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1. Name of Horizontal Initiative: Federal Tobacco Control Initiative (FTCS)
2. Name of lead department(s): Health Canada
3. Lead department program activity: Substance Use and Abuse
4. Start date of the Horizontal Initiative: *
5. End date of the Horizontal Initiative: *
6. Total federal funding allocation (start to end date):
7. Description of the Horizontal Initiative (including funding agreement):
8. Shared outcome(s):
9. Governance structure(s):
10. Planning Highlights:
12. Federal Partner Program Activity | 13. Names of Programs for Federal Partners | 14. Total Allocation (from Start to End Date) | 15. Planned Spending for 2011-12 |
---|---|---|---|
Total |
16. Expected results by program as per (13):
12. Federal Partner Program Activity | 13. Names of Programs for Federal Partners | 14. Total Allocation (from Start to End Date) | 15. Planned Spending for 2011-12 |
---|---|---|---|
Total |
16. Expected results by program as per (13):
Total Allocation For All Federal Partners (from Start to End Date) | Total Planned Spending for All Federal Partners for 2011-12 |
---|---|
17. Results to be achieved by non-federal partners (if applicable):
18. Contact information:
Cathy A. Sabiston
Director General, Controlled Substances and Tobacco Directorate
(613) 941-1977
cathy.a.sabiston@hc-sc.gc.ca
1. Name of Horizontal Initiative: Defence of Canada Against Third-Party Claims in Tobacco Litigation
2. Name of lead department(s): Health Canada
3. Lead department program activity: Substance Use and Abuse
4. Start date of the Horizontal Initiative: 2010-2011
5. End date of the Horizontal Initiative: 2012-2013
6. Total federal funding allocation (start to end date): $45,738,000
7. Description of the Horizontal Initiative (including funding agreement):
The purpose of this horizontal initiative is to defend Canada against third party claims in tobacco litigation. The source of funding for this initiative is:
8. Shared outcome(s):
Canada is defended against third-party claims in tobacco litigation.
9. Governance structure(s):
The Interdepartmental Assistant Deputy Minister Steering Committee on Tobacco Litigation co-ordinates the defence efforts. The committee is co-chaired by Health Canada, Agriculture and Agri-Food Canada and Justice Canada. The responsibilities of the Steering Committee include:
10. Planning Highlights:
In 2011-12, with guidance and support from Justice Canada, Health Canada and Agriculture Canada will continue to prepare for and defend Canada against third-party claims in tobacco litigation as required.
Federal Partner Program Activity | Names of Programs for Federal Partners | Total Allocation (from Start to End Date) | Planned Spending for 2011-12 |
---|---|---|---|
PA 2.5 Substance Use and Abuse | Defence of Canada Against Third-Party Claims in Tobacco Litigation | $29,742,000 new funding $9,000,000 existing reference levels |
$10,787,000 new funding $3,000,000 existing reference levels |
Total | $38,742,000 | $13,787,000 |
Expected results by program:
Federal Partner Program Activity | Names of Programs for Federal Partners | Total Allocation (from Start to End Date) | Planned Spending for 2011-12 |
---|---|---|---|
Internal Services | Defence of Canada Against Third-Party Claims in Tobacco Litigation | $5,136,000 new funding $1,860,000 existing reference levels |
$1,922,000 new funding $380,000 existing reference levels |
Total | $6,996,000 | $2,302,000 |
Expected results by program:
12. Contact information:
Louis Proulx
A/Director, Health Canada Litigation Support Office
123 Slater Street
Ottawa, Ontario K1A 0K9
613-954-5851
louis.proulx@hc-sc.gc.ca
1. Name of Horizontal Initiative: Action plan to Protect Human Health from Environmental Contaminants
2. Name of lead department(s): Health Canada
3. Lead department program activity: Sustainable Environmental Health
4. Start date of the Horizontal Initiative: 2008-2009
5. End date of the Horizontal Initiative: 2012-2013
6. Total federal funding allocation (start to end date): $84.6M
7. Description of the Horizontal Initiative (including funding agreement):
Recent surveys show that Canadians are concerned about environmental contaminants. There is a clear need to ensure that Canadians have credible information on the impact of chemicals in the environment and the steps that they should take as a result.
The Government has already taken steps to address environmental contaminants through the Chemicals Management Plan and the Clean Air Agenda, focusing on substances which have known potential for harming human health and the environment. Both industry and stakeholders have been supportive of these initiatives but continue to insist that decisions be made based on scientific evidence. This requires mechanisms such as monitoring, surveillance and research to ensure that the effectiveness of interventions to address known potential risks can be assessed and that emerging risks can be detected.
The Action Plan to Protect Human Health from Environmental Contaminants is designed to further protect the health of Canadians from environmental contaminants while increasing the knowledge-base on contaminant levels and potential impacts on health, in particular:
$13.1M has been allocated to Health Canada from 2008-2009 to 2012-2013 to develop an Environmental Health Guide for Canadians, as well as tailored guides for First Nations and Inuit communities. The objective of the guide is to help make Canadians aware of the risks that harmful environmental contaminants may pose to their health along with direct actions that they can take to reduce these risks and improve their health. The Guide, Hazardcheck, was published March 1, 2010.
