The first step of the review process, which was proposed by Lord Howe, is a formal public consultation (reported in BioNews 663). The consultation aims to seek views on whether:
all functions should transfer to the Care Quality Commission (CQC) (apart from research which would pass to the Health Research Authority) and the HFEA would be abolished, or;
all functions should transfer as above but a limited number of functions would transfer to organisations other than the CQC, or;
the HFEA should retain its functions and deliver further savings.
The Government's preferred option is the first. But here at the Association of Clinical Embryologists (ACE) - the professional body representing clinical embryologists in the UK and abroad – we have grave concerns about dissolving the HFEA. As such, we are joining other organisations such as the British Medical Association, the British Fertility Society and the Royal College of Nursing to ensure our views are heard by completing the consultation.
Since Louise Brown, the first IVF baby, was born in 1978, we have not only seen unprecedented advances in the technology used in fertility treatment, leading to ever improving outcomes, but public acceptance of fertility treatment has also grown. The HFEA has played a pivotal role here through both its regulatory and public-facing presence, supporting hundreds of thousands of people in the UK through their fertility journeys.
Over the last 20 years, the HFEA has developed robust regulatory mechanisms. These well-defined processes and safeguards have enabled practitioners in the UK to pursue areas of research and practice that have been much harder to engage elsewhere.
What's more, the expertise the HFEA has accrued means it is uniquely equipped to deal with highly sensitive and emotive issues that can arise during fertility treatment. Indeed, it has debated and ruled on a number of high profile, highly sensitive issues such as sex selection, payments to sperm and egg donors, and 'saviour siblings' (where an embryo is selected to be a tissue match for a sick sibling).
While we acknowledge that the CQC already registers a wide range of NHS and independent health care providers, ACE is not convinced that the CQC is well placed to fulfill the current role of the HFEA. The HFEA's specific function is to ensure that the Human Fertilisation and Embryology Act is enforced and that fertility centres work within this complex legislation. To move the core functions of the HFEA into the CQC may result in a loss of the expertise and experience which the HFEA has worked long and hard to establish.
This move could also expose patients and clinics to an increased risk of error or incident during an inevitable and potentially lengthy period of transition. An example of this is data collection - the CQC does not routinely collect large volumes of data on a scale that is currently submitted by fertility centres. It is essential that accurate data is held, especially with respect to donor-conceived children.
Beyond the questionable effect dissolving the HFEA would have on efficiency within the sector, there is also the impact that losing the HFEA could have on patients. It is trusted as the industry body that regulates treatment and helps patients put their hope and trust in the fertility centre they choose for their treatment. And ultimately, patient safety must be paramount.
To lose the expertise of the HFEA and the level of public confidence it has established, will not help fertility centres continue to develop and offer their patients the best possible standards of care. In fact, it is likely undermine the good work done to date and deny patients the support they need when they need it most.
But that is not to say that the process could not be improved. ACE of course supports reviewing and improving the regulatory process to make NHS systems more efficient. And in truth, most of us working in the sector would welcome a more efficient approach to inspection and licensing.
As such, it is essential that alongside this consultation, work is done to review how the process could be improved. Work led by the professional bodies is underway to suggest how the regulatory process should be bettered and the stronger relationships between the sector and the regulator will hopefully lead to a positive future.
An alternative proposal could be to align the CQC and HFEA, maintaining the HFEA brand and expertise rather than dissolving it altogether. Both inspection processes could be amalgamated into one, reducing the inspection burden both to clinics and inspectors. This would fulfill the Government's three aims: strengthen the effectiveness of regulation in this area; clarify the regulatory landscape for service providers; and reduce the complexity of the regulatory landscape.The consultation period ends on 28 September and the final decision is due to be made later this year. ACE would encourage as many people as possible to contribute to this important review process.