Health Products and Food Branch Strategic Plan 2007-2012 Achievement Highlights

Health Products and Food Branch Strategic Plan 2007-2012 Lessons Learned and Moving Forward

We made substantial progress in supporting each of the six broad strategies articulated in the Health Products and Food Branch (HPFB) Strategic Plan 2007-2012. Over the last five years, we were faced with high profile situations requiring quick and effective responses, such as the listeriosis outbreak, the H1N1 Pandemic and a medical isotope supply disruption. We clearly demonstrated that we are well positioned to address emerging issues and challenges. We successfully undertook activities to ensure that we remain a modern and responsive regulator, advanced national and international collaboration, and integrated openness and transparency into our day-to-day work.

During this time, we have learned that our future work needs to be driven within the context of a modernized regulatory framework. To address this, the Regulatory Roadmap for Health Products and Food was developed to guide the way as we modernize our regulations and create a solid foundation to address the challenges of today and of the future. We have also learned the importance of taking a critical look at the way we do business to improve our regulatory environment, such as our successful updates to the cost recovery framework and review of performance standards for health products. The need to continue to find efficiencies in our strategies, leveraging our work with partners, both within and outside our borders remains integral to our work. Our experiences have also taught us that the best use and management of our human and financial resources will ultimately facilitate our way forward, especially as we begin the process to implement the federal Deficit Reduction Action Plan in 2012.

Canadians can be confident that our programs for biologic and radiopharmaceutical drugs, food and nutrition, medical devices, pharmaceutical drugs, and natural health products will continue to be strong over the course of the next three years. The planning and reporting associated with each program's activities in the areas of licensing, surveillance, compliance and enforcement, will continue to build momentum as we move forward in collaboration and consultation with Canadians.

The following highlights note our key achievements from 2007 to 2012.

Strategy 1: Adopt a lifecycle approach to regulating health products

• We held stakeholder workshops and technical discussions to validate and refine a lifecycle approach to regulating health products. Our Regulatory Roadmap for Health Products and Food sets the foundation for the implementation of a modernized regulatory framework for products throughout the lifecycle and will be applied to regulatory frameworks, including food, consumer health products (non-prescription), professional use health products (prescription), medical devices and veterinary health products.
• We reviewed the Natural Health Products Regulations in 2006-2007 and implemented the required changes following the development of a discussion paper and stakeholder consultations in 2007.
• In 2007, we developed and implemented new regulations for the safety of cells, tissues and organs for transplantation. The Blood Regulations, under the Authority of the Food and Drugs Act, were published in Canada Gazette Part 1 in 2012.
• We strengthened post-market activities, including surveillance and monitoring of safety and therapeutic effectiveness. Post-market surveillance performance standards were implemented in 2010.
• We worked in collaboration with the Public Health Agency to bring about a change in reporting process to bring vaccines in line with other health products. Vaccine market authorization holders now report serious adverse events that occur in Canada, as well as serious unexpected adverse events that occur outside of Canada to the Canada Vigilance Program.
• We updated a Compliance and Enforcement Risk Evaluation Guide GUI-0091 for health products in 2011. We began a pilot whereby Good Manufacturing Practices inspections are scheduled according to risk prioritization.
• We published guidance documents to clarify product categorization when a product may fit more than one regulatory definition, such as for products at the interface of cosmetics-drugs (2009), food-natural health products (2010); and to clarify new criteria in assessing products such as antiperspirants, diapers and medicated skin care products (2010).
• We cleared the backlog of veterinary drug submissions in March 2009. Review performance for veterinary drug, biologic and medical device submissions was within time targets at the end of March 2011. We established review targets for natural health products that are being met over 95% of the time since August 2010. Review performance for pharmaceutical drugs is internationally comparable with March 2011 performance standards being met for all submission types with the exception of generic pharmaceutical drugs and notifiable changes.
• Between 2007 and 2012, we maintained a backlog-free status for biologics and we introduced a new framework for the authorization of subsequent entry biologics (biosimilars).

Strategy 2: Promote health through a modernized food regulatory system and a proactive approach to nutrition

• We improved the pre-market review process for food and veterinary drugs with the implementation of submission management initiatives including the issuance of updated guidance documents for a streamlined process.
• We developed educational tools as part of the Food and Consumer Safety Action Plan, to maximize the safety and nutritional quality of the Canadian food supply and minimize risks (e.g. e.coli contamination of ground meat, exposure to Trans Fat, etc.). From 2009-2011, we completed regulatory amendments related to enhanced labelling of food allergens, gluten sources and added sulphites as well as to permit the use of 28 new food additives, including the approval of "micocin" to prevent listeria growth in ready-to-use meats. In addition, we have updated our guidelines for analytical methods to ensure greater harmonization with international organizations.
• We implemented the foodborne contaminants initiative of the Government's Chemical Management Plan. Between 2006 and 2011, decisions were published for 187 substances of the 200 highest priority chemicals, with food considerations following risk assessment and risk management processes. We also held expert consultations and developed monitoring programs to reduce risks of Bisphenol A in food packaging and acrylamide formation in food products.
• Based on the first national nutrition survey in over 30 years, we published data on nutrient intakes and eating patterns in 2009. We advanced progress on food and nutrition indicators, data collection methods and reporting; launched Canada's Nutrition and Health Atlas in 2007; and published data on household food insecurity and breastfeeding practices in 2010.
• We informed Canadians about healthy eating with several publications and interactive tools posted on Health Canada's website. In addition to several publications such as Eating Well with Canada's Food Guide and a web-based My Food Guide (2007), we translated Canada's Food Guide into 10 languages (2008) and launched the Eat Well Be Active Toolkit for educators (2010).
• We developed and implemented a strategy for a healthier and safe food supply, in partnership with Agriculture and Agri-Food Canada and the Canadian Food Inspection Agency, including long-term monitoring (e.g. food safety assessments) of the food-to-health pathway (ie. includes all the components that lead from food production and consumption to their impact on the health of Canadians). We are also working with stakeholders on the Growing Forward Regulatory Action Plan aimed to address regulatory challenges to the marketing of safe and innovative food.

