COMPROMISE AMENDMENTS - European Parliament
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European Parliament
2014-2019
Committee on the Internal Market and Consumer Protection
2018/0018(COD)
09.07.2018
COMPROMISE AMENDMENTS
1 - 21
Draft opinion
Cristian-Silviu Buşoi
(PE622.139v01-00)
on the proposal for a regulation of the European Parliament and of the Council
on health technology assessment and amending Directive 2011/24/EU
(COM(2018)0051 – C8-0024/2018 – 2018/0018(COD))
AM\1155930EN.docx PE623.734v01-00
EN United in diversity ENAM_Com_NonLegCompr
PE623.734v01-00 2/18 AM\1155930EN.docx
EN1. Compromise amendments on transparency and confidentiality
Compromise Amendment 1
Rapporteur, EPP, S&D, ECR, ALDE
Compromise amendment replacing all relevant amendments, including: 39, 66, 67
Proposal for a regulation
Recital 15 a (new)
Text proposed by the Commission Amendment
(15 a) The cooperation between HTA
authorities should be based on the
principles of good governance, objectivity,
independence and transparency.
Or. en
Compromise Amendment 2
Rapporteur, EPP, S&D, ECR, ALDE
Compromise amendment replacing all relevant amendments, including: 55, 56, 57, 58, 68
Proposal for a regulation
Recital 28 b (new)
Text proposed by the Commission Amendment
(21) Joint clinical assessments and joint (21) Given the sensitive nature of health
scientific consultations necessitate the sharing information and the confidential handling
of confidential information between health of commercially sensitive data, these
technology developers and HTA authorities should be safeguarded at all times. Joint
and bodies. In order to ensure the protection clinical assessments and joint scientific
of such information, information provided to consultations necessitate the sharing of
the Coordination Group in the framework of confidential information between health
assessments and consultations should only be technology developers and HTA authorities
disclosed to a third party after a and bodies. In order to ensure the protection
confidentiality agreement has been of such information, information provided to
concluded. In addition, it is necessary for any the Coordination Group in the framework of
information made public about the results of assessments and consultations should only be
joint scientific consultations to be presented in disclosed to a third party after a
an anonymised format with the redaction of confidentiality agreement has been concluded
any information of a commercially sensitive with the notification of the technology
nature. developer that has provided the
information. In addition, it is necessary for
any information made public about the results
AM\1155930EN.docx 3/18 PE623.734v01-00
ENof joint scientific consultations to be
presented in an anonymised format with the
redaction of any information of a
commercially sensitive nature. It should be
clarified that the provisions concerning
protection of confidential information do
not in any way prevent public disclosure of
joint scientific consulations being
evaluated. The clinical data employed, the
studies, the methodology and the clinical
results used should be made public. The
highest possible level of public openness in
scientific data and assessments will allow
progress to be made in biomedical research
and ensure the highest possible level of
confidence in the system.
Or. en
Amendment 3
Rapporteur, EPP, ECR, ALDE
Compromise amendment replacing all relevant amendments, including: 7
Proposal for a regulation
Article 3 – paragraph 6
Text proposed by the Commission Amendment
6. Members of the Coordination 6. Members of the Coordination
Group, and their appointed representatives Group, their staff and their appointed
shall respect the principles of representatives shall respect the principles
independence, impartiality, and of independence, impartiality, and
confidentiality. confidentiality. They shall be subject to a
duty of professional secrecy under Union
or Member State legislation both during
and after their term of office, with regard
to any confidential information which has
come to their knowledge in the course of
the performance of their tasks or exercise
of their powers.
Or. en
Note: the Rapporteur asked support of the groups for this single amendment on
transparency/confidentiality. It will not be included in the voting list.
