25 Amendments of Biljana BORZAN related to 2018/0018(COD)
Amendment 173 #
Proposal for a regulation
Recital 1
Recital 1
(1) The development of health technologies is a key driver of to improving health policies through access to more progressive health tecohnomic growth and innovation in the Union. Itlogies, and thus achieving a high level of health protection. At the same time, health technologies are an innovative sector of the economy which forms part of an overall market for healthcare expenditure that accounts for 10% of EU gross domestic product. Health technologies encompass medicinal products, medical devices and medical procedures, as well as measures for disease prevention, diagnosis or treatment.
Amendment 193 #
Proposal for a regulation
Recital 6
Recital 6
(6) While Member States have carried out some joint assessments within the framework of the EU co-funded joint actions, the production of output has been inefficient, relying on project-based cooperation in the absence of a sustainable model of cooperat. This was done in three stages, under Article 15 of Directive 2011/24/EC, through three joint actions, each with specific objectives and a specific budget: EUnetHTA 1, 2010 to 2012 (EUR 6 million); EUnetHTA 2, 2012 to 2015 (EUR 9.5 million); and EUnetHTA 3, launched in June 2016 with an end date of 2020 (EUR 20 million). Use of the results of the jointGiven the timescales for these actions, includand ing their joint clinical assessments, at Member State-level has remained low, meaning that the duplication of assessments on the same health technology by HTA authorities and bodies in different Member States within identical or similar timeframes has not been sufficiently addressed. interests of continuity, this Regulation establishes a more sustainable way of ensuring the continuation of the joint assessments. The main outcomes of this co-working to date include: the HTA Core model, which provides a framework for HTA reports; early dialogue between HTA bodies and EMA; a database for sharing projects that are planned, ongoing or recently published by individual agencies (POP database); a data and knowledge base for the storage of information, and the stage reached in the assessment of promising technologies or the request for supplementary studies arising from the HTA; and a set of adjustment tools developed to help HTA agencies adapt reports from one context to another.
Amendment 198 #
Proposal for a regulation
Recital 10
Recital 10
(10) In order to ensure a better functioning of the internal market and contribute to a high level of human health protection it is appropriate to approximate the rules on carrying out clinical assessments at national level and clinical assessments of certain health technologies at Union level, and which also support the continuation of voluntary cooperation between Member States on certain aspects of HTA. This approximation should guarantee the highest quality standards and be aligned to best available practice. It should not stimulate a convergence towards the lowest common denominator and force HTA bodies with more expertise and higher standards to accept lower requirements. It should rather lead to an improvement of the HTA capacity and quality at the national (and regional) level.
Amendment 210 #
Proposal for a regulation
Recital 15
Recital 15
(15) In order to ensure a Member-State led approach to joint clinical assessments and scientific consultations, Member States should designate national HTA authorities and bodies which inform decision-making as members of the Coordination Group. The designated authorities and bodies should ensure an appropriately high level of representation in the Coordination Group and technical expertise in its sub- groups, taking into account the need to provide expertise on the HTA of medicinal products and medical devices. The organisational structure should respect the distinctive mandates of the sub-groups conducting the joint clinical assessments and the joint scientific consultations with separate member of the sub-groups performing these functions to avoid any conflict of interest.
Amendment 233 #
Proposal for a regulation
Recital 23
Recital 23
(23) The Union should continue to support voluntary cooperation on HTA between Member States in areas such as in the development and implementation of vaccination programmes, and capacity building of national HTA systems. Such voluntary cooperation should also facilitate synergies with initiatives under the digital single market strategy in relevant digital and data-driven areas of health and care with a view to the provision of additional real world evidence relevant for HTA.
Amendment 234 #
Proposal for a regulation
Recital 23 a (new)
Recital 23 a (new)
(23a) In order to ensure efficient decision-making and facilitate access to medicines it is important that appropriate frameworks and structures exist for cooperation across decision-makers at key stages of the medicines’ life cycle. This will help to avoid delays between marketing authorisation and subsequent decisions on access within the national healthcare systems. Relevant stages in the medicine life cycle are early dialogue on evidence plans as well as regulatory approval and HTA relative effectiveness assessments. These frameworks and structures shall facilitate exchange of information and knowledge whilst respecting the different remits of each decision maker.
Amendment 239 #
Proposal for a regulation
Recital 27 a (new)
Recital 27 a (new)
(27a) The availability of sufficient capacity at the national (and regional) level is of paramount importance in order to ensure contribution from all Member States to the joint work. The Union will therefore provide funding for training and capacity building to stimulate exchange of experience between national authorities and experts and ensure alignment of quality standards together with a balanced distribution of the workload.
