The Falsified Medicines Directive (FMD 2011/62/EC) (European Commission 2011) is designed to eliminate counterfeit medication and limit potential risk of harm to the public. We know that the world has changed since this directive was conceived. While enshrined in law (Moore 2019), we risk not being able to deliver on this directive (Barrett & Al-Mousawi 2018; Barrett 2020). The UK leaves the Europe Union on the 31st of December 2020, with it access to the ‘national verification system’ whereby dispensed medicines get verified against a European central database for their authenticity is lost.
This makes the UK a target for flow of falsified medicines into its domestic market and as a route into Europe. Nobody wants this, except the spurious agents involved in the business of providing substandard medication. The UK also provides globally admired universal care and is responsible for securing and supplying medicines to patients via the NHS. Medicine costs have been rising (Acosta et al. 2019; Batista et al. 2019; European Medicines Agency 2018; Hughes 2019; Miljković et al. 2019) and can be linked to currency fluctuations and policy (Ewbank 2018; Kanavos et al. 2011; Kanavos et al. 2020). The concern is that there will be potential trade wars and with them, further volatility (e.g., currency, geopolitics, supply routes, and natural resources) putting medicine access at risk. Globally, we face increasingly difficult choices with concern about patients’ access to medicines.
The path to regulatory approval also seems convoluted and expensive for most small-scale manufacturers. Increasingly, there are fewer large manufacturing sites and these are controlled by a few market participants. Looking at strategic, regional, and political pressures is vital when thinking about securing medicine supply across the world. Resources and research need to be dedicated to this area, as its importance is likely to grow.
The author has no competing interests to declare.
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