$54.5M has been allocated to Statistics Canada from 2008-2009 to 2012-2013 towards conducting the Canadian Health Measures Survey (CHMS) and $5.6M from 2008-2009 to 2012-2013 for Health Canada to conduct the First Nations Biomonitoring Initiative (FNBI). The CHMS is used to collect information from Canadians about their general health and lifestyles and includes collection of blood and urine specimens to be tested for environmental contaminants among other things. The CHMS will not provide data on First Nations on-reserve or Inuit communities. Data for First Nations' peoples on reserve will be captured under the First Nations Biomonitoring Initiative.
$5.9M has been allocation to the Public Health Agency of Canada from 2008-2009 to 2012-2013 to enhance surveillance of congenital anomalies.
$5.5M has been allocation to the Public Health Agency of Canada from 2008-2009 to 2012-2013 to conduct surveillance of developmental disorders.
8. Shared outcome(s): Reduce health risks to Canadians (particularly vulnerable populations) from environmental contaminants
9. Governance structure(s):
All action plan initiatives take advantage of governance and management structures already established for ongoing government programs such as: the Canadian Population Health Statistics Program, the Chemicals Management Plan, the Healthy Living and Chronic Disease initiative of the Public Health Agency of Canada, as well as components of existing national surveillance systems developed by the Public Health Agency of Canada in partnership with stakeholders.
Each program within Health Canada, the Public Health Agency of Canada and Statistics Canada will be fully responsible for the management of initiatives they are leading within the action plan. Consultations and stakeholder involvement will be governed through consultative structures and interdepartmental committees already established.
A tripartite governance structure between Health Canada, the Public Health Agency of Canada and Statistics Canada will be used to oversee the implementation of the Canadian Health Measures Survey (CHMS). The CHMS will use the existing Canadian Population Health Statistics Program as a governance structure, which includes senior officials from all three federal organizations.
10. Planning Highlights:
Environmental Health Guide for Canadians
The Environmental Health Guide for Canadians has been developed with partners across the Health Portfolio and with the Canadian Mortgage and Housing Corporation to raise awareness of environmental hazards among Canadians and to inform them of what they can do to reduce their exposure to these risks such as carbon monoxide, household chemicals, second-hand smoke, and lead). Background research is also underway for a Guide focusing on senior's health.
A marketing campaign was launched in March 2010 to promote the new Environmental Health guide and to raise awareness of the link between health and the environment. A marketing campaign for 2010-11 will focus primarily on social media including: outreach to Mommy blogger communities and a viral quiz. To compliment the on-line tactics, public engagement events will be hosted at 150 retail locations over 3 consecutive weekends in March 2011 thereby educating Canadians on the environmental issues that could impact their health through face-to-face discussions. A First Nations and Inuit campaign is also underway to support tailored Guides. This includes a general Home Guide, Outdoor Guides with a seasonal focus (fall/winter and spring/summer) and another for First nations and Inuit Youth Guide.
Background research is underway for fact sheets designed for health care providers and teachers/students which will be developed in 2011-12.
2011-12 activities are currently being planned to build on the momentum generated from the launch of the campaign. Partnerships with various non-Governmental and private sector collaborators are being discussed. As well, public relations and outreach activities will continue throughout the year.
First Nations Biomonitoring Initiative
The First Nations Environmental Health Guide-Your Health at Home, What you can do is now complete and is available on the Health Canada Website and has been mailed out to First Nations communities across Canada. The text for the First Nations youth Guide and Spring/ Summer outdoor guides have been developed and are being reviewed by Aboriginal stakeholders. Activity booklets for First Nations youth are also in development. The text for the Inuit Home Guide has been developed and review is underway by Aboriginal stakeholders. For 2011-12, all First Nations Guides should be completed and distributed to First Nations communities across Canada. The Inuit Youth Guide and outdoor Guides should be developed and reviewed by Aboriginal partners during 2011-2012.
Over the next two years, the First Nations Biomonitoring Initiative will be in the implementation phase. This fiscal year, a pilot project in two First Nations' communities is being carried out to assess the logistical and operational requirements of conducting a health survey in a remote versus non-remote First Nation community. In 2011/12, a full-scale health survey will be conducted in First Nations' communities across Canada.
First Nation priorities will be determined and suitable biomonitoring parameters, sampling protocol, and parameters for an ethics review are to be developed including mechanisms to ensure appropriate comparability of data with the CHMS are in place. Sampling of selected communities is expected to commence.
Enhanced Congenital Anomalies Surveillance
In 2011-2012 the Public Health Agency of Canada (PHAC) will continue to work with the provinces and territories on implementation of congenital anomalies surveillance systems in the various jurisdictions. It will also continue its participation in the International Clearinghouse for Birth Defects Surveillance and Reporting, and PHAC will organize the 9th Annual Scientific Meeting for the Network.
Surveillance of Developmental Disorders
In 2011-2012 the Public Health Agency of Canada (PHAC) will build on previous developmental work for the surveillance of autism, as the target developmental disorder for the initiative. The focus will be on establishing the surveillance methodology, including indicators, data sources, and sampling approach if indicated. This work will be done collaboratively with experts in the field, other levels of government and other stakeholders.
Canadian Health Measures Survey
In 2011-12 the CHMS team will be working simultaneously on three cycles of the survey:
CHMS Cycle 1: Data dissemination and data release will continue in FY 2011-12 with the release of all Cycle 1 data to the public domain. The CHMS biobank will be available for access by researchers according to published protocols.
