Dear EPF Members and Allies,

Welcome to the first EPF Mailing of 2012. The New Year has started well for EPF and our membersWe are honoured and proud to recieve fo the first time an operatng grant from the European Commission . It is a very exciting time as we also prepare to launch the new IMI project EUPATI together with our fellow Consortium members (see this article) and move forward on other key projects. January has also seen the launch of SUSTAINS, which is focussing on electronic health records (see article 16).

On the policy side, we are advancing on our work on the chronic diseases reflection process information to patients, personalised medicines and the revision of the medical devices Directive (see article 4 and article 8). Another key focus for us in the new Public Health Programme ‘Health for Growth’ (see article 3). We are delighted to be collaborating very closely with the European Public Health Alliance on achieving a programme that embraces health, wealth and equity – and prevention, health promotion and patient centred chronic disease management.

The EPF secretariat team has expanded over the last few weeks and we are very happy to welcome two new members of the team (see “Secretariat” section).

Our Annual General Meeting is in early spring on 18, 19 of April 2012. We will be undertaking preparatory work with our members in relation to the Strategic Planning Session that will take place on the second day of the meeting. This will be to ensure that our members and their needs and aspirations drive where we go during the next EU programming period 2014 – 2020.

Concerted work is also underway with regard to our Value + capacity building programme. It will enter its first phase in 2012 with strategic planning work with national patient organisations, and needs assessment with selected newer European EPF members that have been established relatively recently.

This Mailing also looks back at key events we have been involved in since our last issue and our contributions from a patients’ perspective. Key highlights are the EUnetHTA conference in Gdansk in December the celebration with the European Nursing Community of the 40th Anniversary of the European Federation of Nurses, and discussion with CPME on our Joint Principles underpinning our collaboration. Our trusted partnership with fellow NGOs representing the spectrum of health professionals is absolutely fundamental to our vision and our goals.

In that spirit, we look forward to our continued joint work in 2012!

Warmest greetings, EPF President Anders Olauson EPF Director Nicola Bedlington

EPF Mailing Issue 1 (42)

30 January 2012

www.eu-patient.eu

TABLE OF CONTENTS EU POLICY UPDATE ................................................................................................................................................................................................................................................... 1 1. CROSS-BORDER HEALTHCARE: EUROPEAN COMMISSION ESTABLISHES EHEALTH NETWORK ............................................................................................................................. 1 2. REVIEW OF THE EU CLINICAL TRIALS DIRECTIVE ................................................................................................................................................................................................ 2 3. FUTURE EU HEALTH PROGRAMME ................................................................................................................................................................................................................... 3 4. CHRONIC DISEASES REFLECTION PROCESS ........................................................................................................................................................................................................ 3 5. INFORMATION TO PATIENTS UPDATE ............................................................................................................................................................................................................... 4 6. EPF SURVEY ON PATIENT SAFETY- REMINDER ................................................................................................................................................................................................... 5 7. MEDICAL DEVICES ............................................................................................................................................................................................................................................ 6 8. REVIEW OF THE PROFESSIONAL QUALIFICATIONS DIRECTIVE ............................................................................................................................................................................ 6 9. MEDICAL RESONANCE IMAGING (MRI) DIRECTIVE UPDATE ............................................................................................................................................................................... 7 10. REVIEW OF THE DATA PROTECTION FRAMEWORK ......................................................................................................................................................................................... 8 11. PATIENT SAFETY- MEETING OF THE PATIENT SAFETY AND QUALITY OF CARE WORKING GROUP .................................................................................................................... 10 12. CALL FOR PROJECT 2012 TO SUPPORT THE INNOVATION PARTNERSHIP ON ACTIVE AND HEALTHY AGEING ................................................................................................... 11 PROJECTS & INITIATIVES .......................................................................................................................................................................................................................................... 13 13. CHAIN OF TRUST ........................................................................................................................................................................................................................................... 13 14. RENEWING HEALTH ...................................................................................................................................................................................................................................... 13 15. EUPATI ......................................................................................................................................................................................................................................................... 14 16. SUSTAINS ..................................................................................................................................................................................................................................................... 15 CONFERENCES & EVENTS ......................................................................................................................................................................................................................................... 15 17. “NEW QUALITY DEVELOPMENTS IN HEALTHCARE” - EU EXPERT CONFERENCE, NOVEMBER 18, WARSAW ...................................................................................................... 15 18. WHO EURO CONFERENCE - "MODERN HEALTH CARE DELIVERY SYSTEMS AND THE ROLE OF HOSPITALS", 21-22 NOVEMBER 2011, BRUSSELS ............................................... 16 19. EUROPEAN HEALTH LITERACY CONFERENCE BRUSSELS, 22 NOVEMBER 2011 ................................................................................................................................................. 17 20. CHRONIC CONDITIONS IN AN AGEING POPULATION, NOVEMBER 22, BRUSSELS ............................................................................................................................................ 18 21. CELEBRATING THE 40TH ANNIVERSARY OF THE EUROPEAN FEDERATION OF NURSES, 24 NOVEMBER 2011 ..................................................................................................... 20 22. MOBILE DOCTORS, MOBILE PATIENTS - HOW DOES PATIENT SAFETY TRAVEL IN EUROPE? - CPME CONFERENCE ON 25 NOVEMBER 2011 ...................................................... 21 23. EPF BOARD MEETING 28 NOVEMBER 2011 .................................................................................................................................................................................................... 21 24. EFPIA PATIENTS THINK TANK, 29 NOVEMBER ................................................................................................................................................................................................ 22 25. EHN PATIENT SEMINAR, 30 NOVEMBER 2011 ................................................................................................................................................................................................ 22 26. MICROSOFT HEALTH USER GROUP, NOVEMBER 30-DECEMBER 2, BRUSSELS - INNOVATION FOR THE BENEFIT OF PATIENTS .......................................................................... 22 27. EUROPEAN PARLIAMENT WORKSHOP ON CLINICAL TRIALS, 1 DECEMBER 2011 ............................................................................................................................................. 23 28. 4TH ANNUAL HEALTH TECHNOLOGY ASSESSMENT WORLD EUROPE 2011 30 NOVEMBER - 01 DECEMBER 2011 ............................................................................................. 24 29. EUNETHTA CONFERENCE, DECEMBER 8-9, GDANSK, POLAND - THE IMPACT OF NEW HEALTH TECHNOLOGIES ON PATIENT’S PERSPECTIVE.................................................... 24 SECRETARIAT .......................................................................................................................................................................................................................................................... 25 30. AU REVOIR GAYA .......................................................................................................................................................................................................................................... 25 31. WELCOME GIULIA AND CYNTHIA .................................................................................................................................................................................................................. 25 32. EPF ON THE MOVE ........................................................................................................................................................................................................................................ 26 33. CALENDAR .................................................................................................................................................................................................................................................... 27

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EU Policy update

1. Cross-border healthcare: European Commission establishes eHealth network

On 22 December 2011, the European Commission adopted a Decision establishing an eHealth Network. The eHealth network is based on Directive (2011/24/EU) on patients' rights in cross-border healthcare. It will aim to foster voluntary cooperation between Member States to ensure EU wide interoperability of electronic health systems and wider use of eHealth. Specifically, the network will draw up guidelines on the minimum set of common data to be included in patient summaries to be transferred across borders; methods to enable the use of medical information for public health and medical research; and on common identification and authentication measures to ensure transferability of data in cross-border healthcare

EPF fought hard to include eHealth cooperation in the cross-border healthcare directive (Article 14), as eHealth and telemedicine services form an essential support to patient safety and the continuity of care across borders. EPF therefore welcomed the inclusion of a European eHealth network in the Directive. However, we regret that this provision is weakened by being voluntary. Furthermore, no stakeholder involvement is mentioned (unlike the HTA Network, also established by the Directive). Furthermore, EPF is concerned that the safety and quality standards applicable to eHealth should be the same as to non-electronic health services – something that is not clearly expressed in the Directive.

As readers will know, EPF is involved in eHealth through our participation in several ongoing EU-funded projects. We will follow the activities of the new eHealth network with great interest, and aim link up to our ongoing activities and projects where appropriate.

More information:

• EC decision establishing the eHealth network available here. • Council conclusions on “safe and effective care through eHealth” (2009) here.

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• EPF’s statement on the adoption of the cross-border healthcare directive available here.

2. Review of the EU Clinical Trials Directive The progress on clinical trials has been extensively documented in previous issues of the Mailing. Following two rounds of public consultation, and several stakeholder events, the European Commission’s proposals for the future EU legislation on clinical trials are to be published during the second quarter of 2012.

EPF and several representatives of our member organisations met on 21 November 2011 to discuss the direction of the review. Present at the meeting were Commission officials responsible for this dossier, who explained the Commission’s approach and answered questions. The Commission’s proposals will centre around simplifying the application procedures, and implementing a risk-adjusted approach to clinical trials.

From the patients’ perspective, EPF has argued that certain aspects, such as information to patients an informed consent, should be harmonised to guarantee equitable access to high quality information on clinical trials to all patients, regardless of which Member State they live in. furthermore, EPF has called for more patients representation on ethics committees.

The EPF Secretariat is currently preparing an updated position document, which will be put to a member consultation in due course.

More information:

• EPF’s previous responses to the consultations can be found here. • The European Commission concept paper can be found here.

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3. Future EU Health Programme

The European Commission’s proposal for a new health programme, titled “Health for Growth”, was published on 9 November 2011. Background on EPF’s advocacy activities independently and jointly with EPHA has been provided in previous issues of the EPF Mailing.

EPF is currently consulting members in order to submit a formal position statement on the Health for Growth Programme. The proposal is currently awaiting the first reading in the Parliament, with Françoise Grossetête MEP (EPP, France) as the rapporteur, and shadow rapporteurs being Glenis Wilmott MEP (S&D, UK) and Milan Cabrnoch MEP (ECR, Czech Republic).

More information:

• The European Commission’s proposal for the Health for Growth programme is available here. • The EU 2020 strategy is available here. • EPF’s joint letter with EPHA is available here.

4. Chronic diseases reflection process

The Commission launched a reflection process on chronic diseases in early November 2011, following a request by the Council in its Conclusions on “Innovative approaches for chronic diseases in public health and healthcare systems”, adopted on 7 December 2010. The reflection process aims to produce an EU strategy on chronic diseases; the process is likely to conclude during the first part of 2013.

The European Commission and Member States are asked to lead the process “in close dialogue with relevant stakeholders”, including patients. The Commission is expected to launch a public consultation in the early part of 2012. In the first place, the Commission consulted the EU Health Policy Forum (EUHPF), of which EPF is a member. EPF participated in the drafting process to

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develop the EUHPF response, which took place mainly during the winter holiday period. Our extensive input given in consultation with the Policy Advisory Group and the Board, focused in partiuclar on the role of health systems, equity of access, quality of care, patient involvement and patient empowerment.

Following the launch of the Commission’s public consultation, EPF will circulate a draft consultation paper to all members to develop EPF’s response. For a copy of the EUHPF paper, please contact the EPF Secretariat.

More information:

• EU Health Policy Forum

5. Information to patients update

The European Commission’s revised legislative proposals on Information to patients were finally taken off the agenda of the Council discussions on 1-2 December 2011; the Council then decided to ask the Commission to split the proposals, separating those provisions related to pharmacovigilance from the “rest”.