PE623.734v01-00 4/18 AM\1155930EN.docx
ENCompromise Amendment 4
Rapporteur, EPP, S&D, ECR, ALDE
Compromise amendment replacing all relevant amendments, including: 78
Proposal for a regulation
Article 3 – paragraph 8 – point d a (new)
Text proposed by the Commission Amendment
(da) ensure the highest level of
transparency of the clinical data being
evaluated. In case of information of a
commercially sensitive nature, the
confidentiality shall be strictly defined
and justified and the confidential
information shall be well-defined;
Or. en
Compromise Amendment 5
Rapporteur, EPP, S&D, ECR, ALDE
Compromise amendment replacing all relevant amendments, including: 106, 176
Proposal for a regulation
Article 27 a (new)
Text proposed by the Commission Amendment
Article 27 a
Common rules on data
1. The Commission shall be empowered to
adopt delegated acts in accordance with
Article 31 concerning data collection,
interoperability of data and the
comparability of data.
2. Assessors and co-assessors shall have
full access to the data used by the
authorities responsible for granting the
marketing authorisation of a medicinal
product, as well as the possibility of using
or generating additional relevant data for
the purposes of assessing a medicinal
AM\1155930EN.docx 5/18 PE623.734v01-00
ENproduct in the context of a joint HTA.
3. The confidential handling of
commercially sensitive data shall be
safeguarded at all times.
Or. en
2. Compromise amendments on conflicts of interest
Amendment 6
Rapporteur, EPP, S&D, ECR, ALDE
Compromise amendment replacing all relevant amendments, including: 146
Proposal for a regulation
Article 17 - paragraph 1 - point b
Text proposed by the Commission Amendment
(b) the rules for determining the (b) the rules for determining the
stakeholders to be consulted for the stakeholders to be consulted for the
purpose of this Section. purpose of this Section, including on
avoiding conflicts of interest.
Or. en
Compromise Amendment 8
Rapporteur, EPP, S&D, ECR, ALDE
Compromise amendment replacing all relevant amendments, including: 170
Proposal for a regulation
Article 26 – paragraph 1
Text proposed by the Commission Amendment
1. The Commission shall establish a 1. The Commission shall establish a
stakeholder network through an open call for stakeholder network through an open call for
applications and a selection of suitable applications and a selection of suitable
stakeholder organisations based on selection stakeholder organisations based on selection
criteria established in the open call for criteria established in the open call for
applications. applications. The stakeholder network shall
at least include patient organisations,
health professionals and clinical experts.
PE623.734v01-00 6/18 AM\1155930EN.docx
ENThe selection criteria shall aim at avoiding
conflicts of interest.
Or. en
3. Compromise amendments on consultation
Compromise Amendment 9
Rapporteur, EPP, S&D, ECR, ALDE
Compromise amendment replacing all relevant amendments, including: 82
Proposal for a regulation
Article 4 – paragraph 3 – point c a (new)
Text proposed by the Commission Amendment
ca) consult patient organisations,
health professionals, clinical experts and
other relevant stakeholders.
Or. en
Compromise Amendment 10
Rapporteur, EPP, S&D, ECR, ALDE
Compromise amendment replacing all relevant amendments, including: 101
Proposal for a regulation
Article 6 – paragraph 9
Text proposed by the Commission Amendment
9. The designated sub-group shall ensure that 9. The designated sub-group shall ensure that
stakeholders, including patients and clinical all relevant stakeholders, including patient
experts, are given an opportunity to provide organisations, health professionals and
comments during the preparation of the draft clinical experts, are given an opportunity to
joint clinical assessment report and the provide comments during the preparation of
summary report and set a time-frame in the draft joint clinical assessment report and
which they may submit comments. the summary report and set a time-frame in
which they may submit comments.
Or. en
AM\1155930EN.docx 7/18 PE623.734v01-00
ENCompromise Amendment 11
Rapporteur, EPP, S&D, ECR, ALDE
Compromise amendment replacing all relevant amendments, including: 136
Proposal for a regulation
Article 13 – paragraph 8
Text proposed by the Commission Amendment
8. The designated sub-group shall 8. The designated sub-group shall
ensure that stakeholders, including ensure that all relevant stakeholders,
patients, consumers and clinical experts including patient organisations, health
are given an opportunity to provide professionals and clinical experts are given
comments during the preparation of the an opportunity to provide comments during
draft joint scientific consultation report and the preparation of the draft joint scientific
set a time-frame in which they may submit consultation report and set a time-frame in
comments. which they may submit comments.
