Supplementary Information Tables: 2011–12 Departmental Performance Report

Horizontal Initiatives

• Canadian HIV Vaccine Initiative
• Federal Initiative to Address HIV/AIDS in Canada
• Preparedness for Avian and Pandemic Influenza

Canadian HIV Vaccine Initiative

Name of Horizontal Initiative: Canadian HIV Vaccine Initiative (CHVI)

Name of Lead Department(s): Public Health Agency of Canada (the Agency)

Lead Department Program Activity: Disease and Injury Prevention and Mitigation

Start Date of the Horizontal Initiative: February 20, 2007

End Date of the Horizontal Initiative: March 31, 2017

Total Federal Funding Allocation (Start to End Date): $111M

Description of the Horizontal Initiative (Including Funding Agreement): The Canadian HIV Vaccine Initiative is a collaborative undertaking between the Government of Canada and the Bill & Melinda Gates Foundation (BMGF) to contribute to the global effort to develop a safe, effective, affordable and globally accessible HIV vaccine. This collaboration, formalized by a Memorandum of Understanding signed by both parties in August 2006 and renewed in July 2010, builds on the Government of Canada's commitment to a comprehensive, long-term approach to address HIV/AIDS. Participating federal departments and agencies are the Agency, Health Canada (HC), Industry Canada (IC), the Canadian International Development Agency (CIDA), and the Canadian Institutes of Health Research (CIHR).

The CHVI's overall goals are to: advance the basic science of HIV vaccine discovery and social research in Canada and low-and-middle-income countries (LMICs); support the translation of basic science discoveries into clinical research, with a focus on accelerating clinical trials in humans; address the enabling conditions to facilitate regulatory approval and community preparedness; improve the efficacy and effectiveness of HIV Prevention of Mother-to-Child (PMTCT) services in LMICs by determining innovative strategies and programmatic solutions related to enhancing the accessibility, quality, and uptake; and enable horizontal collaboration within the CHVI and with domestic and international stakeholders.

Shared Outcome(s):

Immediate (1-3 years) Outcomes

• Increased and improved collaboration and networking among researchers working in HIV vaccine discovery and social research in Canada and in LMICs;
• Greater capacity for vaccines research in Canada;
• Enhanced knowledge base;
• Increased readiness and capacity in Canada and LMICs; and
• An Alliance Coordinating Office established.

Intermediate Outcomes

• Strengthened contribution to global efforts to accelerate the development of safe effective, affordable, and globally accessible HIV vaccines;
• An increase in the number of women receiving a complete course of anti-retroviral prophylaxis to reduce the risk of mother to child transmission of HIV; and
• A CHVI Research and Development Alliance established.

Long-Term Outcomes

• The CHVI contributes to the global efforts to reduce the spread of HIV/AIDS particularly in LMICs.

Governance Structure(s): The Minister of Health, in consultation with the Minister of Industry and the Minister of International Cooperation, is the lead Minister for the CHVI. An Advisory Board is in place and is responsible for making recommendations to responsible Ministers regarding projects to be funded and oversees the implementation of the Memorandum of Understanding between the Government of Canada and the BMGF. The CHVI Secretariat, housed in the Agency provides a coordinating role to the Government of Canada and the BMGF. An Alliance Coordinating Office was established, which will lead and promote the CHVI Research and Development Alliance and provide administrative support to the CHVI Advisory Board.

Performance Highlights: In 2011–12, CHVI participating departments and agencies continued to implement activities initiated in 2010–11. For example, the selection and establishment of an CHVI Research and Development Alliance, including the Alliance Coordinating Office (ACO); the completion and awarding of CIDA-CIHR large team grants; providing training and mentoring programs for capacity building to address identified needs of developing national regulatory authorities; enhancing the access, quality and uptake of PMTCT services; the establishment of a new transfer payment fund to encourage private sector participation; the continued development of an approach to move the HIV vaccine translational support fund forward; and supporting CHVI regulatory capacity-building activities.

Demandes de contrôle judiciaire concernant les demandes d'ordonnance d'interdiction relatives à l'article 6 du Règlement sur les médicaments brevetés (avis de conformité) - Résumé au 31 mars 2017

Comments on Variance: N/A

Expected Results and Results Achieved:

ER 1.1: New vaccine policy approaches and increased community involvement.

RA 1.1: Ongoing and increased support to domestic and international stakeholders in addressing HIV vaccines policy issues, building capacity and promoting global harmonization of regulatory pathways, and improving preparedness.

Support for national and international fora attended by researchers, funders, policy makers, community stakeholders and advocates from around the world highlighting recent developments in HIV vaccine research and promoting greater involvement and collaboration among stakeholders. Support education and training opportunities for young and early career investigators to advance HIV prevention research.

ER 2.1: Efficient and more timely transition from preclinical research into clinical trials.

RA 2.2: Increased number of clinical trial lots manufactured for promising HIV vaccine candidates.

RA 2.1 & 2.2: A landscape study was conducted which provided an overview of the current Canadian HIV vaccine research landscape, and identified strengths in Canadian HIV research and barriers in moving vaccine candidates from discovery to clinical trials. The information collected will be used to inform the development of an approach for the Translational Support Fund.

ER 3.1: Establishment of a strong and vibrant network of HIV vaccine researchers and other vaccine researchers both in Canada and internationally.

RA 3.1: The ACO has been established to lead and promote the CHVI Research and Development Alliance. The Alliance brings together leading researchers from the public and private sectors, as well as the international community, to develop innovative solutions to the challenges facing HIV vaccine research and development. More specifically, the ACO will be responsible for: building and sustaining the Alliance; prospecting innovative proposals to respond to identified research and development gaps; promoting synergies between Alliance members; and identifying and enhancing Canada's unique niche, strengths and expertise of the public and private sectors.

The ACO is developing a report titled Framework to Guide the Canadian HIV Vaccine Research and Development Alliance, which will help to identify a long-term agenda for the Alliance that will be used to inform decision-making and direct Canada's HIV vaccine research efforts, both in Canada and internationally. The report is expected to be completed in fall 2012.

ER 3.2: Development of innovative solutions to the challenges facing HIV vaccine research and development (such as strengthening career development opportunities for young and early-career investigators).

RA 3.2: Using the Framework to Guide the Canadian HIV Vaccine Research and Development Alliance, the ACO will work with the Alliance members to prospect innovative proposals to respond to identified research and developments gaps.

ER 3.3: Effective communications, strategic planning, coordination, reporting and evaluation within the Government of Canada.

RA 3.3: Provided ongoing horizontal coordination and policy advice on CHVI related issues to participating departments and with the Bill & Melinda Gates Foundation.

The Agency prepared, and disseminated several communication products regarding the CHVI and completed the CHVI Performance Management Strategy.

*A Budget Transfer Agreement was established to allow a transfer of funds between Internal Services and Health Products in the amount of 0.1M for 2011–12. These funds were used to address ER 4.1.

Comments on Variance: N/A

Expected Results and Results Achieved:

ER 4.1: Promote the harmonization and exchange of domestic and international best practices, policies and protocols related to the regulation of vaccines and clinical trials.

RA 4.1: Provided technical and policy expertise at domestic and international forums and shared best practices and promoted harmonization of policies related to the regulation of HIV vaccines and clinical trials, including participation at the African Vaccines Regulatory Forum and the 2011 AIDS Vaccine Satellite Symposium on addressing critical regulatory issues in AIDS vaccine research.

ER 5.1: Ensure that trials with HIV vaccines are performed in accordance with the internationally accepted principles of Good Clinical Practices.

RA 5.1: Developed training material and provided training on Good Clinical Practices, and a course on the Assessment of Clinical Trials Applications which was delivered to participants from foreign regulators at the HC International Regulatory Forum in October 2011.

ER 5.2: Strengthen the regulatory capacity of developing national regulatory authorities targeted for vaccine and clinical trial submissions, including those related to HIV/AIDS.

RA 5.2: Implemented capacity building initiatives to develop national regulatory authorities to help strengthen their ability to regulate clinical trials and license HIV vaccines. This included the launch of the CHVI Regulatory Capacity Mentorship Program in July 2011 which provided a targeted approach to address issues related to HIV vaccine and clinical trials submissions.

Comments on Variance: Three rounds of project proposals were submitted to the CHVI Advisory Board in June 2011, September 2011 and February 2012. Board approvals were issued in August 2011, October 2011 and March 2012. The difference between the planned expenditures of $3.0M and actual expenditures of $1.3M relates to the initial set-up of the program and administrative processes.

Expected Results and Results Achieved:

ER 6.1: Further advancement of new and innovative technologies in pre-commercial development at small and medium- sized enterprises that operate in Canada for the prevention, treatment and diagnosis of HIV.

RA 6.1: In 2011–12, 11 contribution agreements were signed with Canadian small and medium enterprises to support research and development of an HIV vaccine and other technologies related to the prevention, treatment and diagnosis of HIV.

Comments on Variance: For ER 8.1 and ER 9.1, planned yearly spending changed for respective projects to accommodate programmatic needs for implementing partners. This resulted in an increase in actual spending in 2011–12.

Expected Results and Results Achieved:

ER 7.1: Increased capacity to conduct high-quality clinical trials of HIV vaccine and other related prevention technologies in LMICs through new teams of Canadian and LMICs researchers and research institutions.

RA 7.1: A six-year, $16.0M project spanning 2008–09 to 2013–14 is in place with the Global Health Research Initiative. This project will strengthen the capacity of researchers and research institutions to conduct high quality clinical trials and build site capacity to conduct HIV vaccine clinical trials in low and middle-income countries. Since 2008–09, the following has been accomplished:

• In 2010–11, multi-year capacity building sub-grants totalling $12.3M were awarded to nine teams made up of Canadian and African researchers: 5 teams awarded up to $1.8M, 2 teams awarded up to $1.35M, 2 smaller grants approximately $300,000 each.
• In 2011–12, five complementary research grants of up to $57,000 were awarded to young African researchers were made available to the seven capacity building grant recipients. The total granted was $261,500.

ER 8.1: In collaboration with CIHR, increased capacity and greater involvement and collaboration amongst researchers working in HIV vaccine discovery and social research in Canada and in LMICs through the successful completion of the development stage of the Team Grant program to support collaborative teams of Canadian and LMIC researchers.

RA 8.1: A seven-year project in partnership with the CIHR ($17.0M from 2010–11 to 2016–17) will strengthen the capacity of researchers, promoting greater involvement and collaboration among researchers working in HIV vaccine discovery and social research in Canada and LMICs. Since 2010–11, the following has been accomplished:

• In 2010–11, nine collaborative teams of Canadian and LMIC researchers were funded to support the development of Large Team Grant - HIV/AIDS Vaccine Discovery and Social Research program applications.
• In 2011–12, the nine collaborative teams submitted applications for large team grants and five teams were awarded for multi-year funding.

ER 9.1: Increased number of women receiving a complete course of anti-retroviral prophylaxis to reduce the risk of mother-to-child transmission of HIV.

RA 9.1: An agreement is in place with the World Health Organization for $20M over the five years from 2010–11 to 2014–15 to enhance the availability, quality and uptake of prevention of mother to child transmission services. WHO is implementing the project in Nigeria, Zimbabwe and Malawi.

