Calls for UK to look again at animal transplants after US success
DOCTORS and experts have called for the NHS to renew its plans for patients to receive animal organ transplants after shelving nascent legislation 15 years ago.
The success of two pig transplants into human patients in the US in as many weeks has led to calls to overhaul the myriad regulatory obstacles facing patients and scientists in the UK.
Experts have criticised the “shortsighted” decision to disband the UKXIRA – UK Xenotransplant Interim Regulatory Authority – in 2006, when the prospect of xenotransplants were a “long way in the future”.
It was set up in 1997 to help British policymakers navigate the stormy waters of the emerging field and dissolved owing to a lack of development.
But now, the use of genetically-modified organs to treat humans is no longer a pipedream and clinical trials may soon be a reality. Three UK law professors spoke to The Sunday Telegraph about the issue.
Prof Sara Fovargue, from the University of Sheffield, said: “Xenotransplantation raises particular legal and ethical issues which require careful consideration by a specialist regulatory body, such as the now disbanded UKXIRA.
“It is presently unclear whether if a xenotransplant was performed in the UK, it would be regulated as an experimental treatment or procedure, or as clinical research. It is vital that the regulatory pathways are clear, so that potential patients or research participants are appropriately protected.”
Sheila McLean, from the University of Glasgow, added: “When UKXIRA existed, the concept of xenotransplantation of whole organs seemed a very long way in the future, but now – although still experimental – it has become closer on the horizon and inevitably throws up moral and ethical issues which require informed and expert analysis.” Marie
Fox, from Liverpool University, said: “It was a very shortsighted decision to disband UKXIRA, as I argued at the time. The UK’s history of regulating the issue has been very reactive, when it was absolutely clear that at some point these procedures would be back on the agenda.”
The US is the current global superpower when it comes to xenotransplants, because of looser ethical and legal regulations than in the UK, as well as bountiful private investment. “Under current rules, a study involving xenotransplant of GM organs in humans could apply for permission to start in the NHS,” a Human Research Authority spokesman said.
The Medicines and Healthcare products Regulatory Agency said: “While transplant procedures with pig hearts are not human medicinal products and are therefore not regulated by the MHRA, no such transplants would take place in the UK without extensive ethical and safeguarding consideration.”