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Document 52018AP0369
Amendments adopted by the European Parliament on 3 October 2018 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)) 1 1
Amendments adopted by the European Parliament on 3 October 2018 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)) 1 1
Amendments adopted by the European Parliament on 3 October 2018 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)) 1 1
OJ C 11, 13.1.2020, p. 94–176
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
13.1.2020 |
EN |
Official Journal of the European Union |
C 11/94 |
P8_TA(2018)0369
Health technology assessment***I
Amendments adopted by the European Parliament on 3 October 2018 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)) (1)
(Ordinary legislative procedure: first reading)
(2020/C 011/23)
Amendment 1
Proposal for a regulation
Citation 1
Text proposed by the Commission |
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Amendment |
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, |
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Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 114 and 168(4) thereof, |
Amendment 2
Proposal for a regulation
Recital 1
Text proposed by the Commission |
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Amendment 3
Proposal for a regulation
Recital 1 a (new)
Text proposed by the Commission |
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Amendment 4
Proposal for a regulation
Recital 1 b (new)
Text proposed by the Commission |
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Amendment 5
Proposal for a regulation
Recital 1 c (new)
Text proposed by the Commission |
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Amendment 6
Proposal for a regulation
Recital 2
Text proposed by the Commission |
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Amendment 7
Proposal for a regulation
Recital 2 a (new)
Text proposed by the Commission |
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Amendment 8
Proposal for a regulation
Recital 2 b (new)
Text proposed by the Commission |
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Amendment 9
Proposal for a regulation
Recital 3
Text proposed by the Commission |
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Amendment 10
Proposal for a regulation
Recital 3 a (new)
Text proposed by the Commission |
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Amendment 11
Proposal for a regulation
Recital 4
Text proposed by the Commission |
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Amendment 12
Proposal for a regulation
Recital 4 a (new)
Text proposed by the Commission |
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Amendment 13
Proposal for a regulation
Recital 4 b (new)
Text proposed by the Commission |
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Amendment 14
Proposal for a regulation
Recital 5
Text proposed by the Commission |
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Amendment 15
Proposal for a regulation
Recital 6
Text proposed by the Commission |
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Amendment 16
Proposal for a regulation
Recital 6 a (new)
Text proposed by the Commission |
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Amendment 17
Proposal for a regulation
Recital 7
Text proposed by the Commission |
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Amendment 18
Proposal for a regulation
Recital 8
Text proposed by the Commission |
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Amendment 19
Proposal for a regulation
Recital 10
Text proposed by the Commission |
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Amendment 20
Proposal for a regulation
Recital 11
Text proposed by the Commission |
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Amendment 21
Proposal for a regulation
Recital 12
Text proposed by the Commission |
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Amendment 22
Proposal for a regulation
Recital 13
Text proposed by the Commission |
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Amendment 23
Proposal for a regulation
Recital 14
Text proposed by the Commission |
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Amendment 24
Proposal for a regulation
Recital 15
Text proposed by the Commission |
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Amendment 25
Proposal for a regulation
Recital 15 a (new)
Text proposed by the Commission |
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Amendment 26
Proposal for a regulation
Recital 16
Text proposed by the Commission |
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Amendment 27
Proposal for a regulation
Recital 16 a (new)
Text proposed by the Commission |
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Amendment 28
Proposal for a regulation
Recital 17
Text proposed by the Commission |
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deleted |
Amendment 29
Proposal for a regulation
Recital 17 a (new)
Text proposed by the Commission |
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Amendment 30
Proposal for a regulation
Recital 18
Text proposed by the Commission |
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Amendment 31
Proposal for a regulation
Recital 19
Text proposed by the Commission |
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Amendment 32
Proposal for a regulation
Recital 19 a (new)
Text proposed by the Commission |
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Amendment 33
Proposal for a regulation
Recital 19 b (new)
Text proposed by the Commission |
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Amendment 34
Proposal for a regulation
Recital 19 c (new)
Text proposed by the Commission |
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Amendment 35
Proposal for a regulation
Recital 20
Text proposed by the Commission |
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Amendment 36
Proposal for a regulation
Recital 20 a (new)
Text proposed by the Commission |
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Amendment 37
Proposal for a regulation
Recital 21
Text proposed by the Commission |
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Amendment 38
Proposal for a regulation
Recital 21 a (new)
Text proposed by the Commission |
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Amendment 39
Proposal for a regulation
Recital 21 b (new)
Text proposed by the Commission |
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Amendment 40
Proposal for a regulation
Recital 22
Text proposed by the Commission |
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Amendment 41
Proposal for a regulation
Recital 23
Text proposed by the Commission |
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Amendment 42
Proposal for a regulation
Recital 24
Text proposed by the Commission |
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Amendment 43
Proposal for a regulation
Recital 24 a (new)
Text proposed by the Commission |
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Amendment 44
Proposal for a regulation
Recital 24 b (new)
Text proposed by the Commission |
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Amendment 45
Proposal for a regulation
Recital 25
Text proposed by the Commission |
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Amendment 46
Proposal for a regulation
Recital 25 a (new)
Text proposed by the Commission |
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Amendment 47
Proposal for a regulation
Recital 25 b (new)
Text proposed by the Commission |
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Amendment 48
Proposal for a regulation
Recital 25 c (new)
Text proposed by the Commission |
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Amendment 49
Proposal for a regulation
Recital 26
Text proposed by the Commission |
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Amendment 50
Proposal for a regulation
Recital 27
Text proposed by the Commission |
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Amendment 51
Proposal for a regulation
Recital 28
Text proposed by the Commission |
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Amendment 52
Proposal for a regulation
Recital 28 a (new)
Text proposed by the Commission |
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Amendment 53
Proposal for a regulation
Recital 28 b (new)
Text proposed by the Commission |
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Amendment 54
Proposal for a regulation
Recital 30
Text proposed by the Commission |
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Amendment 55
Proposal for a regulation
Recital 31
Text proposed by the Commission |
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Amendment 56
Proposal for a regulation
Recital 32
Text proposed by the Commission |
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Amendment 57
Proposal for a regulation
Recital 34
Text proposed by the Commission |
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Amendment 58
Proposal for a regulation
Article 1 – paragraph 1 – introductory part
Text proposed by the Commission |
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Amendment |
1. This Regulation establishes: |
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1. Taking into account the results of the work already undertaken in the EUnetHTA Joint Actions , this Regulation establishes: |
Amendment 59
Proposal for a regulation
Article 1 – paragraph 1 – point a
Text proposed by the Commission |
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Amendment 60
Proposal for a regulation
Article 1 – paragraph 1 – point b
Text proposed by the Commission |
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Amendment 61
Proposal for a regulation
Article 1 – paragraph 2
Text proposed by the Commission |
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2. This Regulation shall not affect the rights and obligations of Member States with regard to the organisation and delivery of health services and medical care and the allocation of resources assigned to them. |
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2. This Regulation shall not affect the rights and obligations of Member States with regard to the organisation and delivery of health services and medical care and the allocation of resources assigned to them. Furthermore, this Regulation shall not interfere with the exclusive national competence of Member States for national pricing or reimbursement decisions. |
Amendment 62
Proposal for a regulation
Article 2 – paragraph 1 – point b a (new)
Text proposed by the Commission |
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Amendment 63
Proposal for a regulation
Article 2 – paragraph 1 – point b b (new)
Text proposed by the Commission |
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Amendment 64
Proposal for a regulation
Article 2 – paragraph 1 – point e
Text proposed by the Commission |
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Amendment 65
Proposal for a regulation
Article 2 – paragraph 1 – point g a (new)
Text proposed by the Commission |
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Amendment 202
Proposal for a regulation
Article 2 – paragraph 1 – point g b (new)
Text proposed by the Commission |
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Amendment 66
