Written evidence submitted by NOAH (FS0033)
NOAH represents the UK animal health industry – including the companies that research, develop, manufacture and market licensed animal medicines in the UK. NOAH member companies are responsible for around 97% of the UK animal medicines market, at the forefront of R&D, science and innovation.
We are pleased to contribute to this consultation, which we will address very much from the perspective of the security of food derived from animals farmed in the UK – predominantly cattle, sheep, pigs, poultry and fish.
Q1 What are the key factors affecting the resilience of food supply chains and causing disruption and rising food process – including input costs, labour shortages and global events? What are the consequences for UK businesses and consumers?
NOAH believes putting measures in place to improve animal health will have a positive influence on the resilience of food supply, we will focus on these measures in this submission.
Taking an animal health perspective delivers benefits in terms of welfare, productivity, sustainability and the resilience of UK farms – all helping farmers to adapt to changing times caused by external events, such as the UK’s exit from EU, increased input costs and changing climate conditions. NOAH’s overall priority is to help secure a sustainable long-term future for farming and the rural economy.
Addressing this topic can be split, from our perspective, into two parts:
1 Availability: Innovation and supply of animal medicines
1.1 Expedite the Veterinary Medicines Regulation Review
To ensure continuity of supply of food to UK consumers from UK farms and so they can compete on a global market, farmers need to be able to adopt and implement innovation. This includes tools, such as veterinary medicines, to improve the health of the animals they keep.
NOAH members are at the forefront of delivering cutting-edge innovations, for example, pioneering new vaccines to prevent disease, diagnostic tools, digital technologies, as well as real-time monitoring and surveillance to catch the first signs of any ill health.
Veterinary medicines are, quite rightly, regulated to a rigorous, high standard and the regulation that controls their authorisation and supply, the UK Veterinary Medicines Regulations 2013 (VMR), is on the cusp of review, with a consultation due from the regulatory authority, the Veterinary Medicines Directorate (VMD), imminently. This consultation has already been delayed. A failure to expedite this update and to ensure that our Regulations are fit for purpose will lead to the UK becoming a lower priority market for new product launches, thus potentially impacting the availability of new veterinary medicines and solutions for UK farmers. We urge that parliamentary time is given to the VMR Review, and that there is no further delay.
1.2 Regulations and regulators fit for innovation
The Review gives an opportunity for the Government to reduce unnecessary administrative burden, which would encourage innovation, support competitiveness and increase the availability of choice of veterinary medicines here in the UK.
The new VMR needs to be fit for purpose to be able to respond to new technologies. It is also important that the regulatory body itself, the VMD, has available sufficient resource with the necessary expertise to carry out their vital role in supporting animal and public health.
1.3 Northern Ireland – a special case
The majority of animal health companies have operated historically in both Great Britain (GB) and Northern Ireland (NI) with the NI business being managed and supplied from GB.
NOAH member companies are growing increasingly concerned about the implications of the Northern Ireland Protocol (NIP) for their ability to fulfil regulatory requirements to maintain product authorisations, the impact on supply chains and disruption to product supply – with impact on farmers and their ability to produce food.
NI is a small market for products meaning that the introduction of any NI specific requirements, either from a regulatory or supply chain point of view, poses serious challenges to product supply.
The NIP in its current form will lead to NI specific requirements putting many products at risk of being discontinued for the NI market.
An ‘all island of Ireland’ Marketing Authorisation (product licence) approach is not the solution. Products authorised in the Republic of Ireland are not automatically legally authorised in NI. The UK regulatory agency for veterinary medicines, the VMD remains the regulator for NI.
Industry estimates that between 40%-50% of product portfolios are already at risk of being removed from the NI market, resulting in a negative impact on disease status and animal health and welfare – with consequential impact on NI farmers able to continue to supply.
Agreement between the UK and EU has already been achieved to adapt the NIP for human medicines which addresses many of the industry concerns – we seek similar solutions to those agreed for human medicines.
1.4 Complexity of medicines supply – importance of trade deals
Consistent supply of food from animals could be interrupted by disease, hence potentially impacted by interruption to tools to support animal health and prevent this disease. This could include new diseases, as climate changes impact the disease profile of the UK.
The majority of veterinary medicines used in the UK are manufactured outside of the UK. Supply chains for finished veterinary medicines generally work on a ‘just in time delivery concept’ and for this to function, smooth functioning supply chains without delays when moving across borders is essential. Issues such as warehouse availability and cost, warehouse conditions for temperature sensitive products such as vaccines and product stability and shelf life all prevent companies from being able to maintain large quantities of warehoused veterinary medicinal products in reserve here in the UK.
Furthermore, decisions around manufacturing strategy including manufacturing sites (for both active ingredients and finished veterinary medicines) are usually driven at a global level within individual companies. This means changes to this strategy are highly complex, with very long lead in times. Manufacturing sites produce products for multiple countries and regions, not with a focus on manufacture for individual countries only. Our member companies’ products, including active ingredients, excipients and finished products, often move on multiple occasions across multiple borders - this means that functioning trade agreements with multiple countries and regions and a smooth flow within global supply chains are needed to avoid disruption to product supply and availability.
Whilst companies make every effort to maintain supply, there is a vulnerability to disruption, given the complexity of international supply chains for veterinary medicines and animal health products. As a result, we welcome government efforts to mitigate against disruption and consider what can be done to mitigate against such problems.
