As Novel Coronavirus (COVID-19) continues to spread across the globe, in an effort to prepare for all eventualities, on 10 February 2020, the UK Government passed into law The Health Protection (Coronavirus) Regulations 2020 (“CV Regulations“). We have since seen the World Health Organization declaring the COVID-19 outbreak a pandemic, drastic restrictive measures being taken internationally, and on 12 March, the UK Government announced that the UK has moved into the so-called ‘Delay’ phase in its COVID-19 plan and thereafter introducing a number of strict measures to, for example, limit the movement of persons. More recently, the Coronavirus Bill, after receiving Royal Assent on 25 March, became an Act of Parliament as the Coronavirus Act 2020 (“CV Act“). The CV Act now revokes the CV Regulations and is in force. The UK Government continues to issue a wide range of guidance notes on the official Government website (“Official Website” – access it here), which is updated on a daily basis.
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. The UK regulatory authorities have also started implementing a number of fast-tracking mechanisms for purposes of facilitating the placing on the market of, for example, medicines and medical devices, to tackle the effect of COVID-19.
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.
The CV Act (available here) enables the UK Government to respond to the current emergency situation and manage the effects of the pandemic. The CV Act contains temporary measures intended to either amend existing legislative provisions or introduce new statutory powers which are designed to mitigate the far-reaching impacts of COVID-19. In terms of the CV Act, the previously published CV Regulations are now revoked, and replaced with the provisions contemplated in Schedule 21 of the CV Act, which deals with powers of the Government relating to potentially infectious persons in England. In terms of section 89 of the CV Act, the majority of the provisions of the Act are intended to expire after two years.
Whilst it is not the intention of this guidance note to describe the content of the CV Act in detail from a public health perspective, the CV Act addresses, amongst others, the following themes:
- emergency registration of health professionals. The CV Act introduces new registration powers for the Registrars of the Nursing and Midwifery Council (NMC) and the Health and Care Professions Council (HCPC) to help to deal with the increase in those needing medical care and any shortage of approved staff to assist;
- temporary registration of social workers. The CV Act provides emergency registration powers for the relevant Registrars of Social Work to temporarily register fit, proper and suitably experienced persons as social workers to address any shortage of social workers in the children’s and adult social care sectors as a result of increased staff absenteeism;
- health service indemnification. The CV Act includes powers to provide indemnity for clinical negligence liabilities arising from NHS activities connected to the diagnosis, care or treatment of a person who has been diagnosed as having COVID-19 or is suspected, or is at risk, of, having the disease. These powers are not exercisable where indemnity arrangements are already in place (whether under an insurance policy or otherwise) covering the clinical negligence liability in question;
- NHS and local authority care and support. Currently, the prescribed process of discharging patients from hospitals may take some time. The CV Act therefore allows the simplification and expedition of the procedure for discharge from an acute hospital setting for those with a social care need;
- powers relating to potentially infectious persons. As mentioned above, the CV Regulations (which only applied to England) provided for the detention, isolation and screening of, and other appropriate restrictions to be imposed upon persons who have or may have COVID-19, or who have arrived in England from an area in which the virus is prevalent. Upon the Secretary of State making a declaration that the incidence or transmission of COVID-19 constitutes a “serious and imminent threat to public health“, the provisions in the CV Regulations would be triggered. The Act now revokes the CV Regulations and includes similar provisions for the screening and isolation of certain persons, including powers to impose other restrictions and requirements. There is now a consistent, UK-wide approach, since these provisions in the CV Act apply to the UK as a whole. These provisions would similarly be triggered if the relevant authority is of the view that the incidence or transmission of COVID-19 constitutes a “serious and imminent threat to public health“. As at 27 March, the Official Website states that the risk level in the UK remains “high“. The provisions of Schedule 21 of the CV Act are therefore not yet in operation. This guidance note will be updated to address these far-reaching measures if the risk level in the UK escalates; and
- powers relating to events, gatherings and premises. The CV Act empowers the relevant authorities to prohibit or restrict events and gatherings, and to close premises, if the public health situation deems it necessary.
