18 Amendments of Sirpa PIETIKÄINEN related to 2018/0018(COD)
Amendment 177 #
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1a) For this reason, it is essential that the development and design of health technology is done, from the very beginning, together with intended users to ensure the accessibility of the health technology for different kinds of users. The participatory development process should further consider the adaptability of health technology to the individual needs of each user with regards to the interfaces, applications and programmes design and functionality.
Amendment 266 #
Proposal for a regulation
Article 3 – paragraph 2 a (new)
Article 3 – paragraph 2 a (new)
2a. The Commission shall nominate two representatives of patient organisations as full members of the Coordination Group, to be selected from a list of eligible candidates drawn up by the European Commission following a public call for expressions of interest. The patient representatives will hold voting rights.
Amendment 292 #
Proposal for a regulation
Article 3 – paragraph 8 – point d
Article 3 – paragraph 8 – point d
(d) ensure appropriate involvement of stakeholders in its work, including of intended users of health technology;
Amendment 296 #
Proposal for a regulation
Article 3 – paragraph 8 – point e – point iii
Article 3 – paragraph 8 – point e – point iii
(iii) identification of emerging health technologies and analysis of the accessibility of health technologies to ensure they do not unintentionally increase inequalities in access to health;
Amendment 306 #
Proposal for a regulation
Article 4 – paragraph 3 – point c a (new)
Article 4 – paragraph 3 – point c a (new)
(ca) consult with the representatives of patients and intended end-users of health technology and take into account their needs and opinions.
Amendment 344 #
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1 (new)
Article 6 – paragraph 2 – subparagraph 1 (new)
The information should note how intended users of the health technology have been involved in the planning, development and design of the technology.
Amendment 348 #
Proposal for a regulation
Article 6 – paragraph 2 a (new)
Article 6 – paragraph 2 a (new)
2a. The designated sub-group shall also request additional data from relevant sources, such as patient registries, databases or European Reference Networks, where this is deemed necessary to complement the information provided by the developer and to perform a more accurate clinical assessment of the health technology.
Amendment 361 #
Proposal for a regulation
Article 6 – paragraph 5 – point a – subpoint 1 (new)
Article 6 – paragraph 5 – point a – subpoint 1 (new)
The analysis shall include consideration for the accessibility of the technology concerned and how to ensure it does not increase inequalities in access to health.
Amendment 504 #
Proposal for a regulation
Article 18 – paragraph 2 – introductory part
Article 18 – paragraph 2 – introductory part
2. In the preparation of the study, the Coordination Group shall equally consult:
Amendment 532 #
Proposal for a regulation
Article 22 – paragraph 1 – introductory part
Article 22 – paragraph 1 – introductory part
1. TIn consultation with all relevant stakeholders, including patient organisations, the Commission shall adopt implementing acts concerning:
Amendment 539 #
Proposal for a regulation
Article 22 – paragraph 1 – point a – point iii
Article 22 – paragraph 1 – point a – point iii
(iii) the consultation of patients and patient organisations, clinical experts, and other stakeholders in clinical assessments.
Amendment 553 #
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, and to enable the participation of patient and consumer representatives in the stakeholder network, joint clinical assessments and scientific consultations. Assessor and co- assessors shall be entitled to a special allowance compensating them for their work on joint clinical assessments and joint scientific consultations in accordance with internal Commission provisions.
Amendment 565 #
Proposal for a regulation
Article 26 – paragraph 1
Article 26 – paragraph 1
1. The Commission shall establish a stakeholder network through an open call for applications and a selection of suitable stakeholder organisations, including patient organisations, based on selection criteria established in the open call for applications.
Amendment 571 #
Proposal for a regulation
Article 26 – paragraph 3 – introductory part
Article 26 – paragraph 3 – introductory part
3. The Commission shall organise ad- hocregular meetings between the stakeholder network and the Coordination Group in order to:
Amendment 576 #
Proposal for a regulation
Article 26 – paragraph 4
Article 26 – paragraph 4
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 observerparticipants.
Amendment 578 #
Proposal for a regulation
Article 26 – paragraph 5
Article 26 – paragraph 5
5. On the request of the Coordination Group, the stakeholder network shall support the Coordination Group in the identification of further patient and clinical expertise for the work of its sub-groups.
Amendment 583 #
Proposal for a regulation
Article 27 – paragraph 2
Article 27 – paragraph 2
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. Information shall in principle be publicly accessible unless there are specific reasons to restrict access.
Amendment 586 #
Proposal for a regulation
Article 27 – paragraph 2 a (new)
Article 27 – paragraph 2 a (new)
2a. A comprehensive summary report that is understandable to lay persons shall be provided for the publications referred to in paragraph 1. The content of that summary report shall be specified in consultation with patients and consumers’ organisations.