European Commission Vice President Gunter Verheugen says he is “more convinced than ever” that EU rules on the provision of information to patients regarding prescription drugs musto be updated.

Improving and liberalising the provision of drug information are one of three priority areas addressed by the Commission’s proposed package of pharmaceutical legislation – the others being improved pharmacovigilance to reduce adverse drug effects and measures to protect EU consumers from counterfeit drugs. However, while the latter two are progressing towards adoption, the information directive is being held up by continued disagreements between the EU health ministers.

Breaking the deadlock on the directive will fall to Spain, which takes over the six-month rotating presidency of the EU in January, as any progress before year-end is unlikely, Commissioner Verheugen has told a meeting of the European Parliament’s health and environment committee.

Politicians should be concerned by the fact that policy in the area of information to patients is currently being influenced by European Court of Justice decisions, he told the MEPs, and stressed that the need to update the current rules is not based on the interests of the pharmaceutical industry but on supporting patients and protecting them from “hidden advertising.”

“It is necessary to have a clear border between information and advertising. In the pharma industry there are marketing practices which are not acceptable. The ban on advertising is being circumvented by industry which is exploiting a grey area. In print and on-line media there are contributions behind which are the interests of the industry, but the patient doesn't know it because it is hidden,” said Commissioner Verheugen, who also heads up the Commission’s Directorate General for Enterprise and Industry, whose responsibilities include regulatory and industrial policy for the pharmaceutical industry.

The EU health ministers are scheduled to discuss the Commission’s pharmaceutical package at a meeting in Brussels on December 1. France, Germany and Spain are among the countries which are opposed to any liberalization of the controls on the provision of information on prescription medicines to patients, while regulators in Denmark, Sweden and the UK are supportive of the Commission’s proposals.

Last month, the UK Medicines and Healthcare products Regulatory Agency (MHRA) concluded a public consultation (MLX 358) on the Commission’s proposals. Among the groups making submissions to the Agency were associations representing the pharmacy profession, who expressed concerns about whether the rigorous standards which will be needed across the EU “to ensure that information supplied to patients meets the standards set and doesn’t lean towards promotion” can be properly enforced.

The MHRA and the Association of the British Pharmaceutical Industry (ABPI) should be able to enforce standards across the whole industry – not just among members of the ABPI, according to the Association of Independent Multiple Pharmacies (AIMp), the Company Chemists’ Association (CCA), the National Pharmacy Association (NPA) and the Pharmaceutical Services Negotiating Committee (PSNC).

However, they told the MHRA: “we are concerned that industry bodies in other EU countries may not hold their members sufficiently to account,” and have called for the establishment of overall monitoring/enforcement at EU level “to ensure standards are maintained, with national regulators policing the information rigorously.”