A number of specific offences are provided for in the CV Act. For example, section 23 of Part 2 to Schedule 21 (although not yet in operation) provides for a number of offences, for example: the failure, without reasonable excuse, to comply with any direction, reasonable instruction, requirement or restriction given to or imposed on the person under Part 2 of Schedule 21; absconding or attempting to abscond while being removed to or kept at a place in terms of Part 2 of Schedule 21; etc. A person guilty of an offence under Part 2 of Schedule 21 would be liable, upon summary conviction, to a fine not exceeding level 3 on the standard scale, which is currently £1,000.
At this stage, apart from the CV Act, the main source of official guidance from a public health perspective is the Official Website and the various links it includes. With the escalation of the risk level to “high“, and progression to the ‘Delay’ phase, the guidance is no longer focussed on travel to and from affected areas, but general guidance regarding self-isolation, social distancing and what to do if any person experiences symptoms. The current guidelines from the UK Chief Medical Officers (based on advice of the Scientific Advisory Group for Emergencies) are not to leave home if experiencing coronavirus symptoms and to call NHS 111 for guidance.
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: travel advice (see here); health professionals (see here); schools and other educational settings (see here); immigration (see here); employers and businesses (see here); the transport sector (see here); residential care, supported living and home care (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 and medical devices
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 MHRA has stated that it is prioritising work to support and authorise the development of vaccines, clinical trials of new medicines, clinical investigations of new medical devices, and helping to manage the supply of medicines and other healthcare products in light of the COVID-19 outbreak. The MHRA now too issues COVID-19-specific guidelines on a regular basis on its website (see here).
From a clinical study perspective, back in February, the UK Government 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 while longer before early human trials can begin, and several more months before it is understood whether a vaccine can effectively protect people. 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. The MHRA has issued specific guidelines regarding clinical trials of new medicines for the prevention/treatment of COVID-19 (see here). Similarly, the NHS Health Research Authority has very recently updated its guidelines for the expedited research ethics approval process for COVID-19-related studies (see here).
Medical devices such as remote patient monitoring devices and in vitro diagnostic devices such as COVID-19 testing kits promise to assist with the fight against the impact of COVID-19. With regard to medical devices, the MHRA has published guidance relating to, amongst others: the regulatory status of equipment being used to help prevent COVID-19 (such as face masks, hand sanitizer, gloves, etc.) (see here); the possibility of applying to the MHRA for authorisation to supply certain non-CE marked devices in the interest of the protection of health, as well as the fast-tracking of approvals of medical devices during the COVID-19 outbreak (see here); the pre-authorisation process for purposes of placing a COVID-19 test kit on the UK market (see here); and the ‘minimally acceptable’ specification for ventilators to be used in UK hospitals during the COVID-19 outbreak (see here).
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.
At the European Union (“EU“) 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. The EMA also recently announced that it provides a full fee waiver for scientific advice applications from developers of potential therapeutics or vaccines against COVID-19. The EMA also provides COVID-19-related guidance on its website, which should be consulted regularly.
The EMA, European Commission (“EC“) and national authorities of Member States have organised the first meeting of the EU Executive Steering Group on Shortages of Medicines Caused by Major Events to discuss measures aimed at addressing the impact of COVID-19 on the supply of medicines in the EU. This group is mandated to identify and coordinate EU-wide actions to protect patients when medicines in the EU are at risk of supply shortage (for example, due to a temporary lockdown of manufacturing sites in areas affected by COVID-19 or travel restrictions impacting shipment). The group will also take measures to ensure that patients and healthcare professionals across the EU are kept informed in a consistent and transparent manner about the risks and the remedial actions taken. In a press release, the EMA has reminded companies that they have an ongoing obligation to ensure the continuity of supply of their medicines, which includes implementing appropriate resilience measures, as well as an obligation to report any possible shortages to EU authorities.
As regards the regulation of medical devices on an EU level, the EC announced on 25 March that it intends proposing the postponement of the date of application for Regulation (EU) 2017/745 regarding medical devices for one year, which was due to take effect at the end of May 2020. This postponement would certainly relieve pressure on national authorities, notified bodies, manufacturers and other actors and will allow them to fully focus on priorities related to the COVID-19 pandemic.
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 licensing and supply of medical devices, 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. On 25 March, the FSA published additional guidance aimed at food business (available here), which provides focussed information relating to food hygiene practice, managing employee sickness, social distancing, etc.
Insofar as the COVID-19 situation continues to evolve 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, marketing authorisation application processes, as well as other available routes.