12 Amendments of Maria GRAPINI related to 2018/0018(COD)
Amendment 39 #
Proposal for a regulation
Recital 2
Recital 2
(2) Health Technology Assessment (HTA) is an evidence-based process that, which must synthesize medical information in a transparent and impartial manner, and which allows competent authorities to determine the relative effectiveness of new or existing technologies. HTA focuses specifically on the added value of a health technology in comparison with other new or existing health technologies.
Amendment 41 #
Proposal for a regulation
Recital 4
Recital 4
(4) The outcome of HTA is used to inform decisions concerning the allocation of budgetary resources in the field of health, for example, in relation to establishing the pricing or reimbursement levels of health technologies. HTA can therefore assist Member States in creating and maintaining sustainable healthcare systems and to stimulate innovation that delivers better outcomes for patients and which should aim to achieve the best cost- effectiveness ratio.
Amendment 52 #
Proposal for a regulation
Recital 18
Recital 18
(18) The establishment of a time-frame for the joint clinical assessments for medical devices should take into account the highly decentralised market access pathway for medical devices and the availability of appropriate evidence data required to carry out a joint clinical assessment. As the required evidence may only become available after a medical device has been placed on the market and in order to allow for the selection of medical devices for joint clinical assessment at an appropriate time, it should be possible for assessments of such devices to take place following market launch of medical devices and, if possible, in the presence of producers.
Amendment 54 #
Proposal for a regulation
Recital 20
Recital 20
(20) In order to facilitate effective participation by health technology developers in joint clinical assessments, such developers should, in appropriwell- motivated cases, be afforded an opportunity to engage in joint scientific consultations with the Coordination Group to obtain guidance on the evidence and data that is likely to be required for the purposes of clinical assessment. Given the preliminary nature of the consultation, any guidance offered should not bind either the health technology developers or HTA authorities and bodies.
Amendment 56 #
Proposal for a regulation
Recital 21
Recital 21
(21) Joint clinical assessments and joint scientific consultations necessitate the sharing of confidential information between health technology developers and HTA authorities and bodies. In order to ensure the protection of such information, information provided to the Coordination Group in the framework of assessments and consultations should only be disclosed to a third party after a confidentiality agreement has been concluded with the notification of the technology developer that has provided the information. In addition, it is necessary for any information made public about the results of joint scientific consultations to be presented in an anonymised format with the redaction of any information of a commercially sensitive nature.
Amendment 63 #
Proposal for a regulation
Recital 25
Recital 25
(25) In order to ensure a uniform approach to the joint work provided for in this Regulation, implementing powers should be conferred on the Commission to establish a common procedural and methodological framework for clinical assessments, procedures for joint clinical assessments and procedures for joint scientific consultations. Where appropriate, dDistinct rules should be developed for medicinal products and medical devices. In the development of such rules, the Commission should take into account the results of the work already undertaken in the EUnetHTA Joint Actions. It should also take into account initiatives on HTA funded through the Horizon 2020 research programme, as well as regional initiatives on HTA such as the Beneluxa and Valletta Declaration initiatives. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council.13 _________________ 13 Regulation (EU) No 182/2011 of the 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).
Amendment 97 #
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
3. The designated sub-group shall appoint, from among its members, an assessor and a co-assessor from different Member State to conduct the joint clinical assessment. The appointments shall take into account the scientific expertise necessary for the assessment.
Amendment 135 #
Proposal for a regulation
Article 13 – paragraph 3
Article 13 – paragraph 3
3. The designated sub-group shall appoint from among its members, an assessor and a co-assessor, from different Member States, with responsibility for conducting the joint scientific consultation. The appointments shall take into account the scientific expertise necessary for the assessment.
Amendment 138 #
Proposal for a regulation
Article 13 – paragraph 12
Article 13 – paragraph 12
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 1090 days following the start of the preparation of the report referred to in paragraph 4.
Amendment 165 #
Proposal for a regulation
Article 24 – paragraph 2
Article 24 – paragraph 2
2. The funding referred to in paragraph 1 shall include funding for the participation of Member States' designated health technology authorities and bodies in support of the work on joint clinical assessments and joint scientific consultations. Assessor and co-assessors shall be entitled to a special allowance, approved by the Commission, compensating them for their work on joint clinical assessments and joint scientific consultations in accordance with internal Commission provisions.
Amendment 177 #
Proposal for a regulation
Article 29 – paragraph 1
Article 29 – paragraph 1
1. No later than fiveour years after the publication of the report referred to in Article 28, the Commission shall carry out an evaluation of this Regulation, and report on its conclusions.
Amendment 181 #
Proposal for a regulation
Article 34 – paragraph 3
Article 34 – paragraph 3
3. The Commission shall, within three month60 days 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.