Asked by: Lord Kinnock (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government, further to the speech by the Foreign Secretary on 14 February, which provisions in the current regulatory framework of the EU inhibit the development of new stem cell technology in the UK.
Answered by Lord O'Shaughnessy
Provisions in the current regulatory framework of the European Union do not specifically inhibit our present requirements for the development of new stem cell technology.
The United Kingdom and the EU start from a position of close regulatory alignment. As part of exit negotiations, the UK Government will discuss with the EU and Member States on how best to continue cooperation in the field of research, including clinical trials, medicines and medical devices, and data sharing, to ensure patient safety and public health.
As my Rt. hon. Friend the Prime Minister stated in her speech on our future economic partnership with the European Union last Friday, the UK will need to make a strong commitment that its regulatory standards will remain as high as the EU’s. That commitment, in practice, will mean that UK and EU regulatory standards will remain substantially similar in the future. Our default is that UK law may not necessarily be identical to EU law, but it should achieve the same outcomes.
As my Rt. hon. Friends the Secretary of State for Health and Social Care and the Secretary of State for Business, Energy and Industrial Strategy have stated previously, we have three principles which will help us rise to the challenge of developing a new regulatory system post Brexit:
- patients should not be disadvantaged;
- innovators should be able to get their products into the UK market as quickly and simply as possible; and
- the UK continues to play a leading role promoting public health.
Asked by: Lord Kinnock (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty’s Government why adult sufferers from sickle cell anaemia who could benefit from stem cell treatment are not able to receive such treatment under the NHS when child sufferers can; and whether they are considering changing this policy.
Answered by Lord O'Shaughnessy
Decisions related to the provision of stem cell transplantation are an operational matter for NHS England. Stem cell transplants for sickle cell disease in adults are not routinely commissioned by NHS England. Whilst stem cell transplants can be effective for some carefully selected patients, stem cell transplantation can also lead to a number of complications, some of which can be severe and life threatening.
NHS England commissioning policy for stem cell transplants is kept under review in the light of the latest clinical evidence. The National Institute for Health Research is currently inviting research proposals for a multicentre randomised control trial to address the clinical and cost effectiveness of stem cell transplantation in adults with severe sickle cell disease. Evidence from this trial will inform NHS England commissioning policy related to stem cell transplants in adults with sickle cell disease.