TAIEX Workshop
on Cross-border Healthcare Directive
COOPERATION
ON HEALTH TECHNOLOGY ASSESSMENT
( HTA )
Prof. Juozas Galdikas, MD, PhD
Kazimieras Simonavicius University
Vilnius, Lithuania
Ankara, 27-28 April, 2015
LISBON TREATY
DUE TO LEGISLATION & STRATEGIES
RELATED TO HTA ( 1 )
Art. 168 ( 1 ) of the Treaty of the functioning of the EU ( TFEU ):
- A high level of human health protection is to be ensured in the
definition and implementation of all Union policies and
activities.
Art. 114 of TFEU:
- Is the appropriate legal basis since the majority of the provision
of this directive aim to improve the functioning of the internal
market and the free movement of goods, persons and services.
LISBON TREATY
DUE TO LEGISLATION & STRATEGIES
RELATED TO HTA ( 2 )
Art. 114 ( 3 ) of TFEU:
- Explicity requires that, in achieving harmonisation, a high level
of protection of human health is to be guaranted taking
account in particular of any new development based on
scientific facts.
DIRECTIVE 2011 /24 / EU
DUE TO LEGISLATION & STRATEGIES
RELATED TO HTA ( Article 15 ) - 1
1. The Union shall support and facilitate cooperation and the
exchange of scientific cooperation among MS within a
voluntary network connecting national authorities or bodies
responsible for HTA designed by the MS. The MS shall
communicate their names and contact details to the EC. The
members of such a HTAN shall participate in, and contribute
to the network’s activities in accordance with the legislation
of MS, where they are established. That network shall be
based on the principle of good governance including
transparency, objectivity, independence of expertise, fairness
of procedure and appropriate stakeholder consultation.
DIRECTIVE 2011 /24 / EU
DUE TO LEGISLATION & STRATEGIES
RELATED TO HTA (Article 15) - 2
2. The objectives of the HTAN shall be to:
A - support cooperation between national authorities or bodies;
B - support MS 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;
DIRECTIVE 2011 /24 / EU
DUE TO LEGISLATION & STRATEGIES
RELATED TO HTA (Article 15) - 3
2. The objectives of the HTAN shall be to:
C - support the analysis of the nature and type of information that
can be exchanged;
D - avoid duplication of the assessment;
DIRECTIVE 2011 /24 / EU
DUE TO LEGISLATION & STRATEGIES
RELATED TO HTA (Article 15) - 4
3. In order to fulfill the objectives set out in the paragraph 2,
the HTAN may receive Union aid. Aid may be granted in order
to:
A - contribute to the financing of administrative and technical
support;
B - support collaboration between MS in developing and sharing
methodologies for HTA including relative effectiveness
assessment ;
DIRECTIVE 2011 /24 / EU
DUE TO LEGISLATION & STRATEGIES
RELATED TO HTA (Article 15) - 5
3. In order to fulfill the objectives set out in the paragraph 2,
the HTAN may receive Union aid. Aid may be granted in order
to:
C - contribute to the financing of the provision of transferable
scientific information for use in national reporting and case
studies commissioned by the network;
D - facilitate collaboration between the network and other relative
institutions and bodies of the Union;
E - facilitate the consultation of stakeholders on the work of the
network.
DIRECTIVE 2011 /24 / EU
DUE TO LEGISLATION & STRATEGIES
RELATED TO HTA (Article 15) - 6
4. The EC shall, in accordance with the regulatory procedure
referred to in the Article 16 ( 2 ), adopt the necessary
measures for the establishment, management and transparent
functioning of this network.
5. Arrangement for granting the aid, the conditions to which it
may be subject and the amount of the aid, shall be adopted in
accordance with the regulatory procedure referred to in Article
16 ( 2 ). Only those authorities and bodies in the network
designed as beneficiaries by the participating MS shall be
eligible for Union aid.
DIRECTIVE 2011 /24 / EU
DUE TO LEGISLATION & STRATEGIES
RELATED TO HTA (Article 15) - 7
6. The appropriations required for measures provided for in this
Article shall be decided each year as part of the budgetary
procedure.
7. Measures adopted pursuant to this Article shall not interfere
with MS’ competencies in deciding on the implementation of
HTA conclusions and shall not harmonise any laws or
regulations of the MS and shall fully respect the responsibilities
of the MS for the organisation and delivery of health services
and medical care.
