This chapter provides an overview of the federal government’s role and initiatives related to the promotion of innovation in health care in Canada. Witnesses appearing before the Committee identified four main areas in which the federal government is currently playing a role in this area, including: the development of a regulatory framework that is responsive to innovations in pharmaceuticals and medical devices; the funding of research leading to the development and commercialization of innovative technologies and innovative practices in health care; providing support for the evaluation of the clinical and cost effectiveness of health care technologies, including pharmaceuticals, medical devices and clinical procedures; and investing in the development and adoption of e-health and telehealth across Canada, including in First Nations and Inuit communities.

A. Regulation of Pharmaceuticals and Medical Devices

According to a federal official, Health Canada is responsible for the regulation of food and health products, which involves assessing the health-related benefits and risks of products such as pharmaceuticals, biologics and medical devices.[5] In order to ensure that Canada’s regulatory system remains responsive to scientific innovation, the Committee heard that the Department was taking steps to modernize its regulatory framework to support emerging technologies. In particular, the Committee heard that Health Canada had introduced a priority review process that would allow for a shorter review time for new drugs and devices intended for the treatment, prevention or diagnosis of serious, life-threatening or severely debilitating diseases or conditions. The Committee heard that, under the priority review process, the review time for a typical new active drug substance has been reduced from 300 days to 180 days, and for a class IV or high-risk medical device, the review time is now 45 days, as opposed to 90 days.

The Committee heard that this change to the regulatory system has resulted in Canadians having timelier access to new innovative therapies and treatments.[6] For example, Health Canada granted priority review status to the Edwards Sapient heart valve, which was licensed on 22 June 2011. This heart valve provides certain patients who cannot undergo open heart surgery with the option of a valve replacement. In the area of oncology, Health Canada approved Jakavi, a treatment for the effects of a rare blood cancer, on 19 June 2012 through its priority review process, because the treatment had demonstrated a marked and durable improvement in patient quality of life. Finally, the Committee also heard that through the priority review process, Canada became the first country in the world to licence a stem cell therapy for the treatment of transplants in children in May 2012.

In addition to the priority review process, the Committee heard that Health Canada is enhancing access to innovative therapies by establishing internationally competitive performance targets for its review times for all drugs; providing 30-day default review process for applications for clinical trials; and enhancing access to drugs that have shown promising results in clinical trials.[7]

Furthermore, the Committee learned that Health Canada is also taking steps to promote technological innovation by reducing the regulatory burden on industry. For example, in response to the globalization of the health products industry, the Department is collaborating with other jurisdictions to promote the harmonization of regulatory standards and technical requirements in order to reduce duplication in reviewing and evaluating new drugs and devices.[8] In addition, Health Canada has produced guidance documents for manufacturers to facilitate the authorization of innovative drugs and treatments, such as biologics, plant molecular pharming, cellular therapies and pharmacogenomics.[9] Meanwhile, the Department has also developed new regulations for positron-emitting radiopharmaceuticals. These regulations reduce the administrative burden on researchers by introducing an abbreviated clinical trial application process for studies evaluating these new imaging agents.[10]

B. Supporting Research and Commercialization of Emerging Health Care Technologies and Innovations in Health Care Delivery

The Committee heard from Dr. Alain Beaudet, President of the Canadian Institutes of Health Research (CIHR), that the federal government supports innovation in health care by providing research funding for the development of emerging health technologies, as well as innovations in the delivery of health care.[11] CIHR works in partnership with other federal partners, including the Natural Sciences and Engineering Research Council of Canada (NSERC), the National Research Council of Canada and Genome Canada to provide research funding in this area. According to Dr. Beaudet, since 2006, CIHR has invested more than $200 million to fund over 200 projects related to robotics, nanotechnology and medical devices.[12] Table 1 outlines CIHR’s initiatives and investments related to technological innovation in health and health care delivery based upon a written submission provided by the agency.[13]

Table 1 – CIHR’s Technological Innovation Initiatives and Investments

Area of Research	Initiative(s)	Funding
Innovative Drugs and Devices	Proof-of-Principle Program (PoP), the Joint CIHR–NSERC Collaborative Health Research Program (CHRP) and the Networks of Centres of Excellence Program fund research that may lead to the development of innovative drugs and devices. PoP has led to the creation of 150 start-up companies.	Between 2006 and 2012, CIHR invested approximately $24 million in PoP.
Robotics	Funds research at the frontline of natural sciences, engineering and health sciences.	CIHR invested approximately $14.9 million in over 90 projects related to robotics.
Nanotechnology	CIHR funds nanomedicine[14] through the Open Program, the Regenerative Medicine and Nanomedicine Initiative, and the Collaborative Health Research Program.	Between 2006 and 2012, CIHR has invested over $121 million in over 400 projects.
Innovative Health Care Delivery	CIHR’s signature initiatives involving large scale funding, including the Community-Based Primary Health Care initiative, the personalized medicine initiative, evidence informed health care and the Strategy for Patient-Oriented Research all address different aspects of emerging technologies and health care delivery.	N/A.[15]
E-health and telemedicine	CIHR has supported over 80 research projects since 2006 focusing on the evaluation of health, law, ethics and the development of new e-tools.	CIHR has invested $10 million since 2006.

