WHA47.16 (1994) WHO ethical criteria for medicinal drug promotion
Promoting Rational Use of Medicines: Core Components - WHO Policy Perspectives on Medicines, No. 005, September 2002
The following references are copied from WHO's Essential Medicines and Health Products Information Portal
BUKO Pharma-Kampagne and IPH Bangalore have made a survey of the business behavior of Bayer Health Care, Boehringer Ingelheim and Baxter in India. The results: these companies sell many irrational preparations and offer only few essential innovations. Bayer and Boehringer Ingelheim conduct numerous clinical trials in India, but they prefer to search for new applications of their blockbusters instead of doing research in the field of neglected diseases. Especially Boehringer Ingelheim has a poor pharmaceutical portfolio with 70% of irrational drugs and no essential preparation. On the other hand, the company renounce to strictly assume their patent rights in the case of nevirapine. This important Aids drug can therefore be generically produced in India at a low price, which ensures access to this drug for poor countries, in particular in southern Africa. Whereas 64% of Bayer products sold in India are rational, the aggressive patent policy of that German company blocks access to the innovative cancer drug sorafenib (Nexavar®). The company Baxter has a quite good product portfolio with 88% of rational products including 44% of essential drugs. But many of those products do not have a generic alternative in India. Their price is high and excludes the poor from access.
In today’s environment, the main focus of the critical mass towards the multinational companies is on access to new patented and more expensive products. Many of them essential medicines, but many more non-essential ‘me-too’ medicines developed to get a piece of the blockbuster cake or to go from one patent to the next (evergreening). However, there are also other issues that BigPharma could be confronted with and help us solve. One of them is unethical marketing of products with no medical value or which are potentially
This report describes ways in which pharmaceutical companies provide the public with information about diseases and conditions. It provides an overview of the various methods used, and the impact that public information campaigns can have. The aim of this report is to demonstrate how companies use public information campaigns about diseases and conditions as tools to market their medicines. In the research, we have carried out three case studies to demonstrate how various methods are applied and the parties are involved...
Consumers trust doctors to act in the best interests of their patients. However, most consumers are largely unaware of the influence of the pharmaceutical industry’s marketing on the very health professionals they rely on. Between 1995 and 2005, the percentage of total spending on sales and marketing was by far the biggest corporate expense for the pharmaceutical industry. The excesses of drug marketing are well recognised by industry insiders. A survey conducted by Price water house Coopers showed 94% of industry stakeholders said that pharmaceutical companies spent too much money on advertising.
In this report, Consumers International seeks to highlight the marketing practices in emerging and developing economy markets4 by leaders in the pharmaceutical industry. Since direct-to-consumer advertising (DTCA) is banned in most countries health professionals are the primary targets for the sales tactics of the drug companies. Consequently, the scope of our report focuses on doctor-directed promotion.
The World Health Organization (WHO) has developed a medicines strategy and established Ethical Criteria for Medicine Promotion, advertisement, and publicity, to support and promote the health protection of citizens through the rational use of medicines.
Considering the influence of medicine promotion, advertisement, and publicity on users and their consumption habits, and consequently the effect on health systems and the potential harmful results on individual and collective health, there is a need to improve, broaden, and define ethical criteria to strengthen public health protection and reduce risks associated to medicine use. Within this framework, it is particularly necessary to build awareness and protect the most vulnerable sectors of the population, such as children, the elderly, pregnant women, and persons with chronic diseases.
First, Do No Harm: Financial Conflicts in Medicine
(2013; 53 pages)
We explore financial conflicts of interest faced by doctors. Pharmaceutical firms frequently pay physicians in the form of meals, travel, and speaking fees. Over half of the 334,000 physicians in our sample receive payment of some kind. When a doctor is paid, we find that he is more likely to prescribe a drug of the paying firm, both relative to close substitutes and even generic versions of the same drug. This payment-for-prescription effect scales with transfer size, although doctors receiving only small and/or infrequent payments are also affected. The pattern holds in nearly every U.S. state, but it is strongly and positively related to regional measures of corruption.
