The government has decided that the respected brand name of the Human Fertilisation and Embryology Authority (HFEA) will remain but an independent review has been carried out in response to the consistent calls in the Department of Health (DH) consultation for reform. These calls were not for minor procedural adjustments but fundamental re-evaluation.
The culture of the HFEA is now one based on self-aggrandisement and self-preservation. But cultural problems with fertility treatment in England and Wales do not stop there and other stakeholders must also be called to account. The DH and commissioners maintain the cultural view that infertility is not part of the routine NHS agenda despite the recommendations of the National Institute for Health and Care Excellence (NICE). This leaves the private sector with its business agenda dominating clinical provision unacceptably.
In 1984, the Warnock Report included the following statement: 'What is common [...] is that people generally want some principles or other to govern the development and use of the new techniques. There must be some barriers that are not to be crossed, some limits fixed, beyond which people must not be allowed to go. Nor is such a wish for containment a mere whim or fancy. The very existence of morality depends on it'.
Acknowledging this emphasis on morality, Parliament passed the HFE Act that established the limits which have served the sector well for over 20 years and been the envy of many other countries. The appointed regulator (HFEA) was established to ensure that these limits are maintained, but their adopted role as the guardians of morality rather than the servants of legislation is of concern.
The culture in an organisation depends on its leadership. The HFEA has always had a high profile leader. The current chair is an esteemed and honoured academic with numerous leadership roles. Her public face is maintained through her many media activities and it is not surprising therefore that the HFEA has a culture that uses the media to promote its views and authority; our fertility regulator appears to actively seek a high public profile.
Since 2009 the HFEA has released 72 press statements, 33 of which primarily related to internal organisational activities and 19 were comments on external events. Medical practice provides many moral challenges but rarely, even in other fields of reproduction (abortion, antenatal diagnosis) do the regulators take central stage in media. A moral basis for the high public profile of the HFEA is difficult to justify. The HFEA has a remit to provide information: this is not the same as self-publicity.
The disadvantage of risk-based regulation is that it is in the interest of a regulator to highlight adverse events, however infrequent, as this justifies its continued existence. Thus it is in the interest of the HFEA to portray IVF treatment as high-risk and contentious, both morally and medically. This is even in the face of evidence that the desired end result of fertility treatment (pregnancy), not the treatment itself, is the greatest risk to both the mother and child.
Unsurprisingly, then, we see the HFEA highlighting rare adverse events (as in a press release in 2012 on an incident in Denmark, unrelated to UK procedures). The HFEA reports on the outcome of inspections and concentrates primarily on negative aspects. A regulator has a more secure future if the public perceive that they are at risk from those being regulated.
The concern for self-preservation within the HFEA is further reflected in its inward-looking focus on internal procedures which appear to overshadow the task to which it was assigned. Review of the publications produced by the HFEA in 2012 found six of 11 relating to internal activities of the organisation.
The medical and scientific practice of advanced reproductive technologies in the UK is remarkably similar to that in most western countries despite the UK's unusual regulatory set-up (1). This suggests that practice would not change were no 'special case' made and if the activities of the fertility regulator were similar to those in all others areas of medicine. There is a perception that the HFEA has a positive influence on clinical practice, but this is not backed by evidence.
For 20 years, the increasing self-assurance of the HFEA has resulted in clinics adopting the path of least resistance. For instance, almost all clinics have recently had a condition added to their licence that their multiple pregnancy rates will be not more than 10 percent this year. It is likely that there will be breaches of this condition, but it is easier for clinics to agree and assume that the HFEA will not close them down.
This licence condition (which is arguably outside the remit of the HFEA) does not reflect the complexity of the scientific data, the professional debate, the financial considerations, the legal implications nor the voice of the patients. It should have been more robustly challenged by the clinics. It speaks of a dysfunctional relationship between the regulator and the regulated.
Do these cultural problems cause harm? Fuelling the moral debate has little benefit except to give a louder voice to the small pressure groups who actively oppose IVF. Promotion of clinical procedures as high risk provides excuses for over-burdensome regulation. Separation from mainstream NHS procedures simply spurs the private sector and reinforces the DH position that infertility is still considered to be outside the NHS funding remit despite the NICE recommendations.
Only 40 percent of treatments are funded by the NHS in the UK. Despite the widespread use of similar eligibility criteria, the UK is near the bottom of the table for IVF utilisation compared to the rest of Europe (2). This is no longer acceptable and bringing the service into the NHS throughout the UK would place it properly into routine clinical practice. A crucial step towards this would be to establish an appropriate national tariff for IVF that reflects the true cost of provision. The current lack of tariff enables the private market with its high profit margins to flourish.
The Warnock Committee debate centred on the moral status of the human embryo and the consequence is that IVF treatment is now an accepted clinical practice. The moral debate must now address the culture that has evolved around the provision of treatment. It is no longer acceptable that, despite the NICE recommendations and the needs of the patients, those involved at all levels of service provision are locked into a culture that promotes self-interest.