Canadian access to pork insulin at risk if Health Canada adopts 1,400 per cent fee increase, says sole supplier

This story is an exclusive from Hill Times Research Health. To find out more, register for a free trial now. A Health Canada decision in April 2020 to eliminate a discount for pharmaceutical manufacturers with low Canadian sales volumes could result in a 1,400-per-cent fee hike for the only company in the world that manufactures pork insulin. The United Kingdom-based manufacturer, Wockhardt UK Inc., has said it cannot continue to supply Canada with the medicine if the department implements the fee. This would leave approximately 200 to 400 Canadian diabetics at risk of not having access to this type of insulin. Wockhardt is not making that much money, "if any money" on pork insulin, said Pamela Fanaras, director of scientific affairs at Nucro-Technics in Toronto. Nucro-Technics is retained by Wockhardt UK to conduct quality control for the manufacturer's insulin upon importation in Canada as the manufacturer does not have a Canadian office. Ms. Fanaras and Constantine Fanaras, operations director at the family-owned company, spoke to Hill Times Research Health on behalf of Wockhardt UK during an Aug. 10 Zoom interview. She said Wockhardt told them if the fees increase as outlined in Health Canada’s updated fee schedule, it “simply cannot continue to make the product available” in Canada. "They’re really keeping it alive for compassionate reasons. For them to have to absorb such a huge increase just to continue to sell their product in Canada, it doesn't make sense as a business to do that. I mean, you're basically asking them to pay to make it available with such a huge fee." The loss of Hypurin, the brand name for Wockhardt UK’s pork insulin, would mean switching around 200 to 400 diabetics in Canada to biosynthetic human insulin (BHI), which is more widely available. That could have a dramatic impact on the health and quality of life of those diabetics. Nucro-Technics has received many letters from diabetics describing their experiences of having switched from pork insulin to BHI, according to Constantine Fanaras, operations director at the company. Diabetics have told him about going into comas, experiencing glycemic shock, and being in and out of hospitals after the change to their prescriptions. “These letters usually end with, ‘If I don't get , I will die.’ And what we're really trying to do is avoid this type of situation, because it's people at the end of the day that are on the other end of this. It's not just an academic exercise in fees and costs,” said Constantine Fanaras. Some diabetics experience allergic reactions to human insulin and have chosen to continue using animal insulin, according to Kimberley Hanson, executive director of federal affairs at Diabetes Canada. Based on the number of vials of pork insulin distributed in Canada, Diabetes Canada estimates that between 200 and 400 diabetics use pork insulin in Canada, according to Ms. Hanson. Health Canada reached out to Diabetes Canada's Kimberley Hanson (seen in 2018 with Conservative MP Marilyn Gladu) to ask about the impacts of a possible pork insulin shortage. Photograph courtesy of Ms. Gladu's office “Some people have very significant different reactions to their insulin,” Ms. Hanson said in a phone interview on Aug. 8. “It's unfortunate for them that it’s a small number of humans so it could seem like, ‘well, sort it out.’ … It's a very, very literally life-threatening condition day in and day out at the best of times. And these poor folks are not experiencing the best of times on a good day.” Health Canada charges pharmaceutical manufacturers various fees to conduct business in Canada. Where Wockhardt UK would see a massive hike is in the establishment license fee, which allows the company to import Hypurin into Canada. Under Health Canada’s updated fee schedule, Wockhardt UK would be expected to pay approximately $30,000, according to Pamela Fanaras. That is a dramatic rise from the $2,000 she said it has been paying annually on average, amounting to a 1,400 per cent increase. Health Canada said that the base establishment license fee prior to April 2020 was $24,202. However, Wockhardt UK has benefitted from a discount the department applied to account for the low sales of Hypurin. That discount was previously available to any pharmaceutical manufacturer who sold low volumes of medicines in Canada. Health Canada stopped using that low-sales discount in April 2020. Pork insulin is used by up to 400 Canadian diabetics. Roughly 2.3 million Canadians aged 12 and older report having diabetes, according to a 2018 Statistics Canada report. BHI is the more widely used form of manufactured insulin for diabetics. Fee increases meant to 'reflect current costs' of regulatory work The department declined an interview request but did respond to Hill Times Research’s questions by email on Aug. 10. It said that it updated its fee schedule for human drugs on April 1, 2020, after a two-year consultation. It said it “updated its fees to reflect current costs,” and that the