European Union (EU) member states must act urgently to ease the “slot crisis” – the current block on assessing new generic applications caused by the lack of resources at national medicines agencies – in order to deal with growing demand, says the European Generic medicines Association (EGA).

The generics industry in Europe is highly competitive, with as many as 30 companies competing on a single product, the EGA’s director general, Greg Perry, told the association’s scientific and regulatory affairs conference last week.

Generics now account for nearly 50% of all medicines dispensed in the EU, but only make up 18% of pharmaceutical spending, which explains how they save EU patients €25 billion each year, said Mr Perry. Moreover, generics account for 70% of all applications under the EU Mutual Recognition Procedure and 85% of applications under the Decentralised Procedure, making the industry the primary user of these procedures, he added.

However, the industry faces significant hurdles to market entry as a result of anti-competitive activities, as was illustrated by the recent preliminary findings of the European Commission’s investigation into the tactics used by brand-name drugmakers to delay or block generic competition, he said.

In addition, the growing economic pressures on healthcare budgets are “exerting further demands on generic companies, and these pressures require corresponding efforts on the part of legislators and regulators to ensure both high-volume generic competition and immediate access to generic competition after patent expiry,” he added.

The Commission’s long-awaited package of pharmaceutical sector reforms, published last December, will create a “win-win” situation for EU citizens, industry and regulators, said Mr Perry, although he added that the EGA has reservations on one aspect of the proposal that would require “certain repetition of key information already provided to patients as potentially confusing and counterproductive to public health.”

He also emphasised the EGA’s concerns with the Commission’s proposals to liberalise industry information to patients over the possible misuse of that information as a marketing tool. It is crucial to the EGA that the new legislation ensures better, rather than simply more, information to patients in order to avoid any form of direct marketing and undue commercial influence over consumers, he said.

Medical students slam EU patient info plan

Meantime, medical students have also warned that the Commission’s plans to allow drugmakers to give information on prescription drugs is "is troubling for the future objective use and funding of medicines.”
The proposals may have some of the negative side effects of direct-to-consumer (DTC) advertising, such as increasing the profile of profitable branded drugs, which will raise spending on prescription medicines by patients and the National Health Service (NHS), the students write in a letter to the British Medical Journal (BMJ).

The Commission must abandon its proposals and “explore options for providing a more impartial and unprejudiced system of high-quality peer-reviewed information,” say the students, who are representatives of Medsin, a student global health network, and PharmAware, a UK campaign aiming to maximise ethical interactions between healthcare professionals and pharmaceutical companies.

Another letter in the same issue of the BMJ points out that opposition has already led to the Commission’s proposals being significantly watered-down and that they could still be defeated altogether.

For example, television and radio have been dropped as channels for dissemination, while printed media has became more tightly defined as “health-related publications,” writes Don Redding, head of policy at the Picker Institute Europe, which has campaigned strongly against the proposals.

At whatever stage it reappears, the proposal can be defeated if patient and professional groups make their views known to members of the European Parliament and to member governments, both of whom will need to approve the measures before they become law, says Mr Redding.