CHMS Cycle 2 data collection, which began in August 2009, will continue during FY 2011-12. The CHMS cycle 2 data collection will continue through fall 2011 and data collection response rates will be monitored regularly to ensure adequate representation of the Canadian population by age group and sex.
CHMS Cycle 3 content planning has started in FY 2009-10. During FY 2011-12 specifications for data collection and processing applications, operations manuals, and lab and clinic manuals will be developed. Pilot testing and feasibility studies will be conducted to determine appropriate operational processes and to ensure high response rates and quality data.
Federal Partner Program Activity | Names of Programs for Federal Partners | Total Allocation (from Start to End Date) | Planned Spending for 2011-12 |
---|---|---|---|
PA 3.1 Sustainable Environmental Health | Environmental Health Guide for Canadians | $13.1M | HECS: $0.385M FNIHB: $0.490M PACCB: $0. 925M |
PA 4.1 First Nations and Inuit Health Programming and Services | First Nations Biomonitoring Initiative | $5.6M | FNIHB: $1.7M |
Total | 18.7M | 3.5M |
Expected results by program:
Federal Partner Program Activity | Names of Programs for Federal Partners | Total Allocation (from Start to End Date) | Planned Spending for 2011-12 |
---|---|---|---|
PA 2 Social Statistics | Canadian Health Measures Survey | $54.5M | $14M |
Expected results by program:
Federal Partner Program Activity | Names of Programs for Federal Partners | Total Allocation (from Start to End Date) | Planned Spending for 2011-12 |
---|---|---|---|
PA 1.2 Surveillance and Population Health Assessment | Enhanced Congenital Anomalies Surveillance | 5.9M | $1.6M |
Surveillance of Developmental Disorders | $5.5M | $1.5M | |
Total | $11.4M | $3.1M |
Expected results by program:
12. Contact information:
Suzanne Leppinen
Director, Horizontal and International Programs
Safe Environments Directorate, Healthy Environments and Consumer Product Safety Branch, Health Canada
613-941-8071
Suzanne.Leppinen@hc-sc.gc.ca
1. Name of Horizontal Initiative: Early Childhood Development (ECD) Strategy for First Nations and Other Aboriginal Children.
2. Name of lead department(s): Health Canada (HC)
3. Lead department program activity: First Nations and Inuit Health Primary Health Care
4. Start date of the Horizontal Initiative:
5. End date of the Horizontal Initiative:
6. Total federal funding allocation (start to end date):
7. Description of the Horizontal Initiative (including funding agreement):
The ECD Strategy for First Nations and Other Aboriginal Children was announced on October 31, 2002. The Strategy provides $320 million over five years to: improve and expand existing ECD programs and services for Aboriginal children; expand ECD capacity and networks; introduce new research initiatives to improve understanding of how Aboriginal children are doing; and work towards the development of a "single window" approach to ensure better integration and coordination of federal Aboriginal ECD programming.
In December 2004, as first phase of a "single window", Cabinet approved an additional $45 million over three years (beginning fiscal year 2005-06) and $14 million ongoing to improve integration and coordination of two ECD programs-- Aboriginal Head Start On Reserve (AHSOR) and the First Nations and Inuit Child Care Initiative (FNICCI).
The objectives of these funds are to increase access to and improve the quality of ELCC programming for First Nations children on reserve, and improve integration and coordination between the two programs through joint planning, joint training and co-location.
The Strategy also includes Indian and Northern Affairs Canada (INAC)-funded child/day care programs in Alberta and Ontario.
8. Shared outcome(s):
The ECD component complements the September 2000 First Ministers F/P/T ECD Agreement. It seeks to address the gap in life chances between Aboriginal and non-Aboriginal children by improving the developmental opportunities to which Aboriginal children (and their families) are exposed at an early age (0-6 years).
The ELCC component complements funding released to provinces and territories under the March 2003 Multilateral Framework for Early Learning and Childcare (ELCC) to improve access to ELCC programs and services.
9. Governance structure(s):
10. Planning Highlights:
In collaboration with partners and stakeholders, federal departments will continue to build on evidence to inform programming and capacity building efforts, and to enhance linkages and integrate services to better support Aboriginal children and their families. These activities will be measured through performance reports and evaluations of program relevance and effectiveness. Coordination of training efforts across programs will be a key area of focus for 2011-12.
The First Nations and Inuit Child Care Initiative (FNICCI) will continue to provide access to quality child care services for First Nations and Inuit children whose parents are starting a new job or participating in a training program under the new Aboriginal Skills and Employment Training Strategy (ASETS). ASETS is the successor program to the Aboriginal Human Resources Development Strategy (AHRDS), which expired on March 31, 2010. Better collaboration/synergies among FNICCI and Aboriginal Head Start on Reserve (AHSOR) centers will be a priority over the coming years. Risks: infrastructure limitations, size and remoteness of communities running these initiatives.
