Annex B
all the people who work
within them—must take responsibility for ensuring that they
apply the right standards and quality so that patients receive
the appropriate treatment in the best way. The HFEA must ensure
that its systems of regulation are as effective as possible, including
working in co-operation with clinics, so that it can spot and
tackle areas of weakness. Groups representing patients and other
interests must also help ensure that deficiencies and room for
improvement are identified so that they can be addressed.
The Government has an important role to play
too. I want to take the opportunity today to set out two key issues
that the Government intends to address in order to help maintain
an effective and admired regulatory regime for assisted reproduction
and embryo research in the UK in the future.
REVIEW OF
THE HUMAN
FERTILISATION AND
EMBRYOLOGY ACT
1990
The Human Fertilisation and Embryology Act has
been in force since 1991. It was landmark legislation at the time,
setting up the HFEA and introducing the first regulatory regime
in the world specifically for the newly-developing field of assisted
reproduction. Since then, over 73,000 babies have been born in
the UK as a result of treatment procedures regulated under the
Act. The success of this has, as I have mentioned, led to the
fundamental elements and principles of the Act being studied and
adopted across the world.
Bearing in mind the speed at which new technologies
in the fertility field develop, and the complex ethical issues
often associated with them, the Act has stood the test of time
remarkably well. It has been subject to Parliamentary scrutiny,
such as the House of Lords' report on stem cell research in 2002,
and legal challenges, such as the 2002 judicial review as to whether
cloned embryos are covered by the Act. It has withstood these
challenges successfully.
It continues to provide effective safeguards
and quality assurance for research that involves embryos and for
the 30,000 patients who undergo fertility treatment in the UK
each year.
However, any cutting-edge legislation, no matter
how successful, at some stage needs to be reconsidered and any
necessary readjustments made to ensure that it continues to be
effective. The Human Fertilisation and Embryology Act is no exception.
The nature of assisted reproduction and embryology is such that
new procedures and technologies are being developed that could
not have been envisaged when the Act was first drafted.
It is also important to consider to what extent
the Act is able to take account of changes over time in the public
perception of ethical issues it covers. The Act is, after all,
based on debate that took place in the 1980s.
In addition, now that the Act has been in operation
for nearly 13 years, consideration needs to be given to the extent
to which any perceived weaknesses in the Act may need to be addressed.
There are also international developments to
bear in mind. As you will be aware, this spring the European Union
is likely to adopt a Directive on setting standards of quality
and safety for the donation, procurement, testing, processing,
storage and distribution of human tissues and cells, including
gametes and embryos. Although the standards that would apply to
fertility clinics have yet to be negotiated and would not come
into force until 2006, we have to consider the impact the Directive
will have on the Act.
Taking all these various developments into account,
I have decided that the time has come to review the Human Fertilisation
and Embryology Act.
My intention is that the review will begin in
2004 and will be undertaken by the Department of Health. It will
include a full public consultation exercise in 2005. Many of you
will know that the House of Commons Science and Technology Committee,
chaired by Dr Ian Gibson, has announced its intention to look
into human reproductive technologies and the law. We welcome this.
Our review will obviously take full account of the work of the
Committee and its report, which I understand is planned for publication
in Autumn this year.
Whilst the review will be wide-ranging, I should
make it clear that we do not intend to open up the fundamental
principles of the 1990 Act. The intention is to consider whether
it needs to be updated and, if so, how. There are certain issues,
such as embryo research, stem cells and cloning that have been
extensively and conclusively debated in Parliament in recent years.
I therefore do not intend that the review will go over that
same ground again.
The type of issue that I do see the review
addressing includes consideration of whether greater flexibility
needs to be introduced to enable a wider range of assisted reproduction
techniques to be regulated. This would apply to currently unregulated
procedures as well as new ones. In doing so we will need to look
at what techniques and procedures may be on the horizon and beyond.
I also envisage that the review will consider
if changes need to be made to enable the most effective use of
the information held on the HFEA's database register. For instance
to support follow-up research on the health of children born following
assisted reproduction. There is a wealth of information contained
on the register that we should ensure can be drawn on where appropriate.
I also believe it is important that the review
considers if more flexibility needs to be introduced to help the
HFEA in its role as regulator. I am sure that the HFEA will be
keen to let me have its views on that.
Many of you will no doubt also have views on
areas that you would like the review to consider, and improvements
that you would like to see made. To enable people to feed in comments
pending the consultation exercise we have set up a web-page on
the Department's web-site outlining the review and giving details
of where preliminary views can be submitted by any interested
parties.
Although I cannot say at this stage what the
outcome of the review will be, my aim is to ensure that the Human
Fertilisation and Embryology Act is well-placed to continue to
be effective in the 21st century. It is an aim that I am sure
we all share, and I look forward to the interesting views, debates
and suggestions that the review will undoubtedly generate as it
progresses, including work done by the Science and Technology
Committee.
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