69 Amendments of Cristian-Silviu BUŞOI related to 2018/0018(COD)
Amendment 25 #
Proposal for a regulation
Recital 2
Recital 2
(2) Health Technology Assessment (HTA) is an evidence-based, multidisciplinary process that allows competent authorities to determine the relative effectiveness of new or existing health technologies and should be carried out in a systematic, independent and transparent manner. HTA focuses specifically on the added value of a health technology in comparison with other new or existing health technologies.
Amendment 32 #
Proposal for a regulation
Recital 12
Recital 12
(12) In order to ensure a wide application of harmonised rules on clinical aspects of HTA and enable pooling of expertise and resources across HTA bodies, it is appropriate to require joint clinical assessments to be carried out for all medicinal products undergoing the central marketing authorisation procedure provided for under Regulation (EC) No 726/2004 of the European Parliament and of the Council,11 which incorporate a new active substance, and where those medicinal products are subsequently authorised for a new therapeutic indication. Joint clinical assessments should also be carried out on certain medical devices within the meaning of Regulation (EU) 2017/745 of the European Parliament and of the Council12 which are in the highest risk classes and for which the relevant expert panels have provided their opinions or views. A selection of medical devices for joint clinical assessment should be made based on specific criteria given the need for greater clinical evidence concerning all of these new technologies. _________________ 11 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). 12 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
Amendment 43 #
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 template. 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 framework are updated at the frequency deemed necessary by the Commission to ensure that they should be adapted to the evolution of science. In developing the methodological framework, the Commission should consider the specificity and corresponding challenges of certain types of health technologies, advanced therapies or life- prolonging therapies where innovative clinical study designs may be required. These may result in evidential uncertainty at the time of the marketing authorization. As such innovative clinical study designs are often accepted for the purposes of regulatory assessments, the methodology for joint clinical assessments should not prevent these health technologies from reaching patients. The Commission should therefore ensure that the methodology provides for a sufficient level of flexibility to enable an adequate assessment of such health technologies. 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 evidence, as well as the acceptance of indirect treatment comparators. 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 44 #
Proposal for a regulation
Recital 12
Recital 12
(12) In order to ensure a wide application of harmonised rules on clinical aspects of HTA and enable pooling of expertise and resources across HTA bodies, it is appropriate to require joint clinical assessments to be carried out for all medicinal products undergoing the central marketing authorisation procedure provided for under Regulation (EC) No 726/2004 of the European Parliament and of the Council,11 which incorporate a new active substance, and where those medicinal products are subsequently authorised for a new therapeutic indication. Joint clinical assessments should also be carried out on certain medical devices within the meaning of Regulation (EU) 2017/745 of the European Parliament and of the Council12 which are in the highest risk classes andclassified as high risk class IIb implantable devices and class III devices pursuant to Article 51 of Regulation (EU) 2017/745 for which the relevant expert panels have provided their opinions or views. A selection of meda scientific opinion in the framework of the clinical devices for joint clinical assessment shouldaluation consultation procedure pursuant to Article 54 of that Regulation and which have already been made based on specific criteriarketed in at least one Member State. _________________ 11 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). 12Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
Amendment 45 #
Proposal for a regulation
Recital 13
Recital 13
(13) ITo ensure timely patient access to health technologies across the Union, in order to ensure that joint clinical assessments carried out on health technologies remain accurate and relevant, and in order to avoid duplications between the regulatory assessments carried by the European Medicines Agency and the joint clinical assessments, it is appropriate to establish synergies, and conditions for the updating of assessments, in particular where additional data available subsequent to the initial assessment has the potential to increase the accuracy of the assessment.
Amendment 48 #
Proposal for a regulation
Recital 16
Recital 16
(16) In order that the harmonised procedures fulfil their internal market objective and at the same time support access to medical innovations, Member States should be required to take full account of the results of joint clinical assessments and not repeat those assessments. Compliance with this obligation does not prevent Member States from carrying out non-clinical assessments on the same health technology, or from drawing conclusions on the clinical added value of the technologies concerned as part of national appraisal processes which may consider clinical as well as non-clinical data and criteria. It also does not prevent Member States from forming their own recommendations or decisions on pricing or reimbursement.
