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Chapter 22-25 - very detailed txtbook notes!

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Health Studies
Michelle Silver

Chapter 22Profits first The pharmaceutical industry in CanadaCanadas researchbased pharmaceutical companies RxDformerly called Pharmaceutical Manufacturers Association of Canada PMAC The pharmaceutical industry has never claimed to be motivated byaltruism but rather by profit for survivalEli Lilly and Benoxaprofen Oprenshortly after drug appeared in British pharmacies British officials found out about the first of 8 deaths resulting from suspected adverse reactions to Opren that occurred between May 1 1981January 19829 months later in Canada after coming for trials Eli Lilly didnt tell Canadian officials about the reported deathsBristol Myers Squibb and Pravastatintried to block a study that showed that all statin drugs have similar effects so that it would not decrease their profitsMerck Frosst and VioxxDrug Vioxx made for arthritic pain showed increase in cardiovascular events such as heart attacks and strokesRefused to use patients with cardiac problems in their trials because of thisLed to thousands of heart attacks and strokes and deathsrdPharmaceutical industry is 3 place in all industries in terms of profitRxD believe that claims of high profits are an illusion created from treating their expenditures as expenses against current income rather than capitalizing these outlays as an investment itemAccounting rate of return could actually understate rather than overstate the real or economic rate of returnby allowing RxD companies to treat research and development as an expense the government is granting them an indirect subsidy to fund their risk taking effortsIndustry uses the high cost of research as a justificationindustry sponsored researchers claim that it costs about US 802 Million to discover and bring a new drug to the marketAlso claim that their costs are recovered in only 13 of new productsThis claim is refuted by others because they say that this estimate only considers new chemical entities NCEs that have been developed inhouse and doesnt include drugs that were developed conjointly with other institutions like the government universities and other companiesDrug prices in Canada were amongst the highest in the worldPatent protection was major causeDecision of liberal government was to extend compulsory licensing to allow companies to receive a license to import drugs into Canada rather than having to manufacture it hereBill C22Gave companies introducing new drugs a minimum of seven years and usually 10 years of protection from compulsory licensing and the introduction of generic competitionBill C91Because of NAFTA and TRIPS Trade related aspects of intellectual property rightsCanada completely eliminated compulsory licensing with this bill Bill S17 then further amended this bill to extend the patents of 30 drugs which added about 40 M to Canadas drug prescriptionsCGPACanadian Generic Pharmaceutical Associationlobbying arm of generic drug industryHealth products and food branchHPFBHighest governing body for pharmaceuticalsGoverns drug safety quality and efficacyClientele PluralismSituation in which state has high degree of concentration of power in one agency but a low degree of autonomyHPFB is perfect exampleState relinquishes some of its authority to the private sector actors who pursue objectives with which officials are in broad agreementAllows industry to draft new policies to be in charge of drug promotion2 Governing bodies in charge of advertising1 Pharmaceutical Advertising Advisory board PAAB and 2 Code of practice from RDBoth codes suffer enforcement problemsPrivate sector is now major funder of HPFB in Therapeutic Products Directorate TPD which regulates drug industry This is because of downsizing by the government because of federal deficitCost RecoveryThis is when the government cut down its funds for the HPFB for example and then turned to private sector to find funds for operatingUntil March 1997government controlled the advertising of OTCs Over the Counter Drugs but in April was turned over to Advertising Standards CanadaThis will probably lead to loosening of standardsThere is a regulation to ban the use of directtoconsumer advertising DCTA of prescription drugsBut companies are pushing against this and Zyban for smoking cessation was recently advertised to consumers and nothing happened to GlaxoSmithKlinePharmaceutical companies invested more money as a result of Bill C22 and C91But 40 of this money they invest were tax writeoffs anywaysIs Canada really getting a lot of benefit from RDFrom January 2000 to December 2004112 new active substances were marketed in Canada for Human use and only 12 of these we felt to be breakthrough medicationThe restoffered little or no therapeutic benefitsAnd also if these drugs were developed elsewhere they would have ended up in Canada anywaysRD industry may leave many questions untouchedFor example for reproductive healthThey would only fund research that would lead to a new patentable drug ignoring topics such as behavioural factors involved in the cause and prevention of infertilityAnother exampleOnly 211 largest RxD companies are investing in Malaria and non are investing in African Sleeping sickness
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