The split proposals are expected to be published very shortly, and no other changes are expected to the content of the proposals. Linda McAvan MEP (S&D, Ireland) was appointed the rapporteur on the separated pharmacovigilance dossier, while Christofer Fjellner (EPP, Sweden) will continue on the remaining ITP dossier.

The pharmacovigilance proposals are expected to be “fast-tracked” through the legislative procedure, in order to be integrated in the implementation process of the new EU pharmacovigilance legislation adopted at the end of 2010.

Still, several Member States remain reluctant to discuss the other ITP proposals. EPF is engaging the EP rapporteur and the 2012 EU Presidency countries in order to push for this dossier to be given a chance in the second reading.

More information:

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• EC revised proposals on information to patients available here • EPF’s previous position statements on this issue available here and here.

6. EPF survey on patient safety- Reminder EPF launched on 6th of December 2011 an online survey for its members, to collect patient organisations’ views and experiences regarding the implementation of Council Recommendations of 9 June 2009 on patient safety and quality of care.

This survey is of fundamental importance, as the European Commission must produce a report by 9 June 2012 on the impact of the Recommendation, to assess whether the recommended measures are working effectively, and to consider whether there is a need for further action. To achieve this, the Commission has set a survey that is addressed only to Member States.

EPF considers it essential at this stage to take a proactive stance and assess the implementation of the Council Recommendation also from the patients’ perspective. EPF was closely involved in its development, and the Recommendation contains specific provisions to improve patient information and empowerment, and to involve patient organisations in the development of policies and programmes in Member States. The EPF survey is a unique opportunity for patient groups across the EU to present their views concerning the state of patient safety, and patients’ involvement in patient safety, in their country. It is also crucial to identify possible obstacles to full implementation of the recommendations in Member States.

EPF encourages its members to reply to the survey without delay. We also kindly ask the support of member organisations that are pan-European umbrellas in specific disease areas, in circulating this survey to their own member organisations in different EU Member States. This is particularly important to get a full pan-European picture, including from Member states where there is no national coalition of patients at the moment.

Next Steps:

• The survey is opened until 29 February 2012

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• The responses will be analysed and a summary report prepared, which will be submitted to the Commission and shared with EPF’s members. The information gleaned through this survey will also feed in EPF’s ongoing work in the area of patient safety and quality of care, including the forthcoming Joint Action.

For more information or for link to the online survey, please contact EPF Policy Officer.

7. Medical devices The European Commission has announced that the recast of the framework for Medical Devices will take the form of two regulations – one for medical devices and the other for in vitro medical devices. This will be accompanied by a Communication regarding innovation in medical devices for the benefit of patients, consumers and healthcare professionals. The proposals and the Communication are expected to be published in the 2nd Quarter 2012.

EPF met with the European Commission on 23 November 2011 to present our general position. The Commission has appeared receptive to our views in relation to patient involvement. On the same theme, EPF and Eucomed will hold the third Medtech dialogue in Spring 2012, where we will discuss our respective positions on the legislation

8. Review of the Professional Qualifications Directive Following two public consultations to which EPF gave input, the European Commission adopted on 19 December 2011 a proposal to review Directive 2005/36/EC on the recognition of Professional Qualifications (available here). EPF previous response and a joint statement with EPHA, BEUC and EWL are available here.

The protection of patients was identified as one of the eight main issues the review will focus on. To reach this aim the Commission proposes to:

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• Clarify the rules as regards language checks for healthcare professionals: in case of professions with patient safety implication competent authorities may carry out language checking if requested by national healthcare system, or in case of self-employed professionals non-affiliated to the healthcare system, by representative national patient organisations.

• Put in place a proactive alert mechanism between competent authorities for healthcare professionals under disciplinary sanctions

• Increase transparency between Member States on their continuous professional development procedures, through public reports published after the entry into application of the directive and every five years thereafter.

Other measures include the setting up of a voluntary European Professional Card, the extension of the scope of the directive to remunerated traineeships, and update of the minimum training requirements for automatic recognition professions (which include doctors, medical specialists, nurses, dentists, pharmacists and midwifes).

Next Steps

• EPF will send very shortly a draft position paper to its full membership for consultation, based on previous responses. • MEP Bernadette Vergnaud (S&D, France) was appointed rapporteur in the committee responsible, the Internal Market and

Consumer Protection (IMCO) committee. The first exchange of views in IMCO should take place on 28 February. The two committees for opinion are employment and social affairs, and culture and education.

• The Plenary sitting will take place end of November 2012 (provisional date).

9. Medical Resonance Imaging (MRI) Directive update

As reported in previous issues of this mailing (see our November 2011 issue), EPF supports the derogation for MRI proposed by the European Commission as part of the proposal to revise the Directive on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields).

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Several Member States have been opposing this derogation during the discussion at the Council in late 2011. No agreement had been reached, and a compromise whereby each Member State would decide of the derogation on a case by case basis was in discussion. At the European Parliament, as of December there was generally cross-national cross-party support for the derogation.

EPF alerted its membership and sent a request for actions in December, to ensure that the use of MRI for medical or research purposes is not curtailed in the European Union.

Next Steps:

• EPF will attend a meeting of the Alliance for MRI on 25 January, to receive an update on the situations at the Council and the European Parliament. The alliance for MRI is a coalition of European parliamentarians, patient groups, leading European scientists and the medical community, which together are seeking to avert the serious threat posed by EU health and safety legislation to the clinical and research use of MRI.

• EPF will contact the Danish Presidency to express our support for the derogation and expose the patients’ perspective on the negative consequences the limits would have for patient care and research.

• At the European Parliament the Environment and Public Health Committee will hold its vote on 24/25 January 2012, the Employment and Social affair Committee (responsible) will have its vote on 13th February 2012. The plenary vote is foreseen for March 2012.

For more information, please contact Laurène Souchet.

10. Review of the Data Protection framework

The European Commission is currently drafting a proposal on Data Protection to review the 1995 Data Protection Directive. The aim of the data protection framework is to protect individuals’ fundamental rights (article 8 of the EU Fundamental Rights Charter) and freedoms of persons with respect to the processing of personal data, while allowing the free flow of these data within the EU.

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The 1995 Directive laid down general rules to define when the processing of personal data is lawful. It also established key rights for individuals as regard their personal data.

The objective of the revision is to address the lack of sufficient harmonisation of data protection rules across EU Member States. Technological developments (internet, eHealth, mobile apps) and globalisation are posing new challenges for the processing of personal data, and increasing the risk to privacy. New ways of collecting personal data, less detectable, have also been developed. The European Commission also aims to strengthen individuals’ rights, through improving information, and enhancing control over one’s own data with new rights

However data protection raises particular issue in healthcare and for patients.

• Health data as a sensitive category • Healthcare as a particular area • The rights of patients may be limited for public health reasons. This is the case, within the current framework for the

individual right to access their own data- member states may decide of rules to access medical records through healthcare professionals under the current framework.

• Other areas where sharing of data is required- patient organisations as data controllers

Next Steps

• The European Commission’s directorate for Justice have published its proposal for a regulation on 25th January 2012, the European Parliament and the Council will then discuss it under the ordinary legislative procedure.

• EPF will, shortly after, consult its full membership to adopt a position and bring the patients’ perspective into the debate.

Links

• Data protection directive, citizen’s summary, European Commission, available here. • For more information on the review of the data protection legislative framework, please see the dedicated page on DG

Justice website here.

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For more information please contact EPF Policy Officer.

11. Patient Safety- Meeting of the Patient Safety and Quality of Care working group

The Patient Safety and Quality of Care working group held a meeting on 21 November 2011, Laurène Souchet attended as EPF representative. The European Commission presented preliminary results of the response sent by Member States to its questionnaire on the implementation of the Council Recommendations on patient safety and quality of care. The European Commission will publish its report on implementation in June. EPF informed the working group that it is conducting independently a survey to gather patient organisations’ perspective on the implementation, based on the Commission’s questionnaire (see article 6).

A representative from Avedis Donabedian Research Institute presented the project “Deepening our Understanding of Quality Improvement in Europe” (DuQuE). It studies the effectiveness of quality improvement systems in European hospitals. The overall aim is to test whether organisational quality improvement and culture, professionals' involvement, and patient empowerment are associated with the quality of care in European hospitals ( measured in terms of clinical effectiveness, patient safety and patient involvement). The project should provide a list of hospital quality improvement systems which correlates positively with patient outcomes. The field work is being carrying out in hospitals of 8 countries and regions. The project is running from November 2009 for approximately 3 years and a half.

Ivan Solan from the Iberoamericano Cochrane Center presented the contributions from Cochrane Collaboration to Patient Safety. His full presentation is available here.

The French Haute Autorité de la Santé (HAS) presented an update on the Joint Action on Patient Safety and Quality of Care in which EPF is involved.

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The group also discussed potential follow up action to the Krakow Statement on education in quality of care and patient safety available here. The last point discussed by participants was the future work and focus of the group, in parallel to the implementation of the Council Recommendations.

Links

The agenda, list of attendees and PowerPoint presentations are available on the European Commission’s patient safety webpage here. The minutes of the meeting will soon be available on this page. More information on the DuQuE project is available on the dedicated website here. For more information please contact Kaisa Immonen Charalambous.

12. Call for project 2012 to support the Innovation Partnership on Active and Healthy Ageing On 11th January the European Commission organised an info session to present the specific objective and funds allocated to support the European Innovation Partnership on Active and Healthy Ageing (EIP AHA) as part to the 2012 call for project under the health programme. 4 millions are allocated, to fund 3 to 4 projects under this heading. The aim of this action is to support the deployment of innovative solutions for care provision in terms of innovative policies and business models for collaborative and

integrated care systems, based on a continuum of care approach. It will also focus on chronic diseases management and in particular for patients with multiple chronic conditions.

Mr Jacques Remacle, Director of the health unit of the European Executive Agency for Health and Consumers (EAHC) presented the health programme, and the call 2012 which was launched on 8 of December and will close on 9 March 2012. He explained the selection process for projects, and gave general advice on how to prepare a viable project. He also presented in more details the 3 objectives for the specific funds and action to support the EIP-AHA:

Supporting change in care delivery model (including integrated care, innovative care with management model rather than technology). This action is supporting systems change, and will also ensure the transfer of knowledge gained in the process of change implementation to other relevant entities, i.e. entities responsible for care organisation and delivery across the EU.

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Partnering for change: to support stakeholder cooperation in changing social and care systems. Support for older people’s health:

1) Through better collaboration and coordination, (e.g. support and dissemination of models of good/best practice to promote the health of ageing populations or strengthening data systems)

2) through capacity building, (e.g. development of health literacy programmes) 3) preventing frailty 4) identifying measures to ensure that ageing considerations are taken into account in devising new health policies.

Maria Iglesia Gomez, head of the unit Innovation for Health and Consumers in DG Sanco, introduced the partnership’s objectives and the existing funding tools. She explained in more details the 3 actions supported by the EAHC call described above. She presented the strategic framework of the EIP AHA. She also gave information regarding the future call/invitation for commitment of the Partnership. These calls are different from call for projects, as they do not entail financial supports for participants. Her full presentation is available here.

