Canada - World Health Organization Regional Office for Europe

More documents

Recommendations

Info

52 Health systems in transition Canada The constitution confers exclusive jurisdiction over the patenting of new inventions, including novel prescription drugs, to the federal government. The Patent Office is part of the Canadian Intellectual Property Office, a special operating agency associated with the Federal Department of Industry Canada. In the late 1980s and early 1990s, the federal government shifted policy direction by increasing patent protection to the OECD norm of 20 years and by abolishing compulsory licensing in an effort to increase the level of investment, research and development by the international pharmaceutical industry in Canada (Anis, 2000). At the same time, the federal government established the PMPRB to regulate the factory gate prices of patented drugs (see section 2.3.2). Provincial and territorial governments use a number of regulatory tools to contain the cost of their respective drug plans although these vary considerably across jurisdictions. These regulatory tools include reference pricing (reimbursing on the basis of the lowest cost pharmaceutical in a given therapeutic category), licensing, bulk purchasing, tendering and discounting (Paris & Docteur, 2006; Grootendorst & Hollis, 2011). 2.8.5 Regulation of medical devices and aids The federal government regulates medical devices through the Medical Devices Program in the Therapeutic Products Division of Health Canada. Diagnostic and therapeutic medical devices fall under one of the four enumerated classes in the Medical Devices Regulations of the federal Food and Drugs Act (see Table 2.4). The Medical Devices Program assesses the safety, effectiveness and quality of medical devices by a combination of pre-market review, post-approval surveillance and quality systems in the manufacturing process (Health Canada, 2007). Canada is also an active participant in the International Medical Device Regulators’ Forum, which is working towards harmonizing the regulation for medical devices in all participating countries. Health Canada is also engaged in two bilateral harmonization initiatives, one with the Food and Drug Administration in the United States to develop, manage and oversee a new process that will allow a single regulatory audit to satisfy the needs of multiple regulatory jurisdictions, and the second with the Therapeutic Goods Administration in Australia to mutually recognize Quality Management Systems certification for medical device manufacturers (Health Canada, 2007).
Health systems in transition Canada 53 Table 2.4 Health Canada’s medical device classification under the Food and Drugs Act Device class Risk Examples Licence requirements I Lowest Reusable surgical instruments, bandages and laboratory culture media II Low Contact lenses, pregnancy test kits, endoscopes, catheters III Moderate Orthopaedic implants, glucose monitors, dental implants, haemodialysis machines IV High Cardiac pacemakers, angiogram catheters, cranial shunts Source: Health Canada (2007). 2.8.6 Regulation of capital investment Device licence not required but establishment where device is made or distributed must be licensed Manufacturers require a Health Canada licence before selling or advertising medical devices. Manufacturers are also required to renew licence annually In contrast to the federal regulation of medical devices, capital investments in health care are regulated at the provincial level. In most cases, formal laws and regulation do not exist. Instead, P/T governments make an annual decision on capital projects through the budget process. Similarly, RHAs also make decisions based on their own annual budgets although P/T ministries of health make major capital investment decisions, such as new hospital construction. Independent hospitals make their own capital investment decisions but those that have contracts with RHAs will work in tandem with the RHAs on major capital expansions. Private health care organizations delivering non-medicare services, including long-term care, rehabilitation, dental and vision care services, are generally free to make their own capital investment decisions without regulatory oversight. In the 1990s, some provincial governments, such as Alberta and Saskatchewan, enacted laws to regulate the establishment and expansion of private facilities providing acute care services including surgery clinics (McIntosh & Ducie, 2009). Despite the rapid growth in private surgery clinics, most provincial governments have been slow to introduce comprehensive regulation and monitoring (Lett, 2008; Glauser, 2011).
Page 1 and 2:
Health Systems in Transition Vol. 1
Page 3 and 4:
Health Systems in Transition Gregor
Page 5 and 6:
Contents Preface . . . . . . . . .
Page 7 and 8:
Preface The Health Systems in Trans
Page 9 and 10:
Acknowledgements The HiT on Canada
Page 11 and 12:
List of abbreviations Abbreviations
Page 13 and 14:
List of tables and figures Tables p
Page 15:
Abstract Canada is a high-income co
Page 18 and 19:
xvi Health systems in transition Ca
Page 20 and 21:
xviii Health systems in transition
Page 22 and 23:
xx Health systems in transition Can
Page 24 and 25:
xxii Health systems in transition C
Page 26 and 27: 2 Health systems in transition Cana
Page 34 and 35: 10 Health systems in transition Can
Page 43 and 44: 2. Organization and governance Cana
Page 45 and 46: Health systems in transition Canada
Page 75: Health systems in transition Canada
Page 83: Health systems in transition Canada
Page 88 and 89: 64 8000 7000 6000 5000 4000 3000 20
Page 90 and 91: 66 6.0 5.0 4.0 3.0 2.0 1.0 Health s
Page 105 and 106: 4. Physical and human resources The
Page 107 and 108: 5 4 3 2 1 Health systems in transit
Page 115 and 116: 4.0 3.5 3.0 2.5 2.0 1.5 Health syst
Page 117 and 118: 1.0 0.9 0.8 0.7 0.6 0.5 0.4 1.2 1.1
Page 123 and 124: 5. Provision of services Although i
Page 127 and 128:
Health systems in transition Canada
Page 129 and 130:
Page 131 and 132:
Page 133 and 134:
Page 135 and 136:
Page 137 and 138:
Page 139 and 140:
Page 141 and 142:
Page 143:
Page 146 and 147:
122 Health systems in transition Ca
Page 148 and 149:
Page 150 and 151:
Page 153 and 154:
7. Assessment of the health system
Page 155 and 156:
Page 157 and 158:
Page 159 and 160:
Page 161 and 162:
Page 163 and 164:
Page 165 and 166:
Page 167 and 168:
Page 169:
Page 172 and 173:
Page 174 and 175:
Page 176 and 177:
Page 178 and 179:
Page 180 and 181:
Page 182 and 183:
Page 184 and 185:
Page 186 and 187:
Page 188 and 189:
Page 190 and 191:
Page 192 and 193:
Page 194 and 195:
Page 196 and 197:
Page 198 and 199:
Page 200 and 201:
Page 202 and 203:
Page 209 and 210:
The Health Systems in Transition pr
Page 211:
The European Observatory on Health
show all

Canada - World Health Organization Regional Office for Europe

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?