As the Novel Coronavirus (COVID-19) epidemic continues to spread across the globe, in an effort to prepare for all eventualities, the UK Government has recently passed into law The Health Protection (Coronavirus) Regulations 2020 ("CV Regulations"). Thankfully, to date, the CV Regulations are not yet applicable, but meanwhile the UK Government is maintaining a close watch on the situation and issuing a wide range of guidance notes on the Government website, updated daily.
COVID-19 also raises a number of questions from a public health perspective, for example: the need for rapid development of a vaccine and/or other treatment; concerns over the continued supply of medicines generally, given that a considerable proportion of active pharmaceutical ingredients (APIs) used (especially in the generic pharmaceutical market) are sourced from China and other affected areas; and the risks of importing foodstuffs into the UK from affected areas.
COVID-19 is caused by a newly discovered type of coronavirus. Coronaviruses circulate among animals and they are zoonotic, meaning sometimes they can pass from animals to people. Sequencing of COVID-19 has shown that it is very similar to a known bat virus found in China, and to the SARS coronavirus which spread rapidly in 2002, but there are still many unanswered questions about how it is spread.
On 10 February 2020, the CV Regulations (available here) were published under The Public Health (Control of Disease) Act 1984, as amended. Although the CV Regulations are currently “in force” (in relation to England only), article 3(1) thereof provides that the CV Regulations only apply when the Secretary of State for Health and Social Care declares, by notice published on the relevant www.gov.uk website ("Official Website" - access it here), that the incidence or transmission of COVID-19 constitutes a "serious and imminent threat to public health". As at the time of the writing, the Official Website states that the risk level in the UK is still "moderate". Therefore, at present, the CV Regulations do not apply and the specific processes contemplated in such regulations are not legally enforceable. In the event that the CV Regulations are triggered into action, they will provide for a number of specific restrictions, screening requirements, isolation/detention provisions, etc. This guidance note will be updated to address these far-reaching measures if the risk level in the UK escalates.
Suffice to state that, at this stage, other than the advice on the Official Website which is aimed at all individuals, there are, for example, no legally enforceable obligations on persons (for example, employers) to report any incidence of COVID-19 to public authorities or shut-down workplaces. For any employment law-related concerns, please refer to our guidance note in our COVID-19 series (available here).
At this stage, the main source of official guidance from a public health perspective is the Official Website and the various links it includes. The guidance on the Official Website is not legally enforceable, but the most noteworthy of them include the guidelines from the UK Chief Medical Officers (based on advice of the Scientific Advisory Group for Emergencies) for travellers and other persons who may be affected by COVID-19. At the time of writing this note, all returning travellers must call NHS 111, stay indoors and avoid contact with other people immediately, if they have travelled to the UK from:
- Hubei province in China in the last 14 days, even if such persons do not experience any symptoms;
- Iran, lockdown areas in northern Italy (as listed on the Official Website) or special care zones in South Korea (as listed on the Official Website), since 19 February, even if such persons do not experience any symptoms;
- other parts of mainland China or South Korea, Hong Kong, Japan, Macau, Malaysia, Singapore, Taiwan or Thailand in the last 14 days, and have a cough, high temperature or shortness of breath (even if symptoms are mild); and
- other parts of northern Italy (anywhere north of Pisa, Florence and Rimini), Cambodia, Laos, Myanmar or Vietnam since 19 February, and have a cough, high temperature or shortness of breath (even if symptoms are mild).
In addition to the above, specific guidance notes are being published on the Official Website and are updated on a daily basis. Some of these specific guidance notes include those that are aimed at: health professionals (see here); schools and other educational settings (see here); immigration (see here); employers and businesses (see here); the transport sector (see here); social or community care and residential settings (see here); etc.
It is very important for all individuals and businesses to keep a close watch on the Official Website, as it is updated on a daily basis.
Vaccines, clinical trials and supply of medicines
There are currently no commercially available medicines specifically authorised to treat or prevent COVID-19 infections. According to recent press releases, a number of pharmaceutical companies have announced their intentions to develop vaccines for the prevention of COVID-19 and in doing so join the race to tackle the outbreak.
