ADVANCED THERAPY MEDICINAL PRODUCTS (15023/05)
Letter from the Chairman to Rt Hon Jane
Kennedy MP, Minister of State, Department of Health
Your Explanatory Memorandum and Initial Regulatory
Impact Assessment dated 14 December 2005 were considered by Sub-Committee
G on 9 February.
We note that these important proposals are at
an early stage of consideration, that the Government is still
studying and carrying out consultations on them and that Working
Group discussions about them have only just started.
We agree with your view that any legislation
in this area should be proportionate and risk-based. We would
also expect the most thorough attention to be paid to all ethical
aspects of the Proposal and will want to be satisfied that all
the relevant interested parties in the UK have been fully consulted.
Although we note your initial view that it may
be difficult to establish detailed costs and assess the overall
impact of the proposal, we expect the Government to make every
effort to carry out as thorough a regulatory impact assessment
as possible. We will want to examine that assessment very carefully.
We also note that the Government is reviewing
the appropriateness of the proposed Treaty base (Article 95) in
the light of the ECJ judgement of 6 December 2005 in the "Smoke
Flavourings" case (ECJ C-66/04).
In the circumstances, we are holding this document
under scrutiny. We look forward to receiving the results of your
further study and consultations about the proposal, as well as
your emerging conclusions on the appropriateness of the proposed
legal base. We would also be glad to know when you expect to be
in a position to submit a revised Regulatory Impact Assessment
and what timescale is envisaged for the Working Group discussions.
10 February 2006
Letter from Rt Hon Jane Kennedy MP to
I am writing further to your letter of 10 February
2006 following your committee's consideration of the explanatory
memorandum and initial regulatory impact assessment submitted
by the Department of Health on 14 December 2005.
Negotiations on the European Commission's proposals
for a Regulation on advanced therapies/tissue engineering are
at an early stage, having commenced in the Council of Ministers
working party in January 2006 under the Austrian Presidency. The
Presidency has indicated that the dossier will be given priority
in the first half of 2006 and there will be regular negotiating
sessions throughout this period. Since the Commission published
its proposals for advanced therapies/ tissue engineering in November
2005, proposals have also been published for an amending Directive
following the review of the Medical Devices Directives. There
is a linkage between both sets of legislative proposals and my
officials are considering them in the round.
To inform the development of the UK position,
the Department of Health/Medicines and Healthcare products Regulatory
Agency has had extensive dialogue with a range of stakeholders
including hospitals, academic researchers, medical charities,
industry and consumer groups. The position I outline below very
much reflects the concerns that have been raised with us by interested
parties. Overall, discussions with a range of stakeholders confirm
that there is broad support for legislation on tissue engineering
but that further clarification of, and/or adjustment to, the proposals
is desirable in a number of areas, especially relating to issues
of definition and scope of the proposals. There is also a strong
concern to ensure that regulation is proportionate; products should
not be subject to a more onerous regime than is justified. Further
meetings with stakeholders are planned to take place on a regular
basis during the negotiations to work through the complex issues
arising from the proposals.
Our overall objective in the negotiations is
to achieve a coherent regulatory framework in the interests of
public health and in order to provide the regulatory clarity industry
requires to attract investment in this innovative area of bioscience.
I can assure the committee that the Government
will be mindful of the ethical aspects of the proposals. We wish
to protect the UK position in relation to the use of embryonic
stem cells in accordance with existing safeguards. The Commission's
proposals envisage that there would be national flexibility over
whether to prohibit the use of particular kinds of cells. Given
the divergence of views within Europe this seems a realistic way
forward and mirrors the outcome reached on the recent Tissues
and Cells Directive.
Our assessment of the two sets of current legislative
proposals is that, while they have a number of benefits, in aggregate
they do not fully address an existing problem, that some products
containing human or animal tissue/cells and used for medical purposes
fall into gaps between the medicines and medical devices regulatory
regimes. We believe that some of these products would continue
to be inadequately regulated under the current proposals. In negotiations
we have raised the issue of "gap" products and are seeking
a resolution that ensures products can be regulated in a way that
is coherent, proportionate and reflects the characteristics of
the product. More generally, we will seek to ensure that the specific
provisions of the Regulation and, if it is agreed, the follow
up technical requirements and guidelines are proportionate and
The other key issue relates to the proposed
exemption for hospitals under the Regulation. The proposal would
exempt products from the requirements set out in the Regulation
where the product is both prepared in full and used in a hospital
in accordance with a medical prescription for an individual patient.