Next Steps:

• The call/invitation for commitments are to be published on the European Innovation Partnership website in the first or second week of February at the latest. The European Commission would like to start actions before the summer.

• The Commission will then set up a “market place” where stakeholders who have offered commitment will be able to share their idea for actions.

Links:

More information call for proposals and guide for applicants are available on the EAHC website. The webcast of this info session can still be viewed online here. For more information please contact Laurène Souchet.

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Projects & Initiatives

13. Chain of Trust

The "Chain of Trust" project, led by EPF, started off in January 2011 with the overall objective of assessing and raising awareness of the perspective of the main end users of telehealth services across Europe. Our readers will recall that throughout 2011 a number of activities were implemented in order to gather evidence of users’ perspective on telehealth. These included a literature review, an online survey, and six National Workshops. See: www.chainoftrust.eu.

In January 2012 the Chain of Trust consortium started implementing EU-level focus groups involving leaders of the four user groups identified for this project, i.e. patients, doctors, nurses and pharmacists. These focus groups are meant to validate the information gathered through the previous activities and will pave the way for the activities envisaged in the framework of WP5 dedicated to awareness-raising of user perspective. The focus group with patients was held in Brussels on 21 January and involved 11 patient leaders from sever different European countries.

In Quarter I 2012 the consortium will also start disseminating the preliminary results of the project that are being consolidated in a first public deliverable that should be available in mid-February.

More information: www.chainoftrust.eu/news

14. RENEWING HEALTH

The RENEWING HeALTH project aims to implement large-scale real-life test beds in nine European Regions for the validation and subsequent evaluation of telemedicine services for patients with chronic conditions. The project uses a patient-centred approach and a common assessment methodology (MAST). See: www.renewinghealth.eu

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The project’s User Advisory Board (UAB), which EPF is co-managing together with EHTEL (the European Health Telematics Association), held its fifth meeting in Brussels in early December 2011. During that meeting, it was decided to organise a regional meeting with representatives of real users of the piloted telemedicine services in Treviso (IT) alongside the Project’s VII Steering Committee meeting taking place on 8-9-10 February 2012. EPF is in charge of organising this user meeting which will involve some 30 representatives of patients, informal carers, health professionals and health managers. Through this meeting the UAB intends to validate through hands-on user experience the User Requirement Framework (see User Requirements Deliverable) - a document designed to serve as a reference framework for the representation of user needs, requirements and expectations in relation to telemedicine.

The next European-level UAB meetings will focus on reviewing the results of pilots’ mid-term evaluation reports which should start to be available as of Quarter II of 2012.

For further information please contact Walter Atzori or visit the project’s website at: www.renewinghealth.eu

15. EUPATI

The EUPATI project is starting now with the overall objective of raising patient awareness of pharmaceutical research. From 2012, the EUPATI academy will provide educational material and resources for patient representatives and the lay public on personalised and predictive medicine, design and conduct of clinical trials, drug safety and risk/benefit assessment, pharmaco-economics as well as patient involvement in drug development.

EPF is leader of the EUPATI project (WP1 project coordination) and leads on WP6 “Deployment and Quality Assurance”. From 1 February you can read more about this project on the newly launched website www.patientsacademy.eu .

The Grant Agreement was signed in December 2011 and a kick-off meeting is planned in Brussels on 6 March 2012.

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16. SUSTAINS

The SUSTAINS project’s kick off meeting was held in Uppsala (SE) on 9-10 January. SUSTAINS is a three year project providing patient access to Electronic Health Records. EPF active involvement in this project will help us substantiate our policy work in this key area.

SUSTAINS will provide a rich basket of services based on giving citizens online access to their EHR. The services proposed have been distilled from the experience of European regions which have already pioneered such access. Although each of these services has a specific objective, all the services contribute to the achievement of a new paradigm in healthcare in which the citizen/patient is not any longer a passive subject, but he/she becomes an active player in the management of his/her own health.

To get the whole picture about this new project, please follow this link.

Conferences & events

17. “New Quality Developments in Healthcare” - EU Expert Conference, November 18, Warsaw

The conference on “New quality developments in healthcare” was held on 18th November, 2011 in Warsaw. It was organized by Polish Ministry of Health and National Center for Quality Assessment in Health Care in conjunction with the European Society for Quality in Healthcare (ESQH). This was the occasion for Polish Presidency to provide a forum for an interactive debate in the context of Joint Action on Patient Safety and Quality of Care and the Directive on Patients’ Rights in Cross - Border Healthcare. Besides, this event was a follow up of the conference organized under the auspices of the Slovenia Presidency in Kranjska Gora (June 2008).

The conference was attended by delegates from European Society for Quality in Healthcare, Ministries of Health of EU Member States, European Commission, Standing Committee of European Doctors, European Federation of Nurses Associations, European

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Patients’ Forum, European Heart Surgeons Association, Polish Society for Quality Promotion in Healthcare, Committee on Ergonomics of the Polish Academy of Sciences and other experts.

The goal of this event was to raise the attention on the necessity of preparing and implementing innovative solutions (smart quality tools) and citizen participation including self-care and responsibility. The perspective was the different development level of health systems, current strategies of quality care management and escalation of costs and citizens’ expectations. Adopting solutions in this field is a challenge for all health systems.

Click here to look at the presentation of Tomasz Szelagowski, EPF Treasurer and member of EPF Board.

18. WHO EURO conference - "Modern Health care delivery systems and the role of hospitals", 21-22 November 2011, Brussels

This Workshop was organised by the Belgium Federal Public Health Service in collaboration with WHO Europe and tackled Modern Health care delivery systems and the role of hospitals. Nicola Bedlington participated in this workshop on behalf of EPF and gave a patient’s perspective based on the work EPF is undertaking in this area. In particular, the workshop aimed to move a step further on the road to better integration and coordination of health care service delivery, by setting the scene for:

1. Reviewing the current situation in relation to hospital and health systems reform across the region, including patient choice perspective

2. Creating a shared understanding of the current state of health care delivery systems and their capacity and willingness to address change

3. Sharing stakeholders’ experiences and best practice models, both theoretical and applied, in the search of optimized solutions to increase health care delivery performance

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4. Exploring criteria for determining which areas should be prioritized and the potential methods for addressing challenges identified

a) At the operational level – improving effectiveness, quality, safety, patient experience and efficiency b) At the organizational level – governance, budgeting, health workforce development and distribution etc c) At the financial level - payers and policy makers d) In integrating systems and levels of care to support and strengthen improvement at all of the levels mentioned above

5. Identifying unanswered questions, gaps in our knowledge and areas where further research is needed

6. Seeking expert guidance in how best WHO can continue supporting Member States in these areas.

For more information, please download this package of documents.

19. European Health Literacy Conference Brussels, 22 November 2011

Health literacy goes to the heart of EPF‘s work and we were delighted to participate in the European Health Literacy Conference in November. It is the culmination of an EU survey on health literacy led by Maastricht University in which EPF was a collaborating partner. More than 150 people from more than 20 countries took part in the conference and discussed the developments and policy impacts of the health literacy survey results. European Health Commissioner John Dalli opened the conference which was endorsed by several members of the European Parliament: Christofer Fjellner, Karin Kadenbach, Pat the Cope Gallagher and Antoniya Parvanova.

Nicola Bedlington represented EPF’s viewpoint on health literacy , in particular in relation to eHealth literacy and looked at the opportunities to move forward on health literacy at EU level.

For comprehensive information on the event, please follow this link.

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20. Chronic conditions in an ageing population, November 22, Brussels

The first debate on Parkinson’s disease was held in the European Parliament late last year and generated unprecedented awareness about the disease in Brussles. Organised by the European Parkinson’s Disease Association (EPDA) and entitled “Chronic diseases in an ageing population – a spotlight on Parkinson’s disease”, the room was packed with over 80 people, including more than 20 Members of the European Parliament (MEPs) and their parliamentary assistants.

Linda McAvan MEP, who has a personal interest in brain disorders and Frieda Brepoels MEP, hosted the debate, which was moderated by ex-MEP and European health champion John Bowis OBE. Maria Iglesia-Gomez and Paul Timmers, European Commission officials in public health and health innovation policy, both spoke on the European Innovation Programme on Active and Healthy Ageing.

The event launched The European Parkinson’s Disease Standards of Care Consensus Statement. These guidelines describe for the first time how Parkinson’s disease should be managed- putting patients at the centre and highlight the areas that need to be focused on in order to effect change. “There has been little progress in the definition of good-quality care in Parkinson’s disease – until now,” said Iglesia-Gomez. “The

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Consensus Statement proposes practical strategies that can help improve Parkinson’s standards of care across Europe.”

The event’s highlight saw Branko Šmid, a Slovenian man who has had Parkinson’s for 25 years, arriving in a wheelchair having come ‘off’ his treatment to demonstrate the effects of Parkinson’s when no medication is available. He returned 20 minutes later, back on his treatment, and was able to eloquently discuss his disease. It was a poignant demonstration that highlighted to all present the importance of the right treatment for the right person at the right time.

Brepoels closed by saying, “What an excellent event this has been, I have learned a great deal about Parkinson’s disease through the exchange of truths, of ideas and best practices across different member states. Let’s work together – there’s a lot to do.”

www.epda.eu.com/parkinsons-consensus-statement

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21. Celebrating the 40th Anniversary of the European Federation of Nurses, 24 November 2011

EPF has developed a longstanding collaboration with the European Federation of Nurses. In celebration of its 40th anniversary, the EFN launched the book “Nurses’ Voice in the EU Policy Process” at a dinner hosted by MEPs Marian Harkin and Liz Lynne, bringing together MEPs, Commission officials, EFN members, and key stakeholders. EPF was invited to contribute to the book, describing the synergies between EFN and EPF and our joint advocacy and project work over the last few years, reflecting the importance of the relationship between patients and nurses.

At the event, Marian Harkin stressed the role of nurses as key players in shaping the health policy followed by Liz Lynne pointing out how the EFN made the nurses voice heard in policy making, telling real stories and talking about real people. The EFN President, Unni Hembre, recalled the evolving process of the EFN which has led to its success as a key stakeholder. She emphasised the inclusiveness of the EFN in creating strong alliances with the EFN members and with EU stakeholders, before Maria Iglesias Gomez remarked that nurses are real partners to work with for achieving concrete results in everyday life.

The book “Nurses’ Voice in the EU Policy Process”, outlines the history of the EFN from the sixties, building the capacity for the future nurses’ voice within the EU and Europe. Liesbeth Verloove (Kluwer) highlighted the role of the EFN’s history in defining the world that we would like to live in.

Powerful words came from Irene Donadio, Nicola Bedlington and Monica Kosinska, as they collectively presented the debate on the ‘European Citizens’ Voice’, the ‘Civil Society’s Voice’, the ‘Patients’ Voice’ and the ‘Women’s Voice’; voices that jointly highlighted the empowerment of nurses and women to influence the policy-making process in the European sphere.

Contact Mr Paul De Raeve, General Secretary of the European Federation of Nurses Associations, for more information.

