Good morning, Chair, Vice-Chairs, and members of the Standing Committee on Health.
My name is Gary Lacasse. I'm the executive director of the Canadian AIDS Society. Thank you for inviting CAS to appear before your committee at its inaugural meeting to discuss the current blood donation restrictions imposed on men who have sex with men, or MSM, as we call them in the health portfolio.
The Canadian AIDS Society is a national coalition of community-based organizations dedicated to strengthening Canada's response to HIV and AIDS, which includes ongoing collaboration with community partners and Canadian stakeholders to monitor and maintain the safety of Canada's blood supply, particularly since 1997, with the release of Justice Krever's report of the Commission of Inquiry on the Blood System in Canada.
Over the years, the Canadian AIDS Society has worked closely with Canadian Blood Services and other stakeholders to realize in July 2013 a change to the blood donation deferral policy affecting men who have sex with men from “indefinitely” to a period of five years since the last sexual encounter. At the time, we saw the change as a positive incremental step towards a deferral policy that would ultimately focus on gender-neutral, behaviour-based, risk-factor criteria, rather than sexual orientation.
Since then, CAS has continued its collaborative and consultative role with CBS to review evidence and scientific data collected over the last several years, and we supported Minister 's announcement in June 2016 to move to a one-year deferral step. We find that this is the right direction, with a view to ultimately removing any remaining barriers to MSM blood donation.
The long-standing CAS position on this issue is quite simple and straightforward. We believe that there should be a behaviour-based screening policy for blood donations, rather than one that focuses on populations based only on their sexual orientation or gender.
In essence, CAS continues to advocate for a safe blood supply that is also respectful of human rights. That fact is that screening guidelines have been and remain discriminatory for both male and female donors. The current screening questions in CBS donor questionnaires single out specific population groups, and in particular. men who have sex with men, regardless of their actual behaviours and practices.
For male donors, the screening questionnaire asks, “In the last 12 months, have you had sex with another man?” For female donors, it asks, “In the last 12 months, have you had sex with a man who, in the last 12 months, has had sex with another man?” Replying in the affirmative to these questions renders one ineligible to donate blood.
Similarly, transgender persons are also subject to a screening policy that discriminates based on whether or not a transperson has undergone gender-confirming surgery, regardless of their risk behaviour.
The current deferral period, which is not evidence-based practice, operates by assuming that certain groups are more likely to taint the blood supply. CAS has advocated and continues to advocate for studies to provide behavioural research evidence to support the move towards non-discriminatory screening criteria based on behavioural risk. With behavioural research, it will be possible to gather data on low-risk versus high-risk donors based on their sexual behaviour, irrespective of their sexual orientation or gender identity.
To this end, we welcome the recent announcement by CBS for a two-day meeting to be held in January 2017 with national and international stakeholders to identify research priorities for closing knowledge gaps that impact donor eligibility for men who have sex with men. The stated goal of the meeting is to examine alternative screening approaches for blood donors and alternative technologies to provide data to change the current donor eligibility requirements.
There is currently no international consensus on deferrals for MSM. Many countries, such as the United States, the United Kingdom, Australia, New Zealand, Sweden, and the Netherlands, have implemented or are implementing a one-year deferral. Others, such as Italy and Spain, have no deferral periods for MSM, preferring to assess donor risk through specific behaviour.
In conclusion, I would like to emphasize that stigma and discrimination remain key concerns and barriers in our struggle to reduce and ultimately eradicate HIV transmission in this country. Despite the reduction in the deferral period to one year since the last sexual encounter, this restriction applying to MSM blood donors continues to foster a culture of discrimination and stigma that hinders our ability to reach our goal.
Over the years, CAS has consistently advocated for a scientific evidence-based approach and has worked closely with Canadian Blood Services and various stakeholders to create a safe blood system without discriminating against certain groups. Even though we are not there yet, in recent years we have certainly been moving in the right direction, from a total ban on MSM in the past, to a five-year deferral period in 2013, and then moving to a one-year deferral period implemented this past August.
In the near future, we look forward to scientific and behavioural-based alternative screening approaches for blood donors, maximizing the use of new available technologies, to change donor eligibility requirements to create a safe blood supply that is also respectful of human rights. This is a realistic and achievable goal.
I thank you again for the opportunity to provide our views on this important matter.
Thank you very much, Mr. Chair and committee members, for the opportunity to discuss the blood donor eligibility criteria for MSM.
