Health Products and Food Branch 2004-05 Performance Report - Highlights

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We conduct pre-market regulatory evaluation of health products and food, with a focus on benefit/risk assessment and making process improvements to improve efficiency, effectiveness and responsiveness, while maintaining Health Canada's high safety standards.

Transformed regulatory processes.

A regulatory platform for the 21st century.

Expanded collaboration with international regulatory authorities.

Leveraged national partnerships.

Enhanced health innovation.

Monitoring and Surveillance

Increasing responsiveness to public health issues and greater vigilance of safety and therapeutic effectiveness in real world use.

We collect information on adverse reactions to health products, provide health risk assessments, identify and alert Canadians to health and safety risks and ensure health products meet Canadian and international standards.

Improved risk management and communications as a shared responsibility with stakeholders.

Improved assessments based on research and surveillance.

Enhanced post-market surveillance of safety and therapeutic effectiveness.

Effective compliance and enforcement.

Integrated role in health system.

Authoritative Information

Providing authoritative information for healthy choices and informed decisions by Canadians.

We provide useful, reliable and timely information about the risks and benefits of health products, food and nutrition.

Useful and credible evidence-based information.

Improved public awareness and healthy choices.

Supportive conditions to enable Canadians to make informed and healthy choices.

Strategic and coordinated communications.

Public and Stakeholder Involvement

Improving transparency, openness and accountability to strengthen public trust and stakeholder relationships.

We are improving accountability to Canadians through enhanced stakeholder and public involvement in our work and through improved and increased public reporting of results.

Increased public accountability.

Enhanced transparency.

Improved openness.

A Strong Organization

Building a nationally-based organization with the capacity and flexibility to fulfill its mandate in an ever-changing environment.

We are investing in our workforce and strengthening the quality assurance and management tools, systems and processes that are vital to our continuing stability and effectiveness as an organization.

Strengthened nationally-based capacity for sustainable performance.

Improved management tools and systems.

Strategic management of corporate commitments and obligations.

Leveraged technology to support a high-performing organization.

Strengthened responses to emergencies.

Key Performance Indicators

• Pre-market submissions reviewed within performance targets.
• Modernized legislative tools, policies and regulatory approaches developed and implemented.

We reduced the review backlog for new pharmaceutical drug submissions by 89% and for biologic drug submissions by 7%². We also reviewed 25% of new pharmaceutical drug submissions within established time targets, a 100% increase over last year.

We reviewed 67% of high risk and 81% of lower risk medical device applications within performance targets, significant improvements over last year.

We assessed 99% of Special Access Requests (for the provision of pre-market drugs and medical devices for treating patients with serious or life-threatening conditions) within performance targets.

As part of E-Review³, we rolled out an electronic review tracking system and began testing a new records and document information management system.

We launched a new scientific Laboratory Information Management System that will allow for better monitoring and tracking of biologics and genetic therapies that may present high risks to Canadians.

We evaluated over 3,000 submissions related to food additives, packaging materials, novel and processed foods.

The review of some 13 submissions for novel foods (e.g., genetically-modified animals and plants) was completed.

We reviewed over 90% of veterinary drug submissions over 18 months old⁴.

We migrated 15,000 records to a new veterinary emergency drug release system.

We introduced new policies and regulations regarding the chemical and microbiological safety, and nutritional value of Canada's food supply.

We analyzed stakeholder comments on revised safety assessments guidelines for novel foods and responded to recommendations made by expert committees on food biotechnology.

We continued to work closely with the Canadian Food Inspection Agency (CFIA) to support the implementation of new nutrition labelling regulations, and to provide advice on the labelling of food allergens and the potential risks associated with undeclared allergens.

To support the development of informed strategies for reducing the amount of trans fatty acids in food, we gathered expert input on fat reformulation strategies and viable, healthful alternatives.

We completed consumer testing of vitamin and mineral additions to foods, informing the development of regulatory amendments on food fortification⁵.

We updated national standards for cells, tissues and organs, furthered the development of a national regulatory framework and began compliance inspections.

We released guidance on the prevention of West Nile Virus and SARS transmission through transplantation.

We streamlined submission requirements and implemented industry guidance for submissions in the International Conference on Harmonization (ICH) Common Technical Document (CTD) format. By co-Chairing the ICH Global Cooperation Group, we helped promote a better understanding and use of ICH guidelines, encouraged dialogue around good harmonization practices and enhanced the capacity of other nations' drug regulatory programs.

