The Pharmaceutical Industry and Health Canada: Values in Conflict?…
The Pharmaceutical Industry and Health Canada: Values in Conflict?
According to the Food and Drugs Act (Federal legislation dealing with medicines), Health Canada can order the withdrawal of any medication without first consulting with the company that makes it
Companies are often extremely reluctant to lose products, especially if they are ones that are generating large sales revenue
Most serious deficiency in Health Canada's powers is its lack of the authority to require the manufacturer to undertake any new studies into the product's safety once a drug is on the market
In past five or six years, Health Canada has embraced a concept known as "smart regulation." This means that Canada should "regulate in a way that enhances the climate for investment and trust in the markets" and "accelerate reforms in key areas to promote health and sustainability, to contribute to innovation and economic growth, and to reduce the administrative burden on business"
"Risk management" is an element of smart regulation that has an essential role in building public trust and business confidence in the Canadian market and regulatory system.
"Precautionary Principle:" Means not only taking into account known risks of a drug but also potential risks even if the evidence for them is weak. In these circumstances, the precautionary principle would say that the product should either not be marketed or should be marketed under significant restrictions.
Characteristics of the Pharmaceutical Industry
Capitalist economy - Main goal is to make profit
Profits and Public Values
When profits and the public interest conflict, companies put their financial interests first
Uses 2 main arguments to justify its high profit levels. First, it claims that discovering new drugs is a highly risky venture where only 1 in 10,000 chemicals that are initially screened ever makes it to to market. Second, is the high cost of developing a new drug.
Driven by a block-buster mentality
Companies are almost exclusively focused on products that can be patented & that will be used by large numbers of people with chronic diseases who live in First World countries
Value of Research Done in Canada
The research that the pharmaceutical industry conducts in Canada is largely comprised of clinical drug trials (Testing drugs on humans)
Research in this industry may leave many questions untouched
Focuses the attention at therapies directed at the individual rather than looking more broadly at the social causes of many problems
If there is little research funding available to look at the socio-economic construction of sexual practices then researchers will ignore this area
Besides visiting doctors' offices and leaving samples behind, pharmaceutical companies engage in a variety of other forms of direct and indirect promotion
Direct promotion: Advertising in medical journals and providing hospitality to doctors "in order to facilitate greater interaction around the company's business"
Indirect promotion: Companies will, under certain circumstances, be able to "provide financial support for maximum of ten individuals to attend an international CHE event"
When new drugs are marketed, they are promoted extremely heavily in order to start generating revenue for the company involved
User Fees in Drug Regulation and Their Consequences
Health Canada has traditionally been under-resourced for the activities it is required to undertake with respect to prescription and non-prescription medicines
Operates through a system known as "clientele pluralism:" A term that describes the relationship between agency of the state and the industry that it is charged with regulating, whereby some of the authority of the state is transferred to the industry
The state has a high degree of concentration of power in one agency - Health Canada - but a low degree of autonomy
The Canadian government regulation of drug safety, quality, and efficacy is almost solely the responsibility of Health Canada
Regulation of Promotion
The Food and Drugs Act gives the Canadian government the theoretical ability to regulate all forms of drug promotion; however, under the model of clientele pluralism, the government has turned its authority over to the brand-name pharmaceutical industry and the Pharmaceutical Advertising Advisory Board
"Self-regulation:" The process by which an industry is allowed to regulate its own behaviour
The governments and pharmaceutical manufacturers' associations have different missions and goals
Mission of the government: To protect public health by encouraging rational prescribing
Mission of trade association: Primarily to increase sales and profit