The Committee was provided with specific examples of how these research investments have led to the development of innovations in health care. Dr. Beaudet highlighted CIHR-funded projects that support the development and commercialization of medical devices to help persons with disabilities.[16] For example, Dr. Ptito from the Université de Montréal has developed a sensory substitution device that could potentially help blind people with navigation through the use of a tongue display unit that transmits visual information through a camera to the person’s brain, enabling the person to develop strategies to avoid obstacles and move adequately. Similarly, the Committee also heard about CIHR funded researchers at Ryerson University who have developed an artificial muscle-operated arm that allows one to control an artificial limb just by thinking about it, which offers a greater range of movement than traditional prostheses, and does not require the amputee to undergo invasive surgery. According to Dr. Beaudet, these researchers have translated their work into commercial success through the creation of a start-up firm, Bionik Laboratories, which has attracted interest from major hospitals in Canada and the United States.

The Committee heard how CIHR’s Regional Partnerships Program has played a role in developing treatments for diseases as a result of discoveries made in genomics.[17] Dr. Beaudet explained that through early funding from CIHR, Dr. Patrick Parfrey and his colleagues from Memorial University were able to discover a gene responsible for young men in Newfoundland dying suddenly from heart failure. This discovery led to the development of a simple blood test to determine whether an individual has the condition and the implantation of defibrillators in those who test positive for the gene. This has resulted in virtually  eliminating  this sudden death syndrome in Newfoundland and Labrador.

In addition, the Committee also received a written brief from NSERC, which outlined how its federally funded research programs are leading to the development and commercialization of different health technologies and innovations in clinical practice.[18] The brief described how NSERC’s Idea to Innovation Grant program, which provides funding to college and university faculty members in the early stages of developing new technologies and seeking to bring these technologies to market[19], has led to the development of new medical devices. For example, with the help of an NSERC Idea to Innovation grant, researchers at the University of Calgary were able to develop a medical device to treat obstructive sleep apnea and upper airway resistance, which led to the creation of a company called Calgary-based Zephyr Sleep Technologies. The medical device is now available in the United States and the company has plans to seek regulatory approval in Canada and Europe in 2013.

The brief also outlined how NSERC supports academics developing technologies to improve surgical techniques through its NSERC/Medtronic Industrial Research Chair program.[20] For example, Professor Carl-Éric Aubin, holder of the NSERC/Medtronic Industrial Research Chair in Spine Biomechanics at the École Polytechnique de Montréal, has developed surgeon-friendly software that allows users to virtually plan a spinal instrumentation surgery, and a patient positioning device to provide optimal alignment during a procedure. The brief explained that Professor Aubin’s efforts to improve biomedical devices and treatment approaches of spinal pathologies will lead to further innovations in surgical technologies.

Finally, the brief also highlighted the Networks of Centres of Excellence of Canada, which offers different programs to mobilize Canada’s expertise in research, development and entrepreneurship in strategic areas and to address specific issues.[21] The Networks of Centres of Excellence of Canada provide grants to not-for-profit corporations supporting the commercialization of pharmaceuticals and medical devices through public-private partnerships, such as: the Quebec Consortium for Drug Discovery ($20,847,181 for 2009–2017); the Centre for Drug Research and Development ($22,955,575 for 2008–2018); the Centre for Commercialization of Regenerative Medicine ($15,000,000 for 2011–2016); MaRS Innovation ($29,911,150 from 2008–2016); and the Centre for Probe Development and Commercialization ($28,755,575 from 2008–2018).

