Activities of Bolesław G. PIECHA related to 2018/0018(COD)
Plenary speeches (1)
Health technology assessment (debate) PL
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU PDF (1 MB) DOC (258 KB)
Amendments (33)
Amendment 203 #
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. __________________ 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 204 #
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. JointCollaborative 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 viewon medical technologies should be conducted on a voluntary basis. A selection of medical devices for jointcollaborative clinical assessments should be made based on specific criteria. __________________ 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 209 #
Proposal for a regulation
Recital 14 a (new)
Recital 14 a (new)
(14a) In order for the clinical assessment to be used for the purposes of the national reimbursement decision, it should concern the population for which the drug would be reimbursed in a given Member State. The assessor and the co- assessor should have the responsibility for choosing a representative number of populations.
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 220 #
Proposal for a regulation
Recital 18
Recital 18
(18) The establishment of a time-frame for the joint clinical assessments for medical devices should take into account the highly decentralised market access pathway for medical devices and the availability of appropriate evidence data required to carry out a joint clinical assessment. As the required evidence may only become available after a medical device has been placedRegulations (EU) 2017/745 and (EU) 2017/746 set new requirements for high-quality data on the safety and efficacy of medical devices and in-vitro medical devices, which include clinical investigations and evidence on the clinical benefit onf the market and in order to allow for the selection of medical devices for joint clinical assessment at an appropriate time, it should be possible for assessments of such devices to take place following market launch of medical devicesdevices. Therefore medical devices and in-vitro medical devices shall not be part of the EU joint assessment.
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 223 #
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 accesset access of health technologies. This work focusses solely on the efficacy of health technologies. This work and 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.
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 242 #
Proposal for a regulation
Recital 30
Recital 30
(30) During the transitional period, participation in joint clinical assessments and joint scientific consultations should not be mandatory for Member States. This should not affect the obligation of Member States to apply harmonised rules to clinical assessments carried out at a national level. During the transitional period, Member States not participating in the joint work may at any time decide to participate. In order to ensure a stable and smooth organisation of the joint work and the functioning of the internal market, Members States which are already participating should not be allowed to withdraw from the framework for joint work. Clinical assessments which start in Member States before the application of this Regulation should be continued, unless Member States decide to stop them.
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 313 #
Proposal for a regulation
Article 5 – paragraph 1 – point b
Article 5 – paragraph 1 – point b
Amendment 314 #
Proposal for a regulation
Article 5 – paragraph 1 – point b
Article 5 – paragraph 1 – point b
Amendment 319 #
Proposal for a regulation
Article 5 – paragraph 1 – point c
Article 5 – paragraph 1 – point c
Amendment 321 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
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 365 #
Proposal for a regulation
Article 6 – paragraph 5 – subparagraph 1 (new)
Article 6 – paragraph 5 – subparagraph 1 (new)
The assessor and the co-assessor shall make sure that the choice of relevant patient groups is representative for the Member States participating to enable them to take appropriate decisions on funding these technologies from national health budgets.
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 445 #
Proposal for a regulation
Article 9 – paragraph 2 a (new)
Article 9 – paragraph 2 a (new)
2a. Member States may update the clinical assessments for their own use taking into account their local conditions. If a Member States decides to take such a decision, it shall inform the Coordination Group. The Coordination Group may oppose within the period of 3 months only if a majority of three fourth votes against it.
Amendment 451 #
Proposal for a regulation
Article 11 – paragraph 1 – point f
Article 11 – paragraph 1 – point f
Amendment 498 #
Proposal for a regulation
Article 16 – paragraph 1 – point f
Article 16 – paragraph 1 – point f
Amendment 507 #
Proposal for a regulation
Article 18 – paragraph 2 – point e
Article 18 – paragraph 2 – point e
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 516 #
Proposal for a regulation
Article 19 – paragraph 1 – subparagraph 1 (new)
Article 19 – paragraph 1 – subparagraph 1 (new)
Groups of Member States which share a common need identify, define and conduct collaborative clinical assessments on medical devices and in vitro diagnostics, as defined by Article 19(1) (b). The composition of these groups can vary.
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 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.
Amendment 593 #
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 sectormay consider the work already undertaken in the EUnetHTA Joint Actions.
Amendment 594 #
Proposal for a regulation
Article 33 – paragraph 1
Article 33 – paragraph 1
1. Member States may delay their participation in the system of joint clinical assessments and joint scientific consultations referred to in sections 1 and 2 of Chapter II until ... [insert date 35 years after the date of application].
Amendment 595 #
Proposal for a regulation
Article 33 – paragraph 3 a (new)
Article 33 – paragraph 3 a (new)
3a. By way of derogation from Article 8 paragraph 1, Member States may choose to continue clinical assessments initiated before the date of application of this Regulation or the date referred to in paragraph 1 of this Article, if applicable.