Thanks, Jean-Paul.
As I'm sure the committee is aware, the bacteria that causes Lyme disease is Borrelia burgdorferi, which is a spirochete, a type of organism similar to syphillis but with many different characteristics.
To date, there has been no evidence of transfusion transmission of this bacterium. In spite of the fact that several studies have looked at donors who have been infected with Lyme disease and are bacteraemic and at the recipients of blood products from those donors, there has been no evidence of transfusion transmission. In all cases those patients tested negative for Lyme disease.
Canadian Blood Services does not test blood donors for Lyme disease, and we are not alone in this. There is no blood supplier in the world that tests blood donors for Lyme disease, including the United States, which has a high prevalence, as I'm sure you know, of Lyme disease, particularly in the northeastern U.S. No one, then, tests blood donors for Lyme disease.
Given that none of the blood operators globally has expressed a demand or a need for testing for Lyme disease, none of the companies that produce these assays has developed a test and submitted it either to Health Canada or to the FDA for approval. As you know, at Canadian Blood Services all of the testing we use for screening our donors must be approved by Health Canada.
That said, the move towards pathogen reduction technologies removes the need for specific testing for each type of pathogen. Pathogen reduction technologies prevent transfusion-transmitted diseases by very effectively killing bacteria, parasites, and most viruses that may be present in the unit. The bacteria that causes Lyme disease is no different. It would be inactivated by this technology.
These technologies are gradually becoming available in Canada. There is currently a Health Canada-licensed product for the treatment of plasma, and there is another product currently under review by Health Canada for the treatment of platelets. Unfortunately, there is no pathogen reduction technology yet on the market for the pathogen inactivation of red blood cells. That is a more challenging process.
There are, however, several companies that are in clinical trials, so we're hoping that such technology will be available within the next couple of years. While there is currently no evidence of transfusion transmission of Borrelia burgdorferi, the implementation of pathogen inactivation technologies in the future would eliminate even a theoretical risk.
Today, what we currently do is defer any donors who are diagnosed with Lyme disease from donating blood. If a donor comes in and says, “I recently was told I have Lyme disease”, they are told that they are not allowed to donate until they are feeling completely well and are finished any treatment they may be on.
We also ask donors, as the first question when they come in to donate blood, “Are you feeling completely well today?” If the donor cannot answer that question with a yes, they are told that they are not allowed to donate that day.
We also ask about medications. We ask about whether donors are under a physician's care for any reason, and we defer donors if they are. This is not only for the protection of the recipient but also for the protection of the donor, because we don't want a donor who is feeling unwell donating blood, obviously.
We also ask donors, if they become ill after their donation, to contact us and let us know, and donors frequently do this. If they develop an infection or respiratory symptoms post-donation, they often will call us and let us know, and then we can make a decision on whether the unit they have donated needs to be quarantined or not.
It should be noted—because I am often asked whether we ask about tick bites—that blood suppliers in North America do not ask about a history of tick bites prior to donation. This is because individuals are often unaware that they have been bitten by a tick, and so the history in that respect is unreliable. However, if a donor volunteers that they've recently had a tick bite, we ask them to not donate that day and to come back in six months' time.
Our work and engagement in this area has been long-standing. We've been actively monitoring concerns over transfusion transmission of Borrelia burgdorferi and we have actually had many discussions about this, not only within Canada but on the committees that I sit on, which include the AABB transfusion transmitted diseases committee, and also the European Blood Alliance's emerging infectious diseases committee. There is active monitoring of this around the world.
As part of our ongoing commitment for transparency and openness, we have also engaged with stakeholders and, a number of years ago, met with patient advocates to address their concerns. We commit to continue to do that.
Thank you.