The update of the rules is also described by EPF as an opportunity to introduce "more genuine transparency and public access to information on decisions taken by national authorities." It points out, sardonically, that the title of the European Union's legislation on pricing and reimbursement—the "Transparency Directive"—alludes only to ensuring that national rules are transparent to pharmaceutical companies. Patients and the public are, it says, left out in the cold.

In addition, information about pricing and transparency decisions, procedures, and criteria should be readily available to patients and citizens, as well as the identities of the people or bodies that make the decisions. For EPF, the objective of the review should be to create what it terms a genuine culture of transparency. This means, it says, bring more clarity into the way that medicines prices are decided on. As it points out, there are currently wide discrepancies in the price of some medicines across the European Union. But its solution includes not only opening up the bureaucratic processes to wider public scrutiny. "Consideration should also be given to how transparency is handled by the pharmaceutical industry," it says, in a tone that will set alarm bells ringing in many corporate headquarters.

The EPF ambitions also include patient involvement in health technology assessments. This too ventures into sensitive territory for drug firms that are already nervous that health technology assessment could be used as a weapon to keep new products off the market. EPF is making a strong bid for giving patients more of a say in this area. But patient groups could prove to be less-than-reliable allies of drug firms in these complex negotiations. Even EPF is aware that access to the decision-making process is not the only issue: patient groups currently lack the competencies and skills to make a real contribution to the assessment process, it acknowledges.

The ambition and energy of patient groups is evident. The question it all provokes, however, is how much influence patient groups have. They may make a lot of noise. But with the big battalions of drug firms and health ministries manoeuvring for this latest European confrontation, who is going to hear the shouts from the sidelines?

A report released in July attempts to quantify the impact of the patient movement—and suggests that these latecomers to the healthcare debate should not be underestimated. It sees them as quick learners with growing clout. According to PatientView, a UK-based consultancy, "the patient movement is proving to be an exception to the rule that change is slow in healthcare systems." It observes that patient groups and other non-governmental health organizations are expanding rapidly, and acquiring new influence. One of the factors crucial to this evolution, it argues, is "the damage inflicted upon mainstream national healthcare systems by tough new doses of fiscal austerity, and by ever-increasing patient demand for services." This is fuelling their growth, and "patient groups have never been so popular." The PatientView analysis concludes that patient groups are acquiring enhanced status and are winning high regard. One of the striking findings is that campaigning activity by patient organizations is now widely perceived as driving government prioritization in healthcare.

Like it or not, European drug firms are going to have to adapt to dealing with patient groups not just in tactical areas of medical specialities, but as a growing force in the broader political debate on healthcare and, over the next few months, on the vital question of pricing and reimbursement rules.

Reflector is Pharm Exec Europe's anonymous columnist, a commentator so close to the action in Europe that his identity must be secret.