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Reflector is Pharm Exec's Brussels correpsondent.
Pair of EU meetings, while well-meant, offered little action and beg the question-what’s the true merit in working together?
Does working together actually work? Or do the mechanisms devised to promote cooperation merely act as a form of polite camouflage, while everyone is really continuing to pursue their own interests?
Some fascinating opportunities for case studies are presented in the health sector, and particularly in the endless debates about medicines. The latest piece of potential evidence emerged in the wake of the April 23 meeting of European health ministers, convened by the Bulgarian government as a key element in its program, right from the start in January of its six-month presidency of the European Union.
The meeting, in the Bulgarian capital, Sofia, had been prominently billed as an opportunity to get to grips with some of the biggest challenges facing health ministers across the continent. In particular, part of the debate focused on how governments could keep up with patient demand for medicines in the face of the twin evils of growing costs and shortages of supply.
Kiril Ananiev, Bulgaria’s health minister, told the European Parliament at the start of the presidency that his aim was to shed light over the coming six months on “the provision of quality treatment based on effective therapies and on the affordability of medicinal products”.
He had already made a similar point at an EU Council meeting: “The EU cannot afford to stay caught in the dilemma between commerce and health in the field of drug policy. We must give a clear signal that people’s health is a priority.”
But the out-turn of the April meeting in this regard was meager, to judge from the official communiqué released at its conclusion. After five paragraphs dealing more extensively with other issues-ranging from nutrition policy to confidence in regulatory systems-all that the Bulgarian presidency had to say on the medicines question was: “Ministers also discussed issues related to the effectiveness and accessibility of medicines, including patients’ problems caused by parallel drug exports. In this respect, cooperation among member states is of particular importance.”
When a communiqué merely says that a subject was discussed, and offers no conclusions whatsoever, it is reasonable to question whether the discussion led to anything at all. When the non-conclusion is followed by a bland statement that cooperation is important, the distinct impression is that cooperation, for all its importance, was conspicuous by its absence from the discussions. That might be a glib inference to draw if it were not that the discussion of medicines prices and access has already and repeatedly shown itself particularly resistant to cooperation.
Notoriously, another well-meant exercise in working together on medicines prices and access fell apart dramatically two months ago, when officials from around a dozen member states walked out of talks with the drug industry on how to construct an agenda for more effective cooperation.
That meeting, in Brussels on March 9, had been planned to build new purpose into an emerging series of meetings between European health ministers and European heads of pharmaceutical companies. But agreement could not be found on working methods and on shared priorities on pricing, competition, and access, and European industry associations accused member states of “walking away from a collective decision.” Nonetheless, Dr. Patricia Vella Bonanno, the official in the Maltese health ministry who chairs the process, was simultaneously assuring inquiring media: “There is a strong collaborative spirit within the group and the process is proceeding”-an assurance that inevitably called into question the credibility of that “collaborative spirit.”
The attempts at collaboration on these thorny topics stretch back well into the previous century, in a series of European-level processes bringing together drug firms, health authorities, and consumers in semi-official roundtable meetings, multilateral working parties, and reflection groups. As this column suggested last month, many of the same questions being asked now are almost identical to those that were being asked 20, 30, or 40 years ago.
Does this mean that working together is destined by fate to fail, and that persisting in the face of continued disappointment is a waste of time and an offense against candor?
The answer may depend on defining who the parties are in any attempt at cooperation, and what common interests they really have.
Clearly, for instance, the drug industry has a powerful reason for promoting cooperation among its own disparate membership, as a key to maximizing its chances of influencing policy. The European Federation of Pharmaceutical Industries and Associations (EFPIA), itself the product of an amalgamation of distinct trade groups half a century ago, exists precisely for that purpose, and its possibilities of success depend crucially on maintaining a minimum of shared views among a maximum of diverse individual aspirations. Its US counterpart, the Pharmaceutical Research and Manufacturers of America (PhRMA), is so convinced of the merits of working together that it spent nearly $10 million on lobbying in the first three months of 2018 alone-putting this year on course to beat by a wide margin PhRMA’s total of $25.4 million in 2017, which was itself up by more than 25% from 2016.
Consumers-a broad church embracing citizen groups, non-governmental organizations, patient representatives, and a thousand other shades of public interest activism-have also been seeking new strength in unity in European health debates for the last year. Initially responding to a perceived threat that the EU was going to withdraw totally from health policy, many of these groups have since welded themselves into a coalition that has gained some serious profile under the banner of #EU4Health, and has shown itself capable of establishing a shared agenda on priorities.
It is the third component of this curious triad-Europe’s national governments-that has, perhaps, the most difficulty in establishing a common approach to common problems.
Some of the common problems for national authorities responsible for health are evident: more expensive therapies, rising expectations and growing demand for care, and inequalities of access. But while the essence of those problems is common, their manifestation is widely distinct because of the widely divergent nature of the countries of Europe, and their widely differing approaches to tackling them.
At its most obvious, some countries are much richer than others, and can afford to spend more on health and on medicines without wrecking their public finances. But a near-infinite range of more complex distinctions make common views and common actions almost impossible.
The multiple efforts to work together to provide a common front in negotiating on prices with drug companies are testimony to those distinctions. Belgium and the Netherlands, the pioneers in these efforts, are still a world away from finding a common methodology after years of diligent effort.
The wide variations in disease incidence and therapeutic success among European countries reflect other divergences: epidemiology and medical culture can be as richly varied as language across the continent. Varying levels of affluence within society and across regions create different challenges in terms of health and
access to care. And the nature of the European market for drugs-with prices fixed at national level but with free circulation of goods across national boundaries-adds a further complication. Bulgaria, as a leading example, suffers lack of access to treatment not only from its limited capacity to pay for expensive therapies, but also from shortages caused in part by parallel trade that quite legally acquires bulk medicines at the low prices that Bulgaria imposes on drug suppliers, and exports them to for resale in other EU countries that allow higher prices.
The tentative conclusion that might emerge from this analysis is that working together-clearly a desirable principle, whether on environmental protection, tackling international crime, or defending human rights-will continue to be uphill work in Europe health policy, and that broad consensus on medicines policy cannot begin to emerge among all parties, unless and until national governments find more effective ways of working together among themselves.
Reflector is Pharmaceutical Executive’s correspondent in Brussels