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…
The Court of Justice of the European Union (CJEU) has recently issued a judgment clarifying that wholesale distributors may not obtain medicines directly from pharmacies that do not hold a wholesale distribution licence (WDA). This represents a useful confirmation of the current law, a rule that is set to remain under the new EU Pharmaceutical Package. With its judgment dated September 21, 2023 (Case C-47/22), the CJEU ruled on the interpretation of Article 80, first…
The European Medicines Agency (EMA) has published a draft reflection paper which considers the application of artificial intelligence (AI) and machine learning (ML) to the development, regulation and use of medicines. This paper, which is now open for public consultation, evaluates the risks, benefits and opportunities that AI and ML present to the entire lifecycle for medicines. Underlying the paper is EMA’s concern around the challenges of integrating AI and ML into the medicines lifecycle,…
On 25 July 2023, the EU Commission published its response to the European Citizens’ Initiative’s petition on “Save Cruelty-free Cosmetics – Commit to a Europe without Animal Testing”. The petition received 1.2 million signatures from EU citizens and the EU Commission must respond to petitions gathering 1 million signatures or more. The EU Commission has confirmed the following in response to the requests of the petition: Protect and strengthen the cosmetics animal testing ban The…
We’ve set out our top ten tips on ensuring GDPR compliance if your organisation is procuring AI solutions from third parties, whether this is to train an AI imaging system, integrate AI solutions into a patient-facing app or to allow your staff to make use of generative AI. These tips are based on the issues which we see are attracting regulatory scrutiny in practice, the potential stumbling blocks we’re coming across in supplier terms, as…
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…
At the end of last week, two European Parliament Committees published the latest version of the EU AI Act. The new draft reflects months of political wrangling, but it also demonstrates that EU legislators have listened to the (many) criticisms levied at the EU AI Act until now. So what’s new? We’ve set our top ten changes: Higher penalties: If you thought the previous proposal was eye-watering, it’s about to get steeper. The most serious breaches will…