HESA Committee Report
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Mr.
Marc-Olivier Girard Dear Mr. Girard: I am pleased to respond on behalf of the Government of Canada to the Fourteenth Report of the Standing Committee on Health entitled Technological Innovation in Health Care, tabled in the House of Commons on June 12, 2013. On behalf of the Government of Canada, I wish to thank the Committee members for this extensive and valuable study. The Government of Canada supports the findings of this report and welcomes the Committee’s recommendations. As science and medical technologies continue to advance, so do the expectations of the public and industry. In an effort to meet these expectations and improve the efficiency, productivity and long-term sustainability of the health care system, the Government of Canada will continue to invest in health innovation. Recognizing that health care delivery is the primary responsibility of provinces and territories, our Government has announced a long-term arrangement that will see transfers reach historic levels of over $40 billion by the end of the decade. Underpinning the investments and activities described in this response is the Government’s collaboration with provinces and territories, with whom it works closely to share best practices and improve health systems across Canada. To articulate the Government’s recommendations to the challenges identified by the Committee, this response is organized along the themes of the Committee’s report. It also takes the opportunity to describe the government’s role in health innovation. E-Health, telehealth and telerobotics The report’s recommendations within this theme relate to federal investments in research and development related to e-health tools, particularly those promoting self-care, as well as e-health infrastructure in First Nation communities. As the Committee noted, e-health, or the application of information and communications technologies such as electronic health records (EHR) and telehealth, is an essential element of health care renewal, as it can improve the quality of health care and make Canada’s health care system more efficient and accessible. The Government invests in the development of e-health technology across Canada, both to support provincial/territorial health care systems and through direct investments in First Nations and Inuit communities. Canada Health Infoway As detailed in the Committee’s report, one of the ways this government supports e-health is through Infoway, which represents a federal investment of $2.1 billion. Through investments in consumer health projects across the country, Infoway has supported provinces and territories to build their foundational EHR systems and to develop telehealth initiatives to improve access to health care in rural and remote settings. Infoway also supports the development of e-health tools which give patients better access to services and information. Examples include online patient portals, patient self-scheduling, cancer diagnostic assessment, mental health engagement networking, and consumer access to health information for asthma. As Infoway and its partners build on investments in electronic health systems, including in clinical settings such as physicians’ offices, patients will be better able to access their health information and participate more fully in their own care. Infoway has also collaborated with First Nations and Inuit organizations and provincial/territorial governments on more than 60 projects that use digital health solutions to improve health care for First Nations and Inuit communities. An important example is a project in Manitoba where Infoway, in partnership with the Assembly of Manitoba Chiefs, is implementing electronic medical record systems tailored for the needs of First Nations health centres. E-health for First Nations and Inuit As many First Nation and Inuit communities are remote and isolated, the Committee recognized that e-health technologies have the potential to greatly improve their access to health information, services and care. Health Canada’s eHealth Infostructure Program (eHiP) works with First Nations, as well as Infoway, other federal departments, provincial governments, regional health authorities, and private sector organizations, to support e-health technologies in First Nation communities across the country, as well as in Inuit communities south of the 60th parallel. The Government agrees that Health Canada should continue to prioritize collaboration with partners through eHip. The department will continue to collaborate with provinces to increase broadband connectivity in these communities, given that broadband connectivity is a necessary precursor for the functionality of e-health and telehealth services. An example of this collaboration can be seen in Ontario, where the Northwestern Ontario Broadband Expansion Initiative will bring a state-of-the-art fibre optics network to 26 Nishnawbe Aski Nation communities. The federal government is contributing $23 million to this initiative, which is also being supported by the province and private investments. Budget 2013 provided $48 million over two years to improve the quality of health services in First Nation communities. The bulk of this funding will help to maintain existing investments in connectivity and expand electronic health services in remote and isolated First Nation communities. In addition, since the issue of attracting and retaining health human resources is a very real challenge in remote and isolated communities, the Government has introduced student loan forgiveness for doctors and nurses who work in these communities. Telerobotics The Government agrees with the Committee’s assertions that telerobotics have the potential to improve access to care, particularly in remote and isolated communities. As the technology advances, telerobotic units could prove to be a cost-effective investment for delivering both distant education and clinical services. As such, Health Canada will continue to consider the