MHRA delivers verdict on FMD ‘flexibilities’ as Brexit looms

After a consultation period, the UK drugs regulator has finalised its plans on meeting the safety feature requirements of the Falsified Medicines Directive (FMD).

In a notice (PDF) published over the holiday period, the Medicines and Healthcare products Regulatory Agency (MHRA) says it intends to stick fairly closely to its earlier final draft guidance document that triggered a consultation process that yielded more than 50 comments.

There was of course no suggestion that the overarching requirements of the safety feature regulation– tamper-evident closures and a unique identifier for medicine packs that can be scanned at fixed points along the supply chain from February 9 – would not be implemented. Rather the document focuses on the ‘flexibilities’ in the safety feature Delegated Regulation that give national authorities some leeway in how these are applied in the supply chain.

Overall, that means that despite some objections the UK will opt to allow wholesalers to decommission medicines on behalf of other persons or organisations other than hospitals or pharmacies that are providing medicines directly to the public, a group that could include nursing homes, dental practices, schools and prisons. The responses to the Article 23 provisions generally supported its view that this option is the least burdensome way forward, according to the MHRA.

Other outcomes include a decision not to extend the use of unique IDs for medicines that are “otherwise out of scope for the purposes of reimbursement or pharmacovigilance”, to allow companies to add extra information to 2D codes – provided the information has been fully assessed as part of the medicine’s licensing process – and not to mandate the use of a national reimbursement number.

The regulator also delivered a verdict on Article 26, which gives license to exempt some people in healthcare institutions from decommissioning under certain circumstances. MHRA’s initial proposals saw no practical benefit in that exemption, but after consultation it now recognises some hospital pharmacy departments hold warehouse and distribution agreements and could benefit from a flexible approach, particularly where they operate geographically separate facilities or sites.

No-deal implications

The MHRA also notes that in the event that no deal is agreed “we expect the UK would not have access to the EU central data hub, and therefore stakeholders would be unable to upload, verify and decommission the unique identifier on packs of medicines in the UK.”

The legal obligations for actors in the UK supply chain would be removed, but packs containing the FMD safety features would still be accepted in the UK, provided that they are in line with other UK packaging requirements. Long-term, the intention would be to develop a national falsified medicines framework that would work alongside the FMD.

UK Prime Minister Theresa May’s withdrawal deal will be voted on by parliament next week but seems to be facing fierce opposition on both sides of the house.

May’s draft agreement has been slammed by Brexiteers and pro-EU groups alike, both claiming that it leaves the UK neither in nor out of the EU, and with less sovereignty than now, and defeat elevates the risk of no deal. Momentum seems to be growing for a second referendum that could include three options: May’s deal, no deal, or no Brexit.