House of Commons photoLost her last election, in 2019, with 26% of the vote.
Health September 15th, 2009
Mr. Speaker, I want to be very clear that every Canadian who wants to receive the vaccine will receive it. The vaccine rollout is currently being developed. A special advisory committee made up of chief medical officers is working on that and I expect that vaccine rollout document to be released some time this week.
We are working with the provinces and territories to ensure that all Canadians who want to receive the vaccine will be able to do so.
Questions on the Order Paper September 14th, 2009
Mr. Speaker, in response to (a), despite encouragements and repeated discussion with three manufacturers of animal insulin preparations, and despite the fact that these manufacturers were made aware of the potential financial incentives to them, including the reduction, even to zero, of fees charged for review of therapeutic products, they indicated that, without a sufficiently large, and guaranteed, market, none of the incentives offered were of sufficient interest to them.
It should be noted that two pork derived insulin products are already approved for market in Canada. Nonetheless, should there be additional applications for animal insulins and simultaneous filing in both Canada and the United States, in line with a memorandum of understanding and ongoing collaboration on a wide-variety of issues with the US, Health Canada would ensure that all regulatory requirements are harmonised between the two countries. Harmonisation of regulatory approaches and requirements is already an ongoing activity, and would not be limited to a single class of product(s).
In response to (b), Health Canada is working actively on an educational plan and materials to ensure that the medical community is aware of the issues surrounding the use of insulin of animal origin vs. biosynthetic insulin. These activities are directed at both physicians and patients.
In response to (c), Health Canada does not have the authority to pursue statements in treatment protocols through the Canadian Diabetes Association, CDA. As a professional body, the CDA is independent of the federal government. Despite this, Health Canada can introduce appropriate statements on the labels for all insulin products. The intent of these statements would be to inform physicians in a continuous manner of the reported issues surrounding animal vs. biosynthetic insulin products. Since labels contain a Consumer Information Section, patients would also be informed.
In addition, Health Canada is considering the publication of a short article on the subject in the Canadian Adverse Reaction Bulletin and even send letters to the editors of several continuous medical education publications to reinforce the messages. Finally, there may be an opportunity to update the Fact Sheet, published by Health Canada, on the treatment of diabetes.
In response to (d), the Canada Health Act requires provinces and territories to provide coverage of medically necessary pharmaceutical drugs administered in hospitals. However, there is no federal legal requirement for them to provide such coverage outside of a hospital setting. Provinces and territories of their own accord have developed publicly-funded pharmaceutical insurance plans, including insulin, and decide the terms and conditions for such plans for their residents, including eligible population groups, formularies, and pricing. The 2004 Health Accord has provided substantial additional funding to strengthen health care over a 10-year period to provincial and territorial governments, which they may use to enhance and expand publicly-funded drug plans, including coverage of increased drug costs for their residents.
Questions on the Order Paper September 14th, 2009
Mr. Speaker, in response to (a), the Canadian Institutes of Health Research’s, CIHR, total parliamentary appropriations since inception are as follows:
2000-01: $401.3 million
2001-02: $553.8 million
2002-03: $651.2 million
2003-04: $696.9 million
2004-05: $757.9 million
2005-06: $813.1 million
2006-07: $863.5 million
2007-08: $993.7 million
2008-09: $974.1 million
CIHR currently estimates its 2009-10 total appropriations to be approximately $983.9 million, $973.1 million of which has already been approved by the Treasury Board.
