The animal health industry needs certainty after Brexit to help protect UK animal health and welfare
The Chief Executive of National Office of Animal Health (NOAH) writes about the challenge to ensure UK vets and animal keepers retain access to the range of animal medicines in the UK that are currently available, to support the health and welfare of our farm livestock and pets after we leave the EU.
As Brexit political discussions run on, the UK animal health industry fears that time is running out to make the detailed technical decisions that will ensure UK vets and animal keepers retain access to the range of animal medicines in the UK that are currently available to support the health and welfare of our farm livestock and pets.
Since the Referendum in June 2016, UK animal medicines trade association NOAH has been working hard with its members to understand the implications of Brexit for the industry and to ensure continuity of supply of medicines for UK vets and animal keepers.
Concern is mounting that time is running out to allow businesses to be able to execute a smooth EU Exit process without interruption to the availability of veterinary medicines.
The impact will not just be on UK medicines supply. The risk to supply will impact many other Member States – in particular Ireland and smaller or more vulnerable markets.
A small but vital industry
The animal medicines sector is small, but has a big impact on British life, supporting the health of our pets, and is vital to our food supply, helping protect farm animal welfare by keeping them healthy. It’s vital that our sector’s needs are not lost in the general business clamour. We welcome the recognition of the excellent standards of welfare of the UK’s food producing animals, and the Prime Minister’s support for this into the future.
Like the human medicines industry, animal medicines are heavily regulated, and are equally subject to the stringent regulatory controls of their human counterparts. As with human medicine, there needs to be a close working relationship with the EU, in particular the European Medicines Agency (EMA), post-Brexit. Again, there have been positive words said on this future relationship.
A complex supply chain
In conjunction with European association AnimalhealthEurope, NOAH and the Irish association APHA, recently organised an event in the European Parliament to highlight our sector’s concerns. Co-hosted by UK MEPs, Julie Girling (EPP) and James Nicholson (ECR), Vice-President of the European Parliament, Irish MEP Mairead McGuinness also joined the event, where Brexit’s wider implications for the medicines supply of the EU-27 as well as the UK were discussed.
The production of veterinary medicines and supply to the UK and indeed EU-27 market is totally dependent on complex supply chains that must continue to function effectively after the UK leaves the EU. These supply chains will span the new UK EU border post Brexit. Raw materials will need to arrive at manufacturing sites and veterinary medicines will need to be transported across this border to meet market requirements. Any border delays, complex processes or increased costs will risk medicines availability.
A transition period is vital
NOAH members are adjusting their businesses to Brexit but according to a NOAH survey carried out in May, less than 15% of companies say they are prepared for a ‘hard Brexit’ scenario with the vast majority of respondents (almost 80%) saying they are ‘somewhat/not prepared’ should there be a reversion to WTO rules on 30 March 2019. This is neither through lack of effort, nor through unawareness of the need to act, but due to the magnitude of the tasks involved in such a specialist sector.
In contrast, almost 60% of companies are ‘prepared/very prepared’ for a transition period that would last to December 2020. Even then, the proposed transition period until December 2020 might not be enough in some cases. NOAH welcomes the UK Government’s efforts to secure this implementation period, but to make informed business decisions, clarity is urgently needed about the detail of how this will operate.
What was clear from the European Parliament event was that until there is clarity in relation to the bigger political picture, more detailed discussions cannot take place, say, in the European Parliament to try to agree solutions to our sector’s concerns. Moreover, there is currently no binding agreement, yet industry must make choices and potentially irreversible decisions now, based on the possibility of working without a transition period or facing a hard Brexit on 30 March 2019.
Veterinary medicines could become unavailable: pets and farm livestock could suffer
The survey examined product availability in the UK: almost 55% of respondents reported potential availability issues for the UK market impacting more than 40% of their products. The full spectrum of types of products (from vaccines to painkillers: from antibiotics to wormers) across all animal species (farm, equine and pet) are potentially at risk, with particular concerns raised around the supply chain for vaccines. There will also be potential impact on supply within the EU-27, particularly in Ireland.
There is a very real concern about product packaging. 70% companies are not fully prepared for packaging changes that may be needed, if there is no deal, after 30 March 2019. Packaging and labelling is an important part of the overall veterinary product carrying legally compliant information. It is vitally important for veterinary surgeons and animal keepers to ensure medicines are used correctly. With over 70% of NOAH members currently either manufacturing or having contract manufacturing in the UK for the EU market, the majority of these companies report that they are highly unlikely to be able to make the legally required changes to packaging by 30 March 2019. This means that, unless a solution is found and the transition period confirmed, perfectly safe medicines will go to waste, supply will be interrupted and animals cannot be treated.
Significantly, a large proportion of veterinary medicines have common packaging for the UK and other member states such as Ireland, without some form of agreement to continue these products will no longer be economically viable for either the UK or EU markets. For example, of the veterinary medicines available in Ireland, up to 70% share packaging with the UK, accounting for 60% of turnover. This will obviously have a huge potential impact if packaging between UK (post Brexit) and Ireland can no longer be shared. Every manufacturer would from that moment onwards have to produce dedicated packs for the Irish market, with all the associated costs of smaller volume runs, separate labelling, and most importantly separate stockholding. A solution needs to be found.
Innovation: remaining a primary market
As well as the implications for current medicines availability immediately post-Brexit, there are implications for the innovation and development of new medicines. Decisions to develop a new veterinary medicine are often made on a geographical basis i.e. a treatment for a disease occurring in a number of countries where the animal population is sufficient to obtain a return on investment and the EU is often viewed as a single region. Post Brexit, to ensure that access to new medicines is not delayed or lost for UK animals and to encourage companies to remain in the UK, some form of UK/EU ‘mutual recognition’ which permits a UK registered product access to the ‘EU region’ animal population and vice versa is needed.
Brexit represents an unprecedented challenge in terms of scale and scope for NOAH members’ businesses. The continued health of UK businesses depends on clarity from government, clarity on the implementation period and future trading conditions and the development of a UK regulatory system firmly based on internationally recognised science and technical expertise. It should be aligned, where necessary, with the forthcoming new EU legislation for veterinary medicines, as this is more supportive of innovation than the current regulatory environment. It will be important to ensure vets and animal keepers continue to have access to the medicines they need to maintain the animal health and welfare expected by the British public. UK government must deliver a regulatory environment to encourage innovation, investment, productivity and the development of new veterinary medicines.
Animal diseases do not recognise borders. The ultimate goal is to ensure continuity of animal medicines availability for all veterinary surgeons, farmers and pet owners in the UK and throughout Europe to safeguard animal health and welfare. For that, good words need to be transformed to action: our businesses need certainty and workable solutions need to be put in place to ensure minimum disruption to product development and approval and to maintain authorisations.
For more details see: https://www.noah.co.uk/focus-areas/brexit/