Stephen Dibert Global Practice Lead Life Sciences Foreign Affairs, Trade and Development Canada JBA Seminar - February, 2015

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1 Life Sciences Industry in Canada Stephen Dibert Global Practice Lead Life Sciences Foreign Affairs, Trade and Development Canada JBA Seminar - February, 2015

2 Life Sciences in Canada Canadian life sciences sector is an important contributor to Canada's innovation economy, engaging in creating the medical innovations that will improve health-care delivery and patient care in Canada and abroad. Research, development and manufacturing continuum SMEs developing diagnostics, biopharmaceuticals, pharmaceuticals and medical devices MNCs with research, development and manufacturing operations Contract services provide research and development, clinical trials and manufacturing Canada's world-class health research institutions and research networks are integral partners in research and knowledge translation.

3 Life Sciences in Canada A Key Player in the Global Pharmaceuticals Industry Home to the world s largest pharmaceutical companies, with several of these locating R&D and manufacturing facilities here, Canada offers a dynamic environment with first-rate academic institutions, innovative research networks, a highly skilled workforce, and many partnership opportunities. A Leader in the Medical Devices Industry Canada s medical devices sector is highly diversified, R&D intensive, technology-based and export-oriented. Purchasers include hospitals, physician s offices, laboratories, clinics and patients. Canadian medical devices firms spend, on average, 12 percent of yearly revenues on development, design and commercialization. A Major Opportunity for Growth in the Health IT Vertical Industry Healthcare spending in Canada reached $211 billion in 2013, representing about 11.2% of GDP. A key focus of policy makers has been to harness technology to enhance efficiencies within the healthcare system, with $10 billion to $12 billion to be invested in Health IT infrastructure across the country in the next 8-10 years. A Top-Notch Location for the Conduct of Clinical Trials Canada s ethnically diverse population, broad and universal healthcare coverage, world-leading universities, hospitals and health research centres staffed with highly qualified investigators in all major therapeutic areas make Canada a top quality location for conducting clinical trials.

4 Diversified, Vibrant and Growing Market for Pharmas In 2013, the sector s manufacturing segment employed 27,000 people in 490 establishments. Also, Canadian companies spent close to $900 million in 2012 on R&D activities in the pharmaceutical sector. From 2001 to 2013, total pharmaceutical sales in Canada almost doubled to $21.6 billion, with 89 percent sold to retail and 11 percent to hospitals. Governments account for 42 percent of drug expenditures while private payers cover the remainder. Brand-name products comprise 76 percent of Canadian sales and 37 percent of prescriptions, and generics account for the rest. Pharmaceutical sales in Canada represent 2.5 percent of the global industry, making Canada the eighth-largest market in the world. The Canadian pharmaceutical sector also has a growing presence in international markets; between 2001 and 2012, the value of its exports and imports increased by 136 and 93 percent, respectively. More than half of Canadian production, worth approximately $5.2 billion, is exported, primarily to the United States.

5 Key Strengths in the Pharmaceutical Industry A pharmaceutical sector that spans the industry s spectrum, operating at all levels of the value chain, from basic R&D and innovation to drug product development and contract services Several health-research networks covering all key therapeutic areas and that are ever-more commercially oriented, providing value and expertise to firms securing partnerships with them A total of 200 contract research organizations and contract manufacturing organizations (CROs and CMOs) serving both Canadian and international clients Perfectly suited to the current climate of patent expirations, and the demand for new licensing prospects, partnerships and alternative forms of investment

6 Pharmaceutical Market Access Innovative medicines, generics and over the counter drug products are developed and manufactured in Canada Health Canada regulates the pharmaceutical industry (Food & Drug Act) The review of a drug takes an average of 18 months from the time that a sponsor submits a New Drug Submission until the TPD makes a marketing decision CADTH Common Drug Review reviews new drugs and provides formulary listing recommendations to all publiclyfunded drug benefit plans in Canada except Quebec Payers for prescription drugs Public payers (governments, hospitals) 44% Private sector (insurance companies) 38% Consumer (out-of-pocket) 18%

7 Medical Devices in Canada Canada s Medical Devices Industry is dynamic, export-oriented Canada s medical devices sector encompasses about 1,500 firms employing 35,000 people and exported over $1.9 billion worth of medical devices in Demographic trends, developments in science and engineering, and changes in care delivery are contributing to the sector s growth. Canada s medical devices sector is highly diversified, R&D intensive, technology-based and export-oriented. The Medical Devices market is integrated and lucrative In 2012, the global market for medical devices was valued at US$327.7 billion, with the share of the United States spending assessed at US$188.9 billion on medical devices. Canada s medical devices market was estimated at $6.8 billion, ranking it ninth globally. Key business segments of sales in Canada are diagnostic apparatus, consumables, patient aids, orthopaedics and prosthetics. Thanks to North American Free Trade Agreement (NAFTA), Canadian companies have tariff-free access to the U.S. market for medical devices.

