Memorandum by the Association of Medical
Research Charities (AMRC) (Ev 70)
PART 1 OF
THE DRAFT
BILL
Question: What are your views on the proposed
transfer of the functions of the HFEA and HTA to a single new
regulatory authority, RATE?
AMRC comment: We are unsure of the rationale
behind amalgamating the HFEA and HTA, two organisations with different
remits which would fare well to remain separate.
Funding RATE
Question: Should the regulatory body or bodies
be allowed to make charges for licenses?
AMRC comment: There should be a strict limit
on what the regulator can charge researchers, agreed in consultation
with funding organisations and reviewed regularly. High charges
will have an adverse effect on the ability to conduct research.
PART 2 OF
THE DRAFT
BILL
Inter-species embryos (for example, cytoplasmic
hybrid embryos)
The text of the draft Bill (particularly in
clause 17 and Schedule 2) reflects the position in the Government's
White Paper that the creation of hybrid and chimera embryos in
vitro is prohibited, but that a regulation-making power would
allow Parliament to agree exceptions to that prohibition for research
purposes.
On publication of the draft Bill, the Government
announced that it now intends to accept (in part) the approach
advocated by the Commons Science and Technology Select Committee,
that legislation should provide for certain inter-species entities
to be created for research purposes under licence by the Regulator
within a 14-day limit. The Government proposes that the entities
to be permitted should be limited to those listed in clause 17(2)
inserted section 4A(5)(b) to (d) on page 9 of the draft Bill (see
also paragraph 1.12 of the introduction to the draft Bill on page
ix). This would exclude from the licensing regime "pure hybrids"
as described in clause 17(2) inserted section 4A(5)(a) and (e)
on pages 9 and 10.
The Science and Technology Committee, in its
recent Report "Government proposals for the regulation of
hybrid and chimera embryos", goes further than the Government's
new position and recommends that legislation should be permissive
and provide that "in general, the creation of all types of
human-animal chimera or hybrid embryos should be allowed for research
purposes" under licence by the Regulator (recommendations
22 and 26 on page 63 of that Report). Furthermore, the Committee
recommended that licensing should not allow for the development
of interspecies embryos past the 14-day limit unless proved necessary.
Question: Do you support:
(i) the approach signalled by the Government
in the White Paper;
(ii) the new approach announced by the
Government (as outlined above); or
(iii) the approach recommended by the
Commons Science and Technology Committee?
AMRC comment: We strongly endorse option iii,
and urge adoption of the approach recommended by the Commons Science
and Technology Committee.
Research licences
In addition to the new provisions on inter-species
embryos, clause 18 and Schedule 2 of the draft Bill consolidate
the purposes for which licences for research can be granted and
extend the principle purposes listed in paragraph 6 of Schedule
2.
Question: How should Parliament approach legislating
for those purposes for which licences for research may be granted
in the future (arising out of future research) but that are not
yet determined? Should such judgements be left to the regulatory
body or bodies to determine?
AMRC comment: We accept that the regulator should
take responsibility for these judgements.
Question: How should Parliament or the regulatory
body or bodies take public views and public engagement into account?
AMRC comment: There is a risk that complex issues
such as this can become bogged down in consultation for which
the purpose is unclear and therefore not helpful, and as a substitute
for appropriate decision-making. This has to some extent already
occurred, resulting in the ongoing delay to grant licences for
apparently promising research.
AMRC encourages debate about medical research,
respects and acknowledges sensitive feelings surrounding this
issue, welcomes the recently announced "national discussion"
on stem cell research, notes previous and current public consultations
and works to promote the "patient voice" wherever possible
and practicable.
When parliament seeks to legislate/regulators
to regulate complex topics, they rightly seek the views of experts
in the field. This raises two key questions: firstly, how to find
a balance between consultation and allowing decision-making by
an elected parliament, and secondly, how to identify the appropriate
"experts". Should parliament/regulators heed the views
of scientists who believe such work will revolutionise research,
patients whose focus may be to support much that could alleviate
suffering, or religious or pro-life groups for whom such research
is simply unthinkable? What this issue has demonstrated is that
we have yet to master the right engagement mechanisms which enable
decision-making in the context of an ongoing conversation or consultation
with the public.
It is crucial that this consultation be both
knowledge-based and proportionate. Above all, AMRC recommends
that the first step in meaningful public engagement must be ensuring
accurate information is in the public domain, and taking public
views into account should follow rather than precede this. We
have worked closely on a project of just this sort regarding the
use of animals in medical research, where teenage and adult audiences
were informed about the range of issues through a play, Every
Breath, and then encouraged to debate and decide. In many cases,
audiences which were by their own description un- or ill-informed
about the issue before seeing the play were able to form an opinion
after hearing the arguments. Repeatedly seeking public views in
an information-vacuum and where the response is therefore likely
to be overwhelmingly emotion-based or ill-informed is unhelpful.
Storage limits
Clause 22 of the draft Bill proposes to increase
the statutory storage period for embryos from 5 years to 10 years
to match the statutory storage period for gametes.
Question: Do you support the proposal to increase
the storage period from 5 to 10 years? Should the storage period
for gametes and embryos be limited by statute at all?
AMRC comment: We are not sure of the rationale
behind the need to have time limits of this specificity.
June 2007
| 
