Mr. Speaker, I am pleased to have this opportunity today to take part in this important discussion on the outbreak of Ebola in West Africa and our response both at home and abroad.

I would first like to highlight that there are no confirmed cases of Ebola in Canada, but Canada must be prepared for a case to come here. Provincial and local health officials are the lead on any Ebola case in Canada, but the Public Health Agency of Canada continues to assist them to ensure that they remain prepared.

We have five Ebola rapid response teams in place, which include lab expertise that can quickly confirm a diagnosis, and emergency supplies from our national strategic stockpile, such as masks, gloves, and gowns. These rapid response teams would support the provincial and territorial authorities in their response should a case of Ebola occur.

Technical guidance and protocols to detect and manage suspected cases of Ebola infection have also been shared with provinces and territories and with the transportation sector. Front-line staff have been trained to screen international travellers arriving in Canada for communicable diseases and to refer any travellers suspected of being ill to quarantine officers.

However, I would like to focus my remarks today on the ability of vaccines to prevent and combat Ebola, and more specifically, on the government's role in the regulation of vaccines.

A safe and effective vaccine would be an extremely important public health tool to help prevent Ebola and contain future outbreaks. Indeed, Canadian scientists at the Public Health Agency National Microbiology Laboratory in Winnipeg invented an experimental Ebola vaccine that has shown great promise. I am very pleased to see that Canada is making up to 1,000 vials of this vaccine available to the World Health Organization, as they are best suited to determining how and where they can be deployed as safely, quickly, and ethically as possible.

On the home front, I would like to talk about Health Canada's role as a regulator of vaccines. I would like to talk about what it does, how co-operation with our international partners is beneficial and vital, and most importantly, how the process would work should some of this experimental Canadian vaccine need to be used on compassionate grounds within Canada.

Canada, like many other countries worldwide, exercises tight regulatory oversight of all vaccines, because they are usually given to very large numbers of healthy individuals to help prevent disease. All vaccines made available to Canadians are subject to a strict approval process, which is conducted by Health Canada. Health Canada is the national authority responsible for evaluating the quality, safety, and efficacy of vaccines for human use in Canada.

Prior to the approval of a new vaccine, the manufacturer must file a submission with scientific and clinical evidence that demonstrates that the vaccine's health benefits outweigh the risks and that the vaccine is effective and of suitable quality for Canadians. Clinical trials that take place in Canada must also be approved by Health Canada prior to their commencement.

However, it is not necessary for trials to be conducted in Canada for a vaccine to eventually be authorized here. Adherence to the internationally accepted standards of good clinical practice helps ensure that clinical trials conducted in other countries meet the high standards of evidence needed to support authorization in Canada. With clinical trials, the issue is the quality of the science, not where the science is done. This is especially important in the context of the current Ebola outbreak, as supplies of investigational products are extremely limited.

Furthermore, as part of the overall approval process, Health Canada conducts an evaluation of the manufacturer's facilities to assess the quality of the vaccine manufacturing process and to determine that the manufacturer is able to carry out the necessary quality controls for the vaccine. The manufacturer must also provide samples of the vaccine for testing in Health Canada laboratories.

After Health Canada's evaluation, if the conclusion is that the benefits of the vaccine outweigh any potential risks, the vaccine is granted market authorization and can be sold in Canada.

After approval, Health Canada continues its regulatory oversight by conducting a lot-release program and regular inspections of the manufacturer's facilities to make sure that best practices for drug manufacturing are being followed.

Potential adverse events associated with the vaccine are monitored by Health Canada and the Public Health Agency of Canada through active and passive surveillance systems.

The Ebola outbreak in West Africa is a global issue that requires a collaborative international response. Health Canada and the Public Health Agency of Canada are working in close collaboration with other national regulatory and public health authorities to respond.

Ebola vaccines under consideration are at an early investigational stage of development. There are no approved interventions available at this time. Vaccines for the prevention of Ebola are only now starting to be evaluated for safety or efficacy in human trials. In addition, supplies are currently extremely limited.

As I mentioned earlier, Canada has donated doses of our experimental Ebola vaccine, originally developed by the Public Health Agency of Canada, to the World Health Organization to help respond to the outbreak.

While many of the potential vaccines and therapies for Ebola have shown promising results in animal studies, evaluation in humans is necessary to confirm that these benefits are also seen in humans and that the benefits outweigh the risks. This is a critical component of product development and approval.

Accelerating the development and approval of Ebola vaccines requires a concerted effort by many different players, including product manufacturers, regulatory authorities, and the World Health Organization. There should also be a balance between the need to provide access to an Ebola vaccine in a timely manner and the need to gather as much information as we can on vaccine quality, safety, and effectiveness.

Health Canada is a member of the International Coalition of Medicines Regulatory Authorities. In September, the members of this coalition jointly released a statement on international regulatory co-operation regarding Ebola. Participating regulatory authorities pledged to join their expertise and to enhance collaboration to help accelerate access to investigational products.

Some of the challenges that regulatory authorities worldwide are dealing with include how to help accelerate the development and regulatory approval of Ebola vaccines and therapies, how to facilitate access for those most in need in the affected countries, and how to ensure that data on the quality, safety, and effectiveness of the vaccines is available as quickly as possible for decision-making.

All of this should be done without compromising the regulatory system in place to protect the health and safety of vaccine recipients. These efforts are being led by the WHO, to which we have donated a significant portion of our vaccine stockpile.

In addition, Health Canada is collaborating specifically with other national regulatory authorities to harmonize the data requirements on the quality, safety, and efficacy of the vaccines that would be required for approval. This work is of benefit to decision-makers in the affected countries in Africa as well as to Canadians.

Most important, there is a global commitment among regulatory authorities to share clinical and safety data on candidate Ebola vaccines in real time. This will enable countries to maximize the amount of data available to support vaccine assessment and approval and to rapidly share any information on potential adverse events following immunization. This has already started happening and is expected to help inform vaccine policy decisions worldwide.

Health Canada is also a member of the African Vaccine Regulatory Forum, which is a World Health Organization initiative aimed at strengthening the vaccine regulatory capacity of national regulatory authorities in Africa. Representatives from 19 African countries constitute the membership. Health Canada is using this network to provide assistance and regulatory advice to regulatory authorities in the affected African countries.

Canada is also preparing in the event that a Canadian needs access to treatment or a vaccine for Ebola. Health Canada has regulatory options available that will accelerate the approval process, if needed, to ensure the health and safety of Canadians.

Let me conclude by saying that the health and safety of Canadians is paramount. Health Canada, as a regulator, is working collaboratively with its national and international partners and the World Health Organization to support product development and to facilitate the regulatory evaluation of an Ebola vaccine.

Lawrence Toet

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