In March 2020, as part of the Cabinet Office-led Ventilator Challenge, the Medicines and Healthcare products Regulatory Agency (MHRA) published a specification for a “Rapidly Manufactured Ventilator System” setting out the clinical requirements for a ‘minimally acceptable’ ventilator for use in hospitals during the COVID-19 outbreak (the RMVS Specification).
The RMVS Specification is designed to enable manufacturers to meet the increased demand for ventilators to support patients suffering with Acute Respiratory Distress Syndrome caused by COVID-19 and has been updated a number of times. Given the extraordinary situation posed by the pandemic, the MHRA’s specification accepts that demonstration of full compliance to ISO 80601-2-12:2020 (the international standard for ventilators) is unrealistic in the required development timeline, although compliance with the essential safety standards for patient safety must still be demonstrated. Further, once the pandemic has passed, the ventilators must be withdrawn unless CE marked by the manufacturer in accordance with the Medical Device Regulations.
Manufacturers quickly responded to the challenge, with a number of consortia and partnerships formed. One consortium, Ventilator Challenge UK, comprises 14 firms including Airbus and Rolls-Royce and is led by High Value Manufacturing Catapult, a group of manufacturing research centres in the UK. It secured MHRA approval for its Penlon Prima ESO2 device in April. A number of other ventilator projects involve a number UK-based Formula One teams such as Red Bull Racing, Mercedes, Renault, Haas and Williams under the umbrella title Project Pitlane as well as Innovate UK.
The UK Government quickly recognised the challenges faced by the consortium in the rapid design and prototype manufacture of new ventilator devices for certification and subsequent production in the treatment of coronavirus patients and acted to de-risk the position of manufacturers in case of legal claims relating to intellectual property infringement (e.g. where designs encroach pre-existing patents, copyright and design rights) or product liability claims such as death ore personal injury to a patient, and patient loss of earnings, caused by defective machines.
This de-risking was done through the issue of Government indemnities, as confirmed by letter from Michael Gove MP to the Chair of the Public Accounts Committee dated 3 April 2020. Any contingent liability in excess of £3m for which there is no statutory authority must be so notified.
The Cabinet Office has now updated the position in a Departmental Minute which advises that IP and product liability indemnities similar to those already given to Formula One Management and the F1 teams are to be provided as part of the BlueSky consortium activities. Whilst the minute states that Government liability under these indemnities could exceed £300,000, it goes on to say that the risk of claims arising is low since the Cabinet Office has no plans to manufacture any ventilators using the BlueSky designs.