By Peter Pitts, President of the Center for Medicine in the Public Interest and former US Food and Drug Administration Associate Commissioner

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 fundamental human right. Yet when it comes to the regulation of medicines, the Europe Union’s highest court recently ruled that individual speech can be curtailed – or even banned. 

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

The case in question involves Danish journalist Frede Damgaard, who ran foul of Danish 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.

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 neighbour 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 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 medicinal 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.’

Journalists aren’t the only ones who will have to watch what they say. If providing information about a drug – even without employment, coordination, r a financial stake in the drug’s success –  constitutes advertising, then octors could face legal sanctions as well.

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 tsars 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.