Strategy 3: Advance international cooperation and be an international leader

• The increasing pace of technological change and globalisation of health products present opportunities for HPFB to seek and promote harmonized standards and technical requirements, regulatory convergence, reduction of duplication, and increased synergy among the world's regulatory authorities.
• HPFB has established and implemented a Branch strategic framework to focus its approach and fulfil its international cooperation objectives:
  1. Developing and strengthening our regulatory cooperation and work-sharing activities with key counterparts;
  2. Being actively involved in harmonization of international standards/technical requirements, and in regulatory convergence initiatives; and,
  3. Strategically engaging with countries that have developing regulatory systems through capacity building initiatives
• From 2007 to 2012, HPFB has worked to create, enhance, maintain, and develop over thirty-five collaborative arrangements with like-minded foreign regulatory authorities to build a solid foundation for advancing HPFB's international initiatives. This foundation helps HPFB in leveraging resources and information through the formation of strategic networks that promote international cooperation and scientific collaboration. For example, we now accept veterinary new drug submissions in European (European Medicines Agency) or in United States (Food and Drug Administration Center for Veterinary Medicine) format for review. In addition, in the area of nutrition, HPFB has leveraged resources and scientific expertise through collaboration with the United States to establish dietary reference intake values for nutrients.
• HPFB has continued to prioritise work-sharing and regulatory convergence initiatives to enhance Branch regulatory capacity and effectiveness such as the Canada-United States Regulatory Cooperation Council, the Heads of Agency Consortium that includes drug regulatory authorities from Australia, Switzerland and Singapore, International Regulatory Cooperation for Herbal Medicines, the International Generic Drug Regulators Pilot, and other regulatory work-sharing initiatives with foreign partners, such as the European Union and the United States.
• HPFB actively participated with multilateral organizations such as the World Health Organization (WHO), Codex Alimentarius Commission, the Food and Agriculture Organization of the United Nations, Pan American Health Organization, Organization of Economic Cooperation and Development, Asia-Pacific Economic Cooperation, International Medical Devices Regulatory Forum, International Conference on Harmonisation and International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products in order to better align regulatory systems and harmonize standards and technical requirements for food and health products. This contributed to modernizing the Canadian regulatory system and enhancing international collaboration on healthy eating issues of priority to Canada.
• HPFB has strategically engaged countries and organizations that have developing regulatory systems through capacity building initiatives such as the annual HPFB International Regulatory Forum, the Canadian HIV Vaccine Initiative, and the Pan American Network for Drug Regulatory Harmonization.
• In striving to improve the Branch's capacity and performance, HPFB has begun to implement the Use of Foreign Regulatory Information initiative including using foreign reviews, to enhance:
  • the robustness of HPFB regulatory assessment;
  • the efficiency of the review process;
  • Canadians' timely access to safe, effective and high quality health products
• The Branch has worked with the WHO and the laboratories of other National Regulatory Authorities to improve testing methodologies and strengthen the scientific expertise and knowledge, contributing to improving regulatory decision-making and efficiencies.
• Under a Regulatory Cooperation Council initiative to enhance, augment and create mechanisms to foster greater international cooperation and alignment in the implementation and enforcement of regulations, HPFB launched the Common Electronic Submissions Gateway (CESG) project with the United States Food and Drug Administration (FDA). The common gateway is a concrete example of leveraging existing capacity and expertise, as well as the implementation of ongoing mechanisms to align regulatory requirements and avoid unnecessary duplication. The Branch completed a joint CESG Concept-of-Operations, a solution architecture and technology Proof-of-Concept with the FDA.

