National Post (National Edition)
Red tape snarls output of COVID gear, firms say
From sanitizer to PPE, federal approval needed
With personal protective equipment in short supply in the battle against COVID-19, many Canadian manufacturers who have retooled and begun producing it say they can’t get it to desperate customers because of red tape.
Health Canada’s stamp of approval involves obtaining a Medical Device Establishment Licence (MDEL) at a cost of $4,590.
To obtain an MDEL, companies need to pay the licensing fees, complete the MDEL application form and email it to Health Canada.
But many firms say that the long wait time has cost them business.
Astley Gilbert, a NorthYork, Ont.-based printing firm, answered Premier Doug Ford’s call for more PPE in late March and applied for a Level 1 licence to sell a polycarbonate face shield on April 6. Rino Dambrosio, the firm’s executive vice-president in Toronto, says that at the time, the turnaround time was supposed to be between 24 and 48 hours. But after filling out the five- to six-page application and submitting photos of the face shield, the firm waited until April 29 for a temporary MDEL. “You feel like the application falls off a precipice,” says Dambrosio.
“Here we are a firm that’s losing 70 per cent of its business due to the outbreak, and we’re sitting on $60,000 worth of material and we’ve lost the opportunity to sell our product to distributors who have a much broader outreach,” he said.
Dambrosio said that although seniors’ homes, private businesses and healthcare workers wanted to order face shields, many went elsewhere.
“It has been a frustration for a number of companies across Ontario,” said Dave Smith, the Conservative provincial representative for Peterborough-Kawartha, who has been hearing from local manufacturers about delays. “We still have one organization which has been waiting for approval for a hand sanitizer.”
Another firm that is making hand sanitizer waited three weeks for approval, said Smith. “They have a 90,000-litre-per-day capacity,” he said.
Yet another firm now producing masks after formerly making filter bags for vacuums, is still in the process of having Health Canada approve its product. It has the ability to make 50,000 to 70,000 masks per month.
Health Canada offers what it calls an expedited application program for manufacturers of PPE.
“Health Canada will expedite the review and issuance of MDELs for companies requesting to manufacture, import or distribute Class I medical devices (such as N95 facepiece respirators, gowns, masks, face shields) or nasal pharyngeal swabs in relation to COVID-19,” reads its website.
Its regular service standard for issuing a MDEL is 120 days. “However, our goal is to process MDEL applications related to COVID-19 as quickly as possible to facilitate access to necessary medical devices,” a Health Canada spokesperson said in an email. “In light of the current demand for medical devices to help combat COVID-19 and the high number of companies making efforts to supply these products in Canada, Health Canada has encountered an unprecedented increase in applications for Medical Devices Establishment Licenses.”
As of April 27, Health Canada said it has expedited the issuance of over 750 MDELs for products such as masks, gowns and respirators, with approximately 450 applications remaining.
“We wanted to get the PPE to the front line workers and customers,” said Rob Press, manager of Astley Gilbert’s signage division, adding that business is starting to pick up. “It was a hard pill to swallow waiting for that MDEL.”
Meanwhile, there are continued shortages of PPE across the country. Last week, Prime Minister Justin Trudeau announced one million N95 masks ordered from China did not meet Canada’s safety standards and had been rejected. And on Friday, the union representing health-care workers in prisons, the professional Institute of the Public Service of Canada, announced that employees did not have adequate protection against COVID-19 and would walk off the job in the coming days if they did not receive it.
Smith said that while he’s buoyed by the surge in support offered by Canadian firms, he wants their products to get into the hands of health-care personnel more quickly.
“It’s great to see the number of businesses that are making a positive difference in Ontario — and in Canada,” he said. “I hate to be in a position where government protocols are barriers. We are in a pandemic.”
IT HAS BEEN A FRUSTRATION
FOR A NUMBER OF COMPANIES.