Email: efn@efn.be - Tel: +32 2 512 74 19 - Web: www.efnweb.eu

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22. Mobile Doctors, Mobile Patients - How Does Patient Safety Travel in Europe? - CPME conference on 25 November 2011

The European Standing Committee of Doctors ( CPME) held a Conference on mobility and patients’ safety in the context of the CPME Board meeting and General Assembly in Warsaw. Nicola Bedlington participated in this event, and explored with CPME members, and representatives from the Polish EU Presidency and the European Commission, the patient safety considerations linked to the EU Directive on Patients’ Rights in Cross Border Health care and EPF’s strategy in working with our members at national level on the provisions of the Directive.

For more information on the Conference please contact the CPME secretariat.

The meeting was also an excellent opportunity for Nicola to meet formally with representatives of the executive of CPME to revisit Joint Principles between CPME and EPF endorsed 4 years ago, and to evaluate our common work since then. There was a strong affirmation of the importance of the joint principles and how they have underpinned the significant collaboration we have at both policy and project level. It was agreed that a joint CPME/ EPF board meeting should take place during the course of 2012 to look at future work priorities in the framework of the next EU Programming period.

23. EPF Board meeting 28 November 2011 The EPF board met in Brussels to review the progress on the work plan 2011, interim accounts and to look forward to 2012, and our key milestones and activities and finance.

Paola Testori –Coggi, Director General SANCO attended part of the meeting and gave the board an overview of the work of the Council High Level Working Group on Health, and preparations for the new EU Public Health Programme.

The board also discussed EPF’s approach to social media and agreed to move forward on a strategy, with a view to launch in April 2012 .

The new staff structure and office move was discussed and agreed. This will take place in late February.

For more information please contact Nicola Bedlington.

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24. EFPIA Patients Think Tank, 29 November

Nicola Bedlington represented EPF at the Think Tank which included on its agenda a presentation of priorities from EPF, the European Multiple Sclerosis Platform, the European Institute of Women’s Health, Roche and Merck. An exchange of views took place on the Information to Patients legislative proposal, the Transparency Directive, the European Innovation Partnership on Active and Healthy Ageing. Nicola gave a presentation on the EUPATI project ( European Patients’ Academy on Therapeutic Innovation) and Data privacy was also on the agenda

For more information contact Erica Poot ericapoot@efpia.org

25. EHN Patient Seminar, 30 November 2011

Kaisa Immonen-Charalambous represented EPF at the European Heart Network (EHN) patient seminar, held on 30 November at the Silken Berlaymont Hotel, Brussels. The session focused on eHealth, with the European Commission’s perspective presented by, while Kaisa gave an overview of EPF’s activities in the area of eHealth and outlined some of the potential benefits for patients, concerns and barriers to overcome, and how EPF is building an evidence-based position through involvement in projects such as Chain of Trust and Renewing Health. For a copy of the presentation please contact the EPF Secretariat.

26. Microsoft Health User Group, November 30-December 2, Brussels - Innovation for the benefit of patients

Microsoft’s vision of the future: home monitoring systems, e-health records and contacts lenses that check glucose levels!

Tomasz Szelagowski, EPF Treasurer and member of EPF Board, took the time to share his insight on the future of healthcare in Europe at the Microsoft Health User Group. Entitled “Partnering for Better Health: improving care, acceleration growth and efficiency”, the event took place in The Square, Brussels, on November 30.

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How innovative technologies can be applied to health was the main focus of the day. The conversation explored ways of harnessing innovation to deliver better services more efficiently and in a way that benefits patients, payers and policymakers. Patients’ opinions rang strongly out thanks to the presence of two patient’s representatives, both M. Szelagowski and M. Johnstone, EPF Board member.

One important milestone was reached, the launch of the “Manifesto for an eHealthier Europe”. Microsoft will focus its business development, partnerships and communications on the six Breakthrough Solutions for Real Impact that they identified in this Manifesto.

The final word was optimism. The event laid another brick in the foundation to overcome some of the challenges: interoperability, data protection, and buy-in from patients and health professionals.

For more information please contact Elena Bonfiglioli.

27. European Parliament workshop on clinical trials, 1 December 2011

Kaisa Immonen-Charalambous represented EPF in a discussion panel at a workshop held in the European Parliament on “The Benefits of a Simplified and Coherent Clinical Trials Framework in Europe”. The event, held on 1 December 2011, was sponsored by Europabio, the European biotech industry association, and hosted by Philippe Juvin, MEP (EPP, France). The workshop focused on discussing how a simplified and coherent clinical trials framework in Europe could benefit patients by improving the development of, and access to, innovative medicines, while contributing to the goals of the EU 2020 strategy. Views were heard from all stakeholders, including prominently the patients’ perspective presented by Flaminia Macchia of EURORDIS. A panel discussion followed.

The next meeting of the Think Tank will take place on 8 March 2012.

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28. 4th Annual Health Technology Assessment World Europe 2011 30 November - 01 December 2011

EPF was invited to join a panel session at this event, to give an overview of EPF’s work on HTA over the past few months.

For an overview of the event and its outcomes please go to on their website.

29. EUnetHTA conference, December 8-9, Gdansk, Poland - The impact of new health technologies on patient’s perspective

European network for Health Technology Assessment (EUnetHTA) conference held in Gdansk, Poland on December 8-9, 2011, was attended by EPF president, Anders Olauson, who gave a presentation describing EPF’s stance and work on HTA. He highlighted the importance of the impact of new health technologies on the personal and professional lives of patients.

He took also the opportunity to raise some issues such as the difficult access to information and communication, the lack of resources, the lack of mutual understanding between patients and HTA experts (language, lexicon) and the cost-effectiveness approach vs. quality-of-life approach.

Next steps for EPF will be to contribute to informing and building capacity among patient organisations, HTA agencies and decision-makers. EPF will also tackle the development of appropriate resources to complement what already exists out there.

More information about EPF Research on EU Patient Involvement in HTA.

For information, Health technology assessment (HTA) is a multidisciplinary process that summarizes information about the medical, social, economic, and ethical issues related to the use of health technology. Its aim is to inform the formulation of safe, effective, health policies that are patient focused and seek to achieve best value.

More information about the EUnetHTA or about the 2011 EUnetHTA conference.

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Secretariat

30. Au revoir Gaya

EPF said goodbye to Gaya its programme officer, Gaya Ducceschi. She left EPF beginning of December to begin her new job in as a consultant for the European Commission. We wish her the best of luck in her new career endeavour and many thanks for her contribution to EPF over the last year.

31. Welcome Giulia and Cynthia

Giulia Evolvi joined EPF in January 2012, after an experience in a European-level medical NGO based in Brussels, where she worked on the administration of international projects and EU funds. She has adegree in Foreign Languages (English, Japanese and French) and a master in World Religious Studies. She then specialized in Fundraising and Marketing for non profit organizations, and volunteered for a medical association. Giulia works at EPF as Programme Officer.

Cynthia Bonsignore has joined EPF in January 2012 as Communication Officer. She is responsible for raising awareness about EPF’s work and influence amongst our members and external stakeholders through the EPF mailing, the Annual Report, press relations, website content updates, Social Medias and other communication tools. She has worked as a freelance journalist for both press and radio stations and as a communication officer in various sectors.

A warm welcome to Giulia and Cynthia.

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32. EPF on the move

“Life is like riding a bicycle. To keep your balance you must keep moving.” Albert Einstein

The EPF secretariat is moving offices at the end of February.

This is due to an enlargement of the EPF Secretariat Team to service the EPF membership and implement our ambitious work programme. We also needed our own meeting room large enough for our on-going governance and project meetings and policy workshops. Crucially, the location we have found is fully accessible to patients with reduced mobility

The new EPF secretariat address is:

Rue du commerce 31 1040 Brussels

Belgium

Phone numbers and e-mail addresses remain the same.

If there are any questions regarding this moving, do not hesitate to contact us.

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33. Calendar

Date Meeting Location Attendance 23 January EPF board meeting Brussels EPF Board 24 January EFGCP Conference on Informed Consent Brussels Nicola Bedlingotn (Co –chair) 6 February European Innovation Partnership on Active and

Healthy Ageing Sherpa meeting Brussels Nicola Bedlington

7 February Commission Working Group on Transparency and Ethics

Brussels Nicola Bedlington

29 February Fundamental Human Rights Platform Meeting Vienna Nicola Bedlington 5 March EPF Board meeting Brussels EPF Board 6 March EUPATI Consortium meeting Brussels Anders Olauson (Chair)

Nicola Bedlington 8 March EFPIA Patients Think Tank Brussels Nicola Bedlington

Kaisa Immonen Charalambous (speaker) 14-15 March COPAC Annual Conference Bucharest Nicola Bedlington (speaker) 15-16 March High Level eHealth Task Force Barcelona Anders Olauson 22 March Healthcare in Europe Economist meeting Brussels Nicola Bedlington (speaker) 27 March EUPATI meeting in the framework of DIA Brussels Anders Olauson (chair) 26-28 March DIA Europe Brussels Anders Olauson (speaker)

Nicola Bedlington (speaker)

This EPF Mailing arises from the EPF 2012 Work Programme, which has received funding from the European Union, in the framework of the Health Programme.

Disclaimer: The content of this EPF Mailing reflects only the author’s views and the Executive Agency is not responsible for any use that may be made of the information contained therein.

Dear EPF Members and Allies,

Welcome to the EPF Mailing. Please note this will be last issue of the Mailing in this form.

Henceforth EPF will produce a monthly e-newsletter to update readers more regularly and more

succinctly on key developments linked to our policy priorities and our project portfolio. More in-

depth analysis will be available on our website. We are confident this approach will be more

user-friendly for both our membership and our wider network of allies and partners.

There have been a number of important policy and programme developments since the last EPF

Mailing. Read about the first meeting of the European Patients’ Academy on Therapeutic

Innovation (EUPATI) Consortium that EPF is leading, and our launch meeting in Copenhagen on

27th

March (section 28). Get the latest news on the European Partnership on Active and Health

Ageing and how you can get involved (section 8). EPF also participated in the High Level eHealth

Task Force (see section 24) and the IAPO Biannual Congress in London (see section 25).

A very important EU consultation is underway on chronic diseases, in which we hope our

members will contribute, both as individual organisations, and collective through EPF. See

section 1 for more details.

Since our last EPF Mailing we have moved offices. The secretariat is now located at 31 Rue de

Commerce, still very close to European Parliament and Commission. Our telephone numbers

remain the same. Visitors to Brussels are very welcome to come to the office, and meet the

Team! We are also pleased to welcome Peter Windey, our new financial and operations

manager, and Clarissa Spencer our new administrative assistant – please see Secretatriat

section.

As we go to press, the board and the secretariat is very focused on our forthcoming Annual

General Meeting and Strategic Planning Seminar (18, 19 April 2012). There, we will explore

carefully with our entire membership our key challenges and goals to ensure that EPF continues

to deliver for patients across the EU. The seminar is the start of an extensive consultative

process that will be finalized at our AGM in 2013 with the endorsement of a new Strategic Plan

that will steer EPF during the next EU Programming Period 2014 -2020. Shortly afterwards we

will hold the Third Patient – Medtech Dialogue to focus specifically on patients’ safety (24

April).We look forward to seeing many of you again in Brussels in the next few weeks!

Looking ahead to June, EPF is honoured to be a partner in the Conference ‘Health and Gender

through Life’, with the support of the Danish EU Presidency. Please go to for important details

on how to register.

