Our work on EU Exit
NOAH Brexit Briefing – ensuring veterinary medicines availability
- The UK exit from the EU represents an unprecedented challenge in scale and scope for animal medicine businesses.
- Vets and animal keepers must continue to have access to the medicines they need to maintain the animal health and welfare standards expected by the British public.
- The health of UK businesses depends on clarity from government on the Implementation Period and future trading conditions.
- UK government must deliver a regulatory environment to encourage innovation, investment, productivity and the development of new veterinary medicines.
- NOAH and our members are open to engage fully to assist UK government in identifying solutions to issues arising from our exit from the EU
Functioning Supply Chains
The production of veterinary medicines and supply to the UK market is totally dependent on complex supply chains that must continue to function effectively. 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 in the UK.
Regulatory Challenges & Solutions
Implementation Period. The animal medicines industry welcomes Government efforts to secure an Implementation Period, but to make informed business decisions, clarity is urgently needed about the detail of how this will operate. Currently, there is no binding agreement but industry must make choices and potentially irreversible decisions now, based on the possibility of working within an Implementation Period or facing a hard Brexit.
Ensuring UK availability of current and 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. Significantly, a large proportion of veterinary medicines are dual labelled 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.
Keeping regulatory efficiencies. For many veterinary medicines, work on EU applications for marketing authorisations is carried out by one or two EU countries, then recognised by the others. This has led to efficiencies and reduced resource needs for businesses and regulators. There are clear benefits to retaining some access to this system so work is not duplicated for the UK and there needs to be a close working relationship with the EU, in particular the European Medicines Agency (EMA), post-Brexit.
Tackling antibiotic resistance. As resistant bacteria can readily move with the international movement of people, animals and food, the UK must continue to collaborate and co-ordinate with the EU in tackling this important issue.
Ensuring food safety and continued trade. To ensure food is free from any harmful residues, maximum residue levels (MRLs) are set for withdrawal periods (i.e. the time between and animal receiving the last dose of a veterinary medicine and the first collection of foodstuffs e.g. milk). Currently this is carried out by regulatory experts at the European Medicines Agency. Following Brexit, the UK will need to avoid costly and unnecessary duplication of work and establish a system to recognise the sound, science-based decisions made by other international authorities, such as the EMA, to adopt the same MRLs for substances and withdrawal period for products on the UK market.
Animal diseases do not respect borders. In the future, we will need to continue to co-operate on European disease surveillance to ensure that measures are in place to prevent and control disease outbreaks in the UK.
Future regulation of veterinary medicines in the UK. Improvements to the regulation of veterinary medicines in Europe will take effect across Europe in the next 3 to 4 years and it will be important for business that the UK regulatory system is able to take advantage of the opportunity to embody similar improvements to the UK regulatory system. A bilateral treaty could be one solution with the UK recognising the EU legislation and providing expertise and capacity from UK. Certain animal health products are currently regulated by the European Food Safety Authority (EFSA). Clarity on a suitable UK process to replace EFSA is urgently required.
Research, Development and Innovation
Helping innovation. Development of new veterinary medicines will continue to be needed to address disease challenges. Incentives to stimulate innovation, for example to provide alternatives to antibiotics, or vaccines for new emerging diseases, must be brought forward and it is important companies can focus their R&D spend on innovation. Any reduction in costly administrative burden, and improvements in the protection of company’s technical documentation will help strengthen the case for R&D investment and development of new veterinary medicines.
Protecting UK science. Clarity over future funding opportunities for scientific research is needed to avoid an erosion of the UK veterinary science base. UK government should consider funding availability for scientists to work in the UK and collaborate internationally ensuring the UK retains its world leading status in veterinary science research.
High standards of animal health are integral to good animal welfare; veterinary medicines are vital for good health, preventing and treating disease in our farm animals and pets. Continued access to these medicines requires a functional supply chain, without border delays and complex processes, on the day one of EU exit. To make informed business decisions, industry urgently needs clarity now on how an Implementation Period would operate. We must not risk the UK becoming a ‘second tier’ country for medicines supply. Vitally, this depends on a negotiated, constructive post-Brexit relationship between the UK Government and the EU.
Download the NOAH contingency planning statement (January 2019)
NOAH’s 4th Brexit Barometer
NOAH is producing a series of reports testing the opinion of the animal medicines industry as to how the view the impact of Brexit on its future and on the future for health and welfare of the UK’s animals.
Download the 4th Report produced in winter 2018 – here
Download the 3rd Report produced in summer 2018 – here
Download the 2nd Report produced in winter 2017/18 – here
Download the 1st Report produced in summer 2017 – here
Industry viewpoints – Brexit Barometer 3
Hear industry experts from Nimrod, AnimalPharm, AnimalhealthEurope, the British Veterinary Association (BVA) and Zoetis discuss their views on the animal medicines industry post-Brexit.
(filmed at NOAH Members’ Day 15 June 2018)
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