Health Priorities of the Italian Presidency of the Council of the EU

The priorities were announced within the 2014 Italian Programme for the EU, a yearly exercise containing Italy’s main action-lines on issues concerning the European institutions. The document was developed by the Italian Ministry of Foreign Affairs and issued by the Italian Presidency of the Council of Ministers.

Below you will find the most relevant information contained within the document’s chapter devoted to the healthcare priorities of the upcoming Italian Presidency, shedding some light on the initiatives to be developed in the next 6 months.

-  The document underlines that the Italian Presidency will have a focus on prevention, through the promotion of healthy lifestyles and prevention of chronic diseases with specific attention to women’s health, respiratory diseases and prospective use of genomics in prevention. Amongst the priorities is also the prevention of communicable diseases with a special focus on promoting the importance of vaccination coverage and on reinforcing the fight against viral hepatitis and HIV;

-  Concerning care delivery, the Italian Presidency will work towards ensuring access to quality treatments that provide the maximum safety for patients and particular attention will be given to balance the relation between cost and efficacy of the treatments. Italian authorities will also cover issues related to pain management and palliative care;

-  Additionally, in the context of the constant migratory flows that have affected Italy and other EU countries, the Italian Presidency intends to propose an initiative to discuss on Health coordination in issues that specificallytouch Mediterranean countries, both from the northern and the southern shore. The main objective of this initiative will be to set new strategies and cooperation mechanisms to face common issues to both shores of the Mediterranean.

Medicinal Products, Medical Devices, IVD:

• The Italian Presidency will work for the advancement of important normative proposals in the field of pharmaceutical products, with special focus on the Directive on the transparency of measures regulating the prices of medicinal products for human use(2012/0035).
• On the process for the new Medical Devices Regulation, the authorities in charge of organising the Italian Presidency recognise that there is a need for a new regulatory framework for Medical Devices, considering the flaws of the past Directive. The Italian Presidency states that they will closely supervise the advancement of the negotiations in order to ensure that the objectives are respected in terms of: pre-marketing control, higher standards and inspections to notified bodies, post-marketing control and on the setting of post-marketing supervision and monitoring mechanisms. There is however no reference made to any urgency to conclude the negotiations and adopt the Regulation.
• The Italian Presidency will boost the revision of the current guidelines concerning the definition and categorisation of “borderline products”.

More information on the source of the document (in Italian) can be accessed here.