Health Canada cleared Grifols, which operates two paid collection clinics in Toronto, to extract plasma from its clients up to 104 times per year<\/p>\n
Advocates are worried Health Canada\u2019s decision to allow a for-profit multinational company to extract blood plasma<\/a> at twice the annual rate of Canadian Blood Services is putting Canadians at risk.<\/p>\n Grifols, a Spanish pharmaceutical firm, opened two paid collection clinics in Toronto last summer \u2014 one in North York and the other in Etobicoke \u2014 which offer up to $100 per visit to clients who donate their blood plasma.<\/p>\n As previously reported by TorontoToday, the company is using a \u201cgamified” payment structure<\/a> and a flurry of social media ads to encourage individuals to sell their plasma as often as twice per week.<\/p>\n Despite the purchase of plasma being illegal in Ontario, Grifols\u2019 business model has been made possible by Canadian Blood Services, the charity tasked with managing the blood supply in all provinces and territories except Quebec.<\/p>\n Facing a shortage of blood plasma donations spurred by the pandemic, Canadian Blood Services \u2014 which has an exemption to the paid plasma ban \u2014 entered into an agreement with Grifols in 2022, allowing the company to serve as its \u201cagent\u201d in Canada and face no barrier to paying individuals for their plasma.<\/p>\n But while Canadian Blood Services is permitted by Health Canada to extract plasma from any individual a maximum of 52 times per year, the federal health department agreed in 2019 to double that rate for Grifols \u2014 permitting the company to conduct up to 104 plasma draws per person annually.<\/p>\n This means Grifols\u2019 clients can be paid to sell their plasma multiple times each week, a rate that would not be allowed at Canadian Blood Services\u2019 donation facilities.<\/p>\n A recent meta study found that twice-weekly plasma collection can cause negative health impacts<\/a> for donors, including impacting an individual\u2019s levels of immunoglobulin, an infection-fighting antibody, and potentially leading to iron deficiency.<\/p>\n The full agreement between Canadian Blood Services and Grifols has never been publicly released. However, in January, Health Canada shared new details with TorontoToday about the company\u2019s operating guidelines, including its maximum permitted plasma draw frequencies.<\/p>\n Two health-care advocates say the revelations raise urgent questions about whether the Canadian government is doing enough to protect the health of Canadians selling their plasma under this new regulatory landscape.<\/p>\n Grifols can extract plasma 104 times per year, per patient<\/p>\n While many other countries have national limits on the frequency with which an individual can donate or sell their blood plasma, no such regulation exists in Canada.<\/p>\n Here, organizations and companies seeking to collect plasma must apply to Health Canada proposing their own maximum rate.<\/p>\n In an interview with TorontoToday, Natalie Mehra, executive director of advocacy group Ontario Health Coalition, said she was shocked that Health Canada\u2019 authorized Grifols to accept 104 plasma donations per year.<\/p>\n \u201cIt\u2019s staggering,\u201d she said. \u201cThe fact that the system is weighed in favour of the for-profit multinational drug company is appalling.\u201d<\/p>\n Mehra said she believes Health Canada\u2019s decision could risk the health of people who make the financial decision to routinely visit a Grifols\u2019 clinic.<\/p>\n When TorontoToday spoke to clients outside of Grifols\u2019 North York clinic last month, all of them said they were there to sell plasma because they needed money.<\/p>\n One man from Scarborough said he was \u201cf\u2014ing broke.\u201d<\/p>\n \u201cI came out because I\u2019m on [Ontario Works] and I get f\u2014 all for money,\u201d he said. \u201cI can\u2019t even afford to eat, so that\u2019s why I\u2019ve come here to give my blood.\u201d<\/p>\n Among the potential health impacts of making frequent plasma donations, low immunoglobulin can cause severe infections, including bronchitis, meningitis or pneumonia, as well as increase the risk of developing autoimmune diseases, according to the Cleveland Clinic<\/a>.<\/p>\n Iron deficiency, meanwhile, can result in extreme tiredness, cold hands and feet, or weakness, owing to an absence of sufficient healthy red blood cells, according to the Mayo Clinic<\/a>.<\/p>\n In a statement to TorontoToday, Grifols said providing safe and pleasant experiences for individuals who sell their plasma is the company’s top priority.<\/p>\n \u201cAcross Canada and around the world, people donate plasma regularly with multiple countries allowing donations of up to twice a week,\u201d the company claimed. \u201cAt each donation, presenting donors undergo a health assessment to ensure eligibility to donate.\u201d<\/p>\n While the United States permits companies to extract an individual\u2019s plasma up to 104 times per year, many other countries, including France, the Czech Republic, Italy and the Netherlands, restrict donations to about 26 times per year \u2014 or once every two weeks.<\/p>\n The 2024 meta study on plasma donations called into question the health and safety claims made by plasma collection companies and industry groups.<\/p>\n “Claims that donating plasma twice a week, as allowed by the [U.S.] Food and Drug Administration, is proven to be safe have often been based on insufficient evidence, mostly involving methodologically flawed observational studies that do not, in fact, support such conclusions,” it said.<\/p>\n Who’s responsible for ensuring patients\u2019 safety?<\/p>\n In response to questions about the safety of high-frequency donations, Grifols stressed it follows all of Health Canada\u2019s regulations and standards.<\/p>\n However, in its emailed statement to TorontoToday, Health Canada said its mandate is to ensure the blood and plasma that is collected in Canada is safe, while donor safety protocols fall under the purview of provincial governments.<\/p>\n \u201cThe decision about the acceptable number of times individuals can donate plasma is a donor health and wellness issue and is generally not one that impacts the safety of the plasma collected,\u201d said a federal spokesperson.<\/p>\n \u201cGenerally speaking, donor safety considerations would be a practice of medicine matter that falls under the jurisdiction of the provinces and territories.\u201d<\/p>\n Mehra called this justification a \u201cpretty thin attempt to evade responsibility\u201d on Health Canada\u2019s part.<\/p>\n \u201cYou can\u2019t both have the power to authorize [blood donation rules] and then say you\u2019re not responsible,\u201d she said.<\/p>\n Ontario\u2019s Ministry of Health did not respond to questions about the safety of high-frequency plasma donations.<\/p>\n Can you be an \u2018agent\u2019 if your authorization is different?<\/p>\n Steven Staples, national policy director with advocacy organization Canadian Health Coalition, said Health Canada\u2019s decision to permit Grifols to collect plasma at a higher rate than Canadian Blood Services also raises questions about whether the company is truly acting as an \u201cagent\u201d of the national charity in Ontario.<\/p>\n \u201cIt doesn\u2019t sound like Grifols is operating on the same basis as Canadian Blood Services,\u201d he said. \u201cI think there\u2019s a good case to be made that the loophole that Grifols is benefiting from to operate in Ontario to get around the ban is weak at best \u2014 and maybe completely false.\u201d<\/p>\n While Ontario has accepted Canadian Blood Services\u2019 claim that Grifols is its domestic agent, British Columbia has not.<\/p>\n