WP1
Appendix 1:
WP1/Exec Comm f-t-f meeting summary, April 18-19, 2012, Rome, Italy
EUnetHTA Joint Action WP1/ Exec Comm meeting Rome, Italy April 18, 2012, 13:00 – 17:30 April 19, 2012, 09:00 – 15:00 Organised by: AGENAS and the EUnetHTA Secretariat Address of the meeting venue: NH Leonardo da Vinci, Via dei Gracchi, 324. 00192 Rome Tel. +39 06 328481 Mobile +45 4062 9357 (Julia Chamova)
Summary report
Agenda
April 18, 2012
1. Opening, practical details
13:00 - 13:10
2. WP Updates a. Secretariat guidance on planning for Oct-Dec 2012 (JA/JA2 overlap)
13:10 – 14:00
3. EUnetHTA and permanent European network on HTA – I a. Commission and MS updates on current developments re:
Article 15 implementation b. Membership issues c. Levels of involvement d. Stakeholder relations/involvement
14:00 – 17:30
Coffee break
15:15 – 15:30
Social dinner: Restaurant Taberna de' Gracchi, Via dei Gracchi, 266
20:00 –
April 19, 2012
1. EUnetHTA and permanent European network on HTA – II a. Governance, management and accountability b. Financing streams c. Working with EU bodies and international organisations /
networks d. Finalising the EUnetHTA Strategy development and moving
to implementation
9:00 – 12:00
Coffee break
10:30 – 11:00
Lunch
12:00 – 13:00
2. EUnetHTA Plenary Assembly, Lisbon, May 24-25 a. Agenda b. Nomination process and elections c. Practicalities
13:00 – 13:30
3. Other issues and conclusion
a. EUnetHTA at HTAi b. EUnetHTA info platform development (JA and JA2) c. JA budget reallocation update
13:30 – 15:00
April 18, 2012 WP Updates Finn Børlum Kristensen (FBK), EUnetHTA Secretariat (NBoH), welcomed the participants to the fifth face-to-face EUnetHTA JA WP1 and Executive Committee meeting and informed that the JA2 grant agreement was signed by the Danish Medicines and Health Authority (former National Board of Health of Denmark) and sent to the EAHC for their final signature. He further presented the meeting’s agenda highlighting its focus on preparation for the EUnetHTA Plenary Assembly meeting (clarifying the set-up of a permanent network for HTA under Article 15 of the cross-border health care Directive (Directive 2011/24/EU). FBK made a brief presentation of the current activities in WP1/WP8 (please see Appendix 1, slide 5). AHTAPol, CVZ, HAS, THL confirmed that they received a request from ECORYS for an interview for the ECORYS’ cost-benefit study regarding the Secretariat for the permanent network for HTA. It was commented that the ECORYS study is based on a number of assumptions and estimates. Anne-Marie Yazbeck, NIPH, introduced herself as a replacement for Eva Turk and informed about the LP plans to organise a meeting in WP2 (preliminary planned for June 2012). Draft agenda for the meeting will be circulated shortly to the WP2 members. All the deliverables of WP2 have been produced and submitted as planned. FBK commented that in case a meeting is to be held it will be beneficial to clarify the October-December 2012 overlap between the JA and JA2 WPs on dissemination. Kristian Lampe, THL, and Marina Cerbo, AGENAS, presented activities in WP4 (Appendix 2). It was agreed that the draft policies being developed by the WP4 Strand A will be reviewed by the Executive Committee prior to undergoing public consultations. Marina Cerbo highlighted the disappointing quality of information on the technologies chosen for the Core HTAs that was provided by the technology developers (ie, only advertising booklets). She also indicated that the collaboration model where 1 organisation is responsible for one domain of the Core model seems to work best. Furthermore, there is a problem with a low response rate on the surveys. Availability of expertise, inadequate resources and a general problem with sharing methodologies were indicated as possible sources for the problem. Daily routine procedures vary from country to country. Level of HTA development in a country also constitutes a factor in an organisation’s ability to actively contribute in general across EUnetHTA. It was suggested that
- a survey’s objectives need to be better explained as well as thorough consideration should be done prior to choosing survey as the format for collecting necessary information
- the approach to answering surveys should differ from an approach to conducting a systematic review
- clearly indicating if answering the surveys is mandatory or voluntary - mapping availability of expertise for developing the surveys via WP3 annual survey
could be helpful Wim Goettsch and Mira Pavlovic presented activities in WP5 (Appendix 3):
- the background review will be published as an article in the scientific journal Value in Health
- the pilot on rapid Core HTA has been a good experience that allowed to further develop the approach to the rapid assessment based on the HTA Core model (ie, focus on the first 4 domains with a checklist of issues for other domains). New collaboration approach with 1-2 organisations being responsible for 3-4 domains with other organisations as reviewers will be tested to see if time for production can be reduced
- there is a problem with recruiting a technology provider to cooperate in the 2nd
pilot – four pharmaceuticals were identified and no company agreed to participate. This has implications for the pilots in JA2
- success and failure factors in implementation of the rapid assessments based on the HTA Core Model will be described with participation of the experts with hand-on experience
- draft guidelines received a lot of comments both from WP members and SAGs indicating real engagement on the issue
- comments received will most likely be divided in the two groups of their immediate relevance for the process and “for future reference” (eg, JA2)
Patrice Chalon, KCE, presented the activities in WP6 (see Appendix 4). Mira Pavlovic, HAS, and Judit Erdos, LBI, presented activities in WP7 (see appendix 5 and 6). It was suggested to have a date of the reports completion in the POP database (eg, another “column” of information “completed and published” with a date). Patrice Chalon confirmed that this is a part of the development plan for the POP Database. The electronic version of the POP database has been launched, however, some partners continue to submit information about the reports in Microsoft Excel sheet format which makes it time- and resource-consuming for POP database managers to transfer this information into the database. Technical solutions for an automatic transfer of info from the Excel sheets are not yet available and seem difficult to provide. Further work is needed on improving the work-flow for all parties involved in the POP Database maintenance and development. It was suggested to investigate an opportunity for an additional financing of early dialogue pilots through the 2013 health programme budget. Julia Chamova, EUnetHTA Secretariat (NBOH) informed about the planning of the JA1 and JA2 overlap period (October-December 2012) (Appendix 1, slide 11). The first draft contributions to the JA2 3-year Work Plan should be delivered to the secretariat in November 2012. Wim Goettsch, CVZ, commented that JA2 WP5 LP and Co-LP will discuss the issue of the planning for achieving the 1
st milestone in JA2 WP5 and get back to the Secretariat shortly
(as well as the number of pilot assessments developed as 1st milestone).
The Secretariat will clarify with the EAHC the rules with regards of combining meetings of WP5 of JA1 and JA2
1.
