5 AUTHORISATION OF HUMAN AND VETERINARY
MEDICINES: DECENTRALISED PROCEDURES
(24460)
8813/03
COM(03) 163
| (a)
Amended draft Directive amending Directive 2001/83/EC on the Community
code relating to medicinal products for human use.
(b)
Amended draft Directive amending Directive 20012/82/EC on the
Community code relating to veterinary medicinal products.
|
| Legal base | Articles 95 and 152(4) EC; co-decision; qualified majority voting
|
| Document originated | 3 April 2003
|
| Deposited in Parliament |
29 April 2003 |
| Department | Health and Environment, Food and Rural Affairs
|
| Basis of consideration |
EM of 14 May 2003 and Minister's letter of 29 May 2003
|
| Previous Committee Report |
None; but see footnote |
| To be discussed in Council
| (a) 2-3 June 2003 |
| Committee's assessment | Politically important
|
| Committee's decision | (a) Cleared
(b) Not cleared
|
Background
5.1 In order to remove obstacles to the internal market
in pharmaceuticals, whilst at the same time ensuring a high level
of public health protection, the Community has gradually developed
a harmonised legislative framework for human and veterinary medicinal
products. The present system is based on two separate procedures
for the granting of marketing authorisations:
- a centralised procedure, granted by a Commission decision
under Regulation 2093/93, and based on a scientific evaluation
from the European Agency for the Evaluation of Medicinal Products
(EMEA), leading to a single marketing authorisation valid throughout
the whole Community;
- a decentralised (mutual recognition) procedure
under Council Directives 2001/82 and 2001/83/EC for those medicinal
products not eligible for the centralised procedure or where the
applicant chooses not to follow that procedure: this has to be
used where an application for a marketing authorisation concerns
two or more Member States, with one carrying out the scientific
evaluation which the others are required to recognise (subject
to the right to raise objections).
5.2 In October 2001, the Commission produced,
as required by Regulation 2309/93, a Report[10]
on its operation to date, accompanied by proposals[11]
to amend the procedures both in that Regulation and in the Community
codes relating to human and veterinary medicines set out in Directives
2001/83 and 2001/82 respectively. We reported on these two documents
at some length on 20 March 2002, and, following our recommendation
to that effect, they were debated in European Standing Committee
C on 18 June 2002.
The current document
5.3 In this document, the Commission has
proposed, in the light of the amendments suggested by the European
Parliament at its first reading on 23 October 2002, a number of
changes to its proposals on the decentralised procedures in Directives
2001/83/EC and 2001/82/EC, which relate respectively to human
and veterinary medicines. The most important of these, together
with the UK's reactions are set out in a joint Explanatory Memorandum
of 14 May 2003 from the Parliamentary of Under-Secretary of State
at the Department of Health (Ms Hazel Blears) and the Parliamentary
Under-Secretary of State (Commons) at the Department of Environment,
Food and Rural Affairs (Mr Elliot Morley).
DIRECTIVE 2001/83/EC
Definition of medicinal product and scope of legislation
5.4 The Commission has rejected a European
Parliament amendment which would have supported the deletion of
new text requiring any product meeting the definition of a medicinal
product to be regulated as such, even in cases where other sectoral
legislation applied. However, it has made a further modification
to the definition of medicinal product, which the Ministers are
concerned would broaden the application of the definition.
Data exclusivity period and definition of a generic
medicinal product
5.5 The Commission original proposal introduced
a 10 years' data exclusivity period,[12]
during which a manufacturer of a generic medicine may not use
licensing data submitted in support of a marketing authorisation,
and it has now rejected a European Parliament proposal to allow
generics companies to submit applications for market authorisations
before the expiry of the period of data exclusivity. The Ministers
say that the UK position, which was negotiated with the research
and generics industries, supports the Commission's approach, together
with a definition of a generic product which would allow the R
& D industry additional data exclusivity from some changes
in composition or form of a medicinal product.
Abolition of renewals/invalidating non-commercial
authorisations
5.6 The Commission supports a European Parliament
amendment, which would involve a single renewal after five years,
and an indefinite authorisation thereafter for both human and
veterinary products, and also introduce a two year "sunset
clause", extending to three years the maximum length by which
a licence can remain dormant. It has also introduced exemptions
to the provision for reasons of public health. The Ministers
say that the UK has consistently opposed proposals to abolish
the current system of renewals and to introduce a "sunset
clause", on the basis that the former would weaken the regime,
whilst the latter would not be workable. However, they add that
other Member States now appear to be united in supporting the
Commission's modified proposals, and that, taken as a whole, these
now contain provisions to review products at any stage in their
life cycle, place responsibilities on marketing authorisations
in relation to risks and benefits of medicines, and confer powers
on competent authorities in this area. In view of this, the Government
is satisfied that the package now proposed, comprising a single
renewal but using other legislative provisions as necessary, will
meet its objective of maintaining robust levels of public health
protection.
Data protection for work to support product switches
from prescription to non-prescription classification
5.7 The Commission has supported in principle
a proposal by the European Parliament to grant a period of protection
from competition when data is supplied by a company to support
a switch in legal classification, and favours a two year protection
period. The Ministers say that the UK supports provisions which
encourage market authorisation holders to consider applying for
such changes as this facilitates safe access to a wider range
of over-the-counter medicines.
