Explanatory Memorandum to COM(2014)558 - Veterinary medicinal products - Main contents
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| dossier | COM(2014)558 - Veterinary medicinal products. |
|---|---|
| source | COM(2014)558  |
| date | 10-09-2014 |
Work on a European legal framework for veterinary medicinal products started in 1965 with the adoption of Directive 65/65/EEC,[1] which required that marketing authorisations be issued before such products could be placed on the market. Since then, numerous other directives and regulations have been adopted to extend and refine the rules, and a harmonised framework has gradually been established. In 2001, all the rules on production, marketing, distribution and use were consolidated in a veterinary medicines code (Directive 2001/82/EC);[2] this was followed by Regulation (EC) No 726/2004.[3] These two acts regulate the authorisation, manufacturing, marketing, distribution, pharmacovigilance and use of veterinary medicinal products over their lifetime. The annex to the Directive 2001/82/EC specifies the data to be submitted in applications for marketing authorisations. Among other things, the Regulation (EC) No 726/2004 lays down the EU procedures applying to medicinal products for human and veterinary use and establishes the European Medicines Agency (‘the Agency’).
In the course of the co-decision procedure for its proposal for a regulation on residue limits of pharmacological active substances in foodstuffs, the Commission submitted a declaration recognising the importance of problems linked to the availability of veterinary medicinal products, the use of veterinary medicinal products in species for which they are not authorised, and disproportionate regulatory burden hampering innovation. The present proposal is the Commission’s follow-up to its declaration.
Stakeholders and Member States have expressed concern that the current legislation does not fully deliver a single market in veterinary medicinal products and fails to meet the Union’s needs as regards the regulation of medicines. In particular, the private and public sectors have indicated the following areas for improvement:
· regulatory burden;
· the lack of availability of veterinary medicinal products, especially for small markets such as that for bees; and
· the functioning of the internal market.
In this regard, it is important to recall that needs of the veterinary sector differ substantially from those of the human sector in relation to medicines. In particular, the drivers for investment for the human and the veterinary medicines markets are different. For example, in the veterinary sector there are many different animal species, which creates both a fragmented market and the need for major investments in order to extend the authorisation of medicines existing for one animal species to another. Moreover, the price-setting mechanisms in the veterinary sector follow a completely different logic. Consequently, prices for veterinary medicines are typically substantially lower than for medicinal products for human use. The size of the animal pharmaceutical industry is only a small fraction of the size of the pharmaceutical industry for human medicines. It is therefore considered appropriate to develop a regulatory framework addressing the characteristics and specificities of the veterinary sector, which cannot be considered as a model for the human medicines market.
The revision of Directive 2001/82/EC and other legislation on veterinary medicinal products is in line with the principles set out in the Commission’s 2013 and 2014 work programmes. The proposal seeks to put in place, while safeguarding public health, animal health, food safety and the environment, an up-to-date, proportionate body of legislation tailored to the specificities of the veterinary sector, aiming in particular to:
· increase the availability of veterinary medicinal products;
· reduce administrative burdens;
· stimulate competitiveness and innovation;
· improve the functioning of the internal market; and
· address the public health risk of antimicrobial resistance (AMR).
These objectives are not only complementary, but also interlinked, as innovation will provide new and better medicines to treat and prevent diseases in animals, while avoiding damage to the environment.
The spread of AMR is a major threat to public and animal health. In November 2011, the Commission launched a five-year action plan,[5] which seeks to mobilise all stakeholders in a joint effort to combat AMR; in particular, Action 2 in the plan aims to strengthen the regulatory framework for veterinary medicinal products. This proposal implements this action.
The Commission’s Communication on honeybee health stresses the importance of proactively protecting bee health, while taking into account the particularities of beekeeping, and acknowledges the limited availability of medicines to treat the diseases that afflict bees. As regards measures to increase availability, the Communication refers to the revision of the legislation on veterinary medicinal products.
The legal bases for legislative measures on animal health, which are essential to public and animal health, environmental protection, trade and single market policy are:
– Article 114 of the Treaty on the Functioning of the European Union (TFEU), which provides for the establishment and functioning of the internal market and the approximation of relevant legal, regulatory and administrative provisions; and
– Article 168(4)(b) TFEU, which covers measures in the veterinary field directly aimed at protecting public health.