C. Evaluation of the Clinical and Cost-Effectiveness of Pharmaceuticals, Medical Devices, and Clinical Procedures

The Committee heard that the federal government also plays a role in the assessment of health technology, including pharmaceuticals, diagnostics, and medical, dental and surgical devices and clinical procedures through the Canadian Agency for Drugs and Technology in Health (CADTH).[22] The Committee heard that CADTH was established as a not-for-profit organization by the federal/provincial/territorial (F/P/T) governments in 1989 with a mandate to provide policy-makers with evidence-based assessment of the clinical and cost effectiveness of pharmaceuticals and health technologies, including devices, diagnostics and procedures. CADTH receives its $22 million operating budget from Health Canada and provincial and territorial governments and reports to the F/P/T deputy ministers of health through a board of directors.[23]

The Committee heard that the purpose of health technology assessment (HTA) is to support the effective management of health technologies through their life cycle to ensure that they are adding value to the health care system; improving patient outcomes and/or health system sustainability; and are true innovations and not simply cost drivers.[24] CADTH provides a range of HTA services in support of these objectives. In particular, the Committee learned about CADTH’s Common Drug Review (CDR) initiative, which is an F/P/T process used to review the clinical and cost effectiveness of new drugs and of existing drugs with new indications. Based upon its review of the evidence, CADTH, through the CDR, provides jurisdictions with recommendations regarding the coverage of pharmaceuticals under publicly funded drug plans in Canada, with the exception of Quebec who has their own system in place. It is important to note that while CDR provides evidence to support coverage decisions, final formulary listing decisions are made by F/P/T governments themselves.

The Committee also heard that CADTH provides comprehensive and complex technology assessments in areas such as robotic surgery, magnetic resonance imaging (MRI) units, medical isotopes and pharmaceutical-based therapies for smoking cessation.[25] In addition, the agency provides more rapid reviews of the medical literature in response to urgent requests from jurisdictions. Finally, CADTH also provides reviews and recommendations regarding appropriate prescribing and utilization of drugs and other technologies to promote effective use of these products.

According to Dr. Brian O’Rourke, President and Chief Executive Officer of CADTH, HTAs conducted by CADTH have made significant contributions to identifying the appropriate use of drugs and other technologies, which have also brought cost savings to health care systems.[26] For example, research conducted by CADTH on the use of test strips to measure blood glucose levels found that people with diabetes who do not use insulin do not need to routinely self-test with these test strips, which account for $500 million in expenditure for both private and public drug plans in Canada.[27] The Committee heard that acting on these findings could save health care systems in Canada between $450 million and $1.2 billion between 2012 and 2015.[28] The Committee also heard that CADTH’s research on surgical robots had confirmed that they do lead to improvements in some short-term outcomes, such as length of hospital stay, blood loss and transfusion rates. Its work also identified ways of making this technology more cost effective, such as using the robot for several different kinds of surgeries, thereby increasing surgical volumes and providing the right kind of support systems for these devices. This research therefore promoted the adoption of innovative technologies in health care systems by optimising their use.

D. Promoting the Adoption of E-Health and Telehealth Across Canada through Canada Health Infoway Inc.

The Committee heard that the federal government is also playing a role in technological innovation in health care by promoting the adoption of e-health and telehealth across Canada through Canada Health Infoway Inc. E-health is a broad term referring to the application of information and communication technologies (ICTs) within the health care sector and has a broad range of applications from administration to health care delivery.[29] Telehealth refers to the delivery of services by healthcare organizations using ICT solutions when the clinic and patient are not in the same location and includes the use of technologies such as live videoconferencing, storing and transmission of data between health care providers, and telemonitoring, the remote monitoring and transmission of clinical data from a patient’s home to a centralized facility for review and action by a health care team.[30]

According to Mr. Richard Alvarez, President and CEO, Canada Health Infoway Inc. was created based upon an agreement between First Ministers to invest in digital health and telehealth systems in order to improve the quality, access and productivity of health care systems.[31] The Committee heard that the federal government had invested $2.1 billion in Canada Health Infoway Inc. and that these funds are being leveraged with financing from provincial and territorial governments and health agencies in support of projects aimed at the development of electronic health records (EHRs),[32] telehealth systems, drug information systems and digital diagnostic imaging.[33] He further explained that projects funded by Infoway must meet its national standards for interoperability to ensure that the ICT systems that they fund will be able to connect to each other both within and between different jurisdictions.[34] In addition, the projects must meet its requirements for the privacy of the data included in these systems.[35]

Mr. Alvarez highlighted for the Committee progress that had been made in e-health and telehealth as a result of investments made by Infoway. According to Mr. Alvarez, a recent study found that Canada has the world’s largest video conferencing network, with 5,700 telehealth sites located in 1,200 communities, including 423 sites in northern, remote First Nations and Inuit communities.[36] This video conferencing network delivered a quarter of a million sessions in 2011, which eliminated the need for patients to leave their communities and their social networks to receive care. The use of this technology has also resulted in innovations in health care delivery, including in the treatment of mental health and drug addictions; monitoring chronic disease patients; remote wound care assessment for diabetics; and consultations among different health care providers in different settings.

