2008 could see the beginnings of an increased role for the pharmaceutical industry in providing medicines information to patients and consumers in the European Union, following the publication of the European Commission’s long-awaited Report on Current Practice With Regard to Provision of Information to Patients on Medicinal Products.

The report is highly critical of current levels of access to information throughout the EU which, it says, remain “very unequal,” even though “patients and consumers have expectations to have access to information…and to be more actively involved in making decisions regarding their treatments.”

Praise for UK initiative
The Commission does however single out for praise the UK Medicines Information Project which, it says, “has shown that the pharmaceutical industry is able to develop information for patients and the general public about medicines, under the direction of a multisector board that includes patients’ organisations, health professionals and the medicines regulator.”

The Project brings together stakeholders including the Department of Health, NHS Direct, the Medicines and Healthcare products Regulatory Agency (MHRA), plus industry, patient and health professional organisations to provide information on treatment options on NHS Direct Online, linked to independently-authored, non-promotional Medicine Guides for individual generic and branded medicines.

As patients have become more empowered and proactive, they are increasingly seeking information about their illnesses and treatment options from an ever-growing and diverse range of sources, says the Commission; in particular, increased use of the internet means that ensuring reliable and good-quality information is available on websites has become essential. Therefore, by the end of the year, it plans to propose amendments to the existing rules which “will put the interests of patients first.”

Such amendments would not remove the current ban on direct-to-consumer advertising of prescription medicines, “making sure that there is a clear distinction between advertising and non-promotional information,” the report stresses. However, the Commission also believes the pharmaceutical industry “has the potential to be an important source of information to respond to the growing demand for more and better information by patients and to help reduce the current information gap, provided that there will be adequate rules to ensure reliability, objectivity and quality of information. Like many patient organisations, most pharmaceutical companies argue that information should of high quality and not be judged by its source. These companies want to be able to produce non-promotional information for patients about their own medicines and diseases and make it public,” it says.

Other EU initiatives involving the industry discussed in the report include: Austria’s Pharmaceutical and Reason project, which is managed and funded jointly by the national chambers of physicians and pharmacists, the industry and social insurance institutions; the Swedish industry association (LIF)’s internet portal, which makes information approved by the regulator available to everyone; the Finnish industry’s consumer version of the national medicines compendium - although the texts are rewritten by pharmaceutical companies and not approved by the regulator; the agreement between France’s medicines regulatory agency (AFSSAPS) and industry association (LEEM) which allows company websites to publish Summaries of Product Characteristics (SPC), package leaflets and European Public Assessment Reports (EPAR) in full, without additions or changes; and the German industry-run Rote Liste Service, which currently offers SPCs to health professionals only.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) said it welcomed the report and applauded the Commission’s “commitment to improving patient access to health information in Europe.” It also stressed that the industry does not consider “US-style” DTC advertising to be an “appropriate” model for Europe.

“Our position remains that pharmaceutical companies are a valuable source of information about health and medicines,” said EFPIA chairman Alessandro Banchi. “The European regulatory framework needs to be modernised in order to make it possible for them to respond to citizens’ legitimate right to benefit from such information, alongside other key stakeholders such as physicians, pharmacists, nurses and patient groups,” he added.

Industry and Commission accused
However, critics continue to claim that what the industry is seeking is direct access to patients and that the Commission is “supportive” of this goal. The consultation organised by the Commission last June on the first draft of its new report was “little more than an attempt to sway public opinion,” according to a joint statement published by the Medicines in Europe Forum, Health Action International (HAI) Europe, the International Society of Drug Bulletins (ISDB) and the Association Internationale de la Mutualite (AIM).

The consultation had revealed that drug companies are aware of the lack of a clear-cut frontier between advertising and patient information, and this “clearly undermines the credibility of the Commission’s plans, which are to allow companies to communicate directly with patients about prescription drugs,” says the statement, adding: “the claim to uphold the ban on advertising for these same drugs would then be no more than a smokescreen.” Measures intended to protect the competitiveness of the European health product industry must not be allowed to undermine the health of European citizens, it stresses.

However, the Commission has pointed out that the 14 patient groups responding to the consultation had generally supported the idea of allowing the pharmaceutical industry a greater role in the provision of information, “with reasons given including that industry has the best knowledge of its products.” Some of the 18 pharmaceutical companies and industry groups responding felt the distinction between advertising and information needed to be clarified, and most saw a need for new legislation at EU level, it adds.

It also notes that while the 73 responses received during the consultation were generally “convergent” on the need to improve information to patients, adopt common standards and quality criteria, distinguish between advertising and information, maintain the ban on DTC advertising of prescription drugs and recognise the Internet as an importance information channel, they expressed “different” views on how to improve the provision of information, the role of industry and mechanisms to regulate and enforce applicable rules.