The news reported today, about the creation and implantation of an artificial windpipe, is great for UK stem cell research and demonstrates strongly how important international collaborations are. An interesting aspect is that the completed organ was constructed off-shore ie, in the UK. Crucially, it is a wonderful proof of concept of UK cell and tissue manufacturing capacity and its ability to export organs that are actually "autologous" ie, made from the patient's own cells.
The technology has immense potential to increase the health, wealth and employment of UK citizens. However, for this potential to be met, the law needs its own "scaffold". With great good timing, the new European Advanced Therapies Medicinal Products Regulation, which comes into force next month, provides exactly this. It dramatically opens up a new market in products such as the one used in this European project.
Despite recent advances, autologous stem cells cannot yet safely produce the range of tissues which may be derived from embryonically-derived cells; notably, nerve cells. Under the "moral opt-out" of the ATMP Regulation, national laws concerning particular sorts of cells (essentially embryonic cells) will remain unaffected by overall authorisation to market products in Europe. As embryo-based therapies come on line, they will not be available in certain territories, with the effect that, for example, therapies in connection with blindness, Alzheimer's and nerve repair, will be unavailable there. As governments weigh up healthcare costs against the costs of stem cell therapy, we might expect pressure to grow on them to change their laws.