Dr Lembit Rägo
Department of Essential Drugs and Medicines Policy, World Health Organization, Geneva
The Fiftieth World Health Assembly requested the Director-General of the World Health Organization (WHO) to collect information on the various aspects and consequences of using the Internet in collaboration with drug regulatory authorities (DRAs), national and international enforcement agencies, consumer groups, professional associations, and the pharmaceutical industry and to convene a WHO ad hoc working group to consider and review the relevant issues . The Fifty-First World Health Assembly requested the Director-General of WHO to review existing legislation, regulations, and guidelines on the Internet and to educate Internet users by developing a guide on medical products and the Internet . In response to this, WHO published the booklet Medical Products and the Internet: A Guide to Finding Reliable Information , which, in addition to English, is available in many other languages, such as Spanish, Italian, Estonian, etc. The guide was intended to serve as a model for Member States to adapt into locally meaningful advice for Internet users in order to help them obtain reliable, independent, and comparable information on medicinal products.
Since then WHO has been keeping communications open with regulatory authorities, industry, consumers, and other involved parties. WHO has prepared a draft Model Web Site for drug regulatory authorities in order to improve access to the regulatory information. It has also made efforts, in collaboration with the World Intellectual Property Organization (WIPO), to control the use of international nonproprietary names (INNs) of drugs as domain names on the Internet. WHO, along with the pharmaceutical industry, is of the opinion that the system designed to facilitate universal identification of active pharmaceutical substances is threatened by companies and individuals registering INNs as Internet domain names. Examples of this include www.sanquinavir.com, www.omeprazole.com, and www.paroxetine.com. There is also the fear of cybersquatters registering a large number of INNs in the hope of selling them for profit, as has been the case with names of countries and personalities. After discussions with WHO and the pharmaceutical industry, WIPO has suggested a ban on the registration of exact INNs because “without any external control over the veracity and reliability of the information relating to the INN, there are risks of confusion posed to health professionals and consumers” .
WHO has also discussed with its partners further steps to be taken to minimize the public health risks of Internet sales of pharmaceuticals. To clarify how WHO Member States regulate e-trade, a questionnaire was prepared and sent to all 191 Member States. Over one-fourth (58) of the countries replied. Only five countries declared that they specifically regulate the promotion and sale of pharmaceuticals through the Internet, but a wide range of sanctions, such as revoking licences, confiscating drugs, imprisonment, and applying financial penalties, was reported. Moreover, very few countries effectively control the export of drugs, which can result in the import of counterfeit or substandard drugs, or of drugs that are unregistered in the receiving country. At the same time, the purchase - and import - of medications via the Internet is often accepted for ‘personal use’. These current practices give good grounds for safety concerns.