Earlier this week, the Regenerative Medicine Expert Group (RMEG) published their report ‘Building on our own potential: a UK pathway for regenerative medicine’. The report is the culmination of work by the RMEG, in consultation with other stakeholders, to develop a strategy and action plan to make the NHS ready to deliver regenerative medicines. In the post below, Helen Cline, Legal Director, Pinsent Masons takes a closer look at the report.
Complex regulation must be streamlined and commercial incentives improved for the UK to remain a hub for regenerative medicine.
The UK Government has identified regenerative medicine as one of the UK’s “Eight Great Technologies”, due to its “huge opportunities for technological advance” and potential economic benefit. The RMEG report rightly concludes that the UK has the “industrial base, the academic excellence and the clinical know-how that is necessary” as well as previous experiences of success in advanced medicine and treatments to “consolidate and build upon its position as a world leader in regenerative medicine”. Even so, challenges remain.
The RMEG is tasked with developing an NHS strategy for regenerative medicine, which it defines as “methods that replace or regenerate human cells, tissues or organs in order to restore or establish normal function”. The report sets out what additional steps are necessary to help researchers develop, and clinicians utilise, technologies that improve the human body’s ability to repair itself.
Regenerative medicine is the “future of medicine” and the proposals in the RMEG report to make navigating the regulatory environment easier are welcome. Regulation in the area of regenerative medicines is complex, reflecting the nature of the technologies and their risks. For example, in the UK there are four regulatory bodies, each regulating distinct aspects of the development of regenerative medicine under different pieces of legislation, as well as a range of other agencies with an oversight role. One of the practical problems for researchers in regenerative medicine is the division of regulatory responsibility between these different bodies. There have already been steps taken towards the streamlining of regulatory advice, with a single point of access, for advice on regenerative medicine rules, available from the Innovation Office within the Medicines and Healthcare Products Regulatory Agency. Regulators have also collaborated on providing guidance on regenerative medicines issues, including developing the UK Stem Cell Tool Kit to provide clear guidance on the regulatory pathways that must be followed in developing a regenerative product derived from stem cells. However, the RMEG’s report correctly highlights that “further steps are needed to ensure that standardisation of processes, and streamlined regulation, are guiding principles in advancing regenerative medicine”.
The RMEG, like the House of Lords’ Science and Technology Committee in their 2013 report, also identifies funding issues as a barrier to the growth of regenerative medicines, and calls on the UK government and industry to come together to develop “an innovative business model that supports the early adoption of regenerative medicines”. It also calls for reviews to be carried out on “the funding for excess treatment costs for cell therapy trials”, with the aim of finding “a mechanism … to ensure that meeting of these costs is not a barrier to clinical trials or the early adoption of technologies”.
While debate in the past has been on the legality of funding research, at least in the US, debate today is on how best to regulate the clinical translation and support the commercialisation of these innovative technologies.
The nature of regenerative medicine research involves creating personalised precision therapies that may provide a cure rather than merely alleviating symptoms. There are, in many cases, high up-front costs associated with these individualised therapies that raise challenges around evaluation, funding and adoption. Unnecessary, excessively complex or burdensome regulation, together with unclear evaluation and funding pathways, could stifle the promise of regenerative medicine. That said, moves to streamline regulation to enable innovation must not put patients at risk of harm and damage the reputation of this field of research at a crucial point in its history.
Ethical and patent issues have also created challenges in the development of regenerative medicines. A ruling by the Court of Justice of the EU last year on the patentability of inventions that emerge from research on human embryonic stem cells highlights some of the divergent opinions on the issues.
Research in the field of regenerative medicine is emotive, especially when it concerns human embryonic stem cells. The debates around regulation and commercialisation include a diversity of opinion on the many ethical, regulatory and legal considerations; one example being patient consent in clinical trials, as the line between research and treatment is blurred in this area of medicine.
The UK Government has demonstrated its commitment to the growth of regenerative medicines research in the UK. Centres of excellence around cutting-edge technology are being assembled with a view to combining research and catapulting it forward; examples include the Cell Therapy Catapult and the new Precision Medicines Catapult. However, for regenerative medicine to flourish, and for the UK to retain its strong position in Europe and globally, a strict but enabling legislative and regulatory framework that facilitates innovation is essential. The current approach to regulation of medicines poses particular challenges in the era of ‘stratified medicines’. There are practical challenges in building the clinical evidence base necessary for approval under current regulatory mechanisms where patient populations are very small. The current regulatory and evaluation processes and policies need to evolve in response to, and in anticipation of, scientific developments that will be critical for the development of the UK’s regenerative medicines industry and the move to a stratified and more personalised approach to developing precision medicines.
The original article is available from Out-Law.com, legal news and guidance from Pinsent Masons.
Read the BIA press release welcoming the publication of the report here.