The European Commission has announced proposals to allow drugmakers to communicate information about their prescription-only medicines to the public, although the Europe-wide ban on direct-to-consumer (DTC) advertising will remain.

The legislative proposal, which forms part of the Commission’s long-awaited package of pharmaceutical sector reforms, says the information provided by manufacturers should not go beyond the details provided in Summaries of Product Characteristics (SPCs), labelling and package leaflets, plus notifications of factual and reference issues such as prices, pack changes and adverse reaction warnings. It also says that such information should be made available only through channels such as health-related publications and Internet websites, and it would have to fulfil “harmonised quality criteria.”

“First and foremost, the information provision will be improved and harmonised across the EU. There will be more possibilities to receive high-quality objective and non-promotional information,” says the Commission, describing the proposals. “Secondly, European citizens shall be able to receive information that is in line with EU legislation. This reduces the risk of receiving misleading and bad-quality information,” it adds.

However, the announcement has been condemned by critics who have consistently opposed any easing of current restrictions, and point out there is still no clear distinction between “information” and advertising. Without this, “allowing direct to consumer information is like letting advertising in through the back door,” said Peter Morrey, public affairs manager of the UK consumer body Which? “This could lead to a similar situation to the US, where people demand specific branded drugs from their doctor when cheaper, equally effective generic drugs are available. In the long run, this could increase the cost and burden to the NHS,” he warned.

The European consumers activist group BEUC also described the plan as opening “Pandora’s box” and urged the European Parliament and Council to “nip this proposal in the bud.”

The Commission’s package of proposals for the sector includes two other legislative proposals, one to tackle the growing issues of counterfeiting and illegal distribution of medicines and another to improve patient protection by strengthening the EU system of pharmacovigilance.

The fourth element of the package is a political communication, which calls for: - the initiation of discussions with EU member states on ways to improve market access by making pricing and reimbursement decisions more transparent; - the development of initiatives to boost EU pharmaceutical research; - intensified cooperation with major partners (US, Japan, Canada) to improve medicine safety worldwide; and – strengthened cooperation with emerging partners (Russia, India, China).

“Everything we are suggesting today builds on the needs and interests of patients,” said Commission Vice President Guenter Verheugen, announcing the package. “European citizens should benefit from safe, innovative and accessible medicines. They should be best informed about available medicines and treatments, since their health is at stake. We wish to restore the EU’s traditional role as the pharmacy of the world,” added Vice President Verheugen, who also heads the Commission’s DG Enterprise and Industry, which has responsibility for the pharmaceutical industry.

The legislative proposal on tackling counterfeits stops short of calling for a total ban on repackaging of medicines, which had been proposed in an earlier version of the document but withdrawn following pressure from parallel importers, who told the Commission that such a measure would destroy their industry. While welcoming the reform package, Arthur J Higgins, president of the European Federation of Pharmaceutical Industries and Associations (EFPIA) points out that the industry still believes the best way to protect patients would be a ban on repackaging. “However, we will work with European institutions to ensure that if there is repackaging of medicines, then patient safety will not be compromised,” he said.

The Commission proposal suggests that certain categories of medicines should bear a safety feature - such as individual product codes or serialisation on the packaging, and seals which reveal any opening of the pack - to help identify counterfeits. Aegate, a company which provides a tool supplying pharmacists with real-time safety information about the quality and safety of medicines before they dispense to patients, welcomed the legislation as a positive safety measure and said that, as a result, it would commit to accelerating the speed of providing its authentication service, which is currently available in Ireland, Greece, Italy and Belgium, to other EU nations.

However, the Commission has been criticised for not proposing specific harmonised rules covering sales of prescription drugs over the Internet. The proposal states that it is for the member states to tackle this problem and adds that they have adopted “very different approaches and regulations” for doing so, but Greg Perry, director general of the European Generic medicines Association (EGA), points out that the Internet is the main source of counterfeiting. The European Commission “may be promoting an over-reliance on technical features rather than an improvement of the behavioural activity of the supply-chain actors,” he says.

- The proposals will now go to the European Parliament and the Council, where they will be discussed and voted on in the European co-decision procedure. Following adoption by Parliament and the Council, they could become law within 18 months at the earliest.