In 2011–12, six research teams, two per country, were awarded research grants. The research teams will study a range of issues including the effectiveness of point of care diagnostics for CD4 counts, task shifting of health care to mother-mentors and other voluntary health workers, using integrated health programming approaches and the use of technology (SMS/text messaging) for better-facility level follow up.

An agreement with the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) was put in place for $10.0M over four years from 2011–12 to 2015–16 to identify community-based interventions with the most potential to enable scale-up of prevention of mother-to-child transmission of HIV (PMTCT) services in sub-Saharan Africa. This project aims to improve progress towards the elimination of pediatric AIDS and to complement ongoing facility-based efforts to improve PMTCT/MCH services by focusing on community barriers. These interventions aim to increase demand, uptake and retention of services. EGPAF will implement the project in Zimbabwe, Uganda and Swaziland.

ER 10.1: Increased capacity of regulatory authorities in LMICs especially those where clinical trials are planned or ongoing, through training and networking initiatives.

RA 10.1: A four-year project in place with the World Health Organization ($2.0M, 2009–10 to 2012–13) will support capacity-building activities to improve regulatory capacity in LMICs, especially those where clinical trials are planned or ongoing. To date, this project from 2009–10 to 2012–13 has:

• Formalized the African Vaccine Regulatory Forum (AVAREF); and
• Delivered good clinical practices inspection courses and evaluation of clinical data courses to a number of the 19 AVAREF country members.

Comments on Variance: N/A

Expected Results and Results Achieved:

ER 11.1: Increased capacity and greater involvement and collaboration amongst researchers working in HIV vaccine discovery and social research in Canada and in LMICs through:

• Ongoing support for operating and catalyst grants undertaken by Canadian researchers;
• Ongoing support for two emerging teams of Canadian researchers; and
• Collaboration with CIDA in award and support of the Large Team Grant program for collaborative teams of Canadian and LMIC researchers.

RA 11.1: Supported new discoveries in vaccine science and increased capacity and collaboration amongst researchers with new and ongoing funding awarded to researchers and teams of researchers working in HIV vaccine and social research in Canada and in LMICs demonstrated by:

• Ongoing funding provided to five Canadian researchers for Operating grants and completed funding for 3 Catalyst grants ;
• Ongoing funding of two teams of Canadian researchers through the Emerging Team Grants – HIV/AIDS Vaccine Discovery and Social Research program; and
• Completed the scientific peer review of nine full applications which were developed with CHVI support in the previous year and began funding five collaborative teams of Canadian and LMIC researchers under the Large Team Grant – HIV/AIDS Vaccine Discovery and Social Research program.

Results to be Achieved by Non-Federal Partners (if Applicable): Non-governmental stakeholders (including research institutions and not-for-profit community organizations) are integral to the success of the CHVI. Their role is to engage and collaborate with participating departments and agencies, the Bill & Melinda Gates Foundation and other funders to contribute to the CHVI goals and to Canada's contribution towards the Global HIV Vaccine Enterprise.

Contact Information:

Marc-André Gaudreau
200 Eglantine Driveway
Ottawa, Ontario K1A 0K9

613-960-2151
marc-andre.gaudreau@phac-aspc.gc.ca

Federal Initiative to Address HIV/AIDS in Canada

Name of Horizontal Initiative: Federal Initiative to Address HIV/AIDS in Canada (FI)

Name of Lead Department(s): Public Health Agency of Canada (the Agency)

Lead Department Program Activity: Disease and Injury Prevention and Mitigation

Start Date of the Horizontal Initiative: January 13, 2005

End Date of the Horizontal Initiative: Ongoing

Total Federal Funding Allocation (Start to End Date): Ongoing

Description of the Horizontal Initiative (Including Funding Agreement): The FI strengthens domestic action on HIV and AIDS, builds a coordinated Government of Canada approach, and supports global health responses to HIV and AIDS. It focuses on prevention and access to diagnosis, care, treatment and support for those populations most affected by HIV and AIDS in Canada — people living with HIV and AIDS, gay men, Aboriginal people, people who use injection drugs, people in prison, youth, women, and people from countries where HIV is endemic. The FI also supports and strengthens multi-sector partnerships to address the determinants of health. It supports collaborative efforts to address factors which can increase the transmission and acquisition of HIV including sexually transmitted infections (STI) and also addresses co-infection issues with other infectious diseases (e.g., hepatitis C and tuberculosis) from the perspective of disease progression and morbidity in people living with HIV and AIDS. People living with and vulnerable to HIV and AIDS are active partners in shaping policies and practices affecting their lives.

Shared Outcome(s):

First level outcomes

• Increased knowledge and awareness of the nature of HIV and AIDS and ways to address the disease;
• Increased individual and organizational capacity;
• Increased Canadian engagement and leadership in the global context; and
• Enhanced engagement and collaboration on approaches to address HIV and AIDS.

Second level outcomes

• Reduced stigma, discrimination, and other barriers;
• Improved access to more effective prevention, care, treatment and support;
• Internationally informed federal response; and
• Increased coherence of the federal response.

Ultimate outcomes

• Prevent the acquisition and transmission of new infections;
• Improved quality of life for those at risk and living with HIV and AIDS;
• Contribute to the global effort to reduce the spread of HIV and AIDS and mitigate its impact; and
• Contribute to the strategic outcomes of partner departments.

Governance Structure(s): The Responsibility Centre Committee (RCC) is the governance body for the FI. It is comprised of directors from the nine Responsibility Centres which receive funding through the FI. Led by the Agency, the RCC promotes policy and program coherence among the participating departments and agencies, and makes sure that reporting requirements are met.

The Agency is the federal lead for issues related to HIV and AIDS in Canada responsible for overall coordination, communications, social marketing, reporting, evaluation, national and regional programs, policy development, surveillance and laboratory science.

Health Canada (HC) supports community-based HIV and AIDS education, capacity-building, and prevention for First Nations on-reserve and Inuit communities south of the 60^th parallel and provides leadership on international health policy and program issues.

As the Government of Canada's agency for health research, the Canadian Institutes of Health Research (CIHR) sets priorities for and administers the extramural research program.

Correctional Service Canada (CSC), an agency of the Public Safety Portfolio, provides health services (including services related to the prevention, diagnosis, care and treatment of HIV and AIDS) to offenders sentenced to two years or more.

Performance Highlights: In 2011–12, federal partners provided inter-sectoral leadership on common approaches to monitoring systems and to program interventions in order to prevent and control HIV and AIDS and related infectious diseases in Canada. Increased national and regional collaboration resulted in a jointly administered applications process for the AIDS Community Action Program and the National Voluntary Sector Response, a shared public awareness monitoring approach for public awareness of HIV and hepatitis C, and focussed partnerships that address research gaps for prevention of HIV and related infections among Aboriginal populations. FI partners engaged with other departments to produce reports for international multilateral organizations, including the International Labour Organization and the United Nations General Assembly Special Session on HIV. Strengthened partnerships and increased collaboration also signalled the beginning of a new phase of on-line information and awareness strategies for HIV and related sexually transmitted and blood borne infections (STBBI). And finally, the increased capacity in strategic and international research sectors to address HIV and related co-infections has created opportunities for greater collaboration among research communities and other stakeholders.

Comments on Variance: The variance of $1.8M consists of $0.6M in grant and contribution transfers to other programs for joint action on Federal Initiative outcomes and $1.2M in activities deferred.

Expected Results and Results Achieved:

ER 1.1: Public health decisions and interventions by public health officials are supported by timely, reliable and accredited reference service testing that accurately captures all the circulating HIV strains in Canada and directs attention to new outbreaks and increases in HIV transmission.

1. Identify best treatments for reduced mother-to-child transmission.
2. Develop standards and methods for testing.
3. Improve understanding of HIV variation.
4. Provide drug resistance information that will guide treatment selection for treatment-naïve patients.
5. Monitor quality of HIV testing in Canada.

RA 1.1: Recent findings from the HIV viral load monitoring PT program have revealed that interpretative criteria in new test kits from several manufacturers may lead to confusing final results potentially affecting clinical management. Real-time external quality monitoring identified problems with a specific HTLV test kit commonly used for cells tissues and organs, potentially affecting transplantation activities. Drug Resistance Reports were generated for all specimens submitted for the Canadian HIV Strain and Drug Resistance Surveillance Program. Public health officials participated in WHO-UNAIDS Network for HIV Isolation and Characterisation. At least three publications were generated through reference testing activities.

ER 1.2: Use of laboratory-generated knowledge is increased.

1. Develop linkages with epidemiologists and other social scientists to examine magnitude of HIV test results and social determinants that have an influence in HIV-infected persons.
2. Identify, confirm, and provide recommendations to address performance of HIV diagnostic test kits in Canada.
3. Collaborate with the Canadian Association of HIV Clinical Laboratory Specialists on standards development for increased quality of HIV diagnostic, prognostic, and drug resistance testing.
4. Collaborate with the Standards Council of Canada and the Clinical Laboratory Standards Institute on the creation and implementation of quality standard guidelines/practices in medical laboratories in Canada and worldwide.
5. Disseminate technical information to partners on HIV testing to enhance quality, reliability, and comparability.
6. Collaborate with CIHR and the British Columbia Centre for Disease Control on funded projects including HIV transmission patterns in at-risk communities in Vancouver in order to determine whether new infections are overrepresented.

RA 1.2: Collaborations were developed with several research organizations on a project linking molecular and social cluster analyses in HIV Transmission. Recent findings from the HIV viral load monitoring PT program have revealed that interpretative criteria in new test kits from several manufacturers may lead to confusing final results potentially affecting clinical management. Real-time external monitoring has identified problems with a specific HTLV test kit commonly used for cells tissues and organs, which could potentially affect transplantation activities.

Agency officials met with provincial lab directors, regulators and other parties with a mandate in HIV testing to identify new technologies and problems with current technologies having an impact on HIV testing in Canada. Mitigation strategies involving alternative test kits were developed. The Agency continues to be represented on both the Standards Council of Canada and the Clinical Laboratory Standards Institute. The presence on both these groups allows PHAC to influence and monitor the state of quality and similar guidelines within Canada, the US and internationally. Technical information was disseminated through various publications.

ER 2.1: Trends are monitored and assessed in reported HIV infections, and patterns of prevalence and risk and health behaviours related to HIV and associated infections among populations most affected by HIV and AIDS in Canada are assessed. This will be achieved by designing and implementing targeted survey data collection, analysis, and interpretation, as well as knowledge transfer and exchange. These efforts will particularly be focussed in areas and in populations that have noted recent increases in HIV infection rates, such as Aboriginal persons in Saskatchewan who inject drugs.

RA 2.1: Work with P/Ts to enhance HIV surveillance and reporting continued.

Memoranda of Agreement were developed to support the province-based work of our Field Surveillance Officers and the tracking of HIV strain and drug resistance in Canada.

Specialized laboratory testing on HIV specimens was performed to determine which specimens come from people who are recently infected to better understand the characteristics of the leading edge of Canadian HIV infection rates.

Laboratory surveillance was conducted for emerging HIV subtypes in order to detect changes in the patterns of HIV infection in Canada.

