Image Credit: World Health Organization
On 16 April 2025, Member States of the World Health Organization (WHO) concluded negotiations on a new international treaty: the Agreement on pandemic prevention, preparedness and response (“WHO Pandemic Agreement”). Set to be adopted at the May 2025 World Health Assembly, this landmark accord aims
Continue Reading What Companies Should Know About the WHO Pandemic Agreement
The joint procurement by the European Commission (“Commission”) and the Member States of COVID-19 vaccines and therapeutics presented a significant milestone in the EU’s management of the pandemic. In the aftermath of the pandemic, there have been repeated calls for more joint procurement. This blog explores the existing mechanisms for joint procurement and also considers the Commission’s proposal for a Critical Medicines Act (“CMA”) and what it would mean for public procurement.
At a high level, there are already various mechanisms for joint procurement of medicinal products and medical devices both with and without involvement of the Commission. The CMA proposal does not fundamentally change that but rather supplements the existing regimes.
The key aspect to be aware of is that both the existing regime and the draft CMA merely establish a framework for joint procurement, including the relationship among Member States and the Commission (if involved). This framework focusses on establishing when joint procurement is possible and the mechanism for getting a joint procurement set up. However, the framework does not specify in what circumstances Member States and/or the Commission might choose to engage in joint procurement, the terms of the tender or any resulting contract.Continue Reading EU Joint Procurement – An Overview
On 18 December 2024, the European Commission published a proposed implementing regulation relating to pharmacovigilance (“PV”) requirements for human medicines marketed in the EU (“Proposal”), which will update European Commission Implementing Regulation (EU) 520/2012 (“Implementing Regulation”). While the core PV requirements, including the obligation to establish and operate a PV system and the key reporting requirements, are set out in Regulation (EC) No 726/2004 and Directive 2001/83/EC, the Implementing Regulation provides detailed requirements on the performance of PV activities, including the need for a PV system master file (“PSMF”), more comprehensive requirements for the PV quality system, and detailed provisions relating to periodic safety update reports (“PSURs”).
The proposed changes aim to harmonize the performance of PV activities by marketing authorization holders (“MAHs”), national competent authorities and the European Medicines Agency (“EMA”), and in some cases widen the scope of the Implementing Regulation’s PV requirements. Other changes are clarificatory in nature.Continue Reading European Commission Consults on Update to Pharmacovigilance Rules
In recent weeks, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published further guidance relating to the implementation of the Windsor Framework. From 1 January 2025, changes due to the Windsor Framework for the licensing, labelling and wholesale dealing of human medicinal products in the UK will become effective. The new measures require, amongst other things: (i) all human medicinal products intended for the UK market to be authorized by the MHRA; (ii) a single UK-wide pack that bears a “UK only” label; and (iii) disapplication of the EU Falsified Medicines Directive 2011/62/EU (“EU FMD”) requirements to UK-wide packs.
Following the MHRA’s initial publication of guidance focusing on the changes to labelling and packaging (please see our blog post here), the Agency has now issued guidance relating to wholesalers and manufacturers (“Wholesaler and Manufacturer Guidance), licensing (“Licensing Guidance”) and advertising (“Advertising Guidance”).
We explore some of the key requirements and recommendations for supply chains and promotional material arising from this new guidance below.Continue Reading Are you Windsor Framework ready? A focus on pharmaceutical supply chains and promotional material
In an earlier blog, we had reported on an interesting litigation case concerning the legal scope of the market exclusivity right for orphan drugs in the EU. Meanwhile, there have been further developments in this court case and its key questions have now been referred to the European Court
Continue Reading European Court of Justice requested to clarify the scope of the market exclusivity right for orphan drugs – German courts remain divided
Those of us who advise on medicines advertising issues have been waiting for much of 2024 for the Association of the British Pharmaceutical Industry (“ABPI”) together with its self-regulatory body for pharmaceutical advertising, the Prescription Medicines Code of Practice Authority (“PMCPA”), to publish the new Code of Practice for the Pharmaceutical Industry (“ABPI Code”). On 23 September 2024, the suspense finally lifted, with the publication of the ABPI Code 2024 (available here). The 2024 ABPI Code replaces the previous version from 2021.
The new ABPI Code incorporates an updated PMCPA Constitution and Procedure, which sets out the procedure for adjudicating upon advertising complaints.