Contents
- RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND IMPACT ASSESSMENTS
- LEGAL ELEMENTS OF THE PROPOSAL
- BUDGETARY IMPLICATION
- Justification and objectives
- Legal basis
- Chapter I: Subject matter, scope and definitions
- Chapter III: Procedures for granting marketing authorisations
- Chapter IV: Post-marketing authorisation measures
- Chapter V: Homeopathic veterinary medicinal products
- Chapter VI: Manufacturing, import and export
- Chapter VII: Supply and use
- Chapter VIII: Controls
- Chapter IX: Restrictions and sanctions
- Chapter X: Regulatory network
- Chapter XI: Final provisions
Better regulation of veterinary pharmaceuticals: how to put in place a simpler legal framework, safeguarding public and animal health while increasing the competitiveness of companies, a public consultation on the key issues of the envisaged legal proposal, was launched on the Commission’s website on 13 April 2010 and was available through the interactive policy-making (IPM) tool until 15 July 2010.[7]
The consultation and a study, An assessment of the impact of the revision of veterinary pharmaceutical legislation, formed the basis of an impact assessment carried out for the Commission between November 2009 and June 2011.[8]
The Commission’s Impact Assessment Board (IAB) released its final opinion in September 2013.
This part contains provisions on the scope of the Regulation. It also sets out clear definitions reflecting the proposed changes.
Chapter II: Marketing authorisations — general provisions and rules on applications
In the Union, only veterinary medicinal products that meet standards of safety, quality and efficacy are authorised. The proposal lays down rules for obtaining a marketing authorisation, specifying that the product in question can be marketed for the approved indications only. The indications are listed in the summary of product characteristics (SPC) included in the terms of the marketing authorisation. Those terms also contain a description of the product’s properties and the conditions attached to its use. Before a marketing authorisation can be granted for a veterinary medicinal product for food-producing species, the Commission has to establish a maximum residue limit for the pharmacologically active substance it contains.
An applicant has to provide certain details on the packaging and labelling of the medicine. The proposal introduces a major simplification of the rules by reducing the compulsory information and introducing harmonised pictograms and abbreviations. This should reduce translation and packaging costs and encourage multilingual packages and labelling. Member States will have a degree of flexibility as to the languages used.
In principle, applicants must prove the quality, safety and efficacy of the veterinary medicinal product. In exceptional circumstances (e.g. in emergencies) and where limited markets are concerned, however, temporary authorisation may be granted without comprehensive data in order to fill therapeutic gaps on the market.
This part of the proposal also includes provisions for generic applications. If a product meets the conditions for a generic veterinary medicinal product, the applicant is not required to prove safety and efficacy and the application will rely on the data provided for the reference product. The proposal contains a definition of generic veterinary medicinal products.
This part also regulates the ‘protection period’ applying to technical documentation submitted in order to obtain or amend a marketing authorisation. It addresses the characteristics and specificities of the veterinary sector. Experience has shown that the needs of the veterinary sector differ substantially from those of the human sector. Also the drivers for investment differ for the human and veterinary medicines market, for example in animal health there is more than one species, creating a fragmented market and necessitating major investments to add other animal species. Therefore, the provisions in this proposal to stimulate innovation cannot be considered as a model for the human medicines market. The protection arrangements prevent applicants for a generic product from referring to the documentation submitted for the reference product. Data provided to extend the generic product to another animal species should also be protected according to the same principle.
Extending the protection periods provided for in Directive 2001/82/EC should create incentives and stimulate innovation in the animal health sector. The current ten‑year period would be maintained for the initial marketing authorisation. In order to encourage industry to extend already authorised products to other species, a further 1 year would be added for any extension of the veterinary medicinal products to another species (up to a maximum of 18 years).
In order to encourage the animal health industry to develop products for minor species, increased protection will apply: 14 years for the initial marketing authorisation for a minor species, and 4 additional years for an extension to a minor species.
So as to secure data protection, any application for an extension must be submitted at least 3 years before expiry of the data protection period. This ensures that companies can place a generic product on the market immediately after expiry of the protection period for the reference product. Product developments for bee medicines will receive increased data protection because of the small size of the market for bee medicines and the lack of effective medicines to treat diseases in bees. The protection applying to environmental data would be the same as that for safety and efficacy data.