Targeted enhanced surveillance studies of street youth (E-SYS) were undertaken in Vancouver, Edmonton, Saskatoon, Winnipeg, Toronto, Ottawa and Halifax which describe the epidemiology of HIV and other STBBI in this population. Knowledge transfer activities were undertaken by most sites to disseminate local findings. National E-SYS findings will be published in 2012 along with the implementation of national knowledge transfer activities.

ER 3.1: Increased knowledge and awareness of the nature of HIV and AIDS and ways to address the disease, as indicated by:

1. The number and type of evidence-based information products developed and disseminated, including the national report on HIV/AIDS Surveillance; the National Report on HIV Drug Resistance Surveillance; comparative international studies of HIV incidence and prevalence; three population-specific reports; an HIV prevention and related co-infection framework; HIV counselling and testing guidelines and a chapter on disclosure; the Canadian Guidelines on Sexually Transmitted Infections; Canadian Sexual Health Education Guidelines information products; interdepartmental pilot projects to address HIV and the determinants of health; augmented HIV case reporting; targeted epidemiological studies among most at risk populations; improved knowledge and characterization of HIV strains in Canada; and implementation of recommendations from the PHAC study of HIV and AIDS funding programs' structure;
2. Ongoing support and guidance provided to partners, including the number and type of knowledge and awareness activities and products, and processes to develop funding proposals aligned with public health priorities;
3. Project data on number of presentations and workshops and their reach;
4. Project data on increases in knowledge of HIV transmission and risk factors among target populations;
5. Identification of novel transmission mechanisms of HIV infection; and
6. The efficacy of policies aimed at addressing HIV transmission.

RA 3.1:

1. Research on the use of new social media among stakeholder communities, resulted in "next generation" outreach and dissemination strategies and increased access to sexual health resources and information for youth and other specific populations . Referrals to PHAC's HIV and related website information from 3^rd party websites doubled between 2007 and 2011.The Canadian Guidelines on Sexually Transmitted Infections was updated, and an expert working group provided advice about future changes. HIV Screening and Testing Guidelines were drafted for dissemination.

   In 2011, PHAC's Population-Specific HIV/AIDS Status Report: Aboriginal Peoples was used by the Canadian Institutes of Health Research (CIHR) to launch a Catalyst Grant call for research proposals on HIV and Aboriginal Health, in partnership with PHAC and Health Canada's First Nations and Inuit Health Branch (FNIHB). The call aimed to stimulate research in areas of need identified in the report and beyond. Three research projects were selected for funding addressing HIV issues among Aboriginal youth, Inuit and HIV-positive two-spirit (gay and bisexual) Aboriginal men.

   Knowledge of the factors that contribute to the spread of HIV infection was also advanced through: augmented HIV and risk behaviour sentinel surveillance programs. Including: I-Track (national enhanced surveillance systems that focus on people who inject drugs (IDU)); M-Track (national enhanced surveillance systems that focus on gay, bisexual and other men who have sex with men or MSM); A-Track (focused on Aboriginal peoples); E-Track (focused on persons who originate from countries where HIV is endemic); and P-Track (focused on persons with HIV infection).

2. The Agency developed a consolidated process to invite and review applications for projects addressing public health priorities under national and regional funding streams between 2012 and 2014.

   As part of outbreak support in Saskatchewan, PHAC provided a full-time senior epidemiologist for one year to help Saskatchewan investigate factors associated with recently diagnosed cases of HIV infection to guide prevention and control measures.

3. Thirty-three of 35 projects funded through the Knowledge Exchange, Specific Populations, Voluntary Sector Response, and Non-Reserve First Nations, Inuit and Métis Communities funding streams reached over 30,000 participants in efforts to increase knowledge and awareness of the nature of HIV/AIDS and the ways in which to address the disease.
4. Sample surveys conducted by five projects showed that about 90% of participants indicated that their knowledge of HIV transmission and risk factors had increased as a result of their participation in a range of funded activities.
5. HIV/AIDS targeted epidemiologic studies continued to address questions and gaps arising from case-reporting surveillance, and to provide statistical support for HIV/AIDS modelling efforts to assess the hidden epidemic and produce national HIV estimates.
6. Modeling and projections activities provided technical support for the estimation of HIV incidence and prevalence in Canada. PHAC began the development of mathematical models to assess the effectiveness of various intervention scenarios.

ER 3.2: Enhanced engagement and collaboration on approaches to address HIV and AIDS, as indicated by:

1. Intersectoral leadership;
2. Coordinated approaches to data collection and dissemination, enhanced collaboration with key stakeholders in the response to HIV and AIDS, and STI's, including committees, partnerships and collaborative documents;
3. Focussed advisory and coordination agendas that link to FI expected results;
4. Engagement of community organizations in the response to HIV and AIDS and the factors that impact those affected and at risk for infection;
5. The number of invitations to submit applications and the number of funded project proposals;
6. Project data on number and type of partnerships; and,
7. Ongoing guidance provided to NGO partners.

RA 3.2:

1. Federal Initiative partners and Human Resources and Skills Development Canada collaborated to prepare a report to Parliament on the International Labour Organisation (ILO) Recommendation 200 – HIV and the World of Work, and a report on Canada's action on the Recommendation. Collaborating Departments and Agencies also produced the 2010–11 UNGASS Country Report (PDF document), which will help inform the UNAIDS 2012 End of Year Report on the Global AIDS Epidemic.
2. New agreements were developed among federal partners to support targeted HIV research and public health interventions for Aboriginal populations.
3. The National Aboriginal Council on HIV/AIDS and the Ministerial Advisory Council (Federal Initiative) met to consider emerging research and evolving programming in HIV prevention and control.
4. Forty-two percent of ACAP projects strengthened organizational capacity. They include provincial organizations, which focus on capacity-building and training to AIDS service and other frontline organizations. Other ACAP capacity-building activities in 2011–12 were related to the funding solicitation. Regional capacity-building events including cultural competence training for health and corrections sector workers; information about treatment as prevention; and promoting evidence-based practice in community agencies. Three invitations to submit applications were launched in December 2011. One hundred and sixteen projects were funded—they focused on public health interventions and outcomes, integrated HIV, hepatitis C, STIs prevention and control, and the determinants of health.
5. Thirty-one projects funded through the Knowledge Exchange, Specific Populations Initiatives, Voluntary Sector Response, and Non-Reserve First Nations, Inuit and Métis Communities funding streams reported over 325 partnerships in 2011–12. Three quarters of the partnerships involved not-for-profit or voluntary sector organizations, while the remainder involved mostly public sector and research organizations. Thirteen partnerships with private sector firms were reported. Sixty percent of reported partnerships were undertaken by projects funded under the Non-Reserve First Nations, Inuit and Métis Communities funding streams, and involved mostly local, municipal and provincial territorial organizations.
6. Ongoing guidance provided to NGO partners. Results in this area are identified under 3.1b.

ER 3.3: Increased individual and organizational capacity to address HIV and AIDS, as indicated by:

1. The accessibility, quality and reliability of HIV molecular diagnostic and monitoring assays;
2. The development and implementation of effective interventions for the prevention and control of infectious diseases in community settings;
3. Sustained support to community-based organizations, including the number of projects funded and funds provided to community-based funding;
4. The number of projects in which target populations contribute to management and delivery of projects;
5. The number and type of capacity building activities for non-governmental and community-based organizations;
6. Project data on actions to improve access to health and social services;
7. Project data on number of volunteers and volunteer hours;
8. Improved methods for determining the immune health of people with HIV; and
9. Identifying key prevention strategies for vulnerable groups.

RA 3.3:

a) The Agency addressed findings related to HIV molecular diagnostic and monitoring programs, and issues of immune health in peer reviewed publications.

b) & c) In December 2011, PHAC undertook a new approach to funding for regional and national activities that identified shared priorities and outcomes for HIV and related communicable diseases, including community readiness for new prevention technologies and vaccines. One hundred and sixteen projects were funded—focusing on public health interventions and outcomes, integrated HIV, hepatitis C, STIs prevention and control, and the determinants of health.. The new funding approach encouraged stakeholders to work across sectors and integrate community responses that address similar populations and modes of transmission, and increased the coherence of the Canadian response to HIV.

d) Twenty-eight out of 34 projects reporting under national funding streams (over 80%) showed that target populations were included in the management and delivery of projects. Of these, 22 focussed on Aboriginal communities, five focussed on people living with HIV and AIDS; and one targeted youth at risk of contracting HIV.

e) Nationally-funded projects reported 51 capacity-building activities for non-governmental and community-based organizations during 2011–12. These activities were geared towards the acquisition of skills, and reached more than 12,000 participants, including over 10,000 workshop participants. Projects funded through the Voluntary Sector Response fund offered the most capacity building activities with 20, followed by Non-Reserve First Nations, Inuit and Métis Communities projects, with 17 and the Specific-Populations Initiatives fund with 13.

Participant surveys indicate improved capacity. In two projects, over 80% of attendees reported increased capacity and skills to address HIV and AIDS as a result of their participation. Moreover, three projects report that approximately 85% of participants indicate that they intend to change their practices for addressing HIV and AIDS (responses varied between 72 and 93%), and another project reports that 86% of its participants have already changed their practices. Individuals or communities who face specific risk conditions were directly involved in a committee or group that provides advice to the governing body in over half of all AIDS Community Action Projects (ACAP), and were employed by over one-third of ACAP projects. People living with HIV or AIDS were directly involved in providing advice to a governing body in over 40% of ACAP projects and were employed by over a quarter of ACAP projects.

f) Six projects reported that, in response to HIV and AIDS and the factors that impact those affected and at risk for infection, they had referred approximately 800 individuals for counselling and HIV testing. Of the 800 individuals referred, approximately 75% were Aboriginal people while 25% were Persons Living with HIV and AIDS.

g) In 2011–12, nationally-funded projects reported an estimated 320 new volunteers and an estimated 14,000 volunteer hours. Additionally, approximately 150 volunteers were given training over the course of the same period.

h) See RA 1 and RA 2.

i) Key prevention strategies included: online and on-site interventions where at-risk populations gather. Peer education was used by ACAP projects, and supported receptivity to messages of testing, prevention and health promotion. Engaging partners from different sectors such as settlement workers and cultural groups was used to reach endemic populations with prevention education. Partnership and community building strategies also brought people together to facilitate prevention for at risk populations. Population specific strategies for women at risk of HIV and AIDS are also identified in PHAC's Population-Specific HIV/AIDS Status Report: Women.

Comments on Variance: NA

Expected Results and Results Achieved:

ER 4.1: Increased Canadian engagement and leadership in the global context through exchanging best practices with global partners to inform global and domestic policies on HIV and AIDS. This will be achieved by supporting the development and dissemination of information, and through increased dialogue and engagement with stakeholders and other Government of Canada departments in three global fora to share expertise and influence policies.

RA 4.1: Portfolio partners provided technical support and coordinated content to the UN High Level Meeting on HIV/AIDS, June 2011, the High Income Country Dialogue on HIV and the Law, September 2011 the UNAIDS Programme Coordinating Board, December 2011 and the Policy Dialogue on HIV and Mental Health - January 30–February 1, 2012.