potential applications of telerobotics for remote First Nation and Inuit communities, as the evidence base for telerobotics grows and as provinces and territories begin to adopt these technologies. E-health Research The Canadian Institutes of Health Research (CIHR) has a long standing commitment to funding research to promote the development, implementation and evaluation of e-health tools. CIHR is currently developing a large-scale e-health initiative focused on the appropriate use, integration and evaluation of health information and communication technologies. In preparation for this new initiative, CIHR has launched two rounds of grant competitions; the first is supporting novel approaches to e-health innovation and the second will support research on the comparative quality and cost-effectiveness of health technologies. CIHR’s next phase of investment in this e-health innovations initiative will fund a range of novel approaches at all stages of development. These activities are conducted in close partnerships with stakeholders in the health system, in order to maximize impact. Pharmaceutical drugs and medical devices The Committee highlighted the role of Health Canada in ensuring Canada’s regulatory system is responsive to the needs of technology businesses and to developments in technology. The department, in its capacity as the federal regulator, evaluates and monitors the safety, quality and effectiveness of medical devices and pharmaceutical drugs. Cognizant of the need to evolve its regulatory tools and environment, Health Canada is currently leading an initiative of regulatory modernization, as outlined in its Regulatory Roadmap. The goal of the Regulatory Roadmap is to implement an efficient, transparent and aligned regulatory system that protects and improves patient and consumer safety, reduces the regulatory burden with an emphasis on small businesses, supports scientific innovation, and makes the widest possible variety of health options and benefits available to Canadians. This goal is consistent with the Cabinet Directive on Regulatory Management, which holds that all federal departments must carefully consider the impact on small businesses of new or amended regulations, while protecting and advancing the public interest in health and safety. These efforts contribute to, and are also guided by, the Government of Canada’s Red Tape Reduction Action Plan to reduce administrative burden on businesses. International Harmonization International harmonization is an integral part of Health Canada’s Regulatory Roadmap, building on several years of successful collaboration between Health Canada and regulatory agencies in other countries. These efforts have resulted in the creation and adoption of a range of standards and processes, greater information sharing, common registries, common application filings, joint reviews, and other work-sharing arrangements necessary to respond to a globalized manufacturing market and the increasing demands to streamline regulatory processes. International collaboration has resulted in the sharing of the global regulatory workload, more informed decisions, and timely coordinated actions. An example is the creation of the Canada-United States Regulatory Cooperation Council in 2011, which has increased regulatory cooperation and better aligned the regulatory systems of the two countries. The International Medical Device Regulators Forum, that includes Australia, Brazil, Europe, Japan, the United States and Canada, is the key forum to advance international harmonization for medical devices. Health Canada, together with its counterpart agencies in Australia, Brazil and the United States, is targeting early 2014 to pilot an innovative medical device single audit program. This model will allow for a single audit of a medical device manufacturer to satisfy the requirements of all four countries, thereby reducing regulatory burden and promoting access to new technologies. Regulatory Modernization Health Canada’s Regulatory Roadmap will produce a sustainable regulatory future with flexibility and foresight to keep pace with developments such as advances in personalized medicine, genomics and nanotechnology. As the technology has advanced, Health Canada has led a number of regulatory initiatives to support innovation by addressing the related regulatory challenges. These include the adoption of the International Conference on Harmonization definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics, developed with a view to harmonize approaches to drug regulation and the development of guidance documents related to personalized medicine and nanotechnology. Drug Development Health Canada’s regulatory modernization efforts are complemented by research aimed at accelerating the drug discovery process and developing safer and more effective drugs. Through organizations such as CIHR, Genome Canada and the Canada Foundation for Innovation (CFI), the Government of Canada is able to support this essential research. Since 2006, the Government of Canada has invested approximately $20 million in the Structural Genomics Consortium to carry out basic science that is relevant to drug discovery. The consortium is a not-for-profit, public-private partnership that has emerged as a Canadian success story. Its activities will continue to be supported until at least 2015-2016 with additional investments of $16 million from international and private partners. Drug development is also supported through the Genomics Research and Development Initiative, in which the Government invests nearly $20 million per year to coordinate federal science departments and agencies in the field of genomics research. The scope of the Government’s genomics work is expanded through collaboration with, and knowledge transfer to, the provinces and territories, academia and the private sector. Partnerships such as these are integral to the process of drug discovery and development. The Government of Canada feeds ideas and innovations into the pharmaceutical pipeline by supporting programs