Pharmacovigilance
5.8 The Commission has proposed that a market
authorisation submitted through the mutual recognition procedure
should include proof that the applicant has the services of a
suitably qualified person responsible for pharmacovigilance, and
that the applicant should include a detailed description of the
systems to be introduced. The Ministers say that the UK industry
regularly puts such plans in place, but that these are not shared
by the Medicines Control Agency. They therefore support these
amendments as increasing the Agency's ability to judge the measures
in place, and as promoting best practice in systems design.
Information to patients
5.9 The Commission has maintained its proposal
that information to patients on prescription-only medicines available
to treat certain chronic illnesses should be provided for a trial
period of three years. The Ministers say that the Government
supports high quality patient information, regardless of its source
and the disease group to which it relates, but regards the Commission's
proposal as drafted as amounting to direct consumer advertising,
which the UK has continually opposed. They will continue to support
a form of words which will enable the UK to continue to provide
high quality and relevant information to patients.
DIRECTIVE 2001/82/EC
Prescription requirements for food-producing animals
5.10 The Commission originally proposed
that all medicines for food-producing animals should be available
only on prescription, but it has accepted in principle a European
Parliament amendment providing a derogation for veterinarians
to use certain other products under specified circumstances.
However, the Ministers say that, whilst the effect of the derogation
would allow the UK to retain its present system for distributing
veterinary medicines, the Commission's acceptance of a further
European Parliament modification has the effect of retaining the
prescription requirement for these products. They say that the
UK is opposed to this, as there are a number of medicines routinely
used by farmers and animal owners for which a veterinary prescription
is not considered necessary: also, the Commission's proposal would
significantly increase costs, and could lead to a reduction in
product availability.
Renewal of marketing authorisations
5.11 The Ministers say that the considerations
here are similar to those arsing on human medicines (see paragraph
5.6 above), but that the veterinary industry is concerned at the
additional costs it will incur as a result of a requirement to
submit a full dossier when requesting an authorisation renewal
after five years.
Prescription cascade
5.12 The Commission originally proposed
two changes to the prescription cascade,[13]
one of which would allow veterinary surgeons treating food-producing
animals to use veterinary medicines authorised in another Member
State as an alternative to an authorised human medicine, whilst
the other would allow equidae never having been intended
for food production to be treated as non-food producing animals.
It has now modified the first of these to extend it to non food-producing
animals, and has accepted a European Parliament amendment to the
second which would allow medicines whose active ingredients do
not have a Community maximum residue level to be used on equidae
meeting these conditions. The Ministers say that the UK supports
both these changes in principle.
Data exclusivity period and definition of a generic
medicinal product
5.13 The Commission has amended this part
of its proposal to align the provisions with those for human medicines.
These changes are supported by the Government.
Pharmacovigilance
5.14 Here too, the changes made mirror those
for human medicines (see paragraph 5.8 above), and are supported
by the UK.
Financial and regulatory implications
5.15 The Government has supplied with its
Explanatory Memorandum of 14 May 2003 a Regulatory Impact Assessment
which covers these two proposals, as well as those set out in
paragraph 14 of this Report on the centralised procedures. As
we have noted in that paragraph, the Assessment highlights the
benefits arising from the proposals, whilst suggesting that, in
the case of human medicines, they mainly involve a fine tuning
of an already rigorous system, and that consequently there do
not appear to be any significant financial implications. In the
case of veterinary medicines, the Assessment says that the proposal
requiring all medicines for food-producing animals, including
horses, to be available only on prescription could significantly
increase the costs of obtaining medicines to farmers and owners
of such animals, and lead to employment difficulties in the distribution
companies. It could also lead to a reduction in the availability
of products to treat species such as bees and some preventative
medicines such as vaccines. However, proposals to allow authorisation
of medicines (and use of medicines under the prescription cascade)
for non food-producing horses without the need for a Community
maximum residue level could offset some of these effects in respect
of horses not destined for food production.
Minister's letter of 29 May 2003
5.16 As noted in paragraph 14, we have received
a letter of 29 May 2003 from the Parliamentary Under-Secretary
of State at the Department of Health (Mr David Lammy) saying that
the Greek Presidency intends at a meeting of the Council on 2-3
June to seek political agreement to a common position on the draft
Regulation laying down revised centralised procedures, and on
the part of this proposal dealing with human medicines (document
(a)). He says that negotiations on the Directive concerning decentralised
approvals of medicinal products for veterinary use (document (b))
have not yet been concluded, but that he expects political agreement
to be reached in the summer.
Conclusion
5.17 For the reasons given in paragraph
14 of this Report in relation to the centralised procedures, we
are clearing the proposal relating to the decentralised authorisation
of human medicines (document (a)). However, we will await further
developments on the decentralised authorisation of veterinary
medicines (document (b)), and are thus holding that proposal under
scrutiny.
10 (22867) 13361/01;see HC 152-xxii (2001-02), paragraph
3 (20 March 2002). Back
11
(23022) 14591/01;see HC 152-xxii (2001-02), paragraph 3 (20 March
2002). Back
12
This may be extended up to one extra year if a significant therapeutic
indication is found during the first eight years. Back
13
This requires another veterinary product, a medicinal product
for human use, or a product prepared extemporaneously to be used
in that order of priority. Back
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