Action points:
- WP2 to clarify the necessity of holding a face-to-face meeting in June - WP5 to clarify the solution for recruiting the technology developer for the 2
nd pilot
(possibly via the Stakeholder Forum) - Follow-up on the financing opportunities for early dialogue pilots through the 2013
health programme budget - Secretariat to clarify the rules with the EAHC regarding the possibility of holding JA1
and JA2 meetings simultaneously - CVZ as JA2 WP5 LP – to clarify the planning for achieving the 1
st milestone in JA2
WP5 (M3 – December 2012) EUnetHTA and permanent European network on HTA – I Jerome Boehm, DG SANCO, informed on the current and future process of implementation of the Article 15 of the CBHC Directive (Appendix 7):
- the first meeting of the CBHC Committee will take place on Sept 18, 2012, where EUnetHTA should provide an input on the objectives and achievements of the current JA and considerations for the permanent network for HTA in Europe. The 2
nd CBHC
Committee meeting will be held on November 28, 2012. - The Committee will have about one year to clarify the objectives, etc for the
Implementing Act - Rules of procedure (rather detailed and complex) are to be developed after the
implementing act is in place - The bilateral meetings with the MS has shown various perspectives on the scope of
the work for the permanent network - It is important to have an understanding at the MoH level on what EUnetHTA does
and for what purpose - The issue of regions within MS: it is necessary to have a national representation and
organize cooperation between regions
1 The JA1 WP5 nad JA2 WP5 have different scopes which is to be taken in consideration when
planning the content of the meeting – especially with the view of combining both.
- Comments on the governance issues indicated the importance of these questions, however, with the view that the process should not be “over-formalised” (ie, the details can be clarified after October 2013, notably after JA2)
- The respective MS health attaches and the MS representatives in the CBHC committee are the communication channel with regards to the activities on the implementation of the CBHC directive
Key discussion points can be summarized as follows:
- The main governance (strategic decision-making) body should have a representation of the MS that ensure effective communication between the “governance” and “production” level (eg, having 2 representatives per MS – one with tech HTA competence and one from the MoH). Having a political representative in the Network assembly could reduce the production level’s independence, but it can also lead to a strong cooperation and synergies; it will be important to regularly inform the members of this body on the activities and results from the “production” level
- Participation at the production level should reflect the HTA organisation at the national level (eg, more than 1 organisation can be nominated with maximum number of nominated organisations)
- Clear distinction of the roles and decision making capacities/power of the Network Assembly (”governance” level) and the Executive Committee (“production” level) should be ensured
- It was unanimously agreed that a Network Forum with representation of all the network participating organisations would be necessary to provide an opportunity for regular network-wide scientific discussions and exchange of experience. It can also serve as an advisory body for the Executive Committee that is to have a direct link to the Network Assembly
- The composition of the Executive Committee should be decided by elections from the organisations nominated to participate in the permanent European network
- Possibly the Network Assembly will have an authority to approve the output of the network (but not the single HTA reports!)
- The role of the Commission in the future network will be a provider of services and financing. Possibly a representative of the Commission can co-chair the Network Assembly
- Of utmost importance is to clarify what is to be done by the network in order to develop an appropriate governance and management structure that supports these activities and level of involvement
Julia Chamova presented the two descriptions of the levels of involvement in the future permanent network (one – from the EUnetHTA strategy document, the other – from the Commission’s presentation during the Gdansk conference) (Appendix 1, slides 16-17). She further presented a new proposal for the levels of involvement Key discussion points can be summarized as follows:
- The new suggested set of levels were accepted as a part of the EUnetHTA Strategy for presentation and endorsement at the Plenary Assembly meeting. A small adjustment (ie, removing “database of impact assessment” from the list of developed EUnetHTA tools) should be made in the Business Model appendix of the strategy
- The EUnetHTA tools and services should be matched to every level to have a better understanding of what activities might correspond to which level
- level of development of HTA in a country might influence the level of involvement in the network (based on this consideration, clarifications should be made with regards to the minimum requirements for each level of involvement)
- Participation in the network can be at different levels for different types of activities (ie, there is no hierarchy in access to various levels)
- Confidentiality issues of accessing and sharing information at different levels should be considered
- Broad view on the type of input from the partners into the network should be taken - For simplifying the understanding of what lies behind each level the following
interpretation was offered: Level one – share and exchange HTA information, Level two – common practice based on shared standards, Level 3 – doing HTA together and using the results at national level individually
FBK presented the issue of membership and participation in the current and future activities of EUnetHTA. During the discussion it was agreed that EUnetHTA should continue its policy of inclusiveness based on the availability of expertise and value that the applying organisations bring to EUnetHTA. It was confirmed that the involvement of the organisations other than the Ministry nominated bodies is indispensable in order to have access to a wider pool of expertise and competence in Europe. The mode of involvement of the organisations that apply for the status of an Associate could be via their contribution either to the activities in the WPs (project-based input) or performing general tasks that are not tied to a specific WP or project (task-based input). The Secretariat is to develop a proposal for the criteria for assessing and accepting the applicants to become EUnetHTA associates (including considerations of the financing sources) The Executive Committee agreed that the current applicants from Germany (GBA and Medical Valley University of Erlangen-Nuremberg) will be considered for acceptance as Associates with the start of JA2 in October 2012 (as JA1 is coming to an end). Medical Valley University of Erlangen-Nuremberg will be requested to provide more detailed information on their sources of finance to make an informed decision regarding the issue of independence from private industry interests (a general issue in relation to university and research institutions). Action points:
- EUnetHTA to prepare input for the September 18, 2012 meeting of the CBHC Committee
- The EUnetHTA Strategy should be adjusted as per the discussions at the meeting on levels of involvement
- The current applicants from Germany should be informed about the decision of the Executive Committee
- The Secretariat is to develop a proposal for the criteria for assessing and accepting applicants to become EUnetHTA associates (including considerations of the sources of finance)
April 19, 2012 EUnetHTA and permanent European network on HTA – II Key discussion points:
- Access to the Core HTA Online tool and cards are open for all EUnetHTA Partners and Associates. Careful consideration of the level of access should be given to other potential users of the tools with a view of the possible sources of revenue and involvement of the technology developers in the HTA process (eg, technology file submissions based on the structure of the Core HTA model?)
- Current ways of engagement with the stakeholders are working well and beneficial (SF and SAGs), however, there is a need to have an additional (albeit not too resource and time consuming) structure/solution for effective communication and appropriate involvement for the pilots. No concrete proposals were made – possibly an issue to discuss with the Stakeholder Forum
- The technical function of the scientific secretariat for the permanent network could not be placed in the Commission. Cooperation with the Commission in the issues of the stakeholder involvement in the current JA proved to be beneficial and should be considered for further development in the permanent network
- The tasks and projects of the future network will provide a basis for the development of a stakeholder involvement practice, however, the principles, approaches and experience gained in the JA is very valuable for being taken forward in the permanent network
- The Executive Committee agreed that the increase of the number of seats from 4 to 6 in each of the SF groups (payers, patients, industry and providers) should be proposed. The current principles allow for involvement of the organisations from the national level as well. The increase should be proposed for endorsement to the Plenary Assembly.