We continued participation with the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Products (VICH). This enables Canada to have guidelines for data registration requirements for new veterinary medicinal products consistent with other countries.

We also hosted a World Health Organization conference on Cells, Tissues and Organs and co-chaired a SARS Vaccine Session at BIO 2004.

In cooperation with the United States Food and Drug Administration (USFDA), we agreed to establish a framework for cooperation on pharmaceutical quality issues, initiated discussions on third party quality systems audits for manufacturers of medical devices and co-sponsored a workshop on dating blood platelets.

In cooperation with Australia's Therapeutic Goods Administration we furthered work on the mutual exchange of information on drug review and regulatory practices, signed an agreement recognizing each others' pharmaceutical good manufacturing process assessments and began work on another agreement regarding quality systems certificates for medical devices. We also signed an agreement with Food Standards Australia and New Zealand to work cooperatively on such areas of mutual interest as the evaluation of novel foods, quantitative microbial risk assessments, and health claims for food and food fortification.

We initiated bilateral discussions with the National Institute for Biological Standards and Control (NIBSC) in the United Kingdom.

Key Performance Indicators

• More and better tools available to all partners responsible for risk management and risk communications capacity in the regulatory system.
• Use of therapeutic effectiveness evidence to support formulary listing decisions for health products.
• Significant number of MedEffect portal users with increases over time.
• Increased number of adverse drug reactions reported to the new regional centres.
• Compliance of industry stakeholders with departmental regulations and standards.

Better Adverse Drug Reaction Protection

... monitoring

We enhanced our capacity to monitor and report on unintended reactions to prescription, non-prescription, biological and herbal drugs approved for the Canadian market. For example:

We added two new regional centres (Manitoba, Alberta) for reporting on adverse drug reactions.

We completed initial work on MedEffectCanada, a new system that gathers and provides information to the health care community on adverse reactions, medication problems and safe product use.

We continued to examine new mechanisms for identifying adverse drug reactions in children. This included undertaking a two-year study ⁸ to determine the feasibility of active surveillance that will help inform the new HPFB Office of Paediatric Initiatives and the possible establishment of dedicated surveillance staff in children's hospitals across Canada.

To support more timely reporting of adverse reaction information, we provided specifications for the development of a handheld wireless tool for medical professionals which will be tested in 2005-06.

The number of new subscribers to our Health Products Information system increased by 18% to reach 10,000 subscribers.

We issued 50% more health product advisories, including 60 advisories for health professionals and 55 for the general public.

Three new therapeutic product inspection programs were implemented to ensure industry compliance with existing and new regulations.

We carried out inspections of 24 (of a targeted 50) establishments to find almost 100% compliance with adverse drug reaction reporting requirements.

We also inspected 45 (of a targeted 70) medical device establishments and five (of a total of 120) cells, tissues and organs establishments. Inspections of medical device establishments fell short of targets as manufacturers developed appropriate responses to new reporting requirements.

We continued to work closely with the Canadian Food Inspection Agency (CFIA) to assess the effectiveness of the Agency's food inspection programs including those for poultry, fish and dairy. The Agency also provided feedback to inform our work to develop and refine food safety and nutritional quality standards and policies.

We continued to work with stakeholders to enhance the content and functionality of the Canadian Nutrient File⁹.

We invested $500,000 to study the amount of nutrients and contaminants such as lead, mercury and other chemicals in Canada's food supply.

Working with Statistics Canada and other partners, we developed the nutrition component of the Canadian Community Health Survey (CCHS) cycle 2.2, Nutrition focus.

Following reports of high levels of chemical fire retardants in farmed fish, we conducted further research on the toxicological effects on humans and concluded that the levels found do not pose an unacceptable health risk.

We are developing new methodologies to determine concentrations of various emerging marine and fresh-water toxins.

We conducted national surveys of foods for various contaminants, including veterinary drug residues and pesticides.

We continued to set maximum residue limits for veterinary drugs in foods derived from animals and established five additional limits.

Key Performance Indicators

• Increased awareness and knowledge among consumers and patients of health products, food and nutrition issues.
• Informed choices made by consumers and patients demonstrating more safe and healthy behaviours relating to health products, food and nutrition.