The principal purpose of the first comprehensive evaluation of the World Health Organization (WHO) Good Governance for Medicines (GGM) programme covering the period 2004–2012 was to analyse experiences and identify in-country lessons after eight years of implementation. Given the WHO commitment to the goal of universal health coverage, and the central role of good governance in its achievement, the basic objectives of the GGM programme are highly pertinent and timely. The evaluation provides an opportunity to inform future work of countries, WHO and partners towards improving governance of the pharmaceutical sector. The importance of good governance for medicines is self-evident. According to the 2010 World health report, global health expenditure has reached US$ 4.1 trillion per year. Expenditure on pharmaceuticals accounts for some US$ 880 billion of this total. In most countries expenditure on pharmaceuticals comprises a large proportion of total health expenditure, both public and private. Effective management of pharmaceutical systems is therefore an essential element of wider health systems governance in order to ensure universal access to affordable, quality medicines and to prevent losses that may occur, including through unethical practices.
The basis for the GGM Programme is a series of WHO Medicines Strategies, beginning with the Second Strategy (2004–2007). The first of its four strategic priorities included "Promotion of ethical practices and development and use of anti-corruption measures in the pharmaceutical sector."
The specific objectives of the GGM Programme are to:
- raise awareness of the impact of corruption in the pharmaceutical sector, and bring this to the national health policy agenda;
- increase transparency and accountability in medicine regulatory and supply management systems;
- promote individual and institutional integrity in the pharmaceutical sector;
- institutionalize good governance in pharmaceutical systems by building national capacity and leadership.
Sir-Cardiovascular diseases are a major cause of death in many parts of the world. Smoking, a sedentary lifestyle, an unbalanced diet, hypertension, obesity, diabetes, and high blood cholesterol concentrations are some of the most commonly cited risk factors...
Spurling GK, Mansfield PR, Montgomery BD, Lexchin J, Doust J, et al. (2010) Information from Pharmaceutical Companies and the Quality, Quantity, and Cost of Physicians’ Prescribing: A Systematic Review. PLoS Med 7(10): e1000352. doi:10.1371/journal.pmed.1000352
Background: Pharmaceutical companies spent $57.5 billion on pharmaceutical promotion in the United States in 2004. The industry claims that promotion provides scientific and educational information to physicians. While some evidence indicates that promotion may adversely influence prescribing, physicians hold a wide range of views about pharmaceutical promotion. The objective of this review is to examine the relationship between exposure to information from pharmaceutical companies and the quality, quantity, and cost of physicians’ prescribing.
Methods and Findings: We searched for studies of physicians with prescribing rights who were exposed to information from pharmaceutical companies (promotional or otherwise). Exposures included pharmaceutical sales representative visits, journal advertisements, attendance at pharmaceutical sponsored meetings,mailed information, prescribing software, and participation in sponsored clinical trials. The outcomes measured were quality, quantity, and cost of physicians’ prescribing. We searched Medline (1966 to February 2008), International Pharmaceutical Abstracts (1970 to February 2008), Embase (1997 to February 2008), Current Contents (2001 to 2008), and Central (The Cochrane Library Issue 3, 2007) using the search terms developed with an expert librarian. Additionally, we reviewed reference lists and contacted experts and pharmaceutical companies for information. Randomized and observational studies evaluating information from pharmaceutical companies and measures of physicians’ prescribing were independently appraised for methodological quality by two authors. Studies were excluded where insufficient study information precluded appraisal. The full text of 255 articles was retrieved from electronic databases (7,185 studies) and other sources (138 studies). Articles were then excluded because they did not fulfill inclusion criteria (179) or quality appraisal criteria (18), leaving 58 included studies with 87 distinct analyses. Data were extracted independently by two authors and a narrative synthesis performed following the MOOSE guidelines. Of the set of studies examining prescribing quality outcomes, five found associations between exposure to pharmaceutical company information and lower quality prescribing, four did not detect an association, and one found associations with lower and higher quality prescribing. 38 included studies found associations between exposure and higher frequency of prescribing and 13 did not detect an association. Five included studies found evidence for association with higher costs, four found no association, and one found an association with lower costs. The narrative synthesis finding of variable results was supported by a meta-analysis of studies of prescribing frequency that found significant heterogeneity. The observational nature of most included studies is the main limitation of this review.