which facilitate academic-industry partnerships such as the Networks of Centres of Excellence (NCE), the Business-Led NCE and the Centres of Excellence for Commercialization and Research programs. Genomic Sequencing As observed in the Committee’s report, how we approach the understanding, diagnosis, prevention, and treatment of diseases is rapidly changing as a result of emerging technologies such as genomics. The Government of Canada, through CIHR and Genome Canada, launched the Genome Canada-CIHR Genomics and Personalized Health Research Competition in 2012; this is the most significant public--private partnership dedicated to advancing the personalized medicine health research agenda in Canada, with $150 million in funding. Genomics research is also supported by the Government through the CFI. Since its inception in 1997, the CFI has awarded over $550 million in research infrastructure funding to 522 individual research projects at dozens of research institutions in every province. This infrastructure funding covers the range of state-of-the-art equipment necessary for genomics research, including the latest generation of sequencers, high performance computing facilities, comprehensive data sets, and precision laboratory devices. Budget 2012 included $500 million for the CFI to support new competitions through which Canadian research institutions can apply for funding for state-of-the-art facilities and equipment. Budget 2013 announced $225 million for advanced research infrastructure priorities and to sustain CFI’s long-term operations. Nanotechnology The Committee stressed the importance of nanotechnology in detecting and treating diseases. Since 2006, CIHR has invested approximately $107 million in nanomedicine research. This supports research that includes the delivery of medical technologies at the molecular level for better diagnosis and treatments for complex health issues such as multiple sclerosis, cancer, diabetes, and stroke. CIHR will continue to explore ways to support nanomedicine applications through its open and strategic programs and through current and planned signature initiatives. The Natural Sciences and Engineering Research Council (NSERC) supports nanotechnology research across post-secondary institutions in Canada. Since 2007, NSERC has provided $4.7 million for nanotechnology research projects in the areas of biochemistry, biomedical engineering, medical sciences and microbiology. Through its existing programs, NSERC will continue to support nanotechnology research. The National Research Council (NRC) supports nanotechnology research through the National Institute for Nanotechnology, a joint initiative with the University of Alberta and the Government of Alberta. The institute’s primary connection to health research is through metabolomic sensors. This work is expected to lead to cost-effective diagnostic testing for various diseases including prostate cancer. The treatment of rare diseases The Committee recognized that technological innovation must be combined with a high degree of collaboration and international partnership to ensure that investments result in valuable and effective treatments. As the Committee heard, Canada has taken a leadership role by being the first country in North or South America to join Orphanet, the world’s first online reference portal for information on rare diseases. Close links will be established between Orphanet-Canada and Health Canada to facilitate knowledge exchange with patients, clinicians and associations in the context of innovative clinical trials and the Orphan Drug Regulatory Framework currently being developed. While Health Canada is not in a position to set up or mandate participation in international rare disease registries, which serve as reference portals by tracking rare diseases, the department will work to ensure that the proposed orphan drug framework enables the alignment of international registries and does not create barriers to such collaboration. International Cooperation on Rare Diseases The Government of Canada works to facilitate international cooperation on rare diseases. This is accomplished in part through Canada’s role as a founding member of the International Rare Diseases Research Consortium. The Scientific Director of CIHR’s Institute of Genetics currently chairs the consortium, which is designed to accelerate medical breakthroughs for people affected by rare diseases. Its objectives are to develop 200 new therapies for rare diseases, along with the means to diagnose most rare diseases by 2020. Health Canada also plays an active role in international research collaboration through E-RARE-2, the European Union’s main instrument for funding research in areas related to rare diseases. Rare Disease Research CIHR supports a range of national and international events which bring researchers together to create what are known as “nodes of excellence” in rare disease research. Through these events, key stakeholders in this field interact with organizations that could leverage the value of these investments. Current consultations with CIHR and Health Canada will be expanded to include the Public Health Agency of Canada, the Networks of Centres of Excellence and Canada’s Strategy for Patient Oriented Research. In general, Networks of Centres of Excellence competitions are open to all research areas. Occasionally, targeted areas for new networks are identified prior to each competition, taking into consideration the amount of funding available, the broad areas already represented by ongoing Networks, and the need to promote or develop specific areas in accordance with national needs and problems. Non-Pharmaceutical Treatments for Rare Diseases The Committee’s report recommends that Health Canada consider whether it is necessary to establish a framework for non-pharmaceutical treatments, such as medical devices used to treat rare diseases, within the orphan drug framework, or whether a parallel framework for non-pharmaceutical treatments should be created. Guided by the Regulatory Roadmap, Health