Amendment 54 #
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 56 #
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, which, for medicinal products shall occur at the time of regulatory approval, whereas for medical devices may occur following market launch of medical devices;
Amendment 57 #
Proposal for a regulation
Article 2 – paragraph 1 – point g a (new)
Article 2 – paragraph 1 – point g a (new)
(g a) ‘patient-relevant health outcomes’ means data that captures or predicts mortality, morbidity, health-related quality of life, including pain, recovery rates, length of stay in hospitals and adverse events, including re-admissions, complications, blood loss, infections;
Amendment 58 #
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 mayshall designate more than one authority or body responsible for health technology assessment which inform decision-making at national level as members of the Coordination Group and one or more of its sub-groups.
Amendment 64 #
Proposal for a regulation
Recital 25 a (new)
Recital 25 a (new)
(25 a) The Commission, together with the Member States, should adapt the framework of joint clinical assessment to vaccines to take into account the preventive nature of vaccines 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 66 #
Proposal for a regulation
Article 3 – paragraph 8 – point c
Article 3 – paragraph 8 – point c
(c) ensure cooperation with all relevant Union level bodies to facilitate additional evidence generation necessary for its work;
Amendment 67 #
Proposal for a regulation
Article 3 – paragraph 8 – point d
Article 3 – paragraph 8 – point d
(d) ensure appropriate involvement of all relevant stakeholders in its work;
Amendment 68 #
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 69 #
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, following the end of the transitional period referred to in Article33(1), with respect to medicinal products, the identification of emerging health technologies shall follow the EMA pre-notification of medicinal products prior to marketing authorisation applications;
Amendment 70 #
Proposal for a regulation
Article 3 – paragraph 10 a (new)
Article 3 – paragraph 10 a (new)
10 a. Each national authority and body responsible for health technology assessment as members of the Coordination Group and its sub-groups, and each member and staff of each national authority and body responsible for health technology assessment shall in accordance with Union or Member State law be subject to a duty of professional secrecy both during and after their term of office, with regard to any confidential information which has come to their knowledge in the course of the performance of their tasks or exercise of their powers.
Amendment 72 #
Proposal for a regulation
Article 4 – paragraph 3 – point c a (new)
Article 4 – paragraph 3 – point c a (new)
(c a) take into account that following the end of the transitional period referred to in Article33(1), with respect to medicinal products, the identification of emerging health technologies shall follow the EMA pre-notification of medicinal products prior to marketing authorisation applications
Amendment 72 #
Proposal for a regulation
Article 2 – paragraph 1 – point g a (new)
Article 2 – paragraph 1 – point g a (new)
(g a) ´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 73 #
Proposal for a regulation
Article 5 – paragraph 1 – point a
Article 5 – paragraph 1 – point a
(a) medicinal products subject to and at the time of 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, and those medicinal products authorised under Article 8 (3) of Directive 2001/83/EC not incorporating a new active substance;
Amendment 79 #
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. With respect to medicinal products, the Coordination Group shall initiate joint clinical assessments in accordance with the EMA pre-notification of medicinal products prior to marketing authorisation applications.
Amendment 81 #
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. The designated sub-group shall requestmeet with relevant health technology developers to submiton the scope of the assessment and documentation containing the information, data and evidence necessary for the joint clinical assessment to be submitted.
Amendment 83 #
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 85 #
Proposal for a regulation
Article 6 – paragraph 9
Article 6 – paragraph 9
9. The designated sub-group shall ensure that stakeholders experts, including patients and clinical experts identified to by the Stakeholder network or by the health technology developer, 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.
Amendment 87 #
Proposal for a regulation
Article 5 – paragraph 2 – introductory part
Article 5 – paragraph 2 – introductory part
2. The Coordination Group shall select the medical devices referred to in paragraph 1 points (b) and (c) for joint clinical assessment based onif the device in question fulfils all of the following criteria:
Amendment 92 #
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 medicinal products.
Amendment 98 #
Proposal for a regulation
Article 9 – paragraph 1 – point b a (new)
Article 9 – paragraph 1 – point b a (new)
(b a) the health technology developer requests an update on the grounds that additional evidence is made available for which the Coordination Group would need to reconsider the conclusions of the initial assessment.
Amendment 99 #
Proposal for a regulation
Article 6 – paragraph 5 a (new)
Article 6 – paragraph 5 a (new)
5 a. The joint clinical assessment report shall not refer to non-clinical assessment domains nor shall it draw conclusions on the added value of the technologies concerned which remain part of national appraisal processes.
