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…
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with this focus upon the changes concerning orphan medicines. 1.The current Orphan Regulation (EC) No 141/2000 will be repealed, and the new orphan provisions will be integrated into the general Regulation laying down the EU procedures for the authorisation and supervision of medicines.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…
Today the European Commission has finally published its Proposal to revise the EU Pharmaceutical legislation, the most momentous reform for over 20 years. This is an eagerly anticipated overhaul of the EU’s pharmaceutical system that has generated a lot of debate and concern since earlier leaked documents showed the far-reaching effect of the measures that were being considered and the impact these could have on the industry. The review is part of the EU’s Pharmaceutical…
The EU Whistleblowing Directive (the WBD) was due to be implemented across the 27 member states by 17th December 2021. There are a few major markets which have yet to implement (11 member states in total). But, with those that have implemented, we now have a good feel for the challenges the WBD poses for global employers. The WBD has an admirable underlying objective – to provide pan-EU protection against retaliation for whistleblowers. But…
Baker McKenzie partner Aarthi Belani, AbbVie head of immunology business development and acquisitions Rachel Strick, Flare Capital Partners co-founder Michael Greeley and Patient Square Capital founding partner Neel Varshney share their insights on M&A trends in the healthtech and biotech sectors for the third episode of the Talking M&A podcast. 🔊 Talking M&A Episode 3 – Spotlight on healthtech and biotech in partnership with #BakerMcKenzie, is available to listen to here: http://spr.ly/60473clHl 16 minute listen…
In brief Starting from 31 January 2023, the Clinical Trial Information System (CTIS), provided for in Art. 80 of Regulation EU 536/2014, will become the single point of access for the submission, authorization and supervision of clinical trial applications in the EU and the European Economic Area (EEA) countries. Key takeaways The single portal was launched on 31 January 2022, initiating the one-year transition period during which sponsors could choose whether to submit a clinical…
In Brief 2023 is gearing up to be an interesting year for those in the life sciences sector, with upcoming reforms to the established regulatory and IP landscapes that will impact innovator strategies in R&D, commercialisation, and patent enforcement. While reforms are currently under draft by the European Commission, the key areas of anticipated change are highlighted in a newly published article in The Life Sciences Lawyer. “EU reforms in the pharmaceutical sector – a…
In brief The first ever guidance on social media has been issued by the Prescription Medicines Code of Practice Authority (PMCPA) to help pharmaceutical companies apply the high standards demanded by the industry’s ABPI Code of Practice to all their online communications channels. The PMCPA Social Media Guidance 2023 has been produced in consultation with the Medicines and Healthcare Products Regulatory Agency (MHRA), the ABPI, and pharmaceutical companies. It includes advice for companies to help them use…
In brief The MHRA lifted some extra burden from the industry by extending the European Commission Decision Reliance Procedure (ECDRP) by 12 months until 31 December 2023. The ECDRP was introduced following Brexit and is available to medicines approved via the EU centralized procedure. Before 31 December 2023, in situations where a Committee for Medicinal Products for Human Use (CHMP) positive opinion has been received, applicants can continue to submit their ECDRP Marketing Authorisation Application (MAA) or…