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AnimalhealthEurope: We need to deliver solutions – but how?

At its recent annual conference, AnimalhealthEurope gathered delegates to discuss the importance of One Health. A hot topic was the role of animal health in this landscape. Animal Pharm analyst Sian Lazell heard how the industry needs to discover innovative solutions and how this can be achieved.

"Veterinary medicines play an important role in addressing the global challenges we are confronted with and deliver societal benefits. Therefore, it is important to not let them reach a bottleneck," said Dr Sabine Schueller, executive director of German industry federation Bundesverband für Tiergesundheit.

"We've heard a lot on funding, control and enforcement when it comes to controlling animal diseases. There's a lot more to that besides research. Before a vaccine can come to market, for example, there comes requirement, with that comes the framework that we work in."

Dr Schueller, a member of both HealthforAnimals and AnimalhealthEurope, showed a timeline demonstrating how animal health has contributed to One Health in the past and delivered solutions, explaining this is something that needs to continue.

However, she said in doing so, the industry will have to cope with a number of challenges intrinsic to its business.

Innovation in veterinary medicine

Although there has recently been some discussion about a lack of innovation in animal health, Dr Schueller said there is a lot of diversity in this space.

"If we start at the top, we provide solutions for the unmet needs. This is the core part, the heart of it," she said. "We can avoid the concept that animals need to be killed in order to control diseases, just by differentiating vaccinated from infected animals. We can protect the new-born, for example, by vaccinating the mother or by vaccinating in the egg.

"We support the responsible use of antibiotics by providing alternatives to defend against diseases or by optimizing the antibiotics themselves."

She also highlighted an important part of innovation is developing convenient forms to deliver medicines. However, she said this is a factor that while important, takes a lot of effort.

Different forms of available vaccination pinpointed by Dr Schueller included baits, spot-ons, pour-ons, eye drops, needless application and flavoured chewables.

Investment for 2025 and beyond

"Companies invest about 8% annual turnover in R&D but they have to invest about 30% of turnover to keep the product on the market. It takes between five and 11 years before you have a product on the market," Dr Schueller said.

"So when it comes to investment decisions, companies have to consider it's a decision they take that's important for 2025 or maybe even beyond. So this decision needs to be on very predictable, solid grounds.

"In the analysis for that, you have to look at scientific and regulatory feasibility, cost projection including manufacturing costs, time to market and approval, and sales forecast, including the sales risks."  

New technology brings opportunities and challenges

Dr Schueller said next to providing effective solutions to controlling infection, such as vaccines and antibiotics, the animal health industry's objective is also to minimize the risk of resistance development with different approaches.

"Quite often, meeting all the demands and matching the expectations seems to be mission impossible."

"New technologies, new modes of action provide opportunity to do so. With that, companies can mostly rely, in Europe, on a science-based evaluation and a transparent licensing procedure," she said.

However, Dr Schueller warned companies also have to consider risks, whether they are scientific, regulatory or economical. Additionally, new technologies bring their own challenges.

"Companies also have to pay attention more to the influence of public opinion and political decision taking," she said. 

"Increased application or precautionary principle is another thing. A low acceptance of new technology is something we also have to face. These factors are difficult to handle and very difficult to plan for. With that, prediction of timelines and probability of success become uncertain.

"Quite often, meeting all the demands and matching the expectations seems to be mission impossible."

She said a benchmark survey by HealthforAnimals, executed in 2015, saw an increasing negative impact in specific areas of regulation that impact on the ability to innovate. Innovation barriers identified included high regulatory density, constantly growing requirements, low acceptance of new technology and a high degree of uncertainty in market realization.  

"According to the companies surveyed, legislation in Europe had an impact on reducing the product range and the coverage of animal species. They see a need for improvement in areas of procedures and regulatory processes, harmonization, protection of technical documentation and pharmacovigilance. So there is a strong need to advance our regulatory framework," Dr Schueller stated.  

"In Europe, we have the chance right now. For example, by increasing the availability of veterinary medicines and the functioning of the internal market, by avoiding unnecessary, expensive re-evaluation of medicinal products, or harmonizing the use of national veterinary medicine products.

"We can stimulate innovation and competitiveness by improving the protection of technical data or by reducing the administrative burden and free up resources for innovation.

"At an international level, we can use VICH standards but also mutual recognition agreements which can help to achieve equal standards in the different regions of the world." 

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