Volume 10, Issue 4 / 2008 - News

News Europe

EHealth: Commission Launches Two Initiatives

The European Commission has launched two initiatives to improve the safety and quality of care to people who require medical assistance while traveling or living abroad: a recommendation on crossborder interoperability of electronic health records (EHR) and the Smart Open Services (SOS) project.


The recommendation aims to provide member states with basic principles and guidelines for ensuring that doctors can gain access to vital information on patients that they are trying to treat, wherever such information may be located in Europe. A key objective of the recommendation, according to the Commission, is “to allow patients to choose to access his/her important information stored in electronic health record systems anywhere at any time.” It invites member states to take action at: the overall political level to set up the necessary regulatory and financial environment to make eHealth infrastructure and services interoperable; the organisational level to create, for example, a common domain accompanied by the necessary interfaces that enable the national domains to interact; the technical level to promote use of technical standards and to establish common interoperability platforms; the semantic level to agree on common priorities and specific applications, and the level of education and awareness raising to monitor and consider all intended and related developments.


The recommendation will be implemented by The SOS project, co-funded by the European Commission. The three-year 22 million euros joint initiative is supported by 12 member states and their industry players, to demonstrate the benefits of such interoperability. It will enable health professionals to access specific medical data such as current medications of patients from other EU countries. In an emergency, sharing of medical information could save many patients’lives.


Annual Work Plan Priorities

DG Sanco is seeking views on priorities for the annual work plan 2009. The Health Programme 2008-2013 entered into force on 1 January 2008. It is intended to complement, support and add value to the policies of the member states and contribute to increased solidarity and prosperity in the European Union by protecting and promoting human health and safety and by improving public health.


The Programme is implemented by means of an annual work plan which sets out the areas that will be funded and gives an indicative budget for each financing mechanism. To ensure that European citizens can give their input into the programme, the Directorate General for Health and Consumers is seeking views on which priorities should be included in the work plan for 2009.


Views on priority areas to be included in 2009 can be sent by 30 September 2008 to: [email protected]


EUPHIX Knowledge System Launched

The EUPHIX knowledge system was recently launched in Leiden, The Netherlands. EUPHIX (www.euphix.org) is a webbased knowledge system for health professionals, policy makers and others. It presents structured European public health information, giving a special insight into similarities and differences between EU member states.


In this website, EUPHIX presents information on topics related to health status, determinants of health, health interventions and systems, health policies, demography and broader public health themes.


Medical Devices Directive

The European Medical Device Industry associations (representing 95% of the medical device industry) resist the European Commission’s proposal to build up a centralised European Agency for Medical Devices. The new authority is planned to regulate medical devices affairs, such as classification and pre-market approval of “highest risk” devices. According to the industry, the concerns of the EU Commission can be addressed through improved implementation of existing measures.


Pharma Package Could Relax Drug Advertising Rules

The proposed new directive on information to patients is expected to be one of the most controversial initiatives in the Commission’s pharmaceuticals package. Current EU legislation allows advertising of non-prescription medicines that are not reimbursed, but bans direct-toconsumer advertising of prescription drugs.


The new rules would maintain the ban on direct advertising of prescription medicines, but would create an opportunity for the industry to provide “additional information” to the public via the media. The pharma package, which is expected to be released in October or November, contains the following three initiatives:

a directive on information to patients concerning pharmaceuticals;

a regulation amending an existing one of the authorisation and supervision of medicinal products for human and veterinary use and a directive modernising pharmacovigilance, and

a legislative proposal to combat counterfeit medicines for human use.

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