Amendment 103 #
Proposal for a regulation
Article 11 – paragraph 1 – point a
Article 11 – paragraph 1 – point a
(a) submissions of information, data and evidence by health technology developers including the protection of developers' confidential information;
Amendment 106 #
Proposal for a regulation
Article 12 – paragraph 3 a (new)
Article 12 – paragraph 3 a (new)
3 a. For medicinal products, Article 12 (2) and 12 (3) shall not apply.
Amendment 116 #
Proposal for a regulation
Article 8 – paragraph 1 – point a
Article 8 – paragraph 1 – point a
(a) not carry out a clinical assessment or an equivalent clinical assessment process on a health technology included in the List of Assessed Health Technologies or for which a joint clinical assessment has been initiated;
Amendment 117 #
Proposal for a regulation
Article 18 – paragraph 1
Article 18 – paragraph 1
1. The Coordination Group shall annually prepare a study on emerging health technologies expected to have a major impact on patients, public health or healthcare systems. Following the end of the transitional period referred to in Article 33(1), with respect to medicinal products, the identification of emerging health technologies shall follow the EMA pre-notification of medicinal products prior to marketing authorization applications.
Amendment 120 #
Proposal for a regulation
Article 8 – paragraph 1 a (new)
Article 8 – paragraph 1 a (new)
1 a. The requirement set out in point (a) of paragraph 1 shall not prevent Member States from carrying out additional assessments on the added clinical value of the health technology concerned, as part of national or regional appraisal processes, which may consider clinical evidence specific to the Member State concerned, as long as they are not included in the joint clinical assessment and are necessary to complete the pricing and reimbursement process.
Amendment 124 #
Proposal for a regulation
Article 22 – paragraph 1 – introductory part
Article 22 – paragraph 1 – introductory part
1. The Commission shall adopt implementingdelegated acts concerning:
Amendment 124 #
Proposal for a regulation
Article 10 – paragraph 1 – point a – point ii
Article 10 – paragraph 1 – point a – point ii
(ii) select medicinal products referred to in Article 5(1)(a) for joint clinical assessment based on the following selection criteria referred to in Article 5(2).:
Amendment 125 #
Proposal for a regulation
Article 22 – paragraph 1 – point a – point ii
Article 22 – paragraph 1 – point a – point ii
(ii) the mechanisms for the interaction between health technology bodies and health technology developers during clinical assessments including as regards to the protection of developer's confidential information;
Amendment 125 #
Proposal for a regulation
Article 10 – paragraph 1 – point a – point ii – point a (new)
Article 10 – paragraph 1 – point a – point ii – point a (new)
a) unmet medical needs, where there is no treatment or only unsatisfactory treatment available;
Amendment 126 #
Proposal for a regulation
Article 10 – paragraph 1 – point a – point ii – point b (new)
Article 10 – paragraph 1 – point a – point ii – point b (new)
b) potential impact on patients and public health, considering, inter alia, the burden of disease measured by mortality and morbidity, and the life-threatening or chronically debilitating nature of the disease targeted by the health technology;
Amendment 127 #
Proposal for a regulation
Article 10 – paragraph 1 – point a – point ii – point c (new)
Article 10 – paragraph 1 – point a – point ii – point c (new)
c) significant cross-border dimension;
Amendment 128 #
Proposal for a regulation
Article 22 – paragraph 1 a (new)
Article 22 – paragraph 1 a (new)
1 a. The methodologies referred to in paragraph 1(b) 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, in a transparent manner, regularly updated to reflect the evolution of science and publicly available.
Amendment 128 #
Proposal for a regulation
Article 10 – paragraph 1 – point a – point ii – point d (new)
Article 10 – paragraph 1 – point a – point ii – point d (new)
d) the available resources of the Coordination Group.
Amendment 129 #
Proposal for a regulation
Article 22 – paragraph 1 b (new)
Article 22 – paragraph 1 b (new)
Amendment 130 #
Proposal for a regulation
Article 22 – paragraph 1 c (new)
Article 22 – paragraph 1 c (new)
1 c. The methodology shall also: a) Provide for a suitable mechanism to create consensus on the identification of the patient-relevant health outcome, taking due account of the roles and preferences of relevant stakeholders, including patients, physicians, regulators, HTA bodies and health technology developers; b) take into account potential changes relating to the relevant comparator at national level due to the rapidly evolving standards of care.
