Manufacturers not liable for faults in rush produced ventilators

Earlier this month, Cabinet Office minister Michael Gove moved to protect new manufacturers of ventilators from liability for legal claims over issues such as faulty equipment and intellectual property.

The decision was part of efforts to scale up the UK’s ventilator manufacturing to provide the NHS with access to more than 18,000 breathing machines.

One new model produced in response to the scheme — and indemnified by the government under Mr Gove’s decision — is now being distributed across the country.

Last month, prime minister Boris Johnson issued a call to manufacturers, asking them to rapidly scale up production of ventilators — which are crucial in keeping covid-19 patients alive.

In a letter to Parliament presented on 3 April, and later reported by the Financial Times, Mr Gove authorised two “contingent liabilities” for the designers and contract manufacturers of ventilators which may be used by the NHS if approved by the Medicines and Healthcare Products Regulatory Authority.

The liabilities cover intellectual property rights and “product liability”, the latter of which includes legal claims over personal injuries sustained due to faulty equipment.

In the letter, Mr Gove said indemnifying the manufacturers from these liabilities was “essential for the emergency provision of ventilators, procured at pace”.

The indemnification includes ventilators such as the new Prima ES02 model produced by Oxfordshire-firm Penlon, supported by major national companies such as Airbus and Rolls-Royce, which are part of the Ventilator Challenge consortium.

Penlon’s model was approved for use in the NHS by the MHRA on 16 April, and the first batch of machines were sent to hospitals — including London’s Nightingale Hospital — last week.

A Cabinet Office source told HSJ the NHS would “very soon” access “thousands” of new ventilators. The health service is thought to have more than 10,000 devices, but health secretary Matt Hancock has said at least 18,000 are needed in total.

Sharon Lamb, a parter at legal firm McDermott Will & Emery, said: “This exemption process exempts the manufacturer from the usual requirement to meet the standards and testing of the Medical Device Regulations, although the MHRA has said that essential safety standards must still be demonstrated.

“Because some manufacturers are likely to be unfamiliar with medical device liability and there is a fast tracked approval process, this indemnity will likely give some comfort who are providing ventilators to hospitals.”

Hospital chief executives have previously highlighted fears to HSJ over a potential shortage of ventilators, but the Cabinet Office said no patient who could have benefited from being treated with a ventilator has been denied access. 

Spare ventilators are allocated to a national reserve with a seven-day-a-week team deciding where to send the machines, depending on demand from hospital trusts.

The Cabinet Office will pay for new ventilators produced by the consortium. The department would not comment on the cost, but said information would be published as part of transparency procedures.