12. Federal Partner Program Activity | 13. Names of Programs for Federal Partners | 14. Total Allocation (from Start to End Date) |
15. Planned Spending for 2011-12 |
---|---|---|---|
First Nations and Inuit Health Primary Health Care | a. Aboriginal Head Start on Reserve (AHSOR) | $107.595 (2002-03 through to 2006-07; $21.519/year). $21.519/year ongoing. Committed in 2002. ELCC $24.000 (2005-06 through to 2007-08, $7.500 in 2005-06, $8.300 in 2006-07; $8.200 in 2007-08). $7.500 in 2008-09 and ongoing Committed in 2005. |
$21.519 $7.500 |
b. Fetal Alcohol Spectrum Disorder - First Nations and Inuit Component (FASD-FNIC) | $70.000 (2002-03 through to 2006-07; $10.000 in 2002-03 and $15.000 thereafter). $15.000/ year ongoing. Committed in 2002. |
$15.000 | |
c. Capacity Building | $5.075 (2002-03 through to 2006-07; $1.015/year). $1.015/ year ongoing. Committed in 2002. |
$1.015 | |
Total | From start to 2009-10 ECD: $295.272 ELCC: $39.000 |
ECD: $37.534 ELCC: $7.500 |
16. Expected results by program as per (13):
Aboriginal Head Start on Reserve (AHSOR):
Fetal Alcohol Spectrum Disorder - First Nations and Inuit Component (FASD-FNIC):
Capacity Building:
12. Federal Partner Program Activity | 13. Names of Programs for Federal Partners | 14. Total Allocation (from Start to End Date) | 15. Planned Spending for 2011-12 |
---|---|---|---|
Health Promotion | a. Aboriginal Head Start in Urban and Northern Communities (AHSUNC) | $62.880 (2002-03 through to 2006-07; $12.576/ year and ongoing. Committed in 2002. |
$12.576 |
b. Capacity Building | $2.500 (2002-03 through to 2006-07; $0.500/year) and ongoing Committed in 2002 |
$0.500 | |
Total | $104.608 | $13.076 |
16. Expected results by program as per (13):
Aboriginal Head Start in Urban and Northern Communities (AHSUNC) :
Capacity Building:
12. Federal Partner Program Activity | 13. Names of Programs for Federal Partners | 14. Total Allocation (from Start to End Date) |
15. Planned Spending for 2011-12 |
---|---|---|---|
Skills and Employment (*) | a. First Nations and Inuit child Care Initiative (FNICCI) | $45.700 (2002-03 through to 2006-07; $9.140/year) and ongoing. Committed in 2002 ELCC $21.000 (2005-06 through to 2007-08; $7.000/year). $6.500/ year ongoing. Committed in 2005 |
$9.14 M $6.5 M |
Social Development (*) | b. Research and Knowledge | $21.200 (2002-03 through to 2006-07); $4.240/year and ongoing. Committed in 2002 |
$2.3 M |
Total | ECD: $107.040 ELCC: $34.000 |
$11.44M $6.5M |
16. Expected results by program as per (13):
First Nations and Inuit child Care Initiative (FNICCI):
Research and Knowledge:
12. Federal Partner Program Activity | 13. Names of Programs for Federal Partners | 14. Total Allocation (from Start to End Date) |
15. Planned Spending for 2011-12 |
---|---|---|---|
The people- social development | a. Capacity Building | $5.050 (total for 2002-03 through to 2006-07; 1.010/year) 2007-2008 and ongoing. Committed in 2002. |
$1.010 |
Total | $8,080 | $1.010 |
16. Expected results by program as per (13):
Capacity Building:
Total Allocation For All Federal Partners (from Start to End Date) | Total Planned Spending for All Federal Partners for 2011-12 |
---|---|
ECD (2002-03 to 2006-07): $320.000 ($60.000 in 2002-03 and $65.000/year hereafter); $65.000/year ongoing. Total from start to 2009-10: $515.000 ELCC (2005-06 to 2007-08): $45.000 ($14.500 in 2005-06; $15.300 in 2006-07; $15.200 in 2007-08); and $14.000/year ongoing. Total from start to 2009-10: $73.000 |
ECD: $63.060 ELCC: $14.000 Total: $77.060 |
17. Results to be achieved by non-federal partners (if applicable):
N/A
18. Contact information:
Cathy Winters, Senior Policy Coordinator,
Children and Youth Division, Community Programs Directorate
First Nations and Inuit Health Branch, Health Canada
Postal Locator 1919A Tunney's Pasture, Ottawa
Telephone: (613) 952-5064
Email: cathy.winters@hc-sc.gc.ca
1. Name of Horizontal Initiative: Food and Consumer Safety Action Plan (Action Plan)
2. Name of lead department(s): The lead is shared between Health Canada (HC), the Canadian Food Inspection Agency (CFIA), the Public Health Agency of Canada (PHAC), and the Canadian Institutes of Health Research (CIHR).
3. Lead department program activity:
4. Start date of the Horizontal Initiative: Fiscal Year 2008-2009.
5. End date of the Horizontal Initiative: Fiscal Year 2012-2013 (and ongoing).
6. Total federal funding allocation (start to end date):
$489.4 million over five years ending in Fiscal Year 2012-2013 (and $126.7 million ongoing).
7. Description of the Horizontal Initiative (including funding agreement):
The federal government is responsible for promoting the health and safety of Canadians. A key part of this role is ensuring that the food, health and consumer products used by Canadians are safe. Adverse consequences associated with unsafe products impact not only the Canadian public, but also the Canadian economy. The Action Plan is a horizontal initiative aimed at modernizing and strengthening Canada's safety system for food, health and consumer products. A number of high-profile incidents, such as lead and ingestible magnets in children's toys, foodborne illness outbreaks, and the global withdrawal of some prescription medicines, have underscored the need for government action.
