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,…
In the third and final post of our ‘Kick Start your Healthcare Reorganisation’ series, we focus on the post-implementation matters often encountered on healthcare and life sciences reorganisations. These range from the many regulatory requirements through to ensuring steps are taken to realise the maximum value from the reorganisation. These post-implementation matters often bring us back to, and illustrate the importance of, careful early planning and seamless implementation. When conducting a multi-jurisdictional reorganisation in the…
In the second post of our ‘Kick Start your Healthcare Reorganisation’ series we focus on the implementation phase of a healthcare and life sciences reorganisation and specifically the following three areas: Whilst each area is individually significant, and is likely to have its own dedicated workstream, it is important to recognise that they each go hand in hand when looking to achieve smooth (and successful) implementation. Document execution First, on multi-jurisdictional projects, with a large…
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 Transform…
Last month, the UK House of Commons debated the current state of regulatory and legal hurdles negatively affecting the development of psilocybin-based (the psychedelic compound most commonly found in ‘magic mushrooms’) therapies for mental and physical health disorders in the UK. The debate resulted from an e-petition, which garnered 11,824 votes in February this year. The debate saw a consensus among Members of Parliament across party lines, collectively supporting the proposal for rescheduling psilocybin from…
In the first post of our ‘Kick Start your Healthcare Reorganisation’ series we focus on the planning phase of a reorganisation in the healthcare and life sciences sector in the context of spin offs, carve outs and other solvent group restructurings. It goes without saying that when preparing for a large reorganisation there is a significant amount of planning required to ensure seamless transition and continuity of supply chain. The industry is heavily regulated which…
Undertaking large, complex corporate reorganisation projects, such as spin offs, carve outs and other solvent group restructurings, always presents challenges to be considered, planned for and overcome. Some of those challenges are inherent to reorganisations in general but there are also those which stem from particular industry factors. Over the next three weeks, we will be focusing on the healthcare and life sciences industry and will, through a series of posts, highlight key considerations at…
On June 13, the French Government released a list of 450 medicines considered “essential” to meet patient priority needs and which require specific measures to ensure their availability. Medicines were selected according to shortage criticality combining frequency of use and severity in case of shortage. The current list is available here but is not set in stone. It is intended to be enriched and updated according to changes in the French population’s needs and the…
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…
In brief Reimbursing medicinal products is critical to ensure that treatments are widely available to patients. This is especially true for innovative products and is expected to become even more important with the EU Pharma reform package. Pricing and reimbursement (P&R) is an area regulated at Member State level, and on average the regulatory approach in Hungary has been on the stricter side for new medicinal products causing delay to market access. However recent legal…
