New location for the EMA
The Member States will make a final decision in November 2017 on where to relocate the European Medicines Agency (EMA). 19 countries have put in an offer to be the new host of EMA. German Health Minister Herman Gröhe is lobbying in Brussels for Bonn’s application to host EMA.
EU drives forward the digitalisation of healthcare
The public consultation on ‘Transformation of Health and Care in the Digital Single Market’ is open until 12 October. A communication is expected from the Commission in December 2017. The consultation, which is aimed at organisations, companies and private individuals, focuses on three main areas:
1) cross-border access to and exchange of electronic health records and electronic prescriptions,
2) collecting and better utilising health data for research purposes,
3) better uptake of digital innovations to allow interaction between patients and healthcare providers.
Furthermore, under the Estonian Presidency of the Council of the European Union, conclusions will be passed in December 2017 on ‘Health in the Digital Society – making progress in data-driven innovation in the field of health’. Prior to this, the Estonian Ministry of Social Affairs is hosting a high-level conference entitled ‘Health in the Digital Society. Digital Society for Health’ from 16-18 October in Tallinn.
Medicinal products and protection of intellectual property
The European Commission is currently examining whether EU incentives for the pharmaceutical industry and the generics sector are in balance. Specifically, this is about whether a supplementary protection certificate, which compensates for a loss of patent validity during the development phase of a product, is actually weighted fairly.
The Commission is also considering a "manufacturing waiver" to allow generics producers to manufacture copies of patent-protected products for third party markets. The Commission is also examining the degree of implementation of the Bolar exemption directive for generics producers and whether the Member States are giving them equal opportunity to test their medicinal products in patent-protected markets. The Commission intends to present a study by the end of 2017. A public consultation will also be launched in autumn 2017.
Measuring antimicrobial resistance
The EU Commission adopted a new action plan to combat antimicrobial resistance in June 2017. It includes the cautious use of antimicrobial medicines and encourages the development and availability of new effective antimicrobials inside and outside the EU. According to the planning of the Estonian Presidency, an in-depth discussion of the action plan is to take place at a high-level conference in Brussels on 23 November 2017.
In addition, indicators will be set up to measure antimicrobial resistance and the use of antibiotics. Three EU agencies - the European Food Safety Authority, the European Medicines Agency and the European Centre for Disease Prevention and Control - intend to publish measurable and globally relevant indicators by the end of the year.
New alignment for Health Technology Assessment
The various institutions in EU countries concerned with Health Technology Assessment (HTA) want to strengthen their cooperation. Better coordination between the European HTA institutions themselves and with the EMA should prevent work being unnecessarily duplicated in each country. In addition, the aim is to ensure that approval studies take into account jointly formulated HTA requirements. This means standardising the data which is needed to measure the value-added benefits of new health technologies. The aim of the Commission is to strengthen cooperation in HTA. It intends to present a legislative or non-legislative proposal by the end of 2017.
Track-and-trace system for cigarettes
The Directorate-General for Health intends to submit draft legislation for a track-and-trace system of cigarette packets this year. The aim is to implement the system by May 2019 in order to tackle cigarette smuggling.