ER 4.2: Enhanced engagement and collaboration on approaches to address HIV and AIDS through supporting the development of advice documents to inform global collaboration on HIV and AIDS and policy coherence across federal government's global activities on HIV and AIDS.

RA 4.2: Portfolio partners in collaboration with other stakeholders produced advisory products including the HIV and Mental Health Policy Dialogue Report, and a Literature Review and Environmental Scan on HIV and Mental Health.

ER 5.1: Areas for improved programming regarding HIV-blood borne sexually transmitted infections (HIV-BBSTI) and tuberculosis (TB) co-infections are identified via enhanced engagement and collaboration on approaches to address underlying factors related to HIV and AIDS through partnerships with the National Native Alcohol and Drug and Alcohol Abuse Program (NNADAP) and the First Nations and Inuit Health Branch's TB Program.

RA 5.1: HIV case management services were enhanced with targeted case management services in some First Nation on-reserve communities, particularly higher risk communities in Saskatchewan. These activities included provision of emotional support and treatment for those co-infected with tuberculosis and hepatitis C.

In British Columbia, NNADAP workers (including addiction, wellness and mental health professionals) attended various workshops and trainings such as HIV Testing & Prevention Strategies, HIV pre & post-test discussion, and partner counselling & referral services.

The Saskatchewan region collaborated with the TB Program on implementing infectious disease satellite clinics in First Nations and isolated communities (e.g., Big River – through Know Your Status project) and La Ronge (through the TB advisory working group).

Collaboration increased through HC's participation in Mental Health and Addictions Task Group, NNADAP participation in HC's HIV Strategy Implementation Group, and participation in discussions related to expanding testing/treatment/case management programs and services.

The Alberta region collaborated to provide program updates to nurses and community health representatives, linking HIV-BBSTIs, and TB risk factors and the importance of testing and follow-up. Training and awareness raising efforts resulted in the incorporation of HIV/AIDS related information into the education and counselling session of healthcare workers. In addition, the Alberta Region TB program has been testing all TB positive clients for HIV in accordance with the recommendations of the Canadian Tuberculosis Standards.

The HIV-BBSTI/TB co-infection literature review increased knowledge in best and promising practices in the areas of testing/screening, pre- and post-test counselling, and case management by streamlining and enhancing HIV/AIDS-BBSTIs, TB, and co-morbidities (e.g., mental illness and substance use) prevention services, thereby providing persons with seamless comprehensive services.

Enhanced case management resulted in the mitigation of negative impacts of mental health and addictions issues in an HIV/AIDS context, particularly injection drug use as a method of HIV transmission.

ER 5.2: Increased individual and organizational capacity to address HIV and AIDS, as indicated by the:

1. Development of a training module to be used by NNADAP workers and community nurses in HIV-BBSTI risk factors;
2. Number of community nurses receiving training on HIV-BBSTI and related health issues; and
3. Number of NNADAP workers receiving training on HIV-BBSTI risk factors and the need for HIV testing.

RA 5.2: Increased individual and organizational capacity to address HIV and AIDS, as indicated by the:

1. The Manitoba region developed HIV Education Series through Telehealth, including various topics such as the basics of HIV, Sexual Health Assessment, and Treatment Management. In addition, the Manitoba First Nations AIDS Working Group (MFNAWG) provided training to youth, community members and NNADAP workers on HIV/AIDS-BBSTIs. Stronger linkages were built with the NNADAP Coordinator that allowed the exchange of information related to education opportunities and expertise on HIV and mental health/addictions.

   The Alberta region developed HIV/AIDS-BBSTI related training modules, including several key approaches and strategies linking risk factors for substance abuse, HIV/AIDS-BBSTI, TB and co-infections, which can be used to support awareness and education in communities. Additional awareness materials developed include presentations, pamphlets, flip charts, games and awareness items for use by NNADAP workers as appropriate for their community and target audience, ranging from large gatherings to individual counselling. Other educational tools developed by the region included:

   A manicure set "Be Aware Don't Share" with a message inside about risks of HIV/AIDS-BBSTI transmission. This tool had so much more impact and resulted in greater opportunities to discuss other risk factors.

   Holistic Wellness, a life skills program, was developed in partnership with 3 Eagle Wellness Society, NNADAP, Mental Health and the HIV/AIDS-BBSTI Prevention program. NNADAP and Mental Health workers were trained to deliver the program in their communities.

   Expecting Respect Manual - this program is delivered at the Annual Youth Gathering, a four-day training session for Youth to learn information on such topics as smoking, substance abuse, bullying, social media, sexual health to HIV/AIDS-BBSTIs, to increase their knowledge to make healthier choices and share with their peers, family and community.

   HIV/AIDS-BBSTI, TB, and NNADAP workers report being able to incorporate HIV/AIDS-BBSTI issues into their work.

   Participants report they are making healthier choices and some are going for testing to know their status. Increased awareness of the risk factors for all people has increased the number of people that are interested in getting tested HIV/AIDS-BBSTI and TB.

2. Number of community nurses receiving training on HIV-BBSTI and related health issues; and The Alberta region trained more than 250 nurses, including CHNs, ZNMs (Zone Nursing Managers), LPNs, Homecare Nurses, Health Care Aids, Primary Care Nurses, Nurse Practitioners and CHRs (Community Health Representatives) on HIV/AIDS-BBSTI and related health issues.

3. Number of NNADAP workers receiving training on HIV-BBSTI risk factors and the need for HIV testing.

   200 NNADAP workers were trained by the Alberta region, including community workers, NNADAP Directors, Mental Health workers and Family Violence workers on HIV-BBSTI risk factors and the need for HIV testing.

   In Saskatchewan, all addictions workers certified through SIIT have an educational component on HIV within the program. The Regional Coordinator attended five regional events providing information on SK HIV Strategy and FNIHB action plan, HIV and addictions, HIV 101, HIV epidemiology in SK, and HIV and Pregnancy

Comments on Variance: $0.4M was transferred to the Canadian HIV/AIDS Research Initiative by the Agency in support of projects related to HIV in Aboriginal populations and CIHR provided additional support for strategic HIV research programs.

Expected Results and Results Achieved:

ER 6.1: Increased knowledge and awareness of the nature of HIV and AIDS and ways to address the disease through the funding of high-quality research and knowledge translation grants in HIV and AIDS. This will be achieved through the ongoing development and administration of strategic research funding programs.

RA 6.1: On behalf of the Federal Initiative, the Canadian Institutes of Health Research (CIHR) invested a total of $22.5M in HIV/AIDS research and research capacity-building in 2011–12. This funding supports biomedical and clinical research; research on health systems and services and social, cultural and environmental determinants of health as well as the CIHR Canadian HIV Trials Network (CTN) and the CIHR HIV/AIDS Community-Based Research (CBR) Program.

In total, including both the Federal Initiative funding and CIHR funding, CIHR supported 298 grants, 203 awards and 18 Canada Research Chairs for a total investment of $45.9M in HIV/AIDS research in 2011–12, CIHR's largest annual investment in HIV/AIDS research to date.

In order to continue to support high quality HIV research and knowledge translation activities, the CIHR HIV/AIDS Research Initiative developed and launched the following research grant funding opportunities:

• Operating Grants: Priority Announcements (3)
• Community-based Research Operating Grants
• Community-based Research Catalyst Grants (2)
• Meetings, Planning and Dissemination Grants (6)
• Knowledge Synthesis Grants: Priority Announcement
• Catalyst Grants: HIV/AIDS and Aboriginal Health
• Team Grant: HIV Comorbidity

The Catalyst Grants: HIV/AIDS and Aboriginal Health competition was developed to support research to understand and improve the situation of HIV/AIDS within Aboriginal populations across Canada. This program in particular was intended to stimulate research in areas of need identified in the "Population-Specific HIV/AIDS Status Report: Aboriginal Peoples' and was supported by the Public Health Agency of Canada, the CIHR Institute of Aboriginal Peoples' Health and the First Nations and Inuit Health Branch of Health Canada. The funding opportunity was launched in July 2011 with three highly rated projects approved for funding in January 2012.

The Team Grant: HIV Comorbidity competition furthers the work of the CIHR HIV/AIDS Research Initiative on its CIHR HIV Comorbidity Research Agenda which had been developed through broad consultation and initiated in 2010–11. This competition, launched in July 2011, will result in significant multi-year investments focused on improving the health of people living with HIV in Canada particularly in the area of HIV and Aging; and HIV, Mental Health and Neurological Conditions. The Comorbidity Research Agenda is supported by a wide range of partners including the Canadian AIDS Society, CATIE, Canadian Treatment Action Council, Canadian Working Group on HIV and Rehabilitation, Mental Health Commission of Canada, Public Health Agency of Canada and several Institutes and initiatives within CIHR.

The research funded under the programs launched in 2011–12 will provide new knowledge to be translated into improved programs, services and treatments for people living with and at risk of HIV in the years to come.

ER 6.2: Increased individual and organizational capacity for HIV and AIDS research through the funding of high-quality capacity-building grants and awards in HIV and AIDS. This outcome is achieved through the ongoing development and administration of strategic research capacity-building funding programs.

RA 6.2: The CIHR HIV/AIDS Research Initiative continues to build research capacity and foster the next generation of HIV/AIDS researchers by providing a range of capacity-building funding opportunities. The following funding opportunities were launched in 2011–12:

• New Investigator Priority Announcement
• Fellowship Priority Announcement (2)
• Doctoral Research Award Priority Announcement
• Community-Based Research (CBR) Master's Awards
• Community-Based Research Doctoral Awards
• Collaborative Centres of HIV/AIDS Community-Based Research

The Collaborative Centres of HIV/AIDS Community-Based Research launched in 2011–12 builds on a 2010 evaluation of the Community-Based Research Program's suite of funding mechanisms. This new funding opportunity was designed to build HIV/AIDS CBR capacity across Canada by enhancing the foundation of existing CBR networks. Funding for the Collaborating Centres begins in 2012–13 and is expected to significantly increase the capacity for HIV/AIDS community-based organizations to conduct their own research focused on Aboriginal and other at risk and priority populations.

In 2011-12, CIHR, with the support of funding from the Federal Initiative, continued to provide funding for a large number of individual training awards as well as for research networks that play an important role in building further capacity for HIV research. For example, since 2009 CIHR has been providing infrastructure funding to two Centres for Research Development in HIV/AIDS in order to mobilize research talent, build capacity and increase the productivity and impact of research. The CIHR Centre for REACH (Research Evidence into Action for Community Health) in HIV/AIDS and the CIHR Social Research Center in HIV/AIDS (SRC) work within networks of researchers, community members and policy makers to foster the national coordination of research efforts in Canada.

ER 6.3: Enable Canadian participation and leadership in HIV/AIDS research in the global context through the funding of internationally focused research projects and partnerships and contributing to relevant FI activities.

RA 6.3: CIHR funds grants and awards focused on HIV/AIDS issues in international settings with investments in both clearly internationally focused projects and projects with a potential impact on the epidemic globally.

ER 6.4: Enhanced engagement and collaboration on approaches to address HIV/AIDS through ongoing participation in FI committees and activities and the development of collaborative activities to address common priorities.

