Results from a global survey commissioned by HealthforAnimals have revealed the most common regulatory barriers shared by animal health markets worldwide.
Since 1996, HealthforAnimals — an organization representing manufacturers of veterinary medicines, vaccines and other animal health products in both developed and developing countries across five continents — has benchmarked the status of regional regulatory frameworks for veterinary medicines. The latest “Global Benchmarking Survey” received a total of 79 responses from across Europe, the U.S., Australia, Japan, China and Brazil.

The focus of the survey centered on animal health and veterinary products, including: pharmaceuticals, in-feed medicinals, biologicals and pesticide-based products.
According to HealthforAnimals, shared barriers include:

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1.The time and expense required for research and development (R&D).
The most significant regulatory barriers to innovation identified were increases in the cost and time for new product development. All regions surveyed were concerned about these increases, with the exception of Canada, where overall new product development time has fallen since 2011 due to decreases in the regulatory review component. The highest costs were reported in Europe, reflecting increases due to the application of requirements for environmental risk assessments and studies addressing the potential development of antimicrobial resistance.

2.Market uncertainty.
The past four to five years have seen mounting political pressure on the animal health sector to address the use of antibiotics in all animals. While the continuing political pressure might result in novel non-antibiotic ways of controlling or preventing disease, the common view is that the current situation introduces tremendous strategic and financial uncertainty into the market.

3.An increase in mandatory defensive R&D (MDR&D) expenditure.
Across the surveyed regions, an average 15-39% of available R&D budget was spent on the studies and regulatory activities necessary to just keep a product on the market. Overall, 55% of the companies surveyed reported an increase in expenditure on MDR&D. In particular, a high percentage of companies in Brazil and the U.S. reported increases in MDR&D expenditures since 2011.

4.Global data harmonization and electronic submissions. 
Incompatibilities in e-submission requirements and the cost of ensuring that data packages are valid for all territories were factors noted as creating a barrier to efficient and productive data sharing. In response to these challenges, survey respondents suggested expanding e-submissions and continuing progress on the harmonization of data sharing.

5.Pharmaceutical guidelines.
A further common concern is that regulatory expectations for animal health products continue to be inappropriately conditioned by human pharmaceutical frameworks, guidelines and procedures. Besides differing in many respects from human health, the animal health sector is around 2.5% of the total global health market ($24 billion in 2015) and encompasses a diversity of species and business types, including companion animal products and livestock.

Commenting on the survey’s findings, HealthforAnimals executive director Carel du Marchie Sarvaas said, “Progress has been made within the industry, and as seen with Canada’s example, where review time has (been) reduced, it is possible to push for greater efficiencies in the regulatory process. Positively, the industry is beginning to make more use of new digital tools and approaches. For Canada, China, Japan and the U.S., there was positive feedback about the regulatory environment from at least 45% of companies.

“Nonetheless, as demonstrated by the survey responses, there remain common barriers to innovation in animal health,” Sarvaas added. “Cooperation on a global level will be required to drive innovation in the animal health sector. This is becoming increasingly important in the face of global health challenges such as antimicrobial resistance.”

He noted that within the antimicrobial resistance debate between industry science and political decisions, “sadly, the voice of science has often not been heeded. Understandably, companies are hesitant to risk investment in developments that might be banned at some unknown point in their pathway to the market, with incalculable cost. It, therefore, remains vitally important that we continue to search for best regulatory practice and opportunities for improvement.”

Global industry goals
HealthforAnimals listed the following as global industry aims:
* Further expand e-submissions and interagency collaboration across territories to make the best use of high-quality foreign data and approvals from well-regulated countries.

* Greater transparency, predictability, efficiency and flexibility of agencies, with enhanced staff training and expertise and increased staff numbers, are seen as critical for agencies to overcome the disruptive effects of changes in regulations and guidelines and to become innovation-ready.

* Reduce the costs of maintaining products on the market by streamlining excessive regulation of minor or frequent changes to products and manufacturing.

* Further improve policies, such as encouraging a deeper and more consistent application of risk-based approaches and using simpler rules for companion animal products, which 32% of companies noted.

To read the 2015 “Global Benchmarking Survey” in full, visit www.healthforanimals.org