The results of clinical trials comprise much of the data required to demonstrate the quality, safety and efficacy of a product. A Union procedure for the authorisation of clinical trials is provided for (this is currently not harmonised).
It is important to safeguard the effectiveness of certain antimicrobials that are essential for the treatment of human infections. Therefore, it is proposed that the Commission be empowered to establish rules excluding or restricting the use of certain antimicrobials in the veterinary sector.
Various marketing authorisation procedures are provided for:
· a centralised procedure, in which the Commission grants an authorisation;
· procedures in which Member States grant the authorisation:
· a national procedure;
· a mutual recognition procedure; and
· a decentralised procedure.
Regardless of whether the authorisation is obtained at Union or national level, the requirements for the safety, efficacy and quality of the product are the same. In all authorisation procedures, a key part of the assessment of an application is the benefit-risk analysis of a product.
The centralised procedure is mandatory for all veterinary medicinal products derived from biotechnology and optional with any other type of veterinary medicinal product. For products that are of interest in the majority of the Member States, access to the centralised procedure can lead to savings for the marketing authorisation holder.
The mutual recognition procedure applies for veterinary medicinal products already authorised in one Member State for which authorisation is requested in respect of two or more Member States. This procedure is based on the principle that a product authorised in one Member State should be recognised by another.
The decentralised procedure applies in cases where a medicine has not received a marketing authorisation in any Member State. It enables applicants to target their product to a limited group of Member States. After a marketing authorisation has been granted for the group of Member States in the original application, marketing authorisation holders can obtain an authorisation for additional Member States without repeated scientific assessment. This should mean that unnecessary duplication of work by competent authorities can be avoided, ease the rolling‑out of national marketing authorisations to other Member States and therefore increase the availability of veterinary medicinal products in the Union.
For the decentralised and mutual recognition procedures, an arbitration mechanism applies if a Member State cannot agree with the scientific assessment. If an applicant cannot agree with the outcome of a Member State’s assessment, it may request re-examination by the Agency. In such cases, the Agency will deliver a scientific opinion to the coordination group of Member States, which will act by consensus or by a majority of votes cast.
Currently, marketing authorisations have to be renewed every five years. The proposal provides for unlimited validity, which will reduce the regulatory burden.
This part establishes a single product database for all authorised veterinary medicinal products in the Union. Competent authorities will be obliged to upload data on national marketing authorisations. Having a readily accessible, up-to-date database of all authorised medicines will mean inter alia improved application of the provisions on the use of veterinary medicinal products outside the terms of the marketing authorisation, as veterinarians will be able to identify the products they need from other Member States.
Post-marketing authorisation measures include amending marketing authorisations and monitoring products after they have been on the market (pharmacovigilance). The terms of the authorisation may need to be amended where, for example, a change to the SPC is proposed. The provisions of Regulation (EC) No 1234/2008 should no longer apply to variations to veterinary medicinal products. The Regulation lays down a system for varying the terms of marketing authorisations that takes account of the level of risk involved. Only changes that substantially affect product safety or efficacy will still require prior authorisation by the competent authorities or the Commission before being implemented.
Veterinary medicinal products tend to have unintended effects when actually brought into use. Pharmacovigilance involves identifying adverse events and determining what action, if any, is required. The objective is to ensure the continuous safety of products once they are authorised. This proposal introduces a risk-based approach to pharmacovigilance whereby certain requirements that do not contribute effectively to public health, animal health or environmental protection (e.g. submitting periodic safety update reports) are relaxed. The Agency will manage a database of adverse events linked to medicines authorised in the Union. It will work together with competent authorities to monitor and evaluate collated data on adverse events linked to similar groups of veterinary medicinal products (signal management process).
Many SPCs of nationally authorised products may differ in some respects between Member States. As a result, dosage, uses and warnings may also differ. This lack of harmonisation could result in discrepancies between the SPCs of the originator and the generic product on the same national market. This part also seeks to harmonise the SPCs for products on the Union market that have been authorised at national level by means of a dual procedure:
· products considered low-risk will be subject to an administrative procedure; and
· products that are by nature more likely to present a risk to animal or public health or the environment will be scientifically re-assessed.
