A monumental announcement was made this month [July 2020] when the European Union confirmed its purchase of enough Remdesivir to treat 30,000 patients.
This follows a deal signed in June between the United States and manufacturers Gilead for more than 500,000 courses of the treatment, which is nearly all of the company’s total output until September.
Sold under the brand name Veklury, Remdesivir is a broad spectrum anti-viral medication administered by injection which has proven highly successful in treating COVID-19 cases through clinical trials since the outbreak started.
The medicine has been authorised for use in the United States, India, Singapore, Japan and the European Union.
As with all anti-viral treatments, Remdesivir comes with a disclaimer of adverse side effects which feature on the labelling. So too does the two safety measures which feature on packaging of prescriptions – a unique identifier (a 2-deminson barcode) and an anti-tampering device.
This treatment is vital to the fight against COVID-19, so much so that countries across the world are queuing to place orders with Gilead. The problem with this is that populations of those countries at the end of the queue may search for alternatives.
The European Union has a strong legal framework for the licensing, manufacturing and distribution of medicines, centred around the Directive on falsified medicines for human use. This means that only licenced pharmacies and approved retailers are permitted to sell them including via the internet.
It confirmed that - until very recently - the most frequently falsified medicines in what are deemed “wealthy countries” were lifestyle medicines including hormones, steroids and antihistamines. However, in developing countries, they have included medicines to treat malaria, tuberculosis and HIV.
Worryingly, the EU confirmed that falsified medicines are on the increase including those in high demand such as anti-viral treatments.
Under its Directive, the EU has introduced an obligatory logo that appears on the websites of companies who are operating legally, making it easier for patients and consumers to identify authorised pharmacies and approved retailers. When the logo is clicked, it links to national regulatory authority websites which list out all legal pharmacies and retailers.
We have no doubt whatsoever that the industry will follow the rules, however it is also important that the industry ups its communications with consumers to help spread the word as to why these measures are in place and to avoid looking for unregulated and falsified medicines. Not only will it prevent recalls of illegal product, but it will also protect the health of many desperate people and their families as the pandemic continues.
For more information on the Directive visit https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0074:0087:EN:PDF