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Industry's grand vision for reshaping the life sciences in Europe may ultimately prove to be a lost cause.
It's difficult to open an email or an envelope in Brussels these days without yet another agenda falling out of it, carrying the promise of a new start. With a new European Parliament installed, a new European Commission president appointed and a new Commission on the way, and guarded optimism that the worst of the recession is over, this outpouring of recommendations and recipes is hardly surprising. Hope springs eternal in the human breast.
The trend is reflected in the medicines sector, with a plethora of manifestos and strategy proposals from industry, regulators, and campaigning organizations. One of the most grandiose is the self-styled "groundbreaking vision towards a life sciences strategy for Europe," launched in high summer by the European Federation of Pharmaceutical Industries and Associations.
This "landmark paper" claims to provide steps towards "an integrated strategy" for the sector in Europe. "With Europe now emerging from the crisis, there is an opportunity to improve health prospects of citizens, while promoting economic growth. As new European leaders and policymakers across the political spectrum begin work to improve Europe's future, EFPIA calls for greater political collaboration," the industry association specifies.
It is reasonable to expect that new European leaders and policymakers will begin work to improve Europe's future. But given the notorious absence of political collaboration in European health affairs, it is imprudent to assume that all that work will improve the situation for the drug industry. Given the fundamental nature of the challenges that Europe is facing, what emerges may actually be worse than the current imperfect context for medicines. EFPIA and other industry advocates of radical change run the risk of jumping out of the frying pan only to find themselves in the fire.
The essence of the EFPIA call to arms is a plea for "a new generation of partnerships and collaborative solutions to address the EU's growing health and competitiveness challenges." It urges changes in perception, more "thinking outside the box," better understanding of future demands and of the value of investment, and the "need to address the system as a whole" in order to create sustainable systems. Of course the central refrain of the vision is "ensuring that the pharmaceutical and life sciences industries—jewels in Europe's economy—continue to thrive." Consequently, much of the content is devoted to the need for the industry to be "highly competitive" and for "innovation-led growth." The merits of the industry—in terms of those familiar claims relating to products, jobs, exports, or research commitment—occupy much of this manifesto.
So, too, does the catalogue of the economic problems the industry faces. EFPIA warns against "making it difficult to obtain innovative medicines, increasing user charges, or delisting services from the benefits catalogue." It complains about the distortion that international reference pricing creates in the European market for medicines—going so far as to call for an urgent review of "the practical operation of the free movement of goods principle in medicines." It blames "the current patchwork of valuation and assessment criteria across Europe" for being "arbitrary and politicized," and "leading to wasteful and costly duplication of effort." And it cautions that "arbitrary financial policies" are inhibiting investment in research.
All this is fair enough. It is the role of a powerful sector association to extol the merits of the sector it represents, and argue the case for it to receive favorable treatment. But there are other voices clamoring to be heard, and other tendencies shaking the ground. The presumption that in all the prospective changes, "medicines have a key role to play," is one that the industry will naturally make. It is not, however, universally shared—and some of the alternative thinking comes from sources which are also powerful.
Not least among those voices is the European Union itself. Its years of ruminations about how to make health systems sustainable have still to lead to definite conclusions, but the trend is evident in the interim decisions it is now reaching. In early July, the EU Council gave legal force to a long series of recommendations that include telling Austria "to reinforce preventive healthcare, for which public spending is below EU average," Croatia that control over public expenditure on healthcare "is not achieved," and France that pharmaceutical spending is one area where "efficiency could be further improved." By contrast, Finland's "stronger focus on prevention" is "credible and relevant."
At a summit in April to discuss chronic disease, Tonio Borg, European commissioner for health, was unambiguous in urging greater emphasis on prevention rather than treatment: "Only a tiny fraction is spent on prevention," he said, asking "Does this proportion make sense, when many of the most prevalent chronic diseases are largely preventable?" And the EU health council in June championed health promotion and disease prevention as "key factors for better health," and recognized "the importance of investing in health promotion and disease prevention in improving the health of the population."
There is a form of selective myopia in the vision of the EFPIA strategy. Its president, Christopher Viehbacher, who is also CEO of Sanofi, said as he outlined the strategy: "Only a significant improvement in health outcomes, supported by increased innovation, can keep healthcare expenditure under control." This is not strictly speaking true. It presupposes that the long-hallowed approach to healthcare expenditure remains intact: that is, seeking better and better medicines to treat more and more illnesses.
That presumption is at the very least questionable, and at worst, may be rendered invalid by a seismic shift in European health strategy that could profoundly modify the resource-allocation between treatment and prevention. If the allocation of resources was inverted (it is customarily estimated that less than 5% of current healthcare spending is devoted to prevention, with the rest devoted to treatment), it might also be possible to keep healthcare expenditure under control and improve health outcomes without the contribution from increased innovation that Viehbacher and EFPIA appear to be counting on. EFPIA quotes European Commission estimates that, without new approaches, average healthcare spending could rise from 7% to 9% of GDP by 2060, placing a strain on national finances. The conclusion EFPIA draws, that "halting and reversing the progression of chronic diseases is the best investment that health systems can make," may be correct—but it may also be true that the objective might be achieved by prevention rather than by treatment.
Against this background, EFPIA may not win the backing it expects for its priorities of "removal of inequalities to better patient benefits," support for "systems to speed access to medicines," or "the building of a thriving innovative life sciences sector." If the outcome of all this radical re-thinking and new partnerships is that much greater priority is given to prevention, EFPIA's ambitions for a "new European life sciences strategy that will benefit patients and society as a whole" may prove to be of no benefit whatever to the drug industry.
On the contrary, budgets for treatment might be subject to cuts much sharper than those that industry currently complains of, and the trends in spending might move resources irreversibly from treatment to prevention. Industry optimists would do well to remember the somber conclusion of that famous couplet about hope springing eternal in the human breast. It concludes tartly: "Man never is, but always to be, blest."
Reflector is Pharmaceutical Executive's correspondent in Brussels.