Or. en
Compromise Amendment 12
Rapporteur, EPP, S&D, ECR, ALDE
Compromise amendment replacing all relevant amendments, including: 143, 144
Proposal for a regulation
Article 16 – paragraph 1 – point d
Text proposed by the Commission Amendment
(d) the consultation of patients, clinical (d) the consultation of patient
experts and other relevant stakeholders; organisations, health professionals,
clinical experts and other relevant
stakeholders;
Or. en
Compromise Amendment 13
Rapporteur, EPP, S&D, ECR, ALDE
Compromise amendment replacing all relevant amendments, including: 147, 148, 149, 150
PE623.734v01-00 8/18 AM\1155930EN.docx
ENProposal for a regulation
Article 18 – paragraph 2
Text proposed by the Commission Amendment
2. In the preparation of the study, the 2. In the preparation of the study, the
Coordination Group shall consult: Coordination Group shall consult all
(a) health technology developers; relevant stakeholders, including:
(b) patient organisations; (a) health technology developers;
(c) clinical experts; (b) patient organisations;
(d) the European Medicines Agency (ba) health professionals;
including on the pre-notification of (c) clinical experts;
medicinal products prior to marketing (d) the European Medicines Agency
authorisation applications; including on the pre-notification of
(e) the Medical Devices Coordination medicinal products prior to marketing
Group established in Article 103 of authorisation applications;
Regulation (EU) 2017/745. (e) the Medical Devices Coordination
Group established in Article 103 of
Regulation (EU) 2017/745.
Or. en
Note: depending on the outcome of the block vote on the inclusion or not of medical devices
in the IMCO opinion, point (e) will be kept or deleted.
4. Compromise amendments on voting majority in Coordination Group
Compromise Amendment 14
Rapporteur, EPP, S&D, ECR, ALDE
Compromise amendment replacing all relevant amendments, including: 74, 75, 76
Proposal for a regulation
Article 3 – paragraph 3
Text proposed by the Commission Amendment
3. The Coordination Group shall act 3. The Coordination Group shall act
by consensus, or, where necessary, vote by by consensus, or, where necessary, vote by
simple majority. There shall be one vote a two-thirds majority. There shall be one
per Member State. vote per Member State.
AM\1155930EN.docx 9/18 PE623.734v01-00
ENOr. en
Compromise Amendment 15
Rapporteur, EPP, S&D, ECR, ALDE
Compromise amendment replacing all relevant amendments, including: 103, 104
Proposal for a regulation
Article 6 – paragraph 12
Text proposed by the Commission Amendment
12. The Coordination Group shall 12. The Coordination Group shall
approve the final joint clinical assessment approve the final joint clinical assessment
report and summary report, wherever report and summary report, wherever
possible by consensus or, where necessary, possible by consensus or, where necessary,
by a simple majority of Member States. by a two-thirds majority of Member States.
Or. en
Compromise Amendment 16
Rapporteur, EPP, S&D, ECR, ALDE
Compromise amendment replacing all relevant amendments, including: 137, 138, 139
Proposal for a regulation
Article 13 – paragraph 12
Text proposed by the Commission Amendment
12. The Coordination Group shall 12. The Coordination Group shall
approve the final joint scientific approve the final joint scientific
consultation report, wherever possible by consultation report, wherever possible by
consensus or, where necessary, by a simple consensus or, where necessary, by a two-
majority of Member States, at the latest thirds majority of Member States, at the
100 days following the start of the latest 100 days following the start of the
preparation of the report referred to in preparation of the report referred to in
paragraph 4. paragraph 4.
Or. en
PE623.734v01-00 10/18 AM\1155930EN.docx
EN5. (Compromise) amendments on the possibility to object and ask updates
Amendment 17
Rapporteur, EPP, ECR, ALDE
Compromise amendment replacing all relevant amendments, including: 18, 107
Proposal for a regulation
Article 6 – paragraph 14 a (new)
Text proposed by the Commission Amendment
14 a. Upon receipt of the approved joint
clinical assessment report and summary
report, the submitting health technology
developer may object in writing to the
Coordination Group and the Commission
within seven working days, providing
detailed grounds for the objections. The
Coordination Group shall evaluate the
objections within 30 working days and
may revise the report if and as necessary.
