On 4 June 2026, the House of Lords debated the adequacy of the law on the regulation of fertility treatment. Moved by Baroness Deech, a former chairwoman of the HFEA, the debate drew contributions from clinicians, scientists, ethicists and policy-makers with expertise in the sector. 

Consent: A significant area of litigation risk

Several speakers identified consent as a live and growing source of legal dispute. The consequences of the current regime include complex consent rules and legal uncertainty around parenthood, especially in cases of relationship breakdown and posthumous conception, and a regulatory regime that cannot keep pace with innovation.

The current regime has led to difficult litigation, especially in cases of relationship breakdown or posthumous use of gametes. The HFEA calls for clearer statutory definitions to protect all parties and reduce judicial uncertainty. For defendant practitioners, this is a critical observation: the absence of clear statutory definitions means that courts are being asked to resolve disputes in a legislative vacuum, which can produce unpredictable outcomes.

Concerns were raised about proposals to shift towards a package-based consent approach. Anyone undergoing or considering fertility treatment and having a conversation with a specialist is likely to be experiencing intense stress and possible feelings of overwhelm. Each part of the process is weighty and should be considered carefully according to the conscience of the individual or couple concerned. The risk for clinics is plain: if a patient later disputes what they consented to - as frequently occurs in negligence claims - the fragmented and complex nature of current consent processes makes it difficult to demonstrate, on the balance of probabilities, that valid, informed consent was obtained at each stage.

The debate also touched on the proposed removal of the requirement for consent to each named research project when embryos are donated to science. Maintaining the requirement for consent to each named project will be important for some and so should not be overlooked. Any relaxation of this standard could expose clinics to future claims where embryos are used in ways a patient did not anticipate, notwithstanding the laudable aim of advancing research.

Unproven add-ons: A significant and growing source of claims

The debate considered the issue of treatment add-ons, with additional interventions marketed to patients at considerable cost and often without a robust evidence base.

More than 52,000 patients undergo IVF treatment each year, and 70% pay for it privately, navigating a complex commercial market at a time of considerable vulnerability. The absence of an explicit reference to patient protection limits the regulator's ability to act when patients are offered and encouraged to pay for treatment add-ons. Not only do these lack official evidence of benefit but, for some, there is evidence of harm.

Baroness Gerada provided a vivid composite account of a patient who had spent nearly £30,000 with still no baby. They spent not on treatment, as she reflected later, but on hope - hope that had been carefully packaged and endlessly sold. She noted that 73% of patients go to extraordinary lengths to raise the necessary funds, only to find that their hopes are never realised. 

In 2023, the HFEA introduced a new five-point rating scheme for add-ons, which was well received, but it remains a regulatory sticking plaster on a structural legislative wound. The HFEA has limited powers to intervene and no explicit statutory principle of patient protection within the 1990 Act. Without legislative backing, it lacks enforcement power.

It was agreed that patients must be told clearly before they pay when a treatment is not evidence-based. Informed consent is not a courtesy; it is a right, and it is a legal and ethical obligation.

Inconsistent inspection standards and regulatory oversight

Lord Winston offered a striking critique of the HFEA's inspection regime, which has direct implications for how regulatory compliance is assessed in litigation. He recounted a situation in which his own laboratory received a "fantastic review" one year and a "terrible review" the following year, for no reason other than a different set of examiners. This resulted in his closest colleague giving up embryo research entirely, having been so depressed by that review.

This is a potentially powerful point; if HFEA inspections are susceptible to inconsistency and the subjective views of individual examiners, some of whom, as Lord Winston noted, were in private practice and were jealous, then a poor inspection result cannot simply be treated as determinative evidence of sub-standard practice. Defendants in medical malpractice may be able to challenge the weight to be attached to adverse regulatory findings by pointing to the structural problems with the inspection regime that have been acknowledged at the highest levels of parliamentary debate.

Data deficiencies: Incomplete HFEA records and their forensic implications

Lord Winston raised a concern of direct forensic relevance: the HFEA's data is materially incomplete. When he asked the HFEA, he was told that we do not know how many eggs are being frozen, how many end up fertilised, how many become embryos or what happens to those embryos - we only know the number of embryos transferred to uteruses and the number of pregnancies. We do not even really know the number of miscarriages, which seems to be at about 15%.

There are something like a quarter of a million eggs recorded as available which have been frozen. So far, some 34,000 of those have been unfrozen in the past year for the purposes of treatment. Of that number, 2,000 embryos were produced, and only 900 pregnancies were produced. We do not even know the number of live births.