In response to (b) total estimated funding for reproductive technology per fiscal year since inception to 2008/09 is as follows:
2000-01: $294,000
2001-02: $341,000
2002-03: $1.2 million
2003-04: $2.8 million
2004-05: $3.4 million
2005-06: $3.4 million
2006-07: $4.2 million
2007-08: $5.1 million
2008-09: $5.0 million
In response to (c), total estimated funding for stem cell research per fiscal year since inception to 2008/09 is as follows:
2000-01: $7.9 million
2001-02: $10.2 million
2002-03: $13.9 million
2003-04: $17.1 million
2004-05: $20.3 million
2005-06: $23.6 million
2006-07: $29.9 million
2007-08: $35.0 million
2008-09: $38.0 million
In response to (d), total estimated funding for embryonic stem cell research, a subset of stem cell research, per fiscal year since inception to 2008/09 is as follows:
2000-01: --
2001-02: $189,000
2002-03: $492,000
2003-04: $619,000
2004-05: $766,000
2005-06: $770,000
2006-07: $1.2 million
2007-08: $2.3 million
2008-09: $3.6 million
Questions on the Order Paper September 14th, 2009
Mr. Speaker, in response to (a), Health Canada has set a goal for itself to address the Natural Health Product, NHP, product licensing backlog by March 31, 2010. This date is not set out in law or regulation--it is an internal deadline adopted by Health Canada. The only date set out in the regulation is December 31, 2009 at which time all natural health products which were previously issued a drug identification number under the Food and Drug Regulations will be required to have a product licence, as per Section 108 of the Natural Health Products Regulations.
Health Canada is confident that, building on our progress to date, we can address the backlog by March 31, 2010.
In response to (b), the Natural Health Products Directorate, together with the Health Products and Food Branch Inspectorate, are currently developing a compliance strategy for 2010.
Significant progress has been made to address the backlog of applications: as of June 2009, 47% of the product licence application backlog has been completed or is in the process of being completed and of the remaining 6661 applications, 48% have been addressed--meaning that the applicant has received at least one deficiency notice from NHPD as part of the assessment of their application. Of the product licence applications not considered in the backlog, 59% have been completed or are in the process of being completed and of the remaining 4836 applications, 25% have been addressed--meaning that the applicant has received at least one deficiency notice from NHPD as part of the assessment of their application. Of all product licence applications received since 2004, NHPD has completed or is in the process of completing 70%.
In response to (c), Health Canada continues to review applications and issue regulatory decisions. Some of those decisions will be refusals. To date, however, there have been more licences than refusals.
The Natural Health Product Regulations, NHPR, require that an applicant submit information to support the safety, efficacy and quality of a product for assessment by the NHPD. An estimated 25-30% of applications received do not include enough information or relevant information to allow the directorate, on behalf of the minister, to conclude that the product is safe and effective.
An applicant that does not include sufficient information in an application, to allow a licence to be issued is provided with an opportunity to submit further information to support the licensing of the product; in 26% of submissions, the applicant chooses not to take this opportunity and does not respond to a request from the NHPD to do so.
In response to (d), Health Canada’s priority is to protect and promote the health of Canadians by ensuring access to natural health products that are safe, effective, and of high quality. Only NHPs that are supported by adequate levels of evidence and carry appropriate labels will be authorized for sale and issued a product licence.
The safety and efficacy evaluation of a natural health product, NHP, includes an assessment of its recommended conditions of use and the existing totality of evidence related to the NHP.The information that is considered acceptable by NHPD in reviewing applications includes a range of data including:
(i) safety and efficacy information that is developed by the NHPD and made available to product licence applicants such as ingredient and product monographs and labelling standards (nearly 150 of these are now available and has been used by applicants to allow for the licensing of thousands of products);
(ii) reference to safety and efficacy information published reference texts and pharmacopeia (e.g., texts for homeopathic medicines and traditional chinese medicines);
(iii) reference to safety and efficacy information from small-scale trials that is publicly available from a variety of sources;
(iv) reference to relevant decisions made by other regulatory agencies.
In response to (e), Bill C-51, An Act to Amend the Food and Drugs Act, died on the Order Paper with the dissolution of Parliament in September 2008. Consultations with stakeholders resulted in revisions and additions to the Bill, which were to be introduced during review by Committee.
One proposed addition was the introduction of a definition for NHPs at the level of the act, clarifying that NHPs are separate from drugs. It is important to note that the proposed amendments to the Food and Drugs Act would not have affected the way that NHPs are regulated in Canada. Under the Natural Health Products Regulations, NHPs are already regulated separately from drugs. The standards of evidence used to assess the risks and benefits of NHPs will continue to incorporate history of use, traditional uses and cultural practices.
