9 Amendments of Sunčana GLAVAK related to 2023/0132(COD)
Amendment 161 #
Proposal for a directive
Recital 9
Recital 9
(9) Medicinal products for rare diseases and for children, should be subject to the same conditions as any other medicinal product concerning their quality, safety and efficacy, for example for what concerns the marketing authorisation procedures, quality and the pharmacovigilance requirements. However, specific requirements also apply to them considering their unique characteristics, and encountered problems such as failure to timely accomplish the paediatric clinical studies and obtain data required for marketing authorization, which results in significant delay of approval in children compared to adults. Such requirements, which are currently defined in separate legislations, should be integrated in general pharmaceutical legal framework in order to ensure clarity and coherency of all the measures applicable to these medicinal products. Furthermore, as some medicinal products authorised for use in children are authorised by the Member States, specific provisions should be integrated in this Directive.
Amendment 238 #
Proposal for a directive
Recital 50
Recital 50
(50) The establishment of a criteria- based definition of ‘unmet medical need’ is required to incentivise the development of medicinal products in therapeutic areas that are currently underserved. To ensure that the concept of unmet medical need reflects scientific and technological developments and current knowledge in underserved diseases, the Commission should specify and update using implementing acts, the criteria of satisfactory method of diagnosis, prevention or treatment, ‘remaining high morbidity or mortality’, ‘relevant patient population’, quality of life and long-term health and developmental consequences relevant for paediatric patients following scientific assessment by the Agency. The Agency will seek input from a broad range of authorities or bodies active along the lifecycle of medicinal products in the framework of the consultation process established under the [revised Regulation (EC) No 726/2004] and also take into account scientific initiatives at EU level or between Member States related to analysing unmet medical needs, burden of disease and priority setting for research and development. The criteria for ‘unmet medical need’ can be subsequently used by Member States to identify specific therapeutic areas of interest.
Amendment 241 #
Proposal for a directive
Recital 50 a (new)
Recital 50 a (new)
(50 a) The development of medical products in underserved therapeutic areas can greatly increase the quality of life for patients. In that regard, elements such as acute or chronic side effects, in particular in relation to the toxicity of a product, as well as the ability of patients to perform regular life activities, the presence of pain and the management of co-morbidities should be considered in the assessment of improving quality of life. The importance of the long-term age appropriate development and maturation of paediatric patients, and of retaining their normal daily activities, can not be overemphasized.
Amendment 341 #
Proposal for a directive
Recital 76 a (new)
Recital 76 a (new)
(76 a) For the purpose of paediatric marketing authorization of medicinal products already approved for use in adults, when the agreed paediatric investigation plan cannot be timely accomplished due to failure to conduct paediatric clinical studies, the competent authorities may consider the evidence obtained from extrapolation of adult data and from the appropriately designed post- marketing long-term studies for monitoring safety and efficacy.
Amendment 556 #
Proposal for a directive
Article 6 – paragraph 5 – subparagraph 1 – point a a (new)
Article 6 – paragraph 5 – subparagraph 1 – point a a (new)
(a a) when the agreed paediatric investigation plan cannot be timely accomplished due to failure to conduct paediatric clinical studies, the evidence obtained from extrapolation and all information on safety and efficacy collected from the appropriately designed post-marketing long-term studies
Amendment 767 #
Proposal for a directive
Article 49 – paragraph 1 – point a
Article 49 – paragraph 1 – point a
(a) the results of all clinical studies, conducted in compliance with an agreed paediatric investigation plan as referred to in Article 6(5), point (a), and (aa) shall be included in the summary of product characteristics and, if appropriate, in the package leaflet, or
Amendment 1350 #
Proposal for a directive
Article 86 – paragraph 1 – subparagraph 1
Article 86 – paragraph 1 – subparagraph 1
Where an application for marketing authorisation, includes the results of all studies conducted in compliance with an agreed paediatric investigation plan, or the supplementary evidence based on extrapolation and/or from the appropriately designed post-marketing long-term studies in pediatric patients receiving the drug, the holder of the patent or supplementary protection certificate shall be entitled to a six-month extension of the period referred to in Article 13, paragraphs 1 and 2 of [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted].
Amendment 1355 #
Proposal for a directive
Article 87 – paragraph 1 – subparagraph 1 – point b a (new)
Article 87 – paragraph 1 – subparagraph 1 – point b a (new)
(b a) to conduct a post-authorisation safety and efficacy long-term study in children receiving the drug “of the label” because the paediatric investigation plan could not be accomplished due to failure to timely complete paediatric clinical studies.
Amendment 1368 #
Member States shall operate a pharmacovigilance system for the fulfilment of their pharmacovigilance tasks and their participation in the Union pharmacovigilance activities including the pharmacovigilance over the post- authorization safety and efficacy long- term studies in children using the drug off label, because of the failed marketing authorization for reasons such as failure to timely complete paediatric clinical studies.