HFEA sets out mission to modernise fertility law

The Human Fertilisation and Embryology Authority (HFEA) has opened a consultation on proposed changes to UK fertility law.

The Human Fertilisation & Embryology Act 1990 (HFE Act) is over 30 years old and while medicine, science, and society have moved on, the HFEA say the law itself has largely stood still and fails to reflect modern fertility practice as well as being inflexible in responding to scientific innovation.

“Much of the fertility law has stood the test of time remarkably well but modern fertility practice, emerging possibilities in research that could benefit patients, and the changing expectations of donors and of families are not reflected in the sector’s 30-year-old law,” said Julia Chain, Chair, HFEA, continuing:

“The HFE Act is the cornerstone of fertility regulation enforced by the HFEA to ensure clinics provide services to patients that are safe and of a high standard; we are uniquely positioned to see where the law works well and where it doesn’t.

With input from an expert advisory group, we have identified where the law needs to be modernised in the interests of patients and their families. This includes providing more up to date powers for inspecting and regulating fertility clinics in the interests of patients and greater choice around donor anonymity. However, it’s important to note that any decision to update the law is for the Government and ultimately Parliament to decide.”

Professional sector experts as well as patients themselves, are being urged to respond to the consultation which opened on 28th February. Changes being considered by the HFEA include:

Patient safety and promoting good practice

• Creating a broader and more proportionate range of regulatory powers so the HFEA can more rapidly impose conditions, suspend all or part of a service for a specific period of time, or impose financial penalties where there have been serious non-compliances.
• Providing the HFEA with broader powers to address fertility services outside licensed fertility clinics.
• Making patient care an explicitly stated principle of the Act, allowing the HFEA to take proportionate action where patient safety is at risk.

Access to donor information

• Providing parental and donor choice where they can opt for anonymity until age 18 (as now) or identifiable information on request after the birth of a child.
• Ensuring all those using donation services have accessed information about the implications (known as implications counselling) of their decision before starting treatment.
• Placing a legal requirement on clinics to inform donors and recipients about the risk of donor conceived children finding out their donor’s identity before the law currently allows at 18 via DNA testing websites.

Consent

• Considering simplifying the consent system to an “opt out” model.
• Supporting more joined-up and safer patient care at fertility clinics and within primary care by allowing automatic record-sharing between clinics and the NHS central records systems; this is already an established model that is used across other specialisms in healthcare.
• Giving patients more opportunity to support research projects by allowing them to give consent for their embryos to be stored for research more generally and used when needed. The opportunity for patients to donate to a specific research project, as stated in current law, should remain.

Scientific developments

• Encouraging innovation by allowing the HFEA to authorise trials for low-risk new practices, with appropriate controls available if the initial promise is not demonstrated in practice.
• Future proofing the law to ensure it is better able to respond to scientific developments and so speed up the potential for new treatment options for patients. This would allow Parliament to approve significant new scientific and clinical developments by means of regulation without re-opening the Act every time.

The HFEA will submit its final recommendations to the Department of Health and Social Care (DHSC) later in the year.