In Brief In a judgment of 18 October 2023 (T-74/21), the EU’s General Court roundly dismissed the appeal by Teva and Cephalon against the European Commission’s 2020 decision imposing fines of approximately €30 million on each of them for concluding an anti-competitive patent settlement agreement back in 2005. In some ways the case is an historic relic: since the US Supreme Court’s 2013 ruling in Actavis and the Commission’s decision a few days later in…
Introduction Following our post here on the EMA’s consultation on the use of Artificial Intelligence (AI) in the medicinal product lifecycle, which is open for public consultation until 31 December 2023, it is the turn of the World Health Organization (WHO) to release a publication outlining key considerations for regulation of artificial intelligence for health. In the same line as the EMA’s reflection paper that aims to initiate dialogue with all groups of stakeholders in…
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…
In brief On 26 June 2023, the Spanish National Court annulled the evaluation system of newly approved medicinal products based on Therapeutic Positioning Reports (“ITPs”) set up by the Spanish Ministry of Health in 2020 (“Plan”). The Court based its decision on the grounds that (1) the system was created without following the legal procedure, and (2) was approved by a body that did not have the authority to do so. The Court concludes that…
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…