It shall approve and submit the final joint
clinical assessment report, the summary
report and an explanatory document
setting out how the objections were
addressed.
Or. en
Compromise Amendment 18
Rapporteur, EPP, S&D, ECR, ALDE
Compromise amendment replacing all relevant amendments, including: 20, 21, 22, 123
Proposal for a regulation
Article 9
AM\1155930EN.docx 11/18 PE623.734v01-00
ENText proposed by the Commission Amendment
Article 9 Article 9
Updates of Joint Clinical Assessments Updates of Joint Clinical Assessments
1. The Coordination Group shall 1. The Coordination Group shall
carry out updates of joint clinical carry out updates of joint clinical
assessments where: assessments where:
(a) the Commission Decision to (a) the Commission Decision to
grant the marketing grant the marketing
authorisation of a medicinal authorisation of a medicinal
product referred to in Article product referred to in Article
5(1)(a) was conditional on 5(1)(a) was conditional on
the fulfilment of additional the fulfilment of additional
post-authorisation post-authorisation
requirements; requirements;
(b) the initial joint clinical (b) the initial joint clinical
assessment report specified assessment report specified
the need for an update once the need for an update once
additional evidence for additional evidence for
further assessment is further assessment is
available. available.
(b a) the health technology
developer requests an
update on the grounds that
additional evidence is made
available for which the
Coordination Group would
need to reconsider the
conclusions of the initial
assessment.
2. The Coordination Group may carry 2. The Coordination Group may carry
out updates of joint clinical assessments out updates of joint clinical
where requested by one or more of its assessments where requested by
members. more than one of its members.
2a. The Coordination Group may carry
out updates of joint clinical
assessments in case additional
important evidence becomes
available significantly prior to the
renewal of the marketing
authorisation.
PE623.734v01-00 12/18 AM\1155930EN.docx
EN3. Updates shall be carried out in 3. Updates shall be carried out in
accordance with the procedural rules accordance with the procedural rules
established pursuant to Article 11(1)(d). established pursuant to Articles 6 and
11(1)(d).
Or. en
Compromise amendment on medical devices
Amendment 19
Rapporteur, EPP, S&D, ALDE
Compromise amendment replacing all relevant amendments, including: 11, 83, 84, 85, 86, 87,
88, 89
Proposal for a regulation
Article 5
Text proposed by the Commission Amendment
1. The Coordination Group shall carry 1. The Coordination Group shall carry
out joint clinical assessments on: out joint clinical assessments on:
(a) medicinal products subject to the (a) medicinal products subject to the
authorisation procedure provided for in authorisation procedure provided for in
Regulation (EC) No 726/2004, including Regulation (EC) No 726/2004, including
where an amendment has been made to the where an amendment has been made to the
Commission Decision to grant a marketing Commission Decision to grant a marketing
authorisation based on a change in the authorisation based on a change in the
therapeutic indication or indications for therapeutic indication or indications for
which the original authorisation was which the original authorisation was
granted, with the exception of medicinal granted, with the exception of medicinal
products authorised under Articles 10 and products authorised under Articles 10 and
10a of Directive 2001/83/EC; 10a of Directive 2001/83/EC, and
medicinal products authorised under
Article 8(3) of Directive 2001/83/EC not
incorporating a new active substance;
(b) medical devices classified as (b) medical devices classified as
class IIb and III pursuant to Article 51 of class IIb and III pursuant to Article 51 of
Regulation (EU) 2017/745 for which the Regulation (EU) 2017/745 for which the
relevant expert panels have provided a relevant expert panels have provided a
scientific opinion in the framework of the scientific opinion in the framework of the
clinical evaluation consultation procedure clinical evaluation consultation procedure
pursuant to Article 54 of that Regulation
AM\1155930EN.docx 13/18 PE623.734v01-00
ENpursuant to Article 54 of that Regulation; that are considered to be a major
innovation and with potential significant
impact on national health care systems;
(c) in vitro diagnostic medical devices (c) in vitro diagnostic medical devices
classified as class D pursuant to Article 47 classified as class D pursuant to Article 47
of Regulation (EU) 2017/746 for which of Regulation (EU) 2017/746 for which
the relevant expert panels have provided the relevant expert panels have provided
their views in the framework of the their views in the framework of the
procedure pursuant to Article 48(6) of that procedure pursuant to Article 48(6) of that
Regulation. Regulation that are considered to be a
major innovation and with potential
significant impact on national health care
systems.