The Action Plan modernizes Canada's regulatory system to enable it to better protect Canadians from unsafe consumer products in the face of current realities and future pressures. The Action Plan bolsters Canada's regulatory system by committing to amending or replacing outdated health and safety legislation with new legislative regimes that respond to modern realities, and by enhancing safety programs in areas where modern legislative tools already exist. The Action Plan helps to ensure that Canadians have the information they need to assess the risks and benefits associated with the consumer and health products they choose to use, and to minimize risks associated with food safety.
The Action Plan is an integrated, risk-based plan and includes a series of initiatives that are premised on three key areas of action: active prevention, targeted oversight and rapid response. We focus on active prevention to avoid as many incidents as possible and work closely with industry to promote awareness, provide regulatory guidance, and help identify safety concerns at an early stage. Targeted oversight provides for early detection of safety problems and further safety verification at the appropriate stage in a product's life cycle. To improve rapid response capabilities and ensure the government has the ability to act quickly and effectively when needed, we work to enhance health and safety risk assessments, strengthen recall capacity, and increase the efficiency in responding and communicating clearly with consumers and stakeholders.
8. Shared outcome(s):
9. Governance structure(s):
The Minister of Health and the Minister of Agriculture and Agri-Food Canada have joint responsibility and accountability for results, and for providing information on progress achieved by the Action Plan.
A Governance Framework has been established and endorsed by all of the partner departments/agencies. To facilitate horizontal coordination, the following Director General (DG)/Executive Director (ED) level Task Forces have been established:
These Task Forces report to a DG/ED level Coordinating Committee. An Assistant Deputy Minister (ADM)/Vice President (VP) level Steering Committee provides direction to the Coordinating Committee. An Oversight Committee of Deputy Heads facilitates the provision of high level guidance to the Steering Committee.
Health Canada's Strategic Policy Branch (SPB) provides the Secretariat function for the Action Plan and plays an integral role in supporting the ongoing operation and decision-making of the governance committees, the oversight and integration of performance against commitments, and providing advice to senior management. SPB is also the lead for coordinating the implementation of the legislative and regulatory initiatives.
Health Canada's Health Products and Food Branch (HPFB) has primary responsibility for implementing Action Plan activities related to health products with support from Health Canada's Strategic Policy Branch (SPB) and the Canadian Institutes of Health Research (CIHR) on one initiative (increased knowledge of post-market drug safety and effectiveness).
Health Canada's Healthy Environments and Consumer Safety Branch (HECSB) and the Pest Management Regulatory Agency (PMRA), along with the Public Health Agency of Canada (PHAC), work together to implement Action Plan activities related to consumer products. The Canadian Food Inspection Agency (CFIA), Health Canada's Health Products and Food Branch (HPFB) and the Public Health Agency of Canada (PHAC) work together to implement Action Plan activities related to food safety.
The Public Affairs, Consultation and Communications Branch (PACCB) provide communications support for all of the above activities and will coordinate or lead many of the horizontal Departmental activities under the Consumer Information Strategy.
10. Planning Highlights:
The Action Plan reflects the need to modernize and sharpen the focus of Government action to protect Canadians and responds to the new technological and economic realities of the 21st century, such as globalization and the introduction of more complex products. The Action Plan is an integrated, risk-based plan with the streams of initiatives (premised on the three key areas of action) aligned to meet these needs.
12. Federal Partner Program Activity | 13. Names of Programs for Federal Partners | 14. Total Allocation (from Start to End Date) | 15. Planned Spending for 2011-12 |
---|---|---|---|
Health Products | Active Prevention | 57.6 | 11.5 |
Targeted Oversight | 34.6 | 10.22 | |
Rapid Response | Existing resources | Existing resources | |
Consumer Products Safety | Active Prevention | 41.0 | 12.5 |
Targeted Oversight | 15.7 | 4.3 | |
Rapid Response | 17.9 | 4.6 | |
Pesticide Safety | Active Prevention | 6.9 | 1.6 |
Rapid Response | 8.0 | 2.1 | |
Food Safety and Nutrition | Active Prevention | 29.6 | 7.1 |
Rapid Response | 1.3 | 0.3 | |
Total | 212.6 | 54.2 |
16. Expected results by program as per (13):
Active Prevention
The Health Products program will initiate regulatory change to include regulatory oversight of the manufacturing of active pharmaceutical ingredients to improve the safety, quality and efficacy of health products. To increase awareness and compliance with regulatory requirements, Health Canada continues to engage in pre-submission meetings with industry, including the ability to better document, track, and monitor and evaluate the exchange of information. These meetings provide an opportunity for the drug submission sponsor to obtain feedback regarding areas of concern prior to filing a submission. In addition, as part of the lifecycle approach, and in the absence of enabling legislation, Health Canada continues to implement an interim strategy for development and review of Pharmacovigilance Plans (PvP) and Risk Management Plans (RMP) with the aim of generating better and new information concerning health products during the pre or post-market phases. A PvP, which can be requested by Health Canada or submitted voluntarily by the manufacturer, identifies and characterizes known or potential safety concerns. RMP, which include a PvP component plus additional risk minimization activities, provide proposals on how to mitigate any identified or potential safety risk by providing additional assurance that the manufacturer has measures in place to react and act quickly if new information concerning the product emerges once on the market. The Active Pharmaceutical Ingredient (API) Inspection Program is dependant on the new API legislation; therefore, API inspections are not possible at this time and targets cannot be set. Preparatory work on inspection training, compliance and promotion work continue while these regulations are pending.