This includes trade deals where trade in veterinary medicines should be free of tariffs and quotas, and rules of origin should not restrict supply and manufacturing processes.
2 Delivery: Preventive health and access to medicines
2.1 Preventive health improves farm resilience and food supply
Preventive health is key to improved farm resilience and greater security for the supply chain from UK farms. NOAH advocates a holistic approach looking at improving livestock management, nutrition and biosecurity – and a progressive vaccination policy sits at the heart of improving health and welfare. For example, NOAH has recently produced a Livestock Vaccination Guideline for ruminants (dairy, beef and sheep)(1) which sets out a vaccination strategy to sit within the toolbox of measures available to manage the health of flocks and herds on UK farms. The Guideline provide a distillation of veterinary clinical experience and research to demonstrate current thinking on a proactive approach to vaccination – getting the most from the tools we have.
Collaboration is vital within the industry and between governments and industry: the aim is to encourage best practice and the discussion between vets and farmers to apply effective vaccination strategies on the farm. For example, as part of the Animal Health and Welfare Pathway in England, an annual health and welfare review has been introduced, with one important facet being that public funding can here contribute to health and welfare – and consequently productivity and resilience enhancement. Particularly in difficult times, we believe this is important and support the Pathway’s prioritisation of endemic diseases such as BVD for cattle and diseases inducing abortion and lameness for sheep. We would like to see this prioritisation continue.
2.2 Veterinary workforce in crisis
However, the veterinary profession, both veterinary surgeons and veterinary nurses, is under extreme pressure with a recruitment and retention crisis. This has been exacerbated by external pressures such as Covid and the UK’s exit from the EU. This was highlighted by the British Veterinary Association, citing a drop of 68% new EU registrants reported by the Royal College of Veterinary Surgeons (RCVS) coming to work in the UK in 2 years as one of the causal elements(2). The Government is aware of these issues, for example through the submission to DEFRA by the RCVS with a view to seek new legislation to replace the Veterinary Surgeons Act 1966 with new legislation(3).
It is imperative that issues surrounding the veterinary workforce are a priority and the Government gives the veterinary profession its support to help alleviate the workforce crisis.
2.3 The POM-VPS classification and SQPs are needed for proactive prevention
To maintain the preventive health plan for farm resilience and a secure food supply, farmers need access to tools such as veterinary medicines and advice. The Suitably Qualified Person (SQP) is an important option for the prescription and distribution of a range of veterinary medicinal products for farm animals. This need is exacerbated by these shortfalls in availability of veterinary surgeons and veterinary services, particularly in rural areas.
Veterinary medicines are legally classified for prescription and supply as POM-V, POM-VPS, NFA-VPS and AVM-GSL. POM-V medicines must be prescribed by a vet, but POM-VPS medicines can also be prescribed and supplied by an SQP.
For the protection of the health and welfare of livestock, the POM-VPS route is a very important distribution channel and necessary to ensure livestock keepers have access to the range of products for which POM-VPS is an appropriate classification, granted by the regulatory authority on the basis of the product profile. These include products which prevent or treat some of the most common parasitic diseases and some vaccines. SQPs are an essential tool to help prevent negative animal health and welfare outcomes arising from such shortcomings – with the forthcoming review of the VMR mentioned earlier, it is important that all the current distribution categories remain and SQPs remain available to help maintain and improve the health of the nation’s animals.
Q4: How will the proposals in the Government’s Food Strategy Policy Paper affect:
We welcome the recognition of the importance of innovation within the Policy Paper and look forward, as a sector, to playing our part in the objective to reduce emissions. We note that the Call for Evidence on feed additives to reduce emissions has been issued but we would also like to re-state the important role that better animal health can have on emission reduction, as well as on farm resilience and productivity.
A report called Acting on Methane was published by the Ruminant Health and Welfare Group in April this year(4). This is a UK wide industry body working on ruminant disease and improving the welfare status of our national flock and herd and the report highlights the role that reducing key endemic diseases in ruminants can play in contributing to the Global Methane Pledge to reduce emissions by 30% by 2030. Delivering improvements in animal health is very much part of this solution and measures such as NOAH’s Livestock Vaccination Guideline can support this work.
Within the Paper, we would like to comment on a few specific sections:
1.2.5 – we welcome the recognition of the Animal Health and Welfare Pathway and the importance of the veterinary visit. We will continue to support efforts towards strengthening resilience of the supply chain at source through improved animal health.
1.5.5 – the aim to reduce barriers and unnecessary bureaucracy is sound: however, for our sector it must be remembered that the animal medicines sector operates on a regional and global basis. For this reason, should the UK diverge excessively from the EU regulatory approach, for example requiring UK specific reports and data to be generated, this will lead to a significant increased administrative burden for animal medicines companies and could impact on the potential for investment in UK animal health and the availability of innovative products for UK farmers. Where possible, UK should adhere to, and encourage uptake and use of the international harmonisation of regulatory requirements, through bodies such as the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) and Codex Alimentarius.
1.6 – in relation to reducing waste, healthier animals mean reduced inputs to produce the same level of food. Hence investment in preventive health is sound, as it can lead to cost and environmental savings.
3.4 – we await the statement on the independent animal health and production scheme. We welcome the holistic consideration to be given to matters like antimicrobial resistance, animal welfare and the environment, and would very much commend placing progressive disease prevention at the heart.
We thank you for the opportunity to comment.
September 2022