EU to ease drugs ad rules in upcoming ‘pharma package’


Advertising rules for prescription medicines, which are currently banned in Europe, could be relaxed in one of the most controversial initiatives expected in the Commission’s upcoming pharmaceuticals package, due in October. 

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:  

  • 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.  
  • 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.

Hereunder is a selection of positions available on the Commission's consultation document on information to patients. To see all individual responses, click here.

The Ministry of Social Affairs and Health of Finland thinks that the information provided by the industry should not go beyond-the key elements in the Summaries of Product Characteristics (SPC) and Patient Information Leaflet (PIL). It states that "information produced by pharmaceutical industry is usually not objective and neutral. Therefore, even with the proposed quality criteria and supervision mechanisms it would be difficult to prevent advertising of prescription medicines to the public. This, in turn, will increase unnecessary consumption of prescription medicines, and hamper with drug cost containment efforts."

The French authorities agree with this position and state that, for them, objective and quality information should be disseminated by the national health authorities. 

Meanwhile, the National Health Service (NHS) of the UK thinks that the pharmaceutical industry "has a role to play" in providing information about their products to patients and the general public and argues that the UK's present risk-based approach is working well. Therefore the upcoming directive "should provide flexibility for these arrangements to continue", according to the NHS. 

The Swedish Medical Products Agency (MPA) also believes that EU patients "should have the possibility to get (“pull”) information from reliable, unbiased sources where the drugs are put into the perspective of other available alternatives" but is against allowing the industry to actively "push" information.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) underlines that the Directive should clearly define what is information and what is advertising, saying that a separate section should be created for the information part. "However, it should be absolutely clear that certain information must remain exempted from this categorisation (and thus also not fall under a system of "monitoring and sanctions")", it adds. 

EFPIA does not consider that television, radio and print mass media, as presented in the Commission consultation paper "would be appropriate ways for the industry to communicate information on specific prescription medicines" to EU citizens. 

The European Generic Medicines Association (EGA) would allow industry to provide patients who are actively searching for information [pull principle] with "the approved registration documents for their own medicinal products" via the company websites. The association believes that companies should not be allowed to publish information via other sources [push principle] "due to the possibility of this being used as a form of individual product promotion and the possibility of undue influence over patients".

The Standing Committee of European Doctors (CPME) underlines that "the prescribing doctor is a fundamental supplier of information to the patient within the context of the patient-doctor meeting". It is in favour of providing unbiased information about medicines to patients via information leaflets or "soft pull" methods. It is not opposed to the provision of information on the websites of pharmaceutical companies, but "does not think it appropriate to allow the industry to inform patients directly by any other means". 

The doctors also underline that a clear distinction between advertising and non-promotional information need to be considered before legal instruments are framed, but has "very considerable doubts that this is possible". CPME also fears that if industry is allowed to "inform" patients directly, it could result indirect advertising, and "interfere with the freedom for doctors to make prescribing decisions based on clinical judgement." 

As for the draft structure for monitoring and imposing sanctions, which proposes industry to inform national authorities upfront about their activities, CPME finds it "complex" and "a means to assist the industry in creating more direct contacts with patients".

In a joint European Social Health Insurance Forum position, the European Social Insurance Platform (ESIP) and the Medicine Evaluation Committee (MEDEV) express deep frustration on the Commission's consultation document. They criticise the consultation preceding and argue that the proposal "goes far beyond" the issues covered by the various consultations. ESIP and MEDEV argue that the document "opens the door to widespread abuse of what is already a very unclear distinction between what is information and what is advertising" and deplore that the "pushed" information on scientific studies related to medicines, prevention of disease, accompanying measures and prices will not be subject to validation prior to dissemination.

ESIP and MEDEV also argue that the Commission puts forward no evidence to support the assumption that allowing industry to provide information directly to consumer will reduce inequalities in access to good-quality objective, reliable and non-promotional information on medicinal products. 

"In the real world, it would be difficult to see what motivation industry had to provide information if it wasn't to promote its products. In the competitive pharmaceuticals market, companies are driven to champion their own medicines; conflict of interest therefore prevents them from providing the comparative yet unbiased information that patients need to make an informed decision about their medication," they state. 

The European Public Health Alliance (EPHA) EPHA believes that the current EU legislation regarding the prohibition of advertising on prescription only medicines "should not be relaxed in any way" and that healthcare professionals should remain the primary source of health information.  

It also expresses its "deep concern over the lack of transparency and representation in the role and set up of the Pharmaceutical Forum, whose conclusions have been both taken up as legitimate in the present legal framework as well as used as reference criteria." 

Furthermore, EPHA expresses concerns about the impact assessment study outsourced by the Commission to Europe Economics. "The process has been surrounded by a severe lack of transparency and its results are not yet available." It therefore stresses the necessity to complete the impact assessment prior to the discussion of any changes to the present legislation. 

The European Federation of Magazine Publishers (FAEP) strongly supports the Commission's approach "to allow the dissemination of validated quality health information in Europe" to allow citizens access the information they are asking for. "No media should be excluded from disseminating this validated health information," it added.

The Health Communications Council (HCC) of the European Association of Communications Agencies (EACA) also supports proposals to "allow information to the public via pushed media as well as on internet websites for medicinal products and prescription medicines". 

Current EU legislation allows advertising of non-prescription medicines that are not reimbursed but bans direct-to-consumer advertising (DTCA) for prescription medicines. It does not include detailed provisions on information on medicinal products, nor prevents member states from establishing their own approaches regarding the issue as rules on advertising are respected. Therefore, the practices may differ between the EU-27. 

For long, the pharmaceutical industry has wanted a change to the EU law on DTCA on prescription medicines to patients as it believes it has too little freedom to inform patients on the products it is legally liable for. DTCA of prescription medicines is currently allowed, for example, in the United States and New Zeland but there is a big debate there on whether the law should be changed.

A Commission report on current practices with regard to information provision on medicines in the EU-27 concluded, in December 2007, that the lack of a Community legal framework for the rules and practices on the issue results in unequal access to information and variable quality of information.

  • 2 Oct. 2008: The High Level Pharmaceutical Forum will present its final conclusions.
  • Oct./Nov. 2008: The Commission will present the pharmaceuticals package.

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