5 Development and regulation of advanced
therapy medical products
| (27059)
15023/05
COM(05) 567
+ ADD 1
| Draft Regulation on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No. 726/2004
Commission staff working document — impact assessment
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| Legal base | Article 95 EC; co-decision; QMV
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| Department | Health |
| Basis of consideration | Minister's letter of 25 March 2006
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| Previous Committee Report | HC 34-xiv (2005-06), para 6 (11 January 2006) and HC 34-xxx (2005-06), para 3 (24 May 2006)
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| To be discussed in Council | No date set
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| Committee's assessment | Legally and politically important
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| Committee's decision | Not cleared; further information awaited
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Background
5.1 In 2001, the Council adopted a Directive on medicinal products
for human use.[15] It
contains rules for Member States to follow on the authorisation,
manufacture, importation, labelling and distribution of medicinal
products. An amending Directive was adopted in 2003.[16]
It includes provision on two advanced therapy medicinal products
— gene therapy medicinal products and somatic cell medicinal
products.
5.2 In 2004, the Council adopted the Cells and Tissues
Directive.[17] It sets
standards of quality and safety for the donation, procurement,
testing, processing, preservation, storage and distribution of
human tissues and cells. The Council also adopted a Regulation
laying down Community procedures for the authorisation, supervision
and pharmacovigilance of medicinal products for human use and
establishing the European Medicines Agency.[18]
5.3 Another new biotechnology has emerged: tissue
engineering. It combines aspects of medicine, cell and molecular
biology, materials science and engineering. The aim of tissue
engineering is to develop products to regenerate, repair or replace
human tissues, such as skin, bone and cartilage.
Previous scrutiny of the draft Regulation
5.4 Gene therapy medicinal products and somatic cell
medicinal products are already regulated under EC law. But tissue
engineered products are not. The purpose of the draft Regulation
is to make rules for the authorisation, supervision and pharmacovigilance
of all three types of product, collectively defined as "advanced
therapy medicinal products".[19]
5.5 When we considered the draft Regulation in January,
the then Minister of State for Quality and Patient Safety at the
Department of Health (Jane Kennedy) told us that the Government
was still considering whether Article 95 of the EC Treaty was
an appropriate legal base for the proposal. Moreover, the document
was being considered by the Medicines and Healthcare Products
Regulatory Agency and the Department of Trade and Industry to
see if it met the Government's objectives. The Government was
seeking the views of the bio-technology and healthcare industries.
5.6 We asked the Minister to tell us:
- the Government's view of the
appropriateness of Article 95 of the EC Treaty as the legal base
for the Regulation;
- the outcome of the Government's consultations
with the biotechnology and health industries;
- the Government's views on the proposal in the
light of its own and the Medicines and Healthcare Products Regulatory
Agency's detailed examination of the draft Regulation; and
- to provide us with progress reports on the negotiations
in the Council.
5.7 Moreover, we asked the Health Committee for its
opinion on the draft Regulation.[20]
5.8 On 25 March, the Minister replied. We have not
been able to find out why the letter did not reach us until 26
May.
The Minister's letter of 25 March 2006
5.9 The Minister's letter referred to draft legislation
the Commission proposed in December 2005 to amend three existing
Directives on Medical Devices.[21]
The Department of Health was considering the links between those
proposals and new proposed Regulation on advanced therapy medicinal
products.
5.10 The letter also said that the Department and
the Medicines and Healthcare Products Regulatory Agency had had
extensive discussions about the draft Regulation with hospitals,
academics, medical charities, industry and consumer groups. Overall,
those discussions indicated broad support for it subject to clarification
and amendment of some of the definitions. Stakeholders also wished
to ensure that regulation is proportionate. There will be further
meetings with them during the negotiations.
5.11 The Minister added that the Government's assessment
of the 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 and animal tissues/cells and used
for medicinal 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 risk based.
"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."
5.12 In response to our question about the Government's
opinion on the use of Article 95 of the EC Treaty as the legal
base for the draft Regulation, the Minister referred us to the
judgment of the European Court of Justice in the Smoke Flavourings
case.[22] In the light
of that judgment, the Government's preliminary view was that it
might have to accept that Article 95 would be appropriate; in
due course, the Government would inform us of its considered opinion.
Conclusion
5.13 We should be grateful for further reports
from the Government on the progress of the Council's negotiations
and, in particular, on the discussions about the links and gaps
between the proposed Directive on medical devices and the draft
Regulation on advanced therapy medicinal projects. We also await
confirmation of, and an explanation of the reasons for, the Government's
opinion on whether Article 95 would provide an appropriate legal
base for the Regulation. Pending receipt of this further information,
we shall keep the document under scrutiny.
15 Directive 2001/83/EC: OJ No. L311, 28.11.2001, p.67. Back
16
Directive 2003/63/EC: OJ No. L159, 27.6.2003, p.46. Back
17
Directive 2004/23/EC: OJ No. L102, 7.4.2004, p.48. Back
18
Regulation (EC) No. 726/2004: OJ No. L136, 30.4.2004, p.1. "Pharmacovigilance"
is the monitoring of the quality, safety and efficacy of marketed
medicines. Back
19
The Regulation would apply to products to be placed on the market
and either prepared industrially or manufactured by a method involving
an industrial process. But the Regulation would not apply to products
wholly prepared and used in a hospital in accordance with a prescription
for an individual patient. Back
20
We reported on the Health Committee's opinion in HC 34-xxx (2005-06),
para 3 (24 May 2006). Back
21
(27152) 5072/06: we cleared the document, without a substantive
report to the House, on 1 February 2006. The three existing Directives
on Medical Devices are Council Directives 90/385/EEC, 93/42/EEC
and 98/8/EC. Back
22
Case C-66/04, United Kingdom v. European Parliament and Council,
judgment of 6 December 2005. Back
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