MEDICAL DEVICE DIRECTIVES (5072/06)
Letter from the Chairman to Rt Hon Jane
Kennedy MP, Minister of State, Department of Health
Thank you for your Explanatory Memorandum (EM)
and Initial Regulatory Impact Assessment (RIA) dated 20 January
which were considered by Sub-Committee G on 2 March.
We note that the negotiations are at a very
early stage and are surprised to see from your Initial RIA that
these negotiations could last more than two years. We wonder why
such a protracted timescale is envisaged.
Although we see that the UK has strongly supported
this initiative from the outset and is satisfied that the Proposal
reflects the UK position, we agree that every effort should be
made to ensure that the requirements are necessary and proportionate
and that the wording of the text achieves what is intended.
As you know, we already hold the Commission's
Proposal for a Regulation on Advanced Therapy Medicinal Products
(15023/05) under scrutiny. I wrote to you about this on 2 February.
We will want to pay particular attention to the possibility of
overlaps or regulatory gaps between this Proposal and that one,
as indicated in your EM and the Commission documentation.
We are also particularly concerned about any
ethical implications of this Proposal, which your EM does not
mention. The Commission Impact Assessment briefly mentions the
need for careful examination over the principle of "informed
consent" as it applies to reprocessed devices, as well as
some liability considerations over such devices. We would be glad
if you would explain the ethical and legal considerations involved
in this and how the Government propose to tackle them during the
negotiations. More generally, we would welcome a statement on
the Government's overall view of the ethical considerations which
apply to this Proposal and how they should be addressed.
The Commission's EM refers to concerns highlighted
during the 2003 review over the competence, consistency of performance
and transparency of the Notified Bodies. We would be glad to know
more about who these bodies are, how they work and to what extent
you believe that the Proposal offers a workable solution to these
We would also welcome your comments on the extent
to which the Proposal adequately covers the respective responsibilities
of the EMEA and national authorities and how good coordination
between the two will be achieved.
Your EM also contains an unexplained reference
to considering "how to police the requirement of having to
provide the named patient with the statement of conformity"
We would be grateful for an explanation of the meaning and significance
of this sentence.
We would also be glad if you could explain how
the text is intended to keep pace with scientific and technological
We note that you intend your Initial RIA to
become an "ever-evolving document" which will need to
be adjusted in the light of negotiations. It would be helpful
to know how you intend to present that "ever-evolving document"
for Parliamentary scrutiny. We will want to examine the likely
impact, especially on small organisations, very carefully and
would expect to see some preliminary conclusions in a revised
RIA based on the indicative costings which you expect to emerge
from the next phase of your consultations.
In the meantime, we will retain this document
under scrutiny and would be grateful if you would report significant
2 March 2006
Letter from Rt Hon Jane Kennedy MP to
Thank you for your letter of 2 March 2006 raising
various points on the Explanatory Memorandum (EM) and Regulatory
Impact Assessment (RIA) dated 20 January. I shall deal with each
of your points in turn.
You question the prediction, in the EM, that
negotiations on the European Commission's proposal to revise the
Medical Devices Directives could take two years. As you will appreciate,
at this early stage in the process any prediction as to how long
completion will take is inevitably imprecise. However, the prediction
was based on a number of factors. Firstly, experience of two earlier
attempts to extend the scope of the Medical Device Directive to
include animal and human tissue. Both attempts failed but only
after lengthy and protracted negotiations. The estimate reflects
our experience of how long it can take to negotiate broadly comparable
pieces of legislation bearing in mind the co decision process.
Second, the issue of products containing tissues and cells affects
the negotiation of both the Medical Devices Directive and the
Advanced Therapy Medicinal Products (ATMP) Directive. It seems
realistic to predict that it may take time to achieve a consistent
view across both sets of negotiations. Thirdly, the impact the
new Accession Member States would have was unclear. In particular
there were some early indications that some would take the opportunity
to argue for more far reaching and fundamental revision of the
Directive than those measure being proposed by the Commission.
Finally, we are aware that the European Parliament may not have
completed its scrutiny until towards the end of the year.
In fact, the Austrian Presidency has given the
dossier high priority. There have already been five meetings of
the Working Group and first reading has been completed. The Presidency
plans to reach some sort of political agreement at the June Health
If this is successful, the speed towards completion
will then depend upon handling by the Finnish Presidency, progress
of the discussions on the ATMP Regulation and any amendments proposed
by the parliament.
In your letter you expressed particular concern
about the ethical implications of this proposal which I take to
relate to tissue engineering. I am sorry that the EM did not cover
this. The Commission's current proposal covers medical devices
which contain human tissue engineered products, as defined in
the ATMP Regulation, and which act ancillary to the device. The
ethical considerations applying to the proposed ATMP Regulations
equally apply here.