Proposal for a regulation
Article 3 – paragraph 2
Text proposed by the Commission |
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Amendment |
2. Member States shall designate their national authorities and bodies responsible for health technology assessment as members of the Coordination Group and its sub-groups and inform the Commission thereof and of any subsequent changes. Member States may designate more than one authority or body responsible for health technology assessment as members of the Coordination Group and one or more of its sub-groups. |
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2. Member States shall designate their national or regional authorities and bodies responsible for health technology assessment at national level as members of the Coordination Group and its sub-groups. |
Amendment 203
Proposal for a regulation
Article 3 – paragraph 3
Text proposed by the Commission |
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Amendment |
3. The Coordination Group shall act by consensus, or, where necessary, vote by simple majority. There shall be one vote per Member State. |
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3. The Coordination Group shall act by consensus, or, where necessary, vote by qualified majority. Procedures undertaken by the Coordination Group shall be transparent with meeting minutes and votes documented and made publicly available, including any dissensions. |
Amendment 68
Proposal for a regulation
Article 3 – paragraph 4
Text proposed by the Commission |
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Amendment |
4. Meetings of the Coordination Group shall be co-chaired by the Commission and a co-chair elected from the members of the group for a set term to be determined in its rules of procedure . |
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4. Meetings of the Coordination Group shall be co-chaired by the Commission, without the right to vote , and a co-chair elected annually from among the members of the group on a rotating basis. Co-chairs shall perform purely administrative functions . |
Amendment 69
Proposal for a regulation
Article 3 – paragraph 5
Text proposed by the Commission |
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Amendment |
5. Members of the Coordination Group shall appoint their representatives in the Coordination Group and the sub-groups in which they are members, on an ad-hoc or permanent basis, and inform the Commission of their appointment and any subsequent changes . |
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5. Members of the Coordination Group, being national or regional assessment authorities or bodies , shall appoint their representatives in the Coordination Group and the sub-groups in which they are members on an ad-hoc or permanent basis. Member States may terminate such appointments where it is warranted by the requirements of the appointment. However, in view of the workload, the composition of sub-groups, or the specific knowledge required, there may be more than one expert assessor for each Member State, without prejudice to the principle that, for the purposes of decision-taking, each Member State shall have one vote only. The appointments shall take into account the expertise necessary in order to achieve the objectives of the sub-group. The European Parliament, the Council and the Commission, shall be informed of all appointments and possible terminations of appointment. |
Amendment 70
Proposal for a regulation
Article 3 – paragraph 6
Text proposed by the Commission |
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Amendment |
6. Members of the Coordination Group, and their appointed representatives shall respect the principles of independence , impartiality, and confidentiality. |
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6. In order to ensure high quality of work , members of the Coordination Group shall be drawn from national or regional health technology assessment agencies or bodies responsible for that field. Members serving in the Coordination Group, and experts and assessors in general, shall not have financial interests in any type of health technology developer industry or insurance company that may affect their impartiality. They shall undertake to act independently and in the public interest and shall make an annual declaration of interests. Those declarations of interests shall be recorded on the IT platform referred to in Article 27 and shall made accessible to the public. At every meeting, members of the Coordination Group shall declare any specific interest that may be considered to adversely affect their independence in relation to agenda items. When a conflict of interest arises, the member of the Coordination Group concerned shall withdraw from the meeting whilst the relevant items of the agenda are being dealt with. The procedural rules for conflicts of interest shall be laid down in accordance with point (a)(iiia) of Article 22(1). In order to ensure transparency and public awareness of the process and to promote confidence in the system, all clinical data being evaluated shall have the highest level of transparency and public communication. Where data is confidential for commercial reasons, its confidentiality shall be clearly defined and justified and the confidential data shall be well delimitated and protected . |
Amendment 71
Proposal for a regulation
Article 3 – paragraph 7
Text proposed by the Commission |
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Amendment |
7. The Commission shall publish a list of the designated members of the Coordination Group and its sub-groups on the IT platform referred to in Article 27. |
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7. The Commission shall publish an up-to-date list of the designated members of the Coordination Group and its sub-groups and other experts, together with their qualifications and areas of expertise and their annual declaration of interest , on the IT platform referred to in Article 27. The information referred to in the first subparagraph shall be updated by the Commission annually and whenever considered necessary in the light of possible new circumstances. Those updates shall be publicly accessible. |
Amendment 72
Proposal for a regulation
Article 3 – paragraph 8 – point c
Text proposed by the Commission |
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Amendment 73
Proposal for a regulation
Article 3 – paragraph 8 – point d
Text proposed by the Commission |
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Amendment 74
Proposal for a regulation
Article 3 – paragraph 10 a (new)
Text proposed by the Commission |
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Amendment |
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10a. The rules of procedure of the Coordination Group and its sub-groups, the agendas for their meetings, the decisions adopted, and the details of votes and explanations of votes, including minority opinions, shall, in any event, be accessible to the public. |
Amendment 75
Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 1 a (new)
Text proposed by the Commission |
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Amendment |
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Points (a), (b) and (c) of the first subparagraph shall be determined according to the extent of their impact on patients, public health or health care systems. |
Amendment 76
Proposal for a regulation
Article 4 – paragraph 3 – point c
Text proposed by the Commission |
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Amendment 77
Proposal for a regulation
Article 4 – paragraph 5 a (new)
Text proposed by the Commission |
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5a. Both the annual report and the annual work programme shall be published on the IT platform referred to in Article 27. |
Amendment 78
Proposal for a regulation
Article 5 – paragraph 1 – point a a (new)
Text proposed by the Commission |
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Amendment 79
Proposal for a regulation
Article 5 – paragraph 1 – point b
Text proposed by the Commission |
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Amendment 80
Proposal for a regulation
Article 5 – paragraph 1 – point c
Text proposed by the Commission |
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Amendment 81
Proposal for a regulation
Article 5 – paragraph 2 – point e a (new)
Text proposed by the Commission |
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Amendment 82
Proposal for a regulation
Article 5 – paragraph 2 – point e b (new)
Text proposed by the Commission |
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Amendment 83
Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 2
Text proposed by the Commission |
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Amendment |
The joint clinical assessment report shall be accompanied by a summary report and they shall be prepared in accordance with the requirements in this Article and the requirements established pursuant to Articles 11, 22, and 23. |
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The joint clinical assessment report shall be accompanied by a summary report, which shall contain at least the clinical data compared, the end-points, the comparators, the methodology, the clinical evidence used, and conclusions as regards efficacy, safety, and relative efficacy, the limits of the assessment, diverging views, a summary of the consultations carried out, and the observations made. They shall be prepared in accordance with the requirements laid down by the Coordination Group and shall be made public, regardless of the report's conclusions. For medicinal products referred to in point (a) of Article 5(1), the joint clinical assessment report shall be adopted by the Coordination Group within 80-100 days in order to ensure compliance with timelines for pricing and reimbursement set out in Council Directive 89/105/EEC (1). |
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Amendment 84
Proposal for a regulation
Article 6 – paragraph 2
Text proposed by the Commission |
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Amendment |
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2. The designated sub-group shall request relevant health technology developers to submit documentation containing the information, data and evidence necessary for the joint clinical assessment. |
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2. The designated sub-group shall request the health technology developer to submit all available up-to-date documentation containing the information, data and studies, including both negative and positive results, that is necessary for the joint clinical assessment. That documentation shall include the available data from all tests performed and from all the studies in which the technology was used, both of which are of paramount importance to ensure that assessments are of high quality. For medicinal products referred to in point (a) of Article 5(1), the documentation shall at least include:
Health technology developers shall be obliged to submit all of the requested data. Assessors may also access public databases and sources of clinical information, such as patient registries, databases or European Reference Networks, where such access is deemed necessary to complement the information provided by the developer and to perform a more accurate clinical assessment of the health technology. The reproducibility of the assessment implies that such information shall be made public. The relationship between evaluators and health technology developers shall be independent and impartial. Developers of health technologies may be consulted but shall not actively participate in the evaluation process. |
Amendment 85
Proposal for a regulation
Article 6 – paragraph 2 a (new)
Text proposed by the Commission |
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Amendment |
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2a. The Coordination Group may justifiably consider, in the case of orphan medicines, that there is no substantive reason or additional evidence to support further clinical analysis beyond the significant benefit assessment already carried by the European Medicines Agency. |
Amendment 86
Proposal for a regulation
Article 6 – paragraph 3
Text proposed by the Commission |
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Amendment |
3. The designated sub-group shall appoint, from among its members, an assessor and a co-assessor to conduct the joint clinical assessment. The appointments shall take into account the scientific expertise necessary for the assessment. |
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3. The designated sub-group shall appoint, from among its members, an assessor and a co-assessor to conduct the joint clinical assessment. The assessor and a co-assessor shall be different from those previously appointed under Article 13(3) except in exceptional and justified situations where the necessary specific expertise is not available, and subject to approval of the Coordination Group. The appointments shall take into account the scientific expertise necessary for the assessment. |
Amendment 87
Proposal for a regulation
Article 6 – paragraph 5 – introductory part
Text proposed by the Commission |
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Amendment |
5. The conclusions of the joint clinical assessment report shall be limited to the following : |
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5. The conclusions of the joint clinical assessment report shall include : |
Amendment 88
Proposal for a regulation
Article 6 – paragraph 5 – point a
Text proposed by the Commission |
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Amendment 89
Proposal for a regulation
Article 6 – paragraph 5 – point b
Text proposed by the Commission |
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Amendment 90
Proposal for a regulation
Article 6 – paragraph 5 – subparagraph 1 a (new)
Text proposed by the Commission |
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Amendment |
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The conclusions shall not include an appraisal. The assessor and the co-assessor shall make sure that the choice of relevant patient groups is representative of the participating Member States in order to enable them to take appropriate decisions on funding these technologies from national health budgets. |
Amendment 205
Proposal for a regulation
Article 6 – paragraph 6
Text proposed by the Commission |
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Amendment |
6. Where, at any stage in the preparation of the draft joint clinical assessment report, the assessor considers that additional evidence from the submitting health technology developer is necessary in order to complete the report, it may request the designated sub-group to suspend the time period set for the preparation of the report and to request additional evidence from the health technology developer. Having consulted the health technology developer on the time needed to prepare the necessary additional evidence, the request from the assessor shall specify the number of working days for which the preparation shall be suspended. |
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6. Where, at any stage in the preparation of the draft joint clinical assessment report, the assessor considers that additional evidence from the submitting health technology developer is necessary in order to complete the report, it may request the designated sub-group to suspend the time period set for the preparation of the report and to request additional evidence from the health technology developer. Having consulted the health technology developer on the time needed to prepare the necessary additional evidence, the request from the assessor shall specify the number of working days for which the preparation shall be suspended. Where new clinical data become available during the process, the health technology developer concerned shall also proactively communicate this new information to the assessor. |
Amendment 92
Proposal for a regulation
Article 6 – paragraph 7
Text proposed by the Commission |
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Amendment |
7. The members of the designated sub-group shall provide their comments during the preparation of the draft joint clinical assessment report and the summary report. The Commission may also provide comments. |
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7. The members of the designated sub-group or the Coordination Group, in a minimum period of 30 working days , shall provide their comments during the preparation of the draft joint clinical assessment report and the summary report. |
Amendment 93
Proposal for a regulation
Article 6 – paragraph 8
Text proposed by the Commission |
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Amendment |
8. The assessor shall provide the draft joint clinical assessment report and the summary report to the submitting health technology developer and set a time-frame in which the developer may submit comments. |
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8. The assessor shall provide the draft joint clinical assessment report and the summary report to the health technology developer for comments. |
Amendment 94
Proposal for a regulation
Article 6 – paragraph 9
Text proposed by the Commission |
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Amendment |
9. The designated sub-group shall ensure that stakeholders, including patients and clinical experts, are given an opportunity to provide comments during the preparation of the draft joint clinical assessment report and the summary report and set a time-frame in which they may submit comments. |
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9. Patients, consumer organisations, health professionals, NGOs, other health technology developer associations and clinical experts may submit comments during the joint clinical assessment within a time-frame set by the designated sub-group. The Commission shall make public the declarations of interest of all consulted stakeholders in the IT platform referred to in Article 27. |
Amendment 95
Proposal for a regulation
Article 6 – paragraph 10
Text proposed by the Commission |
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Amendment |
10. Following receipt and consideration of any comments provided in accordance with paragraphs 7, 8, and 9, the assessor, with the assistance of the co-assessor, shall finalise the draft joint clinical assessment report and summary report, and submit those reports to the designated sub-group and to the Commission for comments. |
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10. Following receipt and consideration of any comments provided in accordance with paragraphs 7, 8, and 9, the assessor, with the assistance of the co-assessor, shall finalise the draft joint clinical assessment report and summary report, and submit those reports to the Coordination Group for comments. The Commission shall publish all comments, which shall be duly answered, on the IT platform referred to in Article 27. |
Amendment 96
Proposal for a regulation
Article 6 – paragraph 11
Text proposed by the Commission |
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Amendment |
11. The assessor, with the assistance of the co-assessor, shall take into account the comments of the designated sub-group and the Commission and submit a final draft joint clinical assessment report and the summary report to the Coordination Group for approval. |
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11. The assessor, with the assistance of the co-assessor, shall take into account the comments of the Coordination Group and submit a final draft joint clinical assessment report and the summary report to the Coordination Group for a final approval. |
Amendment 206
Proposal for a regulation
Article 6 – paragraph 12
Text proposed by the Commission |
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Amendment |
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12. The Coordination Group shall approve the final joint clinical assessment report and summary report, wherever possible by consensus or, where necessary, by a simple majority of Member States. |
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12. The Coordination Group shall approve the final joint clinical assessment report and summary report, wherever possible by consensus or, where necessary, by qualified majority of Member States. Diverging positions and the grounds on which those positions are based shall be recorded in the final report. The final report shall include a sensitivity analysis if there is one or more of the following elements:
The choice of the one or more comparators and patient-relevant endpoints shall be medically justified and documented in the final report. The final report shall also include the results of the joint scientific consultation carried out in accordance with Article 13. The scientific consultation reports shall be made public upon completion of the joint clinical assessments. |
Amendment 98
Proposal for a regulation
Article 6 – paragraph 13
Text proposed by the Commission |
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Amendment |
13. The assessor shall ensure the removal of any information of a commercially sensitive nature from the approved joint clinical assessment report and the summary report. |
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13. The assessor shall ensure that the approved joint clinical assessment report and the summary report contain the clinical information which is the subject of the assessment and set out the methodology and studies used . The assessor shall consult the developer on the report before its publication. The developer shall have 10 working days to notify the assessor about any information it considers to be confidential and to justify its commercially sensitive nature. As a last resort, the assessor and the co-assessor shall decide as to whether the developer’s claim of confidentiality is justified. |
Amendment 99
Proposal for a regulation
Article 6 – paragraph 14
Text proposed by the Commission |
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Amendment |
14. The Coordination Group shall provide the approved joint clinical assessment report and the summary report to the submitting health technology developer and the Commission. |
