The last year has been a bit of a regulatory rollercoaster for anyone involved in the veterinary world. In 2023 we had the new Under Care regulations from the RCVS (our regulator), changing a lot of the details about how and when we are permitted to prescribe. Then we had the CMA report. And now the penny drops with the third major upheaval, as the government passes a series of updates to the law that controls all manufacture, supply, use and advertising of veterinary medicines. 

Table of contents

Acronym soup: VMRs, VMPs and the VMD

So, before we go any further, let’s look at the three key definitions.

VMRs – The Veterinary Medicines Regulations

These are the specific regulations, passed by parliament, that control the use of veterinary medicines. The current version is the 2013 release; this new version is the first major update in 11 years. 

VMD – the Veterinary Medicines Directorate

The VMD are the agency that regulates and enforces the VMRs. They are an executive agency of DEFRA, but functionally are fully autonomous. They carry out medicines authorisation (like the MHRA for human medicines); inspect premises (although this can be delegated to the RCVS, the veterinary regulator, for vet practices which are part of the Practice Standards Scheme); and enforce the regulations. They also consult on and draft the updated regulations.

VMPs – Veterinary Medicinal Products

The VMD regulate all VMPs, and the VMRs apply to everything that qualifies as one, so it’s worth reviewing what sorts of products are classified as veterinary medicines in law. A VMP can only legally be sold if it has a licence (a marketing authorisation) or is classed as exempt under Schedule 6 of the VMRs (medicines for small pet animals). It is a serious offence to sell a product which is a VMD and is not authorised.

Any product can become a VMP (and therefore regulated) if it is either:

  • Medicinal by function – in other words, it contains an active pharmaceutical ingredient that has an effect on the animal. Common pharmaceuticals like painkillers, antibiotics, and even CBD are all VMPs by function because they all contain pharmacologically active ingredients.
  • Medicinal by presentation – in other words, if the way the product is presented would give a member of the public the impression that it treats or prevents disease, it becomes a VMP, and the advertising and sale are restricted. This is why supplements all say things like “supports healthy joints” rather than “treats arthritis” – because the latter is a medicinal claim!

So, what’s changed in the new regulations?

Well, good news first – the basic principles of the regulations haven’t changed much. There are quite a lot of new details about how manufacturers can get their products licensed, and the paperwork they need to provide, but from the point of view of the vet or animal owner, fortunately the changes are relatively small.

Except…

Some of them, while subtle, could have significant impacts on us all.

Mandatory registration of internet retailers

Anyone selling medicines online will need to be registered to ensure that they are compliant with medicines laws. 

An SQP will now be allowed to delegate the supply of medicines to a competent person, as long as they have made the specific decision to supply. This will be similar to the current rules which allow a vet to direct someone else to dispense a medication (e.g.a  veterinary nurse) on their behalf.

New text on written prescriptions

All written prescriptions will need to contain the words “It is an offence under the Veterinary Medicines Regulations 2013 for a person to alter a written prescription unless authorised to do so by the person who signed it”. This is to help reduce prescription fraud.

Recording reasons for a prescription

This is a big one. When prescribing a medicine (except on a written prescription, for some reason) the vet (or SQP or pharmacist, for that matter) must now record the reasons for that prescription. In other words, why they are prescribing that medication. 

Ban on prophylactic (preventative) antibiotic use

This isn’t really that new, but it is being put in legislation for the first time. Overuse of antibiotics is a major threat to both human and animal health. The new laws put in place specific protocols to minimise preventative use of antibiotics. If a vet needs to use them, they can do so, but there are a series of checks they have to do, and record, first. In reality, very few vets are prescribing prophylactic courses of antibiotics anyway, but it’s useful to see it here.

Changes to withdrawal periods

When medications are given to any food producing animal, there are specific periods after which the meat, eggs, or milk cannot be used for human consumption. The prescriber now has an explicit duty to give that information to the owner in a particular way, and there are new calculations to work out what those safe limits are.

It is now illegal to “promote or facilitate” illegal off-licence use of medicines in animals

Another big change! The Cascade is the series of steps that a vet legally has to go through if they want to use medicines which are not licensed for that particular purpose in that particular species of animal. It basically makes it illegal for us to use human medicines if there is a veterinary one licensed; or using a special preparation if there is a human one available (even if they are more expensive).

Breaching the cascade is and always has been illegal (it came into force in an EU directive in 1995 and has been incorporated into every version of the VMRs since, including the new one). However, it is now a specific criminal offence (potentially punishable with jail time!) to promote any such use, or to facilitate it.

How can I find out more?

The VMD is producing new guidance. However, at the time of writing, this is still in draft and the text is not 100% confirmed. We will keep updating this section as more information comes to light.

When does this come into force?

The new regulations come into effect on 17th May 2024. However, there are transition periods before some sections are enforced. In particular…

  • Internet retailers have 2 months to get their registrations in.
  • Written prescriptions will need to be in the new format within 6 months (although prescriptions issued under the old rules in that period will still be valid).
  • Vets will have to record the reasons for their prescriptions within 6 months.

What does it mean for vets and animal owners?

More paperwork, mainly! Essentially, the only provisions that are likely to cause a significant impact are the registration of online dispensaries, the prescription recording, and the ban on promoting illegal use of the Cascade.

Having the online pharmacies and dispensaries registered is a good thing. It means we can all be much more confident in the safety of medicines ordered online. (Especially as the new law also makes the retailer responsible for safe storage of medicines until they arrive with the customer).

The additional recording requirements won’t directly impact animal owners, but might be burdensome for vets. Many will already be recording this anyway, but if not, it becomes an additional task. This might have the effect of pushing consult prices up a little bit, as more time will need to be allocated to record keeping, but I doubt it will be significant.

The ban on “promoting or facilitating” illegal Cascade use is a little different. A good example would be the hypothetical situation where the vet advises a client to give their pet an antihistamine. It would be legal to recommend, in a genuine emergency, that the owner gives their pet one tablet that they have at home. It would now, however, be a criminal offence to recommend, advise, or suggest that the client buy the human product for administering to their animal.

Overall, are the changes good?

Up to a point. There are some good things in here, such as the registration of all internet retailers, and the revised rules for SQPs. The Cascade itself is a controversial point, and I can see the ban on promoting illegal use might be argued, but actually, it’s the Cascade itself that needs to be debated if people don’t like it. Remember, it’s already illegal to break Cascade rules, this just draws people’s attention to it by making the vet or SQP more responsible for their clients’ actions.

Unfortunately, there has been a significant missed opportunity to add more environmental testing into the authorisation process for veterinary medicines; and it would also be nice to see more scientific scrutiny of the large and very lucrative homoeopathic industry.

Overall, though, I suspect for most animal owners it will be business as usual – although there will be a lot of running around by vets and practice managers behind the scenes to make sure everything is done properly on time!

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