“Strategy for EU cooperation on Health
Technology Assessment ( HTA )” - 1
- The HTA Network is a voluntary network, set up by Directive
2011/24/EU ( article 15) gathering all Member States, Norway
and Island. It also associates, as observes, stakeholders
representing industry, payers, providers and patients. The Joint
Action EUnetHTA provides the scientific and technical support
to the Network.
- Adopted unanimously by the HTA Network, Rome, 29 October
2014.
“Strategy for EU cooperation on Health
Technology Assessment ( HTA )” - 2
Objectives:
- Set out its strategic vision, including its long term sustainability.
- Identify priority areas to be addressed through the Network
and to be potentially co-funded by EU.
Vision:
- Evidence is global, decision is local.
- To implement the principles outlined the HTA Network.
“Strategy for EU cooperation on Health
Technology Assessment ( HTA )” - 3
Implement the principles outlined the HTA Network
- Calls on the EC to facilitate interaction and synergies between
the Network and other relevant European networks and bodies,
which could contribute to the activities of the Network and
facilitate a full cycle approach to health technologies.
- Calls upon any possible future cooperation mechanism at the
scientific and technical level (e.g. Joint Action ) to further
develop opportunities for European cooperation spanning the
whole range of technologies and to further explore non-clinical
domains, as appropriate
“Strategy for EU cooperation on Health
Technology Assessment ( HTA )” - 4
Implement the principles outlined the HTA Network
- Calls to involve relevant national and regional actors in line with
national and regional priorities and responsibilities, to facilitate
synergies in all stages of the lifecycle of health technologies.
They include HTA statutory bodies, regulators ( or notified
bodies for Med. Dev. ), authorities responsible for pricing and
reimbursement, health care providers, payers, patient
representatives and research institutes.
“Strategy for EU cooperation on Health
Technology Assessment ( HTA )” - 5
Implement the principles outlined the HTA Network
- Calls upon HTA bodies to reuse joint work, where relevant, in
their national activities.
- Calls upon stakeholders, particularly HT developers to engage
in European activities in HTA, e.g. by taking part in EU joint
pilots.
- Commits to address the facilitating factors outlined above, in
line with the relevant competencies, responsibilities
opportunities.
- Acknowledge the importance of stakeholders’ involvement in
HTA processes at European, national and regional level.
“Strategy for EU cooperation on Health
Technology Assessment ( HTA )” - 6
Implement the principles outlined the HTA Network
- Calls upon HTA bodies to take part in parallel early dialogue
with technologies developers.
- Calls upon technology developers to engage in early dialogue
and scientific advice processes involving both regulators and
HTA bodies.
- Commits to further strengthen interaction between HTA bodies
and the EMA, building on ongoing cooperation within the
EUnetHTA Joint Action.
“Strategy for EU cooperation on Health
Technology Assessment ( HTA )” - 7
Implement the principles outlined the HTA Network
- Commits to developing further links with bodies responsible for conformity
assessment of Med.Dev., within the framework of relevant legislation and
relevant working/expert groups at EU and international level.
- Calls on the EC to facilitate exchange of information with the Network, as
appropriate. For example, when implementing relevant legislative and nonlegislative measures which can contribute to strengthening synergies
between regulators and HTA bodies. Such synergies may be found in the
pharmaceutical sector in the area of pharmacovigilance and evidence
generation, clinical trials; for Med.Dev. In clinical investigations and
evaluation and post-marketing clinical follow-up.
“Strategy for EU cooperation on Health
Technology Assessment ( HTA )” - 8
Implement the principles outlined the HTA Network
- Commits to explore models for long term sustainability of the
cooperation by considering relevant funding opportunities and
by including joint work in national and regional activities, as
appropriate and in line with national requirements.
- Commits to be actively involved in preparing the proposed new
Joint Action on HTA to strengthen the process leading to joint
work and maximize the benefit of European cooperation.
“Strategy for EU cooperation on Health
Technology Assessment ( HTA )” - 9
While its activities are focused to the EU, the Network:
- Welcomes the WHO Resolution on “Health intervention and
technology assessment in support of universal health
coverage”.
- Acknowledges the importance of collaboration initiatives at
global level and aims at promoting synergies, where relevant.