This harmonisation should increase the availability of products in the Union.
Member States or the Commission can request a re-evaluation of veterinary medicinal products available on the market on the grounds that they may pose a risk to animal or public health or the environment. Once this ‘Union referral procedure’ is triggered, the Agency adopts an opinion on the case and the Commission adopts a decision that will apply throughout the Union.
In addition, a system will be set up to record and report the use of antimicrobials. This is one of measures in the Commission’s AMR action plan.
This part lays down requirements and a simplified registration procedure for homeopathic veterinary medicinal products.
This part covers the procedure and requirements for obtaining an authorisation to manufacture, import or export veterinary medicinal products. It lays down the obligations of a manufacturing authorisation holder. These rules will ensure the quality of the medicine available on the Union market.
This part covers the supply and use of veterinary medicinal products after a marketing authorisation has been granted. It imposes new restrictions on the supply of antimicrobial veterinary medicinal products and lays down rules on prescriptions and online sales of veterinary medicinal products.
In order to improve access to veterinary medicinal products in the Union, retailers should be allowed to sell products via the internet if they are authorised to supply them in the Member State in which the buyer is established. Online sales of veterinary medicinal products throughout the Union must be harmonised and ring-fenced, as falsified or substandard veterinary medicinal products represent a threat to public and animal health. Member States may impose conditions, for public health reasons, on supplying veterinary medicinal products to the public via the internet.
The provisions on the use of veterinary medicinal products for species or indications outside the terms of the marketing authorisation are improved as follows:
· the ranking system is abolished and more flexibility introduced, enabling veterinarians to choose the best available treatment for animals under their care;
· withdrawal periods are determined according to a multiplication factor system which takes account of relevant available information;
· specific provisions are included for the use of products in an aquatic environment in order to better protect the environment; and
· the Commission is empowered to exclude or restrict the use of certain antimicrobials.
Inspections by Member States’ competent authorities should ensure that the Union rules are complied with and enforced at national level. The Agency should coordinate the controls of veterinary medicinal products authorised by the centralised procedure. The key change is that the Commission will be able to check Member States’ inspection systems to ensure that the legislation is enforced consistently. This brings the arrangements for veterinary medicinal products into line with those in the food sector.
This part deals with Member State and Union-level measures to tackle risks to public or animal health or the environment. It provides for:
· a procedure for temporary safety restrictions; and
· suspending, withdrawing and varying marketing authorisations; or
· prohibiting the supply of veterinary medicinal products.
This part regulates the Union regulatory network on veterinary medicinal products. Responsibility for veterinary medicinal products is shared between the Member States and the Commission. The fully fledged European network between the competent authorities of the Member States, the Agency and the Commission should ensure that:
· veterinary medicinal products are available on the Union market;
· they are properly evaluated before being authorised for use; and
· their safety and efficacy is constantly monitored.
This part of the proposal specifies the functioning and the tasks of the Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) and the Coordination Group for Mutual Recognition and Decentralised Procedures (veterinary) (CMDv). The main changes are to clarify the remit of the CMDv, which will have more responsibility under the new arrangements and will take decisions by majority voting. These changes should improve the functioning of the network. The CVMP’s tasks are amended to reflect the proposed changes to marketing authorisation procedures and post‑marketing measures.
This proposal repeals and replaces Directive 2001/82/EC. To give those affected sufficient time to adapt to the new legislation, the Regulation will apply as from two years after its publication.
Regulation (EC) No 726/2004 must be amended to take account of the fact that centralised marketing authorisation for veterinary medicinal products is being decoupled from that for medicines for humans. The amendments are proposed in a separate act accompanying this proposal.
It is planned that the costs for the Agency for implementing and applying the new rules are entirely covered by fees charged to industry.
Therefore, the proposal is not expected to have any financial impact on the budget of the EU.
As set out in the legislative financial statement the additional resource needs for the European Medicines Agency are approximately 8 staff plus expenditure for meetings, translation, IT, etc.
The level of fees, their structure, modalities and exceptions will be set at a later stage by the Commission by way of implementing acts. This holds not only for the fees for new tasks for the Agency set out in this proposal, but for all fees in general.
5. OPTIONAL ELEMENTS