In response to (f), Health Canada remains committed to ensuring safe, effective and high quality NHPs. In budget 2008, $33 million over two years was dedicated to implement a new approach to the regulation of NHPs and ensure the safety of Canadians. The government is committed to ensuring that the regulation of NHPs balances the protection of consumers’ health and safety with the freedom to choose alternative products.
Questions on the Order Paper September 14th, 2009
Mr. Speaker, in response to (a), with regard to the commitment to sponsor an ASD stakeholder symposium, in November 2007, a national symposium on autism research was hosted by Canadian Institutes of Health Research, CIHR, to share knowledge and to support dialogue on future research priorities. The report from this Symposium is now available on the CIHR web site.
In response to (b), with regard to the commitment to establish a chair focusing on interventions and treatment for ASD, funding for an autism research chair to address issues related to treatments and interventions was announced at Simon Fraser University on October 20, 2007. This joint initiative with the Government of British Columbia is being supported with $1M in federal funding over five years. Efforts to establish a Chair are currently underway by Simon Fraser University.
In response to (c), between November 2007 and May 2008, the Public Health Agency of Canada, PHAC, undertook a consultation process to examine options for the development of an Autism Spectrum Disorders, ASD, surveillance program in Canada. This process was guided by a steering committee comprised of ASD experts, and included three components:
1. an environmental scan of the current scope of ASD surveillance activities in Canada;
2. a technical workshop on the information needs and data collection options for ASD surveillance; and
3. a broader stakeholder consultation on the information needs of ASD communities and how they would like surveillance information disseminated to them.
The results of this consultation process will be used by PHAC as it undertakes a new national surveillance system for developmental disorders such as autism. This initiative, a component of the federal government’s 2008 action plan to protect human health from environmental contaminants, will be a national sentinel surveillance program to track and assess the linkages between environmental contamination and developmental disorders such as sensory impairments, autism spectrum disorders and attention deficit hyperactivity disorder. Using centres for surveillance expertise, data will be collected from a variety of local sources such as schools, hospitals, community paediatricians, and other health professionals.
In response to (d), with respect to the commitment to establish a dedicated web page on the Health Canada website with ASD information and resources, the website has been created. It provides facts and information on ASD, as well as links to Canadian and International autism organizations. The website can be found at: http://www.hc-sc.gc.ca/hc-ps/dc-ma/autism-eng.php As well, in 2007-08 Health Canada provided $50,000 to the Offord Centre for Child Studies (a research centre dedicated to improving the life quality of children with mental health and developmental problems) to support the dissemination of the latest evidence pertaining to autism through the Canadian Autism Intervention Research Network, CAIRN, via the Network’s website. The Canadian Autism Intervention Network, CAIRN, is a group of parents, clinicians and scientists working to conduct research in early intervention in autism, and is part of the Offord Centre for Child Studies. The web page on the Health Canada website links to the CAIRN website in order to direct Canadians to evidence-based information of a more clinical nature, and complement the content on the Departmental site.
In response to (e), with respect to the commitment to designate the Health Policy Branch of Health Canada as the ASD lead for actions related to ASD at the federal health portfolio level, this was done in 2007. Since then, the Health Policy Branch has become the Strategic Policy Branch, and the Chronic and Continuing Care Division within the Branch holds the lead on the ASD file.
In response to (f), with respect to federal funding for autism related initiatives during fiscal year 2009-10, the federal government has committed $200,000 to Simon Fraser University, as part of the $1M over five years for the Autism Research Chair. In addition, the federal government has a multi-year contribution agreement with the Offord Centre for Child Studies, with $25,000 in 2008-2009 and $50,000 in 2009-10, for a total of $75,000 over two years. This funding will support the development and dissemination of research priorities in Autism Spectrum Disorders, ASD, among parents, policy makers, researchers, health professionals, health educators and individuals with ASD. This work will be accomplished through a national on-line survey, a national conference in fall 2009, and by further updating the Canadian Autism Intervention Research Network website, which is the primary bilingual source for disseminating evidence-based information about ASD in Canada. In fiscal year 2009-10, CIHR has currently committed approximately $3.4 million towards autism research.