- Calls for the EC to include HTA as part of the “EU Health
strategy for Developing Countries”.
“Strategy for EU cooperation on Health
Technology Assessment ( HTA )” - 10
While its activities are focused to the EU, the Network:
- Calls for national authorities and HTA bodies, when acting as
individual members in national or international initiatives on
HTA, to build upon European level developments, to avoid
duplication of efforts and to foster synergies, where relevant.
- Calls for cooperation between national, European and
international research programmes, to align, when possible,
and create synergies between their perspective work
programmes and research priorities.
EUnetHTA Joint Actions ( 1 )
EUnetHTA project ( 2006-2008 )
Strategic objectives:
- to connect public national HTA agencies, research institutions
and MoH, enabling an effective exchange of information and
support to policy decisions by MS;
- to reduce overlap and duplication of efforts and hence promote
more effective use of resources;
- to increase HTA input to decision-making in MS and the EU and
hence to increase the impact of HTA;
- to strengthen the link between HTA and health care policy
making in the EU and its MS;
- to support countries with limited experience with HTA.
EUnetHTA Joint Actions ( 2 )
EUnetHTA project ( 2006-2008 )
Work Packages:
WP
WP
WP
WP
WP
WP
WP
WP
1
2
3
4
5
6
7
8
–
–
–
–
–
–
–
–
Coordination.
Communication.
Evaluation.
Common core HTA.
Adapting HTA.
HTA and health policy.
New technologies.
System to support HTA.
EUnetHTA Joint Actions ( 3 )
EUnetHTA project ( 2006-2008 )
Deliverables:
1. An organizational structure for a European network for HTA
including a supporting secretariat.
2. Elaborated Communication strategy of the network.
3. Internal evaluation of the project.
4. The framework for an external evaluation of EUnetHTA.
5. A generic methodological HTA framework based on current
best practices ( HTA Core Model – TM)
6. Two pilot examples of Core HTA for different types of
questions.
EUnetHTA Joint Actions ( 4 )
EUnetHTA project ( 2006-2008 )
Deliverables:
7. Handbook on Core HTA development
8. HTA adaptation toolkit – from existing HTAs into other
contexts.
9. Applicability testing of core information from existing HTA
reports in various national environment using the toolkit
10. A book containing a systematic overview of the HTA & health
policy links ,,HTA and health policy making in Europe”.
11. An open EUnetHTA stakeholder Forum to exchange views,
expectations/ feedback on HTA with stakeholders.
EUnetHTA Joint Actions ( 5 )
EUnetHTA project ( 2006-2008 )
Deliverables:
12. Web-based toolkit to facilitate European collaboration on
evidence generation on promising health technologies.
13. A structured information service on high volume, costly,
rapidly developing, emerging technologies.
14. A clearinghouse functionality prototype.
15. A handbook on HTA capacity building and institutionalising
HTA.
16. Final report from the project.
17. EUnetHTA Conference ,,HTA’s Future in Europe”.
EUnetHTA Collaboration ( 2009 )
General objectives:
-
Was launched in November 2008 in order to continue the work
of ,,EUnetHTA project 2006-2008’’
-
Was funded by the contribution of its participants from 15 MS:
Austria, Belgium, Denmark, Finland, France, Germany, Italy,
Lithuania, Netherlands, Norway, Poland, Spain, Sweden,
Switzerland, United Kingdom.
-
Took an initiative in development a proposal for Joint Actions
for HTA for 2010-2012 & 2012-2015.
EUnetHTA Joint Actions ( 6 )
EUnetHTA Joint Action 1 ( 2010-2012 )
Strategic objectives:
To develop principles, methodological guidance as well as
functional on line tools and policies for:
- producing, publishing, storing and retrieving structured HTA
information and Core HTAs;
- improve Relative Effectiveness Assessment (REA) by identifying
areas where methodological guidance is needed and by
providing it, suggesting ways to integrate REA of drugs as a
special version of HTA Core Model;
- structured exchange and storage of information on evidence
generation on new technologies;
EUnetHTA Joint Actions ( 7 )
EUnetHTA Joint Action 1 ( 2010-2012 )
Strategic objectives:
To test and implement:
- a web-based toolkit for structured exchange and storage of
information on evidence generation on new technologies;
- application of the Core Model in common production of at least 2
Core HTAs;
- a REA of drugs in line with the Core HTA development;
- real life support of information flow on new technologies
prompting those where parallel assessments of same
technologies are detected and alerting on opportunities for
information sharing and closer collaboration
- provision of contemporary information management system
which ensures compatibility and interoperability across WP’s
tools to support collaborative HTA work, and ensure rapid
dissemination of HTA results within the JA.