8 Medical Devices in Canada Canada s Key Strengths in the Medical Devices Industry Diversified, export-oriented and innovative sector Several specialised networks of world-class researchers Active in the areas of biotechnology, advanced materials, aerospace, microelectronics, telecommunications, software and informatics Examples of leading edge medical device products developed and/or manufactured by Canadian companies: The Neovasc Reducer and Tiara (Vancouver, British Columbia), Novadaq Technologies imaging systems (Toronto, Ontario) Medtronic CryoCath catheter-based products (Montréal, Quebec), Imaging Dynamics digitalradiography-imaging system (Calgary, Alberta), Epocal handheld blood-analysis systems (Ottawa, Ontario) Baylis Medical radio-frequency puncture systems (Montréal, Quebec and Toronto, Ontario) and MedMira point-of-care diagnostics (Halifax, Nova Scotia)

9 Medical Devices Market Access in Canada Health Canada - Medical Device Regulations (Food & Drug Act) Covers the manufacturing, advertising for sale and sale of a medical device Includes importation of a medical device for sale or use on individuals, other than importation for personal use Progressive licensing with Class I, II, III, & IV devices based on risk of harm Class II, III & IV requires ISO Quality Management System certificate Health Canada regulatory review standards: 90 days for Class IV 75 days for Class III 15 days for Class II Governments are payers and hospitals are the major buyers at 80% of market Fragmented path to market

10 Canada s Health IT Sector Canada s Health IT industry enjoys broad public and private support Health IT accounts for about 2% ($4.2 billion) of all healthcare ($211 billion) spend per year. The overall North American Health IT market is forecasted to grow at a compound annual growth rate of 7.4 percent to reach $31.3 billion by 2017 from $21.9 billion in 2012, according to Research and Markets North American Healthcare IT Market Report Canada s Federal and Provincial governments are committed to leveraging ICT technologies to make Canada s healthcare system a high quality and affordable model of healthcare delivery, with fewer inefficiencies. Out of this commitment evolved the Canada Health Infoway group ( Infoway ), an organization mandated to define and coordinate the implementation of Canada s national Health IT initiatives. As of December 31, 2013 the Federal government had provided over CAD $2 Billion to Infoway for the funding of 294 Health IT-related projects.

11 Strengths of the Health IT Sector Main factors behind the strength of Canada s Health IT industry The three major factors likely to propel the Canadian Health IT market are its publicly funded health structure, the prominent role played by Canada Health Infoway, and growing pressures to obtain a better return for every dollar spent on healthcare, due to an aging population and the rise in incidences of chronic diseases. The growing opportunity in the Health IT market has already attracted major global multinationals like Microsoft, Agfa, Siemens and Honeywell into offering Health IT solutions in Canada, in areas such as EMRs, doctor office s IT solutions, and patients mobile access. The talent pool is ready and available: several educational programs dedicated to the field of Health IT are offered in Canada, and Health Informatics educational programs continue to be a sought after field. Solutions provided by Canadian Health IT vendors cover several technology areas including Picture Archiving and Communication Systems, Drug Information Systems, Electronic Health Records, Electronic Medical Records, Clinical Information Systems, and Wireless & Communications.

12 Quality of Clinical Research Clinical Trials in Canada The quality of clinical research in Canada is outstanding, thanks to unique assets stemming from its demographics, health care system and labour force. These assets include Canada s ethnically diverse population, broad and universal healthcare coverage, world-leading universities, hospitals and health research centres staffed with highly qualified investigators who have expertise in all major therapeutic areas. The recently launched Canadian Clinical Trials Coordination center (CCTCC) is an organization whose main priority is to build on and further reinforce Canada s competitive clinical trials environment. Efficiency of Clinical Research Health Canada has decreased its target for the review of clinical trial applications to 30 days, and consistently meets this new goal. Setup times in Canada are among the best in the world, and it currently takes three months on average to set up a clinical trial here. KPMG s Competitive Alternatives report of 2014 gives Canada a 15.9 points advantage on competitiveness over the U.S. for the annual operational costs related to clinical trials administration centers.

13 Thank you Arigatō Stephen Dibert

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