Wishing you all a very happy and productive spring-time.

Warmest Greetings,

Anders Olauson, EPF President

Nicola Bedlington EPF Executive Director

TABLE OF CONTENTS

POLICY ........................................................................................................................................................................................................................................................................................................ 1 1. EU CHRONIC DISEASES REFLECTION PROCESS - CONSULTATION ........................................................................................................................................................................................................ 1 2. EU CLINICAL TRIALS DIRECTIVE: COMMISSION PLANS TO MAKE IT A REGULATION ............................................................................................................................................................................ 1 3. INFORMATION TO PATIENTS: STILL NO PROGRESS IN THE COUNCIL .................................................................................................................................................................................................. 3 4. REVIEW OF THE PROFESSIONAL QUALIFICATIONS DIRECTIVE ............................................................................................................................................................................................................ 4 5. MEDICAL DEVICES .............................................................................................................................................................................................................................................................................. 5 6. MRI DIRECTIVE UPDATE ..................................................................................................................................................................................................................................................................... 6 7. DATA PROTECTION REGULATION – CONSULTATION .......................................................................................................................................................................................................................... 7 8. EUROPEAN INNOVATION PARTNERSHIP ON ACTIVE AND HEALTHY AGEING: COMMISSION CALLS FOR COMMITMENTS AND ISSUES A COMMUNICATION .............................................................. 9 9. REVISION OF THE EU TRANSPARENCY DIRECTIVE ............................................................................................................................................................................................................................. 12 10. FIRST MEETING OF THE NEWLY-ESTABLISHED EHEALTH STAKEHOLDER GROUP ............................................................................................................................................................................... 13

PROJECTS ................................................................................................................................................................................................................................................................................................. 14 11. EUPATI - KICK OFF MEETING AND OFFICIAL LAUNCH ....................................................................................................................................................................................................................... 14 12. SUSTAINS ........................................................................................................................................................................................................................................................................................ 15 13. CHAIN OF TRUST .............................................................................................................................................................................................................................................................................. 16 14. RENEWING HEALTH ......................................................................................................................................................................................................................................................................... 17 15. INTERQUALITY: SPEND NO MORE BUT SMARTER! ........................................................................................................................................................................................................................... 19 16. FOCUS ON WOUNDS INTERNATIONAL - A NEW INTERNATIONAL CONSENSUS ON OPTIMISING WELLBEING IN PEOPLE LIVING WITH A WOUND ............................................................................. 20

CONFERENCES AND EVENTS...................................................................................................................................................................................................................................................................... 21 17. EFGCP ANNUAL CONFERENCE 2012, BRUSSELS, 24-25 JANUARY 2012.............................................................................................................................................................................................. 21 18. MEETING ON “INEQUALITIES AND MULTIPLE DISCRIMINATION IN HEALTHCARE”, VIENNA, 29 FEBRUARY 2012 .............................................................................................................................. 22 19. RARE DISEASES DAY, BRUSSELS, 29 FEBRUARY ................................................................................................................................................................................................................................ 22 20. EPF BOARD MEETING, BRUSSELS, 5 MARCH 2012 ............................................................................................................................................................................................................................ 23 21. HPCB MEETING, EUROPEAN PARLIAMENT, BRUSSELS, 7 MARCH 2012 ............................................................................................................................................................................................. 23 22. EFPIA PATIENTS THINK TANK, BRUSSELS, 8 MARCH 2012 ................................................................................................................................................................................................................. 23 23. EFGCP-EORTC MEETING, BRUSSELS,12 MARCH 2012........................................................................................................................................................................................................................ 24 24. HIGH LEVEL TASK FORCE ON EHEALTH, BARCELONA, 15-16 MARCH ................................................................................................................................................................................................. 25 25. IAPO GLOBAL PATIENTS CONGRESS, LONDON,17-19 MARCH 2012 .................................................................................................................................................................................................. 25 26. SHAPING THE FUTURE OF HEALTHCARE IN GREECE, FINANCIAL TIMES CONFERENCE, ATHENS, 20 MARCH ...................................................................................................................................... 25 27. HEALTHCARE IN EUROPE ECONOMIST CONFERENCE, GENEVA, 22 MARCH ...................................................................................................................................................................................... 26 28. DIA EUROPE, COPENHAGEN, 26-28 MARCH ..................................................................................................................................................................................................................................... 27 29. CONFERENCE ON “GENDER AND HEALTH THROUGH LIFE”, COPENHAGEN, 14-15 JUNE 2012 ........................................................................................................................................................... 27

SECRETARIAT ............................................................................................................................................................................................................................................................................................ 29 30. OFFICE MOVE .................................................................................................................................................................................................................................................................................. 29 31. WELCOME PETER ............................................................................................................................................................................................................................................................................. 30 32. WELCOME CLARISSA ........................................................................................................................................................................................................................................................................ 30 33. EPF ANNUAL GENERAL MEETING AND STRATEGIC PLANNING SEMINAR .......................................................................................................................................................................................... 31 34. CALENDAR ....................................................................................................................................................................................................................................................................................... 32

1

Policy

1. EU Chronic Diseases reflection process - Consultation

The European Commission Directorate General for Health and Consumers has launched a stakeholders’

consultation for the chronic disease reflection process. The Commission’s questionnaire is available

here. EPF prepared a draft consultation response which was sent to all our members on 23 March. EPF

members are welcome to send their comments and input by 23 April at the latest to Kaisa Immonen-

Charalambous. EPF will then circulate to all members a final draft integrating these comments at the end of

April for final input and approval by 6 May.

2. EU Clinical Trials Directive: Commission plans to make it a Regulation

The progress of the revision of the EU Clinical Trials Directive (2001/20/EC) has been

extensively documented in previous issues of the Mailing.

Following two rounds of public consultation, and several stakeholder events, the

European Commission is aiming to publish its proposals for the future EU legislation on

Clinical Trials by June 2012, though according to the latest information this time line may

well stretch to September 2012.

2

Commission plans a Regulation for more uniform application of the rules

The Commission’s proposals will centre around simplifying the application procedures, through the introduction of one single

submission via an electronic portal. Secondly, the Commission wants to improve the assessment of clinical trials and increase

cooperation while reducing duplication and bureaucracy. It also wants to propose a “risk-adjusted” approach to clinical trials. The

legislative proposal will take the legal form of a Regulation, to minimise divergence in interpretation at national level.

EPF advocates for patient involvement

EPF broadly agrees with these aims, but we have argued that from a patients’ perspective, certain aspects such as information to

patients an informed consent, should be harmonised at EU level to guarantee equitable access to high quality information on

clinical trials to all patients, and an informed consent process that results in truly informed consent, regardless of which Member

State a patient lives in. Furthermore, EPF has called for patient involvement across clinical trials, including representation on ethics

committees, and better access to treatment post-trials. Finally, we have contributed input to the question of clinical trials

conducted in countries outside the EU – both to the Commission and via our work with the European Medicines Agency. EPF’s

views are set out in our responses to the Commission’s public consultations.

We are concerned that the Commission’s proposals, particularly as far as ethics assessment is concerned, will not be bold enough

to achieve fully the objectives of harmonisation. We are in touch with the Commission as they draft the text, and following the

publication of the legislative proposal, EPF will re-consult our membership in order to develop an updated position paper.

More information:

EPF’s previous responses to the consultations

The European Commission concept paper

The EU Clinical Trials legislative framework

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3. Information to patients: still no progress in the Council

The Council of the European Union still has not reached a consensus on

whether to proceed with the Commission’s revised legislative proposals on

Information to patients, published in November 2011.

The Council had asked the Commission to split the proposals, separating the

provisions related to the EU pharmacovigilance legislation from the rest of the

proposals, and the split proposals, otherwise unchanged, were published on 10

February 2012.

The pharmacovigilance dossier is expected to proceed quickly through the legislative procedure in order to be integrated in the

implementation process of the new EU pharmacovigilance legislation adopted at the end of 2010. The ENVI Committee is

expected to vote on the proposals on 8 May, and the plenary vote is foreseen for 2-5 July 2012.

The rapporteur in the European Parliament is Ms Linda McAvan MEP (S&D, Ireland)

However, several Member States still remained reluctant to discuss the split dossier on information to patients concerning

prescription medicines. EPF had sent a letter to the Member States’ health attachés prior to the most recent Council discussions,

asking the Council to give the proposals their due consideration; at the time of writing the discussions between Commission and

Member States were concluding, but the fate of the dossier had not been confirmed. EPF will update our members in the coming

weeks on this dossier.

More information:

EC revised (split) proposals on information to patients

EPF’s statement on the Parliament’s first reading of the ITP dossier

EPF’s previous position statements on this issue

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4. Review of the Professional Qualifications Directive

On Wednesday 7 March, EPF Senior Policy Adviser, Kaisa Immonen-

Charalambous, presented the patients’ perspective in a panel discussion on

the proposal to review the professional qualifications Directive that was

published on 19 December 2011 (available here). The panel debated on the

language requirements. In the draft legislation the commission has set out a

proposal for patient organisation to be able to request language testing for

certain categories of healthcare professionals when they wish to establish

within another Member State.

The event was organised by Healthcare Professionals Crossing Borders, an informal network of professional healthcare regulators.

Other key features of the proposal which we presented briefly in our last issue such as the European Professional Cards, the IMI

alert mechanism and the education and training of healthcare professionals where also discussed. A summary of the event as well

as presentations are available here.

Next Steps:

EPF will send this week a member consultation to establish EPF position, based on our previous feedback to the Commission on

the review of Directive 2005/36 available here.

The rapporteur MEP Bernadette Vergnaud (S&D, France) will prepare a draft report that is expected for beginning of July. MEP

Anja Weisgerber (EPP, Germany) is the rapporteur for opinion of the Environment and Public Health (ENVI) committee, and MEP

Licia Ronzulli (EPP,Italy) is rapporteur for opinion in the Employment and Social Affair committee (EMPL).

MEPs in the Internal Market and Consumer Protection (IMCO) committee can propose amendment until 12/09.

The vote in the IMCO committee is excepted for end of November 2012(provisional date).

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5. Medical devices

EPF participated in February to the Medical Devices Expert Group Meetings

(MDEG) on the future proposals for regulations that will revise the current

directives on Medical Devices and In Vitro Diagnosis on 6th and 13th

February. The MDEG is a group of Member States’ competent authorities,

industry and other stakeholder representatives in the area of medical

devices. In closed session it is a forum for competent authorities to discuss

all issues with implementation of the EU legislation on medical devices. EPF

provided preliminary comments regarding the future proposal on Medical

Devices based on our past contributions to the European Commission and a

consultation of the Policy Advisory Group. The proposals for regulations on

medical devices, and on in vitro diagnosis, are expected to be published in

the 2nd quarter of 2012. EPF will then consult its full membership to form a

position on this review.

On 9th February, the Commission recommended to the Member States to

take immediate actions to tighten the control of medical devices in reaction

to the discovery of the fraudulent use of non-medical grade silicone in breast implants in France. Actions recommended by

Commissioner John Dalli include:

verifying the designation of notified bodies to ensure they only conduct assessment for products for which they have the right

expertise, and that they carry out unannounced inspections,

reinforcing market surveillance by Member States, and the support to the development of traceability tools and long term

monitoring for medical devices

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improving the functioning of the vigilance system, for example through encouraging healthcare professionals and empowering

patients to report adverse events.