Expected Results: Enhance knowledge of post-market health products safety risks and oversight of risk management and mitigation strategies to inform decisions and to increase ability to monitor and identify safety concerns before or as they arise.
Performance Indicator: Year over year increase in PvP/RMP submitted by industry. Number of pre-submission meetings per year.
The Consumer Products Safety program will provide information to consumers and work closely with industry to promote awareness, provide regulatory guidance, help identify and systematically assess safety risks at early and ongoing stages of product development, develop standards and share best practices.
Expected results: Increased consumer/industry awareness of health risks and regulatory requirements related to consumer products.
Performance indicators: % by target population aware of information related to consumer product safety and related to exposure to consumer products by: level of consumer awareness; type of target group and # reached; planned industry outreach activities completed by level of establishment; and product category.
Pest Management Regulatory Agency (PMRA) encourages and facilitates industry development and adoption of quality assurance and stewardship programs for the safe manufacture and subsequent selection and use of pesticides and other consumer products containing pesticides. Retailers of pest control products often rely on their distributors for validation of access to products with lapsed registrations, or which have never been registered. Work under this strategy fosters an increased knowledge of the requirements of the Pest Controls Products Act (PCPA) and an awareness of the tools available to validate the status of the pest control products and their label information. These initiatives are critical in promoting the safe and proper use of pesticides and ensuring risk reduction practices are established along the entire supply chain. In addition, stakeholders are engaged in order to test assumptions about the ability and will to comply with product recall or phase-out requirements. This includes such considerations as whether users can follow through with specific requirements when the financial implications are significant.
Expected results: Increased awareness and understanding of product safety obligations, standards and regulatory requirements by industry.
Performance indicators: % of the target population aware/engaged/confident regarding risks and regulatory activities; # of complaints and/or incidents; # of industry situations noted and self corrected; # violations where absence of knowledge of requirements is the cause; and # of stakeholder partnerships formed.
The Food Safety and Nutrition program activity will continue to support the Government as it develops and seeks Parliamentary approval for amendments to the Food and Drugs Act (FDA) to strengthen and modernize food safety provisions. The program will continue to conduct risk mapping exercises, engage industry to address food safety risks, develop strategic partnerships for work sharing opportunities in standard setting with international food regulators, consult with consumers and industry on updated food standards and will update its health risk assessment standard operating procedures to respond to new service standards.
Expected Results: Increased industry and public understanding/engagement in food safety risks and mitigation processes, improved international collaboration in establishing global standards and establishment of the appropriate instrument or mix of instruments, including regulatory and non-regulatory measures (policies, standards, etc), to address immediate areas of concern.
Performance Indicators: # of engagement opportunities with industry, international collaborations; # of guidance/educational tools developed; # of standards, frameworks and policies developed or modified; and # of consultations/engagement activities with Canadians and target populations.
Targeted Oversight
The Health Products program's ability to make and support admissibility decisions at the border as they relate to health products will be strengthened through the establishment of a national border integrity program, which will include among other initiatives: a national standardized process for the handling of health products at the border; establishment of service standards between Canada Border Services Agency (CBSA) and Health Canada; and, undertaking public education activities to inform Canadians of risk associated with the importation of non-compliant health products. In addition, Health Canada will continue to enhance the post-market surveillance elements of the program through increased efforts focused on review of Periodic Safety Update Reports (PSURs) - documents that summarize the worldwide safety experience of a health product at pre-established post-authorization times. The Department will continue to work with its partners to increase reporting of adverse drug reactions through the Hospital-Based Mandatory Reporting project for Adverse Drug Reactions. Implementation of mandatory reporting is however dependent upon passing of relevant enabling legislation. If new legislation is not passed, Health Canada will continue requesting the reports from the hospitals on a voluntary basis, and will continue to coordinate efforts with provincial and territorial agencies to promote voluntary reporting.
In partnership with the Canadian Institutes of Health Research (CIHR), Health Canada has established the Drug Safety and Effectiveness Network (DSEN) (a pan-Canadian network of centres of excellence in post-market pharmaceutical research) in order to fund studies that will inform pharmaceutical decision-making across the health care system. Please refer to Federal Partner #4 CIHR for DSEN's Expected Results and Performance Indicators.
To improve and augment patient and consumer participation in Health Product and Food Branch (HPFB) consultations, a Patient and Consumer Pool will be launched. Efforts in 2011-12 will focus on the establishment of a governance body, the implementation of a recruitment strategy, and the development and delivery of training material.
Expected Results: The TB submission anticipated annual doubling of PSUR volumes (baseline was 125/year in 2007-08), presuming that relevant legislation would be passed in 2010-11. Given that Adverse Reactions are not predictable, it is not possible to set targets related to the volume of reports expected in any given year. Since the Border Integrity Program is reactive, there are no set targets; however, admissibility decisions are tracked and reported quarterly.
Performance Indicators: Year over year increase in PSUR submitted by industry and year over year increase in AR Reports submitted by Institutions. Also tracked are # of patients/consumers recruited; # of patients/consumers trained, # of patients/consumers who have taken part in consultations, patient/consumer satisfaction; and client (HPFB) satisfaction.