As you are aware, this is a sensitive and emotionally charged topic involving the people on both sides of the donation experience: the blood donor wishing to contribute to Canada's blood system and the patient receiving the blood product.
I'll begin by briefly reviewing how we screen blood donors and then provide an overview of the risk assessment and blood testing. I'd also like to outline some of the historical context around MSM and HIV risk as it affects the blood system, touch on what other blood operators are doing internationally, and then discuss the effect of changes to these eligibility criteria on the blood supply.
My colleague, Dr. Devine, will then conclude with an overview of our specific next steps.
As you are well aware, in Canada, blood is regulated as a drug by Health Canada. This means that Canadian Blood Services must demonstrate that the changes to policies and procedures potentially affecting patient safety will not introduce any measurable additional risk to the blood supply system before we receive federal approval for adoption.
Before donating blood, donors are screened to ensure blood donation is safe for them and for the patients who will receive their products. Donors must first complete a questionnaire, and we expect donors to be honest about their exposure risks. Screening personnel then go over the donor's answers and perform additional assessments to determine whether the donor is eligible to donate. Based on their answers, donors are then separated into broad risk categories and are determined to be either eligible or ineligible to donate accordingly.
Donors may be ineligible to give blood for a varying and large number of reasons, including travel, vaccination, tattoos, and many lifestyle issues. This leads me to how we assess risk.
The eligibility criteria presented on the donor questionnaire are determined through multiple risk assessments related to transmissible diseases. As part of this process, Canadian Blood Services monitors transmissible disease testing in blood donations and investigates possible transfusion-transmitted infections in recipients of blood products. We also continually scan the international and domestic environment for emerging pathogens, including, most recently, the Zika virus.
Our risk models are informed by data related to pathogens of interest or related pathogens. We also consider data from population-based studies, such as those performed by the Public Health Agency of Canada. After any significant change to our donor eligibility criteria, we use anonymous surveys to assess the rate of our donors' compliance with the revised donor questions.
We certainly receive many questions from donors about our criteria and why, if we can test blood, we need to have these criteria in the first place. Canadian Blood Services does indeed test every donation for HIV-1 and HIV-2, hepatitis B, hepatitis C, human T-lymphotropic viruses I and II, and syphilis. We also test for Chagas disease on individuals identified as being at risk based on travel, and in the spring, summer, and fall months we also test for West Nile virus.
While our technology is indeed sophisticated and includes state-of-the-art nucleic acid testing, there is a brief period shortly after infection when pathogens are not detectible by current assays. If an individual donates blood during the so-called “window period”, the early stages of infection, our testing processes would not detect the virus, and the blood products manufactured from that donation could be infectious for patients. This window period is indeed now less than 10 days for HIV and hepatitis C, and less than two months for most other pathogens. No test is 100% perfect, however, and can fail for technical reasons or because the pathogen undergoes mutation.
Because of the history of the blood supply system in Canada in the tainted blood tragedy, changes to donor eligibility criteria for MSM have required substantial analysis and ongoing engagement with patient stakeholder groups, including the LGBT communities and many other organizations, to make sure we maintain public trust in the system. When Canadian Blood Services was first established in 1998, on the the heels of the tainted blood tragedy, the criteria for MSM were indeed stringent. If a man had had sex even one time with another man since 1977, he was permanently deferred and ineligible to donate blood. At that time, and for many years following, the MSM population was noted to be a particularly high-risk group. The year 1977 was chosen as ground zero for the arrival of HIV in North America, hence its inclusion in the criteria.
We moved, as the committee well knows, to a policy for a five-year deferral in July 2013. Following our application to make this change, Health Canada asked of Canadian Blood Services and Héma-Québec that we gather a minimum of two years' data to demonstrate that no further risk had been introduced to the blood system before requesting a further reduction in the waiting period for MSM. This was met without issue.
Our data showed that the current one-year deferral policy easily covers the window period for HIV, hepatitis B, and hepatitis C, with the residual risk for these three pathogens being less than one in one million units transfused. Similarly, post-implementation monitoring showed no adverse impacts on the prevalence of HIV in donors, donor compliance, or trust in the system. This data permitted Canadian Blood Services to submit a further application to Health Canada for what is now our one-year deferral policy. This past June, that was approved and took effect in August.
