Libby Amos-Stone

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The MHRA has launched a consultation on proposed updates to the definition of gene therapy medicinal products (“GTMPs”) under the UK Human Medicines Regulations 2012 (“HMRs”). The current definition was originally developed in 2007, and was based on a smaller range of technologies. It is no longer considered to reflect the full range of modern gene therapy technologies now available, including therapies involving synthetic genetic material, new forms of genome editing, and highly engineered cells and tissues. This means there may not be a clear path to market for these technologies under the current legislation.

The proposals aim to address these limitations and align the regulatory framework with current scientific developments. The proposed reforms represent a targeted shift towards a more technology-neutral and mechanism-based approach. The proposals do not change the approval process, classification of existing products, or applicable safety and efficacy standards.

The MHRA is seeking input from stakeholders on whether the proposals are appropriate, proportionate and workable, including whether the revisions cover the correct categories of products, and whether these would cause any unintended consequences or operational challenges. The consultation is open until 22 June 2026 and feedback is requested in the form of a survey. Responses can be submitted online here.

Below, we outline the background, the key proposed changes, and the regulatory considerations that have shaped MHRA’s proposals.

Continue Reading MHRA launches consultation on modernising the definition of gene therapy medicinal products

Background

On 20 April 2026, the Law Commission, an independent organisation established to keep the law of England and Wales under review and recommend reform, announced a new project to consider the potential introduction of a consumer class actions regime in England and Wales. While independent, the Law Commission’s project is sponsored by the Department for Business and Trade (DBT), which is completing its review of the current competition collective (class) action regime that was introduced in the UK in 2015.  There has long been speculation that the government would use competition claims as a pilot before expanding the regime to consumer claims, including product liability and other claims, and this could be the first step in that process.

The Terms of Reference do not shed much further light on the project at this stage, aside from identifying that its purpose is to “set out the benefits and risks associated with the introduction of a collective class actions regime for consumer law claims…”.

However, it is a further signal that consumer protection and providing meaningful recourse for consumers has become a greater policy priority as it follows the recent implementation of the Digital Markets, Competition and Consumers Act 2024, which significantly overhauled UK consumer protection in digital markets, strengthening rights against fake reviews, drip pricing, subscription contract traps and other unfair practices.

This project will not consider substantive consumer rights but is instead squarely focussed on the design of a powerful new private enforcement mechanism to allow opt-out class actions to facilitate mass consumer claims in the UK.  This should be seen against a backdrop of growing pressure on the existing competition collective action regime where claimants have sought to characterise consumer law claims as competition claims in order to bring them before the Competition Appeal Tribunal (CAT) as an opt-out collective action.  The CAT has pushed back on this, reminding parties in one recent case that “competition law is not a general law of consumer protection”. A dedicated consumer class actions regime would remove the need for such creative framing and, in doing so, would significantly expand the pool of claims that can be brought on an opt-out basis.

If the Law Commission’s decision is to recommend the introduction of a class actions regime for consumer claims, then it will also make recommendations as to the design of such a regime.

Continue Reading The Law Commission of England & Wales announces a review of a potential new class actions regime

Today, 6 March 2026, the Council of the European Union (“Council”) published the provisional agreement on the reform of the EU pharmaceutical legislation and the new Directive [link] and Regulation [link]. Formal adoption by the European Parliament and the Council is expected in the coming months. 

Continue Reading Provisional text of the political agreement on the reform to the EU Regulatory Framework for Medicinal Products is published

The Prescription Medicines Code of Practice Authority (PMCPA) has published revised guidance on social media.

Social media has remained a significant focus for the PMCPA in recent years, with numerous companies found in breach of the ABPI Code (the Code) due to activity on social media by the companies themselves, their employees, or associated third parties. Compliance in this space is particularly challenging given the global reach of social media and its inherently public nature, especially when the promotion of prescription-only medicines (POMs) to the public is prohibited in the UK.

