55 Amendments of Andrey KOVATCHEV related to 2018/0018(COD)
Amendment 182 #
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, social, and legal aspects. The scientific aspects of 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.
Amendment 190 #
Proposal for a regulation
Recital 5
Recital 5
(5) The carrying out of parallel assessments by multiple Member States and divergences between national laws, regulations and administrative provisions on the processes and methodologies of assessment can result in health technology developers being confronted with multiple and divergent requests for data. It can also lead to both duplications and variations in outcomes that increase the financial and administrative burdens that act as a barrier to the free movement of the health technologies concerned and the smooth functioning of the internal market. In some justified cases where specificities of the national (and regional) healthcare system and priorities need to be taken into account a complementary assessment on certain aspects might be necessary.
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 201 #
Proposal for a regulation
Recital 11
Recital 11
(11) In accordance with Article 168(7) of the Treaty on the Functioning of the European Union (TFEU), the Member States remain responsible for the organisation and delivery of their healthcare. As such, it is appropriate to limit the scope of Union rules to those aspects of HTA that relate to the scientific aspects of the clinical assessment of a health technology, and in particular, to ensure that the assessment conclusions are confined to findings relating to the comparative effectiveness of a health technologyis confined to the descriptive analysis and the degree of certainty on the relative effects with no ranking or qualification of the level of effects of a health technology. The summary assessment of the scientific analysis contains value judgements and is therefore reserved for the appraisal at national level. The outcome of such assessments should not therefore affect the discretion of Member States in relation to subsequent decisions on pricing and reimbursement of health technologies, including the fixing of criteria for such pricing and reimbursement which may depend on both clinical and non-clinical considerations, and which remain solely a matter of national competence.
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 219 #
Proposal for a regulation
Recital 17 a (new)
Recital 17 a (new)
(17a) The joint scientific consultation, when addressing Orphan medicines, has to ensure that any new approach should not result in unnecessary delays for Orphan Medicinal Products assessment compared to the current situation and taken into account the pragmatic approach undergone through the EUnetHTA.
Amendment 238 #
Proposal for a regulation
Recital 25 a (new)
Recital 25 a (new)
(25a) The Commission, together with Member States, should adapt the framework of joint clinical assessment to vaccines to take into account their preventive nature that brings benefits to individuals and populations over a long time horizon. They should involve the appropriate national bodies in the joint clinical assessment of vaccines.
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 246 #
Proposal for a regulation
Recital 31
Recital 31
(31) In order to ensure that the support framework continues to be as efficient and cost-effective as possible, the Commission should report on the implementation of the provisions on the scope of the joint clinical assessments and on the functioning of the support framework no later than two years after the end of the transitional period. The report may in particular consider whether there is a need to move this support framework to a Union agency and introduce a fee-paying mechanism through which health technology developers would also contribute to the financing of the joint work.
Amendment 253 #
Proposal for a regulation
Article 1 – paragraph 2
Article 1 – paragraph 2
2. This Regulation shall not affect the rights and obligations of Member States with regard to the organisation and delivery of health services and medical care and the allocation of resources assigned to them. Furthermore, this Regulation shall not interfere with the exclusive national competence of Member States for national pricing and reimbursement decisions.
Amendment 256 #
Proposal for a regulation
Article 2 – paragraph 1 – point e
Article 2 – paragraph 1 – point e
(e) ‘joint clinical assessment’ means a compilation and evaluationdescriptive analysis of the available scientific evidence on a health technology in comparison with one or more other health technologies based on the scientific aspects of 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, an descriptive analysis of the relative clinical effectiveness, and the relative safety of the health technology;
Amendment 267 #
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 majority. There shall be one vote per Member States far as possible act by consensus. Abstentions shall not prevent the adoption of decisions by consensus. Where no consensus is reached, the Coordination Group shall act by a majority of two thirds. There shall be one vote per Member State. An absent member’s vote shall count in the vote if a written mandate is given to another member of the group.
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 309 #
Proposal for a regulation
Article 5 – paragraph 1 – point a
Article 5 – paragraph 1 – point a
(a) medicinal products subject to the authorisation procedure provided for in Regulation (EC) No 726/2004, including where an amendment has been made to the Commission Decision to grant a marketing authorisation based on a change in the therapeutic indication or indications for which the original authorisation was granted, with the exception of medicinal products authorised under Articles 10 and 10a of Directive 2001/83/EC; with the exception of medicinal products authorised under Articles 10c and under Article 10 of Directive 2001/83/EC, unless it concerns a new therapeutic indication compared to the reference medicinal product.
Amendment 311 #
Proposal for a regulation
Article 5 – paragraph 1 – point a a (new)
Article 5 – paragraph 1 – point a a (new)
(aa) applications for new therapeutic indications for medicinal products authorised in accordance with Regulation (EC) No 726/2004.