RA 6.4: CIHR continues to actively participate in Federal Initiative committees and activities such as the FI Responsibility Centre Committee, Accountability Working Group and the Consultative Group on Global HIV/AIDS Issues.

In cooperation with Federal Initiative and other partners in HIV research CIHR engaged in a number of collaborative activities in 2011-12. For example:

• In response to the disproportionate incidences of new HIV infections in Aboriginal populations in Saskatchewan, CIHR, in partnership with PHAC and the First Nations and Inuit Health Branch of Health Canada, mobilized efforts to plan an information session outlining sources of research funding and program support. Based on discussions and linkages made, future activities in the province are being planned for 2012-13.
• The Public Health Agency of Canada and First Nations and Inuit Health Branch partnered with CIHR on the aforementioned Catalyst Grants: HIV and Aboriginal Health program. The partnership between these organizations helps make certain coordination of federal programs focused on target populations and that funded research is relevant to the needs of affected communities and policy makers.
• CIHR was a partner on the Health Canada led International Policy Dialogue on HIV and Mental Health held in February 2012. The Dialogue brought together experts in the field from governments, international agencies and civil society around the world to discuss challenges, ideas and solutions to the complex issues of HIV and mental health. Among other things, the Dialogue identified a number of key next steps for furthering work and addressing needs in the field. CIHR contributed both financial and human resources to the event.

Demandes de contrôle judiciaire concernant les demandes d'ordonnance d'interdiction relatives à l'article 6 du Règlement sur les médicaments brevetés (avis de conformité) - Résumé au 31 mars 2017

Comments on Variance: $0.3M was transferred in-year from CSCs global public health budget to cover deficit in salary dollars, related to changes in classification and payment of salary increments since original submission and budget allocation.

Expected Results and Results Achieved:

ER 7.1: Increased knowledge and awareness of the nature of HIV and AIDS and ways to address the disease, as indicated by the percentage of federal offenders who indicate improved general knowledge of HIV and AIDS after attending CSC's Peer Education Course (PEC).

RA 7.1: In 2011–12, 215 inmates attended PEC training, including 11 (5%) female offenders. More than 95% of the PEC trainees had an improvement in knowledge score following the program, which went from a pre-training average score of 41/50 to a post-training score of 48/50. An additional indicator of inmate knowledge and awareness of HIV and AIDS is participation in the Reception Awareness Program (RAP), which contains general information on infectious diseases and health services within CSC and is offered to all newly-admitted inmates. In 2011–12, a total of 3,072 inmates attended RAP.

A key indicator of HIV prevention and control activity in CSC is testing and screening. CSC offers informed voluntary screening and testing for HIV both on admission and regularly throughout incarceration. In 2011–12, over 6,200 inmates were tested for HIV while incarcerated at CSC.

ER 7.2: Enhanced engagement and collaboration on approaches to address HIV and AIDS through the Federal/Provincial/Territorial Heads of Corrections Working Group on Health. The emphasis will be on developing and strengthening partnerships with: provincial and territorial governments involved in addressing HIV/AIDS and sexually transmitted and blood borne infections; federal departments at national and regional levels (e.g., PHAC, First Nations and Inuit Health Branch of Health Canada); and the Council of Chief Medical Officers of Health.

RA 7.2: An in-person meeting of the Federal/Provincial/Territorial Heads of Corrections Working Group on Health developed a work plan outlining the priorities of the working group for 2011–12. The Community Consultation Committee held two in-person meetings and continued to collaborate on emergent issues related to HIV and AIDS and the Federal prison population.

Results to be Achieved by Non-Federal Partners (if Applicable): N/A

Contact Information:

Stephanie Mehta
100 Eglantine Drive
Ottawa, ON K1A 0K9
613-954-4502
stephanie.mehta@phac-aspc.gc.ca

Preparedness for Avian and Pandemic Influenza

Name of Horizontal Initiative: Preparedness for Avian and Pandemic Influenza Initiative

Name of Lead Department(s): Public Health Agency of Canada (the Agency)

Lead Department Program Activities:

• Public Health Preparedness and Capacity
• Disease and Injury Prevention and Mitigation
• Surveillance and Population Health Assessment
• Science and Technology for Public Health
• Regulatory Enforcement and Emergency Response

Start Date of the Horizontal Initiative: June 21, 2006

End Date of the Horizontal Initiative: Ongoing

Total Federal Funding Allocation (Start to End Date): Ongoing

Description of the Horizontal Initiative (Including Funding Agreement): This initiative is directed at mitigating Canada's risk from two major, inter-related animal and public health threats: the potential spread of avian influenza (AI) virus (i.e., H5N1) to wild birds and domestic fowl in Canada; and, the potential for a human-adapted strain to arise resulting in human-to-human transmission potentially triggering a human influenza pandemic. A coordinated and comprehensive plan to address both avian and pandemic influenza is maintained.

The bulk of the initiative is ongoing. Activities have been launched in the areas of vaccines and antivirals, surge capacity, prevention and early warning, emergency preparedness, critical science and regulation, risk communication, and inter-jurisdictional collaboration. To enhance the federal capacity to address an on-reserve pandemic, efforts have been made to increase surveillance and risk assessment capacity to fill gaps in planning and preparedness.

Shared Outcome(s):

Immediate Outcomes

• Strengthened Canadian capacity to prevent and respond to pandemics; and
• Increased internal and external awareness, knowledge and engagement with stakeholders.

Intermediate Outcomes

• Increased prevention, preparedness and control of challenges and emergencies related to AI/PI; and
• Strengthened public health capacity.

Long-Term Outcomes

• Increased/reinforced public confidence in Canada's public health system; and
• Minimization of serious illness, overall deaths, and societal disruption as a result of an influenza pandemic.

Governance Structure(s): In January 2008, the Agency, the Canadian Institutes of Health Research, the Canadian Food Inspection Agency and Health Canada finalized the Avian and Pandemic Influenza Preparedness Interdepartmental/Agency Governance Agreement. The primary scope of the Agreement is the management of specific horizontal issues and/or initiatives relating to avian and pandemic influenza preparedness.

The Agreement is supported by a structure that falls within the auspices of the Deputy Minister's Committee on Avian and Pandemic Influenza Planning. Implementation of the Agreement is led by the Avian and Pandemic Influenza Assistant Deputy Ministers (API ADM) Governance Committee focusing on implementation of the initiatives. The API ADM Governance Committee provides strategic direction and oversight monitoring.

An Avian and Pandemic Influenza Operations Directors General Committee supports the API ADM Governance Committee, makes recommendations to it and oversees the coordination of deliverables.

Performance Highlights: The agency worked collaboratively with its federal partners (Health Canada, the Canadian Institutes for Health Research and the Canadian Food Inspection Agency) to expand activities in avian and pandemic influenza preparedness. This was accomplished through:

• working with certain provinces for pilot projects on vaccine safety best practices;
• participating in working group meetings under the Public Health Network;
• informing the renewal of the Canadian Pandemic Influenza Plan;
• putting pandemic vaccine contracts in place;
• developing of pandemic influenza models to support decision-making surrounding the renewal of the National Antiviral Stockpile; and,
• addressing a long-term strategy for the National Antiviral Stockpile through an existing Interjurisdictional Health Surge Capacity Task Group.

The Agency has also updated current internal strategies to address the H1N1 Lessons Learned.

Demandes de contrôle judiciaire concernant les demandes d'ordonnance d'interdiction relatives à l'article 6 du Règlement sur les médicaments brevetés (avis de conformité) - Résumé au 31 mars 2017

Note: Total Agency planned spending reflects adjustments made to federal funding allocation due to Strategic Review, Expenditure Review Committee, and corporate reductions as well as internal reallocations.

Comments on Variance: Variance to Planned Spending due to increase in spending for Vaccine Readiness under new contract.

Expected Results and Results Achieved:

ER 1.1: Progress made on the development of different clinical-grade commercial H5N1 influenza vaccines.

RA 1.1: The universal influenza vaccine is moving to the first phase of clinical trials in the summer of 2012.

ER 2.1: Construction of the new lab is 60% completed, therefore increased research capacity underway.

RA 2.1: The lab is 60% completed and expected to be ready for occupancy in spring 2013.

ER 3.1: Capacity to rapidly identify and report human cases of avian and pandemic influenza and public health events of international concern is improved though the revamping of the current severe respiratory illness early detection system which includes a pilot study on the Intensive Care Unit (ICU) reporting system.

RA 3.1: A Pilot Study to Ascertain the Use of Intensive Care Units (ICU's) as an Option for the Surveillance of Severe Respiratory Illness (SRI) in Canada was designed and is on schedule to begin in the 2012–13 influenza season.

ER 4.1: Capacity for vaccine-adverse event surveillance and effectiveness monitoring during a pandemic is improved through upgrades to the current Canadian Adverse Events Following Immunization Surveillance System (CAEFISS) database to ensure maximum functionality.

RA 4.1: Two Memoranda of Agreement (MOA) were signed with British Columbia as well as Manitoba for pilot projects on Vaccine safety best practices within provincial jurisdictions. These agreements enable the provinces to operationalize the key National Immunization Strategy (NIS) priorities related to vaccine adverse event monitoring and management. The projects were initiated in 2011 and are ongoing at least through end of fiscal 2012–13. A key NIS priority was to have dedicated staff within the region to coordinate vaccine safety surveillance and this is a key component of the MOAs. A key outcome of the projects is to define feasible and sustainable mechanisms to meet the NIS priorities for vaccine safety within jurisdictions.

ER 5.1: Capacity for increased use of the regional communication systems is improved through the regional Public Health Capacity program.

RA 5.1: Regional Communications Network capacity has improved by having participated in the Public Health Network (PHN) Communications Working Group face-to-face meeting, including a half-day Emergency Risk Communications Exercise; meeting with national PHAC Crisis and Emergency Communications representatives to share updates; sharing best practices from regional experiences (e.g., G8 and G20 in Ont.); participating in cross-border committees and regional emergency communications network committees.

ER 6.1: Response mechanisms are established to respond to an avian or pandemic influenza outbreak in accordance with the World Health Organization (WHO) and Canadian Pandemic Influenza Plan (CPIP).

RA 6.1: Multiple activities were undertaken to inform the renewal of the CPIP post-H1N1, including the establishment of an expert task group by the Public Health Network Council to provide technical and scientific oversight of the CPIP Renewal. Pandemic vaccine contracts were also put into place to enable Canada's rapid access to a Canadian-produced pandemic vaccine for all Canadians. And, a reassessment of Canada's national antiviral strategy was initiated to consider updated evidence-based scientific recommendations and sustainable and cost-effective strategies procurement and management strategies.

ER 6.2: The National Microbiology Laboratory (NML) is capable of working with certified influenza strains as the lead influenza reference centre for Canada.

RA 6.2: Each province continues to maintain at least one laboratory capable of working with influenza strains. Twenty-three labs are currently participating in the NML influenza virus proficiency testing program and twenty-two labs are currently participating in the NML's influenza polymerase chain reaction proficiency panel.

ER 6.3: Quarantine entry and exit screening options are developed and assessed for use during all phases of a pandemic.