Our discussions with stakeholders and in the early negotiations
in the Council have indicated that the proposed exemption raises
complex issues. On the one hand, it is desirable to ensure a consistent
level of public health protection irrespective of where a product
is made and used. On the other hand, there is a need for sufficient
flexibility to ensure that hospitals can carry out their normal
activities, with clinicians taking professional responsibility
for treatments and therapies they deem to be in the interests
of patients. Our position is that it may be better to link the
proposed exemption to the characteristics of the activity rather
than to specific institutional arrangements. My officials are
exploring possible solutions in discussions at national level
and are promoting our position in negotiations in Europe.
My officials are working with stakeholders to
assess the possible costs that might be associated with the proposed
Regulation. We would hope to be in a position to update the initial
regulatory impact assessment once this information has been provided
and hopefully by the summer. However, given that in large measure
tissue engineering is very much at an early developmental stage,
we envisage that it is likely to remain problematic for industry
to produce reliable cost estimates.
The committee will be aware of the Government's
previous position on Article 95. However, in light of the judgement
of the European Court of Justice (ECJ) given on 6 December 2005
in ECJ C-66/04 UK-V-European Parliament and Council of the Union
"Smoke Flavourings", the Government's preliminary view
is that we are now unlikely to have any convincing arguments on
legal base and may therefore have to accept that article 95 is
appropriate in this case. We will confirm our position on legal
base in due course.
I would be pleased to keep the committee informed
of significant developments in negotiations.
25 March 2006
Letter from the Chairman to Rt Hon Jane
Thank you for your letter dated 25 March which
was considered by Sub-Committee G on 4 May together with your
letter dated 21 April about the related Medical Devices Directive
review (reference. 5072/06). We note that negotiations on both
Proposals are being kept in step.
We are glad to know that your negotiations are
being informed by close and continuing consultation with the relevant
stakeholders which have highlighted several important potential
problems, including those of "gap" products and exemption
for hospitals which remain to be resolved.
Thank you for your assurance that the Government
will be mindful of the ethical implications of these Proposals,
to which you already know that we attach the highest importance.
We support your overall objective to secure a coherent regulatory
framework that will protect public health and give industry the
regulatory clarity needed to attract investment. We also share
your wish to ensure that regulation is proportionate and risk-based
and hope that it will be cast in terms that are likely to work
well in practice.
While we also note what you say about the difficulty
of producing reliable cost estimates, we continue to hope the
Government will make every effort to carry out as thorough a revision
of the Regulatory Impact Assessment as possible.
You should be well aware from previous correspondence
of our views on the legal base question. We note what you say
about the potential impact of the ECJ "Smoke Flavourings"
ruling and look forward to learning your definitive view when
you have completed your consideration of the position.
We are also grateful for your promise to keep
us informed of significant developments in negotiations and would
be glad to know when a Council decision might be expected. We
will continue to hold the Proposal under scrutiny in the meantime.
5 May 2006
Letter from Andy Burnham MP, Minister
of State, Department of Health to the Chairman
I am writing in response to your letter of 5
May 2006 following your committee's consideration of Jane Kennedy's
letter of 25 March 2006.
Negotiations on the European Commission's proposals
for a Regulation on advanced therapies/tissue engineering have
progressed under the Austrian Presidency. First reading was completed
under the current Presidency. We do not anticipate early agreement
on the proposed Regulation in the Council working group. The two
key issues that have dominated negotiations so far relate to the
proposed exemption for hospitals and the scope of the proposals.
The committee will be aware that the proposed
exemption for hospitals has raised a range of complex issues.
