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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.
Posted 26 February 2020 by Janet Beal, Senior Research Analyst, Life Sciences, IHS Markit
