The House of Lords Science and Technology committee have released their Regenerative Medicine report. This rather rigorous report was put together after a call for evidence last year, and has now been compiled to give an overview of the current landscape, in terms of current clinical trials and companies in Europe; translation in regards to the regulatory environment and manufacturing; aswell as commericialisation.
22 recommendations were proposed for the regenerative medicine industry to flourish in the UK (click here for the indepth report). It's quite a read so in brief, highlighted recommendations include:
- The Health Research Authority (HRA) to set up a regulatory advice service
- the NIHR establish a regenerative medicine stream of its clinical research network, to aide overcoming trial patient recruitment problems
- Workshops to be set up similar to that of FDA-CIRM to encourage more face-to-face interactions between regulators and researchers
- Number of recommendations to support UK infrastructure and manufacturing capacity
- Department of Health to set up a regenerative medicine expert working group by Dec '14.
- Cell therapy catapult to focus on high growth potential projects through clinical trial to be phase III ready (NB - Collaboration with ReNeuron has been set up in this regard)
- TSB to set up a short support fund for regenerative medicine patents for university researchers
- Ensure pricing and reimbursement are fit for purpose, and an alternative for NICE evaluation is addressed to consider long term savings from high up front costs
- Regarding stem cell tourism they recommend that the Foreign and Commonwealth Office work with the Department of Health to develop a website offering advice for therapies abroad.
- UK government to take lead in promoting harmonisation of regulatory requirements.
It is a call to arms to invigorate the regenerative medicine industry in the UK, and consolidate great and pioneering academic work. It will be interesting in the coming years to evaluate what recommendations have been taken onboard or adapted to meet needs, and what has been disregarded, mainly due to the logistical challenges to implement them.
The report's view on the NICE regards it's current evaluation as inappropriate and will not take into account long term savings. Albeit important, with the economy and NHS in this current climate will be difficult to introduce a radically new system that is an oversight from the NHS working budget. A valid point considering there is likely to be ' £44bn to £54bn funding gap by 2022, with management of chronic diseases accounting for 75% of health costs. It may require short term loss for long term gain, that is unlikely to be popular from any government in charge.