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Position Paper: Proposal for a Regulation on Veterinary Medicinal Products (COM 2014/558)

Executive summary:
IFAH-Europe welcomes the European Commission’s proposal seeking to overhaul EU legislation on veterinary medicinal products. In particular, IFAH-Europe supports the Commission’s objectives aimed at increasing the availability of veterinary medicines, reducing administrative burden, stimulating competitiveness and innovation, improving the functioning of the internal market, and addressing the public health risk of antimicrobial resistance.

IFAH-Europe is particularly encouraged by the European Commission’s chosen instrument of Regulation, a tool that will go a long way to ensuring that the rules governing the manufacture, placing on the market, import, export, supply, control and use of veterinary medicines, as well as pharmacovigilance, will be harmonized across the European Union.

The Commission’s decision to separate the human and veterinary medicines regulatory framework also means that the new legislation is better adapted to the specificities of the veterinary medicines market. The market for animal medicines is very different to that for the human medicines:
• It caters to a wide variety of species with a range of different physiologies and pathologies
• It is substantially smaller, only 2-3% the size of the human medicines sector, and highly fragmented.
• It is almost entirely a private market, with no state reimbursement of the cost of the medicine. The likelihood of animals being treated is critically influenced by the animal owners’ ability to afford the cost of the treatment.
Investing in research to keep animals healthy
IFAH-Europe welcomes the Commission’s proposal to allow greater stimulation of innovation by offering improved protection for technical data, measures that will improve the functioning of the internal market, whilst also seeking to reduce administrative burden, by providing a more efficient regulatory climate. The veterinary medicines sector is faced with a disproportionately high administrative burden, representing an estimated 13% of the sector’s annual turn-over (or double that of the human medicines market).

IFAH-Europe calls for extension to the periods allowed for the protection of technical documentation of veterinary medicines, in order that the enterprises developing these products have the necessary incentives to develop and expand the range of medicines available. This is vital for the treatment of both animals commonly used for food production, companion animals and the so-called minor use minor species (MUMS), including bees, that are in urgent need of better protection against diseases.

Obstacles to innovation and competitiveness
Most veterinary medicines on the market are old products that no longer have any protection of technical documentation. The current regulatory framework does not offer any incentive to support re-investment in existing products or sufficient incentive to extend a product to cover new species. Re-investments in these types of products by both originator and generic companies wil increase the medicines’ availability for a wider range of species and indications. Companies developing these medicines need to be able to work in a climate where they have assurances that their substantial re-investments to further develop these products can offer an equitable return on investment over a reasonable period of time.

Animal health companies spend upwards of €129 million on bringing a new product to market, a process which can take between 5 to 11 years to complete. A regulatory framework that offers adequate periods where the technical documentation of a specific medicine remain the exclusive ownership of a company or SME is essential to maintaining the competitiveness of the veterinary medicines market, and indeed a prerequisite for the development of innovative remedies.

IFAH-Europe would like to see the new Regulation on veterinary medicinal products include a 5-year period of protection for a significant investment in the improvement of well-established products, and an extension of the 10-year period of protection by 3 years for major species and 5 years for minor species. The development of a new antibiotic should warrant a 20-year protection period, given the strict requirements for its development and restrictions on use.

One medicine is not the other
One of the more complex elements of the proposal concerns the suggested harmonisation of the summary of product characteristics (or SmPCs) of existing products. These SmPCs include conditions of use, such as the species they can be used for, what diseases it can be used to treat, how much medicine to administer, as well as safety warnings. The European Commission proposes to harmonise groups of “similar products” (“by product class”), which will include medicines with the same active ingredient and the same pharmaceutical form, but that may have been authorised in different member states with different conditions of use (e.g. indications, dosage and safety warnings). These differences mean that these products are considered legally to be different in each member state, which counteracts the objectives of the single market.

IFAH-Europe recognises the major challenges presented with “class” harmonisation of a group of similar products, and strongly recommends limiting the SmPC harmonisation to a group of the same products, i.e. products from the same manufacturer. It also points out that it is important to include the manufacturing methods and specifications of a product, which may differ for the same product in different Member States, thus adding complexity and added cost to the logistics of manufacturing batches for the EU.

Reducing administrative burden to increase the availability of medicines
The harmonisation of products to enable a strong and efficient single market implies the existence of a well-oiled administrative structure. The current complex system results in a high administrative burden for veterinary medicines and has contributed to a 20% drop in the innovation rate , and lower product availability, especially for minor species and smaller countries.