previous fees were eight years “out of date.” “Health Canada assesses and monitors the safety, quality, and efficacy of drugs made available to Canadians. To support that work, Health Canada charges industry fees to cover a portion of the costs of its regulatory services, which is consistent with international practices,” the email reads. The base establishment license fee is now $28,975, and will increase gradually year over year up to $32,380 in 2023-24. Health Canada said it introduced a new small business strategy to recognize “that the previous fee reduction measure (based on volume of sales) did not directly benefit small business and that many large companies were benefiting inappropriately.” The department bases eligibility for the small business discount on this definition from the Treasury Board Secretariat: “Any business, including its affiliates, that has fewer than 100 employees or between $30,000 and $5-million in annual gross revenues.” Wockhardt UK is not eligible. While it only sells one product in Canada, and in low numbers due to the smaller population that requires it, the company is a part of a larger multinational manufacturer (Wockhardt Limited) with at least 8,600 employees around the world. Its annual revenue for the 2020-21 fiscal year was US$375.94-million, according to the Dun & Bradstreet website, which publishes business data and analytics. The increased fee is not yet in effect for Wockhardt. Nucro-Technics and Health Canada have been in discussions since April 2020 on the issue, and Health Canada has not charged the higher fee while “the situation is under review,” said Pamela Fanaras. The department also hasn’t provided Nucro-Technics with a sense of when a decision will be made, the company said. But the department has been acting in “good faith” and officials have been meeting with them, said Constantine Fanaras. “Everyone’s been as helpful as they can be.” Hill Times Research asked Health Canada for its timeline. The department did not provide one but said Canada's current supply of Hypurin "remains uninterrupted" and is available to patients to treat their diabetes. "Discussions are ongoing between Health Canada and Wockhardt UK Inc. to address continued access to this product in Canada.” Use of animal-sourced insulin begins to decline in mid-1990s Animal-based insulin was the dominant insulin product for diabetics until the mid-1990s. This is when many of the manufacturers who were producing it withdrew those products from the market to focus on producing BHI, which is structurally identical to the human insulin molecule, according to Colleen Fuller, a health policy researcher and a member of T1 International, an organization representing people who use insulin. Ms. Fuller manages her diabetes through animal-sourced insulin. She spoke to Hill Times Research by phone on Aug. 9 and Aug. 11. Ms. Hanson said that when she was diagnosed with diabetes 26 years ago, doctors were no longer prescribing pork insulin to new patients. But those who have been taking animal-sourced insulin before may have experienced severe allergies if they tried to switch to the newer form of insulin, said Ms. Hanson. Colleen Fuller experienced severe health consequences when she switched from pork insulin to biosynthetic human insulin in the mid-1990s. Photograph courtesy of Ms. Fuller Ms. Fuller is one of those diabetics. She used animal-based insulin to manage her diabetes after her diagnosis in 1969. With the availability of BHI in the mid-1990s and declining numbers of animal-sourced insulin products, her doctor switched her prescription. “Within three weeks, I was in the hospital in a coma. I had lost all ability to detect low blood sugar. That’s a life-threatening thing. If you can't detect low blood sugar, then you do go into insulin shock and coma and seizures and so forth,” said Ms. Fuller. Her doctor reduced the amount of BHI she was required to take, but Ms. Fuller still found herself “in and out of comas” for five years. Other reactions included excessive weight loss and chest pains. Once she learned in the late 1990s that pork insulin was still available in Canada, she asked her doctor to switch her back. Three decades later, she said this isn’t just a matter of a licensing fee but that “people’s lives are on the line.” Wockhardt UK hasn’t increased prices in at least 15 years Constantine Fanaras said the issue’s timing is ironic considering that 2021 is the 100th anniversary of the discovery of insulin by Dr. Frederick Banting and Charles Best, who were researchers at the University of Toronto. They sold the patent for the medicine, which made diabetes treatable for the first time, to the university for one dollar to ensure that insulin remained accessible and affordable. Wockhardt UK essentially holds a monopoly position on pork insulin as other manufacturers have dropped out of the market to focus on manufacturing BHI. Even with no competition, Wockhardt UK has ensured that the medicine stays accessible, he said. “Wockhardt hasn't actually changed their prices since they've started distributing this product in Canada,” he