Canada will conduct further analysis and undertake dialogue with stakeholders to assess options for modernizing the medical devices framework in the context of rare diseases. The prevention and management of chronic diseases The Public Health Agency of Canada and CIHR recognize the importance of sharing best practices, as identified by the Committee, and their roles in facilitating the sharing of best practices among industry, researchers and clinicians with respect to technological innovations in the prevention and management of chronic diseases. The commitment to helping Canadians lead healthier lives is illustrated through the 2010 Declaration on Prevention and Promotion. Endorsed by the federal and provincial/territorial governments, it reinforces collaboration and the sharing of best practices across jurisdictions and sectors. The Public Health Agency of Canada gathers and shares successful interventions through the Canadian Best Practices Portal. This web-based portal provides a listing of trusted and credible resources for planning, implementing and evaluating programs designed to promote health and prevent chronic disease and injuries. In addition, CANRISK, a web-based diabetes risk calculator developed by the Agency, helps Canadians identify their risk of having pre-diabetes or developing Type 2 diabetes. It supports Canadians in working with their health care providers to take appropriate measures to avoid or mitigate the onset of this illness. To increase access to CANRISK, partnerships with pharmacy chains have expanded to enable its use in over 2000 pharmacies across Canada. A mobile phone application has also been developed to facilitate even greater use by health care professionals. Several of the core elements of Canada’s Strategy for Patient-Oriented Research (SPOR) are designed to facilitate the sharing of best practices in the prevention and management of chronic diseases, across jurisdictions and among key stakeholders including policy makers, researchers, clinicians, patients, charities and industry. This helps to ensure greater quality, accountability, and accessibility of care. Health Literacy The Committee emphasized that the power of technological innovations to help people prevent or manage chronic illness depends in part on health literacy. The Government of Canada recently collaborated with the Canadian Medical Association and Memorial University to develop an accredited continuing medical education module on health literacy for health professionals. The Canadian Public Health Association and the Canadian Nurses Association were key contributors to this training, which informs health professionals of the impact of low health literacy on patient outcomes and highlights resources and tools to address this issue. At the same time, the Public Health Agency of Canada is developing a more comprehensive health literacy module for public health practitioners as part of its Skills Online initiative. The Agency has also supported national workshops and other activities designed to facilitate health sector and stakeholder action to address low health literacy in Canada. Health literacy is also an important component of Health Canada’s Aboriginal Diabetes Initiative, which supports diabetes prevention in over 600 First Nations and Inuit communities across Canada. This includes providing information and resources for community members and diabetes workers, in a user friendly format, with resources in numerous Aboriginal languages. Managing the costs associated with the adoption of technological innovations in health care The Committee looked not only at the benefits of technological innovation but at the issue of cost. The assessment of health technologies, carried out before and after they enter the marketplace, is an important tool in seeking to manage the costs of technological innovations in the health care system. As legislated by the Food and Drugs Act and the Medical Devices Regulations, Health Canada evaluates and monitors the safety, effectiveness and quality of diagnostic and therapeutic medical devices in Canada, including products that use new technologies. These regulations include provisions for investigational testing, device licensing, quality manufacturing and post-market surveillance. These regulations also provide Health Canada with the authority to request data regarding marketed medical devices, including clinical evidence of their safety and effectiveness. Health Canada can issue a Licence with Conditions for devices whose safety and effectiveness have been demonstrated only in a small patient population or over a limited time period. Typical conditions may require the licence holder to provide periodic reports of existing or post-approval clinical studies, sales figures and summaries of adverse incident reports in Canada and worldwide. A licence can be suspended if the manufacturer fails to comply with the conditions. With the Licence with Conditions provisions, Health Canada is able to collect devices’ post-market performance data that can be used to inform new regulatory requirements. The Government also supports the Canadian Agency for Drugs and Technologies in Health (CADTH) which provides decision-makers with data about the optimal use and effectiveness of drugs and other health technologies. For example, CADTH’s Optimal Use Program works to encourage optimal prescribing, purchasing, and use of drugs and health technologies by health care providers, policy-makers, and consumers. Health Canada’s support for CADTH also contributed to the expansion of the Common Drug Review, as a key step toward improving the efficiency and consistency of formulary decision-making across the country. The federal government provided $16.9M, or close to 78% of the total funding for CADTH in 2012-13. In the area of drug regulation, the Drug Safety and Effectiveness Network (DSEN) was established within CIHR primarily to increase the evidence on the post-market safety and effectiveness of drugs available to public drug plan managers, policy-makers, health