APPENDIX 74
Supplementary memorandum from the Wellcome
Trust
Issues raised concerning the draft Codes of
Practice for depositing and accessing stem cells and stem cell
lines into the National Stem Cell Bank fall into three main areas,
concerned with governance, ethics and intellectual property and
access.
1. The Wellcome Trust raised the above issues
at a meeting with the MRC (11/10/04) who supply the secretariat
for the Scientific Steering Committee of the National Stem Cell
Bank. It was agreed that the Codes of Practice would benefit from
having an introductory section that would set out (in less formal
language) the aims of the Bank and the overarching principles
that would be applied in order to achieve these aims, for example:
to facilitate the sharing of stem cell lines between researchers,
academic researchers should only be charged a nominal fee to access
a cell line; the Scientific Steering Committee of the Bank is
there to provide guidance and assistance on best practice rather
than to act as a regulator etc.
2. As compliance with an HFEA licence for
embryonic stem cell line derivation requires deposition in the
Bank and by extension, compliance with the Codes, it was agreed
that the Codes should state this more explicitly in the introductory
section so it is absolutely clear. It was agreed that the full
impact (and practicability) of the Codes could not be known when
they are launched and that there may well be teething problems
in practice. To address this, it was agreed that it would be preferable
to introduce them as interim guidelines for a pilot (or "beta")
phase during which time adjustments could be made and a degree
of flexibility could be applied in their interpretation to avoid
inadvertent problems.
3. More generally, it was agreed that, where
possible, the language should be revised to reduce the prescriptive/mandatory
tone (especially the use of "must") and to make clear
that the Code is intended to set out recommendations rather than
be mandatory and would allow for a level of flexibility and discretion
in its application.
4. It was agreed that HFEA would have to
be comfortable with this approach in order not to come into conflict
with the statutory requirement for a licence.
5. The MRC has agreed to either raise these
points for discussion at the next meeting of the Scientific Steering
Committee or circulate a revised Code of Practice to members for
comments.
GOVERNANCE
Mandatory aspects
6. Due to the link with the HFEA licence,
and the requirement to deposit embryonic stem lines in the Bank,
the Codes of Practice have quasi-legal force in relation to embryonic
stem cell research. For example, the consequences of a breach
in compliance with the Codes are unclear but ultimately, if serious
enough, for example where a researcher has not followed a consent
procedure in line with that recommended by the Code, then a researcher's
licence could be revoked and the research halted. We believe that
the implications of this are unclear at present and might lead
to the Code having a detrimental affect on the research the Bank
is intended to facilitate. As such we consider that the status
of the Codes and the implications of non-compliance need to be
made clearer.
7. One way forward, which the MRC discussed
with us, would be to introduce the Codes as interim guidance,
allowing some flexibility in their interpretation so they could
develop in a way to reflect both the concerns of the Scientific
Steering Committee and the needs of medical researchers. Once
it was felt the Codes were workable, then they could be made more
directive.
Relationship with HFEA
8. The HFEA are represented on the Scientific
Steering Committee. This is the principal mechanism through which
they ensure they are satisfied with the requirements of the Bank
and the Code. In practice, they do not have the resources to take
a more active role in relation to the regulation of research using
ES cell lines. It will be for the Scientific Steering Committee
as a whole to decide and agree on any changes to the Code.
Existing collections and Imported cell lines
9. It is recognised that there are difficulties
in requiring full compliance with the Codes in both these areas
and thus, it is acknowledged, it is impracticable to apply the
Codes in a hard and fast fashion. Some flexibility is needed to
ensure the Codes are workable in the context of different practices,
both in the past and where stem cells are derived overseas. There
is a general recognition that the Bank needs to minimise bureaucracy
levels. Accordingly, the Scientific Steering Committee is continuing
to streamline its procedures. For example they now only require
an abstract of a research proposal, their job is not to peer review
the science but more to ensure the research is not for a trivial
purpose. As part of this, for existing collections such as NIH
cell lines, the Bank will no longer require evidence of satisfactory
consent but will place their confidence in the NIH process.
Composition and selection of Scientific Steering
Committee
10. The MRC provide the Secretariat to the
Scientific Steering Committee and appoint Committee members. The
Trust has been asked for a nomination for another scientific representative
to join the Committee.
Prioritisation of access (especially to early
passage cells)
11. The process for prioritisation as to
who has first rights of access to cell lines held in the Bank
is still under discussion but in our opinion in the early phases
of the Bank's operation there should be some favourable weighting
given to UK academic researchers over other users, though an element
of the scientific rationale for the proposed use would inevitably
be factored in.
Fate of cell lines that are not accepted by the
Bank and storage of cells lines outside the Bank
12. This is acknowledged as ambiguous but
the intention is that the Bank would become the preferred source
of stem cell lines and that, in time, those not meeting the Bank's
standards would not generally not be used by other researchers.
Stem cell lines that are not accepted by the Steering Committee
or bank for deposition for safety or other reasons will be archived
in quarantine by the bank.
ETHICS
Feedback and Traceability
13. There are considerable difficulties
associated with providing individual feedback of research results
to gamete donors; therefore, consideration might need to be given
to changing the current position on feedback to one of giving
no individual feedback. However, there would be some difficulty
sustaining a no-feedback position across the board (particularly
in relation to highly predictive information relating to conditions
for which treatments are available) so this issue requires further
careful consideration. Traceability is likely to remain a requirement
due to the EU tissue and cells Directive, though there is still
some discussion to be had as to whether this was necessary in
relation to research grade cell lines (given that the Directive
only covers tissue for human application).
Incapacitated adults/children/deceased donors
14. The Scientific Steering Committee has
not formed an opinion on this yet and is awaiting the outcome
of the Human Tissue Bill and the Mental Capacity Bill before elaborating
on the requirements in this regard.
IP AND ACCESS
In-house research by Bank
15. Our understanding is that any in-house
research will be focussed on methodological improvements to storage,
maintenance and bulking-up of stem cell lines. Any IPR that resulted
from this work would reside with the MRC in the first five years
and any royalties raised from exploitation would be wholly ploughed
back into the running costs of the Bank. Other than this type
of research, in-house researchers would have to apply to the Scientific
Steering Committee like any other users and would not receive
preferential access.
Differences between academic and commercial
depositors and users—first option to negotiate a licence
vs reach-through.
16. The Scientific Steering Committee will
not be involved in the terms of Material User Licences (MULs)
but would be available to mediate if a problem arose such as a
depositor blocking another's access due to unreasonable terms.
However, the draft Codes recommend an MUL is in place for all
cell lines deposited in the Bank.
17. The Bank has applied for WIPO accreditation
as a legally recognised place for deposits of biological material
to satisfy patent office requirements.
November 2004
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