To ask Her Majesty's Government what plans they have to protect patients from counterfeit medicines if the Falsified Medicines Directive ceases to apply in the UK after Brexit.
13 December 2018
In the United Kingdom, strict regulatory controls govern the sale, supply, manufacture, distribution and advertising of medicinal products. Although no fatalities in the UK have been attributed to a falsified medicine sourced from the UK regulated supply chain, the potential threat to patient health is recognised and taken seriously across Government.
The European Union Falsified Medicines Directive (FMD) was adopted in 2011 and introduced new harmonised measures to ensure that medicines in the EU are safe and that trade in medicines is properly controlled.
The parts of the Directive that have already been implemented – including tougher rules on the control and inspection of producers of active pharmaceutical ingredients – would be converted into UK law through the Withdrawal Act and therefore remain in place after exit.
The final element of the Directive – the Delegated Regulation for new safety features – is due to come into force in February 2019, including the creation of a central EU data hub. The UK will still be a Member State in February 2019 and will therefore implement the FMD Delegated Regulation in line with our existing obligations.
In terms of what would happens after the UK exits the EU, during an implementation period the UK would maintain the new safety features and retain access to the EU central data hub, with arrangements beyond the implementation period still subject to negotiation. In the unlikely event the UK leaves the EU in March 2019 with no deal in place, then as stated in the Medicines and Healthcare products Regulatory Agency recent No Deal consultation, we expect the UK would not have access to the EU central data hub, and therefore the proposal is that legal obligations related to this would be removed for actors in the UK supply chain. In the interests of public safety, we would then evaluate the options around a future national falsified medicines framework.
Whatever the exit scenario, we will continue to ensure that UK patients are able to access the best and most innovative medicines and that their safety is protected.