Amendment 312 #
Proposal for a regulation
Article 5 – paragraph 1 – point b
Article 5 – paragraph 1 – point b
Amendment 315 #
Proposal for a regulation
Article 5 – paragraph 1 – point b – subparagraph 1 a (new)
Article 5 – paragraph 1 – point b – subparagraph 1 a (new)
The Commission shall, by means of Delegated Acts, include in Article 5 paragraph 1 of this Regulation a specific product category of medical devices if at least five Member States are systematically performing health technology assessments on the same specific product category of medical devices.
Amendment 317 #
Proposal for a regulation
Article 5 – paragraph 1 – point c
Article 5 – paragraph 1 – point c
Amendment 320 #
Proposal for a regulation
Article 5 – paragraph 1 – point c – subparagraph 1 a (new)
Article 5 – paragraph 1 – point c – subparagraph 1 a (new)
The Commission shall, by means of Delegated acts, include in Article 5 paragraph 1 of this Regulation a specific product category of in vitro diagnostic medical devices if at least five Member States are systematically performing health technology assessments on the same specific product category of in vitro diagnostic medical devices.
Amendment 329 #
Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 1
Article 6 – paragraph 1 – subparagraph 1
The Coordination Group shall initiate joint clinical assessments of health technologies on the basis of its annual work programme by designating a sub-group to oversee the preparation of the joint clinical assessment report on behalf of the Coordination Group. Member States may propose additional comparator, which from their point of view represents the relevant evidence-based standard of care in their Member State. In case this proposal has not been taken into account, the relevant Member State may use the mechanism referred to in Article 8 – paragraph 1 a (new).
Amendment 330 #
Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 1
Article 6 – paragraph 1 – subparagraph 1
The Coordination Group shall initiate joint clinical assessments of health technologies on the basis of its annual work programme by designating a sub-group to oversee the preparation of the joint clinical assessment report on behalf of the Coordination Group. For medicinal products referred to in Article 5(1)(a), the joint clinical assessment report shall be adopted by the Coordination Group within 90 days in order to ensure compliance with timelines for pricing and reimbursement set out in Council Directive 89/105/EEC.
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 340 #
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. The designated sub-group shall request relevant health technology developers to submit documentation containing the information, data and evidence necessary for the joint clinical assessment. The submitted documentation must include all available evidence and data for the joint clinical assessment.
Amendment 355 #
Proposal for a regulation
Article 6 – paragraph 5 – introductory part
Article 6 – paragraph 5 – introductory part
5. The conclusions of the joint clinical assessment report shall be limited to the following:
Amendment 356 #
Proposal for a regulation
Article 6 – paragraph 5 – point a
Article 6 – paragraph 5 – point a
(a) an analysis of the relative effects of the health technology being assessed on the patient-relevant health outcomes chosen for the assessment compared to one or more comparator treatments to be determined by the Coordination Group;
Amendment 359 #
Proposal for a regulation
Article 6 – paragraph 5 – point a
Article 6 – paragraph 5 – point a
(a) an descriptive scientific analysis of the relative effects of the health technology being assessed on the patient-relevantclinical health outcomes chosen for the assessment;
Amendment 362 #
Proposal for a regulation
Article 6 – paragraph 5 – point b
Article 6 – paragraph 5 – point b
(b) the degree of certainty on the relative effects based on the available evidence. The assessment shall be based on the clinical endpoints established according to international standards of evidence-based medicine, in particular with regard to improving the state of health, shortening the duration of the disease, prolonging survival, reducing side effects or improving the quality of life. Reference should also be made to subgroup-specific differences.
Amendment 394 #
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 simple majority of Member States. Diverging positions and the grounds on which they are based should be recorded in the final report.
Amendment 407 #
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Where the Commission considers that there are no legal obstacles to the inclusion of the approved joint clinical assessment report and summary report comply with the substantiin a list of technologies that have aund procedural requirements laid down in this Regulation,ergone a joint clinical assessment (hereafter referred to as ‘the list of assessed technologies’ or ‘list’) it shall include the name of the health technology which has been the subject of the approved report and summary report, in a list of technologies having undergone joint clinical assessment (the "the ‘List of Assessed Health Technologies" or the "List")’ at the latest 30 days after receipt of the approved report and summary report from the Coordination Group.
Amendment 413 #
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Where, within 30 days of receipt of the approved joint clinical assessment report and the summary report, the Commission concludes that the approved joint clinical assessment report and summary report do not comply with the substantive and procedurlegal requirements laid down in this Regulation, it shall inform the Coordination Group of the reasons for its conclusions and request it to review the report and summary report.
Amendment 420 #
Proposal for a regulation
Article 7 – paragraph 4
Article 7 – paragraph 4
4. Following the submission of the modified approved joint clinical assessment report and summary report, and where the Commission considers that the modified approved joint clinical assessment report and summary report comply with the substantive and procedurlegal requirements laid down in this Regulation, it shall include the name of the health technology which has been the subject of the report and summary report, in the List of Assessed Health Technologies.
