12 Amendments of Christofer FJELLNER related to 2018/0018(COD)
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 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 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.