WHO definition of drug promotion; “All informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs. “By other words; “any activity undertaken, organized or sponsored by a member company which is directed at healthcare professionals to promote the prescription, recommendation, supply, administration or consumption of its pharmaceutical product(s) through all media, including the Internet.”
Health professionals are exposed to many types of promotion in their daily work. To varying degrees, regulations exist to govern these activities in order to ensure proper prescribing and to protect public health.
Reasons for regulating drug promotion and marketing
Drugs are not ordinary consumers’ products. In most instances, consumers are not in a position to make decisions about when to use drugs, which drugs to use, how to use them and to weigh potential benefits against risks as no medicine is completely safe. Professional advise from either prescribers or dispensers are needed in making these decisions.
However, even healthcare professionals (medical doctors, pharmacists) nowadays are not in capacity to take informed decisions about all aspects of medicines without special training and access to necessary information. The production of medicines, their distribution and dispensing also requires special knowledge and expertise.
Due to sophisticated scientific issues related to medicines just any medical training may not be enough to take fair judgments about their safety and efficacy. Also only basic training in pharmacy may not enable to take proper judgments about medicines quality.
The use of ineffective, poor quality, harmful medicines can result in therapeutic failure, exacerbation of disease, resistance to medicines and sometimes death. It also undermines confidence in health systems, health professionals, pharmaceutical manufacturers and distributors.
Money spent on ineffective, unsafe and poor quality medicines is wasted – whether by patients/consumers or insurance schemes/governments. Governments have the responsibility to protect their citizens in the areas where the citizens themselves are not able to do so.
The pharmaceutical industry provides a valuable and legitimate contribution to society, at the same time, the pharmaceutical industry is a business and its profits are heavily dependent on marketing. The greater the volume of medicines sold, the greater the return on investments.
Promotion is a key factor driving sales volumes, when product sales are given priority over public health, promotion can lead to over-prescribing as well as poor quality prescribing and medicine use. Physicians, pharmacists, researchers, educators, managers and administrators need practical guidance on how to understand and manage their interactions with industry. At the same time, the pharmaceutical industry needs guidance about how to implement its marketing practices so that health outcomes are improved.
The key ethical basis for any guidance is the understanding that the values of clinical care, of the welfare of society and of science should prevail over commercial imperatives and monetary concerns.
Provisions in law governing pharmaceutical promotion usually include four key criteria concerning the information provided in advertising.
• It must be consistent with approved product information;
• And the information must be accurate.
• Balance the risk and benefit information
• Only include information that is supported by strong evidence
When a pharmaceutical product is approved for marketing, it is accompanied by approved product information.
This specifies the use or uses for which the medicine has been approved (indication), dosage and administration, precautions and warnings and information on contra-indications, adverse effects and interactions with other medicines.
For manufacturers’ advertising to be consistent with approved product information, it must stick to approved indications and conditions of use. For example, if a medicine has only been approved for epilepsy, a manufacturer may not advertise it for bipolar disorder or depression.
Physicians, on the other hand, can legally prescribe a medicine for whatever use they wish, within restrictions that may be imposed by employers and institutions. Prescribing for an unapproved use is called ‘off-label prescribing’. A manufacturer may apply for approval for an additional indication for its medicine.
However, until that use is approved, the company cannot legally promote the medicine for that indication. A medicine may be approved for different uses in several countries, which also leads to variations in the promotional claims that can be made legally in different countries.
Ethical issues and guidelines
In addition to prohibiting small gifts and reminder items such as pens, notepads, staplers, clipboards, pill boxes, etc.
Prohibits company sales representatives from providing restaurant meals to healthcare professionals, but allows them to provide occasional meals in healthcare professionals’ offices in conjunction with informational presentations”
Includes new provisions requiring companies to ensure their representatives are sufficiently trained about applicable laws, regulations, and industry codes of practice and ethics
Provides that each company will state its intentions to abide by the Code and that company CEOs and compliance officers will certify each year that they have processes in place to comply.
Includes more detailed standards regarding the independence of continuing medical education.
Provides additional guidance and restrictions for speaking and consulting arrangements with healthcare professionals.