Healthy Skepticism Library item: 4074

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Lexchin J.
Drug makers and drug regulators: too close for comfort: A study of the Canadian situation
Social Science and Medicine 1990; 31:1257-1263

Abstract:

(Limited to parts of article dealing with promotion.) The pharmaceutical industry and the Canadian state interact in a relationship termed clientele pluralism. In such a relationship the state relinquishes some of its authority to private-sector actors, who in turn, pursue objectives with which officials are in broad agreement. In the Canadian situation, one example of this is in the regulation of promotion. Although the Health Protection Branch has the legislative authority to control promotion, it has traditionally turned over this power to the pharmaceutical industry.
Canadian drug laws and regulations have been made increasingly more stringent over the past 40 years and are now considered among the strictest in the world. However, there are still major gaps in the Canadian regulatory process. These deficiencies exist primarily in the areas of the evaluation of the efficacy of ‘old’ (pre-1963) drugs; the reporting of adverse effects of both old and investigational new drugs; and the requirements for and monitoring of clinical drug trials. Each of these problems are discussed and where possible concrete examples are used to show how these gaps have either directly or potentially endangered the health of Canadians. It is the thesis of this paper that these deficiencies result from the close working relationship between the Health Protection Branch, which is responsible for regulating drug safety, quality and efficacy, and the Pharmaceutical Manufacturers Association of Canada, representing the multinational companies. These two groups interact primarily through an extensive system of liaison committees that allow the PMAC to participate in the early stages of drug policy formation. Other groups such as workers and consumers are excluded from such discussions. The HPB has also ceded responsibility for enforcement of regulations to the PMAC in the areas of quality control of manufacturing and pharmaceutical promotion. Restricting the interactions between HPB officials and the drug companies is not a viable option. As long as the present arrangement is in place with privately owned companies being regulated by government, a situation that is likely to prevail for the foreseeable future, then it will be necessary for the two groups to have frequent and close contacts.

Keywords:
*analysis/Canada/regulation of promotion/Health Protection Branch/clientele pluralism/ Pharmaceutical Advertising Advisory Board (Can)/ Pharmaceutical Manufacturers Association of Canada/ Code of Advertising Acceptance (PAAB)/ Code of Marketing Practices (Can)/preclearance of advertisements/REGULATION, CODES, GUIDELINES: AUTONOMOUS BODIES/REGULATION, CODES, GUIDELINES: COMPLIANCE, SANCTIONS, STANDARDS/REGULATION, CODES, GUIDELINES: DIRECT GOVERNMENT REGULATION/REGULATION, CODES, GUIDELINES: INDUSTRY SELF-REGULATION Canada Clinical Trials Consumer Product Safety/legislation & jurisprudence Drug Evaluation Drug Industry* Government Agencies* Humans Legislation, Drug* Technology, Pharmaceutical/legislation & jurisprudence