Medicinal Products

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 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

Last week (28 March 2024), the UK Health Research Authority (“HRA”) published a draft model investigator-initiated study agreement (“mIIS-CTA”) to govern investigator-initiated clinical studies (“IIS”) that involve NHS patients and receive support from commercial partners.  The HRA is calling for comments on the draft mIIS-CTA by 13 May 2024.Continue Reading UK HRA Consults on a New Model Investigator-Initiated Study Agreement

On 26 January 2024, the European Medicines Agency (EMA) announced that it has received a €10 million grant from the European Commission to support regulatory systems in Africa, and in particular for the setting up of the African Medicines Agency (AMA). Although still in its early stages as an agency

Continue Reading EMA announces €10 million of funding to support the establishment of the African Medicines Agency

On 20 November 2023, the UK Government and the Association of the British Pharmaceutical Industry (“ABPI”) ‒ the industry body representing the innovative pharmaceutical industry in the UK ‒ announced a new 5-year voluntary scheme for branded medicines pricing, access and growth (“VPAG”).

Although the parties have announced agreement upon heads of terms, it is already clear this is very significant news for the pricing and reimbursement of branded medicines in the UK.  It is likely to represent a paradigm-shift in the way the innovative pharmaceutical industry will view reimbursement.Continue Reading VPAG – New 5-Year Pricing Agreement Agreed between UK Government and the UK Pharmaceutical Industry Body (ABPI)

On 29 September 2023, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) published further guidance (“MHRA Guidance”) on changes to labelling and packaging for medicinal products intended for the UK market (including Northern Ireland) under the Windsor Framework (agreed between the UK and the EU on 27 February 2023, please see our client alert here). 

The MHRA Guidance follows the Agency’s announcement of new labelling and packaging measures in June 2023, which will take effect from 1 January 2025.  The new measures require, amongst other things: (i) 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”) to UK packs (please see our blog post on this announcement here).

The latest MHRA Guidance provides further detail on the above measures.Continue Reading New MHRA Guidance on the Windsor Framework: Detail on Labelling and Packaging Changes

On 30 August 2023, the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) published detailed guidance on its recently announced new International Reliance Procedure (“IRP”) (see our prior blog and audiocast).  The IRP will apply from 1 January 2024 and will replace and significantly expand on existing EU reliance

Continue Reading Fast-Tracking Approval of Medicines – UK Publishes Detailed Guidance on its New International Recognition Procedure

Orphan drugs have a special position under EU pharma laws. Among other things, the EU orphan drug laws grant the marketing authorization holder (MAH) of an orphan drug a 10 year period of so-called “market exclusivity”. According to Article 8(1) of the Regulation (EC) No. 141/2000 on orphan medicinal products,

Continue Reading German court strengthens market exclusivity right of orphan drugs and the legal position of their marketing authorization holders