Thank you very much to committee members. At Canadian Blood Services we welcome this opportunity.
I'll very briefly tell you about Canadian Blood Services to give you some context on the issue of the Zika virus. As members of the committee know, we're an arm’s-length organization within the larger health care system, supporting transfusion and transplantation medicine across the country. We are regulated by Health Canada under the Food and Drugs Act, but we are funded by the provinces and territories and the ministers of health across the country, who serve as the corporate members of Canadian Blood Services.
Our mandate is to manage the national supply of blood, blood products, stem cells, and related services for all the provinces and territories except Quebec, which has its own agency, Héma-Québec. We also manage for Canadians the national public umbilical cord blood bank. We're involved in the procurement of a variety of plasma-derived drugs for the country. We also lead an integrated interprovincial and national system for organ donation and transplantation. We look forward to talking to the committee about that at another opportunity.
We are dedicated as an organization to providing value to Canadians by improving the health outcomes of patients who depend on transfusion and transplantation by enhancing health system performance and by optimizing costs of the health system. We are an integrated pan-Canadian service delivery model, national in scope, with an infrastructure and governance model that makes us a unique part of the health fabric in this country.
I won't go into any detail with respect to Zika virus—for background, you've heard from colleagues at the Public Health Agency—other than to say that we do have a responsibility for mitigating risks to the blood supply for all viruses. Certainly Dr. Taylor referred to West Nile virus as a similar virus that emerged quite a number of years ago. At that time, we took very rapid and proactive steps to protect the blood supply against West Nile virus. Here we now face the same situation with respect to Zika virus.
What do we know about Zika virus and risks to the blood supply globally, and in particular in Canada? The transmission of Zika virus through blood transfusion was not entirely clear in the early evolution of this. More recently, there have been a couple of cases in Brazil that have strongly suggested that transfusion of blood products is indeed a route through which the virus can be spread.
One important point—certainly Dr. Devine can expand on this should committee members have questions—is that there is no licenced screening test we can put into the blood system today for Zika virus. Unlike the tests we have for West Nile, HIV, hepatitis B, and hepatitis C, there is no screening test that we can routinely do on blood donors. Blood system operators like Canadian Blood Services, in countries where Zika virus is not widely present, have had to resort to the policy of deferring as blood donors the people who have travelled to areas where Zika virus is present.
As the situation emerged, we began to see cases in Brazil in the middle of 2015; subsequently in Colombia, Mexico, Guatemala, El Salvador, Venezuela, and Paraguay by November; and in Puerto Rico by December. By January it was emerging in other parts of the Carribean.
At Canadian Blood Services, we immediately determined, given the frequency of travel of Canadians to this part of the world, that we needed to take some rapid and precautionary measures to protect the blood supply. We consulted with our international scientific and research advisory committee, a group of experts in the field of transfusion-transmitted diseases. We consulted with colleagues at Héma-Québec. We've been in regular conversation with both the Public Health Agency and Health Canada.
I echo what Dr. Taylor said, that we all recognized that the risk was small. Even if we didn't put anything in the way of a deferral policy in place, the likelihood of a transmission through blood transfusion in Canada was very low.
Nonetheless, and in keeping with the precautionary principle that underscores decision-making at Canadian Blood Services, on January 28 of this year we announced our intention to implement a formal risk-based decision-making policy with respect to Zika virus for the blood supply no later than one week after that announcement on February 5. At the time, on January 28, we publicly asked Canadians who had recently travelled to Zika-risk areas to postpone donating blood for a month until we had time to complete a comprehensive risk assessment and determine an appropriate deferral policy for the country.
Dr. Devine and her team of experts immediately began a rigorous risk-based decision-making process. It was primarily focused on ensuring the safety of the blood supply balanced with the security of the blood supply—meaning ensuring that we had enough blood to meet the needs of patients across the country.
We used all available scientific information to understand the nature of the risk and the data on travel behaviour of our donors. We developed a sophisticated risk model based on assumptions, predictions, and experience both with Zika virus as a known pathogen and similar viruses such as dengue virus.