EUnetHTA Joint Actions ( 8 )
EUnetHTA Joint Action 1 ( 2010-2012 )
Work Packages:
WP
WP
WP
WP
WP
WP
WP
WP
1
2
3
4
5
6
7
8
–
–
–
–
–
–
–
–
Coordination.
Dissemination.
Evaluation.
Core HTA.
Relative Effectiveness Assessment of Pharmaceuticals.
Information Management System.
New technologies.
Strategy and Business Model Development.
EUnetHTA Joint Actions ( 9 )
EUnetHTA Joint Action 1 ( 2010-2012 )
Deliverables:
1. An online Tool & Service for producing, publishing, storing and
retrieving HTA information and a new application of the HTA
Core Model.
2. Two new Core HTAs on topics that are pertinent to several HTA
agencies and that can be utilized when producing local HTA
reports on the same topics.
3. A common methodology for the REA of pharmaceuticals
consisting of a tutorial that describes the fundamental
principles of REA and a toolbox that can be used in daily
practice for REA in standardized fashion.
4. An operational web-based toolkit including database
containing information on evidence generation on new
technologies.
EUnetHTA Joint Actions ( 10 )
EUnetHTA Joint Action 1 ( 2010-2012 )
Deliverables:
5. Quarterly communication protocol for information flow on
ongoing/ planned national assessments of same technologies.
6. An Information Management System ( IMS ) and the related
documentation, processes and policies.
7. Building on the communication strategy development during
EUnetHTA 2006-2008 Project, to develop an elaborated
Communication and Dissemination Plan.
8. Development of a stakeholder involvement policy.
9. Development of a collaborative business model for
susstainability.
10. A relative effectiveness assessment of a group of
pharmaceuticals.
11. Final Report from the Joint Action including evaluation of
results.
EUnetHTA Joint Actions ( 11 )
EUnetHTA Joint Action 2 ( 2012-2015 )
Strategic objectives:
- To strengthen the practical application of tools and approaches
to cross-border HTA collaboration.
- To aim at bringing collaboration to a higher level resulting in
better understanding for the EC and MS of the ways to
establish a sustainable structure for HTA in the EU.
- To develop a general strategy, principles and implementation
proposal for a susstainable European HTA collaboration
according to the requirements of Article 15 of the Directive for
cross border healthcare.
EUnetHTA Joint Actions ( 12 )
EUnetHTA Joint Action 2 ( 2012-2015 )
Work Packages:
WP 1 – Coordination.
WP 2 – Dissemination.
WP 3 – Evaluation.
WP 4 – Testing collaborative production of HTA information for
national adaptation and reporting.
WP 5 – Applying the HTA Core Model for Rapid assessment for
national adaptation and reporting.
WP 6 – Information Management Infrastructure and Services
(IMIS).
WP 7 – Methodology development and evidence generation:
Guidelines and pilots production.
WP 8 – Maintenance of HTA Core Model infrastructure to support
shared production and sharing of HTA information.
EUnetHTA Joint Actions ( 13 )
EUnetHTA Joint Action 2 ( 2012-2015 )
Deliverables:
1. Recommendations on the implementations of sustainable
European network for HTA.
2. Final Report from the Joint Action 2.
3. Report on yearly training courses on EUnetHTA tools and
methodology.
4. Report on evaluation of the Project completion including
assessment of impact on secondary users of HTA information.
5. Full Core HTAs.
EUnetHTA Joint Actions ( 14 )
EUnetHTA Joint Action 2 ( 2012-2015 )
Deliverables:
6. Pilot rapid assessments.
7. Report on Information Management Infrastructure and
Services.
8. Guidelines and pilots to improve quality and adequacy of initial
and additional evidence generation.
9. Methodological guidelines and Templates to support production
of Core HTA information and rapid assessments.
10.Upgraded and updated application package of HTA Core Model.
Thank you for attention
E-mail: [email protected]