Medical Device Regulation 2017/745 (MDR) and the In Vitro Medical Device Regulation 2017/746 (IVDR) has been published and enters into force immediately (20 March 2023). What does this mean for your organisation? The amendment extends transitional periods under the MDR for legacy devices (if manufacturers act now) and removes the “sell-off” date under the MDR and IVDR. We’ve set out our top four takeaways below: 1. New extended transitional…
