American and British legislators show different approach towards on-line consumer drugs sale

Washington D.C. 10 January 2000The selling of pharmaceuticals via the Internet constitutes a hot issue governments have trouble dealing with. The problem takes the shape of a many-headed dragon, including various aspects. First of all, there is a growing tendency of pharmacies to go on-line and sell prescription drugs to their clients. In second place, policy makers are faced with the illegal Web-based sale of drugs, prescribed by doctors who are not entitled to perform such actions or on-line drugs delivery without any prescription whatsoever. Thirdly, the on-line sale of pharmaceuticals stimulates the illegal importing of medicine via unregulated foreign company Web sites.

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The North-American consumer market in particular is threatened and plagued by the illegal on-line sale of pharmaceuticals. This explains why the United States federal government has recently taken on a far more severe attitude towards drugs sale via the Internet than the British administration. The United Kingdom does not seem to be confronted as yet with the dubious practices of companies from overseas which are selling drugs of questionable quality via the Web. Consequently, the British Royal Pharmaceutical Society has succumbed to pressure from an Internet start-up to alter the guidelines endorsing the sale of pharmaceuticals on-line.

In the United Kingdom, the sale of prescription drugs on-line was prohibited by directives originally set out for high-street pharmacists before the birth of the Web. But in November last year, Pharmacy 2U defied the regulations by setting up an on-line pharmacy. Daniel Lee, managing director of Pharmacy 2U, stated that he saw the model being successful in the United States and he launched on November 22, 1999. The Royal Pharmaceutical Society came up to see the company and has since changed the regulations to enable the sale of medicines over the Internet.

In contrast with this flexible British regulation, the Clinton Administration on December 28, 1999 announced a proposed new initiative to protect the consumer from the illegal sale of pharmaceuticals over the Internet. This proposal, for which $10 million has been earmarked in President Clinton's Fiscal Year 2001 budget to hire 100 additional staff members at the Food and Drug Administration, would, if approved by Congress, put the federal government on the frontlines of overseeing the on-line sale and distribution of pharmaceuticals to consumers. The proposal however only deals with on-line pharmacies based in the United States, which would, for the first time, have to get approval from the federal government before they are allowed to sell drugs.

The initiative is targeted at "unethical" on-line physicians who prescribe pills to consumers they have never met in states where they are not authorised to work and at "unscrupulous, unlicensed", and "fly-by-night" pharmacies that put on-line consumers at risk. It would create new civil penalties for the illegal sale of pharmaceuticals, give federal agencies new authority to gather information to prosecute offenders, expand federal enforcement efforts, and also launch a new public education campaign about the potential dangers of buying prescription drugs on-line.

The proposal would establish an entirely new federal requirement to enable consumers to identify legitimate Internet pharmacy sites. Sites would have to demonstrate to the Food and Drug Administration their compliance with the federal and state law on pharmaceutical sales before receiving an approval to operate. It would create new civil money penalties of $500.000 per violation for the sale of prescription drugs to an individual without a valid prescription and provide the FDA with administrative subpoena authority to investigate potentially illegal Internet drug sales. The White House briefing portrayed the proposed programmes as necessary. While states license prescription drug sales in their states, the Internet goes beyond the state borders, so there is a necessity for the FDA to step in.

Some of the involved parties in the United States however are sceptic about the new legislative initiative and have pointed out that there are two sources of Internet rogue pharmacies, those in the United States and those overseas. Nothing in the administration's proposal would address the issue of overseas on-line pharmacies, that constitute a substantial part in the whole problem of illegal drugs sale via the Internet, according to their opinion. In any case, the Food and Drug Administration has already launched a Web page in order to inform the customer on the possible dangers of Buying Medical Products On-line.


Leslie Versweyveld

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