Article 28(2) of the proposed Regulation on
ATMPs amends the Medicines Directive 2001/83/EC in order that
under national legislation Member States may prohibit or restrict
the use of any specific type of human or animal cells (eg germ
cells or embryonic stem cells) or the sale supply or use of medicinal
products consisting of or derived from these cells. This is consistent
with the similar provision in Article 4(3) of the Tissues and
Cells Directive 2004/23/EC setting standards of quality and safety
for the donation, procurement, testing, processing, preservation,
storage and distribution of human tissues and cells.
The proposed Regulation on ATMPs requires that
the donation, procurement and testing of human cells or tissues
used in these products are carried out in accordance with the
Directive 2004/23/EC. Chapter III of Directive 2004/23/EC concerns
donor selection and evaluation and includes: principles governing
tissue and cell donation, consent, data protection and confidentiality
and selection, evaluation and procurement. Article 13 on consent
requires that procurement of human tissues or cells shall be authorised
only after mandatory consent or authorisation requirements in
the Member State concerned have been met. It continues that Member
States shall, in keeping with their national legislation, take
all measures to ensure that donors, their relatives or any persons
granting authorisation on behalf of donors are supplied with all
appropriate information. The information requirements for living
and deceased donors are then detailed in the Annex to the Directive.
On the specific point of informed consent as
it applies to reprocessed devices contained in the Commission's
Impact Assessment, you will wish to note that this related to
an earlier suggestion that the scope of the Medical Devices Directive
be extended to include the reprocessing of single use devices.
For a number of reasons however, including ethical and liability
considerations and after discussions with stakeholders, the Commission
has now decided not to propose such a change. However, we are
aware that the European Parliament is being lobbied on this matter
and it may well be that they will want to suggest such a revision
themselves, so we have included our comments about your point
on informed consent anyway.
The Medicines and Healthcare products Regulatory
Agency advises users always to follow the manufacturer's instructions
including those for reprocessing.
However, if the device in question has been
CE marked for re-use, then the reprocessing would not be considered
to be a safety issue or present any increased risk to the patient.
Under these circumstances, although the details of the procedure
and the use and principles of working of the main devices used
in that procedure would fall within the information to be given
as part of informed consent, the fact that the device has been
reprocessed in line with the manufacturer's instructions would
not fall within the information to be supplied to the patient
as part of informed consent. However, if a device CE marked for
single use had been reprocessed, then there is the potential,
under these circumstances, for an increased risk to the patient.
In this case, the fact of reprocessing and the associated potential
risks would fall within the principles of informed consent and
should be discussed with the patient. In considering what information
to provide, case law and DH guidance advises that a patient should
be informed of any material or significant risks that might affect
the judgement of a reasonable patient. More recently, the House
of Lords has ruled that breach of the duty to inform patients
of the significant risks will deny the patient the chance to make
a fully informed decision. This means that the doctor may be found
at fault even if the failure to explain the risks fully did not
cause the damage suffered by the patient.
You also asked about Notified Bodies. These
are independent certification bodies used by manufacturers, of
all but the lowest risk medical devices, to check that the essential
requirements contained in the Directive are met before the device
can be affixed with a CE-marking and placed onto the European
market. The Notified Bodies are designated by their national Competent
Authority (in the UK this is the MHRA) who also regularly monitor
their actual performance to ensure that they are performing their
tasks to an acceptable standard.
The 2003 review, to which you refer, identified
a number of problems affecting Notified Bodies. In particular
it noted an uneven and inconsistent level of performance but concluded
that the authorities responsible for their designation and monitoring
were best placed to address these matters. Accordingly, Member
States and the Commission set up the Notified Body Operations
Group (NBOG) under the Chairmanship of the UK. The group had a
remit to improve the overall performance of Notified Bodies by
identifying and promulgating examples of best practice between
Notified Bodies and those organisations responsible for their
designation and control. Such has been NBOG's success that the
Commission has not proposed any change to the current text relating
to Notified Body activities and no changes have been suggested
during first reading by Member States.
