7 Medicinal products for paediatric use
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13880/04
COM(04) 599
+ ADD 1
| Draft Regulation on medicinal products for paediatric use and amending Regulation (EEC) No. 1768/92, Directive 2001/83/EC and Regulation (EC) No. 726/2004
Commission staff working paper
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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 11 July 2005
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| Previous Committee Report | HC 42-xxxvii (2003-04), para 6 (17 November 2004)
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| Discussed in Council | 3 June 2005
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| Committee's assessment | Legally and politically important
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| Committee's decision | Not cleared; further information requested
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Background
7.1 The main aim of this draft Regulation is to improve the health
of the children of Europe by increasing the research and development
and authorisation of medicines for paediatric use. Under existing
Community legislation, companies must obtain authorisation to
market and manufacture medicines. In order to get authorisation
they have to conduct clinical trials, publish the results and
give guidance on the use of the product (for example, recommended
dosage). It is up to the company, however, to decide what authorisation
to seek. They may, therefore, apply only for authorisation to
market a product for use by adults. It is more expensive to test
products for paediatric use because children's response to a
product can differ radically from birth to the age of 18 and so
more trials are required. It is open to doctors to prescribe a
medicine to children which has been authorised for adults but
not children. At present, more than 50% of the medicines used
to treat children have not been tested and authorised for paediatric
use.
7.2 Article 14 of the Treaty establishing the European
Community (the EC Treaty) requires the Community to adopt measures
with the aim of establishing the internal market. Article 95 of
the Treaty requires the Council to adopt measures for the approximation
of the laws in Member States which have as their objective the
establishment and functioning of the internal market.
7.3 Article 152 of the EC Treaty provides that a
high level of human health protection is to be ensured in the
definition and implementation of all Community policies and activities.
Community action is to complement national policies and is to
be directed at improving public health, preventing human illness
and diseases, and removing sources of danger to human health.
The Council is required to contribute to the achievement of the
objectives of the Article by adopting incentive measures to protect
and improve public health, excluding any harmonisation of the
laws of Member States.
7.4 Article 308 of the Treaty authorises the Council
to adopt proposals which are necessary for the attainment, in
the course of the operation of the common market, of one of the
Community's objectives but for which the Treaty has not provided
the necessary powers.
Previous scrutiny of the document
7.5 The previous Committee considered the draft Regulation
last November.[19] Our
predecessors' report to the House summarised the key provisions
and expressed the initial view that the proposal to require, and
provide incentives for, research, development and authorisation
of medicines for children was welcome. The Committee noted that
the Health Committee was conducting an inquiry into the pharmaceutical
industry. It appeared to our predecessors that the inquiry might
cover matters germane to the scrutiny of the draft Regulation
and they therefore asked the Health Committee for its opinion
on the document. They also asked the Minister to comment on a
number of questions. Pending receipt of the further information
for which they had asked, they kept the document under scrutiny.
7.6 In April, the Health Committee explained to us
that its inquiry had not addressed the question of medicines for
paediatric use in anything like the detail necessary for it to
be able to offer an adequate opinion on the draft Regulation.
The Minister's letter of 11 July 2005
7.7 In her letter of 11 July the Minister of State
at the Department of Health (Jane Kennedy) responds to the questions
posed by the previous Committee. The questions (in italics) and
the Minister's responses to them are given below.
What are the reasons for the Government's doubts
about the use of Article 95 of the EC Treaty as the legal base
for the Regulation?
7.8 The Minister tells us that, in the Government's
view, Article 95 is not an appropriate legal base for measures
which establish a centralised EC procedure or body. Article 95
is concerned with the harmonisation of national law. Setting up
EC procedures or bodies does not in itself amount to the harmonisation
of national law: it is not something which a national law can
do. The Commission's view, on the other hand, is that Article
95 is the appropriate legal base for achieving the aims of Article
14 of the EC Treaty, which includes the free movement of medicinal
products.
7.9 The Minister adds that the issue is not new.
The Government has challenged the use of Article 95 for two previous
(unrelated) Regulations. Those cases are still before the European
Court of Justice and until they are decided the Government will
continue to register its concern about the inappropriate use of
Article 95.
In November 2004 the then Minister told the previous
Committee that, while the Government welcomed the proposed Regulation,
it was considering whether the measure would satisfy two criteria:
first, that it struck the right balance of costs and benefits
for the National Health Service; and, second, that the provisions
were practical and would not create problems for the existing
arrangements in the UK. The previous Committee asked to know the
outcome of the Government's consideration of whether the proposal
met the criteria.
7.10 The Minister tells us that, in the Government's
assessment of the costs and benefits, even on the most pessimistic
assumptions, the health benefits of the proposal would outweigh
the resource costs. The Government's central estimate of the public
expenditure consequences of the proposal is that it would cost
the National Health Service about £75 million a year, within
a possible range of £30 million to £120 million. To
the extent that it can place a value on child health, the Government
estimates that the health benefit of a 25% reduction in the adverse
events which result from off-label prescribing would be about
£120 million.
7.11 The Minister also says that:
"few elements of the proposed Regulation
have the potential to impact on existing arrangements in the UK.
For those that do care has been taken to ensure that problems
will not occur. For example, the proposal includes a provision
which would establish a European paediatric clinical trials network.
In discussions we have made the case to ensure [the] autonomy
of the UK National Paediatric Clinical Trials Network. The proposed
provision will, however, facilitate communication and collaboration
between existing networks across Europe and would act as a useful
information point for pharmaceutical companies looking to conduct
multinational clinical trials."
The Government told the previous Committee that
it would be holding consultations on the draft Regulation. Our
predecessors asked to be told about the responses to the consultations.
7.12 The Minister says that the Government has already
had discussions about the proposal with the Royal Medical Colleges,
medical charities and the pharmaceutical industry. It has recently
issued a public consultation paper and invited responses to it
by 17 August.
The previous Committee asked for progress reports
on the Council's negotiations.
7.13 The Minister tells us that the draft Regulation
was discussed by the Health Council on 3 June and that the European
Parliament will be considering it in September. She says that:
"The proposed provision…to grant an
extension of six months to the supplementary protection certificate
(SPC) for investigating the use of a medicine in children —
in effect, extending the patent holder's monopoly on the product
by six months —has been the most contentious aspect of the
proposal as it impacts on the health budgets of Member States.
At the Health Council on 3 June, most Member States including
the UK, Germany and France indicated their support for the Commission's
proposal for a fixed six months extension of SPC. Slovenia, Poland,
Latvia, Hungary and Slovakia indicated that they favoured a shorter
period of SPC extension given the strength of the generics market
in their countries. …The dossier will be given priority during
the UK Presidency and our aim is to make significant progress
in negotiations in the Council."
7.14 The Minister adds that the Government has proposed
the addition to the Regulation of a provision requiring a review
of the impact of the measure after ten years. The review would
include an analysis of the financial effects of the rewards and
incentives provided in Articles 36 to 38.
7.15 Finally, the Minister says that she will send
us a further progress report after the summer recess.
Conclusion
7.16 We are in no doubt of the importance of this
proposal for child health, while also being mindful of its implications
for public expenditure and the pharmaceutical industry.
7.17 We are grateful to the Minister for her full
and helpful letter. We note the encouraging conclusion emerging
from the Government's further examination of the likely balance
between the costs and benefits of the proposal. We ask the Minister
to provide us with a summary of the responses to the public consultations.
We look forward to her further report on the progress of the negotiations.
Pending this further information, we shall keep the document under
scrutiny.
19 See headnote. Back
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