By Joseph Harvey
Animal Pharm News
July 6, 2016
Joseph Harvey: Overall, will Brexit have a positive or negative impact on Triveritas?
Julian Braidwood: The initial impact of the proposed Brexit has been very positive for Triveritas because of the fall in the value of UK pound sterling, which effectively caused a price drop for our current and future customers. We've already seen a contract being quickly signed and mainly pre-paid, enabling a client to take full advantage of the current favorable exchange rates.
Although Triveritas works mainly in three currencies (pound sterling, Euro and US dollar) most of our central overheads are in pounds and so the weakness of sterling is effectively making us more competitive to international clients.
Triveritas works worldwide and has its dedicated experts located in four EU member states (France, Germany, the UK and Poland), the US and Canada. We also have a network of established collaborators in Japan, China, Australia, New Zealand, South Africa, Argentina, Brazil, Chile, Mexico, Turkey, Italy and Spain. It is a very international business, and if the UK does leave the EU it means we will have expertise based additionally in the important UK market, plus three other EU member states, the US and Canada.
Assuming the UK does leave the EU, there will need to be consideration of the regulatory implications to the animal health industry. For example, there are nearly 350 EU Centralised Marketing Authorisations permitting the sales of novel veterinary products in the UK.
However, these Centralised Authorisations were granted under EU Regulation 726/2004 and are not authorized under UK law. To ensure animal health and welfare are protected then, it is clear these products should continue to be available, for the benefit of the animals and their owners, to allow veterinarians to prescribe suitable therapies, and for the commercial interests of the Marketing Authorisation Holders.
If a Centralised Marketing Authorisation is legally held by a UK company then presumably the ownership will need to continue to be with an entity within the EU or European Economic Area (EEA). It would appear appropriate to stay alert to this situation but it is currently too early to make any changes, especially because one post-Brexit political solution might involve the UK joining the EEA.
Similarly, it is EU Regulation 726/2004, rather than any UK law, which runs the Maximum Residue Level procedure ensuring that consumers of animal products are protected from violative residues that might arise from the use of animal health products.
Not only for consumer protection but also for international trade of edible animal products, it would seem that both the EU and UK would seek a mutually acceptable resolution to this potential issue.
Obviously no-one yet knows the final implications of the UK referendum vote, but it is clear that it is in the interests of both the UK and the EU to establish a positive trading relationship for mutual benefit.
This future relationship between the UK and the EU will include animal health. Triveritas believes it is well placed to expertly assist animal health companies to find solutions cost-effectively tailored to their needs.
JH: Do you think there is a perception from international clients that it will now become harder to work with UK animal health companies post-Brexit?
JB: Clearly international clients will have their own perceptions which are likely to change as the post-Brexit situation evolves, probably over the next two to three years.
Triveritas cannot see any fundamental reasons why international clients might find it harder to work with UK animal health companies post-Brexit. International clients already work in many sovereign jurisdictions and the UK will just be one more.
The UK is the world's fifth-largest economy – a major trading nation – and has large and profitable animal health markets for both companion and food species products. Furthermore, the UK animal health industry has decades of experience in operating to both VICH guidelines and to EU regulatory guidelines and requirements. It would seem that whatever the outcome of Brexit negotiations that UK animal health companies will continue to have global expertise and an international outlook.
The vast majority of animal health companies in the UK are already part of global organizations, and it is thought that all UK companies will remain very keen to trade with international clients.
JH: You have offices in the US and Canada. How will Brexit impact these businesses?
JB: Triveritas is continuing to expand its businesses in North America. Our North American-based regulatory experts cover the FDA's Center for Veterinary Medicine (CVM), the US Environmental Protection Agency, the USDA and the Canadian Food Inspection Agency. This compliments our established European expertise (including the UK post-Brexit) so that these businesses will continue to run coordinated trans-Atlantic projects under one roof as before. It is easier and more cost-effective for our clients to have this single coordinated approach.
Our experience in running VICH veterinary clinical trials will continue to include the use of protocols concurred with CVM of the FDA. Triveritas has already performed trials under a single concurred protocol with recruitment of cases from the US, the UK, France and Germany. Such studies have been performed with electronic data capture and have often followed the use of Parallel Scientific Advice (i.e. having both the US and EU regulators formally address identical issues before starting the trials).
In the last two weeks, Triveritas has grown its US-based monitoring capability. We now have up to five trained experts and are planning to add a further two. In short, we are confident that Brexit will not adversely affect these North American businesses.
JH: Are your clients worried about the possible implications of Brexit?
JB: We have had two clients enquiring about the possible implications of Brexit to their specific development and regulatory projects. In both cases, the clients were not worried but just wanted our help to ensure that appropriate steps were taken to protect their long-term interests. We were able to provide expert advice so that suitable plans could be used to ensure appropriate regulatory outcomes without any potential adverse commercial effects.
Triveritas also works on unregulated companion animal products – it is anticipated these will remain completely unaffected by Brexit.
JH: Are you optimistic for the future?
It is clear that at this stage, no-one knows the implications following Brexit, but with our in-depth understanding of the animal health regulations and product development issues within North America, the EU and the UK, Triveritas remains very optimistic about helping our clients in the future.
Reprinted with permission of Animal Pharm News