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Magda Tovar

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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…

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…

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 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 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…