The "war" against Coronavirus: implications for the Life Sciences industry when regulations are loosened
Politicians have reached for military metaphors when setting out their response to the Coronavirus outbreak. Governments hope that the Life Sciences industry will win the fight against the virus by arming the healthcare sector with pharmaceutical and medical device solutions. In the first of a series of blog posts over the coming months on Coronavirus, we examine the pressures that industry must balance when responding to the call to arms.
An innovative response to Coronavirus is desperately needed from the Life Sciences industry to mitigate the horrible loss of life being reported around the world. Currently available diagnostic tests, ventilators and antivirals do not provide a complete solution in the absence of a vaccine.
Even in less critical times, regulators must walk a difficult tightrope by encouraging innovation whilst also protecting patients from harm. However, the clamour for products that will defeat the virus is such that usual regulatory constraints are being loosened. Nobody could criticise regulators or industry for wanting to work at speed to deliver a solution. However, the safety of vulnerable patients means that the risks of placing new products on the market under these circumstances must be assessed with particular care.
Companies that produce personal protective equipment (PPE), including coveralls, masks and gloves, are under pressure to scale up supply of their products. The European Commission published Recommendation (EU) 2020/403 earlier this month setting out circumstances under which PPE can be placed on the market – even if it does not yet bear the CE mark that demonstrates conformity with regulations. Whilst they will welcome the EU's intervention, manufacturers and insurers should ensure that the limitations of new PPE are understood, and explained to users, before they are made available. Equally, care should be taken over the manuals and training that accompanies PPE so that they are used safely.
The shortage of ventilators has been a headline problem in the UK. Until we have a pharmaceutical answer to Coronavirus, ventilators are the most critical weapon in a hospital's armoury. The UK Government has asked manufacturers of other products to step forward to produce new ventilators. These are products that are classified as medical devices and regulated as such.
Whilst there is a cost to producing ventilators according to a pre-existing design, devices that are already on the market have been tested and assessed by Notified Bodies – without the pressure of the current crisis. They also benefit from having been used for years in hospitals by experienced clinical staff. Manufacture in accordance with existing specifications should therefore result in safe devices. Nevertheless, the Medicines and Healthcare products Agency (MHRA) has given the industry additional protection by issuing Specification RMVS001 for the Rapidly Manufactured Ventilator System. The Specification dilutes the regulatory burden on manufacturers and recognises that full compliance with usual testing standards is not possible in "the current emergency".
It is hoped that by next year, a vaccine will be available. Work to produce a vaccine that would normally take around a decade is being compressed into months. There are reports that several drugs are already entering human trials, including in the UK.
In the UK, the MHRA has stated that it is prioritising the support and authorisation for the development of a vaccine; it is ready to ensure that applications for approval of clinical trials for a vaccine are dealt with as expeditiously as possible. At EU level, the European Medicines Agency (EMA) has also committed to support and fast-track development of vaccines and treatments for Coronavirus.
Clinical trials are needed to test whether new medicines are safe and effective. Sponsors and CROs involved in clinical trials for a Coronavirus vaccine will need to ensure that the risks of participation in clinical trials are made clear to trial subjects, particularly regarding unknown side effects, and that all patients involved receive a high standard of care. Regardless of advice and care given, however, industry guidelines provide for compensation for patients in the event of injury sustained as a consequence of participation in clinical trials; it is therefore vital that sponsors and CROs have adequate insurance cover in place.
Ultimately, regulators may be more comfortable with repurposing existing drugs. For example, Remdesivir is an anti-viral drug that was developed in response to the Ebola outbreak in 2014. Chloroquine and hydroxychloroquine – anti-malarial drugs – are also being mentioned. All have been mooted as potential solutions to the Coronavirus outbreak. The advantage of repurposing existing drugs is that that they have been through clinical trials and their toxicity has already been assessed.
A battle on many fronts
Day to day battles against the pandemic are being waged by healthcare staff in trying circumstances. Governments and regulators hope the Life Sciences industry will increase production of much needed equipment for clinicians, as well as ultimately providing the pharmaceutical solution to win the war against Coronavirus. Whilst the loosening of regulatory constraints is welcome, everyone will benefit from manufacturers ensuring that the speed of industry's response is matched by a proportionate analysis of the risks.
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