Regulation in the U.K.
Additionally, MRC and the U.K.’s Department of Health maintain an online UK Stem Cell Tool Kit designed to navigate cell therapy developers through the country’s numerous regulatory agencies. The toolkit was developed with six regulatory agencies, two of which have been proposed for extinction since last year as part of the U.K.’s ongoing budget-cutting under the coalition government of Prime Minister David Cameron.
The Human Tissue Authority (HTA) regulates stem cell research, overseeing the use of organs and human tissue for therapeutic purposes. The Human Fertilisation and Embryology Authority (HFEA) regulates and oversees the use of gametes and embryos in fertility treatment and research including human embryonic stem cell (hESC) research.
A new health research agency recommended by the Academy of Medical Sciences would take over their oversight role in research, while the healthcare-related licensing operations of HFEA and HTA would continue through the new Care Quality Commission, created to regulate health and social care in the U.K.
But advancing stem and other cell therapies will require more than the proverbial shuffling of government agencies and their duties. The U.K. government’s Business and Innovation Skills department is crafting a “stock-take” study examining the kingdom’s regenerative medicine effort, Dr. Catriona Crombie, MRC program manager for stem cells, developmental biology, and regenerative medicine, told GEN.
“We’re looking at all of the issues and what the barriers might be, whether it is skills gaps or getting people to carry out multidisciplinary work, which is going to be essential to getting this field moving forward,” Dr. Crombie said.
One barrier that has not arisen in the U.K. as in the U.S. is the restriction of research using hESCs on ethical grounds. Dr. Crombie said MRC joined with other funders of cell therapy research to actively promote the benefits of stem cell research, which she credited with a 2008 amendment to the Human Fertilisation and Embryology Act allowing the use of hESCs.
Critics of the amendment said the destruction of embryos entailed in the research was immoral and have since cited progress in research using adult and induced pluripotent stem cells. “By and large, we found the general public is supportive of stem cell research for serious conditions. But people do want cures to serious diseases,” Dr. Crombie said. “I don’t think we avoided the controversy. We probably have a slightly more pragmatic approach to it.”