3 Veterinary medicinal products
| Committee's assessment
| Politically important |
| Committee's decision | Not cleared from scrutiny; further information awaited
|
| Document details | (a) Draft Regulation on veterinary medicinal products (b) Draft Regulation amending Regulation (EC) No. 726/2004 on Community procedures for the authorisation and supervision of medicinal products
|
| Legal base | Articles 114 and 168(4)(c) TFEU; co-decision; QMV
|
| Department | Environment, Food and Rural Affairs
|
| Document numbers | (a) (36344), 13289/14 + ADDs 1-3, COM(14) 558 (b) (36340) 3240/14, COM(14) 557
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Summary and Committee's conclusions
3.1 The EU rules which currently apply to the production,
marketing, distribution and use of veterinary medicines are set
out in two main instruments. Directive 2001/82/EC stipulates that
such a medicine cannot be placed on the market unless it has been
issued with a marketing authorisation either by a Member State
("national authorisation"), or where an authorisation
granted in one Member State is regarded as valid in other Member
States ("mutual recognition"), or under a "decentralised"
authorisation procedure, which enables applicants to target their
product to a limited group of Member States. Regulation (EC) No.
726/2004 sets out centralised procedures under which both veterinary
and human medicines are simultaneously authorised by the Commission
in all Member States on a pan-European basis.
3.2 However, the Commission points out that concerns
have been expressed that these provisions do not fully deliver
a single market, with problems having arisen over the availability
of veterinary medicines, particularly for small markets, and it
also draws attention to the ways in which veterinary and human
medicines — and hence the considerations governing their
authorisation — differ. It has therefore put forward the
draft Regulation at document (a), which would repeal Directive
2001/82/EC, and put in place an up-to-date and proportionate body
of legislation tailored to the specific needs of the veterinary
sector. Also, as the proposal would incorporate into this Regulation
the centralised procedures currently contained in Regulation (EC)
No. 726/2004 for the Commission to grant European-wide authorisations
for veterinary medicines, the proposal at document (b) would make
a number of consequential amendments to that Regulation, so that
it would in future be concerned wholly with human medicines.
3.3 The Government has flagged up a number of detailed
points on which it intends to seek further clarification during
the negotiations, but has given a broad welcome to the proposals.
In the meantime, it has said that it will be providing in due
course a UK Impact Assessment.
3.4 The draft Regulation at document (a) is clearly
of some significance, and, although the Government has said that
it is broadly content with what is proposed, we think it right
to draw it to the attention of the House. However, as the Government
has also said that it will be providing an Impact Assessment in
due course, we propose to hold the document under scrutiny until
then.
Full details of the documents:
(a) Draft Regulation on veterinary medicinal products (36344),
13289/14 + ADDs 1-3, COM(14) 558: (b) Draft Regulation
amending Regulation (EC) No. 726/2004 laying down Community procedures
for the authorisation and supervision of medicinal products for
human and veterinary use and establishing a European Medicines
Agency (36340), 13240/14, COM(14) 557.
Background
3.5 The EU rules which currently apply to the production,
marketing, distribution and use of veterinary medicines are set
out in two main instruments:
· Directive 2001/82/EC, which stipulates
that such a medicine cannot be placed on the market of a Member
State unless the competent authority has issued a marketing authorisation
in accordance with the provisions laid down in the Directive ("national
authorisation"). It also sets out the basis on which an authorisation
granted in one Member State may be valid in other Member States
("mutual recognition"), as well as the particular provisions
applicable to homeopathic products; conditions relating to the
manufacture and import of authorised products; labelling and packaging
conditions; provisions applying to the possession, wholesale distribution
and dispensing of veterinary medicines; the measures needed to
identify and deal with unintended effects (pharmacovigilance);
and the basis on which Member States should exercise supervision
and apply sanctions. The Directive was subsequently amended by
Directive 2004/28/EC, which introduced a "decentralised"
authorisation procedure, enabling applicants to target their product
to a limited group of Member States.
· Regulation (EC) No. 726/2004, which sets
out a centralised procedure under which products are simultaneously
authorised by the Commission in all Member States on a pan-European
basis.
3.6 However, the Commission points out that concerns
have been expressed that these provisions do not fully deliver
a single market, and it says that problems have arisen over the
availability of veterinary medicines, particularly for small markets;
their use in species for which they are not authorised; the disproportionate
regulatory burden which the current procedures impose; and the
impact this has had on innovation. It also notes the extent to
which veterinary and human medicines differ, with the former involving
a range of different species (which creates both a fragmented
market and the need for major investments in order to extend an
authorisation from one species to another); having a different,
and substantially lower, price structure; and being relatively
small.
The current documents
3.7 The Commission has therefore put forward the
draft Regulation at document (a), which would repeal Directive
2001/82/EC, and put in place an up-to-date and proportionate body
of legislation tailored to the specific needs of the veterinary
sector. In particular, it would seek to:
· increase the availability of veterinary
medicines;
· reduce the administrative burdens;
· stimulate competitiveness and innovation;
· improve the functioning of the internal
market; and
· address the public health risk of antimicrobial
resistance, identified in the Action Plan put forward by the Commission
in 2011.
3.8 The proposal would also incorporate into this
Regulation the centralised procedures for the granting of authorisations
by the Commission currently contained in Regulation (EC) No. 726/2004,
thereby bringing into one single measure all the authorisation
routes open to manufacturers of veterinary medicines. As a consequence,
the proposal at document (b) would make a number of amendments
to Regulation (EC) No. 726/2004, so that it would in future be
concerned wholly with human medicines.
