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Unethical pharmaceutical promotion rampant in African countries


A new study undertaken by HAI Africa and presented during the HAI briefing session on Rational Use of Medicines and pharmaceutical promotion, at the just concluded 62nd World Health Assembly in Geneva, revealed how unethical medicine promotion is rampant in five African countries. The study, entitled “Measuring unethical Pharmaceutical Promotion: A study of Advertising in Five African Countries” conducted in Kenya, Uganda, Zambia, Malawi and Madagascar showed how pharmaceutical companies use unethical means to promote their medicine.

Presenting preliminary results of the study HAI Africa’s intern Carole Piriou said although most of the countries involved had some form of regulation on pharmaceutical promotion, there was lack of enforcement of the regulation leading to inappropriate advertisements aimed at health workers and the public.
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Ms Piriou, who is a Masters of Pharmaceutical Sciences student ( Utrecht University, the Netherlands), noted that none of the advertisements published in 2008 in the medical journals studied met all the criteria assessed as by the World Health Organisation's (WHO) Ethical Criteria on Medicine Drug Promotion.

The journals studied were three leading medical journals in East and Central Africa: the Pharmaceutical Journal of Kenya, East African Medical Journal and East and Central African Journal of Pharmaceutical Sciences.   

She said for advertisements to the public, less than half of the materials promoted only approved indications. “In all countries studied except Madagascar, less than 40 percent of the materials mention safety claims,” she revealed. In Madagascar, a significant percentage of advertisements were from France.

The study further found out that only 16 percent of the promotional materials meet all the criteria assessed which include: name of active ingredient, brand name, name and address of manufacturer, use of the word safe only if qualified and major approved indications, major precautions, contraindications and warnings.

Ms Piriou, however, noted that although some advertisement fulfilled all the ethical criteria, they could not be deemed completely ethical because they were clearly promoting the use of branded products over generics and discouraging substitution.

She said the WHO ethical criteria for print advertisement was used for assessment because it provides very precise requirements. “We chose to assess only the criteria to which an objective “yes” or “no” could be answered as to their fulfilment,” she stated and added that given the absence of National Formularies in all the countries involved in the study, the latest edition of the British National Formulary (BNF) was used to address those criteria needing a widely accepted technical reference.

For the advertisements targeted to health professionals, all the advertisements did mention the brand name of the product advertised, but 30% failed to mention its generic name. Less than two thirds of the advertisements limited their claims to the approved indications as compared to the information given in the BNF.

Less than a third of the advertisements accurately depicted the safety information related to the use of the medicines promoted, such as side effects and adverse reactions, contraindications, precautions, warnings, and interactions with other medicines, although those are crucial for appropriate prescribing. She is however quick to note that none of the advertisements assessed did comply with all the criteria.
National regulations

On countries' regulations as regards pharmaceutical promotion, a review of the legislation in the 5 countries revealed very disparate status, with some countries having specific legislation concerning print advertisement such as Kenya, Malawi and Uganda, and while Madagascar and Zambia did not mention medicines promotion. On the other hand, Kenya and Uganda had guidelines for print advertisement while Madagascar, Malawi and Zambia did not.

However, this did not seem to have an influence on the end-point outcome; the level of compliance with the WHO Ethical Criteria. The study established that there is low compliance with WHO Ethical Criteria for print advertisement in the countries studied, as has been found in other parts of the developing world.
 
The study also realised that WHO Ethical Criteria alone are not sufficient enough to tackle certain aspects of unethical pharmaceutical promotion, such as generic substitution.

The study at the same time confirmed that regulations concerning medicines promotion exists in countries, but are poorly enforced and recommended that regulation on promotion should be strengthened in line with the recommendations of resolution WHA 60.16 on rational use of medicines.

HAI Africa proposes education of consumers and health professionals about pharmaceutical promotion so as to safeguard public health and avoid spending on unnecessary medicines.

Next steps
•    HAI Africa plans to raise awareness among consumers, regulators and health professionals about unethical medicine promotion. In this regard HAI Africa will publish the methodology to extend the study to other countries.
•    HAI Africa will also contribute to the drafting of model regulations for national medicines regulatory agencies and work with governments and consumers to monitor their implementation

Contact Information

Health Action International (HAI) Africa Office
4th Floor, Top Plaza off Kindaruma Road Suite 4-2
P.O Box Nairobi - Kenya
Tel: +254 20 2692973 ext 108, Cell phone: + 254 0733 398654.
E-mail:info@haiafrica.org, Web:http:// www.haiafrica.org