2. The Coordination Group shall 2. The Coordination Group shall
select the medical devices referred to in select the medical devices referred to in
paragraph 1 points (b) and (c) for joint paragraph 1 points (b) and (c) for joint
clinical assessment based on the following clinical assessment based on the following
criteria: cumulative criteria:
(a) unmet medical needs; (a) unmet medical needs;
(b) potential impact on patients, (b) potential impact on patients,
public health, or healthcare systems; public health, or healthcare systems;
(c) significant cross-border (c) significant cross-border
dimension; dimension;
(d) major Union-wide added value; (d) major Union-wide added value;
(e) the available resources. (e) the available resources;
(ea) based on a voluntary
submission by a health technology
developer;
(eb) identified by the stakeholder
network.
Or. en
Compromise amendments on delegated and implementing acts
Amendment 20
Rapporteur, EPP, S&D, ECR, ALDE
Compromise amendment replacing all relevant amendments, including: 2, 59, 60, 61, 62, 63
PE623.734v01-00 14/18 AM\1155930EN.docx
ENProposal for a regulation
Recital 25
Text proposed by the Commission Amendment
(25) In order to ensure a uniform (25) In order to ensure a uniform
approach to the joint work provided for in approach to the joint work provided for in
this Regulation, implementing powers this Regulation, implementing powers
should be conferred on the Commission to should be conferred on the Commission,
establish a common procedural and after consulting the Coordination Group,
methodological framework for clinical to establish a common procedural and
assessments, procedures for joint clinical methodological framework for clinical
assessments and procedures for joint assessments, procedures for joint clinical
scientific consultations. Where appropriate, assessments and procedures for joint
distinct rules should be developed for scientific consultations. Where appropriate,
medicinal products and medical devices. In distinct rules should be developed for
the development of such rules, the medicinal products and medical devices. In
Commission should take into account the the development of such rules, the
results of the work already undertaken in Commission and the Coordination Group
the EUnetHTA Joint Actions. It should should take into account the results of the
also take into account initiatives on HTA work already undertaken in the EUnetHTA
funded through the Horizon 2020 research Joint Actions and in particular the
programme, as well as regional initiatives methodological guidelines and evidence
on HTA such as the Beneluxa and Valletta submission template. It should also take
Declaration initiatives. Those powers into account initiatives on HTA funded
should be exercised in accordance with through the Horizon 2020 research
Regulation (EU) No 182/2011 of the programme, as well as regional initiatives
European Parliament and of the Council.13 on HTA such as the Beneluxa and Valletta
Declaration initiatives. The procedural
and methodological framework should be
updated at the frequency deemed
necessary by the Commission and the
Coordination Group to ensure that they
are adapted to scientific evolution. In
developing the methodological
framework, the Commission, in
collaboration with the Coordination
Group, should consider the specificity and
corresponding challenges of certain types
of health technologies, advanced
therapies or life-prolonging therapies
where innovative clinical study designs
may be required. These may result in
evidential uncertainty at the time of the
marketing authorization. As such
innovative clinical study designs are often
accepted for the purposes of regulatory
assessments, the methodology for joint
clinical assessments should not prevent
AM\1155930EN.docx 15/18 PE623.734v01-00
ENthese health technologies from reaching
patients. The Commission and the
Coordination Group should therefore
ensure that the methodology provides for
a high standard of clinical evidence, while
preserving the necessary flexibility, to
enable an adequate assessment of such
health technologies. Such clinical
evidence should include the acceptance of
the best available scientific evidence at the
time of the submission, including, for
instance, data from case control studies,
real world observational data, as well as
the acceptance of indirect treatment
comparators. The methodological rules to
be developed should cover the possibilities
for improvement of clinical evidence in
the cases where further scientific evidence
is nevertheless needed. Those powers
should be exercised in accordance with
Regulation (EU) No 182/2011 of the
European Parliament and of the Council.13
__________________ __________________
13 Regulation (EU) No 182/2011 of the 13 Regulation (EU) No 182/2011 of the
European Parliament and of the Council of European Parliament and of the Council of
16 February 2011 laying down the rules 16 February 2011 laying down the rules
and general principles concerning and general principles concerning
mechanisms for control by the Member mechanisms for control by the Member
States of the Commission's exercise of States of the Commission's exercise of
implementing powers (OJ L 55, 28.2.2011, implementing powers (OJ L 55, 28.2.2011,
p. 13). p. 13).