RA 6.3: Marine training was provided to quarantine officers to enhance their preparedness and response to marine related incidents. Quarantine Services participated in the development of the Migrant Vessel Emergency Response and Preparedness plan, for the Atlantic regions, which includes the roles and responsibilities of the Quarantine Service. This plan is to be exercised in Sydney, Nova Scotia in May 2012, in which Quarantine Services will participate.

ER 6.4: The Health Portfolio Emergency Operations Centre is maintained in a state of readiness.

RA 6.4: The National Emergency Stockpile System (NESS) continues to enable an ability to respond 24/7 as it maintains an on-call schedule.

The Pharmaceutical & Therapeutics Committee along with subject matter experts continued evidence-based decision making in order to strategically renew and modernize NESS assets. The newly created Strategic Asset Management Tool informs acquisition/disposal of assets by providing cost benefit analysis.

ER 6.5: Incident response plans are maintained with P/T departments and non-governmental organizations through testing exercises where the testing criteria are established on lessons learned and through the after action reports and plans which are revised, updated and maintained regularly.

RA 6.5: The Canadian Pandemic Influenza Plan is currently under review/revision. The plan and pandemic preparedness are to be the health portfolio main priority for exercises for year 2013–14.

ER 6.6: Increased efficiency and effectiveness of regional resources placed to facilitate the flow of information between F/P/T levels through the regional public health capacity program.

RA 6.6: The information flow between F/P/T levels continued to be more efficient and effective by having staff and resources placed in Regional Offices working in collaboration with health portfolio partners, other federal departments, the P/Ts and other stakeholders. This facilitated collaboration through a common understanding of priorities—both individual and shared—and rapid two-way dissemination of information to health partners and the public in the event of a pandemic. It also made sure decision-makers are well informed of national-regional developments.

ER 7.1: An updated Human Resources Emergency Response Plan (HR ERP) is implemented by end of fiscal year 2011–12.

RA 7.1: A newly developed framework to update the HR ERP:

• Identifies human resources related event activation gaps and issues and provides corresponding recommendations;
• Outlines and refines the human resources related steps, processes and tools associated with emergency event activations, particularly pertaining to surge capacity; and
• Provides an action plan outlining Framework implementation steps to take place during 2012–13;

The Agency will continue to work with their key clients to update the action plan and validate the Framework during the second quarter of 2012–13, and move towards implementation by the end 2012–13.

ER 8.1: The current number of equipped and trained federal laboratory liaison technicians in place in P/Ts will be maintained.

RA 8.1: The Laboratory Liaison Technical Officer (LLTO) program built public health capacity by providing federally-funded laboratory personnel hosted in provincial public health jurisdictions. LLTOs are dedicated to enhancing pandemic influenza and outbreak preparedness and response by strengthening inter-jurisdictional communication and collaboration, and supporting provincial participation in key national laboratory-based surveillance and microbiology reference service programs and initiatives. Currently, LLTOs are located in six provincial jurisdictions (BC, SK, MB, ON, NB, NL).

ER 8.2: Communications between P/T labs and the NML is improved thereby strengthening the national lab's capacity through a series of meetings throughout the year.

RA 8.2: The Canadian Public Health Laboratory Network (CPHLN) coordinated monthly teleconferences and an annual meeting of federal and provincial public health laboratory representatives to foster national laboratory preparedness and response. The Laboratory Liaison Technical Officers (LLTOs) continued to support communication of information and data between provincial public health laboratories and the NML.

ER 8.3: Components of the Canadian Pandemic Influenza Plan's (CPIP) Annex C (Pandemic Influenza Laboratory Guidelines) are updated as a result of the H1N1 pandemic.

RA 8.3: Annex C of the CPIP was updated post-H1N1. In addition, a CPIP Task Group under the Public Health Network Council was established and will oversee further revisions to the Main Body and annexes.

ER 9.1: Research resources are optimally allocated through proactive research protocols and international collaboration to respond to the needs of avian and pandemic influenza preparedness.

RA 9.1: In its third year of operation, the PHAC/CIHR (Canadian Institutes of Health Research) Influenza Response Network (PCIRN) continued to deliver valuable relevant research related to: Rapid Vaccine Trials; Rapid Program Implementation; Vaccine Coverage; Vaccine Safety; Vaccine Effectiveness; Laboratory Support; Information Technology Support; and Curriculum and Knowledge Translation.

In December 2011, the funding agreement was extended for this Network.

The Agency transferred funds to CIHR to fund work with outcomes generalizable to the pandemic preparedness program. The Capacity for Pandemic Preparedness Grants and Contributions Program funded the Canadian Critical Care Trials Group to develop rapid response research protocols as well as a risk factor database and clinical trial protocols for treatment effectiveness.

ER 10.1: Predictive and assessment models used for pandemic preparedness are developed and established.

RA 10.1: Pandemic influenza models have been developed to support decision-making regarding the renewal of the National Antiviral Stockpile, and the impact of demographic variables on the transmission of pandemic influenza in remote and isolated communities. More specifically, a dynamic, compartment model for pandemic influenza in Canada is structured by age and underlying chronic health conditions to calculate the potential demand for antivirals to treat persons with pandemic influenza infections under a wide-range of scenarios that explicitly incorporate variability in transmission dynamics, disease severity, and intervention strategies. Current and future work will also include new statistical models and methods in the risk assessment framework with respect to emerging pandemics.

ER 10.2: More potential learners in university and college settings are being trained as mathematical modellers to augment public health capacity in mathematical modeling.

RA 10.2: Significant training of both students and existing public health professionals has occurred over the course of 2011–12. In particular, two graduate (master's level) students were supervised by Agency staff and participated in the development of the dynamic models as illustrated in RA 10.1. One graduated in 2011–12 and was recruited by the Agency as an in-house expert working on pandemic preparedness projects.

ER 11.1: Evaluation improvements proposed in the Evaluation Plan for avian and pandemic influenza preparedness are implemented.

RA 11.1: Evaluation Services produced three reviews that provided evidence for future evaluative activities on avian and pandemic influenza preparedness. They are the:

• Lessons Learned Review: Public Health Agency of Canada and Health Canada Response to the 2009 H1N1 Pandemic;
• Evaluation of the National Emergency Stockpile System; and
• Evaluation of the grant and contribution components of the Avian and Pandemic Influenza Preparedness Initiative.

Progress on Management Response and Action Plans (for H1N1) will be monitored by the PHAC Evaluation Committee until all commitments have been addressed. Expected timelines for implementation of specific management responses are specified in the Plans.

ER 11.2: Components of the performance measurement framework are in place at the responsibility-centre level.

RA 11.2: The Performance Measurement Framework that exists will be revised in the upcoming year to align with current activities being undertaken.

ER 11.3: Performance data and evidence are collected using a Web-based system and are used for management and reporting.

RA 11.3: Performance data and evidence have been collected, and will be undergo an analysis in the next year to make certain it's used as a basis for management and reporting.

ER 12.1: Social marketing plans and activities are reviewed and appropriate modifications have been made in light of the H1N1 experience.

RA 12.1: Similar to 2010–11, a seasonal influenza campaign was launched to reinforce the infection prevention behaviours learned during the H1N1 campaign and subsequent national influenza campaign. The H1N1 Preparedness Guide was re-purposed for seasonal influenza as Your Seasonal Flu Guide. The Guide provides Canadians with information on protecting themselves from the virus. It was promoted and distributed through various channels, including Service Canada. Other social marketing activities included ads on buses, search engine marketing and a continued partnership with the Weather Network.

The PHN Social Marketing Working Group exchanged best practices and aligned approaches, where appropriate.

ER 12.2: H1N1 lessons learned in communicating with stakeholders during a pandemic influenza are addressed.

RA 12.2: The PHAC Pandemic Influenza Risk Communications Strategy has been revised to address the H1N1 Lessons Learned.

Activities in 2011–12 include:

1. Establishment of a Communications Network with Non-governmental Organizations to facilitate the exchange of information and coordination of communications activities during a national public health event;
2. Literature review on perceptions and behavioural changes during H1N1; and
3. Literature review on communicating with vulnerable populations during a public health emergency (review focused on new Canadians and the homeless).

ER 13.1: Letters of Agreement with selected placement sites for public health officers across the country are completed.

RA 13.1: All 21 Letters of Agreement and two assignment agreements were completed for placement sites that were active during 2011–12.

ER 13.2: Public health officers and Canadian Public Health Service regional coordinators are in place across Canada.

RA 13.2: CPHS Regional Coordinators continue to provide on-the-ground support to the Regional Office, while providing a pan-regional coordination and support to the National Centre.

ER 13.3: Training modules continue to be developed, and new and existing modules are made available to public health officers in the field.

RA 13.3: 22 Public Health Officers (PHO) attended Field Service Training Institute (FSTI) 2011 in Vancouver and selected courses from among the 28 modules created for the event. Additional training for PHOs was approved as was specifically relevant to site or PHO career-development requirements.

ER 13.4: Competency profiles for public health officers are developed.

RA 13.4: Given the variety of site requirements through the program, the development of standardized competency profiles for PHOs was not deemed to be useful. Rather, competency requirements are addressed through particular attention to the completion of detailed work descriptions prior to 2011–12, six-monthly PHO work reviews, and focussed discussions with PHOs in the completion of the annual performance plans. Through this process, both the learning requirements specific to the PHO interest area, and those related to pandemic preparedness and response are managed.

ER 14.1: Lead time on an outbreak of a pandemic is improved through information sharing, international collaborations and increased surveillance systems.

RA 14.1: PHAC took the lead to host the first global influenza seroepidemiolgy experts meeting in February 2011 and also participated in a follow-up meeting that took place in Stockholm, Sweden in December 2011. This international surveillance collaboration aimed at closing the surveillance gaps identified during the 2009 A(H1N1) pandemic where seroepidemiological data and analyses were not readily available in a timely manner for public health action and policy. The first meeting hosted by PHAC culminated in a peer-reviewed publication titled "Influenza serological studies to inform public health actions: best practices to optimise timing, quality and reporting".

ER 14.2: Pandemic vaccine availability is improved by optimizing the approval processes.

RA 14.2: PHAC worked in close collaboration with Health Canada on the development of new regulations for Extraordinary Use New Drugs, which will allow for expedited approval of vaccines and other drugs in the event of a pandemic. These regulations came into force in 2011–2012.

ER 14.3: The National Antiviral Stockpile is maintained and plans are established for the replacement of antiviral stocks as they reach the end of their shelf-life.

RA 14.3: The Government of Canada has made funding available to support provinces and territories in maintaining their National Antiviral Stockpiles. Further considerations for the long term sustainability of the National Antiviral Stockpiles are under review by the Public Health Network.

Demandes de contrôle judiciaire concernant les demandes d'ordonnance d'interdiction relatives à l'article 6 du Règlement sur les médicaments brevetés (avis de conformité) - Résumé au 31 mars 2017

Comments on Variance: The underspending of $0.2M was due to the inability to fully staff and the lack of need for additional resources in the absence of a pandemic.

Expected Results and Results Achieved:

ER 15.1: World Health Organization (WHO) Guidance on Regulatory Preparedness for Human Pandemic Influenza Vaccines is revised and updated as required.

RA 15.1: No revisions were mandated by WHO in 2011–2102.