added. “We've had the same for it to come in today, as we did in 2006.” (Nucro-Technics’ business relationship with Wockhardt began in 2006.) Nucro-Technics’ share of the insulin price has increased slightly to account for higher shipping costs but he said he believes his company has only increased prices twice over a 15-year period by about one- to two-and-a-half per cent. Diabetics embark on parliamentary letter-writing campaign Ms. Fuller and many other diabetics have written to Health Minister Patty Hajdu (Thunder Bay—Superior North, Ont.), asking her to intervene and stop the fee increase. Ms. Fuller said those letters have also been sent to local MPs and opposition health critics. She has not received a response from Ms. Hajdu’s office. NDP health critic Don Davies has asked Health Minister Patty Hajdu to 'urge' Health Canada to exempt Wockhardt UK from the updated fee schedule. The Hill Times photograph by Andrew Meade When NDP health critic Don Davies (Vancouver Kingsway, B.C.) learned about the situation about a month ago, he also wrote to Ms. Hajdu. His office said he hasn’t received a response. “I'm asking her to urge her ministry to provide a letter of exemption to maintain the annual fee,” said Mr. Davies in a phone interview on Aug. 10. “This is not unprecedented, first of all, they've been doing it for years in this case,” he said, adding that Health Canada has also waived the licensing fee for COVID-19 vaccines. Hill Times Research asked Ms. Hajdu’s office for an interview and was not provided one prior to publication. Requests for comment from Conservative health critic Michelle Rempel Garner’s (Calgary Nose Hill, Alta.) office and a spokesperson for the Bloc Québécois went unanswered. Diabetes Canada’s Kimberley Hanson said she plans on speaking with Health Canada on the issue next week. The department’s division that focuses on drug shortages reached out to Ms. Hanson earlier this year, she said. “Their intention was, as I understood it, to kind of develop a fallback plan should any kind of supply disruptions occur, because there is now only one manufacturer in the world of animal insulin, and that's Wockhardt in the U.K.,” Ms. Hanson said. In their communications with Ms. Hanson, officials told her they wanted to understand the number of people who use pork insulin, why they require that form of insulin, and how those diabetics could be supported if there was a disruption in supply, she said. It was after Health Canada reached out to Ms. Hanson that she learned from diabetics who use Wockhardt UK’s insulin that the department was planning to increase the manufacturer’s fee to import the medicine into Canada. Patients told her it was a part of a cost recovery mechanism, Ms. Hanson said. Medical experts collaborating with Diabetes Canada have said it is “conceptually possible” that someone who has previously experienced the very difficult side effects of switching could “with careful supervision, and support over time,” adjust to human insulin, Ms. Hanson said. “But, I want to say that just because they could switch does not mean that we agree with them being forced to so that Health Canada could get $28,000,” Ms. Hanson added. She stressed she wanted to speak to Health Canada and get more information before Diabetes Canada decides its position on the subject. Diabetics who rely on pork insulin are “facing a number of very significant hurdles to their health and to their quality of life, to begin with. This isn't like I prefer Dove brand antiperspirant or Old Spice kind of issue, right?” said Ms. Hanson. Constantine Fanaras said Wockhardt UK has told his company that they have no “imminent” plans to remove the product from Canada. “They were asked during one of our calls, point blank, is the intention to keep supplying the Canadian market? And they just answered, without this fee increase, yes, the intention is to keep supplying the Canadian market,” he said. Nucro-Technics would like to see Wockhardt UK retain its discount for low sales. “We get that sometimes things do increase over time, but it's really difficult to absorb this type of fee increase and still maintain supply to the market, especially if you don't have a lot of people that are taking this product,” he said. In its emailed statement, Health Canada said, it "recognizes how important animal-based insulin is to the Canadian patients who rely on it on a daily basis. Health Canada remains committed to working with Wockhardt UK Inc. to protect access for Canadian patients.” Tessie Sanci is the health editor of Hill Times Research Health where this story was originally published. Hill Times Research Health is the tool that industry professionals depend on in order to stay ahead of the decision-making curve in federal health policy. You can register for a free trial here. The Hill Times

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Canadian access to pork insulin at risk if Health Canada adopts 1,400 per cent fee increase, says sole supplier

The medicine is used by approximately 200 to 400 diabetics in Canada

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