MEDICAL DEVICE DIRECTIVES (5072/06)
Letter from Andy Burnham MP, Minister
of State, Department of Health to the Chairman
I am writing further to my letter of 13 June
and your reply of 3 July 2006[149].
As requested by you I attach a revised RIA (not printed) on the
basis of the current state of negotiation in the Council of Ministers
Working Group at this point in time.
As your committee will be aware, negotiations
in Council have been ongoing for nearly a year during the Austrian
and Finnish Presidencies. Therefore I thought it would be useful
to update you on the current position.
The biggest issue of contention has been the
overlap with the proposals, also currently under negotiation,
for a European Regulation on Advanced Therapy Medicinal Products
(on which I am writing to you separately). The particular issue
is the extent to which the devices regime should be opened to
products that, while acting in a physical way on the body, contain
human tissues and cells. There is emerging agreement that where
the tissues and cells are non viable the devices regime
should be opened up to accommodate such products. This would be
a welcome development as it would introduce proportionate regulation
for certain products that currently fall into a regulatory gap
between the medicines and devices regime. However, there is disagreement
over the regulatory position of products that would meet the definition
of a device but for the fact that they also contain viable
human or animal tissues and cells. An example would be an
artifical joint with a coating of cells to help it be incorporated
into the body. The Commission, the Presidency and a large body
of Member States maintain that such a product should be regulated
as an advanced therapy medicinal product. The UK is continuing
to argue that the determining factors as to which regulatory regime
applies should be the stated intended purpose of the product and
the principal mode of action. We therefore argue that the possibility
of using the devices regime, with suitable strengthening, should
be opened up for viable as well as non-viable tissues and cells.
We have a number of allies, and possibly sufficient support for
a blocking minority, but this depends on the final position taken
by other MS who have expressed some sympathy with our position.
At present the Presidency has removed all references
to human tissue engineered products from the proposed text of
the Medical Devices Directive on the basis of the Commission coming
forward with a new proposal. It was made clear at the last Council
Meeting by the Commission that any such proposal would only cover
medical devices containing non-viable human cells and tissues
which are ancillary to the device. We disagree with this approach
and we are currently in discussion with other Member States who
take the same view as ourselves on how to take this forward in
Council. In any event it is unlikely that any further detailed
discussion will take place before the incoming German Presidency.
The Finnish Presidency has concentrated a lot
of its efforts on aiming to secure first reading agreement with
the European Parliament (EP). This has been at the expense of
detailed discussion of a number of Member States' positions on
the text itself which has caused some ill feeling in the Council.
A particular issue raised by the European Parliament is that of
reprocessing of not only single use devices should come within
the provisions of the Medical Devices Directive. The UK's view,
supported by virtually all Member States is that the Medical Devices
Directive regulates the first placing on the market and putting
into service of medical devices and the manufacturer must demonstrate
that all the essential requirements covering safety and quality
are met. The Directives do not generally regulate the subsequent
use to which these devices are put. Reprocessing of single use
devices is normally carried out in a hospital setting. Our view
is therefore that such activites are a matter for national law.
The Commission also agrees that the current
revision of the Directives is not a suitable way to introduce
any measures on reprocessing. They are, however, likely to make
a formal commitment to consider all the issues involved with a
view to bringing forward a separate proposal in due course. We
will need to wait and see whether this Commission initiative will
be sufficient for the European Parliament to remove their proposed
additions to the text.
At the Health Council on 30 November the Finnish
Presidency gave a short update on progress during its opening
remarks and I will continue to keep you up to date with developments
with the European Parliament and negotiations during the German
Presidency.
19 December 2006
Letter from the Chairman to Andy Burnham
MP
Thank you for your letter of 19 December 2006
and the accompanying revised Regulatory Impact Assessment (RIA).
This was considered by Sub-Committee G on 18 January.
We take note of the arguments the UK Government
is putting forward to the Commission with a view to improving
the proposed amended Directive. We also note that these negotiations
could continue for some further lengthy period of time.
Our view is that the issues still under discussion—in
particular which of the Medical Devices Directive or the Advanced
Therapy Medicinal Products Regulation should be applied to devices
containing viable human tissues and cells—are technical
in nature, and we are content to accept the arguments being advanced
by the Government.
We are therefore content to clear this item
from scrutiny.
19 January 2007
149 Correspondence with Ministers, 40th Report of Session
2006-07, HL Paper 187, pp 530-531. Back
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