ER 15.2: Finalize Extraordinary Use New Drugs (EUND) regulations and develop accompanying guidance document.

RA 15.2: The Extraordinary Use New Drugs Regulations (EUND) were implemented April 1, 2011 and a draft guidance document was prepared.

ER 15.3: Maintain links established with international regulatory bodies (WHO, Chinese State Food and Drug Administration, United States, Europe, Australia) by continuing to participate in regulatory and technical initiatives which increase the timeliness and availability of information in the event of a pandemic (i.e., pandemic influenza strain).

RA 15.3: Work continued on a joint research project with the Chinese State Food and Drug Administration and significant collaboration occurred with WHO and the United States Department of Health and Human Services (HHS) on future regulatory preparedness initiatives. Health Canada participated in two WHO/HHS co-sponsored international meetings on pandemic preparedness in Sao Paulo, Brazil (June 2011) and Capetown, South Africa (December 2011).

ER 15.4: Review response to the H1N1 events and produce and implement lessons learned.

RA 15.4: The implementation of the EUND Regulations on April 1, 2011, finalized Health Canada's response to the pandemic lessons learned.

ER 15.5: Continue coordinating blood system preparedness through regular teleconferences and regulatory advice/decisions to Canadian Blood Services and Headquarters. Share lessons learned and better practices with WHO Blood Regulators Network.

RA 15.5: Quarterly meetings were held with the blood operators to discuss issues including emergency preparedness. New regulatory provisions to allow for the importation of blood in an emergency such as a pandemic were drafted and published in March 2012.

Health Canada continues to participate in the WHO Blood Regulators Network and led the development of a self-assessment tool for blood regulators which was presented to the WHO's Expert Advisory Committee on Biologics Standardization in October 2011.

ER 15.6: Work with the WHO to develop recommendations for new pneumococcal conjugate vaccine through the WHO Expert Committee on Biologic Standardization.

RA 15.6: Work on this item was completed in 2010.

ER 16.1: Complete review of any anti-viral submissions that may be received.

RA 16.1: The assessment of influenza antiviral submissions was received and completed. These included labelling and information updates in the form of four Notifiable Change submissions and an application for Clinical Trial Authorization.

ER 16.2: Finalize Expedited Pandemic Influenza Drug Review (EPIDR) Protocol, incorporating H1N1 pandemic experiences.

RA 16.2: The final version of the EPIDR Protocol is under evaluation. Competing priorities and limited resources have resulted in the delay of finalization of the protocol. Finalization is now planned for the end of fiscal year 2012-13.

ER 16.3: Ongoing on-the-job reviewer training for the accelerated review. Review procedures for antivirals submissions, before and during pandemic occurrences are established.

RA 16.3: On-the-job reviewer training is ongoing. Staff participate in various pandemic preparedness workgroups as required, to provide clinical and regulatory guidance to health portfolio partners.

ER 17.1: Maintenance of the crisis risk management unit.

RA 17.1: A crisis management plan has been developed and is in place in the event of a pandemic.

ER 17.2: Ongoing post-market assessment of therapeutic products.

RA 17.2: Surveillance of preventative and therapeutic products that may be used in the case of an influenza pandemic was ongoing in 2011-12.

ER 18.1: Educational initiatives regarding passenger conveyance of infection control are integrated into program activities, training and outreach to conveyance operators.

RA 18.1: A Flight Attendant Food Safety Training" program was developed for delivery to Canadian airlines. This outreach activity is intended to address food safety risks onboard aircraft as part of a risk-based approach to public health on conveyances. The program was delivered by Health Canada to five Canadian airlines

A communique to the motor industry was distributed, with an educational brochure entitled "Environmental Health Guidance for Motor Coach Companies and Drivers", supporting the risk-based approach for this sector.

ER 18.2: Collaborate with PHAC, the Public Service Commission, and Indian and Northern Affairs Commission for planning and response.

RA 18.2: Health Canada's FNIHB's national and regional Communicable Disease Emergencies' (CDE) staff continues to work closely with federal, provincial, regional and First Nations' partners to make sure that the needs of First Nation communities are well integrated into pandemic planning activities.

FNIHB's CDE team participated in meetings related to the review process of the Canadian Pandemic Influenza Plan for the Health Sector (CPIP). The CDE team acts as the technical lead for Annex B of the CPIP, Influenza Pandemic Planning Considerations in On-Reserve First Nations.

The national CDE team has regular meetings with AANDC to consolidate efforts to help communities integrate their community-level pandemic plans into the community all-hazards emergency plans to support planning, response and resource utilization.

ER 18.3: Work on surveillance needs with PHAC.

RA 18.3: FNIHB participated in the Canadian Immunization Registry Network where issues such as First Nations Identifiers are discussed.

ER 18.4: Enhanced federal capacity to support First Nations communities in planning and responding to a pandemic.

RA 18.4: FNIHB's CDE team provided input into the Proposed Governance Structure for Pandemic Influenza during Response Time, tabled at PPOC and PHNC.

FNIHB's CDE team participated in the Health Portfolio Public Health Risk Assessment to make sure that the needs of First Nation communities are well integrated into overall emergency management planning activities.

FNIHB's CDE team is a member of the F/P/T Inter-Jurisdictional Sharing of Health Professional Task Group, with a mandate to develop and implement an Operational Framework, based on the F/P/T MOU on Mutual Aid, to facilitate the movement of health professionals between jurisdictions during a public health emergency.

ER 18.5: Increase links with national and regional Emergency Preparedness and Response program staff and with provinces and territories.

RA 18.5: Health Canada's FNIHB CDE team, in collaboration with PHAC, arranged a meeting between the Health Portfolio Emergency Preparedness and Response Coordinators (HP – EPR) and CDE FNIHB Regional Coordinators to clarify roles and responsibilities and to collaborate on related regional emergency preparedness and response activities.

ER 19.1: Continue to support the testing and revision of community pandemic plans.

RA 19.1: The national and regional Communicable Disease Emergencies' staff have developed CDE guidelines, which reflect CDE best practices and H1N1 experiences, to support the development, strengthening, and implementation of CDE plans at the community-level. These guidelines will be disseminated in 2012–13.

The CDE team participated in the revision process of Module 5 – Exercise Builder for First Nations, Inuit and Métis – led by the Public Health Agency of Canada`s Centre for Emergency Preparedness and Response. The module provides planning tools to assist with the design and conduct of s simple influenza tabletop exercise at the community-level. This revised Module will be available in 2012–13.

ER 20.1: Risks to public health on passenger conveyances are mitigated through the development and implementation of emergency preparedness and response policies, programs and training.

RA 20.1: 100% of the new Environmental Health Officers (EHOs) were trained at two quarantine designation training sessions; all EHOs were designated under the Quarantine Act (Two sessions/three EHOs).

Pandemic scenario Table-top Exercise and EPR training session were delivered to five EHOs in Vancouver. A migrant ship scenario table-top exercise and EPR training session delivered to 10 EHOs in St. Johns (two sessions/15 EHOs).

Comments on Variance: None

The original funding allocation for the PHAC/CIHR Influenza Research Network (PCIRN) was slated to end as of March 2012. In late 2011, the Agency and CIHR signed an amendment to the original MOU and as a result, the Agency committed to providing $1.5M per year for the next three years to support PCIRN. This was again to be administered by CIHR. In February, CIHR launched a directed grant Request for Application for the renewal of PCIRN. All funding provided through CIHR must be peer-reviewed; however, the directed grant mechanism enabled CFIA to target this funding opportunity to a specific group. CFIA is currently awaiting the results of the peer-review committee; if approved, PCIRN would receive support from the Government of Canada until March 2015.

Expected Results and Results Achieved:

ER 21.1: Progress on funded projects and outcomes of research are reviewed.

RA 21.1: End of Grant Reports or Progress Reports (for investigators who had obtained an extension to use funds) were requested and collected in March 2012. The key outcomes and achievements identified by researchers in these reports are currently being synthesized into an annual report on the activities and outcomes of the Pandemic Preparedness Strategic Research Initiative (PPSRI). Once finalized this report will be disseminated to all partner organizations, and made publicly available on the CIHR website.

ER 21.2: Uptake of research results is facilitated, and consultations on future research needs are completed through reports and meetings of researchers, stakeholders and decision makers.

RA 21.2: In January 2012, CIHR undertook a medium-term evaluation of the PPSRI. The evaluation examined the initiative design, implementation and delivery, as well as the outcomes and impact of funded projects, and the recommendations of researchers and stakeholders on future research priorities in the field of influenza. A bibliometric analysis to track the publication output of PPSRI investigators and program-specific data through online surveys, key-informant interviews, and case studies were undertaken. Information-gathering activities were completed in March 2012, and preparation of the final report is in progress. As with the annual report, this document will be disseminated to stakeholder organizations and made available to the general public.

Note: Total CFIA planned spending reflects adjustments made to federal funding allocation due to Strategic Review.

Comments on Variance: The CFIA has completed delivering its sixth year of the AI/PI program. As a result, most of the programs activities have become integrated into CFIA's ongoing work. This—combined with the internal reallocation of funds to offset costs for supporting functions—has resulted in a variance between the planned and actual expenditures.

Expected Results and Results Achieved:

ER 22.1: Increased capacity to support enhanced screening procedures for live birds or poultry products at Canada's ports of entry with a view to mitigating the risk of future avian influenza outbreaks in Canada.

RA 22.1: The CFIA and the Canadian Border Services Agency (CBSA) are working together to update the CBSA automated system that supports the Advance Commercial Information (ACI). It is a risk management tool used by CBSA-Targetters at marine ports as well as by Air Cargo Targetters.

ER 23.1: Continuation of stakeholder and general public education, communications and outreach programs in support of the implementation of the National Avian On Farm Biosecurity Standard. Provide stakeholder consultations and develop communication tools to expand education and awareness to the poultry industry service sector.

RA 23.1: Printed copies of both the National Avian On-Farm Biosecurity Standard and the Producer Guide have been distributed, mostly within Canada but requests have also been received from non-Canadian Universities.

CFIA staff engaged in outreach activities related to avian on-farm biosecurity in Ontario, Quebec and British Columbia, in collaboration with their industry and provincial counterparts. In addition, CFIA staff assisted in the revision of World Organisation for Animal Health (OIE) draft Chapters related to avian biosecurity practices.

Biosecurity elements have been included Poultry On-Farm Food Safety program documentation.

A draft Poultry Industry Service Sector Biosecurity Guide was produced after consultation with the multi-stakeholder Avian Biosecurity Advisory Committee. Regional consultation on this draft Guide occurred in Quebec and British Columbia. Further regional consultation will occur, and the document will be finalized in 2012–13.

ER 24.1: No planned expenditures as investments were realized in previous fiscal years.

RA 24.1: NA

ER 25.1: Enhanced/integrated Canadian surveillance system, supported by a robust systems platform and the analysis and interpretation of the data collected to allow more timely identification of potential outbreaks, and more timely response to avian influenza situations. Targeted wild bird surveillance plan for 2011 is currently being reviewed. The Canadian Notifiable Avian Influenza Surveillance System is entering its fourth year of operations, providing a real time relay of sampling and reporting of flock status through the National Centre for Foreign Animal Disease.

