The new Great Britain (GB) veterinary medicines laws are largely pro-innovation (see our previous article Four Ways New Legal Proposals Could Boost the Animal Health Industry in Great Britain), and generally have been welcomed by industry following close engagement with the regulator during the consultation period. While the laws mostly align with new standards introduced in the EU (and Northern Ireland), thereby helping companies to implement similar changes across the region, they diverge in some favorable ways from EU law, eg the new GB laws create the possibility for valuable additional periods of data protection for existing active substances.
The new laws will nevertheless require stakeholders to make further investment and to implement changes to their processes in GB. For example, anyone advertising veterinary medicines, medicated feed or feed additives will have to comply with new advertising laws; manufacturers will need to comply with new labelling requirements; active substance manufacturers/ importers/ distributers will have to become registered and now have an explicit requirement to comply with good manufacturing practices (GMP); wholesalers will have to comply with good distribution practices (GDP); retailers will have to comply with storage and audit requirements; and veterinary groups will need to ensure they have adequate processes to enable their prescribers to comply with additional record-keeping requirements.
The new laws apply from 17 May 2024, but transition periods are available for some requirements, eg advertisers have up to 17 August 2024 to implement the new requirements, and manufacturers have up to 1 April 2029 to implement certain labelling requirements (provided conditions are met).
All stakeholders should familiarize themselves with the requirements that will affect their businesses and prioritize changes in accordance with the applicable transition periods.
We will be discussing these developments further in Sidley's next Animal Health Legal Forum (details will be announced on Sidley's "Global Life Sciences Events" page here or contact cboyle@sidley.com). In the meantime, we set out below our non-exhaustive key takeaways focusing on the topics of innovation, compliance, regulatory and antimicrobial resistance (AMR).
Pro-Innovation Takeaways
- Increased periods of data protection: This will help protect manufacturers’ investments in research and development by preventing generic companies from relying on the innovator’s data for the period of protection.
- New data protection periods for variations: New and separate periods of protection will be available where an existing product is varied to add a new pharmaceutical formulation or a new species, and where the new product is packaged separately and accorded its own marketing authorization number. This is an innovative law that supports investment and moves away from a 20-year trend to limit the available data protection to a single ‘global marketing authorization’ principle in the EU.
- Closing the parallel import route into GB: The new laws remove the ability for distributers to obtain ‘Marketing Authorizations for Parallel Import’, closing the parallel import supply channel into GB. The change means manufacturers will no longer have to compete with ‘parallel traded’ products (versions of their own products purchased in a lower price country and re-distributed to GB). Veterinary surgeons will still be able to prescribe and import small volumes of medicines for animals under their care in accordance with the ‘specials’ scheme.
- Prohibition on compounded products that are a "pharmaceutical equivalent" of an authorized product: This measure, together with stricter controls on the promotion of the 'prescription cascade', will help ensure that licensed products are used where available rather than unlicensed compounded products. Compounded products must also make state on their label "this veterinary medicinal product does not hold a marketing authorization".
- Labelling and packaging: The new laws aim to ensure full alignment with the labelling and packaging requirements in the EU and Northern Ireland, with the option of providing an electronic package information leaflet.
- Location of marketing authorization holder: The marketing authorization holders can either be established in the UK or in a country demonstrated to have equivalent standards, eg the EU. In such instances, having a 'local representative' in GB will remain voluntary.
Compliance Takeaways
- New advertising laws include a requirement to state "prescription decisions are for the person issuing the prescription alone" in adverts for prescription medicines.
- New restrictions on inducements and hospitality, namely the provision of gifts, pecuniary advantages or benefits to persons qualified to prescribe or supply veterinary medicines.
- Hospitality, including travel and accommodation, may potentially be provided to 'animal health professionals' if it is subordinate to the main purpose of the meeting or event.
- Trade practices relating to prices, margins or discounts in existence as of 17 May 2024 are exempted from these restrictions.
- Promotional samples of antimicrobials are prohibited, and additional controls have been introduced for other promotional samples.
- New record-keeping requirements for all stakeholders, including manufacturers, wholesalers, retailers, veterinarians and animal keepers. Businesses will need to ensure their processes and software enable the capture of the requisite data.
- Increased regulatory enforcement powers include new powers for the authorities to seize goods, suspend marketing authorizations, prohibit supply and impose temporary restrictions for breach of the Regulations.
Regulatory Takeaways
- Active substance manufacturers, importers and distributers must comply with GMP and must be registered.
- Wholesalers must comply with a range of new requirements, including compliance with GDP, and must have the services of technically competent staff (including a Wholesale Qualified Person).
- Manufacturers must obtain a separate wholesale dealing license to wholesale.
- Manufacturers must report shortages "as soon as reasonably practicable".
- Additional pharmacovigilance system and personnel requirements have been introduced.
- Retailers must comply with new audit, record-keeping, and storage requirements.
- Online retailers of veterinary medicines must be registered.
- Prescribers must record the reason for prescribing veterinary medicines supplied pursuant to an oral prescription.
- Medicated feed must meet manufacturing and labelling requirements.
Antimicrobial Resistance Takeaways
- Post-authorization studies may be required for antimicrobials to ensure that the benefit-risk balance remains positive.
- Marketing authorizations may be refused on the basis of a negative benefit-risk balance taking into consideration risk of AMR. However, refusal of the authorization on the grounds that the antibiotic is reserved for human use has been removed.
- Restrictions on preventative (prophylactic) use of antibiotics (rather than antimicrobials more generally) although no specific restrictions on metaphylactic use.
- Continued ban on using antimicrobials as growth promoters.
- Stakeholders must provide data on usage of antibiotics on request.
- The new laws are consistent with UK Government's 5-year antimicrobial resistance action plan.
Sidley Austin LLP provides this information as a service to clients and other friends for educational purposes only. It should not be construed or relied on as legal advice or to create a lawyer-client relationship.
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