Online and virtual clinics: An unregulated frontier

Baroness Owen drew the House's attention to the collapse of Apricity Fertility, an online IVF provider, and the legal vacuum it exposed. Patients who had been undergoing IVF treatment were left uncertain about their embryos and were told that the HFEA had no remit to step in and help them. Many people who had entrusted Apricity with their hopes of having a family were left in fear that they might not receive their money back or be able to afford continuing treatment with another provider.

Patients assume that, when a company is central to the delivery of their fertility treatment, there will be regulatory oversight and protections if that company fails. At present, that assumption is not always correct.

Apricity's closure did not fall under the HFEA's regulatory remit, as it was a digital service only. Affected patients were advised to complain through trading standards about the service that was offered.

The implications for practitioners and medical malpractice indemnifiers are significant. Where claims arise from treatment co-ordinated through an online platform, questions of duty of care, the scope of any regulatory obligations, and the chain of liability between virtual co-ordinator and physical licensed clinic will require careful analysis. The current legal framework provides no clear answers, and as services are increasingly fragmented and delivered across multiple sites including online, patients reasonably assume that, if a service presents itself as a fertility provider, it is regulated by the HFEA - but that assumption can be mistaken.

Surrogacy: Legal uncertainty and unresolved liability questions

The debate devoted considerable time to surrogacy law, an area where legal uncertainty is particularly acute. The surrogate remains the legal parent at birth, even in gestational surrogacy where she has no genetic link to the child. Intended parents must apply for a parental order, a process that can take six months, during which they cannot make legal or medical decisions for the child; the child's status is uncertain and so is that of the parents.

Canadian research suggests that gestational surrogate mothers carry three times the risk of severe complications compared to unassisted pregnancies. The question arises as to whether women are properly informed about these risks.

The Law Commission has proposed reforms which would transfer legal parenthood to the intended parents from birth, place greater reliance on consent given before conception and reduce the role currently played by the courts and the Children and Family Court Advisory and Support Service after birth. Some are concerned that the proposals would make it more difficult for a surrogate mother to change her mind and move away from the long-established principle that the woman who gives birth is initially recognised as the child's legal mother. Any change to this framework would fundamentally alter the landscape of potential clinical and legal liability.

Government response: No immediate legislative reform

The government's response, delivered by Baroness Blake of Leeds, was notably cautious. Due to the limited time available to undertake legislative reform and the priorities the government set out in the King's speech, the government are not able to pursue immediate legislative reform of the Act in the current Session. However, the government are considering potential legislative options and, if parliamentary time allows, will ensure that any future reforms support patient safety, reflect societal change and maintain the UK's position as a global leader in fertility regulation.

On surrogacy, the government recognise the significance and importance of this issue and welcome the Law Commission's comprehensive report, but given the limited parliamentary time available and competing legislative priorities, are not currently able to bring forward the reform immediately.

Baroness Deech closed by expressing her disappointment and calling on the government to set up a Select Committee and produce a draft Bill, which is what happened the last time the Human Fertilisation and Embryology Act was revised.

Key takeaways for medical malpractice practitioners

The Lords debate reveals an area of clinical practice operating under regulatory and legislative strain. In the context of medical malpractice, the key takeaways are:

• Consent documentation will remain the most important battleground: The complexity and fragmentation of the current consent regime means that records of what was discussed, when, and how must be meticulous.
• Add-ons are a high-risk area: Clinics that offered unproven treatments without adequately communicating their experimental status face real exposure to claims framed around lack of informed consent and misrepresentation.
• Causation disputes will be hampered by poor sector-wide data: Defendants should invest in obtaining expert evidence that situates any alleged adverse outcome within the full statistical picture of baseline failure rates.
• Regulatory findings are not automatically determinative of civil liability: Lord Winston's critique of inconsistent HFEA inspections provides a basis for challenging the weight of adverse regulatory conclusions in litigation.
• Online and virtual providers sit in a legal grey zone: Defendants in claims arising from hybrid or virtual service models should scrutinise carefully where regulatory duties begin and end.
• Surrogacy claims involving complications carry significantly elevated clinical risk: Defendants will need to demonstrate that surrogates received full and frank information about those risks before any procedure was undertaken.

The message from the Lords is that reform is coming, even if not imminently. Practitioners would be wise to monitor legislative developments closely, as changes to the statutory framework will directly shape the standards by which clinical conduct is assessed in future litigation.