Or. en
Amendment 21
Rapporteur, EPP, S&D, ECR, ALDE
Compromise amendment replacing all relevant amendments, including: 27, 28, 29, 30, 154,
155, 156, 157, 158, 159, 160, 161, 162, 163
PE623.734v01-00 16/18 AM\1155930EN.docx
ENProposal for a regulation
Article 22
Text proposed by the Commission Amendment
1. The Commission shall adopt 1. The Commission shall be empowered to
implementing acts concerning: adopt delegated acts in accordance with
Article 31 concerning:
(a) procedural rules for: (a) procedural rules for:
(i) ensuring that health technology (i) ensuring that health technology
authorities and bodies carry out clinical authorities and bodies carry out clinical
assessments in an independent and assessments in an independent and
transparent manner, free from conflicts of transparent manner, free from conflicts of
interest; interest;
(ii) the mechanisms for the interaction (ii) the mechanisms for the interaction
between health technology bodies and between health technology bodies and
health technology developers during health technology developers during
clinical assessments; clinical assessments;
(iii) the consultation of patients, (iii) the consultation of patient
clinical experts, and other stakeholders in organisations, health professionals, clinical
clinical assessments. experts, and other relevant stakeholders in
clinical assessments, including rules on
avoiding conflicts of interest.
(b) methodologies used to formulate the (b) methodologies used to formulate the
contents and design of clinical contents and design of clinical assessments,
assessments. based on the common tools and
methodologies for cooperation developed after
many years of cooperation through
EUnetHTA Joint Actions, BeNeLuxA and
Valletta. They shall be developed after
consultation of the Coordination Group and
all relevant stakeholders, including patient
organisations, health professionals and
clinical experts, in a transparent manner,
they shall be regularly updated to reflect the
evolution of science and shall be made
publicly available.
For medicinal products referred to in Article
5(1)(a) and Article 32(2), the Commission
shall take into account the distinctive
characteristics of the medicinal product and
medical device sectors. The methodology shall
provide for a sufficient level of flexibility, on
condition that it will maintain the highest
level possible in clinical evidence, allowing an
adequate management of evidential
uncertainty in specific cases, including but
AM\1155930EN.docx 17/18 PE623.734v01-00
ENnot limited to:
a) orphan medicinal products where limited
patient populations may affect the feasibility
of a randomized clinical trial or the statistical
relevance of the data;
b) medicinal products for which the European
Medicines Agency has granted a conditional
marketing authorization pursuant to Article
14(7) of Regulation (EC) No.726/2004 or
which benefit from a PRIME designation
granted by the Agency;
c) Medicinal products authorized based on
clinical evidence from clinical trials with
specific designs to account for the nature of
the health technology or other considerations.
The methodology shall also:
a) Provide for a suitable mechanism to
identify the patient-relevant health outcome,
taking due account of the roles and
preferences of relevant stakeholders,
including patient organisations, health
professionals, clinical experts, regulators,
HTA bodies and health technology
developers;
b) take into account potential changes
relating to the relevant comparator at
national level due to the rapidly evolving
standards of care.
2. Implementing acts referred to in
paragraph 1 shall be adopted in
accordance with the examination
procedure referred to in Article 30(2).
Or. en
PE623.734v01-00 18/18 AM\1155930EN.docx
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