A derogation to impending EU veterinary medicines regulations that permits an EU member state to allow a veterinary prescription to be issued by a professional other than a vet, does not apply to the Republic of Ireland.
Additionally, this derogation cannot facilitate the continued sale of anti-parasitics over the counter by a responsible person (RP) in a licensed merchants or pharmacy.
In the second instalment of our interview with chief veterinary officer (CVO) at the Department of Agriculture, Food and the Marine (DAFM), Martin Blake, we focus on the above issue, and provide clarity on why the status quo of over-the-counter sales can’t continue.
New regulations
From January 2022, coinciding with the new regulations, and on the back of a 2019 report by the Health Products Regulatory Authority (HPRA), anti-parasitic veterinary medicines that are currently available over the counter, will become prescription-only medicines (POMs).
Simply put – a farmer will have to have a prescription or will be unable to purchase these products.
An aim of these new regulations is to – among others – combat antimicrobial resistance and resistance to anti-parasitics.
While this is welcomed, agri-groups, farming bodies, licensed merchants and veterinary pharmacists oppose the POM categorisation of anti-parasitics, and there have been calls for Ireland to avail of the aforementioned derogation.
There are also concerns that these new prescription rules will add complexity to the process for farmers, will limit competition, and will impose a cost burden on farmers.
‘Supply’ versus ‘prescribe’
This particular derogation, the CVO explained, cannot apply to Ireland because our RPs ‘supply’ these products, they do not ‘prescribe’ them, as specified in the derogation.
Northern Ireland, which already has a system of allowing a suitably qualified person (SQP) to prescribe such medicines, can avail of this derogation.
But Ireland’s RP is not the same as an SQP.
And, when the new EU regulations were introduced in 2019, the UK was already permitting an individual other than a vet to issue a prescription. The Republic of Ireland, however, was not.
“This derogation allows member states to allow people who are non-vets to issue prescriptions, if they had such a system in place in January 2019,” explained the CVO.
He added:
“It was suggested by some of the stakeholders that, as these products were being supplied in Ireland – and some people were inferring, prescribed – by people other than non-vets in 2019, that this derogation should be available to Ireland,” he said.
Veterinary medicines – legal advice
The CVO confirmed that the DAFM sought legal advice on this issue, which advised that ‘nobody other than a vet, in Irish law, is permitted to issue a veterinary prescription’.
“That was the primary issue that we sought legal advice on,” he said.
Confusion
Some confusion around the ‘derogation’ may have has arisen from a 2006 EU Directive, which gave a ‘non-prescription status’ to certain veterinary medicines which ‘did not’ or ‘were not known at the time’ to pose a risk to human health.
Under this directive, Ireland availed of an exemption which meant that anti-parasitics were available without prescription.
But the HPRA report referred to above concluded that ‘available scientific evidence shows that anti-parasitic veterinary medicines that are intended for use in food-producing species do not comply with the criteria for derogation from veterinary prescription specified in Regulation 2019/6′.
“The net effect of the HPRA report was that the anti-parasitics no longer met those criteria,” said the CVO. And the DAFM is moving on that now.
Alternatives
But the Independent Licensed Merchants Association (ILMA) has said that alternatives are available.
It has called for the establishment of a regulatory body for RPs, along with a code of practice that would formalise prescribing, address environmental matters and responsible use, and more.
The ILMA has also proposed that the DAFM forms a specific prescription classification just for licensed merchants, separate to a full veterinary prescription.
It has also asked why the DAFM did not do more to defend the current system that exists in Ireland.
According to the DAFM, the CVO wrote to the European Commission highlighting the important role of the RP, as well as licensed merchants and pharmacists.
The EU Commission responded that member countries could avail of the derogation based on the national law at the time.
As mentioned above, in Ireland’s case, that law states that a vet can only issue a prescription.
Veterinary medicines – concerns
When asked about concerns expressed about this prescription-only route, the CVO said:
“Anyone currently supplying these products – be it pharmacist, licensed merchant, co-op store, vet – can continue to supply them in the future.”
And when questioned bout the scale of such a change in Irish agriculture, the CVO said:
“There are some significant changes coming but I am not necessarily sure that they are as seismic as people might believe them to be.
“Essentially, this [new regulations] is about the responsible use of veterinary medicines on farms and I would look at it from this perspective: veterinary medicines are a cost, and if you are not using them properly, you are losing money, and you are also losing productivity.
“The effective use of antibiotcs and anti-parasitics, and any animal medicine, is in everyone’s interest, farmers included.
“This will include change, and change is difficult for everyone but it is not as negative a story as some of the narrative that is out there.”