Mr. Alvarez also explained how investments in digital diagnostic imaging, which collects, stores, manages and shares patient x-rays, computerized tomography (CT) scans, MRI and other images and reports, has increased productivity in health care systems. Research has shown that digital diagnostic imaging has increased the productivity of radiologists and technicians by 25%, allowing for 11 million more exams annually.[37] Moreover, over 90% of most common radiology examinations in Canadian hospitals are now digitized, an increase of 52% from six years ago.[38] The Committee learned that the annual benefits of this technology would be valued at $1 billion, once it is fully implemented.

In addition, Mr. Alvarez outlined how the use of Drug Information Systems, which allow authorized clinicians to access, manage and share patient medication, have resulted in the avoidance of harmful drug interactions and the better management of patient medications. This in turn has led to a savings of $436 million per year and a reported 9% increase in productivity among pharmacists.[39]

Finally, he also explained that Canada Health Infoway Inc. is funding projects to encourage adoption of e-health in clinical settings.[40] For example, the Committee heard that Canada Health Infoway Inc. had launched a challenge to clinical teams to demonstrate their use of innovative solutions for electronic scheduling, medication reconciliation, patient access to their own health information and clinical synoptic reporting. Furthermore, Canada Health Infoway Inc. announced an investment of $380 million for the implementation of an EHRs program in February 2011, which would result in an additional 12,000 clinicians registered in the program by March 2013.[41]

Given that much of the digital health info-structure is in place in Canada, Mr. Alvarez explained that his organization is now looking to the future.[42] Consultations with over 500 stakeholders had revealed that it was important for the organization to focus on: bringing care closer to home; providing to tools to support patient centric models of care; using technology to improve patient safety; and making use of the data provided by electronic health information systems to support research and analysis evaluating the performance of health care systems.

E. Promoting the Adoption of E-health and Telehealth in First Nations and Inuit Communities

The Committee heard that Health Canada is promoting the adoption of e-health and telehealth in First Nations and Inuit communities through its eHealth Infostructure Program. This program is being implemented in close partnership with Aboriginal Affairs and Northern Development Canada, Canada Health Infoway Inc., provincial governments, regional health authorities, private sector organisations and First Nations leaders and communities.[43] The aim of Health Canada’s eHealth Infostructure Program is to ensure that First Nations and Inuit have access to the same quality and availability of e-health services as the rest of the Canadian population. The Committee also learned that the Department had invested approximately $130 million over the past five years in the project.[44]

The Committee heard from Ms. Kathy Langlois, Assistant Deputy Minister from Health Canada, that the the e-Health Infostructure Program focuses on the development of telehealth systems, broadband connectivity, the electronic surveillance of communicable diseases, and providing training and support for health professionals working in First Nations and Inuit communities. With respect to the development of teleheatlh systems, Ms. Langlois explained that there are currently more than 300 telehealth or video-conferencing sites in First Nations’ communities that offer a number of services, including televisitation for family members, tele-education, telediabetes and tele-mental health.[45] Ms. Langlois explained that the program also had plans to introduce more clinical services in these areas.

As sustainable broadband connectivity is a necessary precursor to the use of e-health and telehealth services in First Nations communities, the Committee learned that the eHealth Infostructure Program is investing in the development of broadband networks in partnership with other federal government departments, First Nations communities, provincial governments and services providers. For example, a partnership between Health Canada, SaskTel and the Federation of Saskatchewan Indian Nation was announced in July 2012, which will provide $5.8 million over five years to improve Internet access in 83 First Nations communities.[46] The Committee also heard that $81 million ($23 million from the federal government, $32 million from the Government of Ontario, and $26 million from the private sector) has also been invested in a project to bring fibre optics network to 26 communities in northern Ontario.[47]

To enhance the surveillance of communicable diseases in First Nations and Inuit communities, the Committee was informed that the eHealth Infostructure Program is contributing to the development of Panorama, a bilingual, electronic management and surveillance tool for front-line health care workers dealing with communicable diseases, including their identification, management and control. [48]The Committee heard Panorama will also integrate First Nations and Inuit clients into provincial efforts to implement the program. Certain provincial implementations are expected to proceed in the 2012-2013 fiscal year.[49]

Finally, the Committee also heard about e-health and telehealth initiatives aimed at supporting the needs of primary care nurses working in First Nations and Inuit communities. For example, Health Canada has developed programs aimed at providing primary care nurses with support in the management of medication, as well as providing them with new software to manage prescription labelling and the maintenance of medication inventories.[50] A centralized nurse practitioner 24/7 on-call service has also been established in Alberta to provide consultation and treatment support to primary care nurses on duty in remote and isolated communities.[51]