The UK Medicines and Healthcare products Regulatory Agency ("MHRA") has stated that it is prioritising work to support and authorise the development of vaccines, clinical trials of new medicines, and helping to manage the supply of medicines and other healthcare products in light of the COVID-19 outbreak. Earlier in February, the UK Government also announced that it has pledged £20 million to the Coalition for Epidemic Preparedness Innovations (CEPI) in order to fund the development of new vaccines. With CEPI support, several COVID-19 vaccine development projects have started, but it could take a few months before early human trials can begin, and several more months before it is understood whether a vaccine can effectively protect people.
The National Institute for Biological Standards and Control ("NIBSC"), which forms part of the MHRA, plays an important role in assuring the quality of biological medicines. The NIBSC is currently in the process of developing biological reference materials and drawing on its expertise gained through work on previous virus outbreaks. This should help to ensure availability of biological materials needed to contribute towards global response efforts to combat COVID-19 and to develop a vaccine.
The MHRA has further stated that it, being the UK authority that authorises and inspects clinical trials of new medicines in the UK, is ready to ensure that any applications that it receives relating to COVID-19 vaccines or related treatment are dealt with as expeditiously as possible. For an outline of the clinical trial authorisation process in the UK, see the MHRA website (here).
At the European Union level, the European Medicines Agency ("EMA") has similarly committed itself to support and fast-track the development of vaccines and treatment for COVID-19. In doing so, the EMA is in the process of exchanging information and collaborating with a number of international organisations to expedite the development of a vaccine/treatment. In addition, the EMA has a range of measures in place that can assist developers/prospective applicants to accelerate the development and authorisation of medicinal products.
We would be pleased to provide specific advice on any of the measures that the MHRA and/or the EMA have available to authorise clinical trials, the authorisation of medicinal products and/or otherwise supply medicinal products (for example, conditional marketing authorisation, supply of unlicensed medicines, etc.) in the context of the COVID-19 outbreak.
Going beyond vaccines/treatment for COVID-19, the effect of the outbreak has seen far-reaching negative impact on trade, especially in relation to trade involving China and other affected areas. In the context of API sourcing, in especially the generic pharmaceutical industry, where APIs are manufactured in countries such as China, the continued supply of such APIs in the manufacture of medicines may be impacted, which may have severe implications on the continued supply of medicines globally. This is, of course, a commercial issue and in order to mitigate exposure to risk, pharmaceutical businesses are advised to review their agreements with their API manufacturers in affected areas in order to determine how current events may impact on API supply. In this regard, see here in respect of the impact of COVID-19 on force majeure clauses in commercial agreements.
Importation of foodstuffs into the UK
The question arises whether or not the importation of foodstuffs into the UK from affected areas could raise public health concerns. This will, of course, depend on the nature of the foodstuff in question (and any import for that matter), and must be assessed on a case by case basis. For any specific regulatory advice in the context of the imports/exports amidst COVID-19, please let us know.
Currently, the Food Standards Agency ("FSA") and Animal and Plant Health Agency ("APHA") are generally of the view that the current risk of contracting COVID-19 through the UK food chain is very low. At this stage, there is no indication of any specific changes to the regulatory requirements to import foodstuffs to the UK for COVID-19-related reasons, but the relevant websites of the FSA (see here) and APHA (see here) should be monitored closely for any changes. The FSA is, however, advising all stakeholders to ensure that those persons handling consignments arriving from affected areas should use appropriate personal protective equipment and take appropriate measures from a personal hygiene perspective.
Insofar as the COVID-19 situation is evolving continuously, individuals and businesses are urged to keep a close eye on any legal and other developments that may affect their businesses, and in doing so, manage their exposure to risk. Businesses in the pharmaceutical industry that wish to take up the challenge to join the race to develop vaccines/treatment are also urged to explore the possibilities to fast-track clinical trial and marketing authorisation application processes.