Declan O'Brian: "We’re trying to figure out how to present a new technology in a manner that addresses public perceptions of risk."

IFAH-Europe’s managing director, Declan O’Brien, tells Animal Pharm about how his organization is at the heart of efforts helping to stimulate innovation in the animal health industry.

Declan O’Brien took up his post at the head of IFAH-Europe in 2005, after working at the head of the Irish veterinary medicines industry association, the Animal and Plant Health Association. Now IFAH-Europe is at the heart of efforts to improve the environment for innovationbased animal health companies.

IFAH-Europe is chairing the European Technology Platform for Global Animal Health (ETPGAH), which will make proposals on how research money should be spent under the EU FP7 research program. The platform is a way of getting increased direction into public research, and it includes proposals like creating a list of priority diseases, and pushing for certain targets such as in-feed vaccination against avian influenza virus (AIV).

“The ETPGAH is very simple. We wish to agree on a list of priority diseases, identify the gaps that exist in our ability to control those diseases and develop products to fill those gaps. By coordinating our research effort, we will make progress much more quickly and efficiently,” said Mr O’Brien.

The proposals form part of the Action Plan following on from the Strategic Research Agenda (SRA), which Mr O’Brien said he hoped would be presented to the European Commission by the end of February. “DG Research has been very anxious in all areas to get industry to coordinate the effort for a technology platform - for us it’s a way of trying to get more coordination into public research,” said Mr O’Brien.

He said that many of the recommendations made under the SRA were likely to be funded via FP7. “I believe that some of our key recommendations have a good chance of being accepted, as they represent a consensus view of all stakeholders.”

“Everybody has a different view on the top 20 diseases that need to be tackled, so it took some time to get consensus on this matter.” A major obstacle to stimulating investment into new technology is the issue of patent protection, and Mr O’Brien explained that this was a central part of the proposals.

“It will be recommended that where a project is funded by public funds, there should be a clear plan in place to show how it gets intellectual property protection.”

“Our proposal would be that if DG Research is funding a program, then part of the specification for getting the funding would be a commitment to patent protection. Such protection may make the difference between a commercial partner being able to make a decision to invest in developing the idea, versus deciding that it is commercially impossible to invest - this is the difference between success and failure,” he explained.

Mr O’Brien also pointed out that a significant obstacle to scaling up research in immunologicals was the type of cell line that is used, and one proposal would be that cell lines needed to be scaleable for a proposal to receive funding - as such, appropriate standards should be specified in the project application. “If appropriate cell lines are not used at the start of the research, this may cause tremendous problems for people who want to develop the product,” said Mr O’Brien.

Another proposal is to gather information on infrastructure. For example, a laboratory to work with foot and mouth disease can be very expensive. One proposal suggests that resources should be pooled across organizations and countries so costs can be shared as opposed to duplicating expensive infrastructure.

In addition, exchange of information is something that would be beneficial to furthering innovation. “Education and exchange of researchers is also something we would recommend - people should spend time in other universities and in industry so they can gain knowledge,” he said. Regulation is a potential barrier to innovation, and Mr O’Brien said that this was something that he hoped would be addressed via the Action Plan.

He highlighted the requirements for veterinary medicines to go through similar approval processes as human medicines, even if the economic and social conditions of animal health are very different. For example, in-feed antibiotics used for therapeutic purposes have to be refined up to the point where they could be used as injections.

“That’s completely unnecessary as the medicine will be added to non-sterile feed - the use of a human standard in this context is inappropriate. We believe we should carry out some research asking people where the standards should be the same between both sectors but also where they should be different such that we prove safety, quality and efficacy in the most efficient manner,” he said.

Mr O’Brien believes the issue of societal acceptance of new technology needs to be tackled to stimulate innovation. “We would like to see some research carried out tapping into the social sciences to see what influences societal acceptance of new technologies,” he said.

“We’re trying to figure out how to present a new technology in a manner that addresses public perceptions of risk.

“As we see more and more possibilities for new products coming out of our greater understanding of genetics, we need to know where we can use products that have a greater impact against a disease and how they are going to be externally perceived,” he said.

Mr O’Brien also pointed out that the technology platform had a global aspect because global events affect Europe. “It’s called the global animal health platform as we believe that much of the research would have to be carried out outside the EU, for example in diseases that are not endemic in the EU.

“As an example, if you can reduce the global incidence of avian influenza, then the chances of it getting into the EU are decreased,” he said. The SRA is important, explains Mr O’Brien, because it allows DG Research to know what the consensus priorities for research are within the animal health sector.

“By putting everybody together in the research platform we get them to agree on the priorities,” he explained. The creation of national platforms is also being discussed in European member states, because the majority of research funding is available at national level. “FP7 represents 10% of the total funding of research in the EU, 90% of funding comes from member states.

“So now we are discussing the creation of mirror groups in member states, where stakeholders will come together to see what kind of research in animal health is relevant to them,” he said, adding that the national chief veterinary officers have shown a great interest in the ETPGAH.

IFAH-Europe has also put its weight into setting up a forum aimed at discussing and promoting the responsible use of veterinary medicines, along the lines of the UK’s Responsible Use of Medicines in Agriculture (RUMA). The forum, EPRUMA, is being developed in collaboration with the Federation of Veterinarians in Europe, and COPA-COGECA, the representative organization of European farmers and agricultural cooperatives.

“Part of what we are trying to do is to ensure that products are used in a way that minimizes the possibility of the development of antimicrobial resistance. We are documenting the factors that should be taken into account before an antimicrobial is used,” said Mr O’Brien. Overall, Mr O’Brien and his team at IFAH-Europe are concentrating on creating an environment where innovation can take place, while ensuring safety requirements are met.

“Our mantra that we often use is that all regulatory decisions should be science-based,” he said. “If they are science-based then we have a level of certainty, but if we have politics overriding science then we create a level of uncertainty which can be a major block to innovation. “At the moment the level of certainty is very low, we never know what is around the corner,” he said.

For Mr O’Brien, getting recognition for the animal health industry’s role in protecting human health is at the heart of changing society’s perception of animal health. “Avian influenza has had a role to play in creating recognition for the role of animal health,” he said. “Avian influenza and bluetongue have made that point clearly.”

And it’s the all-important public perception that would lead to a change in policies and clear the way for more innovation in animal health, he said. “We need the European Union to recognize that we are an important partner in safeguarding animal as well as human health in Europe. Political decision-makers must allow us to develop our products in an economic and timely manner such that we can play our role in delivering the benefits of our products to society,” he said.