Strategy 4: Establish strategic partnerships to fulfill our mandate

• We established a Patient and Consumer Participation Pool, to facilitate informed public input in Branch decision-making. We also established or enhanced productive relationships with patient and consumer organizations through an average of ten meetings per year held under our Assistant Deputy Minister Stakeholder Meeting Program.
• We established partnerships to improve the way we collect, assess and disseminate safety and effectiveness information for health products, food and nutrition. In 2008, we partnered with stakeholders to develop and communicate new labelling guidelines on cough and cold products for children. In 2010, we contributed to a multi-departmental initiative on Children's Health and Safety Marketing Campaign to increase awareness of child health issues while showcasing the federal government's expertise. We also began exploring collaboration with Canada Health Infoway to increase awareness of and to encourage more reporting from the public and to improve the quality of adverse event reports.
• In 2008, we participated in the "Be Food Safe" campaign launched by the Canadian Partnership for Consumer Food Safety, involving more than 70 industry, consumer, health and environmental organizations to raise awareness and help reduce the incidence of foodborne illness in Canada.
• Health Canada has effectively reached millions of Canadians in grocery stores, restaurants and pharmacies across the country, thanks to an innovative partnership strategy. Launched in October 2010, Health Canada's Nutrition Facts Education Campaign helps Canadians to make more informed food choices. A partnership with Food & Consumer Products Canada allowed Health Canada to subsequently partner with 34 leading food companies. The shared value for all participating in this partnership was to provide information to consumers on how to best use the Nutrition Facts table tool to make healthy choices.
• We began the Canadian Medical Devices Sentinel Network pilot project in 2009 with 10 healthcare facilities across Canada to report data on adverse events with medical devices. This network was expanded in 2011-2012 to include eight new health care facilities.
• The HPFB's Strategic Science Plan (2009) was distributed to the Canadian Institutes of Health Research, and was used in 2010 to present our science priorities at both the Science Policy Forum of the Professional Institute of the Public Service and at Health Canada's Science Forum.
• We strengthened cooperation with federal-provincial-territorial organizations as well as non-governmental organizations in the health system on a range of issues such as the proposed blood regulations and Health Canada's response to the 2009-2010 medical isotope supply disruption.

Strategy 5: Better integrate transparency, openness and accountability into our day-to-day work

• We implemented a guidance document (2007) on HPFB Advisory Bodies for transparent, open and consistent operations.
• We sought public input (including from Committees such as the Paediatric Expert Advisory Committee) into Health Canada's decisions on issues important to Canadians (e.g. sodium reduction, health claims on food, use of foreign reviews, modernization of food and drug legislation, and food and health product labelling).
• We reviewed 5000 outdated web pages and contributed to the improvement of the Departmental information architecture to enable better access for stakeholders and the general public. Since 2008, we have been posting product monographs on the Departmental website.
• We strengthened our leadership on health and safety issues affecting specific populations for food, nutrition and health products. For example, we completed food safety assessments (e.g. shell eggs) and regulatory amendments for labelling food allergens in pre-packaged foods; and we contributed to broad strategies to help curb childhood obesity and initiatives such as the Integrated Strategy on Healthy Living and Chronic Disease.
• We implemented the standards outlined in the HPFB Policy on Public Input into the Review of Regulated Products and provided opportunities for stakeholders to provide input to the review process through workshops and on-line feedback. Since 2007, we have held approximately 150 public involvement activities annually, employing a series of mechanisms, including advisory bodies, meetings, workshops and social media.
• We are increasingly using innovative platforms to find more collaborative ways to integrate public input in our decision-making using on-line tools such as webinars, webcasts and electronic workbooks to complement traditional methods of gathering feedback.

Strategy 6: Build a nationally-based, flexible organization that can fulfill its mandate and priorities in a changing environment

• We developed an integrated strategy to modernize our information technology systems with Investment Plan projects. An office established in the Resource Management and Operations Directorate in 2011 is overseeing project implementation.
• We built and sustained a highly-skilled, adaptable and motivated workforce through effective recruitment, development and retention strategies. Various recruitment programs were used, including collective staffing pools. Workforce development and retention were enhanced with Directorates actively developing and implementing Health Canada's Biologist (BI) Development Program, and staff training for scientific and core competencies, including exchange programs. We continued to seek feedback from staff and make improvements using consultation tools such as a suggestion box and the Public Service Employee Survey.
• We completed a needs analysis, including options and costs, to increase the Branch laboratory capacity and implemented the Quality Management System in the vaccine and blood product testing laboratories to ensure the quality of testing methods. We are pursuing accreditation for selected laboratory activities in 2012.
• We strengthened the Branch's financial management in 2008 with the implementation of the Budget Management Framework. Parliament approved a new cost recovery framework in 2010 and the updated fee regulations came into force in April 2011. This has brought financial stability to the Branch and positions us to meet our performance standards in key areas.
• We enhanced the Branch's emergency preparedness, including the ability to respond to health threats such as our response to the H1N1 outbreak (2009). We also provided Canadians with access to radiopharmaceuticals during the shortage caused by the shutdown of the reactor at Chalk River and implemented a process to allow the Canadian Red Cross to access medical supplies for humanitarian assistance in global emergencies.
• Through collaboration with federal, provincial and territorial partners, we strengthened regional program delivery. Through an annual joint planning exercise and ongoing bi-weekly meetings, we collaborated with public involvement colleagues in Health Canada's Regions and Programs Branch. Examples include regional consultations and outreach activities on food safety and healthy eating.
• We streamlined our existing Branch governance and established new sub-committees and working groups to support the Branch's strategic and operational priorities. This new governance structure enables integrated decision making and supports efficient management of Branch activities.