35 Amendments of Kateřina KONEČNÁ related to 2018/0018(COD)
Amendment 178 #
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1a) Marketing authorisations for medicinal products are granted by the European Medicines Agency based on the evaluation of efficacy, safety and quality, while it is normally the national HTA agencies that assess comparative effectiveness.
Amendment 181 #
Proposal for a regulation
Recital 3
Recital 3
(3) HTA covers both clinical and non- clinical aspects of a health technology. The EU co-funded joint actions on HTA (EUnetHTA Joint Actions) have identified nine domains by reference to which health technologies are assessed. Of these nine domains, four are clinical and five are non- clinical. The four clinical domains of assessment concern the identification of a health problem and current technology, the examination of the technical characteristics of the technology under assessment, its relative safety, and its relative clinical effectiveness. The five non-clinical assessment domains concern cost and economic evaluation of a technology, its ethical, organisational, patient and social, and legal aspects. The clinical domains are therefore more suited to joint assessment at EU-level on their scientific evidence base, while the assessment of non-clinical domains tends to be more closely related to national and regional contexts and approaches. However, the following should be covered in the description of the technology and be part of the joint assessment: – when ‘patient and social aspects’ complete the information on efficacy and relative effectiveness; – health technologies, whose delivery is typically cross-border and/or involves highly complex organisational aspects.
Amendment 184 #
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. In this regard, greater collaboration between Member States in the field of HTA should also help improve and harmonise standards of care as well as diagnosing and new born screening practices across the EU.
Amendment 188 #
Proposal for a regulation
Recital 4 a (new)
Recital 4 a (new)
(4a) Cooperation in the field of HTA can extend beyond pharmaceutical products and medical devices. Different demands are involved in assessing different technologies, depending on their specific features, meaning that a cohesive approach which can cater for these different technologies is needed in the field of HTA. Moreover, in specific areas such as treatments for rare diseases, paediatric medicines and advanced therapies, the added value of cooperation at EU level will be even greater. The specificities of orphan medicines should be taken into account within the implementation of this proposal in order to ensure rare disease patients are given the same opportunities to access treatments for their conditions.
Amendment 194 #
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. 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). Given the timescales for these actions, and in the 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; 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. However, within the joint actions, the production of output has been inefficient, relying on project-based cooperation in the absence of a sustainable model of cooperation. Use of the results of the joint actions, including 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.
Amendment 196 #
Proposal for a regulation
Recital 8
Recital 8
(8) The European Parliament, in its resolution of 2 March 2017 on EU options for improving access to medicines,9 called on the Commission to propose legislation on a European system for health technology assessment as soon as possible and to harmonise transparent health technology assessment criteria in order to assess the added therapeutic valuerelative effectiveness and the safety of medicines. __________________ 9 European Parliament resolution of 2 March 2017 on EU options for improving access to medicines – 2016/2057(INI).
Amendment 221 #
Proposal for a regulation
Recital 19
Recital 19
(19) In all cases the joint work carried out under this Regulation, in particular the joint clinical assessments, should produce high quality and timely results, and not delay or interfere with the CE marking of medical devices or market access of health technologies. This work should be separate and distinct from regulatory assessments of the safety, quality, efficacy or performance of health technologies carried out pursuant to other Union legislation and have no bearing on decisions taken in accordance with other Union legislation. In the framework of HTA, the joint report should not re-assess the elements on which the marketing authorisation is based, including the quality, safety, efficacy, bioequivalence, or biosimilarity of the medicinal product which have been already assessed during the marketing authorisation process. Similarly, in the case of orphan medicinal products, the joint report should not re-assess the criteria of the orphan designation. However, assessors and co-assessors should have full access to the data used by the authorities responsible for granting the marketing authorisation of a medicinal product, as well as the possibility of using or generating additional relevant data for the purpose of assessing a medicinal product in the context of a joint HTA.
Amendment 227 #
Proposal for a regulation
Recital 21
Recital 21
Amendment 229 #
Proposal for a regulation
Recital 21 a (new)
Recital 21 a (new)
(21a) According to the European Ombudsman, where the information in a document has implications for the health of individuals (such as information on the efficacy of a medicine), the public interest in disclosure will generally defeat any claim of commercial sensitivity. Public health should always trump commercial interests.
