While the UK has not yet seen a major cluster of infections in the current major international outbreak of coronavirus 2019 disease (COVID-19), the government has nonetheless been stepping up its preparedness for such an event. These have included containment measures such as revisions of guidelines for travellers, and the recent introduction of diagnostic spot-checking of patients with general respiratory symptoms. However, one small but significant development was noted by IHS Markit on 25 February – the addition of two long-established medicines to the Medicines and Healthcare Products Regulatory Agency (MHRA)’s list of products for which parallel export is prohibited until further notice.
This list was originally developed by the MHRA and Department of Health and Social Care (DHSC) last October, as a measure to help tackle UK drug shortages of important medicines, by preventing loss of national stocks via parallel export – and its introduction coincided with a growing problem of drug shortages in the UK, together with a need for Brexit no-deal contingency measures. However, the two medicines in question, the antiviral fixed-dose combination lopinavir + ritonavir, and the antimalarial chloroquine phosphate (which is also known to exhibit antiviral activity), were both noteworthy for quite a different reason. Both of these medicines have been highlighted in recent communications from the Chinese Ministry of Science and Technology and the World Health Organisation (WHO) as part of a growing list of potential therapeutics under evaluation as candidates for use in mitigating infections in the COVID-19 outbreak.
Since these two products are both well-established medicines for other conditions, they could be used relatively rapidly on an off-label basis from existing stocks in a local outbreak scenario, if their efficacy against COVID-19 is confirmed. It would therefore seem prudent for the DHSC to take action to preserve national stocks by preventing export at this early stage – since there could be a risk of shortages once efficacy is fully established and international demand for such products grows in neighbouring countries. This was confirmed by a DHSC communication on 26 February – noting that this parallel export ban had been implemented to ensure that the supply of these drugs for existing National Health Service (NHS) patients will remain uninterrupted, should it be needed if the outbreak spreads.
While this is clearly a forward-thinking measure, it should be remembered that both of these medicines are still at the investigational stage as potential COVID-19 therapeutics, with trials still in progress in China, alongside a growing list of existing and novel products. These include favipiravir (Zhejiang Hisun, China), which recently received rapid approval in China for emergency use against COVID-19, the Russian-developed antiviral Arbidol (umefenovir, OTCPharm), and several COVID-19 vaccine projects progressing with several companies, including the US biotech Moderna and major UK pharma GlaxoSmithKline. Confirmatory efficacy and safety data are still emerging for most of these products – although established products are likely to have an advantage in terms of known safety profiles.
The parallel export restrictions on both lopinavir + ritonavir and chloroquine phosphate will be effective from 26 February until further notice – a case where action has been taken to prevent a shortage which has not yet happened.