On February 5 of this year we implemented a deferral policy of 21 days following exposure to Zika-risk areas. Héma-Québec introduced the same deferral policy. That 21-day deferral policy is based on several important criteria: an estimated risk of infection through a unit of blood in the Canadian blood system; available information on the duration of illness and residency of time of virus in the blood stream; the need for a deferral time period that aligned with our computer system so that we could implement it rapidly and effectively; the need for a simple approach that did not require changing every time another country reported Zika virus presence; a calculated impact on sufficiency of supply so we wouldn't lose more donors than could meet the needs of Canadian patients; and most importantly, the introduction of proportionate risk so as to have the right balance of safety and security of supply.
It was known to us at the time that the U.S. Food and Drug Administration was contemplating a 28-day deferral policy, as were several other countries where Zika virus may have been of concern. This concept of a 28-day deferral policy was based on calculations done by an organization in the United States known as the AABB, or the American Association of Blood Banks. Dr. Devine and I have served on the board of that organization. Their committee did two risk assessments: one for 14 days and one for 28 days. They did not do a risk calculation for 21 days. Those two time frames, 14 days and 28 days, were selected because they had been used for deferral policies for other viruses.
Their data showed that a 14-day deferral policy is likely too short from a risk mitigation point of view, so they ended up recommending a 28-day deferral policy. FDA followed this advice from the AABB, and that has become the policy in the United States.
Our risk modelling included a detailed calculation, including the 21-day deferral policy. Our data will show, as does Héma-Québec's, that the risk of a unit of blood being infected with Zika virus and entering the blood supply in Canada with our 21-day deferral policy in place is one in 38 million. The risk using a 28-day deferral policy would be one in 380 million. As context for committee members, the combined risk of HIV, or hepatitis B, or hepatitis C entering the blood supply in Canada today in the face of sophisticated screening tests is about one in 3.8 million. We're confident that our 21-day deferral policy significantly reduces the risk of Zika virus proportionate to other risks we manage.
The region of travel that we have chosen is intentionally very wide. In other words donors who have travelled outside of North America and Europe will be deferred for their 21-day period.
As was mentioned, there are also considerations with respect to donors for cells, tissues, and organs. As I mentioned in my opening remarks, in addition to managing the blood system we are also responsible for managing the stem cell network for Canada and the public umbilical cord blood bank. We are also involved in supporting organ donation and transplantation across the country. We are confident that the risk calculations applied to blood donors will be equally applicable to adult stem cell donors.
Health Canada has indeed provided guidance for cells, tissues, and organ organizations that aligns with our 21-day deferral policy that Canadian Blood Services and Héma-Québec now have in place. While we don't screen organ donors directly—that is done by other provincial organizations—we do believe the advice related to organ donor management provided by Health Canada and the Canadian Transplant Society is appropriate.
Like the Public Health Agency of Canada, we're involved in active monitoring of this evolving situation. We remain in contact with numerous partner organizations, including blood system operators around the globe, provincial and federal public health agencies, and many other organizations managing this entity.
As a closing point, I would like to leave committee members with an understanding of one other technology that, while not available imminently in Canada, is a technology that we at Canadian Blood Services believe is incredibly important from a risk management and risk mitigation point of view. It is a technology known as pathogen inactivation technology. Sitting beside me is one of the world's leading experts in that. She will be happy to answer committee questions.
It is a technology whereby we don't rely on testing for agents in the blood supply but actually depend on technologies to kill or inactivate the pathogens prior to transmission. That technology is not yet licensed and available in Canada, but Canadian Blood Services is on record and working with a clinical trial and the regulator to get licensing of the technology to further enhance the safety of the blood system.
In closing, Mr. Chair, Canadian Blood Services can assure Canadians that we have taken swift and decisive action to mitigate the risk of Zika virus from entering the blood supply in Canada. Canadian patients can continue to depend on us to manage a safe and secure system. We are confident that our rigorous, risk-based decision-making processes have resulted in an appropriate policy for Canada, given what we know about Zika virus today.
Thank you very much.