Advocating for Regulatory Processes & Funding to Address Unmet Animal Health Needs

Animal medicines and health products are necessary to prevent, diagnose and treat disease across over fifty different animal species. Developing innovations that are effective across this diverse landscape is a significant challenge, which is why a policy and regulatory environment that recognizes the unique characteristics of the animal health sector is essential. A new medicine or product can take anywhere from five to 15 years from first discovery until it is available to treat an animal. Animal health in general has less intellectual property protection, meaning the opportunity to recoup this investment is time-limited.

In the United States this problem is even more acute.  In Europe, companies have 10 years data protection once a new product receives a “market approval.” In the U.S., data protection lasts just five years, much of which can be absorbed by the global standard-setting process. For example, establishing Maximum Residue Levels (MRLs) for trade is necessary before a product can be used by producers who wish to export. This means that by the time a product can be widely used, it may have already lost this exclusivity protection and faces generic competition before the innovator can obtain a return on investment.

Furthermore, once a product receives market approval, Good Manufacturing Practices (GMP) that are tailored to human health are often applied to the animal health sector. Without adapted GMP, an animal health product can face unnecessary requirements that may make it financially unfeasible to manufacture. Altogether, this has contributed to a downward trend in the number of new approvals in some markets. In the early 1970s, U.S. approval rates for new animal products were on par with those for human medicine. While the rate of approval for human medicines skyrocketed to a peak of more than 400 by the mid-1990s, approvals in animal health have dwindled below 50.