Animal Health Experts Call for Balanced Regulation to Ensure Availability of Veterinary Medicines

Animal Health Experts Call for Balanced Regulation to Ensure Availability of Veterinary Medicines

25/03/2011

Animal Health Experts Call for Balanced Regulation to Ensure Availability of Veterinary Medicines
London, 24 March 2011 – At the 2nd Global Animal Health Conference, which concluded yesterday, international experts highlighted the urgent need for a balanced regulatory environment which allows for innovation in the development of veterinary medicines. Over 100 animal health experts from around the world participated in the two day conference organised by the European Medicines Agency (EMA), the International Federation for Animal Health (IFAH) and the Drug Information Association (DIA).

Following the conclusion of the conference, IFAH Executive Director Barbara Freischem stated: “We are very pleased with the turnout as well as the content of the conference, which we hope has highlighted a vital and growing concern for the development of animal medicines. The demands of a growing population make it vital that we work even more cooperatively to ensure innovation and availability of medicines and treatments. Partnering with the European Medicines Agency and DIA to address these highly relevant issues, as well as some of the leading minds in our industry, we have been able to share valuable insights.

Though the Animal Health industry comprises only a fraction of the global pharmaceutical market, almost two-thirds of the diseases we know about can pass between animals and people. Consistent, effective regulation allows for additional research and innovation as increasing widespread medicine availability provides the whole world with the capacity to respond quickly to disease outbreaks, which is vital to protect both animal health and public health.”

At the conference it was recognised that there is a mutual benefit to industry and regulatory authorities sharing their knowledge and expertise as new technologies emerge.

IFAH President Eric Marée said: “Through conferences such as this, we hope to help promote an environment that facilitates the supply of innovative, quality products in a safe, consistently regulated and competitive market place. However, the regulatory hurdles currently faced by the industry can sometimes exceed even those of human health products.

Governments and regulators need to take the lead in ensuring a science-based, balanced environment that is equitably enforced. This is particularly important for developing countries, where part of the challenge is getting enough quality products on the markets to treat the relevant diseases. In emerging economies, with often significant agricultural exports, the challenge is to satisfy the requirements of the developed markets they supply while ensuring availability of locally needed products. Harmonisation of regulation for animal medicines would allow treatments to quickly become available across the world.”

David Mackay, Head of the Veterinary Medicines and Inspections Unit of the European Medicines Agency (EMA) concluded: “Availability is a complex issue. It involves creating the right environment for new products to reach as wide a market as possible and for existing products to stay on the market provided their benefits continue to outweigh any risks. This conference provided a unique opportunity for regulators to explore in depth how to strike the right balance between protecting public and animal health while not introducing unnecessary requirements or excessive delays that would impact negatively on availability."

Notes for editors

Topics addressed at the event included:
Opening session on the availability of veterinary medicines – Chaired by IFAH Executive Director Barbara Freischem and David Mackay, Head of the Veterinary Medicines and Product Data Management Unit of the EMA
The need for veterinary medicines in a global context – Chaired by Jeffrey C. Mariner, Veterinary Epidemiologist, International Livestock Research Institute (ILRI), Kenya and Wilhelm von Trott zu Solz, representing Boehringer Ingelheim Animal Health, Germany
Regulation appropriate for needs – Chaired by David Mackay, Head of Unit Veterinary Medicines and Product Data Management, EMA and Ellen de Brabander, Chief Scientific Officer and Head of Global R&D, MERIAL Limited, USA
Innovation in veterinary medicines and appropriate regulation – Barbara Freischem, Executive Director, IFAH and Steven D. Vaughn, DVM Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine, U.S. Food and Drug Administration, USA
Maintaining availability of existing products – Chaired by Kornelia Grein, Head of Veterinary Medicines, EMA and Rene Aerts, Vice-President R&D Biologicals, Intervet-Schering-Plough Animal Health, The Netherlands
Meeting the animal health needs for the 21st century – Chaired by Rick Hill, Director, Center for Veterinary Biologics USDA, Animal and Plant Health Inspection Service, Veterinary Services, USA and Elisabeth Erlacher-Vindel, Deputy Head of Scientific and Technical Department, The World Organisation for Animal Health (OIE), France

About IFAH
The International Federation for Animal Health (IFAH) is an organisation representing manufacturers of veterinary medicines, vaccines and other animal health products in both developed and developing countries across five continents. The mission of IFAH is to foster a greater understanding of animal health matters and promote a predictable, science-based regulatory environment that facilitates the supply of innovative and quality animal medicines, vaccines and other animal health products into a competitive market place. These products contribute to a healthy and safe food supply as well as a high standard of health and welfare for animals and people. For further information on IFAH, please visit www.ifahsec.org

About The European Medicines Agency (EMA)
The European Medicines Agency (EMA) is a decentralised agency of the European Commission whose main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.

About the DIA
The DIA is a neutral, global, professional, member-driven association of nearly 18,000 biotechnology, pharmaceutical, clinical or medical, academic and regulatory professionals, students and patient representatives. Through its international meetings, training courses, online learning and myriad of networking opportunities, the DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies, and services to improve health and well-being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China. For more information, visit www.diahome.org or call the DIA in Europe +41 61 225 51 51.

For further press information please contact 
Kim Hardie, Communications Director