Antimicrobial resistance is a complex and growing health problem worldwide. It has already crossed the borders and its impact goes beyond the severe consequences for human and animal health.
The answer is a One-Health1 approach to tackle its spread and development. Prudent use of veterinary medicinal products by final users also involves proper communication of the characteristics and usage instructions.
The European Union has already experienced the effects of the lack of sufficient emphasis on the distinction between veterinary medicinal products (VMPs), biocides and feed. This distinction is often misrepresented in advertising.
Advertising of VMPs (including those not subject to veterinary prescription) could have negative consequences for public and animal health, but also distorting competition on the market. Fort these two reasons, the new VMP Regulation will improve and strengthen criteria set out for advertisement.
Let’s have a look at the general principles.
In a Member state, advertisement will be allowed only for products authorised or registered in that Member state. It will be necessary to make clear that the advertising aims at promoting the supply, sale, prescription, distribution or use of the veterinary medicinal product, which should not be presented in such a way as to suggest that it could be a feed or a biocide.
Advertisement will have to be consistent with the summary of the product characteristics and will have not to be misleading or lead to incorrect use of product. On the contrary, it will have to encourage its responsible use by presenting the product objectively and without exaggerating its properties. Distribution of samples for promotional purposes will be restricted and they will be given directly to veterinarians or other persons allowed to supply such veterinary medicinal products during sponsored events or by sales representatives during their visits.
What will happen for antimicrobials, specifically?
As we discussed recently2, antimicrobials will be available only by veterinary prescription in all the EU Member states. Only veterinarians and persons permitted to supply veterinary medicinal products in accordance with national law will be allowed to advertise VMP subject to veterinary prescription.
It will not be possible to distribute antimicrobials for promotional purposes as samples or in any other presentation.
One peculiar aspect of the renovated principles for advertisement of VMPs is set out article 121 (Promotion of medicinal products used in animals). When VMPs in general are promoted to persons qualified to prescribe (veterinarians) or supply them, no gifts, pecuniary advantages or benefit in kind may be supplied, offered or promised to such persons unless they are inexpensive and relevant to the practice of prescription or supply of medicinal products. At the same time, these qualified professionals must not to solicit or accept any prohibited inducement.
These principles will not affect hospitality offered directly or indirectly, at events for purely professional and scientific purposes. Also, they do not impact on existing measures or trade practice in Member States relating to prices, margins and discounts.
What is new with these rules?
The power of advertising to influence final users, thus affecting the prudent use, and the role of bribery and corruption of qualified professionals and suppliers has been recognised as factors able to affect the development of AMR with detrimental consequences. This is an extremely important signal from EU institutions.
1 The One Health approach against antimicrobial resistance.
2 Veterinary prescriptions and antimicrobials: new rules from 28 January 2022.