Community pharmacies distribute not only human, but often veterinary medicines too. The safe and correct use of these medicines as well as pharmacovigilance of these medicines are areas where community pharmacists have a view and a role to play. Additionally, pharmacists have a key role to play in ensuring the prudent use of antimicrobials in animals in the context of tackling antimicrobial resistance (see AMR policy).
PGEU welcomes the Commission proposal on veterinary medicinal products (COM(2014)558) which is currently being discussed in the Council of the EU. In particular, the measures aimed at tackling antibiotic resistance, given the need to ensure rational use of antimicrobials in the veterinary sector under ONE Health approach.
The proposal among other matters aims to regulate the retail and dispensing of veterinary medicines. The proposal develops further principles set out originally in the Patients’ Rights Directive1 and the Falsified Medicines Directive2, with respect to the recognition of veterinary prescriptions and the Common Logo for Internet sites selling veterinary medicines. In some respects the proposal goes beyond the measures put in place by these Directives. Moreover, key additional controls included in those Directives have not been repeated by the current proposal. As a general principle, we question whether an appropriate balance has been achieved between the discretion of Member States to regulate retail activity as they see fit within the parameters of the Internal Market, and the legitimate scope of European legislation.
In more detail PGEU has raised specific concerns in respect to the following provisions:
- Internet sale of medicines: The proposed legislation aims at removing existing restrictions on the internet sale of prescription veterinary medication. We believe that this is inappropriate and represents a possible threat to public health. We suggest that similar to existing discretion for human medicines, Member States should be allowed to restrict prescription veterinary medicine sales online.
- Record keeping obligations when supplying non-prescription veterinary medicinal products: We believe that this obligation may impose an unnecessary burden on community pharmacies in particular as pharmacies already keep records of sales data in their computer systems.
- Recognition of prescriptions issued for human medicines prescribed for veterinarian purposes: We believe this possibility needs to be limited to avoid cross border veterinary prescription abuse.
- Special licence for certain medicines: The supply or purchase a certain medicine by pharmacists must not be subject to an additional licence.
- Manufacturing Authorisation Exception: All retailers of veterinary medicinal products are excluded from a manufacturing authorisation when preparing a veterinary medicinal product. We believe that this exception should be revised and limited to suppliers who have the necessary qualification and equipment to prepare quality and safe veterinary medicines.
1 DIRECTIVE 2011/24/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 March 2011 on the application of patients’ rights in cross-border healthcare
2 DIRECTIVE 2011/62/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products