 |
 |
On 3 Nov 2000, at 10:29, Marjorie L. Moorefield wrote: > Good Morning Sid, > Since Canada and most, if not all European countries have > socialized medicine, how can whatever they do be compared > to our "Free Market" Health Care? > just me, > Marjorie > Hi Marjorie and All, We sorta have socialized medicine but with free market elements. And at a BIG cost... But the part Sid wanted to compare was the bureaucracies that control the new drug approval process... In the US - the FDA. In Canada - Health Canada's Health Protection Branch HPB Both require multi-phase clinical trials... Both require double blind studies over at least a year... Both are conservative govt. organizations... Perhaps someone who knows the processes first hand will comment. I personally think they are pretty similar in function. Here is a PHARMA press release from March... March 30, 2000 Canada's Health Care System Reduces Access to New Technology and Impacts Quality if Care for Patients, Says Study Washington, D.C. - Canada’s government-controlled health care system, with its strong emphasis on cost-containment, has adverse consequences on patient access to appropriate treatments, including innovative prescription drugs. That’s the key conclusion of a new study conducted by The Lewin Group for the Pharmaceutical Research and Manufacturers of America (PhRMA). "U.S. policymakers should be aware of the Canadian experience with health care cost-containment policies when considering changes to our own system," said PhRMA President and CEO Alan F. Holmer. "We should learn from Canada’s mistakes and not make the mistake of emulating that system." According to the study authors, the Canadian experience suggests that any cost savings that accrue from price controls are associated with a decline in the quality of health care and with public dissatisfaction. In fact, a recent survey found that 78 percent of Canadians believe their health care system is "in crisis." The Lewin Group study highlights many other problems in the Canadian health care system: Long waits for regulatory approval - Canadians wait on average 7 months longer than Americans for new medicines to be approved. Long waits for coverage of medicines - Even after a medicine is approved by Canada’s drug regulatory agency, patients must wait an average of 5 to 13 months longer before the medicine is put on each province’s formulary, or list of covered drugs. Cost-containment tools used by provincial governments limit the number of medicines available to patients. For example, patients in British Columbia are restricted to two medicines as first-line therapy for arthritis. Three anti-arthritic drugs widely used in the U.S. are not covered under any circumstances. According to Canadian patient groups, health problems have resulted from switching patients from medicines not on the formulary to covered medications. Canadians also experience long waits for physician visits, surgery procedures and high-tech diagnostic procedures. For example, Canadians wait an average of nearly 6 months for cardiovascular surgery and 5 months for a magnetic resonance imaging procedure (MRI). The study warns U.S. policy-makers that tinkering with our own system could result in similar quality problems, stating that "the delays in pharmaceutical access, coverage and reimbursement inherent to the Canadian system could be replicated in the U.S. if the federal government interferes with the free-market delivery of pharmaceuticals." http://www.phrma.org/press/newsreleases//2000-03-30.18.phtml Drug Development and Approval Process Phases of Product Development It takes 12 years on average for an experimental drug to travel from lab to medicine chest. Only five in 5,000 compounds that enter preclinical testing make it to human testing. One of these five tested in people is approved. http://www.allp.com/drug_dev.htm FDA Website http://www.fda.gov/sitemap.html U. S. Food and Drug Administration • Center for Drug Evaluation and Research http://www.fda.gov/cder/ FDA - CDER http://www.fda.gov/cder/regulatory/applications/default.htm From Test Tube To Patient: New Drug Development in the United States http://www.fda.gov/fdac/special/newdrug/ndd_toc.html Benefit Vs. Risk: How FDA Approves New Drugs http://www.fda.gov/fdac/special/newdrug/benefits.html Drug Approval Application Process http://www.pharmquest.com/source/regulatory/approval_application/index.html FDA Improves Drug Approval Process http://www.applesforhealth.com/drugapprove1.html Regulatory - International Sites (Check this one out Sid...) http://www.pharmquest.com/source/regulatory/international/sites.htm Canada - Health Protection Branch HPB http://www.hc-sc.gc.ca/hpb/index_e.html Therapeutic Products Programme: TPP-Web http://www.hc-sc.gc.ca/hpb-dgps/therapeut/htmleng/index.html An Overview of the Product Licensing Framework II September 1997 http://www.hc-sc.gc.ca/hpb-dgps/therapeut/zfiles/english/prod-lic/ovw-plf_e.html Product Licensing Framework II http://www.hc-sc.gc.ca/hpb-dgps/therapeut/zfiles/english/prod-lic/plf-ii_e.html Product Licensing Framework III September 1998 http://www.hc-sc.gc.ca/hpb-dgps/therapeut/zfiles/english/prod-lic/plfiii_e.html Cheers ............ murray [log in to unmask]