- A new open call for expression of interest to participate in the Stakeholder Forum of JA2 will be announced at the beginning of JA2 with the aim of having a new Stakeholder forum in place by the start of 2013.
- Discussion of the roles of various bodies in the organisational structure of the permanent network: the Network assembly is for the MS participation (1 vote per country, possibly with 1+1 representation (technical+political); strategic, endorsing role, meeting once a year; Network Forum for participation of the network organisations for discussing the key scientific and working process issues and having an advisory role to the Executive Committee. Division of responsibility and functions between the Network Assembly and Network Forum should be straight forward and clear.
- Liaising with the respective MS health attachés is important: the money for the network will come for the “Health for Growth” programme (2014+ which has a 7-year budget period). Efforts are now made to pre-allocate a certain amount for the HTA network’s annual budget for a number of budget years (not to go through an annual negotiation procedure)
- Establishing a legal entity for the administrative purposes of eg, receiving grants, holding IPR rights should be strongly considered. It should be clarified within the Commission how it fits with the existing rules on establishing and financing the network.
- Some work process and scientific decision making will be delegated to the Activity Centers while the Network Forum will discuss the key scientific and working process issues. The types of decisions to be made at the Activity Center level should be thoroughly discussed: decisions with network consequences should be brought up in the Executive Committee.
- E-health network rules of procedure can provide valuable insights. DG SANCO will share the document
Marina Cerbo, AGENAS, presented the latest developments in the European regulation on medical devices (Appendix 8). It was commented that EUnetHTA can work on the issue of how to communicate the message from European HTA on assessment of medical devices. First input can be in the fall of 2012 from the exercise of the early advice on devices. It was agreed that the regulatory aspects and HTA aspects should be kept separately. With regards to the financing streams, Jerome Boehm informed that the budget will define the scope of work for the permanent network. Efforts are made to secure money on a multiannual basis. Eligibility criteria for financing the activities would be as it is in the joint action. Some specific activities can be financed through other sources (eg, IMI, FP7, etc). Rules of procedure will clarify the sources of income. It was agreed that WP4 and Secretariat will collaborate in preparation of the discussion of the policy for access to the HTA Core Model tools and information. The Executive Committee does not object to the possibility of having fee for service or membership fee as one of the revenue sources for the permanent network. The long-term perspective should be taken when discussing the financing streams. With regards to collaborating with the international networks and European organisations, it was agreed that cooperation with EMA, CIE and DG Research is prioritised and more formal agreements on cooperation should be put in place. The Executive Committee approved the MoU with the INAHTA to be endorsed by the Plenary Assembly. EUnetHTA Plenary Assembly, Lisbon, May 24-25 JUCH informed about the agenda, nomination process and the practicalities of the Plenary Assembly meeting in Lisbon, May 24-25, 2012. Alric Ruether mentioned that due to the JA2 overlap in the last three months of 2012, some of the agencies will change their status in EUnetHTA (eg, will cease to hold or acquire the status of being Lead/Co-Lead Partner) which may affect their eligibility to run for certain positions in the governance structure of EUnetHTA. FBK clarified that JA and JA2 are phases in the development of the same network, EUnetHTA Collaboration, with a stable core partnership, new members can join (be nominated by the MoH) at any time of the year and therefore could not have an opportunity to vote in elections before the next PA meeting. The overlap will affect a couple of organisations which will not justify holding elections before the next Plenary Assembly is held in March 2013. They can, however, nominate in the period prior to the Plenary Assembly meeting. No objections were raised to the approach.
FBK requested if HAS, THL and CVZ can be approached by CIRS for their project on benefit/risk assessment. It was agreed that CIRS can contact these agencies. Due to lack of time the presentation for the new website development was not made, but the slides are available for information (Appendix 9). They will be discussed in the Task Force on EUnetHTA JA2 websites The meeting was adjourned at 14:30.
Participants List
Name E-mail Organisation Country
Marisa Warmuth Judit Erdos
[email protected] [email protected]
LBI-HTA, Ludwig-Boltzman Institute
Austria
Patrice Chalon [email protected] KCE, Belgian Health Care Knowledge Centre
Belgium
Julia Chamova Finn Børlum Kristensen
[email protected] [email protected]
NBoH, National Board of Health
Denmark
Kristian Lampe
THL, National Institute for Health and Welfare
Finland
FranÇois Meyer Mira Pavlovic
[email protected] [email protected]
HAS, Haute Autorité de Santé
France
Alric Rüther [email protected] IQWIG, Institute for Quality and Efficiency in Health Care
Germany
Marina Cerbo Nicola Vicari Francesca Gillespie
[email protected] [email protected] [email protected]
AGENA’s, Agenzia Nazionale per i Servizi Sanitari Regionali
Italy
Anna Zawada [email protected] AHTAPol, Agency for Health Technology Assessment
Poland
Anne-Marie Yazbeck [email protected]
NIPH, National Institute of Public Health of the Republic of Slovenia
Rep. of Slovenia
Setefilla Luengo Matos [email protected] AETS-ISC III Spain
Wim Goettsch [email protected] CVZ, Health Care Insurance Board
The Netherlands
Jerome Boehm [email protected]
European Commission
WP1
Appendix 1 for Appendix 1
EUnetHTA Joint Action 2010–2012 | www.eunethta.eu
WP1/ Executive Committee
Meeting
April 18-19, 2012
Rome, Italy
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 2
Agenda – April 18
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 3
Agenda – April 19
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 4
WP Updates
Brief overview of the activities in WPs:
WP1/8
WP2
WP3
WP4
WP5
WP6
WP7
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 5
WP1/WP8
WP1:
• delivery of the 2nd interim report – end of April 2012
• Finalising the JA2 grant agreement (ready for the signature by EAHC); ECORYS interview
– Planning for JA and JA2 overlap
• Preparation of the Plenary Assembly meeting (agenda, nomination process, practicalities)
• Daily coordination activities: e-/meetings (preparation and reporting), contact database update, Members Updates, external enquiries (surveys, public consultations, public news, etc), interacting with the scientific – and policy oriented networks/institutions (eg, DG R&I, EMA, IMI, Green Park, Tapestry, AHRQ…)
WP8:
• SF e-/meetings (next SF ftf meeting – September 3, Venice, Italy)
• SAG member lists and confidentiality agreements update
• EFPIA seminar; planned EFP meeting
• All deliverables in place
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
EUnetHTA Joint Action 2010–2012 | www.eunethta.eu
Executive Committee face to face meeting
WP6 Progress report
Patrice Chalon
2012-04-18, Rome, Italy
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
