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))

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EN                                        United in diversity                                      EN
AM_Com_NonLegCompr

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EN
1. 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

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                                                                                                           EN
of 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.

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Compromise 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

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                                                                                                  EN
product 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.

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EN
The 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

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                                                                                                        EN
Compromise 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

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Proposal 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.

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                                                                                                       EN
Or. 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

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5. (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

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                                                                                               EN
Text 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.

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3.      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

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                                                                                                      EN
pursuant 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

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Proposal 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

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                                                                                                      EN
these 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

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Proposal 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

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                                                                                                          EN
not 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

EN
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