In addition, EPF and EUCOMED are organising the 3rd session of the Patient MedTech dialogue on Wednesday 25 April, 10.30am-

4.00pm in Brussels. This dialogue between industry and patient organisations from EPF membership aim at exchanging views on

areas of common interests and on the role of medical technology. The broad theme of this 3rd session will be patient safety and

will include different perspectives of that subject. The agenda and the official invitation will follow shortly for EPF Members, as

well as the minutes of the last meeting. For more information please contact EPF Policy Officer.

Link:

Press Release – Medical Devices, European Commission calls for immediate actions – tighten controls, increase surveillance,

restore confidence available here.

Working groups and task forces list is available here.

6. MRI directive update

The European Commission has proposed an extension for the deadline

for the application of the limits of exposure in the Electromagnetic Fields

Directive (Directive 2004/40/EC), which is due to enter into force in April

2012. The proposal for the extension has been adopted in Employment

and Social affairs (EMPL committee) of the European Parliament, with a

new deadline in October 2013. The extension will now be discussed in

plenary sitting at the European Parliament, and by the Council.

7

In the meantime the current proposal for a Directive on the minimum health and safety requirements regarding the exposure of

workers to the risks arising from physical agents (electromagnetic fields), which contains a derogation for Medical Resonance

Imaging which EPF supports, is expected to be voted in the EMPL committee of the European Parliament in April. The derogation

supported by various health stakeholders notably through the Alliance for MRI has encountered opposition from some Member

States.

EPF alerted its membership and sent a request for actions in December, to ensure that the use of MRI for medical or research

purposes is not curtailed in the European Union. EPF also sent a letter in support of the derogation to the Danish Presidency.

For more information, please contact EPF Policy Officer.

7. Data Protection Regulation – consultation

On 13 March, EPF launched a member consultation on the

proposal for a Data protection regulation which was published

on 25 January The aim of this regulation is to protect

individual’s fundamental right to protection as regards their

personal data, while setting rules to allow the free flow of

these data in the EU (see previous issue). Taking into account

the patient perspective is essential to ensure that the

Regulation preserves quality and safety of care while

protecting individual rights to confidentiality of personal

health data.

8

For Patients, the fundamental right to protection of their data concerning health is an important issue in many different contexts,

such care given through eHealth or in a cross-border context, and clinical trials.

The smooth processing of health data is fundamental for the good functioning of healthcare services, patients’ safety, and to

advance research and improve public health (e.g. with patient registries). On the other hand health data belongs to the category

of sensitive data: unauthorised disclosure of personal health information could negatively impact on an individual patient’s

personal and professional life therefore effective framework need to be put in place for the protection of such data. This also

applies to eHealth apps, to ensure that patients rights are fully protected, through some kind of a certification mechanism based

on clear quality criteria.

Next Steps

EPF Member consultation is opened until 15 April. For further information please contact EPF Policy Officer.

The draft regulation will now be discussed by the Council of the European Union and the European Parliament under the ordinary

legislative procedure. The rapporteur in the leading committee, Civil Liberty Justice, and Home affairs (LIBE) is expected to be

nominated end of march- April. MEP Sean Kelly (EPP, Ireland) has been nominated as rapporteur for opinion for the Industry,

Research and Energy (ITRE) committee.

Links

Directorate General for Justice and Fundamental Rights: Commission proposes a Data protection reform (containing press

releases, factsheets, and more information): http://ec.europa.eu/justice/newsroom/data-protection/news/120125_en.htm

9

8. European Innovation Partnership on Active and Healthy Ageing: Commission calls for commitments and

issues a Communication

On 29 February 2012, the European Commission published a call for commitment to participate in priority actions of the European

Innovation Partnership on Healthy and Active Ageing. The Commission also adopted a Communication "Taking forward the

Strategic Implementation Plan of the European Innovation Partnership on Active and Healthy Ageing", affirming its commitment to

the implementation of the Partnership.

The Commission is now taking the next step and calling for all stakeholders who are ready to get involved and mobilise sufficient

resources in support of one or more of the specific actions defined in the SIP, in partnership with other stakeholders. Please note

this call is not for funding. An overview of calls for proposals for projects in support of the Innovation Partnership is available here.

The call for commitment is available here. The deadline for expressing a commitment is 31 May 2012.

The EIP-AHA Priority actions

The following themed priority actions are being implemented in the first phase of the Innovation Partnership. For the content of

each action, please see the Strategic Implementation Plan and Operational Plan.

Prescription and adherence action at regional level

Falls Prevention Initiative

Action for prevention of functional decline and frailty

Replicating and tutoring integrated care for chronic diseases, including remote monitoring at regional level

Development of interoperable independent living solutions, including guidelines for business models

Innovation for Age friendly environment (the “horizontal action”)

Before expressing a commitment, please read carefully the documentation on the Partnership website, which includes a “guide”

document and “frequently asked questions”.

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What if you are interested but cannot yet commit to a specific action?

The Commission has also launched on 3 April a “Marketplace for innovative ideas”, which will be an interactive online platform

open to all stakeholders willing to get involved in the Partnership but who are not yet ready to submit a commitment to a specific

action. The platform will be available from the beginning of April 2012 through the main Partnership website. Visiting the platform

will be free, and you can become either a passive member or an active registered member.

Background on the Innovation Partnership and EPF’s contribution

Extensive information about EPF’s role in the Innovation Partnership, and our key principles and messages, has been given in past

issues of the EPF Mailing and in our input to the Commission’s public consultation.

EPF was closely involved in the development of the pilot European Innovation Partnership on Active and Healthy Ageing, launched

by the European Commission at the end of 2010. Our President, Anders Olauson, participated in the High-Level Steering Group co-

chaired by Vice President and Commissioner for the Digital Agenda, Neelie Kroes, and the Commissioner for Health and Consumer

Policy, John Dalli; while the Secretariat participated in several “Sherpa” meetings and our member organisations focusing on

priority disease areas of the Commission’s public consultation (diabetes, Alzheimer’s disease/dementias, and Parkinson’s disease)

contributed actively to the debates and workshops. The Steering Group adopted the Strategic Implementation Plan (SIP) of the

Partnership in November 2011.

The overall goal of the Partnership is to add two healthy life years to the average healthy life span of European citizens by 2020.

The wider objective of the EIP is to achieve a “triple win” for Europe:

improving the health status and quality of life of European citizens, particularly older people;

supporting the long-term sustainability and efficiency of health and social care systems; and

enhancing the competitiveness of European industry through business and expansion of new markets.

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The Partnership aims to address key bottlenecks and barriers that

have been shown to hinder the uptake and spread of innovations,

such as fragmented evidence available on innovative solutions,

lack of EU-wide standards and interoperability of systems,

difficulties in scaling-up pilot projects, funding barriers, legal and

other framework conditions, social and healthcare systems’

complexity, organisational and budgetary “silos”, and lack of

integration.

The EIP is not a funding instrument. Rather, it aims to facilitate

new ways of working in partnership, by mobilising and linking up

the different stakeholders, EU institutions, national authorities

and the regional/local level actors, and using already existing

European financial instruments more effectively to support the

implementation of its actions.

The Strategic Implementation Plan (SIP) sets out a vision for a new paradigm of ageing, a vision for “healthy and active” ageing,

and the key action areas that will be addressed by the Partnership. These centre around three broad “pillars” for action:

prevention and early diagnosis; care and cure; and independent living.

Within the pillars, twelve priority action areas were selected to develop into concrete actions. Within these, the Steering Group

chose five priority actions for implementation, focusing on areas that have both the potential to deliver quick results and a

readiness on the part of several partners to start working immediately. In addition to these actions, a horizontal action focusing on

age-friendly environments was selected for implementation.

More information: European Innovation Partnership on Healthy and Active Ageing website

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9. Revision of the EU Transparency Directive

On 1 March 2012, the European Commission published its legislative proposal to review the so-called “Transparency Directive”

(Council Directive 89/105/EEC relating to the transparency of measures regulating the pricing of medicinal products for human use

and their inclusion in the scope of national health insurance systems).

The Commission proposal aims to ensure that medicines enter national markets faster following regulatory approval. This will

happen through streamlining and reduction of the timelines on national decisions for pricing and reimbursement. The Commission

proposal provides a limit of 120 days for Member States to come to a decision on “innovative” medicines, and 30 days on generic

medicines. Currently the deadline is 180 days, but even this is not generally respected by Member States. The Commission also

proposes some stronger enforcement measures for Member States who do not comply with the time limits.

The Commission is, however, careful to stress that the proposal do not interfere with the Member States’ responsibilities for the

organisation and delivery of healthcare, therefore they are only concerned with process, not the substance of the decisions.

EPF consultation

EPF has given input into the public consultation process, stressing the currently wide divergences across the Union in patients’

access to treatment, including medicines, in many chronic disease areas. Cleary, the timelines for decision-making are a key factor

in this, and we welcome the Commission’s proposal to tighten them. Moreover, EPF stressed that the societal context in which

such decision are taken has undergone a profound transformation since 1989: notably, there has been an enormous increase in

patient and civil society engagement in all aspects of public policy. EPF argued that the concept of transparency needs to reflect

this 21st century context and should extend to patients and the public. Unfortunately this aspect is not well reflected in the

Commission proposal.

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Next steps:

The draft report in the European Parliament may be drafted by the summer, with a plenary vote and Council discussions taking

place in the autumn of 2012. It is likely however that the Council discussions of this dossier will extend to 2013. The EPF

Secretariat is finalising an internal analysis of the proposal and will circulate a membership consultation document in the next

week.

More information:

Directive 89/105/EEC

Information from the Commission concerning the review

10. First meeting of the newly-established eHealth Stakeholder Group

The European Commission has established, following a call for expression of interest, an eHealth Stakeholder Group. It comprises

29 European umbrella organisations representing different groups like health professionals and managers, patients and

consumers, industry, standardisation bodies. Their first meeting was held on 29th of March. The purpose was to understand the

role of the group and establishing a 2012 work programme and a modus operandi.

The aim of the group is to ensure an informed dialogue with the European Commission and to add value to policy design and

implementation. Areas for cooperation during the current year were agreed, namely patients’ access to electronic health records,

telemedicine deployment, interoperability, the EC Staff Working Paper and the eHealth Action Plan.

EPF and BEUC will take the lead on work related to patients’ access to EHR.

The next meeting of the group will take place on the 7th of May in Copenhagen during the eHealth Week.

For more information please contact Liuska Sanna, Programme Manager at liuska.sanna@eu-patient.eu

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Projects

11. EUPATI - Kick off meeting and Official Launch

We are pleased to inform our readers that the project “European Patients'

Academy on Therapeutic Innovation” – EUPATI has successfully kicked off. The

start of the project has been marked by two important events; the kick off

meeting of the project Consortium took place in Brussels on the 6th of March

and there was a first public launch at DIA EuroMeeting on 27th March in

Copenhagen.

The consortium, led by the European Patients' Forum, comprises of 29 leading

pan-European patient organisations, academic and not-for profit organisations

as well as EFPIA member companies.