WP6 overview 2012 M25 M26 M27 M28 M29 M30 M31 M32 M33 M34 M35 M36
Meetings 1st
emeeting
4th ftf 2nd e-
meeting
Surveys
Communicat
ion
Members
only site
Developmen
t and testing
Contact
database
updated
site update
Single sign
on
Planned and
ongoing
projetcs
database
2nd release
HTA reports
&
supplement
al materal
Tool
released
Information
about policy
decisions
Report and
w orkflow
delivered
Tools
supporting
day to day
collaboratio
n
Mailing list
server
released
JA2
websites
Training and
support
Evaluation
and final
report
WP Final
technical
report
Evaluation and preparation of WP final technical
report
Development and testing
collaboration w ith existing tool (outside EUnetHTA) is evaluated
vs development of specif ic new tool
Development and testing
collaboration w ith existing solutions (outside EUnetHTA) is
evaluated
Development and testing
Development, testing and provision of learning material
User support
ftf meeting preparation
Survey 2 preparation Survey 2 Survey 2 analysis
Communication on regular basis
Support to adaptation of
information about policy
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
Details Task Comment
2nd survey Delayed due to sick leave
Contact db Hold on due to possible change of infrastructure
POP db release 2 Started, release expected to be delayed
Documents db Not started yet
Information policy
decisions
Evaluation started, see JA2 WP2 “Community of
Practice
Mailing list No started yet
JA2 Websites See below
8
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
JA2 Websites: Project description
Description
Tasks
achieved
• Surveys and interviews
• Requirements synthesised
• Analysis of requirements
• Technical options identified for Website and Intranet
/ workrooms / project management + basic tests
• Preliminary contacts with potential furnishers
(technical information)
Tasks to do • Meeting task force (planned Apr. 24)
• Preparation European tender
Planning • April: meetings task force, preparation tender
• May: tender
• June-July: selection provider
• Oct: Start implementation
• 01/01/2013: Live
9
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
JA2 Websites: participants
10
KCE
Task Force
Secretariat
Susanne Eksell, Gottfried Endel, Judit Erdos, Eleanor Gueguan, Wim Goettsch, Sarah Kleijnen, Leena Raustia, Ingvil Sæterdal, Sorin Stanel, Claudia Wild,
Gudrun Briat, Patrice Chalon, Carl Devos , Kirsten Holdt Henningsen Julia Chamova, Naomi Dayan, Inge Merete Skov
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 11
JA1/JA2 overlap
See Gantt chart! (Excel doc)
• From October 1, 2012 a cost recording system that identifies the costs for JA1 and JA2 SEPARATELY should be in place! The reporting of the activities should also be done separately (time sheets, etc)
• Sept 2012 – Secretariat will inform on the format for JA1 final reporting
• January 15, 2013 – WP final reports for JA1 and AP financial statements
• October – December – development of the JA2 3-year Work Plan
– WP1 meeting in Copenhagen in January 2013
• March 2012 – Plenary Assembly meeting (endorsement of the 3-year Work Plan)
• HOWEVER, October 2012 – JA2 WP4 and WP5 should have a project description in place (WP5 milestone M3; WP4 milestone M8)
• October-December – putting the new JA2 information platform in place
• January – new JA2 web platform goes live!
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 12
EUnetHTA and permanent European
network on HTA
a. Commission and MS updates on current developments re: Article 15 implementation
b. Levels of involvement
c. Membership issues
d. Stakeholder relations/involvement
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 13
EUnetHTA and permanent European
network on HTA
Article 15 implementation timeline - 2012
February-May: Feasibility study to provide estimates on running costs for
different management models
February-June: Country visits to selected Ministries of health. Purpose: to
map the willingness of key HTA countries to engage in an ambitious
approach
24-25 April: Informal Council with discussion session on HTA
24-25 May: Pre-discussion with EUnetHTA on the draft Commission
Decision at the Plenary Assembly
June – July: Stakeholder Consultation on the HTA network
November: Initial Committee Discussion on the HTA network
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 14
EUnetHTA and permanent European
network on HTA
Article 15 implementation timeline - 2013
February-March: Formal Committee Discussion
March-May: Inter-service Consultation on draft implementing act
May-June: Voting in the Committee on the draft implementing act
June-September: Written procedure and adoption of implementing
act
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 15
EUnetHTA and permanent European
network on HTA
Article 15 implementation – Qs to the Commission:
- Legal framework re: establishing a legal entity (eg, to handle IPR
issues)
- Financing rules/limitations/views on financing approaches/income
streams for the permanent network and its Secretariat
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 16
Levels of involvement
EUnetHTA Strategy document (p.2):
EUnetHTA Strategy Commission
Basic level (sharing reports)
Committed level (information and methods are shared within the agreed EUnetHTA framework/using EUnetHTA tools)
Advanced level (common standards and tools are used in collaborative HTA projects)
Level 1: Focus on sharing and exchange of HTA information
Level 2: Development of common generic guidelines for HTA
Level 3: Enable the use of the guidelines at national level for easier sharing of HTA information
Level 4: Coordinated/joint HTA processes with reuse of HTA information at national level
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 17
Levels of involvement
- Common understanding of what is behind each level
- Try to harmonise between the two sets
- Minimum requirements for involvement
- Minimum requirements on agreeing for common processes in the network
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 18
Levels of involvement - new
European network for HTA – levels of involvement
Level 1 (entry level): Sharing and exchange of information
and methods (within the agreed EUnetHTA framework)
Level 2: Development of common generic guidelines for
HTA
• Piloting standardisation of the guidelines use at the
national level (within defined time and access to
resources supporting such piloting; reporting on the
experience)
Level 3: Application of common standards and tools in
collaborative HTA projects with re-use of HTA information
at national level
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 19
Membership issues
- Regional agencies
- EUnetHTA Collaboration Founding Partners
- Number of partners per MS (relevance to Governance issues)
- Orgs that are not nominated but interested to participate - Associates status (on which premises are given?) and their
role and contribution mode
- How to handle independence and conflict of interest issues with non-for-profits that have the private sector financing
- Role of national networks
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Stakeholder relations/involvement
- Stakeholder Forum composition in JA2
- Stakeholder Forum role beyond JA2 (link to governance issues)
- Types of involvement to be considered (post-JA2) - Current governance structure
- Business model considerations
- Other?
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Agenda – April 19
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Governance, management and
accountability – PA: partners or MS representation? Voting rights
– Exec Comm: composition alternatives
– SF: free standing? Managed in connection to the Exec Comm or Plenary Assembly?
