Health Committee on Dec. 8th, 2016

[The Chair, Liberal, Bill Casey]

Order. We are to start a study today. On November 1, the House of Commons Standing Committee on Health agreed that the committee would dedicate the meeting of Thursday, December 8 to initiate a study on the current restrictions when it comes to blood donation imposed on men who have sex with men.

We're very pleased that our guests are here today. We're looking forward to the testimony. At the end of this, we'll decide where we go next with this study. We have invited several groups, as proposed by the members of the committee, but many have declined to come, so we're very appreciative of the witnesses who did agree to come today.

With us today from the Canadian AIDS Society, we have Gary Lacasse and Janne Charbonneau. From the Canadian Blood Services, we have Dr. Graham Sher and Dr. Dana Devine. From the Department of Health, we have Catherine Parker.

We're going to start with the Canadian AIDS Society. You may have 10 minutes for an opening statement, if you like.

[Gary Lacasse, Executive Director, Canadian AIDS Society]

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 Philpott'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.

[The Chair, Liberal, Bill Casey]

Thank you very much.

Now we'll move to Canadian Blood Services.

[Dr. Graham Sher, Chief Executive Officer, Head Office, Canadian Blood Services]

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.

[Dr. Dana Devine, Chief Medical and Scientific Officer, Head Office, Canadian Blood Services]

Thank you.

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.

Thank you.

[The Chair, Liberal, Bill Casey]

Thank you very much.

Now we will move to the Department of Health, with Catherine Parker.

[Catherine Parker, Director General, Biologics and Genetic Therapies Directorate, Health Products and Food Branch, Department of Health]

Thank you.

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.

Merci beaucoup.

[The Chair, Liberal, Bill Casey]

Thanks very much to all of you. I think we've all learned quite a bit already.

Our process is that we go now to a round of seven-minute questions. Then we have a round of five-minute questions and a short round of three-minute questions.

Today we're going to start with Dr. Eyolfson.

[Doug Eyolfson, Liberal, Charleswood—St. James—Assiniboia—Headingley, MB]

Thank you, Mr. Chair.

Thanks to all of you for coming.

Dr. Sher, it's good to see you again. You may have referred to this in your presentation, but I want to confirm it. Do you have knowledge of the current prevalence and incidence of HIV in the MSM population?

[Dr. Graham Sher]

As I mentioned in my remarks, we do follow very closely the Public Health Agency of Canada's published data. We actually have it in front of us. It is true that the most recent set of published data, the 2014 data, show that for the prevalence of HIV, amongst all HIV cases, 54.3% represent the MSM population.

[Doug Eyolfson, Liberal, Charleswood—St. James—Assiniboia—Headingley, MB]

Okay. Would you say that's increasing or decreasing over time? What does the data say?

[Dr. Graham Sher]

In 2011, it was about 50%, and in the 2014 reported data, it was 54%. It's essentially been the same for quite a number of years. Dr. Devine has more information on this as well.

[Doug Eyolfson, Liberal, Charleswood—St. James—Assiniboia—Headingley, MB]

All right. I understand from the record that the safety record since these changes has been excellent. You've said that in 25 years there has not been a case of HIV transmission through the blood system.

[Dr. Graham Sher]

That's correct.

[Doug Eyolfson, Liberal, Charleswood—St. James—Assiniboia—Headingley, MB]

That's remarkable. I congratulate all of you for your efforts.

Now, on this deferral policy, when it comes to other jurisdictions, would you say that this one is among the more stringent or the less stringent? Would you say that other jurisdictions have even less stringent deferral policies than Canada's?

[Dr. Dana Devine]

I'll take that question for you.

If one looks at what's going on globally, we are amongst the countries that have led the change from a permanent deferral to something shorter. About a dozen countries now have either implemented or will be implementing a one-year deferral. Most of the other countries in the world are still on a permanent deferral.

[Doug Eyolfson, Liberal, Charleswood—St. James—Assiniboia—Headingley, MB]

All right.

You said that the current window for HIV is approximately 10 days for infection detectability. Is that right?

[Dr. Graham Sher]

That's right.

[Doug Eyolfson, Liberal, Charleswood—St. James—Assiniboia—Headingley, MB]

Do you see a potential, either in the near future or ultimately, to use that technology to further cut down the deferral to one of shorter duration?

[Dr. Graham Sher]

I'll make one short comment, Dr. Eyolfson, and then Dr. Devine can add to it.

The intent of the work we're going to do in January is really to examine two principal policy directions. Are we simply seeking to further shorten the time period but to keep it as an MSM policy? Or are we going to take a completely different approach, as both we and the Canadian AIDS Society have said, and embark on a policy that does not discriminate on the basis of gender or sexual orientation? We really need to understand that, because just an incremental shortening of the policy doesn't deal with the principal assertion of unfairness and discrimination.

It is possible that what you've mentioned would be one approach. I'm not necessarily sure that it's the ideal or the optimal one, but we need to gather the evidence and the research as to whether there is a different policy approach that we could take altogether, one that would not be simply an incremental shortening of the time period but keeping MSM as the target group. That's the analysis and the research questions that we're going to embark on and seek to answer before we can make the next policy change.

[Dr. Dana Devine]

I'm not sure I have anything to add to that. That really is the direction that we're going in.

[Doug Eyolfson, Liberal, Charleswood—St. James—Assiniboia—Headingley, MB]

Thank you.

Monsieur Lacasse, thank you for coming. I've practised medicine for 20 years, and I am familiar with the discrimination we see in the LGBT community in the general community and when they seek medical care. It is something that in medical education they've been trying to improve: to break down these barriers and to make sure that medical practitioners are aware of these issues and, from our profession's end, to try to fix them.

With regard to the fear and stigma around HIV/AIDS, what steps do you think need to be taken to help address this in the general population and in the medical community to decrease this fear and stigma?

[Gary Lacasse]

In regard to the stigma, are you talking about the population in general and not necessarily the blood services?

[Doug Eyolfson, Liberal, Charleswood—St. James—Assiniboia—Headingley, MB]

It's for the population in general.

[Gary Lacasse]

We need to have some behavioural data about stigma. There hasn't been that much behavioural research done for stigma for HIV. We are desperately looking for funds to be able to research behaviour, because we find that the key to any decrease in stigma or behaviour is through behavioural science. That's what we're looking for.

The stigma associated with it is that when we go to multi-windows of health providers, we get stigma repeatedly, at one window after another. We have people in the Maritimes who are not even getting tested for HIV because they live in a rural community, and they don't access care because it's their cousin who is behind the pharmacy window giving them their meds. That's the reality we live in Canada in rural settings. It's also in cities like Montreal, Toronto, and Vancouver. The stigma is everywhere. We encounter it in the workforce. We encounter it when we go for our groceries. It's in everything.

The stigma has to be addressed globally, really, but we also have to address self-stigmatization first, when somebody is first diagnosed with HIV. I think that's another key where we have to develop more behavioural research in order to understand first why people are self-stigmatizing themselves, so that they can face stigma, then, as they go through life.