Fertility treatment in the UK – whether accessed via the NHS or privately – has always been considered safe, robust and research-led. It has been regulated for the last 30 years, ensuring that the industry has patients' best interests at heart. But recent weeks have seen a major shift in how private fertility treatment can be paid for, with a major clinic group now offering multi-cycle and refund programmes directly for the first time, removing vital separations between medical and commercial decision-making. I and others believe this could have consequences for patient health.
I felt it was important to contribute my voice to the Competition and Markets Authority's (CMA) consultation on draft consumer law guidance for fertility clinics, which coincided with this shift.
For many people, having a child or starting a family is a key milestone in life, and when this doesn't happen naturally it can cause unimaginable heartache. For those starting out on their fertility journey, it can be bewildering and overwhelming and incredibly stressful. When accessing treatment privately there's an added layer of complexity; the choice of clinic, how to compare success rates, how to pay, what to pay for.
I wasn't surprised to read the CMA's assessment that patients struggle to make informed choices.
It's also a sector that's evolving constantly. Ten years ago, no one knew the terms 'multi-cycle' or 'refund programme'. But increasingly and in response to need, these programmes, provided independently to the medical clinics, have become popular with families. They provide some financial certainty over the costs and scope of fertility treatment, and the chance to get money back if unsuccessful.
As they have always been provided independently, there has been a natural separation of medical and financial decisions, maintaining the high standards of patient safety in the UK. There has been no undue pressure on any decision-making, or temptation to alter the way they provide treatment, because independent companies with no influence over this treatment bear the risk of refunding patients. And this has provided another layer of protection in ensuring that decisions are based on patients' best interests.
Every prospective parent wants the best chance to have a baby and many are prepared to stretch themselves financially and emotionally to achieve that goal. Those who work in the fertility sector also undoubtedly have the best intentions when it comes to the health and happiness of those they treat.
With some clinics moving to provide multi-cycle or refund programmes directly for the first time in the UK, however, the waters are being muddied, and the vital separations between medical and commercial decision-making are being eroded.
If the clinics carry the financial risks, then there will be pressure to ensure patients are not refunded. This means that clinics may change their safety margins to protect profitability of treatment. What will be the repercussions for patent safety and choice?
It’s easy to imagine the worst. Some may question how, with this new model in its infancy, we can make a judgment on whether it's safe or not. We can however look to international examples for some of the pitfalls to avoid. In the USA, clinics often provide payment programmes directly to patients, and there is evidence that this can lead to patient detriment.
A key risk is in the type of treatment patients receive. In the USA, clinics have been shown to stimulate their patients with larger doses of medication in search of a higher number of eggs. The average in the US is 16 (compared to 11 in the UK). As a result, patients in the US endure higher rates of often serious complications such as ovarian hyperstimulation syndrome, increased risks of adverse pregnancy outcomes, and higher rates of low birth weights in babies.
Clinics in the USA are also more likely to transfer multiple embryos to enhance their chances of success (and not refund the patient) which increases the chance of multiple births. Crucially, the HFEA identifies multiple births as the greatest risk in IVF.
The CMA's consultation asked us to consider any elements of the patient journey in fertility that may have been missed previously. This is a chance for regulators to consider this new model and the implications for patients, healthcare providers and the sector more widely.
At a recent Progress Educational Trust event examining how to protect patients in the fertility sector in the context of the CMA's consultation, Dr Raj Mathur, chair of the British Fertility Society, made the point that the CMA must not encourage the transformation of a patient-doctor relationship into a consumer-service provider relationship, as this would not serve the interests of the patient.
As the sector adapts, so must the regulation. When the sector began to offer treatment add-ons, the HFEA created a traffic light system to help patients navigate the safest, research-based options.
Now I believe a similar move is needed. As part of the SAFE campaign, along with other voices in the sector, we are urging both the CMA and the HFEA to take a closer look at changes which mean clinics are not just providing medical care, but risk-sharing programmes too. The CMA is due to publish its updated guidance in spring, but there's still time to make your voice heard.
For more information on joining the SAFE campaign, visit our supporters page.
Clinics currently use independent providers to ensure medical decision-making is not polluted by considerations about commercial risk but when a clinic's financial risk is directly connected to treatment outcomes, it's hard to imagine that their behaviour won't change.
Regulatory scrutiny now will protect patients, keeping safety at the heart of the private fertility system, where it should be. By maintaining a system which works well today, this will also protect the reputation of the whole fertility sector which makes a life-changing difference to so many families every year.