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EU Policy Updates

EU Ministers of Health discussing patients’ safety and health 

On December 10, in the framework of the Employment, Social Policy, Health and Consumer Affairs (EPSCO) configuration of the Council of the EU, the Health Ministers of the 28 European Union Member States reviewed the state of play in on-going legislative dossiers, namely the package on Medical Devices and In Vitro Diagnostic Medical Devices, the negotiations between the co-legislators with regard to the Tobacco Products Directive (TPD), Clinical Trials and European Medicine Agency (EMA) fees. EFA has been very active in most of these dossiers and our positions are available here.  See here the video of the press conference after the EPSCO Council with the EU Presidency and the Commissioner for Consumer Affairs and read here for more information.

In the Medical Devices Regulation, positions are still unclear as regards the scrutiny of high-risk medical devices entering the market and the reuse of medical devices. While some Member States would like to have a systematic scrutiny for all high-risk medical devices, others would not like to have a scrutiny at all. If some countries are more flexible and believe that reprocessing should be addressed only at the national level, others are stricter and would like either to prohibit the reprocessing or to make all medical devices reprocessable by default. With the objective of improving patients’ safety without limiting EU innovative power in the field, an agreement should be reached during the next Greek Presidency of the Council that has identified medical devices as a priority and before next European Parliament’s elections.

In addition to these discussions, the Ministers unanimously adopted conclusions on the “Reflection process on modern, responsive and sustainable health systems”. Member States acknowledge the core role of health for the economic prosperity and stress the importance of the principles of solidarity, universal health care accessibility, as well as the horizontal principle “health in all policies”. The document provides the EU Member States with the guidelines on how to ensure that national health systems are resilient to demographic, economic and technological changes. Patients’ safety is put at the heart of all EU policies and this reflects our priorities identified in EFA Manifesto for 2014 European Parliament Election.

Along the same line, and with the aim of seeking the opinion of the civil society on whether patient safety measures included in the 2009 Council Recommendation are implemented and contribute to improving patient safety in the EU, which areas are not covered and instead should be, what should be done at EU level beyond this Recommendation, and whether quality of healthcare should be given more importance in the future EU activities, the European Commission launched a public consultation on patients’ safety and quality of care. The consultation is open until February 28 and is accessible here.

 

EU strengthens its fight against illicit trade in tobacco

On December 10, the Economic and Financial Affairs configuration of the Council of the EU adopted crucial conclusions on stepping up the fight against cigarette smuggling and other forms of illicit trade in tobacco products in the EU. The Council identified areas where additional measures are required, including the detection of illegally traded tobacco products, further improvement of investigations, cooperation with source and transit countries, awareness raising campaigns to discourage people from purchasing illicit tobacco products, and improvement of available expertise in national customs administrations, and other relevant EU and international authorities. Read here for more information.

This document came the day after the EU agreement to sign the World Health Organisation (WHO) Protocol on the Elimination of the Illicit Trade in Tobacco Products, the first Protocol to the WHO Framework Convention on Tobacco Control and signed in November 2012 with the aim of eliminating all forms of illicit trade in tobacco products. Under the Protocol, all those engaged in the tobacco supply chain will be required to conduct due diligence on their customers: they must ensure that sales to their customers reflect the real and legitimate demand, and there is not excess supply that could be used in the black market. The Protocol also foresees the establishment of a global tracking and tracing regime for all tobacco products, within 5 years of its entry into force. This would include unique identification markings, which will help determine the origin of tobacco products, as well as the point at which they are diverted into the illegal supply chain. The Protocol will enter into force 90 days after the deposit of the 40th ratification, and at the moment there are 39 countries in the world that have ratified it, including several EU Member States. For more information, read here.

 

Health priorities of the Greek Presidency

On December 3, the Greek Health Minister Spyridon-Adonis Georgiadis discussed the health priorities with Members of the European Parliament (MEPs) in view of the upcoming Greek Presidency of the Council of the EU. One week later, on December 10, he presented the priorities at the Health Council. The Greek Presidency will prioritise the progress of important legislative proposals in the field of health, pharmaceutical and medical devices, such as those related to tobacco products, clinical trials, pharmacovigilance fees and transparency, while non legislative work will aim at promoting successfully implemented initiatives towards more efficient health care systems and better public health, with a focus on eHealth and health innovation among others. The Greek Presidency is committed to making substantial progress on these dossiers in order to reach an agreement as soon as possible.

