UK

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

Last month we provided an update on the UK Government’s draft post-market surveillance statutory instrument (“PMS SI”) and the UK Medicines and Healthcare products Regulatory Agency’s (“MHRA’s”) intention to run a further public consultation on proposed changes to pre-market medical device regulation under an upcoming statutory instrument (“Pre-Market SI”).

On 14 November 2024, the MHRA launched a consultation on proposed pre-market regulatory changes for medical devices and in vitro diagnostic (“IVD”) devices (the “Consultation”).  The MHRA intends to incorporate the feedback from the Consultation in drafting the Pre-Market SI.Continue Reading MHRA Consults on New UK Pre-Market Medical Device Measures

On 21 October 2024, the UK Government laid the draft Post-market Surveillance statutory instrument (“PMS SI”) before Parliament (see the UK Medicines and Healthcare products Regulatory Agency’s (“MHRA’s”) press release here).  Once implemented, the PMS SI will further amend the UK’s Medical Devices Regulations 2002 (“UK MDRs”) by introducing new vigilance requirements for medical devices already on the Great Britain (“GB”) market.  The proposed updates to the UK MDRs seek to bring it into greater alignment with the EU’s Medical Devices Regulation 2017/745 (“EU MDR”) and In Vitro Diagnostic Medical Devices Regulation 2017/746 (“EU IVDR”), whilst also taking advantage of certain opportunities resulting from the UK’s withdrawal from the EU to build on and diverge from this legislation.Continue Reading UK’s Medical Device Post-market Surveillance Statutory Instrument Laid Before Parliament – What are the Key Changes for Medical Device Regulation?

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

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

The High Court has quashed decisions by the Food Standard Agencies in England, Wales and Scotland (“the FSAs”) that concluded that monk fruit decoctions are a novel food.  The Court ordered the FSAs to re-consider their position by assessing all of the evidence submitted to the FSAs on its own merits, rather than the FSAs’ previous approach of rigidly applying (non‑binding) European Union guidance.  The judgment is available here.  This case is the first of its kind in Great Britain and is relevant for individuals and companies considering whether or not their foods or food ingredients are novel under the GB novel food regime, which requires evidence of significant consumption of a food prior to 1 May 1997 to conclude the food is “non‑novel”, and not requiring a novel food approval. Continue Reading Food Standard Agencies in Great Britain unlawfully classified monk fruit as novel, High Court rules

The Holiday season of 2023 proved to be a busy one for innovative pharmaceutical companies in the UK and their legal and regulatory teams.

UK pharmaceutical companies are already number-crunching through two new price control systems for 2024 (please see our blog and audiocast).  In addition to the UK pricing regime changing, there are proposals to update advertising rules and the procedure for adjudicating upon advertising complaints.   

On 13 December 2023, the Association of the British Pharmaceutical Industry (“ABPI”) published proposals to update the 2021 ABPI Code of Practice for the Pharmaceutical Industry (“ABPI Code”) and the Prescription Medicines Code of Practice Authority (“PMCPA”) Constitution and Procedure (which sets out the procedure for adjudicating upon advertising complaints).  Companies have until 29 February 2024 to contribute to the consultation.

Many of the proposed changes to the ABPI Code are clarificatory in nature, but the planned changes to the complaints process may be of particular interest to in-house legal teams.  These changes are designed to make the PMCPA complaints process less formulaic and more flexible.  This could help manage relatively straightforward cases with greater efficiency, whilst also accommodating for cases which involve serious allegations and/or complex facts.  If implemented as proposed, the changes are likely to give PMCPA cases a more judicial or legalistic feel, particularly when it comes to case management.Continue Reading Consultation on Changes to the ABPI Code and UK Advertising Complaints Process

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)

Roughly a decade ago, countries such as the USA and France introduced ground-breaking transparency and disclosure legislation under so-called “Sunshine Acts.”  Broadly speaking, such legislation made it mandatory for pharmaceutical companies to publish records of payments or other transfers of value made to healthcare professionals (HCPs) and healthcare organizations (HCOs).…

Continue Reading UK Government Consults on Proposals Mandating the Disclosure of Industry Payments to the Healthcare Sector

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