Prohibited from donating blood, people who stayed or lived in Europe in the 1990s may soon be able to roll up their sleeves and contribute to Héma-Québec’s reserves.
In Quebec, more than 120,000 people donate blood regularly to meet the province’s medical needs. However, since 2000, measures taken by Héma-Québec exclude people who have spent several months in the United Kingdom or France between 1980 and 1996. In other words, people born there, but also those who worked or lived temporarily.
The criteria became even stricter in 2005, when Héma-Québec imposed a permanent ban on the donation of blood products to people who had spent 5 years in any Western European country during the same period.
In question? The risk of transmission of Creutzfeldt-Jakob disease, in particular of the form called “variant” which is transmitted to humans through contaminated meat. Quickly fatal, the condition caused a major health crisis in Europe at the end of the 1990s (see box below). It can also be spread by medical procedures – including blood transfusion.
However, the epidemic did not have the magnitude announced: less than 250 cases have been recorded since 1996 worldwide, the majority in the United Kingdom and France.
The measures imposed in the early 2000s are no longer justified today, according to the Dr Marc Germain, Vice-President of Medical Affairs and Innovation at Héma-Québec. He hopes that Héma-Québec will soon obtain authorization to abandon these exclusion criteria. Explanations.
Québec Science: Variant Creutzfeldt-Jakob disease is extremely rare. How to estimate the risk posed by transfusions?
Marc Germain: There have been 3 or 4 well-documented cases of transmission by transfusion in the past. It is therefore a risk that is not theoretical, but it is tiny, and it decreases as time passes. [selon une revue britannique publiée en 2016, aucun cas dû à une transfusion n’a été rapporté depuis 2007].
The only way to be convinced that we face a negligible risk is to model it, to make mathematical estimates of the risk for a person who receives a transfusion in Canada. We did a whole series of scenarios. Even in the most pessimistic, for example if 1 in 2000 people in the UK carried the infection, with a very long incubation period, the risk is estimated to be 1 in 16 million transfusions. It is extremely low; we would have to wait 20 years before seeing a single case! And this is the most pessimistic of scenarios… For the other scenarios, the risk is estimated to be close to zero.
QS: What triggered this desire to revise the exclusion criteria?
MG: We’ve been thinking regarding this question for a few years. About a year ago, our colleagues in Australia managed to convince their regulatory agency to drop this criterion; this represented a significant gain in donors becoming eligible once more, as many Australians had stayed in the UK.
In the USA, the Food and Drug Administration has also issued a statement to the effect that they no longer required the application of these criteria, which were substantially the same as here. So there are precedents; it is time for us to make a similar request to Health Canada.
QS: Can we expect quick approval?
MG: We still need a few weeks before we can submit the submission to Health Canada, because we also have to anticipate the changes in the electronic questionnaires, train the staff… We hope to obtain approval in the current year, and if possible put this in force before the end of 2023.
The lifting of the exclusion criteria would concern all the countries listed. As the risk is highest for the UK, and considered negligible, it is even lower for other countries.
QS: For many people of European descent, this exclusion criterion is upsetting. Do you hope to recruit many new donors?
MG: It’s hard to estimate. When we put the criterion in place 25 years ago, we surveyed the donors, and these measures still excluded 3% of them. However, we made it through without suffering a shortage. Today, would the figure still be 3%? I don’t know. Persons born following 1997 and having emigrated to Canada are not covered by the exclusion. For slightly older people, we hope to get a significant percentage of additional donors.
QS: Are the needs for blood products glaring?
MG: Blood reserves are a bit like fruits and vegetables at the grocery store, you always have to start over! We have to solicit new donors every day. If the situation is going well today, that does not mean that it will be the case in two weeks. These are products with a limited lifespan and demand can be unpredictable. Having new eligible donors is therefore necessarily good news.