Continue Reading UK PMCPA publishes revised guidance for the use of social media

The Prescription Medicines Code of Practice Authority (PMCPA) has published new guidance to provide clarity on the disclosure obligations and commercial governance expected from companies in relation to package deals (Guidance). The Guidance responds to analysis conducted by PMCPA in 2025 which revealed “varying longstanding practices in relation to package deals among companies, particularly in relation to disclosure of transfers of value”.  

Continue Reading UK PMCPA releases new guidance on Package Deals: key takeaways for industry

Growth in UK clinical trials

The UK’s ambition to strengthen its position as a leading destination for global clinical research is beginning to show results. According to a recent MHRA publication, clinical trial applications submitted between January and November 2025 were 9% higher than during the same period in 2024, with particularly notable increases in:

  • Trials in healthy volunteers (+16%)
  • First‑in‑human studies (+5%)
  • Trials being run in the UK for the first time (+7%)

The publication notes that “growth was strongest in early and innovative research, where speed and expert regulatory support can make or break decisions on where companies invest.”

Continue Reading UK Clinical Trials Reform: Early Growth Indicators and Key MHRA Guidance

Following a public consultation, the UK government has outlined plans to publish guidance on disclosing payments made by the medicines and medical devices industries to the healthcare sector. While some stakeholders favour a legislative approach, the government believes that a guidance-based model will enable patients to benefit from industry reporting more quickly, avoiding delays that could arise from introducing legislation and establishing a formal compliance system.

Continue Reading UK Government to Issue Guidance on Industry Payment Transparency

On 11 December, after overnight interinstitutional negotiations between the European Parliament and the Council of the European Union (“Council”) and the European Commission, the institutions reached a provisional political agreement on the reform of the European Union (“EU”) pharmaceutical legislation.

This agreement concludes months of trilogue discussions and follows a much longer legislative process that began with the European Commission’s  proposal adopted in April 2023, the European Parliament’s position adopted on 10 April 2024, and the Council’s position adopted on 4 June 2025 (see our detailed advisory on the Commission’s proposal and our BioSlice blog posts on the Parliament’s and Council’s positions here and here).

The provisional agreement must now be formally adopted by both the Parliament and the Council.

Continue Reading European institutions agree on the reform to the EU Regulatory Framework for Medicinal Products

On 23 October 2025, Advocate General (“AG”) Emiliou delivered his opinion in Case C-118/24: Laboratoires Eurogenerics and Theramex France.[1]

The AG opines on three key questions regarding the use of the decentralised procedure for generic medicinal products:

(i) The national courts of the EU Member States are allowed by EU law to judicially review the legality of a marketing authorisation (“MA”) granted via the decentralised abridged procedure where it is alleged that the medicinal product in question does not meet the criteria of a generic medicinal product. This is applies even if the judicial review is conducted by a national court in an EU Member State other that the reference Member State for the decentralised marketing authorisation procedure.

(ii) The applicant seeking such judicial review does not need to be the marketing authorisation holder for the reference medicinal product or the applicant for the generic marketing authorisation. The applicant could also be a third party with a vested interest, such as the marketing authorisation holder for a biosimilar medicinal product which will be competing with the newly authorised generic medicinal product. This conclusion by the AG remains unaffected by the fact that such applicant  may not be admissible if the action was brought at EU level to the Court of Justice of the European Union (“CJEU”) if the direct and individual concern of the applicant is not demonstrated. According to the AG, it is for the EU Member States in the framework of their procedural autonomy to decide whether a right to challenge an MA exists in these circumstances.

(iii) Chemically synthesised products are not precluded from meeting the criteria to be a generic of a reference biological medicinal product.

This third finding will, if followed by the CJEU, also apply to the centralised marketing authorisation procedure and arguably facilitate market access for synthetic copies of biological medicinal products. It would mean that, in practice, applicants for generics of biological medicinal products would not be required to submit additional pre-clinical and/or clinical data (as opposed to biosimilar applicants) and may potentially benefit, once authorised, from more advantageous pricing and reimbursement conditions (e.g., substitutability at pharmacy level which may not be available for biosimilar medicinal products).

Continue Reading Can a chemically synthesised medicine be authorised as a generic of a biological medicine? And who can challenge this?