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14. The Coordination Group shall provide the approved joint clinical assessment report and the summary report to the submitting health technology developer and the Commission, which shall include both reports on the IT platform . |
Amendment 100
Proposal for a regulation
Article 6 – paragraph 14 a (new)
Text proposed by the Commission |
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Amendment |
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14a. Upon receipt of the approved joint clinical assessment report and summary report, the submitting health technology developer may notify its objections in writing to the Coordination Group and the Commission within seven working days. In such a case, the developer shall provide detailed grounds for its objections. The Coordination Group shall evaluate the objections within seven working days and shall revise the report, as necessary. The Coordination Group shall approve and submit the final joint clinical assessment report, the summary report and an explanatory document setting out how the objections of the submitting health technology developer and the Commission were addressed. |
Amendment 101
Proposal for a regulation
Article 6 – paragraph 14 b (new)
Text proposed by the Commission |
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Amendment |
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14b. The joint clinical assessment report and the summary report shall be ready in not less than 80 days and not more than 100 days, except in justified cases where, owing to clinical necessity, the process needs to be accelerated or delayed respectively. |
Amendment 102
Proposal for a regulation
Article 6 – paragraph 14 c (new)
Text proposed by the Commission |
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Amendment |
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14c. Where the submitting health technology developer withdraws the application for a marketing authorisation, giving reasons, or where the European Medicines Agency terminates an assessment, the Coordination Group shall be informed so that it terminates the joint clinical assessment procedure. The Commission shall publish the reasons for withdrawal of the application or termination of the assessment on the IT platform referred to in Article 27. |
Amendment 103
Proposal for a regulation
Article 7 – paragraph 1
Text proposed by the Commission |
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Amendment |
1. Where the Commission considers that the approved joint clinical assessment report and summary report comply with the substantive and procedural requirements laid down in this Regulation, it shall include the name of the health technology which has been the subject of the approved report and summary report, in a list of technologies having undergone joint clinical assessment (the "List of Assessed Health Technologies" or the "List") at the latest 30 days after receipt of the approved report and summary report from the Coordination Group. |
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1. The Commission shall include the name of the health technology which has been the subject of the report and the approved summary report, regardless of whether or not it has been adopted , in a list of technologies having undergone joint clinical assessment (the "List of Assessed Health Technologies" or the "List") at the latest 30 days after receipt of the approved report and summary report from the Coordination Group. |
Amendment 104
Proposal for a regulation
Article 7 – paragraph 2
Text proposed by the Commission |
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Amendment |
2. Where, within 30 days of receipt of the approved joint clinical assessment report and the summary report, the Commission concludes that the approved joint clinical assessment report and summary report do not comply with the substantive and procedural requirements laid down in this Regulation, it shall inform the Coordination Group of the reasons for its conclusions and request it to review the report and summary report . |
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2. Where, within 30 days of receipt of the approved joint clinical assessment report and the summary report, the Commission concludes that the approved joint clinical assessment report and summary report do not comply with the procedural legal requirements laid down in this Regulation, it shall inform the Coordination Group of the reasons for its conclusions and request a review of the assessment, giving reasons . |
Amendment 105
Proposal for a regulation
Article 7 – paragraph 3
Text proposed by the Commission |
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Amendment |
3. The designated sub-group shall consider the conclusions referred to in paragraph 2 and invite the health technology developer to submit comments by a specified deadline. The designated sub-group shall review the joint clinical assessment report and summary report taking into account the comments provided by the health technology developer. The assessor, with the assistance of the co-assessor, shall modify the joint clinical assessment report and summary report accordingly and submit them to the Coordination Group . Article 6, paragraphs 12 to 14 shall apply. |
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3. The designated sub-group shall review the joint clinical assessment report and summary report taking into account the comments provided by the Commission, from a procedural point of view, prior to a final opinion . |
Amendment 106
Proposal for a regulation
Article 7 – paragraph 4
Text proposed by the Commission |
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Amendment |
4. Following the submission of the modified approved joint clinical assessment report and summary report, and where the Commission considers that the modified approved joint clinical assessment report and summary report comply with the substantive and procedural requirements laid down in this Regulation, it shall include the name of the health technology which has been the subject of the report and summary report, in the List of Assessed Health Technologies. |
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deleted |
Amendment 107
Proposal for a regulation
Article 7 – paragraph 5
Text proposed by the Commission |
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Amendment |
5. If the Commission concludes that the modified approved joint clinical assessment report and summary report do not comply with the substantive and procedural requirements laid down in this Regulation, it shall decline to include the name of the health technology in the List. The Commission shall inform the Coordination Group thereof, setting out the reasons for the non-inclusion . The obligations laid down in Article 8 shall not apply with respect to the health technology concerned. The Coordination Group shall inform the submitting health technology developer accordingly and include summary information on those reports in its annual report. |
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5. If the Commission concludes that the modified approved joint assessment report and summary report do not comply with the procedural requirements laid down in this Regulation, the health technology which is the subject of the assessment shall be included in the List, together with the summary report of the assessment and the Commission’s comments, and all of which shall be published on the IT platform referred to in Article 27 . The Commission shall inform the Coordination Group thereof, setting out the reasons for the negative report . The obligations laid down in Article 8 shall not apply with respect to the health technology concerned. The Coordination Group shall inform the submitting health technology developer accordingly and include summary information on those reports in its annual report. |
Amendment 108
Proposal for a regulation
Article 7 – paragraph 6
Text proposed by the Commission |
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Amendment |
6. For those health technologies included on the List of Assessed Health Technologies, the Commission shall publish the approved joint clinical assessment report and summary report on the IT platform referred to in Article 27 and make them available to the submitting health technology developer at the latest 10 working days following their inclusion in the List. |
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6. For those health technologies included on the List of Assessed Health Technologies, the Commission shall publish, on the IT platform referred to in Article 27 , the approved joint clinical assessment report and summary report as well as all the comments by stakeholders and interim reports , and make them available to the submitting health technology developer at the latest 10 working days following their inclusion in the List. |
Amendment 109
Proposal for a regulation
Article 8 – paragraph 1 – introductory part
Text proposed by the Commission |
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Amendment |
1. Member States shall: |
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1. For the health technologies included on the List of Assessed Health Technologies or in respect of which a joint clinical assessment has been initiated , Member States shall: |
Amendment 110
Proposal for a regulation
Article 8 – paragraph 1 – point a
Text proposed by the Commission |
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Amendment |
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Amendment 111
Proposal for a regulation
Article 8 – paragraph 1 – point b
Text proposed by the Commission |
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Amendment |
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Amendment 112
Proposal for a regulation
Article 8 – paragraph 1 a (new)
Text proposed by the Commission |
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Amendment |
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1a. The requirement set out in point (b) of paragraph 1 shall not prevent Member States or regions from carrying out assessments on the added clinical value of the technologies concerned as part of national or regional appraisal processes which may consider clinical as well as non-clinical data and evidence specific to the Member State concerned which were not included in the joint clinical assessment and which are necessary to complete the health technology assessment or the overall pricing and reimbursement process. Such complementary assessments may compare the technology concerned against a comparator which represents the best available and evidence-based standard of care in the Member State concerned and which, despite that Member State's request during the scoping phase, was not included in the joint clinical assessment. They may also assess the technology in a care context specific to the Member State concerned, based on its clinical practice, or the setting chosen for reimbursement. Any such measure shall be justified, necessary and proportionate to achieving this aim, shall not duplicate work done at Union level and shall not unduly delay patient access to those technologies. Member States shall notify the Commission and the Coordination Group of their intention to complement the joint clinical assessment together with a justification for doing so. |