Funded by the Innovative Medicines Initiative (IMI), the patient-led academy

will develop educational material, training courses and a public Internet library to educate patient representatives and the lay

public about all processes involved in medicines development. Topics will include personalised and predictive medicine, design

and conduct of clinical trials, drug safety and risk/benefit assessment, pharmaco-economics as well as patient involvement in drug

development.

In the first stage of the project the Consortium will work on four main areas:

Conducting a needs assessment amongst representatives of lay patients, patient representatives and the general public to

understand what their educational expectations are

Identifying and collecting education material on medicines development processes to assess what exists already

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Establishing the EUPATI Network

Setting up the IT Platform that will support the deployment of the education programmes.

Should you be interested to know more please visit EUPATI website www.patientsacademy.eu/index.php/en/ or contact Jan

Geissler, EUPATI Director, jan@patientsacademy.eu

12. SUSTAINS

In the previous issue of our Mailing we have announced the official start of the

SUSTAINS project. This three-year project is aimed at developing and deploying a

basket of services in 11 European regions providing patients’ access to

Electronic Health Records (EHR). SUSTAINS comprises several administrative and

clinical services rather different from one another. The common denominator in

terms of usage is that they are all designed to be used by the citizens/patients

from their home or wherever they happen to be, provided they have access to

Internet.

EPF’s main role in this project is to lead on work dedicated to user requirements

elicitation and use cases definition. EPF will also lead on preparing the framework for the assessment of patient empowerment.

The first activity within this context is the implementation of a set of user requirement focus groups involving representatives of

users of the SUSTAINS services in the eleven participating regions. The overall objective of these focus groups is to ensure that the

SUSTAINS services are aligned to the largest extent possible to the needs and expectations of patients and meet the requirements

of health professionals. These focus groups will involve patients, health professionals, citizens and informal carers and will enable

these different categories of users to advise the local project team about the real user needs. By enabling the participating regions

to integrate requirements and concerns of the end users in the design and development of the SUSTAINS services, these focus

groups should ultimately strengthen the acceptance of these services among patients and health professionals, thereby

contributing to their sustainability after the project life-cycle.

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EPF has started to work with the local partners to organise the focus groups which will take place in April-May 2012. The outcomes

of these focus groups will be presented in an integrated report which will also include a list of recommendations on how to

integrate the user perspective in the development of services providing patients’/citizens’ access to EHR.

For more information about the project please click contact Walter Atzori.

13. Chain of TRUST

The "Chain of Trust" project, led by EPF, has successfully completed the

activities planned for the first phase of the project aimed at gathering

knowledge on patients’ and health professionals’ perspective on

telehealth (see www.chainoftrust.eu/objectives).

The last set of activities contributing to this objective, i.e. four European focus groups, one for each of the four constituencies

identified for this project (i.e. patients, doctors, nurses, and pharmacists) were implemented in Brussels between mid-January and

mid-February 2012. Overall 42 participants attended the European focus groups to help the consortium complete the analysis of

users’ perspectives on telehealth, and translate these findings into recommendations the project partners will take forward in the

various raising-awareness activities scheduled to be implemented throughout 2012.

To this end, six National Roundtables will be organised as from mid-spring 2012 in the same countries were the national

workshops took place in autumn 2011 (see EPF Mailing of November 2011). The objective of the National Roundtables is twofold:

Raising awareness of national stakeholders on the project findings and policy recommendations

Promote the integration of users’ perspective in national telehealth agendas and plans.

To effectively support project’s raising awareness activities the Chain of Trust consortium is working on consolidating the results

collected in an intermediate public deliverable which is ought to be released in mid-spring 2012.

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For more information on the Chain of Trust project, please contact Liuska Sanna or visit the project website at

www.chainoftrust.eu.

14. RENEWING HEALTH

The large-scale telemedicine pilot project “RENEWING HeALTH”, in

which EPF participates as co-manager of the User Advisory Board,

entered its third year of implementation. As our readers may

remember, RENEWING HeALTH is extending pre-existing patient-

centred telemonitoring and health coaching services for peole with

chronic conditions to large scale pilots in order to gather evidence

on the use of telemonitoring in real life settings1.

As the interventions in all participating regions has been going on for quite some months already, the focus is now shifting to the

analysis of data being collected in the various pilot sites. The aim here is to make sure that analysis and reporting of results are

similar and comparable project-wise. To that purpose an ad-hoc workshop was held in Treviso on 10th February where experts

within the different evaluation domains of the project’s assessment methodology (MAST) gave practical advice on analysis and

reporting of the results based on guidelines for reporting of scientific studies.

Over the last few months the User Advisory Board (UAB) has been busy finalising the second version of the User Requirement

document. This document, which is continuously reviewed and improved throughout the project lifecycle, provides for a reference

framework for representing needs, constraints and expectations of end-users of telemedicine services. The second version,

complementing the initial literature review carried out in 2010 with outcomes of two rounds of consultations with the

constitiuencies represented in the UAB, is currently being finalised and is ought to be made public in mid-spring 2012. The third

1 A detailed description of each of the individual services piloted in the framework of the RENEWING HeALTH project has been recently added on the project website

(http://www.renewinghealth.eu/health-services)

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version is expected to be realesed in autumn 2012 to include the

outcomes of a series of local meetings with end users of the piloted

telemedicine services.

To that end a first local meeting with users involved in the RENEWING

HeALTH was held in Treviso on 7th February. The meeting has proved

to be very successful in enriching the user requirements framework

through hands-on experience of end users involved in the local sites.

Likewise, the meeting was reported by the local partner (Regione

Veneto) to have been very useful in helping them better understand

what needs to be done in order to maximise end-users’ acceptability,

as one of the key pre-conditions for integarting the piloted

telemedicine programmes into mainstream regional health services.

A second local meeting with RENEWING HeALTH users is set to take

place in Luleå (Norrbotten) on 18th June. The event is attached to the

2012 Arctic Light eHealth Conference (ALEC) where EPF will

participate as a speaker.

The next European-level meeting of the User Advisory Board will be

held in late May and will focus on reviewing the results of pilots’ mid-

term evaluation reports.

For further information please contact Walter Atzori or visit the

project’s website at: www.renewinghealth.eu.

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15. InterQuality: spend no more but smarter!

Annual Meeting - “International Research Project on Financing Quality in Healthcare”

(InterQuality)

InterQuality is a project based on the idea that increasing spending in health not always

leads to a better quality. The objective of the project is to analyse different financing

mechanisms in healthcare in different countries, in order to identify spending models

which can improve quality of healthcare.

EPF’s role is to bring a patient perspective into this review of financing models and to

disseminate the results of the project. Aimed at ameliorating quality of care, InterQuality

will eventually benefit patients and patients’ organisations by improving spending in

health services.

The InterQuality consortium came together at the beginning of February in Hannover, Germany, for the Annual Meeting of the

project. The meeting started with a presentation about the German healthcare system, and the challenges it has to face with an

increasingly ageing population and a lack of recent reforms. The Washington Urban Institute’s presentation showed that financial

incentives should be analysed considering also different contexts, since payment methods are never pure and there are several

dimensions influencing them. The University of Warsaw Partner explained the achievements of their literature reviews, especially

concerning quality, cost and efficiency in financing healthcare methods. As conclusion of the first year of work, partners are

looking forward to achieving successful results in the second year of InterQuality.

Next InterQuality meeting will be in Catania, Italy, on the 24th and 25th of May. After one year focused on literature review, this will

be the occasion for InterQuality consortium to present some achievement also in the comparative analysis of countries’ situations

and payment methods in pharmaceutical, hospital, outpatient and integrated care.

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The first issue of the newsletter is now available on InterQuality website!

The website is also updated with the summary of the InterQuality Annual Meeting.

For more information about the project please click contact Liuska Sanna.

16. Focus on Wounds International - A new international consensus on optimising wellbeing in people living

with a wound

Wounds International has recently published an important international consensus on

wellbeing and effective wound management. The document is targeted at healthcare

professionals around the world and provides a useful resource for healthcare organisations,

policy makers and industry in addressing the needs of those living with a wound. The key

aims of this document are to:

increase understanding of the impact of living with a wound on the wellbeing of

patients and their carers

improve clinicians’ ability to share treatment decisions with patients

highlight ways for clinicians to enter into a dialogue about patient wellbeing

increase clinicians’ ability to implement strategies for cost-effective wound

management.

The consensus is based on the latest research, government initiatives and opinion of a

number of international experts, including medical, nursing, allied health professionals and

researchers. The concerns are not simply with the quality of the treatment of individual

wounds, but rather the human cost of living with a wound and the role of clinicians, industry

21

and organisations in improving the wellbeing of patients

To ensure the patient has a voice within the document, Wounds International facilitated a workshop with two service user groups

at the University of Leeds in the UK. The aim of the workshop was to gain insight into the impact of living with a wound on

patients, their carers and their family members. M

For further details of the consensus document ‘Optimising wellbeing in people living with a wound’ and to download a copy,

please go on Wound International website.

Conferences and events

17. EFGCP Annual Conference 2012, Brussels, 24-25 January 2012

“Informed Consent – How Less could be More: Effecting a paradigm shift so we do inform participants?”

Questions of information and consent were the focus of the EFGCP annual conference in January. The two-day event explored

ways to improve information provided for patients, and how sponsors, researchers and research participants can work together to

influence law, policy and ethics. Nicola Bedlington co-chaired a plenary session on “Change is long overdue – but how do we

achieve it?” A report will be published in due course. For more information about this event visit www.efgcp.be.

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18. Meeting on “Inequalities and multiple discrimination in healthcare”, Vienna, 29 February 2012

Kaisa Immonen-Charalambous participated in a meeting by the EU Agency for Fundamental Rights (FRA) to discuss the results of

its project “Inequalities and multiple discrimination in healthcare”. The project aimed to identify barriers in access to healthcare

services and experiences of discrimination that can affect patients at the intersection of the following grounds: ethnic origin,

disability, age, and gender. The discussions were interesting in view of EPF’s current and future work on discrimination and health

inequalities. The FRA will publish the results of its research in 2012. For further information about the Agency visit

http://fra.europa.eu .

19. Rare Diseases Day, Brussels, 29 February

February 29th was Rare Disease Day 2012, an annual event coordinated by EPF Member EURORDIS at international level, and by

national coalitions of patients’ organisations at national level.” This fifth edition of the rare disease day, which aims at putting the

spotlight on rare diseases and the millions of people affected by them, focused on the theme of solidarity in the fields of rare

diseases. This years’ event highlighted the need for collaboration and mutual support amongst diseases, stakeholders and across

countries. Rare Disease was presented as a model of EU Solidarity, and the added value of EU action in this field was also

discussed.This was followed by presentations of key initiatives in Europe by EURORDIS members such as EURO WABB, the EU

registry for rare diabetes, or ENERCA, the European Reference network of expert centres in rare anaemias

Links:

More information and contact details are available on EURORDIS website

Rare Disease Day 2012 also has a website, where patients with rare diseases are invited to share their stories.

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20. EPF Board Meeting, Brussels, 5 March 2012

The EPF board met on 5 March to prepare the Annual General Meeting: the

accounts and annual report for 2011 were approved and will be circulated in

advance of the AGM. The budget and work plan for 2012 were also finalized and

approved. Preparatory work took place on the forthcoming strategic planning

seminar the day after our AGM. The board adopted a communications strategy

for 2012 and discussed the details of the 2013 work plan submitted with the

Operational Grant application in early March.

