Ventilators stuck behind red tape

A northern company has been left frustrated after it developed a ventilator it says could save hundreds of lives in countries struggling with Covid-19, but 13 months on it is still waiting for the UK government to grant a licence.

Pendle-based Norvap International specialises in the manufacture and supply of veterinary anaesthesia machines and associated products, but it rose to the government’s Ventilator Challenge last year.

£1 million investment

It went on to develop a Covid-specific machine that can run without electricity and be driven by compressed air or oxygen, and submitted an application in May 2020 to the Medicines and Healthcare products and Regulatory Agency (MHRA) for a CE mark – a licence that shows the product meets EU health, safety and environmental protection standards.

The company has ploughed more than £1 million into the project, has 100 units ready for dispatch and parts to build a further 200, but is no further forward in receiving a licence.

Chief executive officer Lizzie Johnston-Hale said: “We participated in the Ventilator Challenge and although the UK didn’t need our ventilators, we were fine with that and that has never been our issue.

“However, after the Ventilator Challenge we designed a far more sophisticated and focused device, a three-in-one ventilator, HFNC [high flow nasal cannula] and CPAP [continuous positive airway pressure] machine to perfectly match all Covid issues.

“We have asked that the government fast-track the process and grant an exceptional use authorisation because these ventilators are needed now.”

The company has had foreign interest in its ventilator, but Johnston-Hale said the equipment needed to be granted a CE mark before it could be exported.

Bill Esterson, shadow minister for international trade, said: “This business has done everything right. They want to help people in India who are desperate for help.

“The government must now do the right thing and assess whether these ventilators are safe and can be used effectively.”

Throughout lockdown there has been a huge demand for the company’s core products, but the investment Norvap has made in the ventilator system has affected the company’s ability to be able to meet those needs.

When Big Issue North contacted the MHRA for a comment on whether the company’s ventilator had been approved or rejected – and if rejected why the company had not been informed – the press office referred the questions to the private company designated to certify appliances, the BSI Group.

BSI referred the questions back to the MHRA, which then re-referred the queries to the BSI.

No timescale given

When Pendle MP Andrew Stephenson contacted the MHRA, its chief executive Dr June Raine responded.

In her letter she says “exceptional circumstances whereby manufacturers are authorised to supply a non-compliant device would only be granted when it was in the interest of protection of health”.

She adds that the “exceptional use” is applied when “devices are necessary to fulfil an immediate clinical need and there are no alternatives or there is a shortage of supply in compliant devices available”.

This is no longer the situation in the UK. The letter does not state that the proposed ventilator has been examined nor does it give any timescale for the process to begin, but recommends the company “follows the normal regulatory route in bringing their products in conformity” – a process they started in May 2020.

Johnston-Hale said: “This is a big issue for the UK if it wishes to be at the forefront of medical innovation and manufacture. The US Food and Drug Administration have a 90-day turnaround provided you have all your detailed test data. We have that data, but no one has assessed it.

“The government has been able to agree use of vaccines incredibly quickly and ahead of the normal time they take to be tested and approved, yet our machine is still awaiting approval.

“We have had potential enquiries from customers across the globe and currently we have had an inquiry from Pakistan. We are offering the C19 ventilator we have created to India because of the emergency situation that has arisen.

“Without a CE mark we couldn’t even donate them to India or elsewhere. We ask for an extension of emergency clearance – examine our units, examine our test data.

“It is our duty, as people, to help the world and also help our country export British manufactured goods. All we are asking for is for our government to help us so we can help others.”

Photo: Norvap CEO Lizzie Johnston-Hale with the Covid ventilator – a sophisticated and focused three-in-one device