One of the last acts of the Obama presidency may be one of its most significant. Cross-party alignment behind the 21st Century Cures Act seems sure to secure its passage and thus increase funding for the national institutes of health, while enabling the FDA to move towards a developing paradigm for drug approval based on patient outcomes.
The news triggered a series of statements doubting the EU’s ability to be similarly ambitious. However, the same thinking is taking place in the EU. An important EMA workshop on adaptive pathways took place last week.
Where the EU falls down, is in the complexity of its regulatory and scientific infrastructure. Research programmes remain predominantly national despite the important role of the Innovative Medicines Initiative and EU framework programmes. There’s nothing wrong with being national, but duplication and lack of scale are to be avoided. Alignment around the best standard of care is inconsistent, as is the level of reliance on real world data to assess the effectiveness of interventions.
That last point is a story on its own. We lack harmonised rules on how health data can be used, which undermines European research and does nothing for patients or for the confidentiality of their data. The recently finalised General Data Protection Regulation has made the situation even more complex, supporting research, but also introducing a complex set of Member State flexibilities that researchers will need to negotiate.
The issue is about more than Europe being “different”. It also contains a threat to our future prosperity. Research is global – as is disease – and with the infrastructural needs of modern research, the complexity of the European landscape is a disadvantage.
In 2014, Science Europe hosted a conference in the Sicilian town of Erice, which concluded that “our ability to organise, integrate and transform health Big Data into better health outcomes depends on the ability to create a permissive and enabling ecosystem. Developing such an ecosystem in Europe relies on data sharing between multiple stakeholders, from public and private organisations involved in biomedical R&D, to other disciplines (for example ICT, social sciences) that must put citizens and patients at their centre.” Erice is reached by a long precipitous road with many hairpin bends. Lets hope Europe’s policy-makers have a superhighway in mind.1