UK manufacturers of ventilators being used to treat coronavirus patients are to be given specific legal protection in the event of any breaches of IP rules or personal injury claims, the Government has confirmed.
Where new kit malfunctions, or is found to be defective or to infringe intellectual property rights, the Government has pledged to shield the manufacturer from compensation claims and legal costs by covering the financial burden of any such claims that arise.
The move comes as the NHS struggles to source rapidly manufactured ventilator systems (RMVS) to combat the COVID-19 pandemic. Government figures suggest the NHS needs a further 8000 of the life-saving devices, to add to the existing inventory of 10,000.
Companies such as Dyson, Rolls-Royce and BAE Systems have joined the effort to manufacture the ventilators in response to a call to industry from Boris Johnson last month.
However, there had been concerns that the accelerated production of such a highly complex device would expose manufacturers to claims, if the ventilators were found to be unsafe or too similar to existing models.
Mechanical ventilators for intensive care are highly regulated devices. The Medicines and Healthcare Products Regulatory Agency (MHRA) has in response to the pandemic expedited the normal testing protocols but at the time of writing, only a modified version of a machine made by Penlon has yet obtained approval, with an industrial consortium to produce 5,000 units.
Enhanced government protection
Cabinet minister Michael Gove wrote to the chair of the Public Accounts Committee on 3 April to disclose two contingent liabilities in relation to the Government’s campaign for RMVS.
The first is to indemnify third-party IP rights for designers and contract manufacturers of the RMVSs, while the second covers product liability and people suffering personal injury or loss of earnings.
The Government routinely informs Parliament when it undertakes a contingent liability above £3m for which there is no specific statutory authority. However, the extent of the protection remains unclear and the Government has not provided detail on the indemnity, such as whether there would be a cap placed on the quantum of liabilities covered.
Some clinical and engineering experts have also expressed concerns about whether the British minimum standards for new devices will produce machines suitable for treating COVID-19.