Appendix 1: WP1/Exec Comm f-t-f meeting summary, April 18 ... · JA2 overlap period (October-December 2012) (Appendix 1, slide 11). The first draft contributions to the JA2 3-year

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


NBoH, National Board of Health

Denmark

Kristian Lampe

[email protected]

THL, National Institute for Health and Welfare

Finland

FranÇois Meyer Mira Pavlovic


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

mailto:[email protected]












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


Agenda – April 19


WP Updates

Brief overview of the activities in WPs:

WP1/8

WP2

WP3

WP4

WP5

WP6

WP7


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


Executive Committee face to face meeting

WP6 Progress report

Patrice Chalon

2012-04-18, Rome, Italy


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


collaboration w ith existing solutions (outside EUnetHTA) is

evaluated


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


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


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


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


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 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



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



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



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


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


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


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


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


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?


Agenda – April 19


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


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


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?


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)?


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)…


Working with EU bodies and international

orgs

Latest developments in device regulation in Europe

– how to handle in JA2?


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 Plenary Assembly

Lisbon, May 24-25

Agenda

Nomination process

Practicalities


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)


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


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

http://www.eunethta.eu/upload/Joint Action/JA WP1/Documents/EUnetHTAOrgGovStructure_Sept292009.pdf

http://www.eunethta.eu/upload/Joint Action/JA WP1/Documents/EUnetHTAOrgGovStructure_Sept292009.pdf


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


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


List of nominees:

• Plenary Assembly Chair:

Mirjana Huic

• Plenary Assembly co-Chair:

• Plenary Assembly 3 seats in Exec Comm:

AHTAPol

35


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


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


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




WP1 Executive Committee

Rome, April 18th-19th 2012

WP4 Strand A Update

FINOHTA/THL


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.


WP1 Executive Committee

Rome, April 18th-19th 2012

WP4 Strand B Update

Agenas


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


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



REA of Pharmaceuticals

(JA1 WP5)

Methodology guidelines and EPAR review

Mira Pavlovic

April 18, 2012


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


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



Executive committee face to face meeting

WP6 Progress report

Patrice Chalon

2012-04-18, Rome, Italy



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


report






evaluated



User support







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



Description

Tasks

achieved










Planning • May: tender



• 01/01/2013: Live

4


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



WP 7 New Technologies

Update on Strand A Activities

Mira PAVLOVIC (HAS, France)


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


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


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




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


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


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


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


Future perspectives

• JA 2 : POP maintenance,

co-operation

• Goal: partners update regularly

w/o reminder e-mails from LBI-HTA


Thank you.

[email protected]

WP1


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


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 .

http://ec.europa.eu/health/medical-devices/regulatory-framework/legislation/index_en.htm



http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1990L0385:20071011:EN:PDF









http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:247:0021:0055:EN:PDF






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



Executive committee face to face meeting

JA2 Websites

Patrice Chalon

2012-04-18, Rome, Italy



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


report






evaluated



User support








Description

Tasks

achieved










Planning • May: tender



• 01/01/2013: Live

3


Surveys & interviews

4


Public site

5

Provide

general

EunetHTA

information


Intranet

6

Support

project

management

Information and

documents to

AP

Provide

sense of

unity

Support

communication

among partners


Work rooms

7

Support

processes

Support group

work

Support of

confidentiality

Support sharing

of group material


Analysis

Overlap

Public site

& intranet

Overlap

intranet &

workrooms

More

information

for public

site


Task force

9

APRIL

26

?

LMS

DMS CMS


NEXT

May - June • European tender

June or July • Selection

Oct - Dec • Implementation

01 Jan 2013 • Live

10