Global Benchmarking Survey of the Animal Health Industry 2015 - Europe Report
Regulatory regimes can make or break the industry’s ability to fulfil its function of providing solutions to prevent and combat animal disease in an effective, cost-efficient and sustainable manner. The Global Benchmarking Survey 2015 report examines the interactions between industry and regulatory systems, particularly the impact of regulations on the animal health industry’s ability to be innovative and competitive. The outcome of this survey provides a wealth of information to support informed policy decisions in the continual search for best regulatory practice and opportunities for improvement.
Twenty years on from the first survey, 69% of respondents report that in Europe current procedures are stifling innovation and 100% of those interviewed cite a reduced range of treatment options available and a lack of availability for certain animal species as a direct result of the current regime.
Despite great efforts to harmonise regulatory procedures for veterinary medicines in Europe, respondents cite the high costs of maintaining products on the market and lack of harmonisation amongst member states for marketing authorisations as two major challenges. Over the past 4-5 years, the biggest concern for those surveyed has been the incapacity to address public concern on antimicrobial resistance (AMR) and the impact this has on policy-making. This creates an unpredictable regulatory environment and has seriously discouraged innovation in this area. The industry wishes to play its part to curb the development of resistance, but companies who once spearheaded the present portfolio of modern antibiotics cannot risk investment in new solutions that might be banned for veterinary use at some unknown point in the future.
There are many positive findings on improvements made to the regulatory processes over the past years with respondents reporting continued satisfaction with the centralised procedure for registering veterinary medicines, more scientific analysis using the benefit:risk approach, modernisation through electronic submissions and greater efficiency in the management of changes to the authorised information on the product. There is also a general welcome for many aspects of the proposed future Veterinary Medicines Regulation, including the approaches to protection of technical documentation, pharmacovigilance, labelling and variation simplification.