technology assessors and regulators to support their decision making. In addition to its regulatory responsibilities, as a catalyst for innovation, the Government of Canada is committed to reducing regulatory burden and to continuing to protect the health and safety of Canadians while allowing the innovations necessary for Canadians to have access to the best health care. Promoting technological innovation in health care in Canada In terms of the promotion and commercialization of technological innovation in health care, the Committee focused on the importance of research and development and the role of public-private partnerships. Through the funding of research and development, this Government has taken significant steps to promote technological innovation in health care. The federal government remains the largest single-investor in Canadian health research and innovation, with investments of approximately $1 billion annually to the CIHR. More than half of this is spent on basic research, which feeds the innovation pipeline and promotes the commercialization of research. The Centres of Excellence for Commercialization and Research program, managed by CIHR, NSERC, and the Social Sciences and Humanities Research Council of Canada (SSHRC), brings together people, services and research infrastructure to position Canada at the forefront of health care innovations. For example, the Centre for Surgical Invention and Innovation aims to develop and commercialize a new class of robotic platforms for less invasive surgical and medical interventions to improve patient outcomes and reduce recovery periods. Through its Open Access Policy released in January 2013, CIHR promotes technological innovation in health care by facilitating the sharing of research knowledge and the translation of findings into policies, new technologies and health practices. This new policy provides greater access to research publications and data, which promotes the ability of researchers in Canada, and abroad to use and build on the knowledge needed to address significant health challenges. Public-Private Partnerships in Technological Innovation Significant federal investments have been made in programs that promote these types of partnerships, such as the Network Centres of Excellence, the Centres of Excellence in Commercialization and Research, and the Business-Led Networks of Centres of Excellence. In 2011-2012 alone, industrial partners invested over $107 million to support a research network funded under these programs, leveraging the contribution of $146 million made by the Government of Canada through the CIHR, NSERC, and SSHRC. Canada’s Strategy for Patient-Oriented Research (SPOR) is a major initiative that promotes technological innovation in health care. SPOR will help to break down traditional silos and spur innovation in health care by promoting collaboration among researchers. SPOR aims not only to develop innovative methods and technologies, but to translate research innovations into practice so that health professionals can deliver the best possible health care to patients. It also includes an important training component to ensure health professionals can fully integrate the results of new innovative research. Innovations in health care delivery The Committee also looked beyond technology to focus on innovative models of care. While recognizing that provincial and territorial governments have primary responsibility for the design and delivery of health care services, the Government of Canada supports innovations that help to improve health care for Canadians. For example, Budget 2012 awarded McMaster University $6.5 million over three years to evaluate team-based approaches to health care delivery which are expected to achieve better health outcomes for patients, while also making the health care system more cost effective. This research project will generate much needed evidence regarding the implementation of team-based health care. Federal funding for several pan-Canadian organizations supports health care innovation in areas such as patient safety, mental health, cancer, health technology assessment and health care improvement. These arm’s length, not-for-profit organizations provide vehicles for the federal and provincial/territorial governments, and health stakeholders, to collaborate on programs and policies of mutual interest. For example:
Health Canada’s Health Care Policy Contribution Program provides funding to provincial/territorial governments, non-profit organizations, educational institutions, and professional associations to develop, implement, and disseminate knowledge, best practices, and strategies for innovative health care delivery. The Government also supports innovative models of care through the implementation of multi-disciplinary teams in remote and isolated First Nation communities. In British Columbia and Alberta nurse practitioners now work alongside other registered nurses. Health Canada has also piloted innovative primary care teams that have led to more efficient delivery of health care services in remote and isolated First Nation communities across Canada. Conclusion In closing, I would again like to thank the Committee for this important work. This report is both timely and highly relevant and it has helped to shed light on the innovations necessary for Canadians to have access to the best health care, now and in the future. I trust that this response articulates the Government’s commitment to leading and fostering innovation in health care, while regulating the safety and efficacy of new technologiesSncerely, Sincerely Rona Ambrose Appendix - List of Recommendations E-Health, Telehealth and Telerobotics
Pharmaceutical Drugs and Medical Devices
The Treatment of Rare Diseases
The Prevention and Management of Chronic Diseases
Managing the Costs Associated with the Adoption of Technological Innovations in Health Care
Promoting Technological Innovation in Health Care in Canada
Innovations in Health Care Delivery
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