The European Parliament could have helped to stimulate R&D into new drugs for rare diseases if it had not stuck so closely to the European Commission’s original proposals on orphan exclusivity periods, we argue in this piece for the Pink Sheet (paywall). This article is a continuation from our previous analysis on the Commission’s proposals for orphan drugs. For further information on this topic please contact Els Janssens, Olha Sviatenka, Magda Tovar and Julia…
In brief The Commission’s Implementing Act on Joint Clinical Assessments for medicines for human use was finally adopted on 23 May 2024. This is the first out of six Implementing Acts for the EU HTA Regulation. With only seven months to go before the HTA Regulation becomes applicable, developers of medicines within the first wave of products subject to the HTA Regulation will need to consider their strategy for EU assessment and its interplay with…
Baker McKenzie has recently conducted a survey across over 100 jurisdictions, asking our Healthcare & Life Sciences global network of specialists to compare the degree of flexibility clinical trial sponsors have to negotiate with sites in clinical trial agreements. We have received input from our healthcare regulatory experts in 105 jurisdictions and are therefore able to build a global picture of how the flexibility afforded to sponsors varies from market to market. The results are…
EU AI Act On 13 March, the European Parliament approved the EU AI Act. The link to the adopted text is available here. The next step is Council’s adoption, expected next month. Following the Council’s sign off, the final text will be prepared for publication in the Official Journal and will enter into force 20 days afterwards. Once adopted, the Act will become applicable in a gradual manner. For products that are already required to…
To future-proof its regulatory system, the UAE cabinet has established the Emirates Drug Corporation (EDC) in September 20231. As a new independent regulator, the EDC will replace the Ministry of Health and Prevention (MOHAP) for the regulation of pharmaceuticals and medical devices. Besides medicines and medical devices the EDC will also be responsible for cosmetics, dietary supplements, GMOs, fertilizers, pesticides, agricultural conditioners and plant growth regulators. The EDC will also take over some competences from the Ministry of Climate Change and Environment…
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…