Still, according to the Public Health Agency of Canada's most recent figures, men who have sex with men account for 54% of new HIV infections in Canada, a higher proportion than other risk categories combined. Large cohort studies of MSM populations in Canada also show a high frequency of risk-related behaviours. The scientific evidence available, however, is inadequate. Most public health research has focused on individuals within the MSM population whose behaviours are considered high-risk for infectious disease. This is the evidence that has informed policies to date. There is little data for those with low risk, such as those in long-term monogamous relationships. New research must be done to generate the evidence required for low-risk groups to be identified and included as eligible donors without introducing risk to the blood system.
Because patterns, causes, and effects of HIV differ by country, there is no international scientific consensus on an optimal deferral policy. With our move to a one-year ineligibility period for MSM, we are asked what impact this will have on the adequacy of Canada's blood supply. Unfortunately, we don't have clear data there yet. After the change from permanent ineligibility to a five-year waiting period, about 100 donors who had previously been ineligible to donate due to having sex with another man returned to donate and were reinstated. Similarly, findings of the post-implementation compliance survey following the five-year deferral suggest that about 400 male donors who had had sex with a man after 1977 but at least five years ago would be eligible to donate annually.
A larger impact on supply may be related to how Canadian Blood Services is perceived by potential donors, particularly younger people who are most concerned about issues of social justice. This is why Canadian Blood Services makes extensive outreach to many organizations, including students, through campus presentations, and many meetings with interested groups. We acknowledge that frustration remains high amongst many stakeholder groups whose members feel that the most recent change to the eligibility criteria did not go far enough to address what they perceive as discrimination.
Our current one-year deferral for MSM is indeed only an incremental step towards more inclusive donor criteria. We recognize that the pace of change for many is frustratingly slow for the vast majority of MSM who are still unable to donate blood under the current criteria. We remain very grateful for the stakeholder collaboration and participation from across the spectrum of organizations, including the Canadian AIDS Society.
Dr. Devine will now briefly take you through the next steps of what lies ahead in terms of future potential changes to the MSM criteria.
As Dr. Sher mentioned, we need solid evidence to support a further regulatory change, and that research and evidence do take some time to collect. In collaboration with scientists, the LGBTQ community, patient groups, and Health Canada, we are now focused on other possible changes to our eligibility criteria that we hope will permit more MSM to be able to donate blood.
With the recently available $3 million in research funding from Health Canada, we can plan and deliver research to work toward more inclusivity for our donors while maintaining the safety and adequacy of the supply of blood products for recipients.
One of the areas of research to explore is possible gender-blind or sexual-orientation-blind screening approaches, among others. For example, such an approach might include asking all donors whether they have had a new sexual partner or more than one sexual partner in a given time frame.
With the support of Health Canada, and in partnership with our sister organization, Héma-Québec, Canadian Blood Services will be holding a two-day meeting at the end of January in 2017 with national and international scientists. The meeting is being held in collaboration with leaders from the Egale Canada Human Rights Trust, the Community-Based Research Centre for Gay Men's Health, and the Canadian Centre for Diversity and Inclusion.
The objectives of this meeting are to inform and update participants on current national and international research, practices, and policy strategies, to identify key research questions to be answered, and then to develop a list of priority areas and potential research projects to answer those questions. We will discuss the barriers to research and how to overcome them. We will cultivate and promote new partnerships and collaborations to advance research in this area, and we will establish the processes for the application and granting of the research funds for this work. The patient and LGBTQ community representatives have been invited to attend the event as impacted observers and will be given an opportunity to address the attendees at the meeting.
Patients bear 100% of the risk associated with blood transfusion and, consequently, with those changes to donor eligibility criteria. Our goal is to maintain the safety of the blood supply while being as minimally restrictive as possible to donors.
We're really looking forward to the January meeting as our next step to help get us there.
Good morning, everyone.
Thank you for having invited me to speak to the committee today. I am pleased to be here to speak to the role Health Canada, as a regulatory body, plays in optimizing the safety of Canada's blood supply. The issue, more specifically, is the role we play with regard to donor program exclusion criteria that apply to men who have had sex with men.
The federal government, through Health Canada, is responsible for regulating the safety of Canada's blood supply. Ensuring that Canadians have access to safe blood has been the cornerstone of Health Canada's response to the Krever Commission of Inquiry on the Blood System in Canada. Canada now has one of the safest blood systems in the world, thanks to the strict standards for the collection and processing of blood that are now in place in Canada. This has been highly effective, with no cases of HIV transmission by blood transfusion in over 25 years in Canada.
