Duty bound

PhilHunt01.jpegPhil Hunt on the unintended consequences of a new growth duty put on UK health bodies 

Later this month, a crucial vote will take place in the Lords on whether to allow mitochondrial donations to treat patients in combatting mitochondrial DNA disease – a devastating illness, for which there is currently no cure.

Two new IVF techniques have been developed that transfer the nuclear DNA (the unique genetic information that makes us who we are) from a patient’s egg, containing faulty mitochondrial, into a donor egg, containing healthy mitochondrial, which has had its nuclear DNA removed. The techniques enable the birth of a healthy child, free from a disease that affects multiple different organs, and which leads to muscle weakness, heart problems and, in serious cases, death.

I support the proposed change in the law but many do not, as a recent impassioned debate in the Commons showed. What unites us all however, is the need for a strong regulatory approach by the Human Fertilisation and Embryology Authority (HFEA). As the Minister Jane Ellison MP said during the debate: The HFEA is highly respected across the globe as a model for the regulation of fertility and embryology treatments and research. Many other countries do not have such a framework.”

Should the regulations pass, the HFEA will be expected to introduce robust systems, as it has in other areas of fertility treatment, to ensure the procedure is carried out safely and effectively. But this is now at risk because the government are intent on pushing through a parallel law to weaken the HFEA’s regulatory position. 

The Deregulation Bill, currently concluding its Lords Report, imposes a duty of economic growth on regulators, specifying that they must consider the promotion of economic growth. This will apply equally to the HFEA, the Human Tissue Authority and the Care Quality Commission.

There is currently no provision in legislation for the HFEA to have regard to economic growth. If a clinic does not meet statutory requirements, it cannot grant a licence or allow a certain activity to take place, regardless of how economically desirable it might be. Similarly, if there have been gross failings at a clinic, regardless of the economic impact of closing it down, the HFEA would be bound to do so in the interests of ensuring patient safety and maintaining public confidence.

The growth duty is surely inconsistent with these requirements? The HFEA’s own website has often acknowledged that it is not an economic regulator. This has been confirmed by Ministers in parliamentary answers. Indeed, the CEO of the HFEA, Peter Thompson recently told BioNews that the authority recognised its responsibility to take action against rampant commercialisation of IVF.

The draft guidance issued with the Deregulation Bill only adds to the concern. In summary, this states that the growth duty does not automatically take precedence over or supplant existing duties held by regulators. But ‘not automatically’ must by implication mean that it is entirely possible for it to take precedence.

The upcoming mitochondria donation vote is hugely important, and must be made in the absolute certainty of the regulatory process. This is no time for ambiguity and Ministers must withdraw their proposals to include the HFEA in the economic growth duty.

Lord Phil Hunt of Kings Heath is Shadow Health Minister in the Lords. He tweets @LordPhilofBrum

Published 11th February 2015

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