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
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
(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
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.
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
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.