The ABPI initially proposed, and consulted upon, updates to the ABPI Code from December 2023 to February 2024 (please see our previous blog post discussing these proposals here). The 2024 ABPI Code includes most of the changes that were proposed and consulted upon, usually with only minor changes to wording. The PMCPA has issued summaries of the changes to the Code and Constitution, which can be found here and here.
The main headline is that the new ABPI Code is very similar to its predecessor. The consultation received over 3,000 comments, with many commentators calling for more extensive changes than those proposed. The ABPI appears to have resisted these calls, preferring evolution over revolution.
The changes take effect on 1 October 2024. However, a transitional period will operate from 1 October 2024 to 31 December 2024, during which time no material or activity will be regarded as breaching the ABPI Code if it fails to comply with the new requirements of the 2024 version. The 2024 ABPI Code will come into full force on 1 January 2025. Notably, though, the PMCPA will begin operating in accordance with the new Constitution and Procedure from 1 October 2024, including the legalistic elements and abridged complaints procedure discussed below.
Of the (relatively few) changes, what should legal and compliance teams take note of?
The new PMCPA Constitution and Procedure makes changes to the process for investigating and adjudicating upon advertising complaints. These changes aim to enhance the flexibility and efficiency of the complaints process. They include: (i) powers for the PMCPA to issue case management directions; and (ii) a new abridged complaints procedure that could apply in certain cases. The changes will likely result in a more legalistic feel to PMCPA proceedings. If the PMCPA notifies a company of a complaint, it may be beneficial to involve legal teams early in the process.
By contrast, changes to a company’s compliance obligations under the new ABPI Code are relatively modest. The updates are generally clarificatory in nature. Some changes essentially consolidate and codify into the Code principles that already exist in guidance and previous PMCPA cases. An example of this is how companies fulfill their obligation to maintain high standards. There is now more detail on this point in the Code, pulling together concepts from various cases.
There are also new rules permitting the use of QR codes to provide access to prescribing information in certain cases.Continue Reading New ABPI Code and PMCPA Constitution and Procedure Published
Last week, on 4 July 2024, the German Parliament (Bundestag) has passed significant changes to the country’s drug pricing and reimbursement laws. Just six months after the German Federal Health Ministry (BMG) presented a first draft bill for a “Medical Research Act” (Medizinforschungsgesetz or MFG), the German
Continue Reading Germany amends drug pricing and reimbursement laws with “Medical Research Act” – Drug pricing becomes intertwined with local clinical research expectations
On April 30, 2024, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) outlined its strategic approach (“Approach”) to artificial intelligence (“AI”). The Approach is a response to the UK Government’s white paper: a pro-innovation approach to AI regulation and subsequent Secretary of State letter of 1 February 2024, and is the culmination of 12 months’ work by the MHRA to ensure the risks of AI are appropriately balanced with the potential transformative impact of AI in healthcare.
AI has the potential to revolutionize the healthcare sector and improve health outcomes at every stage of healthcare provision – from preventative care through to diagnosis and treatment. AI can help in research and development by strengthening outcomes of clinical trials, as well as being used to improve the clinical care of patients by personalizing care, improving diagnosis and treatment, enhancing the delivery of care and health system efficiency, and supplementing healthcare professionals’ knowledge, skills and competencies. Continue Reading MHRA Outlines New Strategic Approach to Artificial Intelligence
On 10 April 2024, the European Parliament adopted its position on the Commission proposal to reform the core EU pharmaceutical legislation (see here and here). In doing so, the European Parliament has met its ambitious timeline to adopt its position before the upcoming Parliamentary elections and marks a significant step in the legislative process.
Parliament’s position comes less than a year since the Commission published its proposal, which consists of a new directive replacing Directive 2001/83/EC and a new master regulation replacing Regulation 726/2004, which will also consolidate the orphan and pediatric medicines regulations (see our prior EU Pharma Legislation Review blog series). Many of Parliament’s amendments to the Commission proposal will be seen as improvements by the innovative industry, but there remain challenges and unresolved questions.
We provide below the top 8 takeaways for industry to consider during the next phase of the legislative process, which is a detailed review by the Council.Continue Reading European Parliament adopts its Position on EU Pharma Law Review: 8 Key Takeaways for Industry