UK FMD CONSULTATION
The Deadline for Feedback on the FMD Consultation: 23rd September 2018
The UK government has recently released (16 July 2018) a consultation document regarding the ways in which the UK should meet its obligations to transpose the ‘safety’ features provisions of the Falsified Medicines Directive (FMD). The document invites any individual, organisation, institution or group that is a stakeholder in or impacted by the UK medicines supply chain, as well as those who manufacture medicines, operate as a wholesaler dealer or supply medicines to the public, to put forward their views on how the UK should proceed. The government has provided a list of questions that broadly state their current view on implementation together with some explanation of why they have taken that stance.
What form of sanctions regime do you think would be the most effective to enforce the regulations across the UK medicines supply chain?
The Government currently favours an approach that would use a mixture of both criminal and civil sanctions, e.g. written warnings and stop notices before criminal sanctions for the most serious breaches.
Can you provide any additional evidence or comment on the existing impact analysis to develop the cost benefit analysis around these specific flexibilities in the impact assessment?
The consultant stage impact analysis has been published alongside the FMD consultation. A major part of the document argues the cost trade off of article 23 businesses decomissioning medecine packs or allowing warehouses to decomission on their behalf.
Do you agree with the Government’s proposed approach not to extend the requirements for the unique identifier or anti-tampering device to any additional products at this time?
The Government feel that extending the requirements would create additional burden on business disproportionate to its benefits because of the diverse way in which medicines are supplied in the UK.
Do you agree with the Government’s proposed approach not to require a reimbursement number, or other national number identifying the medicinal product, to be placed on products bearing the safety features?
The Government feel that requiring a reimbursement number or national number would create a burden for manufacturers; firstly due to extra constraints on packaging because of the need to add additional information, and secondly, by complicating the supply of multi-national packs. They want to map products to UK NHS identifiers through the information required to be uploaded by marketing authorisation holders into the pan-European Repository (European Hub).
Do you agree that manufacturers should be allowed to include information other than the unique identifier in the 2D data matrix?
The UK proposes to allow marketing authorisation holders to use the 2D data matrix code to have other information embedded within it, if desired by the manufacturer, providing the information accessed has been fully assessed as part of the medicines licensing process.
Do you agree with the Government’s proposal to put in place provisions requiring wholesalers to verify and decommission medicinal products bearing the safety features before supplying them to any Article 23 provider authorised to supply medicines to the public?
Article 23 providers include: Persons authorised or entitled to supply medicinal products to the public who do not operate within a healthcare institution or within a pharmacy; Veterinarians and retailers of veterinary medicinal products; Dental practitioners; Optometrists and opticians; Paramedics and emergency medical practitioners; Armed forces, police and other governmental institutions maintaining stocks of medicinal products for the purposes of civil protection and disaster control; Universities and other higher education establishments using medicinal products for the purposes of research and education, with the exceptions of healthcare institutions; Prisons; Schools; Hospices; Nursing homes.
The Government has considered three broad policy options:
1. Requiring wholesalers to verify and decommission on behalf of all Article 23 providers listed above.
2. Requiring wholesalers to verify and decommission for certain Article 23 providers, while leaving others to carry this out themselves.
3. Not requiring wholesalers to verify and decommission on behalf of any of these Article 23 providers, meaning the product would need to be verified and decommissioned by the person supplying it to the public in all cases.
Do you agree that there is no practical benefit to exempting persons operating within a healthcare institution in the UK from the obligations of verification and decommissioning under the conditions set out below?
1. The person authorised or entitled to supply medicinal products to the public obtains the medicinal product through a wholesaler belonging to the same legal entity as the healthcare institution.
2. The verification and decommissioning of the unique identifier is performed by the wholesaler that supplies the product to the healthcare institution.
3. No sale of the medicinal product takes place between the wholesaler supplying the product and that healthcare institution*
4. The medicinal product is supplied to the public within that healthcare institution.
*The wholesaler must belong to the same legal entity as the healthcare institution. This means that that exemption could only apply to a healthcare institution that also holds a wholesaler dealers license. In order to use this exemption, the healthcare institution would instead have to verify and decommission the product under its wholesale license. Since healthcare institutions can already carry out the verification and decommissioning at any time the product is in their possession, the Government does not consider that there is any need to implement this exemption in the UK.
The consultation will close on 23 September 2018.
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