– Coordination: central and distributed? Activity centers (aka “WPs”)?Project management – who is responsible for what
– EUnetHTA products – who and how is responsible for, eg, quality assurance, management of potential legal disputes
• What are the EUnetHTA products – only tools? Or Core HTA information as well?
– Role of the Commission in the future network
– Will EUnetHTA have a “one voice for..” ie, expressing of common position on certain issues?
– Legal entity issue – who is to, eg, hold the IPRs, be legally responsible, collect fees/financing for the network activities
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 23
Network assembly
MS plus SANCO
P&A forum
Coord
inatio
n s
ecre
tari
at
ACTI
VITY
Stakehold
er forum
SAG
Executive
committee
ACTI
VITY ACTI
VITY
ACTI
VITY
SAG SAG SAG
Article 15 network
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 24
Financing streams
Commission:
- What types of activities? Priorities? Who can
receive funding for what – for, eg training
attendance? For, managing Core HTA information
production?
MS:
- Magnitude and form of contribution? How to
connect to the level of involvement and define
minimum financing required?
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 25
Financing streams
Other income sources:
- Fee for services (see Business model)?
- Licensing fees?
- Membership fees for those orgs that are not
nominated by the MS?
- Any limitations on receiving fees for the permanent
network’s Secretariat (Commission’s rules)?
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 26
Working with EU bodies and international
orgs
Issue for JA2 as well as for the permanent network:
- Which EU bodies? How to prioritise?
- Which unit in the governance structure will be the
reference point for engagement with the EU bodies?
- Which international orgs? What type of engagement? - Working together on certain projects, regular contribution during certain
activities of such organisations, strategic aliances; which ones to prioritise
RESOURCE CONSIDERATIONS (STAFF and TIME)…
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 27
Working with EU bodies and international
orgs
Latest developments in device regulation in Europe
– how to handle in JA2?
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 28
Finalising the EUnetHTA strategy
development and moving to
implementation
a) Final endorsement in Lisbon
b) Taking it into the work of JA2 WP1 (as a
part of the 3-year Work Plan)
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 29
EUnetHTA Plenary Assembly
Lisbon, May 24-25
Agenda
Nomination process
Practicalities
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 30
Draft Agenda
A final agenda and info pack will be shared on May 9, 2012
1. Key figures and main achievements of EUnetHTA (short orientation)
2. Discussion about Work Package activities during 2011 (background
information will be sent in advance)
3. Election process of the 3 members in the Executive Committee, PA
chair and deputy chair
4. WP3 NETSCC evaluation based on survey
5. Collaboration with other networks/organisations: EMA; INAHTA;
TAPESTRY and others
6. Ways to enhance the communication with Stakeholder Forum (SF)
7. Procedural matters re: governing principles (including SF policy and
operational procedures)
8. Financial information and grant guidelines (end of JA1 and plans for
JA2)
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
Draft Agenda
9. Ways to increase Implementation of the EUnetHTA tools in MS
• Feedback system to measure efficiency and implementation
of EUnetHTA tools in Member States
• Facilitation of use / integration of core HTA information
• Information Management System (New Websites)
10. EUnetHTA strategy: discussion and endorsement
11. EUnetHTA Business Model, future implementation and stages until full
operation
12. Secretariat role and duties during JA2 and the permanent network
13. Future Article 15 HTA network with regards to the EUnetHTA Strategy
and BM
• Commission’s Article 15 implementation process update (ECORYS
analysis)
• Stakeholder involvement based on the executions
31
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
Nomination process and elections
• Nomination process follows the EUnetHTA Collaboration
Organisational Structure 2009 – 2012 Governance Guiding
Principles http://www.eunethta.eu/upload/Joint%20Action/JA%20WP1/Documents/EUnetHTAOrgGovStructure_Sep
t292009.pdf
• The election process is based on the view that JA1 and JA2 are
a continuation of the same network/project, going through
different phases.
– The guidance on the partners’ eligibility for elections follows this approach
32
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 33
FIMEA
EUnetHTA
JA 2 Associated
Partners
2012 - 15
EUnetHTA
Collaboration
Founding Partners
2009 +
EUnetHTA Joint
Action Associated
Partners
2010-2
NCPHA, Bu
HTA&HSR, DK
Cyprus
IQWIG
CVZ
NICE
DIMDI
A. Gemelli
HVB
Reg Veneto
AIFA
Agenas
THL
KCE
LBI-HTA
HAS
ASSR
CAHIAQ
NBoH
AETSA
MoH Spain
A Diagram to illustrate the distribution of Partners on
EUnetHTA Collaboration Founding Partners, EUnetHTA Joint
Action Partners and EUnetHTA Joint Action 2 Partners
MoH Cz
GÖG
AQAHC, Cr
AVALIA-t
SDU
UTARTU
NSPH
GYEMSZI
HIQA
Partner ?
VEC VASPVT
SSD/MHEC
NOKC
AHTAPol
INFARMED
NIPH
ISCIII
OSTEBA
UETS
SNHTA
SBU
NETSCC
IER
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
Nomination and election process and
elections
• Information regarding the nomination was sent twice
to all partners and is available on the MO website
• The elections will take place during the first PA day,
(May 24, 2012)
• Election for 3 electable seats in the Exec Comm (for
organisations): one year position
• Election for PA chair/ Deputy Chair (for individuals):
two years positions
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
List of nominees:
• Plenary Assembly Chair:
Mirjana Huic
• Plenary Assembly co-Chair:
• Plenary Assembly 3 seats in Exec Comm:
AHTAPol
35
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
Practicalities
• Max no. of participants: 65
• SF participation: 4
• EU Commission participation: 1(2?)
• Hosting organisation: INFARMED
• Location: INFARMED, Parque da Saude de Lisboa,
• Av. Do Brasil, 53, 1749-004 Lisboa
• Accommodation: 4 options in MO-calendar
• Social event: guided tour of Lisbon followed by a dinner
• All relevant information is available on the MO. A full info pack
will be available in the PA area by May 9, 2012
36
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
Update on registration
Current registrations (April 16 deadline):
29 partners (67%) – reminder was sent April 17
1 Commission rep (DG Sanco)
1 Rep from SF (payers)
10 orgs asking for the second participant to attend
Total: 50 persons (with 2nd attendant included)
ECORYS was invited to present the results of their cost-
benefit study
37
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 38
Other issues and conclusion
a) EUnetHTA at HTAi
b) EUnetHTA information platform development (JA and JA2)
c) JA budget reallocation update
d) CIRS interviews on benefit/risk assessment
WP1
Appendix 2 for Appendix 1
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
EUnetHTA Joint Action 2010–2012 | www.eunethta.eu
WP1 Executive Committee
Rome, April 18th-19th 2012
WP4 Strand A Update
FINOHTA/THL
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 2
WP4 Strand A – Update (1) • Online Tool and Service
– Basic functions ok for the two pilot core HTAs
– Advanced functions, including better project scoping, under construction.
