Finnegan's Take

Three years after it was proposed the EU Information to Patients Directive is in limbo

European health ministers have poured cold water on a long-standing EU proposal to allow pharmaceutical companies to provide information on medicines directly to patients.

Ministers say the Information to Patients Directive could increase red tape for government agencies and companies if they are required to vet information which is designed for public consumption.

EU law currently prohibits companies from advertising to consumers but, as part of the 2008 “pharmaceutical package” of new medicines legislation, the European Commission proposed allowing some factual information about medicinal products to be published in newspapers and magazines.

Consumer groups were sceptical of the original plan, fearing it would open the door to the kind of hard-sell drug advertising commonly seen on television in the United States.

MEPs were equally uneasy about some aspects of the Commission’s proposal and insisted that safeguards be put in place to ensure any information shared with the public is objective rather than repackaged marketing material.

The saga has been a case study in how the slow-moving machinery of EU legislation works: the Commission proposes a new law, MEPs amend it in several parliamentary committees before voting on it, and then it falls to the European Council where health ministers decide whether and how to implement it.

Inter-institutional power play

The law now under consideration bears little resemblance to the draft published in 2008. The directive has been in the works for so long that it has seen the election of a new European Parliament in 2009 and the appointment of a new European Commission in 2010.

Perhaps even more significantly, the directive was originally drafted by the Commission’s ‘Enterprise & Industry’ directorate which was then responsible for pharmaceuticals and was widely seen as having a pro-business agenda.

However, in 2010, responsibility for medicines was handed to John Dalli, the new EU Commissioner for Health and Consumers – himself a former Maltese health minister. This shifted the debate towards consumer protection and patient empowerment.

Companies say they want to share fact-based information about products in print and on the internet given the enormous amounts of data and opinion about medicines and diseases already accessible online, some of which is of dubious quality.

Consumer and patient groups argued that any information provided by industry would have to be vetted by independent experts before being put in the public domain and this was one of the aspects of the directive presented to health ministers.

It seems the directive is going nowhere fast as national governments say the need to cut red tape and contain costs for businesses trumps demands for high-quality information on medicines. Paola Testori Coggi, director general of the Commission’s health and consumers arm, said the delay is regrettable but she sees little prospect of an immediate break in the deadlock.

All pain, no gain

Without attempting to judge whether health ministers, MEPs or various arms of the Commission are ‘right’ in their approach to getting this law through, it’s safe to conclude that a huge amount of time and money has been wasted on this mangled legislation – and citizens are none the wiser and no better off.

And people wonder why the EU can’t tackle the ongoing debt crisis…

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