6 things to watch in health care this autumn

From e-health to tobacco tracing, there’s a packed agenda in health care for the rest of 2017.

The rest of the year will be busy in the health arena, with the race to comply with medical device regulations picking up pace.

But there’s other health action coming down the pike. Here’s some of what to expect:

EMA relocation decision: Ministers and diplomats from EU countries will gather at a General Affairs Council meeting in November to decide the new host city for the European Medicines Agency when it leaves London due to Brexit. With 19 cities in the running, expect heavy lobbying among EU diplomats and backroom deal attempts. The new host city will play a crucial role in EMA staff members’ decision on whether to follow the agency or look for a new job in London.

E-health communication: The European Commission will release a policy paper — a so-called communication — on digital transformation in health care, in an effort to use its soft power and infrastructure support to push countries to make patient care across the EU more seamless. It’s expected to include plans to develop a European health record format that citizens can access from anywhere in the EU. It will also look at creating a European decentralized digital infrastructure, enabling the analysis of aggregated health data gathered and stored in different locations to be used for rare and complex diseases.

Pharma incentives: The Commission is examining whether EU incentives for the pharmaceutical and generics sectors are in balance. It’s exploring whether supplementary protection certificates, designed to claw back lost market exclusivity time while a product was in development, are fairly weighted. It’s also considering a manufacturing waiver so generics firms can produce copies of patented products in Europe, and assessing countries’ implementation of the Bolar exemption directive to allow generics firms to test medicines in a patent-protected market. The Commission failed to publish its promised draft by July. Expect progress on this before 2018.

AMR measurables: The Commission’s second action plan to fight antimicrobial resistance was published in June. It seeks to strengthen surveillance and reporting of AMR, boost research and development to prevent and treat infections, and ensure the EU is leading the global AMR fight. One of the first deliverables is defining indicators to measure AMR and consumption of antibiotics. Three EU agencies — the European Food Safety Authority, the European Medicines Agency and the European Center for Disease Prevention and Control — are working on measurable and globally relevant indicators. These should be set before the end of the year.

HTA alignment: By standardizing the data required by EU countries to measure the added value of new medicines — information used in pricing negotiations — drugmakers and therefore health systems could reduce their costs. That’s the theory behind the Commission’s initiative to strengthen EU cooperation on health technology assessment (HTA), to be introduced in 2017.  It undertook an impact assessment over the summer to examine whether there is a need for EU action and to posit available solutions. That’s expected to be sent to the regulatory scrutiny board in October.

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Track-and-trace tobacco system: DG SANTE reassured member countries and the European Parliament it will be able to pass a legal act by the end of the year, establishing a system to track and trace cigarette packs. The system should be implemented by May 2019. However, it seems no one but the Commission thinks it will happen by then. In June, Tibor Stelbaczky, the Hungarian deputy ambassador to the EU, asked the Commission to extend this deadline because there is no time to legally approve the new system within the timeframe.