Professor Jonathan Montgomery, Professor of Health Care Law, and Dr Prince Saprai, Senior Lecturer at UCL Faculty of Laws, were members of the Commission that published ‘The Lancet Commission: Stem cells and regenerative medicine’ on 4 October 2017.
The Commission, led by Professor Giulio Cossu, Chair in Regenerative Medicine (University of Manchester) included Julian Hitchcock, a Life Sciences Lawyer at Marriott Harrison LLP and an honorary lecturer at UCL’s Department of Bioengineering.
The report was published and authored by experts in science, medicine, law, anthropology, ethics, philosophy, health economics and public engagement from UCL, the University of Manchester, Sense About Science, the University of Bristol and industry.
It calls for a coordinated strategy to reform the management of scientific discoveries and clinical experimentation involving stem cells and regenerative medicine. The authors argue that a combination of poor quality science, unclear funding models, unrealistic hopes and unscrupulous private clinics threaten regenerative medicine’s social licence to operate.
To deliver sustainable, clinically significant, and equitable benefits to patients, they say a substantial rethink of the field is needed and that a new strategy should be rooted in ‘better science, better funding models, better governance, and better public and patient engagement’.
The Commission makes a recommendation that it believes could form the basis of a new social contract to ensure that the benefits of stem cell and regenerative medicine are fairly distributed. Science needs to do more to ensure that it is trustworthy; ensuring that scientists are competent and that their work is open and transparent so that they can be properly held to account for the quality of their work. Regulation is problematic because of the transnational basis of stem cell and regenerative medicine.
The Commission proposes a curated international register of studies, which could provide the platform for a range of national accountability systems, co-ordination of publishing ethics to ensure unregistered studies do not get published, and good practice from funders.
These tools are aimed to make it more difficult for rogue researchers to raise false hopes and take commercial advantage of the vulnerability of those for whom medicine can currently offer little. Further work is needed on economic models and the improved gathering of cost-effectiveness data is needed to support societal decisions about the use of such new medical opportunities.
Professor Montgomery said:
‘Stem Cell and Regenerative Medicine holds out great promise, but it has also been unreasonably hyped by some less scrupulous operators for financial gain. This report takes stock of the state of the science. It discusses the ethical and regulatory challenges that must be addressed if we are to ensure that the common good can be promoted and that risks and benefits are justly distributed.
In accordance with the traditions of UCL it brought scholars and practitioners from a wide range of relevant disciplines together to address a challenge of considerable human importance’