Conclusions: With rare exceptions, studies of exposure to information provided directly by pharmaceutical companies have found associations with higher prescribing frequency, higher costs, or lower prescribing quality or have not found significant associations. We did not find evidence of net improvements in prescribing, but the available literature does not exclude the possibility that prescribing may sometimes be improved. Still, we recommend that practitioners follow the precautionary principle and thus avoid exposure to information from pharmaceutical companies.
Is the Introduction of a Priori Control of Advertising of Medicinal Products for Healthcare Professionals Effective in Reducing the Risk of Misuse and Off-label Prescriptions?
(2013; 93 pages) [French]
The off-label uses of a drug have always existed: between 15 and 20% of all prescriptions are reported in the literature, even more in certain areas such as pediatrics, gerontology, or and oncology. Up to 78% of physicians have prescribed drugs for off-label uses according to a recent survey. If those are sometimes justified, recent incidents have shown failures in the whole chain of the drug industry involving many actors: from manufacturers, that sell the medicine to the authorities granting the marketing authorization and reimbursement, to prescribers and pharmacists, not to mention the more or less informed patients who seek and demands results.
In addition, studies show that drugs were involved in 40% of avoidable serious adverse effects. The definition of "avoidable" or "preventable" is "would not have occurred if the treatment had been in line with management considered satisfactory" or "situation that deviates from procedures or outcomes expected in a normal situation and that is or would be a potential source of harm." If medication errors are the most common causes of these unwanted side effects, off-label uses also contribute to them. However, the figures raise the question of the poorly managed uses of the drug...
Among all the provisions that concern the management of prescriptions for the proper use of drugs, there is one about the advertising of medicinal products to healthcare professionals. Indeed, since the budget for marketing and publicity represents approximately 23% of the pharmaceutical companies revenue, and the average yield in additional sales per dollar invested in pharmaceutical advertising was 8.34 USD in 2004, it has been established that the promotional efforts (advertising, sales representatives, congresses, medical journals ..) could have a negative impact on medical prescriptions going against health requirements, as was the situation in the Mediator case: thus, an a priori control of advertising has been restored.
We will consider the merits of this measure regarding both the off-label prescriptions and the misuses.
While international regulatory standards for pharmaceutical promotion exist, many countries, especially developing countries, are not able to adequately regulate pharmaceutical promotion due to lack of resources needed for pharmaceutical regulation or do not simply prioritize regulation of pharmaceutical promotion. In many instances, only self-regulation is implemented by the industrial associations, and the pharmaceutical and advertising industries. This set-up however may be problematic due to inherent conflict of interest in self-regulation.
The regulation of medicines promotion was identified as a critical priority in the Philippines in order to encourage rational use, ensure reasonable pricing of medicines and promote growth of SMEs. A system for pharmaceutical promotion which involves the civil society and other non-state actors as partners in the oversight and monitoring of promotional activities will be significant especially considering the limited resources allotted in the regulation of pharmaceutical promotions. Specific guidelines that define ethical promotion and identify penalties for infringements may also be helpful in ensuring quality use of medicines by patients and at the same time helping the pharmaceutical industry sustain their operations.
The general objective of this study is to propose various regulatory models on pharmaceutical promotions in the Philippines that articulate clear and active involvement of civil society and other non-government stakeholders.
Specifically it aims to:
- present examples/cases of effective civil society-participated regulatory models for pharmaceutical promotions in other countries;
- describe the current regulation process for pharmaceutical promotions in the country for the purpose of identifying its strengths, weaknesses and areas for improvement;
- propose alternative regulatory models for pharmaceutical promotions involving civil society and other non-government stakeholders; and,
- identify needs, resources and other requirements to support implementation of proposed alternative regulatory models.