The lessons of the tainted blood crisis must never be forgotten, and the current regulatory system for blood safety has been designed to ensure that such a tragedy never happens again in Canada. It has also been designed to be sufficiently flexible to allow changes to be made to these standards when new information or technological developments warrant such a change. The safety of the system is paramount, and safety must be based on science.
In our commitment to maintain this high level of safety, Health Canada works in partnership with national and international stakeholders to actively look for any potential blood safety issues and to put into place any precautions, as needed, to stop the spread of infectious diseases through the blood supply. The cornerstone of those partnerships is our relationship with Canada's two blood operators: Canadian Blood Services and Héma-Québec, with whom we collaborate in an open and transparent way while still maintaining our arm's-length regulatory role.
As Dr. Sher has just stated, in Canada, blood is legally defined as a drug and is subject to the requirement of the Food and Drugs Act. A stand-alone set of regulations, known as the blood regulations under the Food and Drugs Act, describes all the stringent requirements that blood operators must meet for the collection, processing, testing, labelling, storage, and distribution of blood in Canada. These regulations are supplemented by comprehensive guidance, which interprets each clause of the regulation in non-legal terms. Blood collection sites across the country must be licensed by Health Canada and are subject to regular inspections by Health Canada inspectors.
The blood regulations mandate a series of steps that the operators must take when collecting blood, resulting in an overlayering of safety steps to maximize safety. The two most critical steps are advance donor screening and the use of state-of-the-art blood testing technology in order to eliminate the possibility of an infectious disease being transmitted to a recipient.
Blood recipients are among some of the most vulnerable of patients in the Canadian health care system, as many would not be able to fight potential infections that could be transmitted via blood. Donor deferrals, which attempt to identify prospective donors at higher risk of transmitting an infection and not allowing them to donate, are used extensively in blood donor screening. Donor testing is not sufficient alone, because, as Dr. Sher has described, despite advances in testing, there remains a period of time known as the window period between infection and the possible detection of a pathogen, during which there is a risk that infected units of blood may not be identified by testing.
Donors are therefore deferred for various periods of time if they are identified as being at higher risk for HIV, hepatitis, malaria, and other infectious diseases. However, specific deferrals are not part of regulatory requirements themselves. The blood regulations require that establishments collecting blood obtain from the donors information about their identity and their medical and social history that is relevant to determining their risk of infectious disease.
The blood operators themselves, meaning the CBS and Héma-Québec, can determine what types of questions are necessary. This is known as “performance-based regulation”, in which a standard is set in regulation but the regulated parties have the flexibility in determining how to meet this standard. Performance-based regulation allows for changes due to advances in technology and science to be implemented without the need for a complicated process to amend regulations and bring them up to date.
Under the blood regulations, the blood operators must have their processes, as well as any changes to these processes, approved by Health Canada. This is accomplished by the filing of a submission containing complete information pertaining to the process or change, which is reviewed by a team of Health Canada scientists.
In Canada, there are no regulations prohibiting MSM and other groups from donating blood. These donor deferrals are part of the processes that CBS and Héma-Québec have developed to meet the standard of safety by deferring a group that is statistically at a higher risk of transmission of certain diseases.
As we have seen recently, this is no longer a permanent deferral. Both CBS and Héma-Québec have worked diligently over the past few years to modify the MSM deferral, work which has resulted in two amendments: from a lifetime to a five-year deferral in 2013, and subsequently to a one-year deferral in 2016. Health Canada approved both of these changes following review of a comprehensive package of information filed by both CBS and Héma-Québec containing scientific information showing that these changes would not diminish the safety of the blood supply.
We acknowledge and support the efforts under way by CBS in researching possible alternatives to the MSM deferral as well as other deferrals. We are open to future submissions for further changes. However, our review of any request for a change to a deferral will be based on the principle that it is supported by current science and would not introduce unacceptable risk to the blood supply. This is a high bar to reach, but both CBS and Héma-Québec have reached it twice already with respect to MSM deferral.
Health Canada's decisions as the regulator must be based on scientific evidence. Therefore, should Health Canada be presented with sound evidence to support that the MSM-specific donor deferral policy can be eliminated without compromising the safety of Canada's blood system, this information will be assessed in accordance with Health Canada's standards.
First of all, I would like to begin my time by saying thank you to my fellow committee members for allowing this study to happen. I think it's long overdue. I appreciate your support for my motion back months ago.
