European Ban on Positive Coverage of Unapproved Drugs Tramples on Free Speech

Viewpoint: Recent Ruling Expands Definition of Advertising in Frightening Ways

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Peter J. Pitts
Peter J. Pitts
Does the European Union believe in the right to free expression? It certainly claims to. Indeed, most of its member countries have legally enshrined it as a foundational human right. Yet when it comes to the regulation of medicines, the European Union's highest court says that individual speech can be curtailed -- or even banned.

The European Court of Justice (ECoJ) recently ruled that writing positively about drugs that haven't been approved for sale by government officials constitutes advertising and thus can be prohibited. This ruling has potentially disastrous ramifications on medically oriented free speech in Europe.

A major case in question involves Danish journalist Frede Damgaard, who ran afoul of his home country's courts in 2003 when he published information online about the health benefits of a pain killer named Hyben Total.

The trouble wasn't that what Damgaard wrote was untrue. Nor was it that Damgaard was on the payroll of the manufacturer, Natur-Drogeriet -- he wasn't. The court cared because Hyben Total had lost its Danish marketing license in 1999 when the government's drug regulator reclassified the product as a "food supplement," meaning it couldn't legally be advertised.

Damgaard's writings were deemed "advertising," and banned. He appealed to the ECoJ, which upheld the lower court's ruling.

The crux of the matter, then, is: What constitutes "advertising"? Europe already bans all direct-to-consumer drug advertising on the grounds that it manipulates consumers rather than informs them.

The ECoJ expands that already strict definition in frightening ways. Anything one writes or says can count, even if the person "is acting on his own initiative and completely independently of the manufacturer and the seller of such a medicinal product," according to the ruling.

Like journalists? Or patient groups? Or doctors? Yes. It's carte blanche for an almost complete gag order on anyone who wants to discuss anything to do with medicines.

Such a standard could have a chilling effect on free speech. Must bloggers writing for foreign audiences refrain from commenting on banned drugs or face prosecution? Hyben Total is still legal in Denmark's neighbor countries Norway and Sweden. Damgaard, writing online, could have been targeting readers outside his home country. Now it seems that even that sort of writing will be prohibited.

Susie S. Ekstrand, of the Danish law firm Lett, puts the matter into perspective: "This ruling is significant because it means anything written about a product that may be deemed [as relating to medicine] in one member state, can be deemed inappropriate and consequences may follow for the author. ... It is a restriction of freedom of speech and journalists need to be careful now, especially those writing online across many member states."

The Council of Europe, which drew up the Convention language in 1950, represents dozens of countries. Denmark was a founding member. Yet, now, the Danish courts and the ECoJ see nothing wrong with obliterating the right to free speech and controlling what citizens can learn about drugs government regulators don't approve.

Put bluntly: If governments don't want citizens to know about a new drug, they now have legal authority to stop anyone who spreads information they don't want people to know.

That's certainly a convenient set-up for the drug czars who decide which drugs the public can access in the first place. What bureaucrat wants to be second-guessed by a meddling citizen, anyway?

Not surprisingly, Danish officials claim the ruling is part of an effort to protect the interests of the public. It looks like the only interests they're protecting are their own.

Where is the European media's outrage on this ruling? And what will we hear from their American cousins?

Peter J. Pitts is partner/director-global health at Porter Novelli, president of the Center for Medicine in the Public Interest, and a former FDA associate commissioner.
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