Questions on the Order Paper September 14th, 2009
Mr. Speaker, in accordance with the 1997 federal-provincial-territorial memorandum of understanding on the establishment of the National Blood Authority, Health Canada provides funds to the Canadian Blood Services, CBS, for research and development on blood safety and effectiveness ($5M/annum since 2000-2001). Beginning in 2008, Health Canada also provides funds to CBS to improve the delivery of organ and tissue donation and transplantation activities in Canada ($3.58M /annum between April 2008 and March 2013).
Funding to the Canadian Apheresis Group ended in 2003. There is no current funding agreement between Health Canada nor the Public Health Agency of Canada and the Canadian Apheresis Group.
Questions on the Order Paper September 14th, 2009
In response to (a), the motion called for exploratory work related to research, regulation and reimbursement of drugs for rare diseases, in collaboration with provinces and territories and stakeholders. The Motion did not establish a program or policy. Initial analysis on motion no 426 was undertaken after it was adopted in May 2008 and before Parliament was dissolved. The Government continues to consider the issue of drugs for rare diseases and the need, if any, for action in areas of federal responsibility. Further work in this area will require the active engagement of provinces and territories, who, as noted above, have primary responsibility for drug coverage.
In response to (b), No stakeholder consultations on the motion were held before the dissolution of Parliament. However, Health Canada officials have discussed related issues with stakeholders, notably the Canadian Organization for Rare Disorders CORD, on numerous occasions. CORD has been an active participant in formal consultations with respect to legislative and regulatory modernization since 2006. The organization has identified data challenges in the review and authorization of products for small populations as a key concern. They have been very supportive of efforts to modernize the Food and Drugs Act and Regulations.
In response to (c), Past analytical work related to the motion and the broader issue of drugs for rare diseases has been conducted within existing resources.
In response to (d), The federal government recognizes the challenges faced by Canadians with rare disorders, and will continue to examine issues related to treatments for rare disorders within the scope of federal role and responsibilities. For example, Health Canada is looking at the regulatory challenges posed by drugs for rare diseases, as part of the department’s ongoing work on regulatory modernization. CORD and other stakeholders have been consulted in this work. It is important to note that prescription drugs provided outside of hospital are outside of the scope of the Canada Health Act and hence, provincial and territorial governments determine, at their own discretion, whether, and under what terms and conditions, to publicly finance prescription drugs, including drugs for rare diseases. The only exceptions are federal populations, e.g., first nations and Inuit, military, veterans, for which the federal government directly provides services. However, the federal government continues to pursue constructive and collaborative work with provinces and territories, including finding ways to better assess drugs for rare diseases for potential reimbursement by our respective drug programs.
In response to (e) To clarify, no program was established through this motion, which called for exploratory work only.
Questions on the Order Paper September 14th, 2009
Mr. Speaker, in response to (a), the Government of Canada was first approached by Mexico for laboratory testing assistance on April 17, 2009.
In response to (b), Mexican authorities did not disclose the number of fatalities attributed to the respiratory disease at the time they first notified Canada of their situation. Events were very unclear at that time.
In response to (c), when Mexican authorities first approached Canada on the H1N1 flu virus, they advised Canada that a number of outbreaks were occurring in different regions in Mexico, with approximately 600 suspect cases of influenza-like illness.
In response to (d), Mexican authorities contacted Canada as they were experiencing what appeared to be a late influenza season with higher than normal rates in health care workers, as well as some severe illness which they assessed as unusual. Laboratory testing in Mexico had failed to yield the diagnosis.
In response to (e), the Government of Canada responded April 17, 2009 offering laboratory and technical assistance to Mexico
Health September 14th, 2009
Mr. Speaker, we are working very closely with the provinces and territories on this issue. In fact, I will be meeting with the provincial health ministers this week in Winnipeg to discuss this very issue.
Aboriginal Affairs June 19th, 2009
Mr. Speaker, in February I met with all the chiefs in Manitoba to discuss many issues related to the delivery of health care in their communities.
This week I also met with them to discuss the H1N1 situation. I also had a meeting with the health minister from the province yesterday.
Again, we are doing everything for the community to respond to the situation with H1N1. Additional staff are there. We have the supplies in the community, and we will continue to provide the services to the residents of those communities.