Amendment 113
Proposal for a regulation
Article 8 – paragraph 2
Text proposed by the Commission |
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Amendment |
2. Member States shall notify the Commission of the outcome of a health technology assessment on a health technology which has been subject to a joint clinical assessment within 30 days from its completion. That notification shall be accompanied by information on how the conclusions of the joint clinical assessment report have been applied in the overall health technology assessment. The Commission shall facilitate the exchange of this information between Member States through the IT platform referred to in Article 27. |
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2. Member States shall submit information, through the IT platform referred to in Article 27, on how account has been taken of the joint clinical assessment report in the health technology assessment at Member State level as well as other clinical data and additional evidence taken into account so that the Commission may facilitate the exchange of this information among Member States . |
Amendment 114
Proposal for a regulation
Article 9 – paragraph 1 – point b
Text proposed by the Commission |
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Amendment |
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Amendment 115
Proposal for a regulation
Article 9 – paragraph 1 – point b a (new)
Text proposed by the Commission |
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Amendment |
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Amendment 116
Proposal for a regulation
Article 9 – paragraph 1 – point b b (new)
Text proposed by the Commission |
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Amendment |
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Amendment 117
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 1 a (new)
Text proposed by the Commission |
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Amendment |
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In the cases referred to under points (a), (b), (ba) and (bb) of the first subparagraph, the technology developer shall submit the additional information. In the event of a failure to do so, the earlier joint assessment would no longer fall within the scope of Article 8. The ‘EVIDENT’ database shall be maintained to gather clinical evidence as it arises from the real-life use of health technology and to monitor the results in terms of health. |
Amendment 118
Proposal for a regulation
Article 9 – paragraph 2
Text proposed by the Commission |
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Amendment |
2. The Coordination Group may carry out updates of joint clinical assessments where requested by one or more of its members. |
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2. The Coordination Group may carry out updates of joint clinical assessments where requested by one or more of its members. Updates of joint clinical assessments are requested when new information has been published or made available which was not available at the time of the initial joint report. When an update of the joint clinical assessment report is requested, the member who proposed it can update the joint clinical assessment report and propose it for adoption by other Member States by mutual recognition. When updating the joint clinical assessment report, the Member State shall apply the methods and standards as laid down by the Coordination Group. Where Member States cannot agree on an update, the case is referred to the Coordination Group. The Coordination Group shall decide whether to carry out an update based on the new information. When an update is approved by mutual recognition or after the Coordination Group’s decision, the joint clinical assessment report is considered updated. |
Amendment 119
Proposal for a regulation
Article 11 – paragraph 1 – introductory part
Text proposed by the Commission |
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Amendment |
1. The Commission shall develop, by means of implementing acts, procedural rules for: |
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1. The Commission shall, in accordance with this Regulation , develop, by means of implementing acts, procedural rules for: |
Amendment 120
Proposal for a regulation
Article 11 – paragraph 1 – point a
Text proposed by the Commission |
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Amendment |
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deleted |
Amendment 121
Proposal for a regulation
Article 11 – paragraph 1 – point c
Text proposed by the Commission |
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Amendment |
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Amendment 122
Proposal for a regulation
Article 11 – paragraph 1 – point f
Text proposed by the Commission |
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Amendment |
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Amendment 123
Proposal for a regulation
Article 12 – paragraph 1 – subparagraph 1
Text proposed by the Commission |
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Amendment |
Health technology developers may request a joint scientific consultation with the Coordination Group for the purposes of obtaining scientific advice concerning data and evidence likely to be required as part of a joint clinical assessment . |
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Health technology developers may request a joint scientific consultation with the Coordination Group for the purposes of obtaining scientific advice concerning the clinical aspects for the optimal design of scientific studies and research to obtain the best scientific evidence, improve predictability, align research priorities and enhance the quality and efficiency of said research, in order to obtain the best evidence . |
Amendment 124
Proposal for a regulation
Article 12 – paragraph 2 – point f a (new)
Text proposed by the Commission |
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Amendment |
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Amendment 125
Proposal for a regulation
Article 12 – paragraph 3
Text proposed by the Commission |
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Amendment |
3. Within 15 working days after receipt of the request, the Coordination Group shall inform the requesting health technology developer whether or not it will engage in the joint scientific consultation. Where the Coordination Group refuses the request, it shall inform the health technology developer thereof and explain the reasons having regard to the criteria laid down in paragraph 2. |
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3. Within 15 working days after receipt of the request, the Coordination Group shall inform the requesting health technology developer whether or not it will engage in the joint scientific consultation. Where the Coordination Group refuses the request, it shall inform the health technology developer thereof and explain the reasons having regard to the criteria laid down in paragraph 2. Joint scientific consultations shall not prejudice the objectivity and independence of joint technological assessments nor its results or conclusions. The assessor and co-assessor appointed to carry them out pursuant to Article 13(3) shall not be the same as the assessor and co-assessor appointed pursuant to Article 6(3) for the joint technological assessment. The subject and the summarised substance of the consultations shall be published on the IT platform referred to in Article 27. |
Amendment 126
Proposal for a regulation
Article 13 – title
Text proposed by the Commission |
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Amendment |
Preparation of Joint Scientific Consultation Reports |
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Joint scientific consultation procedure |
Amendment 127
Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 2
Text proposed by the Commission |
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Amendment |
The joint scientific consultation report shall be prepared in accordance with the requirements in this Article and in accordance with the procedural rules and documentation established pursuant to Articles 16 and 17. |
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The joint scientific consultation report shall be prepared in accordance with the requirements in this Article and in accordance with the procedure and documentation established pursuant to Articles 16 and 17. |
Amendment 128
Proposal for a regulation
Article 13 – paragraph 2
Text proposed by the Commission |
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Amendment |
2. The designated sub-group shall request the health technology developer to submit the documentation containing the information, data and evidence necessary for the joint scientific consultation. |
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2. The designated sub-group shall request the health technology developer to submit the available and up-to-date documentation containing all stages of information processing , data and studies necessary for the joint scientific consultation, such as available data from all tests performed and from all the studies in which the technology was used . A tailored clinical assessment pathway may be developed for orphan medicinal products due to the limited number of patients enrolled in clinical trials and/or the lack of a comparator. All that information shall be made publicly available, upon completion of the joint clinical assessments. The designated sub-group and the health technology developer concerned shall hold a joint meeting based on the documentation described in first subparagraph. |
Amendment 129
Proposal for a regulation
Article 13 – paragraph 3
Text proposed by the Commission |
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Amendment |
3. The designated sub-group shall appoint from among its members, an assessor and a co-assessor, with responsibility for conducting the joint scientific consultation. The appointments shall take into account the scientific expertise necessary for the assessment. |
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3. The designated sub-group shall appoint from among its members, an assessor and a co-assessor, with responsibility for conducting the joint scientific consultation, who shall not be the same as the assessor and a co-assessor to be appointed pursuant to Article 6(3) . The appointments shall take into account the scientific expertise. |
Amendment 130
Proposal for a regulation
Article 13 – paragraph 7
Text proposed by the Commission |
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Amendment |
7. The assessor shall provide the draft joint scientific consultation report to the submitting health technology developer and set a time-frame in which the developer may submit comments . |
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7. The assessor shall provide the draft joint scientific consultation report, and provide it to the health technology developer for comments, setting a time-frame for those comments . |
Amendment 131
Proposal for a regulation
Article 13 – paragraph 8