Amendment 270 #
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
3. The Coordination Group shall act by consensus, or, where necessary, vote by simple majorityo consensus is reached, by a two-thirds majority of Member States present. There shall be one vote per Member State.
Amendment 283 #
Proposal for a regulation
Article 3 – paragraph 6
Article 3 – paragraph 6
6. Members of the Coordination Group, and their appointed representatives shall respect the principles of independence, impartiality, transparency and confidentiality. Members of the Coordination group, their appointed representatives and other experts shall not have financial or other interests in the health technology industry which could affect their independence and impartiality. They shall undertake to act in the public interest and in an independent manner, and shall make an annual declaration of their financial interests. This annual declaration of interest shall be published on the IT platform. Members of the Coordination Group, their appointed representatives and other experts shall declare, at each meeting, any potential conflict of interest with respect to the items on the agenda. In the event of such a conflict of interest, the concerned member of the coordination group, appointed representative or expert shall withdraw from the meeting whilst the relevant items of the agenda are being dealt with.
Amendment 287 #
Proposal for a regulation
Article 3 – paragraph 7
Article 3 – paragraph 7
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 27and other experts, together with their annual declaration of interests, on the IT platform referred to in Article 27. This list shall be regularly updated and accessible to the general public.
Amendment 335 #
Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 2
Article 6 – paragraph 1 – subparagraph 2
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. The summary report shall be made publicly available in a lay-friendly format in all official languages of the European Union.
Amendment 336 #
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. The designated sub-group shall request relevantthe health technology developers to submit all available up-to-date documentation containing the information, data and evidence necessary for the joint clinical assessmentstudies 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 being of paramount importance in ensuring that assessments are of high quality. However, assessors can access public databases and sources of clinical information. The reproducibility of the assessment implies that such information has to be public. In addition, for medicinal products referred to in Article 5(1)(a), the European Medicines Agency shall provide the relevant adopted scientific assessment reports to the Coordination Group.
Amendment 378 #
Proposal for a regulation
Article 6 – paragraph 9
Article 6 – paragraph 9
9. The designated sub-group shall ensure that stakeholders, including patients’ associations and clinical experts, civil society organizations, social partners, consumer organizations, healthcare professionals and NGOs are given an opportunity to provide comments during the preparation of the draft joint clinical assessment report and the summary report and set a reasonable time-frame in which they may submit comments.
Amendment 397 #
Proposal for a regulation
Article 6 – paragraph 12
Article 6 – paragraph 12
12. The Coordination Group shall approve the final joint clinical assessment report and summary report, wherever possible by consensus or, where necessary, by a simpleo consensus is reached, by a two-thirds majority of Member States present.
Amendment 404 #
Proposal for a regulation
Article 6 – paragraph 14 a (new)
Article 6 – paragraph 14 a (new)
14a. The joint clinical assessment report and the summary report must be ready in not less than 80 days and not more than 210 days, except in justified cases where, owing to clinical necessity, the process needs to be accelerated or delayed.
Amendment 475 #
Proposal for a regulation
Article 13 – paragraph 9
Article 13 – paragraph 9
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. All comments, which shall be public and duly answered in the scientific consultation report, shall be published on the IT platform referred to in Article 27 following finalisation of the joint clinical assessment of the health technology for which the consultation was sought.
Amendment 483 #
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 simpleo consensus is reached, by a two-thirds majority of Member States present, at the latest 100 days following the start of the preparation of the report referred to in paragraph 4.
Amendment 517 #
Proposal for a regulation
Article 19 – paragraph 1 – point d a (new)
Article 19 – paragraph 1 – point d a (new)
(da) the tightening of the rules on clinical evidence, including a coordinated procedure for the authorisation of multi- centre clinical research;
Amendment 540 #
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, clinical experts, and other stakeholders in clinical assessments.
Amendment 552 #
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, as well as projects for training and capacity building to support exchange of experience and sharing of good practices between national authorities and experts. 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 564 #
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 based on selection criteria established in the open call for applications. Best practices in preventing conflict of interest shall apply to the selection of members of the stakeholder network.
Amendment 572 #
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 580 #
Proposal for a regulation
Article 27 – paragraph 1 – point d a (new)
Article 27 – paragraph 1 – point d a (new)
(da) list of members of the Coordination Group, its sub-groups and other experts, together with their declaration of financial interests;
Amendment 581 #
Proposal for a regulation
Article 27 – paragraph 1 – point d b (new)
Article 27 – paragraph 1 – point d b (new)
(db) final joint clinical assessment reports and summary reports in a lay- friendly format in all official languages of the European Union;
Amendment 582 #
Proposal for a regulation
Article 27 – paragraph 1 – point d c (new)
Article 27 – paragraph 1 – point d c (new)
(dc) list of organisations included in the stakeholder network;