More than 38% of manufacturers consider the EU’s regulatory framework to be the greatest obstacle for innovation in Europe. One of the main reasons behind this extraordinarily high level of administrative burden are the “disproportionate costs of mandatory defensive research for keeping a medicine on the market” and the EU’s marketing authorization procedures. The large majority of veterinary medicines that do not qualify for the centralized procedure to obtain a single marketing authorisation (to sell these medicines across the EU), have to follow a decentralised procedure or the mutual recognition procedure to obtain the authorisation in the selected Member State(s). This is a resource-intensive, inefficient and burdensome process, resulting in multiple national authorisations, which could be remedied by a single EU marketing authorisation process. IFAH-Europe advocates a move toward the creation of a single EU product database and the elimination of unnecessary tasks and procedures, such as marketing authorisation renewals.

Moreover, the animal health sector welcomes the Commission’s proposal for a more streamlined and risk-based pharmacovigilance system to monitor and signal the safety of products in the marketplace. The new approach allows for the continuous reporting and collection of adverse events in a central EU database, via a mandatory e-submission system, and the creation of a single pharmacovigilance master file per product to avoid unnecessary duplication. Replacing Periodic reporting of Safety Updates (PSURs) at fixed time points with safety updates triggered via a signal management process completes the move to a risk-based approach, and is therefore an integral part to reducing the administrative burden for the sector. Streamlining pharmacovigilance will make it possible for authorities to conduct meta-analyses across companies, Member States and products using similar active ingredients. It provides a powerful tool to detect signals early on and allow for more targeted data analyses, risk assessments and better use of resources at authority level, which will in turn complement the work conducted by companies.

Clear and simple packaging and labels
One of the principal causes of the extraordinarily high administrative burden of the veterinary medicines sector relates to packaging and labelling. According to the Commission’s Impact Assessment, compliance with labelling rules constitutes 34% of the total administrative burden. The cost of packaging is also a factor that is reducing the availability of veterinary medicines in small markets. The impact assessment identified the need for the re-organisation of labelling information to encourage more use of multi-lingual packs, coupled with the use of standard pictograms and abbreviations. The Commission’s proposal introduces significant improvements and brings clarity, and IFAH-Europe wishes to build on this to bring some additional refinements to the proposed legislation, such as allowing flexibility for additional information stated on the immediate and outer labels, to be compliant with information contained in the summary of product characteristics (SmPC).
Safeguarding animal, public health and the environment
The animal health industry commends the European Commission’s efforts to combat antimicrobial resistance, safeguard public health and ensure the continued availability of effective antibiotics, which is crucial to animal health and welfare, farmers’ livelihoods, sustainable agriculture, food safety and public health.
A precursor to the continued availability of antibiotics must be a new Regulation that is science-based, reflecting the recommendations of the European Medicines Agency on restrictions on use and reserve lists. But the new legislation should also ensure that the development of new antibiotics are stimulated, by extending the periods for protection of technical documentation to 20 years.

IFAH-Europe strongly advocates that, if an authorised veterinary medicine is available, meaning it has been shown to be safe and work to treat animals, it must be prescribed in preference to a human medicine. Human medicines should only be prescribed to animals as a last resort.
Further, the animal health industry supports the collection of data on the sale of antibiotics and the introduction of clearer definitions for terms including “antibiotic”, “antimicrobial, “biologicals” and “immunologicals”. IFAH-Europe does not support the online sale of antimicrobials.

IFAH-Europe welcomes the creation of a legal framework around internet sales of veterinary medicines, a practice that is already common in the EU. Internet sales will help develop the internal market, however, it is important that the online sales of veterinary medicines do not compromise public health, or the safe use of veterinary products.

Recent discussions on the Commission proposal have also focused on the availability of environmental data relating to veterinary medicines, to avoid duplication and divergent decisions. IFAH-Europe welcomes this debate and recommends that end point data from environmental studies should be published in the Public Assessment Reports (PARs) that accompany every authorised medicine. This will have several advantages over suggestions for introducing a monograph system . Publishing the necessary data in the PAR will utilise existing processes, will bring all the necessary data for an environmental risk assessment into one place (such as intended usage patterns) and will be considerably less challenging and burdensome than the monograph system.

In summary, the animal health industry in Europe is encouraged by the Commission’s proposal for new regulation of veterinary medicines and suggests a number of changes that will facilitate innovation, harmonisation and more responsible use of veterinary medicines. The animal health industry anticipates that the new EU legislation will give it the tools to develop innovative and much-needed medicines that safeguard not only animal, but also human and environmental health. The cost of controlling animal disease and the threat of emerging animal and zoonotic diseases poses a very significant threat, not only to the health but also the economy of Europe. As a result, it is vital the changes made to the Regulation on veterinary medicines stimulate innovation, rather than adding further burden to the animal health industry.

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