An expert group of doctors, academics, pharmaceutical company representatives and government officials has recently published a report (“Building on our own potential: a UK pathway for regenerative medicine”) affirming the UK’s ambition to become a leader in the research, manufacture and clinical use of regenerative medicine. The report also identified recommendations for further streamlining the regulation of the development of regenerative medicines, and developing an EU-wide consensus on the correct application of the EU regulatory framework.
“Regenerative medicine” is a term used to refer to methods that replace or regenerate human cells, tissues or organs in order to restore or establish normal function. It can include cell-based therapies, tissue engineering and gene therapy, and covers established therapies and emerging new technologies.
In July 2013, the House of Lords Science and Technology Committee recommended that a regenerative medicine expert working group be established with the goal of developing an NHS regenerative medicine delivery readiness strategy and action plan. In its response three months later, the government broadly agreed with the Committee’s recommendations. The Regenerative Medicines Expert Group was subsequently set up under its chairman, Sir Michael Rawlins, and released its report and accompanying recommendations in March 2015.
The report identifies various aspects of the regulatory framework which require improvement, including:
- there is a disparity in categorisation across EU Member States “for products which straddle the boundary between cellular therapies regulated under the EU Tissues and Cells Directive and those regulated as medicines under the Advanced Therapy Medicinal Products (ATMP) Regulations”, which include somatic cell therapies, tissue engineered products, gene therapy products and combination products. The report calls for the UK’s Medicines and Healthcare Products Regulatory Agency (“MHRA”) to press for an EU-wide consensus on this issue, and suggests this could include consideration of a European classification scheme coordinated by the European Medicine Agency’s Committee for Advanced Therapies and subsequently adopted by all Member States;
- making changes to the “Hospital exemptions” scheme which allows for the marketing of unlicensed medicinal products; and
- considering whether applications for approval of clinical trials involving gene therapy products can be incorporated into the HRA’s existing Integrated Research Application System (IRAS).
The report praises the announcement by the relevant regulatory bodies in this field (the Health Research Authority (HRA), the Human Tissue Authority (HTA), the Human Fertilisation and Embryology Authority (HFEA) and the Medicines and Healthcare products Regulatory Agency (MHRA)) that the MHRA’s Innovation Office will provide a ‘one-stop shop’ for all regulatory queries.
The report makes other recommendations in relation to the role of NICE in pricing and reimbursement, and in relation to the adoption of regenerative medicine by the NHS.
Finally, the report also recommends the establishment of a dedicated ministerial group for regenerative medicine in the UK, and points out that issues over funding could be hampering the growth of this field of medicine.
Following publication of the report, the Minister for Life Sciences, George Freeman, issued a letter of response in which he reiterated the government’s commitment to regenerative medicine as “an essential element of our strategy to harness the potential of emerging life sciences technologies in support of our health and growth priorities.”
In his letter, the Minister indicated that he did not support the establishment of a ministerial group for regenerative medicine, stating that this may lead to delay and complexity. Instead, the Minister suggested the development of a “high-level group” with oversight of the implementation of the report’s recommendations and reporting annually to the government.
It appears that the UK government supports the proposals set out in the report, and further developments are therefore likely. Therefore, it seems certain that the House of Lords Science and Technology Committee will continue to closely monitor progress in this area.
The expert report and the government response are available to download here.