• Healthy ageing as an approach of keeping people healthy at later life, is one of the main objectives of the European Health Strategy 2008-2013. This issue has also been dealt with by previous Presidencies, achieving various findings, one of which demonstrates that healthy ageing is closely related to the implementation of preventive and health promoting health from early years of life. Within the framework of the year 2012 as the European Year of Active Ageing and Solidarity between generations, the Cyprus Presidency taking into consideration the current economic crisis and the ageing of population, aims at underlining the need to review the structure of health care services and redirect investments for cost reduction in the healthcare sector. Cyprus Presidency through its planned activities will further develop work in the area of healthy ageing by collecting evidence and highlighting best practices which prove that Healthy Ageing is a matter of continuous process that requires the implementation of health promotion and disease prevention programmes. In this effort, key elements will be, among others, the multidisciplinary approaches involving both individuals and their community, and their application throughout the lifecycle, from early stages of life until the late years.

    Relevant Links:

    European Year for Active Ageing and Solidarity between Generation

    European Innovation Partnership on Active and Healthy Ageing

    Europe 2020

    Health Strategy

    Health Programme 2008 - 2013

  • Addressing serious cross border health threats is one of the major health issues to be dealt with both by the member states and the EU. Experiences and lessons learnt from previous years show that strong capacity building and collaboration mechanisms are necessary to cover all types of serious cross-border health threats and require that aspects of prevention and communication are also addressed. In December 2011, the European Commission adopted a legislative proposal regarding several ways to address serious cross border threats to health. The main objective of the proposal is the protection of the European citizens from a wide range of health threats such as chemical, biological or environmental in nature and the provision of fully co-ordinated response in the event of a crisis. The Cyprus Presidency, taking into account the Commission’s initiative, as well as the fact that collaboration should not only be limited at EU level, but also be extended to other neighbouring non-EU countries and international organizations, will further develop activities towards this direction. Thus, focus will be given on advancing the discussions on this proposal and on activities for promoting the regional dimension of health security and capacity building.

    Relevant Links:

    Proposal for a decision of the European Parliament and of the Council on serious cross-border threats to health

  • The Cyprus Presidency considers the issue of organ donation and transplantation as a one of the pure acts of altruism and social solidarity. At the same time, it recognizes the shortage in human organs intended for transplantation throughout Europe and aims to highlight the need for coordinated actions in the field, at community level. The European Commission, in addressing the challenges in the area of organ donation and transplantation in the EU, moves forward on the establishment of coordination and cooperation mechanism among member states. For this reason, there relevant legislation has been adopted, as well as an action plan for organ donation and transplantation for the period 2009-2015. The midterm evaluation of the Action Plan is expected to be completed during the second half of 2012.

    In light of these, the Cyprus Presidency plans to adopt respective Council Conclusions, which will further invite the member states, the European Commission and the other EU institutions for concrete actions in ensuring public awareness on the importance of organ donation and transplantation and securing EU funds for the development of respective programmes in this field.

    Relevant Links:

    Organ donation and transplantation

  • Pharmacovigilance is defined as the group of actions relating to the continuous monitoring and evaluation of the safety of medicinal products upon their release in the market, identify any rare and potentially severe reactions. The main objective of pharmacovigilance is the continuous assessment of the benefit – risk assessment of all licensed medicinal products. The legal framework of pharmacovigilance is defined by the EC Regulation 726/2004 on medicinal products, centrally approved by the Directive 2001/83/EC for products approved on national level (including those approved by mutual recognition and decentralised procedures). In September 2010, the European Parliament approved the amendment of the Directive 2001/83/EC and the Regulation (EC) 726/2004 on pharmacovigilance (Regulation (EC) 1235/2010 and Directive 2010/84/EU) aiming to greater patient safety, and therefore, in safeguarding/ promotion/ improvement of public health. The new legislation will come into force as from July 2012.

    Relevant Links:

    The EU pharmacovigilance system

  • Clinical trials are related to experiments on humans, aiming at discovering or verifying the results of one or more testing medicinal products. The requirements for conducting clinical trials within the EU are defined by the Directive 2001/20/EC of the European Parliament and the Council, as amended by the Directive 2005/28/EC. On the 10th of December 2010, the Commission issued a Communication to the European Parliament, the Council, the European Economic and Social Committee and the Regional Committee for “Safe, Innovative and Accessible Medicinal Products: a new vision for the pharmaceutical sector”, which announced the forthcoming evaluation of the implementation of the Directive on clinical trials. The evaluation shall include, inter alia, options for improving the functionality of the Directive at hand, aiming at the submission of legislative proposals, if appropriate, taking into consideration the global aspect of clinical trials. In February 2010, a public consultation was launched, based on a discussion paper on the revision of the Directive 2001/20/EC and a proposal for a revised legislation that regulates the clinical trials is expected to be dealt with by the Working Party on Pharmaceuticals and Medical Devices during the Cyprus Presidency.

    Relevant Links:

    Clinical Trials

  • In the work programme of the Commission for 2011 the revision of the Directive 89/105/EEC was announced. The Directive aims at ensuring the transparency of measures adopted by the member states, in order to control the pricing and reimbursement of medicinal products. The Directive does not affect national policies related to pricing and organization of social insurance systems, except to the extent considered necessary to ensure transparency. The Directorate General Enterprise and Industry conducted a public consultation during the first half of 2011 and an impact analysis of the impact review of Directive 89/105/EEC. In March 2012, the Commission adopted a proposal for a Directive of the European Parliament and Council Directive, on the transparency of measures that regulate the pricing of medicinal products for human use, as well as their inclusion in the public insurance health systems and the cancellation of Directive 89/105/EEC. The proposed Directive aims to simplify the procedures and to replace the Directive 89/105/EEC, which no longer reflects the complexity of pricing and reimbursement procedures within the member states. The discussion of the proposal at the Working Group on Medicinal Products and Medical Devices has been initiated by the Danish Presidency and it will be continued by the Cyprus Presidency and the work will proceed in this direction at the level of the European Parliament as well.

    Relevant Links:

    Pricing and reimbursement of Medicinal products

  • The three directives on medical devices aim to protect the health, ensure the safety of EU citizens and allow the proper functioning of the single market. The results of a public consultation launched in May 2008 for possible recasting of the medical devices directives, led to the need for a fundamental revision of the existing directives in order to simplify and strengthen the current EU legal framework for medical devices to meet the growing expectations of European citizens. Additionally, the recent incidents with breast implants and large Metal-on-Metal hip replacements, revealed the need for increased coordination between the member states in order to guarantee patient safety. The Cyprus Presidency will initiate the discussions of the new legislative proposals at the Council.

    Relevant Links:

    Medical Devices