 

First calls under Horizon 2020

Last month, we informed you about the European Parliament’s plenary vote on Horizon 2020, the new EU research programme. On December 3, the Council adopted the final text of the programme and the first calls were launched one week later, on December 11. With a budget of nearly 80 billion EUR over seven years, Horizon 2020 is the biggest EU research programme, and one of the main publicly funded research programmes worldwide. Societal challenges are getting the bigger slice of the cake with almost 30 billion EUR, with a total of around 7.47 billion EUR to be invested in the societal challenge “Health, demographic change and wellbeing”. This topic will involve two calls in 2014 and 2015, with a budget of 549 million EUR in the first year. Particularly, the “Personalising health and care” call is structured into seven main themes that are: understanding health, ageing and disease; effective health promotion, disease prevention, preparedness and screening; improving diagnosis; innovation treatments and technologies; advancing active and healthy ageing; integrated, sustainable, citizen-centred care; and improving health information, data exploitation and providing an evidence based for health policies and regulation. This is in line with the outcomes of the event we held in collaboration with the European COPD Coalition last month (the report is now available here) and with our Manifesto. Read here for more information.

 

EP Written Declaration on allergies: one month to go

As we informed you earlier this year, on October 21, 11 Members of European Parliament (MEPs) presented a Written Declaration on recognising the burden of allergic disease with the objective of calling on the EU Commission and the Member States to act to tackle allergies in Europe. MEPs have time until January 21 to sign the Written Declaration and at the moment only 86 MEPs have signed. As the signatures of the majority of the Members of the European Parliament are required, our partner organisation, the European Academy of Allergology and Clinical Immunology (EAACI) started a Facebook and Twitter campaign to support this important document. The Written Declaration is perfectly in line with our Manifesto and we call on Members of the European Parliament to sign this document and limit the burden of allergies in Europe.

 

Regulation on F-gases: affecting inhalers?

On December 18, the Committee of Permanent Representatives (COREPER I) endorsed the agreement reached by the Lithuanian Presidency and the European Parliament on the Proposal for a Regulation on fluorinated greenhouse gases, the objective of which is to protect the environment by reducing emissions of fluorinated greenhouse gases. EFA has advocating together with the International Primary Care Respiratory Group (IPCRG) and the European Hospital and Healthcare Federation (HOPE) towards the European Parliament and the Council to include a specific exemption for medical applications of critical use. Indeed, Hydrofluorcarbon-Based Metered-Dose Inhalers (such as inhalers containing the medicines used to treat asthma) contain F-gases and, nonetheless, they continue to be necessary for the adequate treatment of some people with chronic and long-term respiratory diseases, especially children, elderly people and those seriously ill from these diseases. The details of the final text are still not available and we will keep you updated in the near future.

 

WHO summit on non-communicable diseases

On December, 3-4, the World Health Organisation organised a European Ministerial Conference on the Prevention and Control of Non-communicable Diseases in the Context of Health 2020 in Ashgabat (Turkmenistan). Ministers of Health in the WHO European Region presented their achievements in prevention and control of non-communicable diseases over the past two years, and with the Ashgabat Declaration they committed to joint action in this area in the short and long terms. Read here for more information.

During the conference the document “Prevention and control of non-communicable diseases in the European Region: a progress report” was presented. It gives an overview of what has been done and what needs to be done to reduce alarming numbers of morbidity and mortality of non-communicable diseases in Europe. The “European Tobacco Control Status Report” was published and discussed during the summit too. This document, 10 years after the adoption of the WHO Framework Convention on Tobacco Control, looks back and takes stock of the situation in order to effectively target actions towards a decrease in tobacco use and to further stimulate the discussion for achieving a tobacco-free Europe.

 

EFA Policy Survey

EFA is launching a significant development by starting for the first time a comprehensive policy survey to its members, instead of just consulting on a case-by-case basis on a specific policy dossier. In the survey, members will be asked about their satisfaction with EFA’s activities in EU policies in order to determine priorities and EFA policy direction focused on members. Members can take the survey here.

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