Text proposed by the Commission |
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Amendment |
8. The designated sub-group shall ensure that stakeholders , including patients and clinical experts are given an opportunity to provide comments during the preparation of the draft joint scientific consultation report and set a time-frame in which they may submit comments. |
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8. The health technology developer , patients, health professionals and clinical experts may submit comments during the joint scientific consultation. |
Amendment 132
Proposal for a regulation
Article 13 – paragraph 9
Text proposed by the Commission |
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Amendment |
9. Following receipt and consideration of any comments provided in accordance with paragraphs 6, 7 and 8, the assessor, with the assistance of the co-assessor, shall finalise the draft joint scientific consultation report and submit the draft report to the designated sub-group for comments. |
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9. Following receipt and consideration of any information and comments provided in accordance with paragraphs 2 , 6, 7 and 8, the assessor, with the assistance of the co-assessor, shall finalise the draft joint scientific consultation report and submit the draft report to the designated sub-group for comments. All comments, which shall be public and answered when required, shall be published on the IT platform referred to in Article 27, following finalisation of the joint clinical assessment. The published comments shall include stakeholders comments and any differences of opinion expressed by members of the sub-group in the course of the procedure. |
Amendment 133
Proposal for a regulation
Article 13 – paragraph 10
Text proposed by the Commission |
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Amendment |
10. Where the joint scientific consultation is carried out in parallel with scientific advice given by the European Medicines Agency, the assessor shall seek to coordinate with the Agency as regards the consistency of the conclusions of the joint scientific consultation report with those of the scientific advice . |
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10. Where the joint scientific consultation is carried out in parallel with scientific advice given by the European Medicines Agency, the assessor shall seek to coordinate the time-frame . |
Amendment 207
Proposal for a regulation
Article 13 – paragraph 12
Text proposed by the Commission |
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Amendment |
12. The Coordination Group shall approve the final joint scientific consultation report, wherever possible by consensus or, where necessary, by a simple majority of Member States, at the latest 100 days following the start of the preparation of the report referred to in paragraph 4. |
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12. The Coordination Group shall approve the final joint scientific consultation report, wherever possible by consensus or, where necessary, by qualified majority of Member States, at the latest 100 days following the start of the preparation of the report referred to in paragraph 4. |
Amendment 135
Proposal for a regulation
Article 14 – paragraph 2
Text proposed by the Commission |
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Amendment |
2. The Coordination Group shall include anonymised summary information on the joint scientific consultations in its annual reports and the IT platform referred to in Article 27. |
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2. The Coordination Group shall include summary information on the joint scientific consultations in its annual reports and the IT platform referred to in Article 27. That information shall include the subject of the consultations and the comments. The scientific consultation reports shall be made public upon completion of the joint clinical assessments. |
Amendment 136
Proposal for a regulation
Article 14 – paragraph 3
Text proposed by the Commission |
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Amendment |
3. Member States shall not carry out a scientific consultation or an equivalent consultation on a health technology for which a joint scientific consultation has been initiated and where the contents of the request are the same as those covered by the joint scientific consultation . |
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3. Member States shall not carry out a scientific consultation or an equivalent consultation on a health technology referred to in Article 5 for which a joint scientific consultation has been initiated, unless additional clinical data and evidence were not taken into account and such data and evidence are considered necessary. Such national scientific consultations shall be submitted to the Commission for publication on the IT platform referred to in Article 27 . |
Amendment 137
Proposal for a regulation
Article 16 – paragraph 1 – point a
Text proposed by the Commission |
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Amendment |
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Amendment 138
Proposal for a regulation
Article 16 – paragraph 1 – point d
Text proposed by the Commission |
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Amendment |
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Amendment 139
Proposal for a regulation
Article 17 – paragraph 1 – introductory part
Text proposed by the Commission |
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Amendment |
The Commission shall be empowered to adopt delegated acts in accordance with Article 31 concerning: |
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The Commission shall be empowered to adopt implementing acts in accordance with Articles 30 and 32 concerning: |
Amendment 140
Proposal for a regulation
Article 17 – paragraph 1 – point a – introductory part
Text proposed by the Commission |
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Amendment |
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Amendment 141
Proposal for a regulation
Article 17 – paragraph 1 – point a – point iii a (new)
Text proposed by the Commission |
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Amendment |
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Amendment 142
Proposal for a regulation
Article 17 – paragraph 1 – point b
Text proposed by the Commission |
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Amendment |
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deleted |
Amendment 143
Proposal for a regulation
Article 18 – paragraph 2 – point b
Text proposed by the Commission |
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Amendment |
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Amendment 144
Proposal for a regulation
Article 18 – paragraph 2 a (new)
Text proposed by the Commission |
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Amendment |
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2a. When preparing the study, the Coordination Group shall ensure that commercially confidential information provided by the health technology developer is adequately protected. To that end, the Coordination Group shall give the health technology developer an opportunity to submit comments with respect to the contents of the study and shall take due account of those comments. |
Amendment 145
Proposal for a regulation
Article 19 – paragraph 1 – introductory part
Text proposed by the Commission |
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Amendment |
1. The Commission shall support cooperation and the exchange of scientific information among Member States on: |
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1. The Commission shall support any further cooperation and the exchange of scientific information among Member States on the following issues : |
Amendment 146
Proposal for a regulation
Article 19 – paragraph 1 – point d a (new)
Text proposed by the Commission |
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Amendment |
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Amendment 147
Proposal for a regulation
Article 19 – paragraph 1 – point d b (new)
Text proposed by the Commission |
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Amendment |
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Amendment 148
Proposal for a regulation
Article 19 – paragraph 1 – point d c (new)
Text proposed by the Commission |
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Amendment |
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Amendment 149
Proposal for a regulation
Article 19 – paragraph 1 – point d d (new)
Text proposed by the Commission |
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Amendment |
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Amendment 150
Proposal for a regulation
Article 19 – paragraph 1 – point d e (new)
Text proposed by the Commission |
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Amendment |
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Amendment 151
Proposal for a regulation
Article 19 – paragraph 3
Text proposed by the Commission |
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Amendment |
3. The cooperation referred to in paragraph 1 points (b) and (c) may be carried out using the procedural rules established in accordance with Article 11 and the common rules established in accordance with Articles 22 and 23. |
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3. The cooperation referred to in paragraph 1 points (b), (c), (db) and (de) may be carried out using the procedural rules established in accordance with Article 11 and the common rules established in accordance with Articles 22 and 23. |
Amendment 152
Proposal for a regulation
Article 20 – paragraph 1 – point b
Text proposed by the Commission |
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Amendment |
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deleted |
Amendment 153
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1 a (new)
Text proposed by the Commission |
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Amendment |
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Where relevant and appropriate, Member States shall be encouraged to apply the common procedural rules and methodology referred to in this Regulation for the clinical assessment of medicinal products and medical devices not falling within the scope of this Regulation and carried out by Member States at national level. |
Amendment 154
Proposal for a regulation
Article 22 – paragraph 1 – introductory part
Text proposed by the Commission |
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Amendment |
1. The Commission shall adopt implementing acts concerning: |
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1. Taking into account the results of the work already undertaken in the EUnetHTA Joint Actions, and after consulting all relevant stakeholders , the Commission shall adopt implementing acts concerning: |
Amendment 155
Proposal for a regulation
Article 22 – paragraph 1 – point a – point i
Text proposed by the Commission |
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Amendment |
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Amendment 156
Proposal for a regulation
