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Regulating innovation in a changing world – A reflection by Barbara Manukian

Nowadays, as a fertility doctors, we are facing couples who are trying to optimise their success in their assisted reproduction treatment. At the same time, world is changing and innovation is a reality, as a consequence, many new techniques – or “adds-on”- are emerging showing promising results. However, not all of them have been proven to improve pregnancy and birth rates. For that reason, there are regulatory rules to help clinicians and everyone involved in the management of fertility couples to offer these techniques, which according to the speaker Mr Peter Thompson, are the most significant reputational risk facing the fertility sector.

“Add-ons” are being offered in the majority of fertility clinics in the UK. In 2018, 86% of them offered at least one add-on. Most of the time, they are offered with an extra cost, sometimes they are included in treatment package. Among the common features are claim to improve the chances of having a healthy baby and they also cover a range of interventions: genetics tests, drugs, surgery and equipment. Unfortunately, not all of them are evidenced.

The main issue is the supply by fertility clinics and demand by patients who are requesting these techniques based on information they have either obtained, heard or been given.

On the one hand, clinics are offering add-ons, but there is no clear consensus among who work in clinics. Some of them are offering them enthusiastically showing a sign of health and vitality of the sector. Others offer but they are opposed to charging for or offering add-ons unless there is robust evidence that they are safe and effective and lastly, other clinics, are not very keen but feel trapped by the demands of a commercial world.

On the other hand, patients, who are desperate for a baby, demand almost anything. Most of the time they are confused by the available information. Patients are having unnecessary tests and paying more money for their treatment.

In terms of solutions, there are action which can be taken. We need culture and consensus with principles of responsible use of add-ons, where clinics have up-to-date information about evidence behind them which should be given to patients, in order to inform them of the experimental nature or whether there is evidence of safety or effectiveness. In that sense, the traffic light rating system is a useful independent evidence that clinics and patients can trust to offer add-ons. Patients should also have access to unbiased information before treatment is offered and informed consent signed, as well as, extra charges that those add-ons might have.

The conclusion in the lecture was that good regulation provides the conditions that encourage responsible innovation, but regulatory rules will not solve problems of add-ons and it require an effort from professionals and clinics.

Mr Peter Thompson