You also ask about the respective responsibilities
of the European Medicines Agency (EMEA) and national authorities
and co-ordination between the two. The current text of the Medical
Device Directive requires the EMEA and national medicine regulatory
authorities to assess the safety and quality and usefulness of
medicinal substances and stable blood derivatives incorporated
within a device and which acts ancillary to the device. The Commission's
proposals would extend the competence of the EMEA even further
by requiring it to assess the safety and quality of a tissue engineered
product added to a device with an ancillary action. These views
are given by the EMEA and the national medicines agencies to the
Notified Body who has to take such opinions into account when
deciding whether or not to issue an EC Certificate of Conformity
to the medical device manufacturer. Co-ordination therefore occurs
primarily between the EMEA and national medicines regulatory agencies
and the notified bodies and is already a feature of the existing
regulatory systems. We are not aware of any particular problems
in practice in the level and effectiveness of this co-ordination.
The reference to "how to police the requirement
of having to provide the named patient with the statement of conformity"
relates to the Commission's proposal to require a statement containing
information about the device to be given to each patient receiving
a custom made device. In practice the proposal would place a legal
obligation on, for example, a dentist to provide the statement.
Failure to do so would be a criminal offence. We believe that
in practice such an obligation would be difficult, if not impossible,
to effectively enforce. You will wish to note, however that in
negotiations our concerns were shared by several other Member
States and has resulted in the proposal being provisionally amended
to say that statement should only be given to the patient on request.
As far as keeping pace with scientific and technological
changes, the Medical Devices Directive already requires manufacturers
to make their device in accordance with state of the art and contain
a provision to enable the Directives to be amended if scientific
or technological changes warrant such amendments. Finally, and
in accordance with Cabinet office guidance, our RIA is an "ever-evolving
document" in that it will constantly be updated as negotiations
progress. We are working with stakeholders to assess the possible
costs that might be associated with the proposed revision proposal.
The RIA has been posted on the MHRA website along with the Commission's
proposals and we have requested comments.
We will keep the Committee informed as negotiations
develop and provide you with a revised RIA on the basis of the
current consultation exercise.
21 April 2006
Letter from the Chairman to Rt Hon Jane
Thank you for your letter dated 21 April which
was considered by Sub-Committee G on 4 May at the same time as
your letter dated 25 March about the related Advanced Therapy
Medicinal Products (ATMP) Directive (reference 15023/05).
We are grateful to you for giving such a thorough
explanation in response to the queries raised in my letter dated
2 March. Your promise to keep us informed as negotiations develop,
and to submit a revised RIA based on your current consultation
exercise, is most welcome.
We note that, on the one hand, you say that
experience shows that negotiations on the Directives could last
up to two years and are complicated by issues arising from the
parallel negotiation of the ATMP Directive and by uncertainty
over the position of new Member States. Yet, on the other hand,
you say that the Austrian Presidency plans to reach "some
sort of political agreement" at the June Health Council.
We find this surprising and potentially worrying.
It is clear from your letter that a great deal of clarification
of the proposals is still needed and the sensitivity of such issues
as tissue-engineering arising from the ATMP Directive is bound
to be an additional complication. We would be most reluctant to
contemplate granting scrutiny clearance to enable "political
agreement" as soon as June if serious issues, especially
related to ethical considerations, had not been fully and satisfactorily
resolved by then.
We would be grateful for your thoughts on this
apparent dilemma and will continue to hold the document under
scrutiny for the time being.
5 May 2006
Letter from Andy Burnham MP, Minister
of State for Delivery and Reform, Department of Health to the
Thank you for your letter of 5 May to Jane Kennedy
responding to her letter of 21st April.
In your letter you express concerns at the Austrian
Presidency's intentions to try and achieve "some sort of
political agreement" at the Health Council during their Presidency.
Your concern was that there were sensitive issues still to be
resolved before any sort of agreement could be reached. The Health
Council took place on 1-2 June, and in the event the Presidency
simply presented a Progress Report, on which there was no discussion,
which highlighted all the issues still to be resolved including
the tissue engineering elements referenced in your letter. The
latest position on those discussions is covered in a separate
letter from me in answer to your letter on the Advanced Therapy
Medicinal Products Regulation.
I will continue to keep you up to date as negotiations
progress and will provide you with a revised RIA as promised.
13 June 2006
Letter from the Chairman to Andy Burnham
Thank you for your letter dated 13 June. This
was considered by Sub-Committee G on 29 June together with your
separate letter of the same date on the related question of the
Advanced Therapy Medicinal Products (ATMP) Regulation (reference
15023/05) to which I am replying separately.
We are glad to see that the Austrian Presidency
did not, after all, attempt to achieve "some sort of political
agreement" at the June Health Council. Our view remains that
much more careful and detailed consideration is needed, especially
over the sensitive issues such as tissue engineering and the potential
linkage with the ATMP Directive.
We will continue to hold this document under
scrutiny and look forward to your further progress reports as
negotiations proceed under the Finnish Presidency. We also look
forward to seeing your revised RIA as promised.
3 July 2006