3.9 At the same time, the Commission says that document
(a) would continue to provide a basis for ensuring that veterinary
medicines are safe for the animals to which they are administered,
for the consumers of food produced from them, for users of the
medicines, and for the environment, and that they are effective
and of appropriate quality. Much of the existing framework would
be retained, with the application of a benefit-risk assessment
continuing to be a key element in determining whether a product
should be authorised, but the proposal would introduce a number
of changes, as follows:
· a major simplification would be achieved
by a reduction in the amount of compulsory information on the
packaging and labelling, together with the introduction of harmonised
pictograms and abbreviations, thereby reducing translation and
packaging costs, and encouraging multilingual packaging and labelling;
· instead of having to be renewed after
five years, marketing authorisations would in future be of unlimited
duration;
· the current ten-year protection period[10]
would still apply for the initial marketing authorisation in the
case of medicines for cattle, sheep, pigs, chickens, dogs and
cats, but, in order to encourage the extension of already authorised
products to other species, a further year would be added in each
of such cases (up to a maximum of eight years);
· also, in order to encourage the development
of products for species other than cattle, sheep, pigs, chickens,
dogs and cats, a 14 year[11]
protection period would apply to the initial marketing authorisation
in such cases, with an additional four years for an extension
to a minor species;
· a single product database would be established
for all authorised veterinary medicines, with Member States being
required to upload information on national marketing authorisations;
· a harmonised EU procedure would be introduced
for the authorisation of the clinical trials used to demonstrate
a product's quality, safety and efficacy, and food producing animals
used in such trials would not be permitted to enter the food chain,
unless the product administered has already been authorised;
· the Commission would be empowered to establish
rules excluding or restricting the use of certain antimicrobials
in the veterinary sector;
· the summary of product characteristics
(SPC) included in the terms of marketing authorisations issued
by national authorities would be harmonised;
· new restrictions would be imposed on the
supply of antimicrobial veterinary medicines, a system would be
set up to record and report on their use, and, where there is
no authorised veterinary medicine for a particular species or
disease, rules would be established for prescriptions, principally
in order to address concerns relating to antibiotic resistance;
· rules would also be established for online
sales (which would be encouraged in order to improve access to
veterinary medicines);
· only those permitted to prescribe or supply
veterinary medicines would be able to advertise them.
The Government's view
3.10 In his Explanatory Memorandum of 26 September
2014, the Parliamentary Under Secretary at the Department for
Environment, Food and Rural Affairs (George Eustice) says that
the Government welcomes the proposed Regulation for veterinary
medicines in that it maintains the current regulatory framework,
whilst taking steps to increase the availability of veterinary
medicines in Europe through strengthening the single market, providing
improved data protection and reducing administrative burdens in
several areas especially as regards veterinary medicines with
a small market. However, he says that the detail of how the revised
authorisation routes will operate needs to be resolved, and that
it will be necessary to ensure that the measures are appropriately
resourced across the EU.
3.11 In the meantime, he comments that:
· Although harmonisation of SPCs is a worthwhile
aspiration in that it removes confusion, helps to achieve fair
competition and could ultimately reduce the regulatory burden
for the pharmaceutical industry, the number of products involved
make this a very complicated issue, which will require significant
resource from the pharmaceutical industry and from Government,
and take many years to achieve. The Government intends to question
how the Commission envisages that this work will be financed.
· Although clinical field trials are already
regulated in the UK, that is not the case in many Member States,
and the introduction of EU controls is welcomed as a means of
ensuring safety and encouraging more such studies to be undertaken.
However, the restriction on farmed animals used in clinical field
trials from reaching the food chain promises to significantly
increase costs, compared with the present UK system (which permits
animals used in clinical field trials to go into the food chain,
provided they have been treated with medicines meeting criteria
of safety for human ingestion and an appropriate withdrawal period
has been applied). The UK will seek to negotiate to maintain the
status quo so as to prevent the cost of these trials from increasing
significantly and to avoid encouraging their being run outside
the EU.
· The proposed changes in the rules for
prescribing of veterinary antibiotic medicines to permit veterinarians
to dispense antibiotics only against their own prescriptions seems
intended to reduce the risk of antibiotic resistance developing
in animals, but the proposals could lead in practice to less responsible
use of antibiotics, and the Government therefore intends to clarify
this with the Commission. Also, although the intention to restrict
the use of some antibiotics in the absence of an authorised veterinary
medicine and reserving certain antibiotics for human use only
has been introduced to address the risk of antibiotic resistance,
the principles of how the antibiotics will be identified needs
to be determined.
· The existing Directive for veterinary
medicines prohibits the advertising of veterinary medicines to
members of the general public, but, as farmers have specific knowledge
and skills related to their role, the UK Government has taken
the view that they were not members of the general public in this
context, and has permitted the farming press to carry advertisements
for veterinary medicines. In the recent past, the Commission moved
to open infraction proceedings because of objections to the UK's
policy, and, after an open debate with other Member States, the
Government agreed to comply with the Commission's views in return
for a lifting of the infraction proceeding: as anticipated, the
proposed Regulation would restrict the advertising of prescription
only veterinary medicines to those who can supply the medicines.
3.12 There are 14 implementing acts within the proposed
Regulation, which the UK does not see as an issue, since it will
be possible to negotiate their final form. There are also nine
Delegated Acts proposed, but, as UK officials will be actively
involved on the expert committees which will be consulted, these
too are unlikely to be an issue.
3.13 Finally, the Minister says that, due to the
size of the proposal, negotiations are expected to continue until
late 2017. In the meantime, an Impact Assessment for the UK is
under preparation, and is likely to be submitted within the next
six months (though the costs are highly dependent on the particular
proposals, and could change significantly during the negotiations).
Previous Committee Reports
None.
10 To prevent an applicant for a generic product from
referring to the documentation submitted for the authorisation
of the reference product. Back
11
This would be 18 years for bee medicines. Back
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