On the one hand, it is desirable to ensure a consistent level
of public health protection irrespective of where a product is
made and used. On the other hand, there is a strong case for ensuring
there is the necessary flexibility to ensure that current tissue
engineering activities that are carried out in hospitals can continue.
There is also recognition that an exemption expressed in ill defined
terms could offer a loophole for those wishing to avoid regulation.
Given the complexities of the proposed exemption, our position
is that it might be preferable to link the exemption to the characteristics
of the activity rather than to specific institutional arrangements.
No real consensus has emerged among Member States on this issue
The committee will be aware of our concerns
that under the proposals some products containing human or animal
tissues/cells and used for medical purposes would fall into gaps
between the medicines and medical devices regulatory regimes.
We have raised this issue in negotiations and there is acknowledgement
that some products would indeed fall into a regulatory gap. We
will continue to seek a resolution that ensures products can be
regulated in a way that is coherent and reflects the characteristics
of the products. As you know, we are pursing a single approach
on this issue across the two separate negotiations on this Regulation
and on the revision of the Medical Device Directives, on which
I am writing separately to you.
In negotiations there was a proposalwhich
has attracted significant supportthat all products containing
viable human or animal cells and tissues should be regulated as
medicines, and all products containing non viable cells and tissues
should fall under the devices regulatory framework. We are concerned
that this approach would cut across existing arrangements for
deciding the regulatory category of products (included combination
medicine/medical device products) and we have argued that a product
should be regulated on the basis of its mode of action and intended
purpose. We expect to receive confirmation of the priorities for
the Finnish Presidency in the very near future and I would be
pleased to keep the committee informed of significant developments
I can assure you that my officials will continue
to work with stakeholders to assess the possible costs that might
be associated with the proposed Regulation. I believe it is important
to emphasise that much of this type of activity is at an early
developmental stage and we know from our ongoing discussions with
stakeholders that it is likely to remain problematic to produce
reliable cost estimates. We would hope that once the final shape
of the proposed regulatory framework begins to emerge it may prove
more realistic to develop cost estimates. We are, however, committed
to updating the regulatory impact assessment to reflect developments
in negotiations in Europe and to include any estimates provided
by stakeholders, including from industry.
In relation to legal base, the European Court
of Justice (ECJ) has recently given its judgment in the ENISA
case. The UK lost its arguments on legal base in this case. Therefore,
as previously stated the Government's preliminary view is that
we are now unlikely to have any convincing arguments on legal
base. We will confirm our view on the proposed legal base for
the Regulation in due course.
13 June 2006
Letter from the Chairman to Andy Burnham
Thank you for your letter dated 13 June which
was considered by Sub-Committee G on 29 June.
We note that negotiations have been continuing
under the Austrian Presidency and that no real consensus has emerged
so far over the proposed exemptions of hospitals, although there
has apparently been some acknowledgement of the problem of the
regulatory gap between the regulatory regimes for some products
containing human or animal tissues or cells.
We are glad the Government is continuing to
adopt a single approach to the related issues of this Regulation
and the Medical Devices Directive (reference 5072/06), about which
I am also replying to your separate letter of the same date.
We also note your concerns over the proposal
that all products containing viable human or animal cells and
tissues should be regulated as medicines while those containing
non-viable cells and tissues should fall under the devices regulatory
framework. We have some sympathy with your argument that products
should be regulated on the basis of mode of action and intended
We are glad to see that your officials are continuing
to work with stakeholders to try to assess the possible costs,
though we accept the difficulty of making realistic cost estimates
when many of the activities involved are at an early development
stage and when the final shape of the proposed Regulatory Framework
We also note that the recent ECJ judgment in
the ENISA case seems to support the Government's preliminary view,
as reported in Jane Kennedy's letter to me dated 25 March, that
the Government is now unlikely to have any convincing arguments
on the legal base. But we look forward to receiving your definitive
view on that as soon as it is reached.
Finally, we note that the Government expect
confirmation of the Finnish Presidency's priorities in the very
near future and welcome your assurance that we will be kept informed
of significant developments in your negotiations.
We will continue to hold this item under scrutiny
pending your further reports.
3 July 2006