Brussels, 12 July 2018
Interinstitutional files:
2018/0018(COD)
WK 8585/2018 INIT
LIMITE
CODEC
COMPET
IA
MI
PHARM
SAN
WORKING PAPER
This is a paper intended for a specific community of recipients. Handling and
further distribution are under the sole responsibility of community members.
WORKING DOCUMENT
From:
General Secretariat of the Council
To:
Working Party on Pharmaceuticals and Medical Devices (HTA)
Subject:
Proposal for a Regulation of the European Parliament and of the Council on health
technology assessment and amending Directive 2011/24/EU
Delegations will find enclosed the presentation on Articles 3 and 6 of HTA proposal given by the
Commission at the meeting of the Working Party on Pharmaceuticals and Medical Devices on 11 July
2018.
WK 8585/2018 INIT
DG LIFE.2.C LA/ns
LIMITE
EN
Article 3
HTA Coordination Group (CG) – High Level
CG Sub-groups
Joint
Joint
Identification of
Voluntary
clinical
scientific
emerging health Cooperation
assessments consultations
technologies
⇓
Stake-
(JCA)
(JSC)
⇓
Collaborative
holder
⇓
⇓
Input for annual
assessments /
Network
JCA reports
JSC reports
work programme
non-clinical
domains
MP
MD
MP
MD
MP
MD
Preparation of the annual work programme/annual reports,
updates of the common requirements and guidance documents
EC Secretariat
1
Article 3
Set-up
HTA Coordination Group (CG) – High Level
• MS designate
1+ national HTA authorities / bodies as
members
•
Members appoint their
representatives
• Meetings co-chaired by Commission and elected co-
chair
• CG
may meet in different configurations
• Decisions by
consensus or, where necessary, by
simple majority
• 1 vote per Member State (not per member)
2
Article 3
Tasks
HTA Coordination Group (CG) – High Level
• Adopt RoP (e.g. tasks of assessors, co-assessors,
subgroups, procedures for adoption of documents)
• Establish sub-groups (min. 5 sub-groups)
• Coordinate and approve the work of its sub-groups
Annual work programme
Annual report
JCA / JSC reports
3
Set-up
Article 3
and tasks
CG – Sub-Groups
• MS designate
1+ national HTA authorities / bodies as
members
•
Members appoint their
representatives
•
Standing sub-groups carry out work on:
Joint Clinical Assessments
Joint Scientific Consultations
Identification of Emerging Health Technologies
Voluntary Co-operation
Horizontal sub-group (prep annual work programme/annual
reports, update working documents/guidelines)
• May meet in different configurations.
• Send docs for approval to CG.
4
Joint Clinical
Article 6
Assessments
In practice: CG – SG - Assessor interaction for JCAs
• CG initiates JCA by designating sub-group
• Sub-group:
agrees on the scope of the JCA = PICO (Patient Populations,
Intervention, Comparators, Clinical Outcomes)
appoints assessor and co-assessor
requests the submission of dossier (mandatory submission of data &
evidence)
• Assessor with co-assessor:
check contents of submission
consults
External experts (patients, clinical experts)
health technology developer (fact-checking)
sub-group
Commission
incorporates comments
submits draft report to sub-group
5
Joint Clinical
Article 6
Assessments
In practice: CG – SG - Assessor interaction for JCAs
• Sub-group peer reviews the draft report
• Assessor prepares the final draft report
• CG approves the final draft report
• Assessor removes any commercially sensitive
information
• CG sends the approved report to the Commission and
the health technology developer
6
Document Outline