21. HPCB meeting, European Parliament, Brussels, 7 March 2012

“The new recognition of professional qualifications Directive: what’s at stake for patient safety?”

Kaisa Immonen-Charalambous represented EPF in a meeting organised by Health Professionals Crossing Borders (HPCB) at the

European Parliament, to discuss the proposals to review the Professional Qualifications Directive. The meeting was hosted by

MEPs Emma McClarkin and Antoniya Parvanova (ALDE, Bg). Kaisa participated in a panel discussion on “Language requirements:

what’s at stake for patient safety?”. The discussion was very lively and the patients’ voice was definitely heard by the full room of

participants. For more information visit the website www.hpcb.eu

22. EFPIA Patients Think Tank, Brussels, 8 March 2012

Kaisa Immonen-Charalambous and Nicola Bedlington represented EPF at the EFPIA Patients Think- Tank. A specific morning

workshop was devoted to personalised medicine. Kaisa gave a presentation on this topic from the stand-point of patients, based

on the work of the EPF Policy Advisory Group. Ruxandra Draghia-Akli (DG Research) presented Commission initiatives in the field

of personalised medicine. Jola Gore-Booth (europacolon) gave a presentation on Personalised medicine in cancer, and Horst

24

Kramer from Roche explored how companies are addressing personalised medicine. Please contact the EPF secretariat for a copy

of these presentations.

The afternoon session looked at the revision of the Clinical Trials Directive, with a presentation by Fabio D'Atri (DG SANCO), and

update on the Data Privacy Directive and an Update on the Transparency Directive (please see the policy section of this Mailing for

more details from EPF’s perspective). The meeting also heard from three members of the Think Tank (GSK , European Men’s

Health Forum and Pfizer on their policy and research priorities for 2012.

23. EFGCP-EORTC meeting, Brussels,12 March 2012

“Road Map Initiative for Clinical Research in Europe: Multi-Stakeholder Round

Table on Consensus and Strategy Development. How Should the Future

Clinical Trial Authorisation Work?”

Kaisa Immonen-Charalambous represented EPF at this roundtable event held at

the EORTC Headquarters, organised by the EFGCP in partnership with EORTC

and EFPIA, and held at the EORTC headquarters in Brussels. EPF co-chaired the

discussion session on assessment of clinical trials applications, and provided a

patient perspective on the proposed new legislative framework. More

information and the event programme is available at www.efgcp.be

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24. High Level Task Force on eHealth, Barcelona, 15-16 March

Anders Olauson participated in the third High Level Task Force on eHealth in Barcelona, which developed further the Task Force’s

vision and approach to eHealth. This will be presented at the eHealth Week in Copenhagen in May.

Whilst in Barcelona, Anders also took the opportunity to visit the Spanish Patients’ University and discuss with leaders there how

such a model could be replicated in the framework of an EU wide Health Literacy initiative.

25. IAPO Global Patients Congress, London,17-19 March 2012

Kaisa Immonen-Charalambous participated in the 5th Global Patients’ Congress which this year took place in London. She

presented EPF’s work on the EU Pharmacovigilance legislation in a parallel session on global health policy. As usual, the Congress

provided a lot of ideas that will feed into our work at the European level. Also, during the Congress IAPO launched its consultation

on indicators to measure the patient-centeredness of healthcare, to which EPF will be seeking the views of our members.

The Congress programme and photos are available at www.patientsorganizations.org A report will be published in due course.

26. Shaping the future of healthcare in Greece, Financial Times conference, Athens, 20 March

EPF Board Member Philip Chircop participated to the conference “ Shaping the future of healthcare in Greece: Caring, curing,

securing” organised by the Financial times ltd in Athens on 20 March. The event reunited Greek and international experts and

stakeholders to discuss the current situation and future of healthcare in Greece.

Philip Chircop presented the central role that patients need to play in current and future health related policies in Greece, and in

the EU. He made a strong case for tackling the issue of health inequalities as well as other challenges, and urged the Institutions

and governments to prioritize healthcare in the current economic context. He also called on the EU and Member State to “ to put

26

in place, rational and ambitious strategies, to support health literacy and patients’ empowerment, and to involve patient

organisations, in health policy and research”.

More information and copies of speakers’ presentation are available on the conference’s website here.

27. Healthcare in Europe Economist Conference, Geneva, 22 March

Nicola Bedlington represented EPF at the annual Economist

Conference in Geneva. She participated in a panel debate

led by Professor Richard Sullivan, King's Health Partners

Integrated Cancer Centre on healthcare reform, based on

two key notes from Recep Akdağ, Minister for Health,

Turkey and Sir Andrew Dillon, CEO of NICE.

For more information about the meeting and its outcomes

go to:

http://cemea.economistconferences.com/press/single-

unified-european-healthcare-system-unlikely-common-

initiatives-prevention-and-innovativ

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28. DIA Europe, Copenhagen, 26-28 March

Several EPF members and representatives were present at the

DIA Europe meeting in Copenhagen, as part of the DIA Fellowship

Programme. It was an important opportunity to launch the

EUPATI project, with a special session chaired by Anders Olauson.

See http://www.patientsacademy.eu/index.php/en/ for

information and the video streaming of this event.

Anders also participated in a session on HTA. Nicola Bedlington

participated in the plenary session which addressed ethical

practices in the pharmaceutical sector and chaired a session on

active and healthy ageing.

For more information on the DIA meeting in Copenhagen, please go to

www.diahome.org/diahome/FlagshipMeetings/home.aspx?meetingid=25205.

Register as soon as possible!

29. Conference on “Gender and Health through Life”, Copenhagen, 14-15 June 2012

EPF is please to invite you to join us for the ‘Gender and Health through Life’ Conference on 14th-15th June, 2012 at the

Copenhagen University Hospital, Rigshospitalet. The conference is supported by the Danish EU Presidency and organised by the

European Men’s Health Forum, European Patients’ Forum, the Danish Men’s Health Society and the European Cancer Patient

Coalition.

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Keynotes:

Men’s Health & Premature Death in Europe – Prof Alan White, LM University, UK.

Women’s Health and Healthy Ageing – Ms. Hildrun Sundseth, European Institute of Wom-en’s Health, BE

Gender and Healthy Ageing – Dr. Carsten Hendriksen, Copenhagen University, DK Two parallel sessions with panel:

Gender and Mental Health with Merete Nordentoft, Maria Fe Bravo Ortiz, and Svend Aage Madsen

Getting it Right - Gender in Prevention, Health Promotion and Patient- Centred Chronic Dis-ease Management with Susanna Palkonen, Olesya Kolisnyk, and Dorota Sienkiewicz.

Panel discussion: Is there a need for gendered health policies?

Agenda of the event Day 1 – June 14

Morning Round Table Workshop “Gender based cancer information and early diagnosis” Keynotes:

Gender and Social Determinants of Health – Prof Finn Diderichsen, Department of Public Health, Copenhagen University, DK

Gender and Health in the Workplace - Ms. Jane Korzack, Vice President of The Federation of Danish Workers, DK

How Men’s and Women’s Health Affects each Other and Society - Dr Selwyn Hodge, Chair Royal Society for Public Health, UK

Conference End: Recommendations for a Gendered Health Policy in Europe – Dr. Ian Banks, North Ireland and EMHF. Followed by panel discussion

Day 2 – June 15

Please note that the conference does not cover expenses or hotel accommodation.

For further details and to receive an invitation please contact: genderandhealth.2012@gmail.com

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Secretariat

30. Office move

As announced in our previous mailing EPF Secretariat has now moved to its

new offices. Ideally located in the EU quarter, the office is also fully accessible

to patients with reduced mobility. Premises include meeting room and spare

desk to welcome our Members in Brussels.

New address:

European Patients’ Forum

31, rue du Commerce

B-1000 Brussels

Belgium

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31. Welcome Peter

Peter Windey joined EPF in March 2012 as Finance and Operations Manager. A Belgian national,

he holds a degree of chartered accountancy and a bachelor in accounting from the “Institut des

Carrières Commerciales” in Brussels.

Peter began his career in the 80s in accounting and financial positions in various private sector

companies.

More recently, he worked for the Belgian Cooperation Agency and, from 2002 to 2011, he was the

finance and administrative responsible of the ProInvest programme funded by the European

Development Fund.

32. Welcome Clarissa

In February EPF has welcomed Clarissa Spencer. She has 15 years’ experience of working in an

administrative support role for both public and private held companies. Clarissa gives

administrative support to the office management and the team.

A warm welcome to her.

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33. EPF Annual General Meeting and Strategic Planning Seminar

EPF Annual General Meeting (AGM) will be held on 18 April in Brussels. As we approach the end of our original strategic plan, the

Spring Seminar organized on 19 April at the AGM will be the occasion to work with our Membership, through analysis and debate,

to develop a new strategic plan covering the period 2014-2020, in line with the next EU Programming period.

The seminar will review what has been accomplished in recent years in relation to the strategic goals established in 2007 and

identify new challenges at a time when Europe and public health services are conditioned by a wide-scale economic crisis. It will

be an opportunity to share with our Members experiences and views and reflect on the organization’s development (its growth,

its priorities, and its relationship with different partners).

During the seminar, EPF members will be called upon to participate actively in the establishment of a new framework that will

provide the direction of EPF’s goals and objectives for the next years.

In line with our Youth Strategy Members are strongly encouraged to nominate a young delegate to participate at both events and

giving the opportunity to be a representative of the Youth Group.

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34. Calendar

Date Event Place Attendance

April 3 Conference on Active and Healthy Ageing

Brussels, Belgium Nicola Bedlington - speaker

April 12-13 Patient Empowerment Conference Copenhagen, Denmark Nicola Bedlington - Speaker

April 17 Belgian Pharmaceutical Conference Brussels, Belgium Nicola Bedlington - Speaker

April 16-17,

Healthcare Innovation Conference Brussels, Belgium Anders Olauson & Nicola Bedlington - Speaker

April 18-19 EPF AGM and Spring Seminar Brussels, Belgium All

April 25 EPF – EUCOMED Dialogue Meeting Brussels, Belgium Nicola Bedlington – Co-chair

7-9 May eHealth week 2012 Copenhagen, Denmark Anders Olauson

7 May SUSTAINS 1 Steering Committee Meeting

Copenhagen, Denmark Walter Atzori

24-25 May Kick-Off meeting of the Joint Action on Patient Safety and Quality of Care

Copenhagen, Denmark Nicola Bedlington & Kaisa Immonen-Charalambous

31 May - 1 June Nordic Conference on cross cooperation on rare diseases

Reykjavik, Iceland Anders Olauson - speaker

12-13 June Hospage Conference Germany Anders Olauson - speaker

14-15 June Gender and ageing conference Copenhagen, Denmark Susanna Palkonen – speaker & Nicola Bedlington – Co-chair

18 June RENEWING HeALTH Local Meeting of the User Advisory Board

Luleå, Sweden Walter Atzori

18-19 June Artic eHealth Light Conference Norrbotten, Sweden Liuska Sanna & Walter Atzori

25-27 June HTAi conference Bilbao, Spain Liuska Sanna