Evidence of meeting #36 for Health in the 42nd Parliament, 1st session. (The original version is on Parliament’s site, as are the minutes.) The winning word was donors.
A recording is available from Parliament.
NDP
Director General, Biologics and Genetic Therapies Directorate, Health Products and Food Branch, Department of Health
I'm sorry.
NDP
Don Davies NDP Vancouver Kingsway, BC
That's okay.
When did that request first come into Health Canada to review this policy and make the change?
Director General, Biologics and Genetic Therapies Directorate, Health Products and Food Branch, Department of Health
To go to the one year, I believe we started discussing that in the previous year, 2015—what would be the data required, what type of information we would need to see—through a series of meetings and then subsequently received the submission.
NDP
Don Davies NDP Vancouver Kingsway, BC
There had been no prior requests from Canadian Blood Services or Héma-Québec to the previous government. The first request came to the current Liberal government? Or it came just toward the end of the Conservative government?
Director General, Biologics and Genetic Therapies Directorate, Health Products and Food Branch, Department of Health
The only two actual requests we've had were for the change from the indefinite to five years in 2013, and then subsequently the change from five-year to one-year earlier this year.
NDP
Don Davies NDP Vancouver Kingsway, BC
Thank you.
Second, is there any country or jurisdiction in the world that has no restriction on the MSM population donating blood and simply relies on behaviour-based questioning?
Chief Medical and Scientific Officer, Head Office, Canadian Blood Services
I'll take that one, if that's okay.
The answer is yes. There's a small number of countries that don't ask any questions about MSM at all. Spain and Italy are probably the most often cited countries who do that. They have a different process from what we have. Their donors are screened by physicians for the most part, so you have a different quality of ability to gather information about an individual's risk as opposed to the sort of bucket-screening that most blood operators do. There's a couple of countries in South and Central America that have also changed. I believe that Mexico removed their MSM questions about a year and half ago.
NDP
Don Davies NDP Vancouver Kingsway, BC
Is there any data from those jurisdictions that would indicate that there's any higher risk to the safety of the blood supply?
Chief Medical and Scientific Officer, Head Office, Canadian Blood Services
The most thorough data that are out there come from Spain. They have actually seen an increase in the number of donors that they're picking up as HIV positive, and it is associated with MSM behaviour. In Spain right now, their health ministry is considering two different paths. For their data, part of which is the kind of behavioural research my colleague was speaking about, part of this relates to the fact that they think they might be asking the questions the wrong way and need to redesign their questionnaire. But they are also considering aligning themselves with most of the European countries that are moving to a 12-month deferral, so they would actually then reimpose a time-based deferral in Spain. Italy's data are not consolidated; I can't answer for Italy.
NDP
Don Davies NDP Vancouver Kingsway, BC
Okay.
In my next question, I want to rationalize two different parts of this. I think I may know the answer, but I want to make sure that I do. Both Dr. Sher and Health Canada have repeated several times that there is no 100%-safe test for pathogens.
You've talked about the window of between nine days and two months whereby a pathogen could get into the blood supply. You've said that safety is paramount and that it's based on the science. You look for potential risks and put in whatever protections are needed.
Also, Dr. Sher, I wrote down your words that you “expect donors to be honest”.
My question is about Health Canada's policy with respect to allowing paid plasma donors. The theory is that if you're paying donors to give plasma and you're appealing to vulnerable populations—poor people, drug users—you're creating an incentive for them to come. If they need money for the donation, the theory—and the worry—is that if you ask them about their behaviour, they have a financial incentive to be less than honest. I've been told and led to believe that there is no issue there with respect to plasma, yet....
I'm trying to square these two things. Are the tests 100%? Are donors' questions important or not? Or is it the difference between the way the plasma and the blood supply, whole blood, is stored and tested that makes these two different issues?
Chief Executive Officer, Head Office, Canadian Blood Services
I'll try to answer briefly. It's a complicated set of questions, Mr. Davies, but the short answer is that in blood donor systems around the world, such as Canadian Blood Services and many organizations like ours around the world, we do not pay donors. That's been a long-standing principle of non-remuneration for voluntary blood donors.
There is a commercial plasma industry whereby donors are reimbursed between $25 and $40, typically. The debate has often gone around whether the reimbursement process causes a higher-risk type of donor to come and participate. The evidence is abundantly clear—and I've actually presented it to this committee in a different setting—that when you look at the plasma products that come off the production line at the end of the process, whether they come from paid donors or unpaid donors, there is absolutely no safety difference whatsoever. The products are identically safe. The reason for this is not only the screening questions and testing, but also that plasma goes through a different set of additional purification and inactivation steps that render the product extraordinarily safe. But that's for plasma products: that's why the argument and the evidence is clear that paid donors and unpaid donors result in equally safe products.
