The new rules would maintain the general ban on direct advertising for prescription drugs but would allow industry to provide "additional information" to the public via the media.
A proposed new Directive on information to patients is expected to be the most controversial element of the Commission's 'pharma package', which will contain other measures such as modernisation of rules on "pharmacovigilance" and an update of existing rules on counterfeiting.
But professional doctors associations, health NGOs and member state officials remain on high alert and wonder what more information patients could possibly need. The Standing Committee of European Doctors (CPME) stressed in particular that "the prescribing doctor is a fundamental supplier of information" and said it was not "appropriate to allow the industry to inform patients directly by any other means".
In addition, they are concerned that the new directive is buried in a "package", which will make it more difficult for EU lawmakers to handle at once in detail.
Some argue that the Commission's public consultation document, issued earlier this Spring, reveals radical changes to the legislation as it would allow industry to "push" information to patients. To balance this, it only proposes a complex 'post-hoc' monitoring and sanction system by national authorities.
Those opposed to the new rule argue that, if the industry were allowed to inform the public directly, a system should be put in place to oblige pharma groups to validate the information according to certain quality criteria. Allowing industry to "push" information to patients would also lead to increased or inappropriate consumption of medicines, they warn. This, they argue, is because patients would increasingly ask their doctors for prescriptions based on the advertisement and not according to their actual needs.
Brian Ager, the director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA), told EurActiv that the industry was "not that interested" in the push-side measures - and certainly not on TV or radio.
Instead, the industry would like to be able to provide the already approved information on its products on a more "digestable" and user-friendly form on the internet, said Ager. He said the industry thinks that patients need to be able to "pull" more information on the products they use if they wish to. Pharma companies could perhaps also produce leaflets on certain medicines, he added.
The final proposal is said to take largely account of the results of the High-Level Pharmaceutical Forum working group on information to patients. The forum has been working on the issue since 2005 and will present its final results on 2 October.
The "pharmaceutical package", which is due for publication in October or early November, will contain three separate initiatives under an "umbrella" Communication on the future of the single market in pharmaceuticals for human use, which will outline the Commission's vision, strategy and action plan for building-up a genuine single market for the sector:
- A Directive on information to patients concerning pharmaceuticals which will propose an information strategy for providing EU citizens with understandable good-quality, objective, reliable and non-promotional information about the benefits and the risks of medicines and treatments. It will maintain the current ban on direct advertising of prescription medicines and aim to clearly differentiate advertising and non-promotional information.
- A Regulation amending regulation on the authorisation and supervision of medicinal products for human and veterinary use and a Directive amending a Directive on modernising pharmacovigilance. The overall aim is to strengthen and rationalise the process of monitoring the safety of medicines, making sure legitimate drugs are marketed safely.
- A legislative proposal to combat counterfeit medicines for human use. It will propose a series of measures to protect citizens against the risk of counterfeit drugs by eventually banning repackaging of medicines.