Better regulation for fertility treatment: a review of the options

Government intends to save money by improving the efficiency of regulatory bodies, of which the Human Fertilisation and Embryology Authority (HFEA) is one. Providers of fertility treatments also favour more efficient regulation as it would help them improve their own services.

This common purpose - the need for improved efficiency - is reflected in the consultation announced by the Government (reported in BioNews 663). The central question is how it should be achieved, the favoured option being the integration of HFEA functions into existing organisations.

Providers and purchasers of NHS care are the target audience of the consultation, and as the NHS looks to implement the NICE (National Institute for Health and Clinical Excellence) guideline more fully, regulatory cost is becoming a significant drain on resources. Thus the NHS is being asked to select the option that gives the best savings and it's that consideration that I address here.

The consultation gives three options that can be briefly summarised as:

(1) abolish the HFEA and absorb its functions into the Health Research Authority (HRA) and Care Quality Commission (CQC);

(2) as (1) but with some functions allocated to other organisations;

(3) retain the HFEA and require further efficiency savings.

The third option, I think, can be dismissed - the 'status quo' is not an optimistic long-term strategy. Actions already taken by the HFEA have made significant savings in infrastructure and administration (where office moves are concerned, for example). Further savings will need reform of the regulatory process but experience demonstrates that HFEA process changes have increased expenditure. Figures from the HFEA's reports show that between 2000 and 2009 expenditure increased from £1.7m to £7.1m while the number of clinics/treatments rose from 116/46,398 to 134/61,530 per annum. Thus, despite plans for efficiency savings, the regulatory cost per clinic rose from £14,796 to £53,843. Given this history, option (3) does not look promising.

Options (1) and (2) are similar and follow the same drive to streamline regulatory services and reduce duplication. With option (1), there is the risk that the current HFEA regulatory practices will continue under the direction of the CQC executive without significant change. Although there are senior staff savings to be made, it is unlikely that any further efficiency savings will result unless the regulatory process is also revised. The professional societies have argued strongly that process revision is both necessary and potentially cost-efficient.

Option (2) has the advantage that it is more likely to force change but risks fragmentation and continuing duplication so needs to be considered carefully. However, there are two functions that sit more comfortably elsewhere. Firstly, policy decisions should be made by an accountable body and it is logical that this should be a Department of Health-led function. Although high profile, policy issues arise infrequently and are probably better dealt with on an ad hoc basis by relevant bodies for each issue.

Secondly, donor-conceived adults wanting to trace their donor are in a similar situation to adopted adults tracing birth parents. The expertise and support needed is not found in the CQC. Devolution of these functions should improve practice. Cost savings are anticipated as, with minimal investment, the work could be absorbed into existing organisations.

HFEA data collection and storage has primarily related to clinic licensing. Thus it is probably best that this stays with the CQC. Current HFEA procedures for data collection have been criticised and much simpler methods are proposed by the professional societies. If adopted, these could replace the HFEA register without the loss of data, and would represent significant cost savings for both the clinics and the regulator.

There remains a concern that the CQC has little experience of laboratory accreditation. Nonetheless, the principles of regulation within a quality management system are generic and collaboration between the professional societies, the current HFEA expertise and the CQC should provide an appropriate structure against which a compliance assessment can be made that could improve efficiency.

The transfer of research regulation from the HFEA to the new HRA has been widely supported. Apart from the statutory requirement for licensing, all the HFEA regulatory oversight duplicates that of the National Research Ethics Service (NRES). Experience tells us that the NRES process is more efficient and ethically robust, particularly since it works within the context of other medical research.

Potential cost savings of the transfer to the HRA are unclear because not all research-related activity costs are identified in the HFEA accounts. Nonetheless, the HFEA has only 27 research licences compared with about 6,000 projects regulated by NRES so it is likely that the work could be absorbed with minimal additional resources.

Providers who anticipate that reforms will ease the regulator's requirement for compliance are misinformed. This reorganisation is an opportunity to improve efficiency. With appropriate support from the professionals, it could be more robust but justifiable and accountable.

Purchasers who are concerned that compliance against standards might fall with a revised regulatory process should be reassured. The most important issues relating to the creation and use of embryos remain subject to primary legislation. There is a significant opportunity to cut costs but this will require radical change.