Pharmacy Voice is encouraging the European Commission to ensure there is proportionate implementation of the Falsified Medicines Directive, avoiding unnecessary bureaucracy.
In its response to the European Commission’s consultation ‘Delegated Act on the detailed rules for a unique identifier for medicinal products for human use, and its verification’, Pharmacy Voice also asks that existing patient-focused working practices should be supported and the system should not impose undue restrictions on the developments of new and innovative services for patients.
Gareth Jones, from Pharmacy Voice said:
“Patients have complete faith that the medicines they receive from their community pharmacist are the authentic product and the Directive should help to ensure that this remains the case. This is one of the most significant European directives for community pharmacy that we have ever seen and its impact will be felt by pharmacists working across the EU. It is important that we see a risk-based and proportionate implementation of this directive – protecting patients but not introducing unnecessary bureaucracy.
Pharmacy Voice specific comments include:
All pharmacy owners should expect that information on the volume of their business remains confidential. There should be an explicit recognition that the pharmacy owns the data that it adds to the repository.
The Directive has the greatest chance of successful implementation if all prescription only medicines require authentication but over the counter medicines are not included apart from exceptional cases.
The authentication requirement must allow for MDS packs to remain available on the market.
Original pack dispensing is required in the UK to ensure that the anti-counterfeiting system can work here.
Pharmacists should have the professional discretion to undertake retrospective authentication or temporarily suspend authentication altogether, in the case of systems failure.
Pharmacy Voice has issued the response jointly with PSNI and IPF.
The consultation can be ready by clicking here.