Amendment 235 #
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, distinct 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 and in particular the methodological guidelines and evidence submission templates. 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 initiative. The procedural and methodological frameworks shall be updated at the frequency deemed necessary by the Commission to ensure that they are adapted to the evolution of science. In developing the methodological framework, the Commission shall consider the specificity and corresponding challenges of certain types of health technologies, such as medicinal products for rare diseases, certain advanced therapies or certain life-prolonging therapies. Inherent data limitations often lead to evidential uncertainty at the time of marketing authorisation. The Commission should ensure that the methodology provides for a sufficient level of flexibility to enable an adequate assessment of such health technologies, similarly to the practice established at the European Medicines Agency and the acceptance of innovative clinical study designs. Such flexibility should include the acceptance of the best available scientific evidence at the time of the submission, including, for instance, data from case control studies, real world observational data, as well as the acceptance of indirect treatment comparisons. 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 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 237 #
Proposal for a regulation
Recital 25 a (new)
Recital 25 a (new)
(25a) The Commission, together with the Member States, should adapt the framework of joint clinical assessment to vaccines to take into account the vaccines preventive nature that brings benefits to individuals and populations over a long time horizon, and should involve the appropriate national bodies in the joint clinical assessment of vaccines. The adaption of the framework should be completed by the end of the implementation period to ensure that it is ready to be used during the transition period.
Amendment 252 #
Proposal for a regulation
Article 1 – paragraph 1 – introductory part
Article 1 – paragraph 1 – introductory part
1. TBased on the results of the work already undertaken in the EUnetHTA Joint Actions, this Regulation establishes:
Amendment 258 #
Proposal for a regulation
Article 2 – paragraph 1 – point e
Article 2 – paragraph 1 – point e
(e) ‘clinical assessment’ means a compilation and evaluation 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 at the time of regulatory approval;
Amendment 259 #
Proposal for a regulation
Article 2 – paragraph 1 – point g a (new)
Article 2 – paragraph 1 – point g a (new)
(ga) ‘appraisal’ means drawing conclusions on the added value of the technologies concerned as part of national appraisal processes which may consider clinical as well as non-clinical data and criteria.
Amendment 261 #
Proposal for a regulation
Article 2 – paragraph 1 – point g b (new)
Article 2 – paragraph 1 – point g b (new)
(gb) ‘patient-relevant health outcomes’ means data that captures or predicts mortality, morbidity, health-related quality of life and adverse events.
Amendment 263 #
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 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. In addition to Member States representatives, the Commission will also nominate: (a) two representatives and two alternates of patients’ organizations as full members of the Coordination Group and its sub-groups, selected from a list of eligible candidates drawn up by the European Commission, following a public call of expression of interest, so that the list includes appreciably more names than there are posts to be filled; (b) two additional members, chosen on the basis of their specific scientific competence, as full members of the Coordination Group. The patient representatives will hold voting rights; however, their vote, will be reported in the minutes of the meeting, will not be counted for the adoption of joint reports.
Amendment 264 #
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 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 which inform decision-making as members of the Coordination Group and one or more of its sub-groups..
Amendment 294 #
Proposal for a regulation
Article 3 – paragraph 8 – point d
Article 3 – paragraph 8 – point d
(d) ensure appropriate and regular involvement of stakeholders in its work;
Amendment 332 #
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, and taking into account the results of the work already undertaken in the EUnetHTA Joint Actions and EUnetHTA procedures for joint clinical assessments of pharmaceuticals.
Amendment 349 #
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 complete the information provided by the developer and to perform a more accurate clinical assessment of the health technology.
Amendment 350 #
Proposal for a regulation
Article 6 – paragraph 2 b (new)
Article 6 – paragraph 2 b (new)
2b. Relevant health technology developers shall include developers of technologies that are already authorised and which serve as comparators for the new one.
