Jonathan Buisson
Drug wholesalers and distributors in the UK would be willing to scan medicines they deliver to some non-healthcare facilities that supply drugs to the public and pick up the £25.7m bill as part of adhering to the EU’s Falsified Medicines Directive (FMD).
Martin Sawer, executive director of the Healthcare Distribution Association, said wholesalers were backing a proposal from the Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulator of medicines and medical devices, that the sector should take responsibility for verifying and decommissioning supplies of medicines on behalf of some, but not all, non-healthcare institutions that have ‘Article 23’ status under the FMD.
The FMD, Europe-wide regulation to clamp down on counterfeit products entering the supply chain, introduces a pan-Europe barcode system for medicines in the supply chain to confirm their authenticity. The new system applies to the UK regardless of Brexit, and is due to come into force on 9 February 2019.
The MHRA is currently consulting on two potential roles for drug wholesalers and distributors in the new system.
One is that the sector takes on responsibility for verifying and commissioning the drugs they deliver to all non-healthcare institutions. These so-called ‘Article 23 premises’ include opticians, dentists, care homes and prisons. An impact assessment has estimated the ten-year cost to be £473.2m.
However, as an alternative — and cheaper — option, the MHRA has proposed that wholesalers only have this verifying and commissioning role for some Article 23 institutions which, over a decade, would cost just £25.7m.
“We are aligning with the MHRA view that the cheaper option is the one to go for where wholesalers would verify and decommission most, but not all, Article 23 institutions,” Sawer told The Pharmaceutical Journal on 26 July 2018.
He said premises that would fall outside members’ remit could include prisons or other institutions that have their own pharmacy.
“The challenge is [for us] to have time to take on board this cost and to ensure that it doesn’t cost the NHS more money, but is money which is spent over a period of time,” he said.
“We have signed up to the principle but we need to see whether the £25.7m cost over ten years is a realistic figure. But the cost of medicines in the supply chain should not go up over the ten years.”
The MHRA consultation runs until 23 September 2018.