New Information

... on adverse drug reactions

We continued to provide current, reliable and easy-to-understand information to Canadians on a wide range of topics. For example:

We distributed the Canadian Adverse Reaction Newsletter to over 99,000 physicians, pharmacists and other subscribers across Canada and around the world. We also assessed information available on the effectiveness and safety of health products including those affecting children.

We continued working on policy development and implementation plans to make product monographs accessible to the public.

We distributed fact sheets on new topics such as the safe disposal of pharmaceutical products.

We began the revision of Canada's Food Guide to Healthy Eating to ensure that it promotes a pattern of eating that meets nutrient needs, promotes health, minimizes the risk of nutrition-related chronic disease, and is more relevant and understandable to Canadians. In addition, we conducted research on how to make the Food Guide more applicable and appealing to Canadians.

We continued to disseminate a variety of healthy eating resources, including Canada's Food Guide to Healthy Eating. The Canada's Food Guide to Healthy Eating webpage registered a 15% increase in visits and was the most visited page on Health Canada's website.

We published two new infant feeding recommendations and disseminated approximately 40,000 copies to health professionals.

We also distributed resources to assist consumers to better understand the new nutrition labels on pre-packaged food products, including approximately 300,000 copies of the Nutrition Labelling tearsheet for consumers and over 30,000 Nutrition Labelling posters, with distinct resources for First Nations and Inuit. A series of articles was produced for distribution to the public through News Canada.

Key Performance Indicators

• Improved public and stakeholder opinion about the Branch's accountability for results and the timeliness and transparency of its regulatory process.
• Sustained public confidence and trust in health products, food and the regulatory system.
• Increased stakeholder awareness of the Branch's business and decision-making processes.
• More individuals accessing information online.
• Increased public involvement in Branch program and policy development, implementation and decision-making.

We responded to nearly 2,600 requests for information within a one-day timeframe, a 55% increase in the number of requests handled last year.

We also began work to establish a new Office of the Public Ombudsman to handle complaints, concerns and feedback from individuals and organizations about our work.

We continued to seek new ways to give Canadians and health stakeholders the opportunity to have their say on important health product and food safety issues, while ensuring timely regulatory decisions and progress. For example:

We held 34 meetings with 17 advisory committees that were established to provide advice and feedback on such issues as neuropathic pain, breast implants, and reprocessing of medical devices.

We held workshops with 134 participants in 11 cities across Canada as part of the process of developing a new Public Involvement Framework.

We also undertook over 100 separate activities to consult on topics such as the Public Involvement Framework, cells, tissues and organs, food fortification, Canada's Food Guide to Healthy Eating, maximum residue limits for veterinary drugs, and the online publishing of Summary Basis of Decisions outlining the rationale and scientific basis of our regulatory decisions.

Patients and consumers across Canada took part in a pilot information and training session on HPFB decision-making processes concerning the review of drugs for safety purposes before they are authorized for sale in Canada.

We also hosted a national stakeholder forum to share information and solicit input on key initiatives, such as the federal government's Smart Regulations Initiative, and legislative renewal for food safety and nutritional quality policy.

Key Performance Indicators

• Sustainable and flexible workforce.
• Improved science capacity.
• Reduced number of workplace health and safety incidents.
• Use of resource tracking systems linked to performance.
• Meeting immediate and ongoing information management and technology needs.
• Implemented emergency preparedness plans and guidelines.

To ensure our capacity to protect essential operations and maintain services to Canadians during emergencies, we developed and tested business continuity plans.

We contributed to an Emergency Preparedness Partnership Framework between Health Canada and the Canadian Food Inspection Agency.

We developed a Food-borne Illness and Outbreak Response Protocol to ensure clear roles, responsibilities and coordination of food-borne illness outbreaks by federal, provincial and territorial food and public health agencies.

We released an upgraded version of the Program Management and Reporting System that complements the existing departmental financial system.

We continued to refine our management framework, including approaches to recovering revenues, planning, budgeting and reporting.

We continued to consolidate all information technology functions, including creating common database applications, and consolidating IT equipment and infrastructure.

We continued to implement initiatives regarding identification of essential records, retention and disposition programs.

We have invested in new technologies such as E-review, and using the Internet to improve communications with our stakeholders and Canadians generally.

We took advantage of technological advances to support information sharing. Through CANLINE, for example, we enabled federal, provincial and territorial stakeholders to share inform and create a national repository of data on chemical contaminants in food. Through eLEXNET, we facilitated real-time sharing of laboratory information.