RA 25.1: CFIA continued diagnostic support associated with the Inter-Agency Wild Bird Survey for influenza A viruses. This included further characterizing specimens that the Network Laboratories have identified as H5 and/or H7 positive as determined by real-time RT-PCR assay. In 2011 CFIA characterized an H7N3 virus isolated from a mallard captured in a bait trap in Chaplin Lake, Saskatchewan and an H7N7 virus isolated from a mallard captured in a bait trap in Jackfish Lake, Manitoba (H5 and H7 variants of AI are of significance due to their potential to be highly pathogenic).

CanNAISS continued operations this year, with a total of 627 chicken and turkey farms actively sampled and incorporating an additional 18,000 voluntary enhanced surveillance samples from 45 breeding flocks. Monthly progress reports were prepared and distributed to stakeholders. A comprehensive report on CanNAISS for 2010 and for 2011, containing program description, analysis of data and interpretation of results, is in the final review process.

ER 26.1: Initiatives to strengthen regulatory capacity during outbreaks, including a review and analysis of current legislative/regulatory framework continues.

RA 26.1: In 2011–12, the regulatory framework for reportable diseases was updated to change highly pathogenic avian influenza to highly pathogenic avian influenza and low pathogenicity H5 and H7 referred to as notifiable AI to reflect the current international nomenclature and subtypes of concern.

Compensation maximums for animals ordered destroyed were adjusted to reflect market realities.

ER 27.1: Management and evaluation of CFIA's AI activities, including ongoing performance measurement to monitor results.

RA 27.1: The AI Oversight Committee and Animal Health Business Line continue to update/modify the performance measurement strategy and present to the external evaluation committee.

In response to the 2010 Fall Report of the Auditor General of Canada, Chapter 9 - Animal Diseases, the Notifiable Avian Influenza Hazard Specific Plan (NAIHSP) has been updated (see emergency response plan section for more details).

ER 28.1: Continued implementation of the "Be Aware and Declare" international border biosecurity outreach campaign. Ongoing media monitoring and training and risk communications related to AI prevention, preparedness and response activities.

RA 28.1: Through the "Be Aware and Declare!" outreach campaign, the CFIA maintained partnerships with 21 international airlines that either broadcast the "Be Aware and Declare!" public service announcement or distributed brochures to passengers on flights to Canada.

Under the umbrella of the broader animal health awareness campaign, information was shared with key stakeholders, such as producers and industry associations, via calendars, brochures, news releases, posters, public notices and face-to-face interactions.

Media monitoring and risk communications related to AI prevention, preparedness and response activities also continued.

ER 29.1: Continued training that will contribute to a skilled and experienced workforce ready to respond to an AI outbreak. A national training initiative for avian influenza response in three core areas is scheduled for the winter of 2011.

RA 29.1: Cold Weather Field Trial - Bio-containment, Cleaning and Disinfecting (C&D), and Logistics Working Groups (Generic Training) - November 20-25, 2011. CFIA inspection staff participated in the field trial to get on hands experience to perform extensive C&D, and bio-containment.

ER 29.2: Continued development of training materials (instructor-led and e-learning) in support of emergency response procedures and plans and of trainers in support of end-user training.

RA 29.2: Internal Avian Sampling Field Exercise, Oshawa, ON, June, 2011

The scenario encompassed the activities CFIA Animal Health staff undertook in responding to a premises under suspicion of disease, as indicated in the Animal Health Functional Plan. During the exercise, staff established premises zoning for bio-containment; practised donning and doffing of personal protective equipment; and collected samples from suspect premises.

CFIA continued training that contributed to a skilled and experienced workforce ready to respond to an AI outbreak. The Operations Emergency Planning and Preparedness project (OEPP) is currently developing a deployment strategy which will include EOC and safety orientation for responders. ICS- in 2011 training was delivered to staff at the National level upon request. In 2012 an e-leaning ICS will be available on line. A fit testing / poultry handling drill was held in March 2012. Western Area is implementing processes to document and track 1) fit testing, 2) ER training, and 3) ER personnel inventory. CFIA completed several exercises and drills based on NAI scenarios in the Western Area. The Objectives of the exercises varied but included AI first responder procedures, biosecurity, donning and doffing, surge capacity (Canadian Veterinary Reserve).

ER 30.1: A multi-disease version for the Canadian Emergency Management Response System (CEMRS) application for national surveillance/outbreak use will be available. Translation of CEMRS is currently underway. CEMRS is now used routinely for outbreak document management.

RA 30.1: Translation of the Canadian Emergency Management Response System (CEMRS) was completed and the bilingual version tested. CEMRS Super User training is scheduled for fall 2012.

ER 31.1: Continued development and updating of emergency response procedures and plans.

RA 31.1: CFIA continued with the development and updating of emergency response plans and procedures. The CFIA Emergency Response Plan, the Animal Health Functional Plan and the National Logistics Emergency Response Plan are being revised to reflect that an occupational health and safety advisor position be located at an incident command level for all suspected zoonotic outbreaks. The roles and responsibilities are being reviewed and adjustments will be made to plans accordingly.

The Notifiable AI Hazard specific plan (NAIHSP) was completed November 2011, including the Appendix M (movement outbreak situation) which was subject to a large consultation with industry, Chief Veterinary Officers, CFIA staff and poultry practitioners (see performance and evaluation program above).

The Animal Health Working Groups have been provided with project management and other resources in order to complete any outstanding essential procedures for emergency response. Training material will be developed for these procedures and incorporated into field training and exercises for the purpose of validating these procedures. A nationally coordinated and evaluated approach to the conducting of emergency training events is under development.

ER 32.1: Continued development of models to better understand the influence and interaction of various factors on the spread of AI and the effectiveness of the various methods used to control and eradicate the disease. A retrospective analysis of the data arising from the 2004 AI outbreak in Abbottsford, BC, is coming to completion after five years' work. There will be several publications in 2011 describing the key risk factors affecting disease transmission of AI.

RA 32.1: First drafts of a descriptive study and an epidemic process study have been completed for the 2004 AI outbreak in Abbotsford, BC. An additional three papers are pending completion.

From January 2011 to March 2012: 5 risk assessments and scientific advice were completed on AI risk issues, including those related to importation of live birds from various AI-infected countries, and those related to the importation of animal product that might contain the AI virus.

ER 33.1: Investment through research in an improved federal capacity for control, risk assessment, diagnostics and vaccines on avian influenza issues will allow a better understanding of the spread of influenza and the effectiveness of disease control measures. These investments will allow more timely and evidence-based decision-making on avian influenza responses, helping to reducing the risk of transmission to humans and mitigating economic and production losses.

RA 33.1: Research efforts aimed at improving surveillance capabilities include the development of a suspension microarray based on Luminex technology that will enable the multiplex detection of antibodies to various influenza A virus antigens (H5, H7, NP, N1, N2, etc.). CFIA collaborated with Lethbridge on a Defence Research and Development Canada's Chemical, Biological, Radiological, Nuclear and Explosives (CBRNE) Research and Technology Initiative (CRTI) supported project aimed at developing an electronic microarray able to detect viral genes for all 16 hemagglutinin subtypes and all nine neuraminidase subtypes. This technology will prove useful in detecting mixed infections in either poultry or wild bird samples. Other research efforts include work on the development of a diagnostic test to be used to be able to differentiate infected from vaccinated animals; the molecular basis of avian influenza virulence affecting adaptation from natural reservoirs to domestic poultry; immune response of turkeys to specific strains of the avian influenza virus; and development of an in vitro test for the evaluation of the potency of an avian influenza DNA vaccine for chickens.

ER 34.1: CFIA staff continue to provide assistance to the World Organisation for Animal Health (OIE) Central Bureau in the Communications Department in an effort to promote the development and implementation of science based standards. Furthermore, the CFIA continues to support the OIE's mandate and efforts to assist member countries in the control and eradication of animal diseases, including zoonotics, through its annual contribution to the OIE. In addition, the CFIA continues to support the development of capacity to address emergence of risk at the animal level through the Canadian chapter of Veterinarians Without Borders.

RA 34.1: The CFIA continued to be active internationally. For example, the North American Plan for Avian Influenza and Pandemic Influenza (NAPAPI) was completed in 2011.

The CFIA engaged Australia, the United States, New Zealand, the United Kingdom, and Ireland to exchange best practices for managing activities such as destruction, disposal, decontamination, and surveillance. Incorporation into CFIA plans and procedures was made where such inclusions added value.

CFIA continued its annual contribution to the OIE, which supports science-based international standard setting for Animal Health which underpins trade in animal products.

CFIA continued to support the Canadian chapter of Veterinarians Without Borders. This organization works with governments, educational institutions, non-governmental organizations, local communities, farmer's groups and international agencies to tackle root-cause issues affecting public health, animal health and ecosystem health in developing communities around the world.

ER 35.1: Future AI vaccines will be purchased on an "as needed" basis.

RA 35.1: NA

ER 36.1: Maintenance of access protocols and bank of antivirals to provide appropriate protection to federal employees, enabling a more timely and effective response to an avian influenza situation and better protection of Canadians.

RA 36.1: The CFIA continued to have access to the antiviral based on the Memorandum of Understanding with the Agency.

ER 37.1: No planned expenditures as investments realized in previous fiscal years.

RA 37.1: NA

ER 38.1: Maintaining, coordinating and managing the Canadian Animal Health Surveillance Network, an integrated network of federal, provincial and university labs. This network allows for rapid testing, detection and reporting of AI.

RA 38.1: CFIA continues to improve its ability to characterize influenza A virus isolates through whole genome sequencing and phylogenetic analysis. Examples for 2011 include the analysis of swine origin H3N2 viruses and a wild bird origin H10N8 virus. Both submissions were associated with reproductive problems in turkeys in Ontario.

Plans are underway to improve our sequencing capabilities by acquiring a next generation sequencing platform which will allow CFIA to look viral quasispecies. This is a potentially important capability because it will enable CFIA to look for variants possessing genetic signatures that have been associated with poultry adaptation and virulence within the viral population.

CFIA continues to provide training both on-site and via teleconference to CAHSN laboratories on several diagnostic test protocols. A number of protocols have been revised. Four laboratories have obtained containment certification and five laboratories have achieved ISO 17025 accreditation for specific diagnostic tests.

ER 39.1: Continued development of a viable response plan, including HR capacity and data management tools.

RA 39.1: Case plans are under development for identified gaps in approaches to enabling adequate and efficient sourcing of human and material resources in the event of an emergency need for responders. This includes the development of national strategies for the national stockpile of emergency equipment, the deployment procedure for response staff, and the potential development of specially trained responders in each Area for national deployment.

ER 40.1: Continued training of a reserve of professional veterinarians to enhance surge capacity, expertise and rapid response capability for animal disease control efforts.

RA 40.1: A table-top exercise was completed in February 2012 involving both the Canadian Veterinary Medical Association and the CFIA. The initiative was a success and produced beneficial results which included the simulated call-up and use of Reservists.

Results to be Achieved by Non-Federal Partners (if Applicable): N/A

Contact Information:

Dr. John Spika
130 Colonnade Road
Ottawa ON K1A 0K9

613-948-7929
john.spika@phac-aspc.gc.ca