Strasbourg, France, 23 October 2002: Members of the European Parliament today voted overwhelmingly to adopt Reports laying down clear measures to combat the animal medicines availability crisis. The Reports called for increased data protection - aimed at stimulating innovation - and reduced bureaucracy, aimed at speeding medicines' access to market. Most importantly, the Parliament's Reports recognise that the medicines availability crisis now affects all animal species, not solely "minor" or niche species and diseases.

"There are two elements to tackling the medicines availability crisis," explained Bill Hird, Member of the FEDESA Board of Directors. "The first is making sure that new medicines are being developed and reach the patients where they are needed; the second is to make sure that existing licensed products remain on the market. The Parliament's Reports go a long way to ensuring this is the case. But there are still two areas where we are hoping the Member States will improve the situation further," he continued.

Stimulating New Medicine Development - Step 1 in Solving the Crisis
The Parliament broadly supported the Commission's original proposals regarding data protection for new products - the "protected" period aimed at allowing companies to recoup investments made in bringing a new product to market. However, importantly they went further than the original draft, proposing protection for all species and new indications. "This is a very important step forward," explained Mr. Hird. "The Parliament has recognised that the medicines availability crisis is no longer limited to any sector but affects all animal species."

Keeping Existing Products On the Market - Step 2 in Solving the Crisis
The Parliament also supported the Commission's proposal to remove the requirement to re-license products every 5 years, even if no issues had been raised during a product's use. The requirement to re-license every 5 years has been identified as one of the major causes of the medicines availability crisis - companies simply cannot justify the repeated expenditure required to go through the licensing procedure every 5 years for products that may only be needed in small volumes. However, for new products, the Parliament proposed a compromise, whereby a license would need to be renewed after the first 5 years - giving a chance to check that there are no issues to be resolved. Thereafter, a raft of improvements to the constant, in-use surveillance system ("Pharmacovigilance") will provide constant safety monitoring.

Horses - A Special Animal With Special Requirements!
The European Parliament also rose to the challenge of solving the so-called "horse problem". Horses suffer from a particular lack of medicines, because they are regarded as a "food-producing species" by European law. Thus, their medicines must now pass the additional consumer safety studies required for food-producing species, meaning that many horse medicines have been lost from the market. Under the Parliament's proposals, companion- and sporting-horses - which are not intended to be eaten - will be able to have access to medicines provided appropriate identification schemes are in operation - the so-called "horse-passport."

…But Member States Urged to Complete the Job!
The European Parliament has taken some important steps to solve the medicines availability crisis, but there are still two main areas of concern.

Compulsory use of the Centralised Procedure will compromise medicines availability
"One area where the impact of the Commission's proposals on medicines availability is not fully understood is the requirement to register all new products via the Centralised Procedure," explained Mr. Hird. "This will have a serious impact on medicines availability. The Centralised Procedure should be a one-stop-shop for medicines that are needed throughout Europe. However, if a medicine is only needed in one region - for example, if a disease or a species is only found in one area - there is no need to get a licence for the whole of Europe. Some diseases - like heartworm - and some species - like salmon and reindeer - are only found in certain regions. Thus, medicines to treat them are only required in one area, and the number of potential patients is very small. Forcing products to be licensed centrally means an expensive process, for a potentially very small number of sales. "Going central means not just paying the cost of the licensing procedure itself, but it is also all of the related costs - such as translating the product literature into 13 languages - that may mean many products simply don't get licensed because the sums don't add up," explained Mr. Hird. "This is especially important when you consider that it is often Small- and Medium-Sized Enterprises (SMEs) that are developing niche products for local species."

And data protection provisions must encourage new product development for animals
Another area of concern is the Parliament's proposal that generic companies can submit applications for a marketing authorisation in Year 8 - effectively shortening the data protection period by 2 years. This may be very important in the human medicinal sector - where costs of treatment are, more often than not, borne by the national health services. But in the animal sector, where such health budget concerns are not an issue - all animal treatments must be paid for privately - the emphasis must be on developing new products! "To suggest that stimulating generics in the veterinary sector is more important than having new products is the wrong way around. We don't have enough products to start with - encouraging generics is not going to solve that problem. The emphasis must be on encouraging new animal medicines. If not, the medicines availability crisis is set to continue."

The Parliament has taken some very important steps forward in improving the regulatory framework for animal medicines in Europe. And the Rapporteurs, Mrs. Grossetête and Mrs. Müller, must be congratulated for their work. However, it is vital that the Member States now back up the work done by the European Parliament and take the last steps needed to establish a framework that will solve the medicines availability crisis.

NOTES TO EDITORS:
1. The EU's Regulatory framework was identified as the Number One cause of the Veterinary Medicines Availability Crisis, in a study released in January 2002. The research, carried out by Business Decisions, Ltd. on behalf of FEDESA, reveals that the Regulatory Framework governing the development, registration and licensing of medicines is the Number One obstacle both to development of new products and, significantly, also to making use of existing products. Both these elements are the key to ensuring that animals have access to licensed veterinary medicines.

2. The extent of the medicines availability crisis was outlined in a study carried out by the University of Gent. These revealed that the crisis was no longer confined to so-called "minor" species, but had also become a problem for even relatively common species like cats and dogs. More information is available from macg.htm.

3. FEDESA, the European Federation of Animal Health, represents the animal health industry in Europe. Its membership comprises national associations and companies.

4. Animals need medicines:
- If an animal falls ill, it should be able to receive treatment;
-Owners should have the right to be able to arrange treatment for their companion animals if they become ill, or have access to licensed products to prevent this occurring;
- Farmers should be able to treat their livestock with a registered, approved medicine if they fall ill;
- The public has the right to be protected from diseases that can be passed on to humans; and
- Consumers have the right to expect that animals - whose produce they eat - are free of disease.