Patients Wade Into the Pricing Debate

An important third party is pressing to make its voice heard in the European debate on pharmaceutical policy and pricing. It's no longer just a matter of manufacturers battling with the national health ministries—patients, as the end users of medicines, are demanding a larger institutional role in decisions on the services they receive. Over and above the questions of costs and bureaucracy, the more important issues of equity and patients' rights are at stake. And these, according to patient groups, are critically threatened by delays in access to treatment.

Patient associations have waded vigorously into the intense debate now starting on how to update the 20-year-old European Union regimen for pricing and reimbursement. Their intervention brings an additional dimension to the concerns voiced so far about this review of fundamental EU rules—notably pharmaceutical companies' fears that the outcome may mean tougher assessments of relative efficacy, or warnings from national health ministries that demands for faster decision-making are unrealistic. "The revision of the rules is important for patients," too, says the European Patients Forum (EPF)—which represents more than 50 diverse patient organizations.

For all its diversity, EPF runs a tight ship. It has already drafted a position on the proposals that emerged from the European Commission last February, and it set a deadline of the end of July for its members to comment. It wants to be sure it is equipped to maximize patient input into the formal debates on the new legislation that will start in the European Parliament and the European Union's Council of Ministers after the summer break. So EPF is liaising with the commission, key members of the European Parliament, and what it loosely refers to as "other stakeholders" to prepare the ground for influencing the debates as proposals are turned into laws.

The starting point of the draft EPF position is that "there are currently wide and unjustifiable delays in access to new medicines across the European Union." Accordingly, it is offering strong backing for the commission's recommendations of tighter time limits for national decision-making. "A revision should not result in any lengthening of the existing time frames," says EPF, which is even urging that sanctions should be imposed to ensure that member states move faster.

One of its targets is the inconsistency displayed by national drug pricing and reimbursement regimes in Europe, which it blames for leading to inequalities in access to high-quality medical care. Patients with chronic diseases are particularly vulnerable, it says, because of decisions based on national and regional assessments of the effectiveness of medicines. "This type of discrimination is inadmissible in the European Union", declaims the EPF. It goes on to argue that delays in treatment "also have a societal and economic impact," in that they ignore the benefits of early diagnosis and treatment, and neglect the potential for avoiding complications of illness and unnecessary interventions or hospitalizations.

EPF has been busy in many other areas too. In early July it took part in a dialogue with industry on EU policy in health and medical innovation—an event known as the Patients' Think Tank, organized by the European Federation of Pharmaceutical Industries and Associations. This focused particularly on the big themes of ensuring access to medicines in the context of budget constraints and the current economic crisis, and patient groups emphasized the risks from the European tendency to undervalue medical care and to overstress the importance of cost containment.

It is moving increasingly into boosting the capacity of its member organizations, too, by providing training in advocacy and campaigning. Thirty patient organizations from Bulgaria, Hungary, and Romania and eight pan-European disease-specific patient organizations will take part in a pilot scheme later this year.

Some of this pressure could be good news for pharmaceutical firms. The argument for wider patient access to treatment is a long-standing demand of drug companies frequently unable to persuade cash-strapped health ministries to grant reimbursement status for innovations.

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.