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IFAH reveals outcome of Global Benchmarking Survey on Animal Health Industry

Calls for realistic risk assessment approach in order to achieve best regulatory practice

Brussels, 20 November 2012 – The fourth successive five-yearly Benchmarking Survey commissioned by the International Federation for Animal Health (IFAH) highlights the need to work globally towards a benefit: risk assessment framework. The findings come at a time when governments around the world are weighing the direct and indirect costs of regulatory policies for veterinary medicines.

Key findings in the report include:

• Time to gain registrations, i.e. time to market, has increased in all regions, with the notable exception of Canada, where consultation and collaboration between regulatory agencies and industry associations has been particularly successful.

• Cost of gaining registration increased in all regions, and, again with the exception of Canada, beyond the cumulative inflation in the countries over the time considered.

• Key recommendations include the suggestion for best practices in one region to be considered in others; increased sharing of information between industry and regulators regarding veterinary knowledge or innovation; and a continued dialogue between industry and regulators to achieve a realistic risk assessment approach that weighs benefits and risks afforded by a given product. Snapshot of results from the regions include:

o 89% of Australian interviewees believe that the current regulatory framework is one of the biggest obstacles to innovation. o In Canada, where a considerable improvement has been achieved since 2006, challenges include the importation and use of non-approved pharmaceuticals, and manufacturing requirements that equal those of human health products.

o In Europe, as a result of the European Commission’s focus on ‘Better Regulation’ and the on-going review of veterinary medicinal product legislation, the overall outlook is relatively positive. However, concern over increasing demands is shared globally. o While the Japanese regulators’ increasing acceptance of high quality data from other regions was welcomed by the industry, the sequential timelines of the many committees involved in regulatory processes remains a challenge.

o In the US, three agencies were surveyed: The Center for Veterinary Biologics, US Department for Agriculture; The Center for Veterinary Medicine, Food and Drug Administration; and the Environmental Protection Agency. The Environmental Protection Agency, included in the survey for the first time, received the lowest scores.

o A lack of clear lines of responsibility between the three agencies for biotechnology-derived products is seen as a challenge going forward.

The survey collected 21,000 individual data points and up to 400 free-text responses from IFAH’s member companies and some local member companies of IFAH’s member associations in Australia, Canada, Europe, Japan and the USA in 2011. The aim was to examine interactions between industry and regulatory systems, particularly the impact of regulations on the animal health industry’s ability to be innovative, competitive, and effective. The United States and Europe each account for approximately one third of global sales, significantly higher than other regions. Japan’s share of global sales is over twice that of Australia and Canada. The results of the latest survey come at a time when governments are examining the roles and costs of their regulatory agencies. The findings can play an important role in supporting informed policy decisions during this review period and provide an opportunity to analyse and learn from best practices across regions. While there has been progress since 2006, significant concerns and challenges remain and in many instances outweigh positive changes. Barbara Freischem, IFAH’s Executive Director, comments: “The findings of this survey provides an invaluable wealth of information to support informed policy decisions in the continual search for best regulatory practice and opportunities for improvement.” “Crucially, the survey shows that the most important measures – time and cost to market – have continued to increase in all key regions with the exception of Canada, while zero-risk regulatory mandates have continued to slow product development and innovation. A realistic risk assessment approach within a benefit : risk evaluation framework is essential, in order to manage and improve this impediment to animal health.”

Notes for editors

A concise summary (11 pages) with data appendices, as well as a PowerPoint presentation are available for download from www.ifahsec.org. For more detailed information on the regional reports, please contact the relevant industry association or see their websites:

• Australia: www.animalhealthalliance.org.au/; Australia Report

• Canada: www.cahi-icsa.ca/

• Europe: www.ifaheurope.org; Europe Report

• Japan: www.jvpa.jp/jvpa/

• US: www.ahi.org

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