Through targeted oversight actions, the Consumer Product Safety program activity works to detect safety problems as early as possible and at all stages in a product's life cycle. Under the Canada new Consumer Product Safety Act, Consumer Products Safety program will have improved authorities to ensure investigative actions are being taken to determine the safety profile of products and to verify that preventative measures are being implemented.
Expected Results: Improved Information and reporting of consumer product safety related incidents (by industry and consumers).
Performance Indicators: # of health-related consumer product incidents reported including type of injury/illness and product category examined (i.e., Consumer Products, Cosmetics) that cause illness/risk; # complaints received; # advisories and warnings issued; and # product recalls issued/recall monitoring/recall effectiveness.
The Food Safety & Nutrition program activity has no targeted oversight funding under this initiative.
Rapid Response
The Government is equipped to respond rapidly to remove unsafe consumer products from shelves, preventing them from reaching consumers. While the Department continues to operate with a step-wise approach to compliance and enforcement by working with industry to voluntarily take corrective actions the Canada Consumer Product Safety Act (CCPSA) offers new measures to protect Canadians from unsafe consumer products. This includes a general prohibition against products that pose an unreasonable danger, the authority to order industry to recall* and/or take other corrective measures and in the case of industry's failure to act in a timely manner, Health Canada's ability to initiate a recall and/or corrective measures to ensure the health and safety of Canadians.
*Recall is a process by which the responsible establishment in Canada notifies consumers of the danger associated with a product and this notice should be accompanied by all of the following steps:
(The recall may also include other corrective measures in a separate order.)
Expected results: Improved industry compliance with product safety obligations.
Performance Indicators: % and # of inspected registrants/firms/users that are compliant** ('C') / non-compliant ('NC') with standards/acts/regulations /guidelines including Consumer Product Safety Regulations and cyclical enforcement (Product Category).
**Compliance is measured by a monitoring approach. Compliance results are determined by monitoring activities following initial inspection. Due to the non-license (post-market) nature of the consumer products industry, compliance verification is limited to primary level establishments and targeted to the highest levels of trade.
PMRA enhances compliance targeting and enforcement capacity in support of expanded regulatory authority under the PCPA, and maintains public confidence in pesticide product safety. In conjunction with other federal and provincial regulators, Health Canada continues the development and implementation of an evidence and risk-based approach to identify and act on situations of higher risk associated with non-compliance. Activities continue to include the enhancement of current information/intelligence networks, analysis and an updated targeting strategy to verify the presence of compliance and the reasons that non-compliance was found to exist. Activities also include an updated strategy to address the importation of unregistered consumer pesticides where the safety would be unknown.
Expected results: Improved risk-based monitoring of products.
Performance Indicators: # monitoring reports; #, % of targeted inspections on products/industries/sector of high risk to health; # follow-up inspections; and # and/or % pest management products monitored.
Under the rapid response pillar the Food Safety and Nutrition program activity will continue its participation in the Partnership for Consumer Food Safety Education with the goal of promoting the "Be Food Safe" campaign and will continue to develop new education materials for consumers to promote food safety in an effort to reduce foodborne disease outbreaks in Canada. In addition, it will develop a strategy for addressing the findings of a Public Opinion Research in February 2010 that measured the percentage of population aware of and engaged in food safety risks, alert systems and safety systems.
Expected Results: Increased public understanding of food safety risks, alerts systems and safety systems.
Performance Indicators: % of targeted population aware, engaged in food safety risks, alert systems and safety systems; and # of web hits of consumer oriented web pages.
12. Federal Partner Program Activity | 13. Names of Programs for Federal Partners | 14. Total Allocation (from Start to End Date) | 15. Planned Spending for 2011-12 |
---|---|---|---|
Food Safety Program Internal Service |
Active Prevention | 114.2 | 26.6 |
Targeted Oversight | 77.0 | 18.6 | |
Rapid Response | 32.2 | 7.2 | |
Total | 223.4 | 52.4 |
16. Expected results by program as per (13):
Active Prevention
The Canadian Food Inspection Agency's (CFIA) food safety initiatives aimed at ensuring active prevention include measures to enable government to better understand and identify food safety risks and to work with industry to implement effective food safety risk mitigation strategies. The CFIA, along with its federal partners, will strive to strengthen food safety standards and regulations and will engage Canadians in making decisions with respect to food safety.
In 2011-12, the CFIA will continue to work with Health Canada on data collection and risk mapping towards identification and characterization of areas of concern, including imported food ingredients, produce, mycotoxins in cereals and undeclared allergens. Risk maps will identify gaps in standard-setting and policy development and will assist in focusing operational efforts on areas of greatest risk.
A proposed regulatory scheme intended to minimize the risk of unsafe products entering the Canadian marketplace will be introduced. The proposed scheme would enable identification of importers bringing food products and ingredients into Canada and verification of industry's compliance with minimum food safety requirements.
The CFIA will publish guidance for industry on preventative food safety systems and will promote the implementation of these systems in high-risk areas.
Compliance activities and marketplace monitoring for the correct application of the revised "Product of Canada/Made in Canada" policy will continue.
Discussions with key trading partners on approaches to managing high-risk source countries will be ongoing, as well as collaboration with specific high-risk countries on managing food safety risks.
Expected results: Better understanding of high-risk sectors and better identification of potential food safety hazards for the development of effective preventative risk mitigation strategies; reduction in food safety hazards/risks; improved industry compliance; industry implementation of preventative food safety systems; establishment of standards, regulations, and policies that contribute to the prevention of food safety issues through the product lifecycle.
