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Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.
European consumers are concerned that faster drug development processes being pushed by regulators can be unsafe for patients. With the EMA spearheading discussion on medicines adaptive pathways to patients, or MAPPs, more convincing is needed.
European drug regulators and industry share many hopes for faster drug development through new early access schemes such as adaptive pathways. But European consumers take a different view. "We are concerned that this new fast-track procedure can expose patients to unnecessary health risks," says the European consumer organization, BEUC, in a new briefing paper. They say "medicines would be put on the market before there is complete information about their safety."
The European Medicines Agency has been spearheading discussions on adaptive pathways – MAPPs, as it is often abbreviated to, for medicines adaptive pathways to patients – and since 2014 has been running a pilot project which is already delivering some new ideas on ways of moving ahead with early and progressive patient access to a medicine making use of the existing European Union regulatory framework. For the EMA, this is intended to maximize the positive impact of new medicines on public health by balancing the need for timely patient access with the importance of providing adequate, evolving information on benefits and risks. BEUC is less sanguine. It sees MAPPs as "sidestepping the standard benefit-risk assessment for licensing a medicine," and wants to see tight limits imposed on the exercise. Right now, it says the scope of the project is insufficiently clear because there is no definition of what circumstances it should be used in, and the monitoring of medicines’ safety and efficacy that the scheme depends on is "difficult and not fully operational." To satisfy consumers, the scheme would need to "ensure that patients receive appropriate information about the higher risks associated with medicines approved through faster procedures", and upgrade safeguards for patients "in case of harm". Deep suspicions about ulterior industry motives in pushing the MAPPs agenda are evident in the BEUC position. "Faster revenues for pharmaceutical companies cannot be the driver of any early access scheme," it says. "Patients’ safety should never be undermined because of commercial considerations." And it rejects any pleading that MAPPs will help lower the cost of new medicines. "There is no evidence," it says. The consumers' challenge is the second shot across the bows of the concept in a matter of weeks. In May a group of academics wrote to the EMA setting out their concerns too. The signatories included some prominent skeptics who have long harbored the belief that regulators and industry are often too closely linked for the public good – notably Professor Silvio Garattini, director of the Mario Negri research centre in Italy, who has been warning against regulatory laxity for more than 30 years. Garattini and his colleagues said EMA's justification for MAPPS is not "very convincing." Couching their criticism in very careful language, they said there were a lot of questionable assumptions in the EMA calculations rather than hard data, so "your initiative is so far mostly based on interpretation of current problems." Guido Rasi and Hans-Georg Eichler, the two top EMA officials behind MAPPs, politely replied to Garattini saying the agency "values contributions from stakeholders on its initiatives, as feedback and open debate are essential for adapting and fine-tuning concepts and approaches and ensuring that they meet stakeholders’ expectations." Their letter refined the way they expressed some of the EMA ambitions and envisaged its mechanisms, but they stuck firmly to their belief that the need for better drug development methods have to be found. The more recent statement from European consumers presents EMA with a further challenge – answering questions not only about scientific methodology, but about the more pressing question of who will pay and how much MAPPs will cost. "We believe that any new initiative in this field should address the challenge of the affordability of medicines in Europe," it says. A reply from Rasi and Eichler is awaited with interest.