As the UK leaves the EU, the European Medicines Agency and the European Commission are working to align EU member states and to help them deal with similar problems.
Manufacturers are being encouraged use European CMOs. If this is it comes to fruition it should help to relieve the pressure on the supply chain to some extent.
The use of technology to scan the “2D” barcodes in line with the Falsified Medicines Directive and to increase efficiencies will help to minimise the risk of falsified medicines entering the supply chain within the EU and the UK providing the UK does not redact the legislation.
It is rumoured that the UK cannot be easily removed from EMVS due to technical reasons.
There has been a steady increase in physical thefts and diversion of medicines by criminals within the UK and the EU. The MHRA strives hard to ensure the quality and integrity of medicines in the UK supply chain to keep patients safe and to be sure they get the best clinical outcome and are not harmed by their medicines.
The MHRA are recruiting new inspectors to help with the onerous task.
The manufacturers are under huge pressure as often generic medicines are sold with minimal margins, new regulatory, packaging and quality requirement posed by Brexit and FMD have resulted in many products being under increasing scrutiny as to their viability. Active Substance providers have closed down for several reasons which has not helped the supply chain and caused delays in manufacturing increased costs and shortages. There is a real fear that some medicines will just not be produced for the UK or EU markets.