Pharmaceuticals and the Internet Drug Regulatory Authorities' Perspective - Joint NLN-WHI Workshop, 24-25 September 2001
(2002; 80 pages) Voir le document au format PDF
Table des matières
Afficher le documentExecutive Summary
Afficher le documentOverview of activities by the World Health Organization - Dr Lembit Rägo
Afficher le documentOverview of activities by the Nordic Council on Medicines - Dr Ola Westbye
Fermer ce répertoireCountry Experiences
Afficher le documentSweden: Publication bias of clinical trials - Dr Juliette Säwe
Afficher le documentThe Netherlands: Pharmaceuticals and e-commerce - Dr Hans Heuvelmans
Afficher le documentDenmark: Web site of the Institute for Rational Pharmacotherapy - Ms Karin Friis Bach
Afficher le documentDenmark: Danish Medicines Agency web site - Mr Karsten Jørgensen
Afficher le documentSouth Africa: The South African perspective on medicine regulation - Dr Wilbert Bannenberg
Afficher le documentTunisia - Dr Amor Toumi
Afficher le documentEstonia - Dr Main Uusküla
Afficher le documentBulgaria: Bulgarian Drug Agency - Rozalina Asenova Kulaksazova
Afficher le documentThe Danish Consumer Council - Ms Margrethe Nielsen
Afficher le documentSwedish Industry Association - Dr Håkan Mandahl
Afficher le documentIntroduction to discussion points - Dr Lembit Rägo
Afficher le documentQuality aspects - Dr Ola Westbye
Afficher le documentPilot study on drug regulatory web sites: Current status and future challenges - Ms Elodie Jambert
Afficher le documentThe WHO model web site for drug regulatory authorities - Dr Lembit Rägo, Ms Elodie Jambert, Mr Jorg Hetzke
Afficher le documentConcluding discussion
Ouvrir ce répertoire et afficher son contenuAnnexes
Afficher le documentReferences
Afficher le documentBack cover
 

South Africa: The South African perspective on medicine regulation - Dr Wilbert Bannenberg

Dr Wilbert Bannenberg
World Health Organization, South Africa

The current problem is that Internet pharmacies exist but the control is only on the physical movement of products. Another problem is that there are port health officials at main post offices and airports, but they are able to check only 5% of incoming parcels. There are counterfeit drugs, and 10% - 25% of the drugs are stolen. The private sector is where the expensive drugs are found. There are large differences between rich and poor countries and within countries, between urban and rural areas, between hospitals and clinics, white and black segments of the population, and men and women.

A consultation on drugs and the Internet was held by the Medicines Control Council of South Africa (MCC),* and all stakeholders were invited. The conclusions were that more information is needed. What can be done to improve the situation? What are the priorities? What is the impact of code-of-conduct and quality seals?

* The health sectors in South Africa cover 42 million people, 5.2 million (12%) of whom are HIV positive.

The Medicines Control Council is the DRA for South Africa. It has 24 members and is chaired by Professor Peter Eagles.

Much of the information available to consumers is misleading promotional material. The recommendations, therefore, were that information that is unbiased, objective, evidence-based, and comparative should be provided. Consumers have the right to such information, and e-mail and web sites are good communication tools. MCC has to set a good example.

Both good-quality and biased information is spreading fast through the Internet, which is why DRAs should treat dispensing good-quality information as an urgent priority.

Medicine is a combination of product, information, and context:

• The product is the chemical substance, the form and dosage, the packaging, the distribution system, and the brand name.

Information is an essential part of a medicine and should be objective. The following questions concerning information may be asked: Is the information objective? How should the product be used? How should it be prescribed? When should it be stopped?

• The context is culture, beliefs, attitude, perception, demand, use, and commercial pressures. The regulatory controls on medicines should focus more on the context, which plays an important role.

There are significant HIV/AIDS-related problems, but there is no advice from the government on how to provide information about HIV care, drugs and treatment guidelines, availability of drugs in the country, etc.

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Dernière mise à jour: le 19 janvier 2012