It is not only the specific issue of clinical trials rules that hangs in the balance as Europe shifts from 2013 to 2014. Many of the outstanding questions about the European Union's attempt to update its rules will not be answered until the European Parliament finds time in the new year to examine the outline agreement reached in late December. But there are other issues of equal—if less direct–importance to the clinical trials community that have been left unresolved at the end of the old year, and which imply a long wait before any turn-round can be expected in the uncertainty besetting drug development in Europe.
Some are highly specific to medicines – notably the continuing arguments over access to clinical trial data, or over how much drug companies will have to pay the European Medicines Agency for its new duties as a pharmacovigilance watchdog, or over what sort of agreements companies can reach with one another over patent disputes without falling foul of European anti-trust law.
But other issues, with much broader scope, threaten also to exert a powerful influence on the context in which drugs are designed, tested and deployed. The tone for some of these discussions was set by Vytenis Povilas Andriukaitis, Lithuanian health minister, as he chaired the December meeting of the EU health council. "The EU member states have to be proactive," he said: "Our healthcare systems have to be ready to withstand current and future challenges."
The efforts to ensure sustainable health systems in Europe – and national health ministers signed up to an agenda for change at the December council meeting – have multiple implications for clinical trials. Most obviously, the austerity that is driving economic policy-making in Europe is hitting current drug pricing and reimbursement in many countries, with all the repercussions that carries for supporting drug development programs. Even in the UK, long seen as a country with a research-friendly approach, the latest modification to drug pricing has drawn sharp criticism from the innovative pharma sector.
The new medicines pricing agreement that comes into effect there as from January 1 "will stifle life sciences investment," according to the UK's BioIndustry Association. Steve Bates, the association's CEO, said: "Decisions which affect the commercial environment for medicines have a significant impact on the UK's attractiveness for direct global R&D investment and on our biotech ecosystem." The BIA has repeatedly warned that government proposals put at risk future investment in the UK R&D base. "The perception of the UK as a market for innovative products has an important bearing on the global investment decisions of multinational biopharmaceutical companies," said Bates.
At the same time, reflections on sustainable health systems are fuelling a reappraisal of the allocation of national health budgets in Europe – and the strikingly low sums currently devoted to prevention are being increasingly highlighted. The obvious corollary is that spending on treatment – currently larger by an order of magnitude – is coming under ever more intense scrutiny. That can be seen in the sharp tone of political rhetoric from European health campaigners resentful of what they see as excessive funding of medicines research; more concretely, it is also perceptible in the approach being taken by the EU in its own allotment of research funding for health.
The same trend is reflected in strategic economic thinking in Europe. Over the last year, the engagement of economic affairs ministers in discussions of health policy has become more frequent and more influential. During 2013, the EU broke a longstanding taboo, by abandoning its traditional hands-off approach to national healthcare spending decisions. For the first time since the EU was created, recommendations were issued to national governments on how to make their healthcare spending plans more cost-effective – and the high cost of prescriptions featured prominently in the list of problem issues that were identified.
Even if the European economy does pick up in 2014 – and that is a big "if" – the strains on the funding of health systems will not ease, because the ageing of the population, the increased incidence of chronic disease, and the relentless rise in the costs of new treatments will continue to oblige healthcare planners to intensify the search for value-for-money. So despite the huge attention devoted during 2013 to identifying problems, 2014 offers little prospect of immediate solutions. Those conducting clinical trials too, dependent as they are on the overall health of the healthcare sector, can allow themselves few illusions about a rapid turnaround for them from the new year.