Dr Hans Heuvelmans*
Public Health Supervisory Service, Health Care Inspectorate, Netherlands

* Dr Hans Heuvelmans of the Netherlands Inspectorate is the only ‘cyber-drug-inspector’ among the European agencies.

There is nothing specific in the laws and regulations of either the European Union or the Netherlands on Internet matters and e-pharmaceuticals. While quality standards have been harmonized, the individual Member States are responsible for registration, and developing a standardized approach continues to be a challenge. For example, over-the-counter drugs can be obtained from drug stores in the United Kingdom and the Netherlands but not in all European Union countries.

It is also legal in the Netherlands and the United Kingdom to run an ‘Internet pharmacy’. The physical prescription needs to be sent to the pharmacy, but all other communication can be done via e-mail or the Internet. Examples of Internet sites targeted towards selling pharmaceuticals in the Netherlands include nine pharmacies, four drug stores, chat boxes, e-auctions, and apotheek.org. The success of these Internet pharmacies is based on the difference in manufacturers’ prices and taxation. For example, pharmaceutical prices in Germany are 30% higher than those in the Netherlands. The difference in taxes between countries ranges from 0%-25%, and costs for delivery can range from 20%-50%. Although less than 1% of drug sales are currently handled through the Internet, this can be expected to increase.

The types of activities carried out by the Health Care Inspectorate include monitoring information on pharmaceuticals, the trade in pharmaceuticals - both legal and illegal - and prescriptions. Sales of all kind of products, including controlled substances, are carried out on the Internet, and in addition to legitimate pharmacies and drug stores there are also many charlatans.

Information versus advertising

In the European Union, there are many legal cases against either Member States or companies testing the limits in areas where the regulations are not precise. The number of such cases is expected to increase because there are many areas not clearly covered by law. For example, some pharmacies in the Netherlands sell to Germany, which is legal in the Netherlands but illegal in Germany. These medications are delivered by courier service (as an extension of the pharmacy’s service, perhaps).

Measures for information, preparation, cooperation

How should we deal with these activities? What can be done? There are several actions that can be taken. There is information (based on day-to-day practice) that must be prepared, made accessible, and kept up to date. Working in cooperation with the public is important. Effective measures for control must also be taken when necessary. For example, the maximum fine for illegal handling of pharmaceuticals used to be US$4000 or a prison sentence of six months; the fine is now US$40 000 or a maximum of six years imprisonment.

One problem, however, is monitoring these activities, which can be a monumental job; at present, only 5% of the mail is screened in the Netherlands and the United States. Another problem is customs control. Inside the European Union there is no customs control, with free movement of products among Member States.

Many companies are trying to do a good job, but there is still a real need to protect and inform the public. While professional guidelines for pharmacy services online have increased, quality seals like those of the Health on the Net (HON) Foundation (http://www.hon.ch/home.html) and the Which? Web Trader can help consumers judge the quality of the information on a web site for themselves. A European working group is also currently drafting guidelines on the quality of health-related web sites [6]. The role of the health authority is to explain to consumers what can and cannot be guaranteed, but the question is how far we need to go in protecting the consumer.

In pharmaceuticals and e-commerce, there are both legal and illegal activities that are increasing over time. In order to monitor these activities and to protect consumers adequately, we need international contacts, and we have to use existing agencies such as WHO, FDA, etc.

Discussion and comments

Is there a web site for the public? It is under construction.

Are more specific regulations necessary? There is no need for more specific regulations at the moment. Present legislation is adequate for most issues, but no one can screen all web sites. Most information comes in via complaints.

Rogue web sites abound, and only rarely is one able to stop them. DRAs should concentrate on the physical distribution of drugs from these Internet pharmacies at post-offices and through courier agencies.

Biased information is a problem. The industry - the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) and the Association of the British Pharmaceutical Industry (ABPI), for example - has updated its voluntary codes to include promotion through the Internet [7].

Quality seals are sometimes misused and can be difficult to monitor. WHO and NLN have dropped their efforts, but IFPMA announced they will establish an industry quality seal soon. The HON code is the most widely known.