What we're talking about here is whether the donors themselves have increased frequency of transmissible diseases. Because we don't have the pathogen reduction steps in the fresh blood system, it's one of the arguments against any reimbursement at all. We really need to distinguish the finished products coming off the production process contrary to what we're talking about here, which is the safety of blood that doesn't have that additional step in it yet. This is one of the reasons that, as Dr. Devine said, it's a tiered safety net. You don't reimburse, you ask questions, you test, and you rely on honesty, and this results in extremely safe blood components for recipients.
Liberal
Sonia Sidhu Liberal Brampton South, ON
Thank you, Chair.
Thank you to all our witnesses.
My question is for Dr. Sher. The court found that scientific evidence was lacking to support the indefinite deferral period for MSM to donate blood at the time. The deferral period has since been reduced twice, first to five years, and then to one year. In light of the present scientific evidence, what length of time do you recommend?
Chief Executive Officer, Head Office, Canadian Blood Services
Again, I'll perhaps provide the answer that I gave to Dr. Eyolfson. Dr. Devine can add to it.
We do not believe that it is a matter of randomly choosing a time period. The evidence was gathered in 2013 to support our five-year submission. The scientific evidence showed at the time that if we adopted that time period we would not negatively impact the safety of the system.
There is one very important element that, through your question, I would like to put on the table for the committee as a whole. A lot of the requirement that we had to do in 2013 was to ensure we could get the patient groups, who are the bearers of the risk here, onside with any policy change. For many, many years, patient groups in this country said they would not accept any change beyond the permanent deferral. We worked with them, as we did with advocates on the LGBTQ side, to say, let's take this in an incremental, evidence-based approach. We got all groups and a body of evidence to support a five-year policy. Once we had a further two years of evidence, we were able to show that a one-year policy would result in no further safety change.
The body of work we're now going to do, as Dr. Devine summarized, is to look at whether we go down to a shorter time period—six months, three months, four weeks—or we go to an entirely different screening process altogether that is not time based and that is much more inclusive for all donors, but doesn't alter the safety profile of the blood system? As Dr. Devine and I have both said, that's the evidence that is missing at the moment, and that's the research work that Dr. Devine and her colleagues are going to lead in Canada so that we can create a body of evidence to support our next submission to Health Canada.
I would argue that it's not good policy and it's not evidence-based policy to just choose another number—12 weeks or 24 weeks—because it doesn't deal with some of the concerns around this policy, which are concerns of inclusivity and fairness. We're trying to balance creating a body of evidence while at the same time recognizing the discriminatory aspects of the policy and also protect the safety of the blood for recipients, which is our ultimate mandate.
Put all of that together, and it could be another time period shorter than 12 months, or it could be a different set of approaches targeting either high-risk MSM individuals but not low risk, or not targeting anything at all. It's really that gamut of issues that we need to look at very carefully. Dr. Devine and her team will collaborate. It's behaviour-based research, social research, and scientific research all combined.
Liberal
Sonia Sidhu Liberal Brampton South, ON
Thank you.
My next question is for the Canadian AIDS Society. Individuals who are infected with HIV are sometimes unaware they are infected. What initiatives should we take to promote testing?
Executive Director, Canadian AIDS Society
It's funny you should ask, because we launched this year's testing campaign just last week. We do testing campaigns across Canada, but the issue is also to get a national testing reference guide across Canada developed, because the testing is not at the same level in all territories and provinces across Canada, which is a hindrance to getting tested.
We do have broader-based testing campaigns specifically for high-risk populations. That's where we work and what we strive for. All of our members across Canada actively promote testing for people who are not infected with HIV, but also for those who are infected with HIV, because it's also extremely important for people living with HIV to have secondary prevention against other blood-borne diseases. That's an effort that's continuously being done with all community organizations and health providers across Canada.
Liberal
Sonia Sidhu Liberal Brampton South, ON
Thank you.
My next question is for Health Canada.
On the federal government's role in ensuring the safety of the blood supply, I've heard about the safety procedures. Do you think they need to be improved or are you satisfied with the safety procedures?
Director General, Biologics and Genetic Therapies Directorate, Health Products and Food Branch, Department of Health
I'm sorry. With our safety procedures and regulations...?
Director General, Biologics and Genetic Therapies Directorate, Health Products and Food Branch, Department of Health
The regulations for blood in Canada have been completely modernized and updated, and we are very committed to keeping them as updated as they need to be to reflect any changes in technology, so we're quite confident in the strength of our regulatory process. It is very intense. The regulatory requirements are very high. We have an inspection program of blood collection establishments. There is ongoing reporting that is necessary from the blood operators, so we're quite confident in our system.
