9 Amendments of Mihai ŢURCANU related to 2018/0018(COD)
Amendment 40 #
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, while patients have the right to health protection and protection against the financial, social and medical consequences of the disease, as well as unrestrained access to the latest therapeutic discoveries, which should be guaranteed by law in all Member States.
Amendment 49 #
Proposal for a regulation
Recital 17
Recital 17
(17) The time-frame for joint clinical assessments for medicinal products should, in as far as possible, be fixed by reference to the time-frame applicable to the completion of the central marketing authorisation procedure provided for under Regulation (EC) No 726/2004. Such coordination should ensure clinical assessments can effectively facilitate market access and contribute to the timely availability of innovative technologies for patients. AIn certain Member States, clinical assessments can start even before the marketing authorization has been granted by the Commission. To support the objectives of this Regulation and to avoid that the joint clinical assessments results in delays in those Member States compared to the status quo, as a rule, the process should be completed by the time of the publication of the Commission decision granting marketing authorisation.
Amendment 70 #
Proposal for a regulation
Article 1 – paragraph 1 – introductory part
Article 1 – paragraph 1 – introductory part
1. Taking into account the results of the work already undertaken in the EUnetHTA Joint Actions, this Regulation establishes:
Amendment 71 #
Proposal for a regulation
Article 2 – paragraph 1 – point e
Article 2 – paragraph 1 – point e
(e) 'clinical assessment' means a compilation and evaluationanalysis of the available scientific evidence on a health technology in comparison with one or more other health technologies based on the following clinical domains of health technology assessment: the description of the health problem addressed by the health technology and the current use of other health technologies addressing that health problem, the description and technical characterisation of the health technology, the relative clinical effectiveness, and the relative safety of the health technology;
Amendment 73 #
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
2. Member States shall designate their national authorities and bodies responsible for health technology assessment which inform decision-making at national level 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. Each Member State may appoint to the Coordination Group at least one authority or body responsible with expertise in the field of medicinal products.
Amendment 98 #
Proposal for a regulation
Article 6 – paragraph 5 – point a
Article 6 – paragraph 5 – point a
(a) an analysis description of the relative effects of the health technology being assessed on the patient-relevant health outcomes chosenagreed for the assessment;
Amendment 154 #
Proposal for a regulation
Article 22 – paragraph 1 – introductory part
Article 22 – paragraph 1 – introductory part
1. The Commission shall be empowered to adopt implementing acts in accordance with Article 31 concerning:
Amendment 161 #
Proposal for a regulation
Article 22 – paragraph 1 a (new)
Article 22 – paragraph 1 a (new)
1 a. The methodologies referred to in point (b) of paragraph 1 shall be developed on the basis of the existing EUnetHTA methodological guidelines and evidence submission templates. They shall be developed and agreed after consultations with all stakeholders, regularly updated to reflect the scientific evolution and shall be made publicly available.
Amendment 175 #
Proposal for a regulation
Article 27 – paragraph 2 a (new)
Article 27 – paragraph 2 a (new)
2 a. All confidential data provided by a manufacturer shall be covered by a clear confidentiality agreement. The Commission shall also ensure the protection of confidential data against unauthorised access or disclosure, and ensure the integrity of data stored against accidental or unauthorised destruction, accidental loss or alteration.