Amendment 130 #
Proposal for a regulation
Article 11 – paragraph 1 – point a
Article 11 – paragraph 1 – point a
(a) submissions of information, data and evidence by health technology developers, including the protection of developers' confidential information;
Amendment 133 #
Proposal for a regulation
Article 23 – paragraph 1 a (new)
Article 23 – paragraph 1 a (new)
2. The data and evidence referred in paragraph 1(a)(i) shall be limited to the best available evidence at the time of the submission for clinical assessment and may include data from other sources than randomized clinical trials.
Amendment 136 #
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. The Commission services shall take the following criteria into account when assessing applications:
Amendment 137 #
Proposal for a regulation
Article 26 – paragraph 1 – point i (new)
Article 26 – paragraph 1 – point i (new)
(i) demonstrated current or planned engagement in HTA development (activity reports, work plans, position papers, active working groups, EU-funded actions);
Amendment 138 #
Proposal for a regulation
Article 26 – paragraph 1 – point ii (new)
Article 26 – paragraph 1 – point ii (new)
(ii) professional expertise relevant to the aims of the Pool at EU level;
Amendment 139 #
Proposal for a regulation
Article 26 – paragraph 1 – point iii (new)
Article 26 – paragraph 1 – point iii (new)
(iii) communication /dissemination capabilities
Amendment 140 #
Proposal for a regulation
Article 26 – paragraph 1 – point iv (new)
Article 26 – paragraph 1 – point iv (new)
(iv) geographical coverage of several Member States, with preference for a balanced coverage;
Amendment 141 #
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 clinicalrelevant experts nominated by the stakeholder network to attend meetings of the Coordination Group as observers.
Amendment 142 #
Proposal for a regulation
Article 27 – paragraph 1 a (new)
Article 27 – paragraph 1 a (new)
1 a. Following the end of the transitional period referred to in Article 33(1), with respect to medicinal products, the identification of emerging health technologies shall follow the EMA pre- notification of medicinal products prior to marketing authorisation applications.
Amendment 145 #
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.
Amendment 147 #
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 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 222 #
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-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 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 257 #
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 and its relative clinical effectiveness, and the relative safety of the health technology;
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 347 #
Proposal for a regulation
Article 6 – paragraph 2 a (new)
Article 6 – paragraph 2 a (new)
2a. Where the health technology under assessment is an orphan medicinal product, the Coordination Group shall consider whether a joint clinical assessment is necessary based on the availability of any additional data and evidence, further than the ones already submitted to the European Medicines Agency for the purposes of establishing a significant benefit assessment pursuant to Regulation (EC) No 141/2000. Where the Coordination Group subsequently concludes that there is no substantive reason or additional evidence to support further clinical analysis beyond the significant benefit assessment already carried by the European Medicines Agency, the conclusions of the joint clinical assessment report shall be in line with the opinion of the Committee for Orphan Medicinal Products.
Amendment 441 #
Proposal for a regulation
Article 9 – paragraph 1 – point b a (new)
Article 9 – paragraph 1 – point b a (new)
(ba) the health technology developer requests an update on the grounds that additional evidence is made available for which the Coordination Group would need to reconsider the conclusions of the initial assessment.
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 508 #
Proposal for a regulation
Article 18 – paragraph 3 – subparagraph 1 (new)
Article 18 – paragraph 3 – subparagraph 1 (new)
When preparing the study, the Coordination Group shall ensure that commercially confidential information provided by the health technology developer is adequately protected. To this end, the Coordination Group shall give the health technology developer an opportunity to submit comments with respect to the contents of the study and shall take due account of those comments.
Amendment 541 #
Proposal for a regulation
Article 22 – paragraph 1 – point a – point iii a (new)
Article 22 – paragraph 1 – point a – point iii a (new)
(iiia) ensuring that the assessments of medical devices can take place at the appropriate point in time after market launch, allowing for the use of clinical effectiveness data, including real world data. The appropriate time point shall be identified in cooperation with relevant stakeholders.
Amendment 542 #
Proposal for a regulation
Article 22 – paragraph 1 – point b
Article 22 – paragraph 1 – point b
(b) methodologies used to formulate the contents and design of clinical assessments. Common methods as well as data requirements and outcome measures shall take into account the specificities of medical devices and in vitro diagnostics.
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 589 #
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 implementation of the provisions on the scope and use of the joint clinical assessments and on the functioning of the support framework referred to in this Chapter.
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.