Documents Considered by the Committee on 22 October 2014 - European Scrutiny Committee Contents


3 Veterinary medicinal products

Committee's assessment Politically important
Committee's decisionNot 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 baseArticles 114 and 168(4)(c) TFEU; co-decision; QMV
DepartmentEnvironment, Food and Rural Affairs
Document numbers(a) (36344), 13289/14 + ADDs 1-3, COM(14) 558 (b) (36340) 3240/14, COM(14) 557

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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