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Applied Clinical Trials
How the European Union is impacting current Pharmaceutical trends.
The rhythms of the European Union are very particular - with a new commission and a new parliament every five years, with multi-annual programming of budgets and research programs over seven-year cycles, or with its semi-annual rotation of the presidency of the council of ministers. But at the end of 2014, even the asynchronous EU was beginning to experience some of that guarded optimism familiar to everyone who approaches the traditional cheer of the festival season with an eye on the prospects for the coming twelve months.
The EU's mid-winter consolation was driven largely by the recent appointment of a new team to run its affairs. There is a new president of the commission, in the shape of Jean-Claude Juncker, with a promise of a new plan, and all the accumulate wiles of a veteran EU insider (he was prime minister of Luxembourg for eighteen years). There is a new president of the council, in the shape of Donald Tusk, the former prime minister of Poland, with a reputation for robust views, particularly in respect of Russia. And there is a new head of the EU's foreign affairs department, in the shape of Federica Mogherini, from Italy, bringing unaccustomed youth to senior EU posts.
It is profoundly incongruous that an organization more than half-a-century old, covering nearly 30 countries with half-a-billion people, and generating almost a quarter of the world's GDP, could be so insecure that a few new faces, can alter perceptions of itself. But that is the EU as it enters 2015 - insecure, lacking focus, and searching half-heartedly for solutions to the numerous challenges it faces.
Pharmaceutical executives with more pressing business concerns may not care enough about what goes on inside the black box of the Brussels machine, as long as their operating context remains broadly the same. And broadly speaking, it has. Over recent years, even decades, the EU offered a stable platform - political, social, economic, scientific, regulatory - in a world of rising globalization and prosperity. But the security of that beneficent operating context can no longer be taken for granted. The EU itself faces unprecedented challenges and strains - with persistent stagnation turning to deflation, with that eternal odd-man-out, the UK, flirting with ending its 42-year-old membership in the wake of a general election this May, with the EU's erstwhile unofficial joint leaders, France and Germany, now barely on speaking terms, and with the instability generated by Russia's interventions in Ukraine now intensified by the rise of home-grown Islamist extremists bringing terror to the heart of the continent.
Stability for a business means some sort of predictability behind the economics as well as the political and social environment. And with Europe labouring under public-spending controls, that ever-sensitive discussion of drug pricing will take on a new dimension. Innovations with the merit - and prices - of Sovaldi are not greeted with open arms. Instead they are provoking payers and governments into forming common fronts against what some of them have started to openly depict as drug-industry exploitation. And although French and Italian attempts to build a buyers' cartel had faltered by the end of 2014, there is still strong resistance among many regulators and payers to the logic of transforming the rigid evaluation procedures that currently inhibit early patient access to useful medicines. Europe's composite make-up of multiple national authorities makes any such shift more complex - and probably slower - than in the US or in other single-authority territories. The European Union access to rich data that permits new diagnostic and therapeutic approaches is going to depend in part on how, in 2015, and how it resolves the long-running stand-off over its draft data protection law. This law noting the advocacy of privacy remains dismissive of pleas for flexibility from the science community.