Healthy Skepticism Library item: 19867

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

Towards a New Strategy
Health Horizons 1997; 33:

Abstract:

Unethical drug promotion continues

There is evidence that unethical drug promotion continues to be a problem in many parts of the world, particularly in developing countries “where pharmaceutical regulatory capacity is often weak or even non-existent”, according to international healthcare observers.

Health experts recognize that it is now necessary “to bridge the gap between policy and practice” and recommend that “any strategy or operational plan should look not just to government but to all actors in the pharmaceutical sector”, including educators, health professionals, consumers and the pharmaceutical industry.

Ethical drug promotion is of “vital importance” if drugs are to be used properly and safely, and “it should be in keeping with national drug policy”, experts stated in a recent meeting in Geneva, during which two multicountry studies on the implementation of the WHO Ethical Criteria (one in certain countries of Latin America, the other in countries of the Western Pacific and South East Asia) were reviewed. The findings showed that in some countries legislation exists that could be used to control drug promotion; but often this legislation omits areas of drug advertising covered in the Ethical Criteria and in industry self-regulatory codes and mechanisms – such as the IFPMA Code. According to the studies, regulatory authorities do not have the financial resources nor the qualified personnel to control drug promotion, and very few countries have adopted regulations based on the Criteria. “They should do so urgently”, the experts declare.

Industry sources emphasized the high degree of correlation in the positions in the Ethical Criteria and the IFPMA Code and called on interested organizations and key actors in the field to make use of the Code. They stressed that the adverse publicity aspects of the self-regulatory industry Code constituted “the most effective disciplines on promotional behavior of companies”.

Industry specialists also underlined the importance of any analysis of promotional activities clearly distinguishing “between IFPMA-associated companies – who must adhere to the Code – and local companies which frequently dominate the local market in the volume of prescriptions filled”. Next to the legitimate issues surrounding promotion of pharmaceuticals, industry experts are of the opinion that “some other priority – and as legitimate – issues should be addressed in a global health strategy concerning pharmaceuticals”, for example, innovation, finding new treatment for diseases, access to quality medicines in developed and developing countries, and counterfeiting.

The international expert group agreed on recommendations to enhance the “awareness and adoption” of the Ethical Criteria and of self-regulatory industry codes, to promote “coverage and enforcement” of provisions governing drug promotion, and to develop instruments to monitor drug promotion, and to develop instruments to monitor drug promotion. The industry committed itself to ensuring “wide distribution of information” about the IFPMA Code to relevant government officials and medical associations, especially in developing countries, and to reducing “any gaps that may exist within the industry” regarding the knowledge of the Code and “the necessity to apply it in all promotion practices”.

Self-regulation of Marketing Practices
The position of the pharmaceutical industry

“The global pharmaceutical industry is the primary source of information about its products and recognizes its responsibility for ensuring that this information is accurate and does not mislead.”

“The promotion and marketing of a new pharmaceutical product is an essential extension of the research development and authorization of the product. Control over promotion and marketing is exercised by the pharmaceutical industry at both international and national level through a variety of codes and self-regulatory mechanisms. These work alongside government regulatory measures where they exist, and provide the necessary safeguards, where regulations is weak or non existent.

“At the international level the IFPMA Code of Pharmaceutical Marketing Practices is the self-regulatory code which applies to industry promotion of medicinal products intended for use under the supervision of a healthcare professional. The Code is binding on the companies within the membership of the Federation wherever they market the products worldwide.”

“Control at international level is also exercised by the internal guidelines and operating procedures developed by global companies to cover their marketing operations in all parts of the world.”

“At national level, self-regulatory codes, drawn specifically to meet local circumstances and requirements and incorporating the principles set out in the IFPMA Code are operated by local associations which represent the pharmaceutical industry in that country”.

“All self-regulatory measures, however, work on the principle that national regulatory requirements decisions and procedures must take precedence.”

Self-Regulatation of Marketing Practices
International Pharmaceutical Issues Handbooks