Amendment 351 #
Proposal for a regulation
Article 6 – paragraph 2 c (new)
Article 6 – paragraph 2 c (new)
2c. When relevant developers are requested to submit documentation necessary for the joint clinical assessment, they have the obligation to do so. Failure to do so will result in an explicit mention in the report.
Amendment 367 #
Proposal for a regulation
Article 6 – paragraph 7
Article 6 – paragraph 7
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. A minimum time frame of 30 work- days is provided for members of the sub-group to comment on the draft report, and procedural aspects will be decided as provided for in Article 11. The Commission may also provide comments.
Amendment 379 #
Proposal for a regulation
Article 6 – paragraph 9
Article 6 – paragraph 9
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. To ensure appropriate consultation on the draft summary report, different versions in different EU languages should be available.
Amendment 402 #
Proposal for a regulation
Article 6 – paragraph 13
Article 6 – paragraph 13
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. The developer shall be consulted on the report before its publication with a period of 20 working days to flag any information it considers confidential and to justify its commercially sensitive nature. In last resort, the assessor and the co-assessor shall decide.
Amendment 403 #
Proposal for a regulation
Article 6 – paragraph 14 a (new)
Article 6 – paragraph 14 a (new)
14a. Upon receipt of the approved joint clinical assessment report and summary report, the submitting health technology developer may object in writing to the Coordination Group and the Commission within 7 working days. The developer shall provide detailed grounds for their objections. The Coordination Group shall evaluate the objections within 7 working days and revise the report, as necessary. It shall approve and submit the final joint clinical assessment report, the summary report and an explanatory document detailing how the objections were addressed to the submitting health technology developer and the Commission.
Amendment 411 #
Proposal for a regulation
Article 7 – paragraph 1 a (new)
Article 7 – paragraph 1 a (new)
1a. All of the necessary steps leading to the inclusion of the name of the health technology which has been the subject of the approved report and summary report shall be completed by the time of the publication of the Commission decision granting marketing authorisation.
Amendment 440 #
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
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 itsthe completion of the national/regional report. 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.
Amendment 444 #
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The Coordination Group may carry out updates of joint clinical assessments where requested by one or more of its members. Updates 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 report is decided, the member who proposed it can update the report and propose it for adoption by other Member States by mutual recognition. When updating the report, the Member State will apply the methods and standards as defined by the Coordination Group. In case Member States disagree with the update and it cannot be adopted by consensus, the case will be referred to the Coordination Group that will decide whether to carry out an update based on this new information. When an update is approved by mutual recognition or after the Coordination Group has carried out an update, the joint report is considered updated.
Amendment 448 #
Proposal for a regulation
Article 11 – paragraph 1 – point c
Article 11 – paragraph 1 – point c
(c) determining the detailed procedural steps, including for appeal mechanisms for health technology developers, and their timing, and the overall duration of joint clinical assessments;
Amendment 461 #
Proposal for a regulation
Article 13 – paragraph 2
Article 13 – paragraph 2
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. In light of the challenges related to conducting a clinical assessment for orphan medicines due to the limited number of patients enrolled in clinical trials and/or the lack of a comparator, a tailored clinical assessment pathway should be developed for this category of treatments.
Amendment 530 #
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
1. Where a clinical assessment is carried out by a Member State, that Member State shall provide the Commission with the clinical assessment report and summary report at the latest 30 working days after the completion of the health technology assessment. The summary report shall be written in an understandable manner for the general public.
Amendment 543 #
Proposal for a regulation
Article 22 – paragraph 1 – point b
Article 22 – paragraph 1 – point b
(b) methodologies to be consistently used to formulate the contents and design of clinical assessments.
Amendment 569 #
Proposal for a regulation
Article 26 – paragraph 3 – introductory part
Article 26 – paragraph 3 – introductory part
3. The Commission shall organise ad- hoc meetings between the stakeholder networks, such as industry, patient groups and clinical experts, and the Coordination Group in order to:
Amendment 591 #
Proposal for a regulation
Article 32 – paragraph 2
Article 32 – paragraph 2
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 and shall build on the work already undertaken in the EUnetHTA Joint Actions.