The UK will need to establish its own systems in parallel with that of the European Union for life sciences in the event of a No Deal Brexit, according to a report from the House of Commons Exiting the EU Committee.
Brexit
The committee also reported it has heard No Deal will impose significant costs on business who operate in the UK, and suggest it could make the UK market less attractive.
The Medicines and Healthcare products Regulatory Agency (MHRA) would take on the functions that are currently undertaken by the EU for medicines on the UK market, while applications for marketing authorisations for new medicines will need to be submitted both to the EU, and to the MHRA for approval in the UK.
The report, titled ‘The consequences of “No Deal” for UK business,’ states: “Under no deal, and in the absence of any other agreement, the UK would be outside the EU’s regulatory architecture. For those medicines that are to be licensed and supplied in the EU, the European Medicines Agency (EMA) has said that marketing authorisation holders and the batch testing of medicines will need to be transferred to entities in the EU, and new medicines in the UK would need to be licensed separately.”
Also mentioned was the most significant threat to an uninterrupted medicines supply is disruption at the short straits crossing. The BioIndustry Association also added that there is a ‘real threat of counterfeit medicines entering the UK supply chain’ and urged the government to reconsider the decision to revoke the Falsified Medicines Directive (FMD).
The report also notes that the UK being treated as a third country by the EU and no provisions on the exchange of data between the two – potentially harming the impact on tracking counterfeit medicines and participating in clinical trials.