Pilot testing delayed from M23 to M27/M29.
– Concept paper 2nd version under review in OTS WG
• Screening Model
– 2nd public draft ready. Lots of feedback and suggestions for improvement
gathered. Final version Dec 2012.
• Policies
– Survey results analyzed, soon to review within WP4, then SAG and public
consultation. Delayed, process simplified to meet project timeline.
EUnetHTA Joint Action 2010–2012 | www.eunethta.eu
WP1 Executive Committee
Rome, April 18th-19th 2012
WP4 Strand B Update
Agenas
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 4
WP4 Strand B – Update (1)
• Two surveys to obtain more information on the
technologies of the two core HTAs have been
conducted.
Following the low response rate, both surveys were
sent again to EUnetHTA Partner with new deadlines.
• Further information has been sought from the
manufacturers of 3 genetic tests for breast cancer; the
(disappointing) answers were received and shared
among Domain Teams
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 5
WP4 Strand B – Update (2)
• Core HTA 1 (Genetic Tests for BC) has completed first
drafts from the following domains:
– TEC (Description and technical characteristics of technology)
– SAF (Safety)
– EFF (Clinical effectiveness)
– ORG (Organizational aspects)
• Core HTA 2 (AAA Screening): has completed first drafts
from all domains; second draft is in progress.
• A Workshop in Wien took place on March 29-30:
discussion on protocol drafts, domain drafts and
Validation of Core HTAs
• Recruitment of new reviewers: a message for all EUnetHTA
partners for availability of new reviewers in some Domains
is being written.
WP1
Appendix 3 for Appendix 1
EUnetHTA Joint Action 2010–2012 | www.eunethta.eu
REA of Pharmaceuticals
(JA1 WP5)
Methodology guidelines and EPAR review
Mira Pavlovic
April 18, 2012
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 2
Update on activities WP5: SG4 Ongoing actions
3rd drafts received by all authors – 1st batch: (5 March 2012)
• Clinical endpoints
• Composite endpoints
• Surrogate endpoints
• Choice of comparator
• Direct and indirect comparisons
– 2nd batch: (16 April 2012)
• HRQoL
• Safety
• Internal validity
• Applicablity
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 3
Update on activities WP5: SG4 Ongoing
actions
Guidelines WP5 and SAG
consultation
EMA and Public
consultation
• Clinical EP
• Composite EP
• Surrogate EP
• Choice of comparator
• Direct and indirect
comparisons
March 7- April 13
• All comments received
and sent to the authors
on April 18
• Revised versions
expected by May 7
May 14 – July 14
• HRQoL
• Safety
• Internal validity
• Applicablity
Just started:
April 17 – May 25
June 29 – Sept. 14
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 4 4
EPAR improvement project
Parallel Review
EUnetHTA
• Each EPAR was reviewed by two HTA organisations from the EUnetHTA network
• Participating 10 HTA organisations were AETSA, AIFA, CAHIAQ, CMPT, CVZ, NICE, NOKC, HAS, HVB, UVT
EMA
• First review of all EPARs performed by a single reviewer (not responsible for the writing of any of the reports)
• Subsequently a peer review was performed through a senior member of staff
• Same questionnaire
• Same assessment scales
• Same evaluation tool
EPARs subject to the review:
• Pumarix, Esbriet, Teysuno, Xeplion, Xiapex, Gilenya, Halaven,
Jevtana, Pravafenix, Trobalt
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 5 5
EPAR improvement project
Parallel Review
• 4th EMA - EUnetHTA meeting (HAS, Paris): 22 Feb.
2012: presentation of the outcome of the parallel
EPAR review
• Future actions:
– EUnetHTA (coordinated by HAS) to make a consolidated
proposal for further improvements of the EPAR, highlighting
expectations
– New EUnetHTA EMA face-to face meeting to solve the
remaining issues
– The EMA-EUnetHTA parallel EPAR review will be presented
to the CHMP and published (in Value in Health)
WP1
Appendix 4 for Appendix 1
EUnetHTA Joint Action 2010–2012 | www.eunethta.eu
Executive committee face to face meeting
WP6 Progress report
Patrice Chalon
2012-04-18, Rome, Italy
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
WP6 overview 2012 M25 M26 M27 M28 M29 M30 M31 M32 M33 M34 M35 M36
Meetings 1st
emeeting
4th ftf 2nd e-
meeting
Surveys
Communicat
ion
Members
only site
Developmen
t and testing
Contact
database
updated
site update
Single sign
on
Planned and
ongoing
projetcs
database
2nd release
HTA reports
&
supplement
al materal
Tool
released
Information
about policy
decisions
Report and
w orkflow
delivered
Tools
supporting
day to day
collaboratio
n
Mailing list
server
released
JA2
websites
Training and
support
Evaluation
and final
report
WP Final
technical
report
Evaluation and preparation of WP final technical
report
Development and testing
collaboration w ith existing tool (outside EUnetHTA) is evaluated
vs development of specif ic new tool
Development and testing
collaboration w ith existing solutions (outside EUnetHTA) is
evaluated
Development and testing
Development, testing and provision of learning material
User support
ftf meeting preparation
Survey 2 preparation Survey 2 Survey 2 analysis
Communication on regular basis
Support to adaptation of
information about policy
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
Details Task Comment
2nd survey Was delayed due to sick leave, now started
Contact db Hold on due to possible change of infrastructure
POP db release 2 Started, release delayed to 3rd quarter 2012
Documents db Started
Information policy
decisions
Evaluation started, see JA2 WP2 “Community of
Practice”
Mailing list No started yet
JA2 Websites See below
3
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
JA2 Websites: Project description
Description
Tasks
achieved
• Surveys and interviews
• Requirements synthesised
• Analysis of requirements
• Technical options identified for Website and Intranet
/ workrooms / project management + basic tests
• Preliminary contacts with potential furnishers
(technical information)
Tasks to do • Meeting task force (planned Apr. 26)
• Preparation European tender
Planning • May: tender
• June-July: selection provider
• Oct: Start implementation
• 01/01/2013: Live
4
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
JA2 Websites: participants
5
KCE
Task Force
Secretariat
Susanne Eksell, Gottfried Endel, Judit Erdos, Eleanor Gueguan, Wim Goettsch, Sarah Kleijnen, Leena Raustia, Ingvil Sæterdal, Sorin Stanel, Claudia Wild,
Gudrun Briat, Patrice Chalon, Carl Devos , Kirsten Holdt Henningsen Julia Chamova, Naomi Dayan, Inge Merete Skov
WP1
Appendix 5 for Appendix 1
EUnetHTA Joint Action 2010–2012 | www.eunethta.eu
WP 7 New Technologies
Update on Strand A Activities
Mira PAVLOVIC (HAS, France)
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 2
WP 7 Objectives • Strand A
Facilitating evidence
generation on new HT
- criteria to select new technologies in need of further evidence