Amendment 424 #
Proposal for a regulation
Article 7 – paragraph 5
Article 7 – paragraph 5
5. If the Commission concludes that the modified approved joint clinical assessment report and summary report do not comply with the substantive and procedurlegal requirements laid down in this Regulation, it shall decline to include the name of the health technology in the List. The Commission shall inform the Coordination Group thereof, setting out the reasons for the non- inclusion. The obligations laid down in Article 8 shall not apply with respect to the health technology concerned. The Coordination Group shall inform the submitting health technology developer accordingly and include summary information on those reports in its annual report.
Amendment 436 #
Proposal for a regulation
Article 8 – paragraph 1 a (new)
Article 8 – paragraph 1 a (new)
1a. This shall not prevent the Member States from complementing the joint clinical assessment with clinical assessments comparing the technology against a comparator which represents the best available evidence based standard of care in this Member State which, despite the Member States request during the scoping face, will not form part of the joint clinical assessment and which is necessary to complete the health technology assessment in that Member State. Any such measure should be justified, necessary and proportionate to achieving this aim. Any national assessment complementing the joint clinical assessment should follow the methodology established in accordance with Article 22. Member States shall notify the Commission and the Coordination Group of their intention to complement the joint clinical assessment together with a justification for doing so no later than 2 weeks after the Coordination Group has laid down the specific requirements for the joint assessment of the specific technology.
Amendment 443 #
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 through 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 450 #
Proposal for a regulation
Article 11 – paragraph 1 – point c
Article 11 – paragraph 1 – point c
(c) determining the detailed procedural steps and their timing, and the overall duration of joint clinical assessments;
Amendment 492 #
Proposal for a regulation
Article 14 – paragraph 2
Article 14 – paragraph 2
2. The Coordination Group shall include anonymised summary information onpublish the joint scientific consultations in its annual reports andin the IT platform referred to in Article 27.
Amendment 522 #
Proposal for a regulation
Article 20 – paragraph 1 – introductory part
Article 20 – paragraph 1 – introductory part
The common procedural rules and methodology established in accordance with Article 22 and the requirements established in accordance with Article 23 shall apply to: the joint clinical assessments carried out in accordance with Chapter II. Where relevant and appropriate Member States can apply these common procedural rules, methodology and requirements for clinical assessments of medicinal products and medical devices carried at national (and regional) level.
Amendment 526 #
Proposal for a regulation
Article 20 – paragraph 1 – point a
Article 20 – paragraph 1 – point a
Amendment 527 #
Proposal for a regulation
Article 20 – paragraph 1 – point b
Article 20 – paragraph 1 – point b
Amendment 547 #
Proposal for a regulation
Article 22 – paragraph 1 a (new)
Article 22 – paragraph 1 a (new)
1a. Procedural rules and methodologies referred to in paragraph 1 shall follow the output of the EUnetHTA Joint Actions, be developed and agreed between all stakeholders in a transparent manner, updated periodically and publicly available.
Amendment 548 #
Proposal for a regulation
Article 22 – paragraph 1 b (new)
Article 22 – paragraph 1 b (new)
1b. The methodology mentioned in paragraph 1(b) shall also take into account : – the lifelong effect of a vaccine through appropriate time horizon of the analyses; – indirect effects such as herd immunity; – elements independent from the vaccine as such, for example coverage rates linked to programmes.
Amendment 550 #
Proposal for a regulation
Article 23 – paragraph 1 – point a – introductory part
Article 23 – paragraph 1 – point a – introductory part
(a) the contentformat and templates of:
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 566 #
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 applicationssuch as legitimacy, representation, transparency and accountability.
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 573 #
Proposal for a regulation
Article 26 – paragraph 3 – point b a (new)
Article 26 – paragraph 3 – point b a (new)
(ba) seek input into the annual work programme and the annual study prepared by the Coordination Group;
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;
Amendment 585 #
Proposal for a regulation
Article 27 – paragraph 2
Article 27 – paragraph 2
2. The Commission shall ensure appropriate levels ofpublic access to the information contained in the IT platform for Member State bodies, members of the stakeholder network, and the general public.
Amendment 588 #
Proposal for a regulation
Article 28 – paragraph 1
Article 28 – paragraph 1
No later than two years after the end of the transitional period referred to in Article 33(1), the Commission shall report on the implementationpresent an evaluation report focusing among other things on the impact of the provisRegulations on the scope of the joint clinical assessments and on the functioning of the support framework referred to in this Chapteraccessibility of new technologies for patients, health systems sustainability, HTA quality and capacity at the national (and regional) level, as well as the progress with regard to research and development of innovative medicinal products in areas of unmet need.
Amendment 592 #
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 consider the work already undertaken in the EUnetHTA Joint Actions.
Amendment 596 #
Proposal for a regulation
Article 34 – paragraph 1
Article 34 – paragraph 1
1. Member States may carry out a clinical assessment using means other than the rules provided for in Chapter III of this Regulation, on grounds related to the need to protect public health or other overriding reasons of public interest in the Member State concerned and provided the measure is justified, necessary and proportionate as regards achieving that aim.
Amendment 597 #
Proposal for a regulation
Article 34 – paragraph 3
Article 34 – paragraph 3
3. The Commission shall, within threone months 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 threone month period, the planned clinical assessment shall be deemed to be approved.