Article 22 – paragraph 1 – point a – point ii
Text proposed by the Commission |
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Amendment |
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Amendment 157
Proposal for a regulation
Article 22 – paragraph 1 – point a – point iii
Text proposed by the Commission |
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Amendment |
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Amendment 158
Proposal for a regulation
Article 22 – paragraph 1 – point a – point iii a (new)
Text proposed by the Commission |
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Amendment |
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Amendment 159
Proposal for a regulation
Article 22 – paragraph 1 – point a – point iii b (new)
Text proposed by the Commission |
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Amendment |
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Amendment 160
Proposal for a regulation
Article 22 – paragraph 1 – point b
Text proposed by the Commission |
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Amendment |
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Amendment 208/rev
Proposal for a regulation
Article 22 – paragraph 1 a (new)
Text proposed by the Commission |
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Amendment |
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1a. Within [6 months] from the date of entry into force of this Regulation, the Coordination Group shall draw up a draft implementing regulation concerning the methodologies to be consistently used to carry out joint clinical assessments and consultations and shall define the content of those assessments and consultations. The methodologies shall be developed on the basis of the existing EUnetHTA methodological guidelines and evidence submission templates. In any case, the methodologies shall comply with the following criteria:
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In the case of a medical device, the methodology shall be adapted to its characteristics and specificities, taking as a basis the methodology already developed by EUnetHTA. The Coordination Group shall submit the draft implementing regulation to the Commission for endorsement. Within [3 months] of receipt of the draft measure, the Commission shall decide whether to endorse it by means of an implementing act adopted in accordance with the examination procedure referred to in Article 30(2). Where the Commission intends not to endorse a draft measure or to endorse it in part or where it proposes amendments, it shall send the draft back to the Coordination Group, setting out the reasons. Within a period of [six weeks], the Coordination Group may amend the draft measure on the basis of the Commission’s indications and proposed amendments, and resubmit it to the Commission. If, on the expiry of the [six-week period], the Coordination Group has not submitted an amended draft measure, or has submitted a draft measure that is not amended in a way consistent with the Commission’s proposed amendments, the Commission may adopt the implementing regulation with the amendments it considers relevant or reject it. In the event that the Coordination Group does not submit a draft measure to the Commission within the time limit in accordance with [paragraph 1], the Commission may adopt the implementing regulation without a draft having been submitted from the Coordination Group. |
Amendment 162
Proposal for a regulation
Article 23 – paragraph 1 – introductory part
Text proposed by the Commission |
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Amendment |
The Commission shall be empowered to adopt delegated acts in accordance with Article 31 concerning : |
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The Coordination Group, following the same procedure set up in point (a) of Article 2(1) shall establish : |
Amendment 163
Proposal for a regulation
Article 23 – paragraph 1 – point a – introductory part
Text proposed by the Commission |
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Amendment |
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Amendment 164
Proposal for a regulation
Article 23 – paragraph 1 – point b
Text proposed by the Commission |
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Amendment |
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Amendment 165
Proposal for a regulation
Article 24 – title
Text proposed by the Commission |
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Amendment |
Union Funding |
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Funding |
Amendment 166
Proposal for a regulation
Article 24 – paragraph 2 a (new)
Text proposed by the Commission |
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Amendment |
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2a. The Union shall ensure stable and permanent public funding for the joint work on HTA that shall be conducted without the direct or indirect funding by developers of health technologies. |
Amendment 167
Proposal for a regulation
Article 24 – paragraph 2 b (new)
Text proposed by the Commission |
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Amendment |
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2b. The Commission may establish a system of charges for health technology developers requesting both joint scientific consultations and joint clinical assessments which it shall use to finance research regarding unmet medical needs or clinical priorities. Such a system of charges shall under no circumstances used to finance activities under this Regulation. |
Amendment 168
Proposal for a regulation
Article 25 – paragraph 1 – point a
Text proposed by the Commission |
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Amendment |
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Amendment 169
Proposal for a regulation
Article 25 – paragraph 1 – point b
Text proposed by the Commission |
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Amendment |
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Amendment 170
Proposal for a regulation
Article 25 – paragraph 1 – point d
Text proposed by the Commission |
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Amendment |
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Amendment 171
Proposal for a regulation
Article 25 – paragraph 1 – point f
Text proposed by the Commission |
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Amendment |
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Amendment 172
Proposal for a regulation
Article 26 – paragraph 1
Text proposed by the Commission |
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Amendment |
1. The Commission shall establish a stakeholder network through an open call for applications and a selection of suitable stakeholder organisations based on selection criteria established in the open call for applications. |
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1. The Commission shall establish a stakeholder network through an open call for applications and a selection of suitable stakeholder organisations based on selection criteria established in the open call for applications, such as legitimacy, representation, transparency and accountability . The organisations to be addressed by the open call for applications shall be patient associations, consumer organisations, non-governmental organisations in the field of health, health technology developers and health professionals. Best practices in preventing conflict of interest shall apply to the selection of members of the stakeholder network. The European Parliament shall have two representatives in the stakeholder network. |
Amendment 173
Proposal for a regulation
Article 26 – paragraph 2
Text proposed by the Commission |
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Amendment |
2. The Commission shall publish the list of stakeholder organisations included in the stakeholder network. |
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2. The Commission shall publish the list of stakeholder organisations included in the stakeholder network. Stakeholders shall not have conflict of interest and their declarations of interests shall be published in the IT platform. |
Amendment 174
Proposal for a regulation
Article 26 – paragraph 3 – introductory part
Text proposed by the Commission |
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Amendment |
3. The Commission shall organise ad-hoc meetings between the stakeholder network and the Coordination Group in order to: |
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3. The Commission shall organise a meeting between the stakeholder network and the Coordination Group at least once a year in order to promote a constructive dialogue. The roles of the stakeholder network shall include : |
Amendment 175
Proposal for a regulation
Article 26 – paragraph 3 – point a
Text proposed by the Commission |
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Amendment |
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Amendment 176
Proposal for a regulation
Article 26 – paragraph 3 – point b
Text proposed by the Commission |
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Amendment |
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Amendment 177
Proposal for a regulation
Article 26 – paragraph 3 – point b a (new)
Text proposed by the Commission |
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Amendment |
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Amendment 178
Proposal for a regulation
Article 26 – paragraph 3 – point b b (new)
Text proposed by the Commission |
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Amendment |
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Amendment 179
Proposal for a regulation
Article 26 – paragraph 3 – point b c (new)
Text proposed by the Commission |
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Amendment |
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Amendment 180
Proposal for a regulation
Article 26 – paragraph 3 – point b d (new)
Text proposed by the Commission |
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Amendment |
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Amendment 181
Proposal for a regulation
Article 26 – paragraph 3 – subparagraph 1 a (new)
Text proposed by the Commission |
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Amendment |
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The interests and the founding documents of the stakeholders, as well as a summary of annual meetings and possible activities, shall be published on the IT platform referred to in Article 27. |
Amendment 182
Proposal for a regulation
Article 26 – paragraph 4
Text proposed by the Commission |
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Amendment |
4. On the request of the Coordination Group, the Commission shall invite patients and clinical experts nominated by the stakeholder network to attend meetings of the Coordination Group as observers. |
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4. On the request of the Coordination Group, the Commission shall invite patients, health professionals and clinical experts nominated by the stakeholder network to attend meetings of the Coordination Group, as observers. |
Amendment 183
Proposal for a regulation
