An important third party is struggling to make its voice heard in European pharma discussions. Drug pricing is not just a matter of manufacturers battling with health ministries, insist groups representing the end-users of medicines — that is, the patients. 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, ranging from giants like Alzheimer Europe to smaller outfits such as the Malta Health Network or the Estonian Chamber of Disabled People.
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 EU’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.” 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 EU,” 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.
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 EU’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.
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 EU. 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 their new products off the market, rather than as a lever to squeeze them into reimbursement regimes and allow them adequate prices. 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 competences and skills to make a real contribution to the assessment process, it acknowledges. Some pharmaceutical industry executives are speculating on the effect of incorporating avowedly loose cannons into an already tense arena.
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?