She said that veterinary generics manufacturers could take advantage of the new landscape. Generics have a 45% share of total global veterinary sales, with sales of generics forecast to outstrip patented veterinary medicines by 2010. Dr Cromie said that generics were firmly established in developing regions.

The Bolar clause in EU legislation highlighted the lack of harmonization among member states and would go some way to improving the situation, the conference heard. This clause states that a generics company can initiate the approval process for a product while the original is still under patent. Several activities could be exempt in some member states but not in others, and differences in interpretation by the courts and member states might become problematic for companies.

Dr Cromie suggested that the Bolar text could eventually bring benefits, by stimulating R&D in the EU and by standardizing laws and procedures in the EU and the European Economic Area. It would also give greater legal certainty than the present national provisions, she added.

Dr Katie Barrett of Huntingdon Life Sciences agreed that it took more time to develop a product in the EU than in the US, and said that the Environmental Risk Assessment (ERA) must not further delay the process. Veterinary drug manufacturers are now required to include an ERA as part of the benefit/risk assessment of a veterinary product.

She said that careful and thorough study design could help with the approvals process. However, R&D was frequently used to maintain an existing product on the market than to develop a new medicine, creating a return on investment that was often hard to calculate. Dr Barrett emphasized that the quality of data underpinning an application should be validated to avoid possible problems.

Dr Alex Tait, senior environmental safety assessor of the UK's Veterinary Medicines Directorate (VMD), presented a regulatory perspective of the Environmental Risk Assessment (ERA). ERA is mandatory for all marketing authorizations (MAs), including those for generics. When applying for a generic MA, manufacturers cannot use existing ERA data, a topic that has angered many generics companies. They must also follow VICH guidelines, an agreement on Europe, the US and Japan aimed at harmonizing technical requirements for veterinary product registration. Although they can use data already in the public domain, published data must refer to specific studies, and end points and published summaries of ERA are not allowed.

Yes, give me a free trial in print and online in PDF and online Name: Surname: Job Title: Company: Address: City: Country: Post/Zip Code: Tel: Email:     Privacy Policy

Dr Tait compared the VICH guidelines with those of the CVMP. The VICH guidelines have a two-phase assessment, but with no regional details, while the CVMP ones are due to be updated. Dr Tait said that the first phase of an ERA could be quite short, possibly one or two pages, pointing out that this stage assesses exposure, not risk.

Rhona Banks, director of regulatory affairs at Triveritas, gave an industry view of the amendment of variations requirements. She said the current situation of national variations was too complicated, with each country having its own systems. The industry was keen to have a centralized, evaluation system led by the European Medicines Agency, the EMEA.

The EU is trying to simplify legislation, and Dr Banks was optimistic that positive change was imminent, such as the proposed variations system, which would also cover national variations. Work sharing, currently problematic for regulators, was one of the special procedures covered by the variation system. National authorities rejected the idea of an EMEA-led system, but other systems were under discussion.

Regulators speaking at the conference were keen to show they understood the concerns of veterinary medicine manufacturers. Dr Gabriel Beechinor, director of veterinary medicines at the Irish Medicines Board (IMB), agreed that the regulatory environment is complex and challenging, especially for smaller companies.

Many medicines are abandoned by manufacturers before being authorized, and defensive spending was twice as high as in North America. In smaller markets, there was little impetus to develop new animal medicines because they were unlikely to present a substantial return on investment.

The EU's guideline on data required for medicines for minor use or minor species (MUMS) attempts to combat the loss of veterinary medicines and their indications throughout the EU. It was adopted by the EU's science committee for veterinary products, the CVMP, last month.

Dr Beechinor said that it established legal provisions to address national problems. These include the ability to authorize medicines already approved by another member state, introducing conditional authorizations and allowing the designation of medicines for sport horses.

Member states are moving towards MUMS, but are not yet using all the provisions, the conference heard. The Heads of Veterinary Medicines Agencies (HMA-V) expects to monitor MUMS in the future, examining issues as they arise. Member states need to take steps to encourage the uptake of MUMS, possibly through more work sharing, said Dr Beechinor.

The conference discussed the role of consumers and worker protection organizations in animal health issues. Dr Emma Soto of the European Commission's Health and Consumer Protection DG Sanco said that the public was interested in animal health. She is involved in the drafting and management of EU legislation concerning animal health at DG Sanco.

She highlighted high-profile cases, such as bovine spongiform encephalopathy, which had led to traceability initiatives across the EU, as well as new feed legislation and a ban on certain ingredients in feed. The decline in BSE cases, from 37,300 affected animals in 1993 to 320 in 2006, demonstrated the success of introducing safety, traceability and responsibility to the EU's food laws, she said.

Per Have, senior scientific officer at the European Food Safety Authority (EFSA), said that consumer confidence had been damaged by food scares such as BSE and traces of dioxin found in food. Consumers had lost faith in the food chain and they were starting to distrust public authorities and bodies.

Mr Have said that the stamping out strategy for controlling animal diseases was highly unpopular and had called attention to animal diseases. Prevention was better than cure, but vaccination was a difficult strategy in many ways. When evaluating it, EFSA had to examine issues relating to whether vaccination was fit for purpose, along with protocols and the effectiveness of vaccination for specific diseases.

Although EFSA should actively consider consumers as a stakeholder group, a question and answer session revealed that when it consulted on vaccinating poultry against avian influenza, no consumer groups were consulted, only the industry, the conference heard. Mr Have said consumers should be involved. But poultry was safe as a foodstuff for consumers after vaccination against the virus, and that there were advantages for poultry industry workers if poultry were vaccinated, he said.