Article 27 – paragraph 1 – introductory part
Text proposed by the Commission |
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Amendment |
1. The Commission shall develop and maintain an IT platform containing information on: |
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1. Building on the work already undertaken by the EUnetHTA Joint Actions , the Commission shall develop and maintain an IT platform containing information on: |
Amendment 184
Proposal for a regulation
Article 27 – paragraph 1 – point d a (new)
Text proposed by the Commission |
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Amendment |
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Amendment 185
Proposal for a regulation
Article 27 – paragraph 1 – point d b (new)
Text proposed by the Commission |
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Amendment |
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Amendment 186
Proposal for a regulation
Article 27 – paragraph 1 – point d c (new)
Text proposed by the Commission |
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Amendment |
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Amendment 187
Proposal for a regulation
Article 27 – paragraph 1 – point d d (new)
Text proposed by the Commission |
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Amendment |
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Amendment 188
Proposal for a regulation
Article 27 – paragraph 2
Text proposed by the Commission |
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Amendment |
2. The Commission shall ensure appropriate levels of access to the information contained in the IT platform for Member State bodies, members of the stakeholder network, and the general public . |
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2. The Commission shall ensure public access to the information contained in the IT platform. |
Amendment 189
Proposal for a regulation
Article 28 – title
Text proposed by the Commission |
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Amendment |
Implementation Report |
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Evaluation report on the transitional period |
Amendment 190
Proposal for a regulation
Article 28 – paragraph 1
Text proposed by the Commission |
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Amendment |
No later than two years after the end of the transitional period referred to in Article 33(1) , the Commission shall report on the implementation of the provisions on the scope of the joint clinical assessments and on the functioning of the support framework referred to in this Chapter . |
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At the end of the transitional period referred to in Article 33 and before the harmonised system for health technology assessment established under this Regulation becomes mandatory , the Commission shall submit an impact assessment report on the whole of the procedure that has been introduced, which shall evaluate, among other criteria, the progress made in relation to patient access to new health technologies and the functioning of the internal market, the impact on the quality of innovation, such as the development of innovative medicinal products in areas of unmet need, on the sustainability of health systems, the HTA quality and the capacity at the national and regional level, as well as the appropriateness of the scope of the joint clinical assessments and the functioning of the support framework. |
Amendment 191
Proposal for a regulation
Article 31
Text proposed by the Commission |
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Amendment |
Article 31 Exercise of the Delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Articles 17 and 23 shall be conferred on the Commission for an indeterminate period of time from … [insert date of entry into force of this Regulation]. 3. The delegation of power referred to in Articles 17 and 23 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Articles 17 and 23 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. |
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Amendment 192
Proposal for a regulation
Article 32 – title
Text proposed by the Commission |
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Amendment |
Preparation of Implementing and Delegated Acts |
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Preparation of Implementing Acts |
Amendment 193
Proposal for a regulation
Article 32 – paragraph 1
Text proposed by the Commission |
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Amendment |
1. The Commission shall adopt the implementing and delegated acts referred to in Articles 11, 16, 17, 22, and 23 , at the latest by the date of application of this Regulation. |
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1. The Commission shall adopt the implementing acts referred to in Articles 11, 16, 17 and 22, at the latest by the date of application of this Regulation. |
Amendment 194
Proposal for a regulation
Article 32 – paragraph 2
Text proposed by the Commission |
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Amendment |
2. When preparing those implementing and delegated acts, the Commission shall take into account the distinctive characteristics of the medicinal product and medical device sectors. |
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2. When preparing those implementing acts, the Commission shall take into account the distinctive characteristics of the medicinal product and medical device sectors, and shall consider the work already undertaken in the EUnetHTA Joint Actions . |
Amendment 195
Proposal for a regulation
Article 33 – paragraph 1
Text proposed by the Commission |
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Amendment |
1. Member States may delay their participation in the system of joint clinical assessments and joint scientific consultations referred to in sections 1 and 2 of Chapter II until ... [insert date 3 years after the date of application]. |
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1. Member States may delay their participation in the system of joint clinical assessments and joint scientific consultations referred to in sections 1 and 2 of Chapter II until ... [insert date 4 years after the date of application] for medicinal products referred to in points (a) and (aa) of Article 5(1), and until ... [insert date 7 years after the date of application] for medical devices referred in Article point (b) of Article 5(1) and for in vitro diagnostic medical devices referred in point (c) of Article 5(1). |
Amendment 196
Proposal for a regulation
Article 34 – paragraph 1
Text proposed by the Commission |
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Amendment |
1. Member States may carry out a clinical assessment using means other than the rules provided for in Chapter III of this Regulation, on grounds related to the need to protect public health in the Member State concerned and provided the measure is justified, necessary and proportionate as regards achieving that aim. |
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1. Member States may carry out a clinical assessment using means other than the rules provided for in Chapter III of this Regulation, on the grounds set out in Article 8(1a), and on grounds related to the need to protect public health in the Member State concerned and provided the measure is justified, necessary and proportionate as regards achieving that aim. |
Amendment 197
Proposal for a regulation
Article 34 – paragraph 2
Text proposed by the Commission |
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Amendment |
2. Member States shall notify the Commission of their intention to carry out a clinical assessment using other means together with the justifications for doing so. |
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2. Member States shall notify the Commission and the Coordination Group of their intention to carry out a clinical assessment using other means together with the justifications for doing so. |
Amendment 198
Proposal for a regulation
Article 34 – paragraph 2 a (new)
Text proposed by the Commission |
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Amendment |
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2a. The Coordination Group may assess whether the request fulfils the grounds referred to in paragraph 1, and may submit its conclusions to the Commission. |
Amendment 199
Proposal for a regulation
Article 34 – paragraph 3
Text proposed by the Commission |
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Amendment |
3. The Commission shall, within three months of the date of receiving the notification provided for in paragraph 2, approve or reject the planned assessment after having verified whether or not it complies with the requirements referred to in paragraph 1 and whether or not it is a means of arbitrary discrimination or a disguised restriction on trade between Member States. In the absence of a decision by the Commission by the end of the three month period, the planned clinical assessment shall be deemed to be approved. |
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3. The Commission shall, within three months of the date of receiving the notification provided for in paragraph 2, approve or reject the planned assessment after having verified whether or not it complies with the requirements referred to in paragraph 1 and whether or not it is a means of arbitrary discrimination or a disguised restriction on trade between Member States. In the absence of a decision by the Commission by the end of the three month period, the planned clinical assessment shall be deemed to be approved. The Commission’s decision shall be published on the IT platform referred to in Article 27. |
(1) The matter was referred back for interinstitutional negotiations to the committee responsible, pursuant to Rule 59(4), fourth subparagraph (A8-0289/2018).
(2) OJ C 263, 25.7.2018, p. 4 .
(3) Directive 2011/24/EU of 9 March 2011 of the European Parliament and of the Council on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).
(4) OJ C 438, 6.12.2014, p. 12.
(5) OJ C 438, 6.12.2014, p. 12.
(6) European Parliament resolution of 2 March 2017 on EU options for improving access to medicines – 2016/2057(INI).
(7) European Parliament resolution of 2 March 2017 on EU options for improving access to medicines – 2016/2057(INI).
(8) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
(9) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
(10) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
(11) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
(12) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
(*1) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
(*2) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).
(13) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
(14) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
(15) Interinstitutional Agreement between the European Parliament, the Council of the European Union and the European Commission of 13 April 2016 on Better Law-Making (OJ L 123, 12.5.2016, p. 1).
(16) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).
(17) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).
(1) Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems (OJ L 40, 11.2.1989, p. 8).