The Commission has put forward today a proposal to boost cooperation amongst EU Member States for assessing health technology.
Health Technology Assessment is a multidisciplinary process that summarises information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased and robust manner.
The Commission's proposal aims to make innovative health technologies available to Europe's patients, make better use of available resources and improve business predictability. The proposal also seeks to ensure that when Health Technology Assessment is performed, the methodologies and procedures applied are more predictable across the EU and that joint clinical assessments are not repeated at national level, thereby avoiding duplication and discrepancies.
The proposal sets out the following four pillars for joint work of Member States at EU-level:
Joint clinical assessments focusing on the most innovative and potentially impactful health technologies for maximum EU-added value;
Joint scientific consultations whereby developers of a health technology can seek the advice of Health Technology Assessment authorities on what type of data and evidence is likely to be required in the submission for Health Technology Assessment;
Identification of emerging health technologies to help ensure that the most promising health technologies for patients and health systems are identified early and included in the joint work; and
Voluntary cooperation in areas outside the scope of mandatory cooperation, for example on health technologies other than medicines and medical devices (e.g. surgical procedures), or on economic aspects of health technologies.
Individual EU countries will continue to be responsible for assessing non-clinical (e.g. economic, social, ethical) aspects of health technology, and making decisions on pricing and reimbursement.
The proposal will now be discussed by the European Parliament and the Council of Ministers. It is expected that once it is adopted and enters into force, it will become applicable three years later. Following the date of application, a further three-year period is envisaged to allow for a phase-in approach for Member States to adapt to the new system.
The Commission formally adopted the new Code of Conduct for Members of the European Commission that President Juncker had announced in his State of the Union Address.
This new Code takes effect as of today and is applicable to all current Members of the Juncker Commission, in line with President Juncker's push for greater transparency since the beginning of his mandate.
The modernised rules set new standards for ethical rules in Europe. Beyond the President's earlier proposal to extend the "cooling-off" period from currently 18 months to two years for former Commissioners and to three years for the President of the Commission, the new Code of Conduct sets clearer rules and higher ethical standards and introduces greater transparency in a number of areas. It also creates an Independent Ethical Committee with reinforced status – replacing the current Ad hoc Ethical Committee – to strengthen scrutiny and to provide advice on ethical standards.
The Commission has today endorsed horizontal provisions for cross-border data flows and personal data protection in trade negotiations. Protection of personal data is a fundamental right in the European Union and can therefore not be subject to negotiations in the context of EU trade agreements. The preferred avenue for the EU are “adequacy decisions”. Dialogues on data protection and trade negotiations with third countries can complement each other but must follow separate tracks – like currently with Japan and South Korea. The Commission has looked into how best to advance the EU's interests in this area – especially in cases where an “adequacy decision" (recognising an equivalent level of data protection of a third country) cannot be realistically reached in parallel to ongoing trade negotiations.
The Commission's work was carried out by a project team lead by First Vice-President Frans Timmermans and has resulted in a balanced position that could be used in trade negotiations to address data flows, without prejudice to data protection issues. It would allow the EU to tackle protectionist practices in third countries, while ensuring that such trade agreements cannot be used to challenge the strong EU rules on the protection of personal data.
The Commission's position endorsed today will determine its approach to data flows and data protection in trade agreements until the end of the mandate.
Commissioner for Trade, Cecilia Malmström and Commissioner for Agriculture and Rural Development, Phil Hogan debriefed the College about the latest developments in the negotiations towards a trade agreement with the four founding members of Mercosur, namely Argentina, Brazil, Paraguay and Uruguay. They informed Commissioners about the outcome of the constructive ministerial meeting which took place yesterday and stressed that a chief negotiators meeting will take place on Friday to take the discussions further.
The European Commission appointed today the current Deputy Secretary-General Paraskevi Michou as Director-General of its Migration and Home Affairs department – the first woman to hold that post. The appointment will take effect on 1 March. The current Director-General Matthias Ruete, one of the Commission's most experienced senior officials, will become Hors-Classe Adviser for strategic matters related to Energy Union, Security Union, Subsidiarity and Proportionality in the Secretariat-General.
Source: EU Commission News