Performance indicators: Performance indicators for the food portion of the Action Plan are presently under review and will be reported on in the following performance report.
Targeted Oversight
Targeted oversight initiatives include enhanced inspection of identified high-risk food sectors and targeted import control measures such as border blitzes to intercept non-compliant food products before they are distributed, thus preventing contaminated products from reaching consumers. The CFIA will continue to adapt its food safety inspection practices for high-risk sectors. The bulk of inspection capacity will be dedicated to evaluation and verification of industry's control systems in both the domestic and imported food sectors. Method development and testing in targeted areas will continue, and front-line capacity will continue to increase. Border blitz plans will be reviewed and revised in light of the experience gained from the first three years of the Action Plan, and IM/IT business solutions for supporting enhanced tracking of imported food products will be further developed.
Expected results: Improved industry compliance with food safety standards; modern tools and new risk-based approaches contribute to improved safety of imported foods.
Performance indicators: Performance indicators for CFIA's activities under the food portion of the Action Plan are presently under review and will be reported on in the following performance report.
Rapid Response
Towards ensuring rapid response to food safety issues and emergencies, enhanced recall capacity will enable the Government of Canada to effectively respond to and conduct investigations for an anticipated increased number of food recalls resulting from targeted oversight activities. Targeted consumer risk communication activities and products will also improve Canadian's awareness of food safety issues and recalls and will help consumers better protect their health.
In 2011-12, the CFIA will continue to increase human resource capacity to address identified food safety issues. Enhancements to food safety recall and investigation methodology will continue.
Expected results: Timely and efficient recall capacity in the face of increased identification of potential risks through targeted testing and other information; better public understanding of food safety risks; increased consumer use of various food safety alert systems; and increased public trust and confidence in the food safety system.
Performance indicators: Performance indicators for CFIA activities under the food portion of the Action Plan are presently under review and will be reported on in the following performance report.
12. Federal Partner Program Activity | 13. Names of Programs for Federal Partners | 14. Total Allocation (from Start to End Date) | 15. Planned Spending for 2011-12 |
---|---|---|---|
Health Promotion | Targeted Oversight | 4.5 | 1.3 |
Chronic Disease Prevention and Control | Targeted Oversight | 3.5 | 1 |
Disease and Injury Prevention and Mitigation | Active Prevention | 18.3 | 4.1 |
Total | 26.3 | 6.4 |
16. Expected results by program as per (13):
Active Prevention
The Public Health Agency of Canada (PHAC) will modernize and strengthen Canada's food safety systems by use of molecular typing, by expanding the Canadian Integrated Program for Antimicrobial Resistance Surveillance (CIPARS) integrated surveillance systems and C-EnterNet surveillance infrastructure, and use of decision making models in priority areas.
Expected results: Increased understanding of food safety risks by HC, PHAC and CFIA.
Performance Indicators: % of reports tracked, # of peer-reviewed publications, # of issue papers provided to departmental colleagues and stakeholders.
Targeted Oversight
Through ongoing and expanded data collection, analysis and reporting on the rates, patterns and circumstances of unintentional injury of Canadians, focusing on children and seniors, PHAC will contribute to the evidence base for policies, practices and programs for injury prevention and control.
Expected results: More and better data on accidents, injuries, illnesses and deaths due to consumer products. Engagement of risk assessment stakeholders
Performance Indicators: # and type of databases created/improved against plan; # of cases of product- related injuries; risk assessments of consumer-related injuries; and # and type of data/reports from key stakeholders.
12. Federal Partner Program Activity | 13. Names of Programs for Federal Partners | 14. Total Allocation (from Start to End Date) | 15. Planned Spending for 2011-12 |
---|---|---|---|
Health and Health Services Advances | Targeted Oversight | 27.1 | 8.9 |
Total | 27.1 | 8.9 |
16. Expected results by program as per (13):
Targeted Oversight
The Canadian Institutes of Health Research will make investments and focus efforts in advancing the Drug Safety and Effectiveness Network to increase the available evidence on drug safety and effectiveness to regulators, policy-makers, health care providers and patients and to increase capacity within Canada to undertake high-quality post-market research in this area.
Work will continue on engaging interested parties during the development of the Network, delivering on peer reviewed funding opportunities for the initiative and responding to strategic direction received from the DSEN Steering Committee.
Expected results: Increased knowledge of post-market drug safety and effectiveness to inform decisions and increased capacity in Canada to address priority research on post-market drug safety and effectiveness.
Performance Indicators: Evidence of the dissemination of research knowledge to the target audience.
Total Allocation For All Federal Partners (from Start to End Date) | Total Planned Spending for All Federal Partners for 2011-12 |
---|---|
Health Canada | 54.2 |
Canadian Food and Inspection Agency | 52.4 |
Public Health Agency of Canada | 6.4 |
Canadian Institutes of Heath Research | 8.9 |
Total | 121.9 |
17. Results to be achieved by non-federal partners (if applicable):
Not applicable.
18. Contact information:
Hélène Quesnel, Director General, Legislative and Regulatory Policy Directorate, Strategic Policy Branch, Health Canada
Telephone: (613) 952-3484, fax: (613) 946-1430
e-mail: helene.quesnel@hc-sc.gc.ca.