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.
On current projections, the discussions in the European Parliament should last through to November, and culminate in a vote
by the parliament as a whole in January 2013. Initial discussions in the council—tentatively started by the current Cypriot
presidency of the European Union— are judged likely to gather speed and substance from the beginning of 2013, when Ireland
takes over the presidency.
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.