Without question, our priority is a safe blood supply here in Canada. I know that our second priority is the expansion of the donor base for that blood system.
The government announced in June that they would reduce this ban from five years down to one year, and it showed me that science supported a reconsideration of our donation policies here in Canada. Is this one-year ban now based solely on science? Is the ban still somewhat arbitrary? That is what I was hoping to get from you here today. You've provided a lot of answers, and I appreciate that.
I do have some questions, and my first one is for Ms. Parker; I don't know if it's “Dr. Parker” or “Ms. Parker”. Of course, Canadian Blood Services and Héma-Québec submitted their research to Health Canada in early 2016 in asking that the deferral for men having sex with men be dropped to one year. That was done in June, but you have not divulged the research to back up this decision. I know that others couldn't get this research through access to information, ATIP, and I suspect that most of this research was done with taxpayer dollars. Will you, or CBS, or Héma-Québec provide that supporting research to this committee?
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?
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.
Thank you very much, Mr. Chair.
Thank you to all the witnesses for being here today.
My first question is for the Canadian AIDS Society.
First, Gary, I want to say thank you for all your good work over the years. We've heard that Canada is a leader, and I think a lot of it is due in part to organizations such as yours and the on-the-ground organizations.
When we learned recently that the cut and reduced by a substantial amount funding to HIV and AIDS organizations across the country, I was a little shocked and surprised, frankly, particularly at how it was done. We know that organizations such as yours are on the front lines. You promote education and awareness, and you provide information and resources on the ground, on the front lines.
As we've heard, testing and prevention are the key to this issue. I was wondering if you could give us your opinion. How do you see these cuts affecting the progress that has been made in regard to HIV and AIDS to date, particularly in terms of the educational part of it, the prevention and the outreach?
Well, we were happy to hear that we are getting transitional funding for the next year from the federal and from the Public Health Agency, but it is a band-aid reaction to the cuts that are happening. There's a change, a shift, and the landscape is changing, but it should not be to the detriment of people living with HIV. That's our stance. That will be our stance in our advocacy, and I'll be moving forward to get full funding for 2018 and increasing the funding to the community action fund, which will be pro-rated, with maybe an injection of more funds to our countrywide efforts against HIV.
The front-line services, which do prevention, treatment, and support work on the front lines, are the most affected by this funding cycle. Also, because we're focusing only on prevention for people who are HIV negative, for everybody who is living with HIV, it's about making sure that they stay undetectable, because we know now, with science, that people who are on their medication become undetectable and cannot transmit new HIV cases down the road. It's imperative, in the 90-90-90 approaches with UNAIDS, that we have a holistic approach to how we do prevention of HIV. We believe strongly that this is missing in the Canadian effort with the new funding cycle for community organizations.
That's what we'll be lobbying and going towards. I think that if we maintain a holistic approach to fighting HIV on all levels, it will ultimately be better for all Canadians, because we will reach zero transmission by 2030 if the money is put towards getting to that.
I'll perhaps begin. I made that comment a few minutes ago.
I think it's a very important question. Certainly when Canadian Blood Services began its work in 1998, we initially made extensive outreach to the patient communities, because they were really the ones who bore the brunt of the consequences of the so-called tainted blood era in Canada. I think we have understood for many years that with every decision we make with respect to blood safety, the ultimate bearers of risk are those who receive blood. Donors are not obligated to be donors, but recipients are involuntary in their receipt of blood. If you have a car accident or cancer, and your physician prescribes blood, you don't really have a whole lot of choice, typically, in getting it. We have always recognized that every decision we make has to bear in mind the recipient as the ultimate bearer of that risk.
That said, with respect to the MSM policy, we have worked enormously hard with patient advocacy and patient stakeholder groups, as we have with stakeholders on the other side, the LGBT community. For many years the patient groups said, “We're not interested in a change to the policy. It suits us just fine. We don't care that it's broad and discriminatory.” But we were able to bring them along and have them recognize that there's a balance here. There a fairness issue. You can still protect safety at the same time.
That is why we landed on a five-year policy as step one. It is why, with greater trust and confidence, we moved to the one-year period. As Dr. Devine said, the patient groups will be front and centre in helping understand and inform the research agenda. It's essential that we keep onside that community along with the individuals who feel discriminated and left out. We really have to work with stakeholders on all sides of the equation here, but the patients are the ones who bear the risk.