Medicines and Medical Devices Bill

Written Evidence submitted by NOAH (the National Office of Animal Health) (MMDB14)

Who we are:

1. NOAH (the National Office of Animal Health) has been representing companies that research, develop, manufacture and market licensed animal medicines in the UK since 1986. NOAH represents the UK animal health industry, promoting the benefit of safe, effective, quality products and services for the health and welfare of all animals.

Summary:

2. NOAH supports this Bill in enabling an update on the 2013 Veterinary Medicines Regulations (VMR), with the importance of having a sound veterinary medicines regulatory system with an appropriate legislative basis.

3. There is a need for UK VMRs to be updated as a priority, as they have not been updated since 2013. There are several areas that could be improved upon and regulatory systems in other parts of the world are being updated to reflect the changes that are needed to facilitate innovation. Some of the headline issues are detailed below.

4. Safety: pharmacovigilance systems that monitor product safety post-authorisation have a legal basis. These systems are improving as information technology systems improve and simplify the processes and this needs an appropriate legal basis. The transmission of appropriate information using IT systems using pre-defined formats can also reduce admin burden for vets and for animal medicines companies, so that product safety can be improved while at the same time reducing admin burden on animal medicines industry.

5. Antibiotic resistance: the UK livestock industry has already made significant progress in voluntarily improving antibiotic stewardship. Nevertheless, more progress can be made and the Veterinary Medicines Directorate (VMD) need a legal basis should they wish to take any further measures to ensure responsible prescribing and use of antibiotics in animals.

6. Make the UK attractive for vet medicines investment: government could provide incentives to encourage innovation, such as increased protection of technical documentation for new and innovative products, making the UK a more attractive country to invest in new product research and development. More resources could made available by reducing the administrative burden, enabling redirection towards research and development.

7. Product innovations: The industry estimates are that the veterinary medicine sector faces twice the admin burden of the human medicines sector. Steps to improve this would be welcome. This is not ‘watering down’ safety but is focussed on improvements in use of IT systems, better formats for transmission of regulatory information between regulators and the marketing authorisation holders.

8. Maximum residue levels (MRLs) for food from treated animals: a key function for VMD to ensure is that food from treated animals remains safe for people to consume. Currently, MRLs are set at an EU level by the European Commission. VMD need legal powers and an appropriate basis to do this in the future, especially as new technologies become available.

9. Enforcement powers: VMD need a legal basis to take enforcement action against any breaches of Veterinary Medicines Regulations to protect both human and animal health.

10. The regulation of medical devices is not appropriate for veterinary medicines, a relatively small sector that relies on human devices to support veterinary patient care

NOAH are happy to provide the Committee with further evidence on this.

June 2020

 

Prepared 10th June 2020