- minimum dataset to share information on policy relevant clinical studies in development
- database (EIFFEL) to share information & facilitate collaboration on additional evidence generation
• Strand B Facilitating exchages on
current HT assessments
- information flow on HT assessments & alerts on parallel HTA projects
- collaboration on HTA projects
- Database (POP) to provide updated information on planned and ongoing HTA projects
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 3
Achieved WP7A Milestones
October 2011 - April 2012
Selection criteria:
• Testing of criteria by WP 7 partners (17 responses
received, analysis ongoing): 2-month delay, to be delivered
end of April
EVIDENT database:
• Additional survey ‘further clarification on EVIDENT’ among
WP7 partners (clarification of issues regarding database’s
characteristics): done
• Public consultation (15 responses database’s content
adjusted): done
• IT implementation: since March 2012
All milestones finalized on time, only testing of criteria
slightly delayed
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 4
Next steps according to the Work plan
Selection criteria:
• Public consultation on the final version: May 2012
• Publication of the final version: June 2012 (2nd WP 7 deliverable)
EVIDENT Database:
• Operational database launch: September 2012 (3rd WP 7 deliverable)
Next FtF meeting: May 10th-11th, Vienna (validation of deliverables)
WP1
Appendix 6 for Appendix 1
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
EUnetHTA Joint Action 2010–2012 | www.eunethta.eu
WP 7B New Technologies
POP database
Claudia Wild, Judit Erdös, Marisa Warmuth
LBI-HTA, Austria
WP 1 face-to-face meeting
18/19 April 2012, Rome/Italy
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
Milestones 2012 M25 M26 M27 M28 M29 M30 M31 M32 M33 M34 M35 M36
FTF Meetings Meeting
preparation
4th ftf
meeting
Vienna
POP database
development
(in coop. with WP
6)
Development and testing database version 2
POP db
2nd
release
Database is routine & regularly used by EUnetHTA partners
POP request
(reminder)
8th request
9th
request
10th
request
11th
request
POP
communication
protocols
8th protocol
9th
protocol
10th
protocol
11th
protocol
Analysis of all
communication
protocols
External analysis of all
protocols
Analysis
report
Coordination of
collaborations on
new high techs
(active brokering)
Coordination of collaboraton (at least 1 per year)
Final report Preparation of final financial and
technical report WP7 (B)
Final
report
provided
to WP 1
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
POP Statistics
7th (Nov/Dec 2011)
Out of 62 EUnetHTA JA partners:
• 40 responded and entered projects into
the database
• 2 responded but DID NOT feed the
database
• 20 did not respond at all (32%)
• Total number of projects: 968
• Alert topics: 83
• Similar projects (within alert topics): 219
8th (Febr/March 2012)
Out of 63 EUnteHTA JA partners:
• 40 responded and entered projects into
the database
• 4 responded but DID NOT feed the
database
• 19 did not respond at all (30%)
• Total number of projects: 1126
• Alert topics: 120
• Similar projects (within alert topics): 320
• Currently the POP database contains:
– 1104 planned, ongoing and recently published projects
– from 41 EUnetHTA JA partners
– from 23 countries
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
Challenges
• Passivity (both in response and in collaboration)
• Priorisation of the requirements in db development according to resources (staff, time)
• Access control of participating partners
• Contact fails: due to turnover at partner agencies no contact person afterwards
• Agencies with VERY MANY projects: NETSCC + NICE (50% of db projects!) continue sending Excel lists 2 step work for LBI-HTA:
– 1st: to sort out their projects
– 2nd: to add MeSH terms
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
Future perspectives
• JA 2 : POP maintenance,
co-operation
• Goal: partners update regularly
w/o reminder e-mails from LBI-HTA
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
Thank you.
WP1
Appendix 7 for Appendix 1
Establishing the HTA network: key issues
Presentation outline
Directive provisions
Overall architecture and adoption process
Issues at stake
Scope of work
Goverance of the network
Link with EUnetHTA
Commission objectives on HTA
Reduce duplication of work for MS.
Cost/ efficiency gains
Reduce national hurdles to market access faced after licensing
Promote the early dialogue (scientific advice) between sponsors and HTA bodies/ payers during the HT. development process
All health technologies to be covered, but particular action needed for pharmaceuticals and MD
Support MS + stakeholders with little HTA capacity
4
Article 15, Directive patients’ rights in cross border care
• From project-based to permanent cooperation on HTA • The objectives of the HTA network shall be to:
• support cooperation between national authorities or bodies; • support Member States in the provision of objective,
reliable, timely, transparent, comparable and transferable information on the relative efficacy as well as on the short- and long-term effectiveness when applicable, of health technologies and to enable an effective exchange of this information between the national authorities or bodies.
• support the analysis of the nature and type of information that can be exchanged;
• avoid duplications of assessments.
Setting up the HTA Network Creation of The Committee on cross-border healthcare
Implementing committee - examination procedure
Launch meeting: 21 June 2011
Draft Implementing act
(under the form of a COM Decision) on:
1) Measures for the establishment, the management
and the transparent functioning of the HTA network
2) Arrangements for granting the aid, the conditions
to which it may be subject and the amount of the aid
Discussion in the Committee
of the draft Implementing act
Vote in the Committee (QMV in favour),
after Commission inter-services consultation
Adoption by COM = HTA Network set up (max Oct. 2013)
Adoption of the rules of procedures by the Network
Possible governance structure Network assembly
(EU27 + EFTA/EEA3 + CR(?)(1 nominated/ country)
Work programme, supervision, adoption of
recommendations/conclusions
Stakeholder
forum
Executive committee (elected by the Network assembly)
Oversees activities initiated in the network
Secretariat Coordination
Cluster of HTA
agencies
(May include
regional HTA ag.)
Etc.
Etc.
Coordination with
EMA, CIE etc.
Stakeholder
advisory groups
EUNETHTA ® brand name?
Pro
du
ction
level
Go
vern
an
ce
level
Issue at stake: formalising the network
• HTA agencies still in a phase of trust-building
• To what extent should the rules of procedures formalise the governance issues?
• Need to find a balance between bringing clarity to MS without blocking the capacity building process
• Possible solution: Agree on general principles in 2013, with agreement on review rules of procedure following the end of JA2?
