A proposal mandating that pharma manufacturers provide patients with safety and efficacy information about their drugs moved one step closer to implementation on Sept. 28, when a sub-committee of the European Parliament voted to support it.

In Europe, patients generally spend three to four minutes with their doctors, not enough time to really understand the products with which they are being treated, said Christopher Fjellner, a Swedish politician, and member of the European Parliament and its Committee on Environment, Public Health and Food Safety (ENVI), which approved Fjellner's report containing the proposal.

Patients are likely to benefit from such a law, but its impact on industry isn't clear. MEPs and EU member state governments argue that the Commission's original proposal was focused more on drug companies' rights to disseminate information rather than the patients' right to access quality information.

The only benefit to industry is a clause that allows the marketing authorization holder to make certain categories of information available to patients, subject to prior approval from the relevant regulator(s), observed Tim Worden, a partner at international law firm Taylor Wessing and a life sciences expert. For centrally authorized medicines, that authority would be the European Medicines Agency (EMA) and for nationally authorized products it would be the medicines authorities in the member states.

Pharmaceutical companies are permitted to make disease-related information available under current EU disease awareness campaign guidelines, but the proposals would also give them rights to be product specific. "Arguably there is a benefit to pharma companies as a result of this: they have the opportunity to position themselves directly with patients through the website or hard copy materials in which they provide the information, Worden said.

The ability to communicate directly with patients and consumers about their products, albeit on a non-promotion, pre-approved basis, allows them to position themselves as a "best practice" operator and to build trust and confidence in their corporate and product brands, he added.

EFPIA Commends Parliament's "Pragmatic" Approach

All EU lawmaking bodies, including the Parliament, the EU Council of Ministers, and the European Commission, as well as member states, oppose introduction of direct-to-consumer advertising for drugs, however. "No so-called push channels, no television, no radio, no magazines would be allowed as channels for information, but whenever patients asks for something, it's not only a possibility for industry to communicate, it's an obligation," Fjellner said.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) said that it has yet to digest the intricacies of the legislative proposal as amended by the European Parliament. However, EFPIA Director General Brian Ager said the parliament should be commended for its pragmatic approach to the proposals. "This contrasts with the situation in a number of member states, where there has been reluctance to even discuss options for providing citizens and patients with improved access to information about their illnesses and treatments," he added.

In Germany, for example, displaying the summary of product characteristics (SmPC) of a drug on a manufacturer's website is illegal, Colin Mackay, spokesperson for EFPIA said. The SmPC is an official description of a pharmaceutical product, which lists the name of the active substance, its composition, uses, dosages, pharmaceutical forms, and known adverse reactions, amongst other information.

Ironically, EU citizens can get this information directly from the website of the EMA. However, the EU cannot oblige Germany to display the same information yet, as without the proposed legislation becoming in fact law, healthcare remains in the competence of the individual member states.

The proposal on the provision of information to patients is part of the European Commission's Pharmaceutical Package, which has been in the works since 2006 and is aimed at making the EU pharmaceutical sector more competitive. Its acceptance by ENVI is an important step in its progress through the legislative process of the EU. As Fjellner is a Swedish MEP, it is hardly surprising that he envisages the information provision to resemble Sweden's FASS, a medicines information engine geared towards both doctors and patients. Steering the legislation towards a model that reflects FASS could make it more acceptable to member states.

Fass only provides product information that is approved by its national authorities and contains no promotional texts or advertising. The four parties involved in maintaining the engine are the Medical Products Agency, the Pharmaceutical Benefits Board, the National Corporation of Pharmacies, and the Swedish Association of the Pharmaceutical Industry (LIF).

"The compromise was adopted by a vast majority in the Committee, which strengthens Parliament's position in negotiations with the Council and the Commission," Fjellner said. The amended legislation must now be put before the EU Council, on which member state health ministers or their representatives sit.

The Council has expressed a relatively negative opinion on the legislation on a number of occasions in the past. In June 2009, during the Czech Presidency of the EU, ministers agreed on the need to improve the information to the general public on prescription-only medicinal products, but feared that the proposed system would be "overly burdensome for competent authorities without leading to significant improvements in the quality of the information provided to patients." In addition, many member states said that the distinction between "information" and "advertising" was not sufficiently clear.

In December 2009, the Swedish Presidency of EU reiterated at a Council meeting the strong concerns of many member states to the proposal. The Commission informed the presidency that it was prepared to show flexibility in order to find a common basis for the future negotiations. The ENVI committee's vote should be viewed against this background and there is good reason to believe that the watered-down version of the proposed legislation will now clear the Council's scrutiny.

- Faraz Kermani (F.Kermani@elsevier.com)

Proposal To Improve Patient Information Attracts More EU Support

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