Issue at stake: scope of the work
The network should allow for different levels of involvement from participating organisations. Our suggestion is that four such levels are defined, e.g.:
• Level 1: Focus on sharing and exchange of HTA information • Level 2: Development of common generic guidelines for HTA • Level 3: Enable the use of the guidelines at national level for
easier sharing of HTA information • Level 4: Coordinated/joint HTA processes with reuse of HTA
information at national level MS should reflect on how they see this in the context of their
national HTA work
Issue at stake: the Network
• 1. Membership: voluntary HTA bodies designated by member States (MS), but: • Can MS appoint an unlimited number of HTA bodies? • What to do with regional HTA organisations? • Will we see members with various status at national
level (public, independent etc.)? • How should stakeholders be involved?
• 2. Decision making process: • Will be fixed through the Network’ rules of procedures :
chairing, voting…but: • What if a MS was not involved in the activity in
question? • How to endorse deliverables from the network?
Issues at stake: Eunethta
• Decision making process:
• Link between the Network and Eunetha
• Governance of Eunetha: Members of the plenary assembly, executive committee, stakeholders forum. Status of
regional agencies?
Adoption of the work program and deliverables, appointments of rapporteurs
Hosting of the secretariat
Formalising interaction with other bodies: Clinical investigation and evaluation, EMA, ECDC, JRC…
Issues at stake: Eunetha
• Financing of the network: • Until end 2015: Joint Action 2 on HTA will finance
all major activities
• Post 2015: To be supported by the Health for Growth program + RTD funds?
• EU financing to support learning curve of the cooperation process
• How to finance early dialogue/scientific advice?
• Capacities • Multi sectoral expertise needed
12
Timeline
• 8 Dec 2011: Kick-off for discussion in Gdansk
• Spring 2012: External feasibility study on cost benefit analysis of various scenarios + consultation with stakeholders on modalities for stakeholder consultation
• Autumn 2012: Draft Commission Decision development, to be discussed in the CBHC committee
• Winter/spring 2013: Discussions in the 2011/24/EU committee
• June/September 2013: Commission adopts the Commission Decision.
• From October 2013: MS nominations to network + discussion/ adoption of the rules of procedures
WP1
Appendix 8 for Appendix 1
Roma, 18-19 April 2012
Regulation of MD in Europe: time to changes?
Marina Cerbo
Medical devices: an entire overhaul of the European authorisation
and surveillance system* for high-risk Medical Devices is urgently
needed (March 2012)
Position paper
AIM (Association Internationale de la Mutualité)
is a grouping of autonomous health insurance and
social protection bodies operating according to the
principles of solidarity and non-profit-making
orientation; 25 countries; 160 million people.
ESIP (European Social Insurance Platform)
Is an alliance of over 40 statutory social security
organisations in 15 EU Member States and
Switzerland.
ISDB (International Society of Drug Bulletins)
Is a worldwide network of bulletins and journals on
drugs and therapeutics that are financially and
intellectually independent of pharmaceutical industry;
35 countries around the world.
MiEF (Medicines in Europe Forum)
It includes more than 70 member organizations
representing patients groups, family and consumer
bodies, social security systems, and health
professionals; in 12 EU Member States.
*Dir. n. 93/42/CEE 14-6-1993
Regulatory framework
Legislation
Based on the New Approach, rules relating to the safety and performance
of medical devices were harmonised in the EU in the 1990s.
The core legal framework consists of 3 directives:
Directive 90/385/EEC regarding active implantable medical devices,
Directive 93/42/EEC regarding medical devices and
Directive 98/79/EC regarding in vitro diagnostic medical devices.
These 3 main directives have been supplemented over time by several
modifying and implementing directives, including the last technical revision
brought about by Directive 2007/47/EC .
Main suggestions…
Considering the serious safety problems with high-risk medical devices in Europe
(e.g. defibrillators, hip implants, breast implants) … we call for a new framework that focuses on
strengthened transparency and patient safety:
(1) Marketing Authorisation The establishment of an independent centralised authorisation system for high-risk medical
devices and implants
(the manufacturer should provide results of a positive benefit-harm balance for patients during
clinical trials; study protocols and results need to be published in a centralised public accessible
database/registry).
(2) Surveillance and Vigilance A strong post-marketing surveillance system
(unannounced inspections by authorities; notification of failures and public alerts; cooperation
among public authorities; traceability and product recalls; unique identifier system combined with
patient/medical devices registries; improved information for patients and health actors).
(3) Reinforcement of Patient Rights and Liability Reinforcement of patients’ and third party payers’ rights (compensation right) in case of harm or
damage.
WP1
Appendix 9 for Appendix 1
EUnetHTA Joint Action 2010–2012 | www.eunethta.eu
Executive committee face to face meeting
JA2 Websites
Patrice Chalon
2012-04-18, Rome, Italy
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
WP6 overview 2012 M25 M26 M27 M28 M29 M30 M31 M32 M33 M34 M35 M36
Meetings 1st
emeeting
4th ftf 2nd e-
meeting
Surveys
Communicat
ion
Members
only site
Developmen
t and testing
Contact
database
updated
site update
Single sign
on
Planned and
ongoing
projetcs
database
2nd release
HTA reports
&
supplement
al materal
Tool
released
Information
about policy
decisions
Report and
w orkflow
delivered
Tools
supporting
day to day
collaboratio
n
Mailing list
server
released
JA2
websites
Training and
support
Evaluation
and final
report
WP Final
technical
report
Evaluation and preparation of WP final technical
report
Development and testing
collaboration w ith existing tool (outside EUnetHTA) is evaluated
vs development of specif ic new tool
Development and testing
collaboration w ith existing solutions (outside EUnetHTA) is
evaluated
Development and testing
Development, testing and provision of learning material
User support
ftf meeting preparation
Survey 2 preparation Survey 2 Survey 2 analysis
Communication on regular basis
Support to adaptation of
information about policy
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
JA2 Websites: Project description
Description
Tasks
achieved
• Surveys and interviews
• Requirements synthesised
• Analysis of requirements
• Technical options identified for Website and Intranet
/ workrooms / project management + basic tests
• Preliminary contacts with potential furnishers
(technical information)
Tasks to do • Meeting task force (planned Apr. 26)
• Preparation European tender
Planning • May: tender
• June-July: selection provider
• Oct: Start implementation
• 01/01/2013: Live
3
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
Surveys & interviews
4
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
Public site
5
Provide
general
EunetHTA
information
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
Intranet
6
Support
project
management
Information and
documents to
AP
Provide
sense of
unity
Support
communication
among partners
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
Work rooms
7
Support
processes
Support group
work
Support of
confidentiality
Support sharing
of group material
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
Analysis
Overlap
Public site
& intranet
Overlap
intranet &
workrooms
More
information
for public
site
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
Task force
9
APRIL
26
?
LMS
DMS CMS
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
NEXT
May - June • European tender
June or July • Selection
Oct - Dec • Implementation
01 Jan 2013 • Live
10