22 Amendments of Francesca DONATO related to 2023/0131(COD)
Amendment 38 #
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1 a) The European Parliament resolution of 12 July 2023 on the COVID- 19 pandemic: lessons learned and recommendations for the future 2022/2076 (INI);
Amendment 39 #
Proposal for a regulation
Recital 1 b (new)
Recital 1 b (new)
(1 b) European Parliament Resolution 2022/2076 calls for further investment in research and development activities geared towards achieving public interest objectives (Article 296) and ‘calls on the Commission to use industrial, intellectual property and pharmaceutical strategies to encourage public funding for research and development projects in order to comply with the principle of open science and to close the persistent gap in research and medicine production through partnerships, technology transfer and the creation of open research centres’ (Article 590);
Amendment 51 #
Proposal for a regulation
Recital 29 a (new)
Recital 29 a (new)
(29 a) The Bonn Declaration includes in the definition of freedom of scientific research the right to critical debate, the protection of plurality of voices, the ‘right to freely define questions, choose and develop theories, collect empirical material and use sound academic research methods to question recognised knowledge and advance new ideas’; the “right to share, disseminate and publish its results openly, including through training and teaching”; “the freedom of researchers to express their views without being penalised by the system in which they work or by government or government censorship or discrimination”;
Amendment 110 #
Proposal for a regulation
Recital 106
Recital 106
(106) Before a medicinal product for human use is placed on the market in one or more Member States, it has to have undergone extensive studies, including non-clinical tests and clinical trials, to ensure that it is safe, of high quality and effective for use in the target population, strictly respecting the timing and phases of the clinical trial. It is important that such studies are undertaken also on the paediatric population in order to ensure that medicinal products are appropriately authorised for use in the paediatric population, and to improve the information available on the use of medicinal products in the various paediatric population. It is also important that medicinal products are presented in dosages and formulations adequate for the use in children.
Amendment 111 #
Proposal for a regulation
Recital 109
Recital 109
Amendment 114 #
Proposal for a regulation
Recital 131
Recital 131
(131) It is necessary to provide for the coordinated implementation of Union procedures for the marketing authorisation of medicinal products, and of the marketing authorisation procedures of Member States which have already been harmonised to a considerable degree by [revised Directive 2001/83/EC] and respect clinical drug trial times.
Amendment 142 #
Proposal for a regulation
Recital 147
Recital 147
(147) Consequently, it is particularly difficult - although it can be justified in accordance with the precautionary principle - to conduct multi-centre clinical trials with investigational medicinal products that contain or consist of GMOs involving several Member States.
Amendment 143 #
Proposal for a regulation
Recital 151
Recital 151
Amendment 182 #
Proposal for a regulation
Article 13 – paragraph 4 a (new)
Article 13 – paragraph 4 a (new)
4 a. the benefit/risk balance is objectively favourable and any adverse reactions are not statistically relevant
Amendment 193 #
Proposal for a regulation
Article 18 – paragraph 1 – point c a (new)
Article 18 – paragraph 1 – point c a (new)
(c a) clinical studies on all aspects of efficacy and safety have been carried out with a monitoring period of at least six months, demonstrating in a sufficiently clear and reliable manner both the efficacy and safety of the medicinal product and the total absence of serious or lethal adverse effects
Amendment 194 #
Proposal for a regulation
Article 18 – paragraph 1 – point c b (new)
Article 18 – paragraph 1 – point c b (new)
(c b) clinical studies are conducted under external supervision by independent parties subject to confidentiality for commercial purposes, but who are able to report to the Agency on the correctness and completeness of the trials carried out
Amendment 195 #
Proposal for a regulation
Article 18 – paragraph 1 – point c c (new)
Article 18 – paragraph 1 – point c c (new)
(c c) for medicines authorised in an emergency, there must be an active pharmacovigilance system – not only passive – also in the consources of the subjects on which the medicine is administered outside the clinical trial.
Amendment 196 #
Proposal for a regulation
Article 19 – paragraph 1 – subparagraph 1
Article 19 – paragraph 1 – subparagraph 1
In duly justified cases, to meet an unmet medical need of patients, as referred to in Article 83(1), point (a), of [revised Directive 2001/83/EC], a conditional marketing authorisation or a new conditional therapeutic indication to an existing marketing authorisation authorised under this Regulation may be granted by the Commission to a medicinal product that is likely to address the unmet medical need in accordance with Article 83(1), point (b), of [revised Directive 2001/83/EC], prior to the submission of comprehensive clinical data provided that the benefit of the immediate availability on the market of that medicinal product outweighs the risk inherent in the fact that additional data are still required. The benefit-risk assessment must be based on reliable, clear and verifiable data and not approximate and based on presumptive or generic assessments.
Amendment 198 #
Proposal for a regulation
Article 19 – paragraph 2
Article 19 – paragraph 2
2. Conditional marketing authorisations or a new conditional therapeutic indication referred to in paragraph 1 may be granted only if the benefit-risk balance of the medicinal product is favourable and the applicant is likely to be able to provide comprehensive data. the benefit-risk assessment must be based on reliable, clear and verifiable data and not approximate and based on presumptive or generic assessments.
Amendment 203 #
Proposal for a regulation
Article 19 – paragraph 8 a (new)
Article 19 – paragraph 8 a (new)
8 a. the benefit-risk assessment should be reassessed every two months on the basis of new available data on the safety and efficacy of the product, on the possible lethal effects of the disease, including when treated, and on the availability of therapeutic solutions to treat it.
Amendment 205 #
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1 – introductory part
Article 20 – paragraph 1 – subparagraph 1 – introductory part
After the granting of a marketing authorisation, the Agency may consider that it is necessary that the marketing authorisation holdershall require the holder of the agency to:
Amendment 207 #
Proposal for a regulation
Article 20 – paragraph 3 a (new)
Article 20 – paragraph 3 a (new)
3 a. The competent authorities of the Member States may withdraw the authorisation for placing on the market the presence of statistically relevant evidence of adverse reactions and serious side effects and shall reserve the same possibility of withdrawal until the labelling and package leaflet of the medicinal product concerned has been updated with those serious side effects
Amendment 208 #
Proposal for a regulation
Article 21
Article 21
Amendment 225 #
Proposal for a regulation
Article 31 – paragraph 1 – point a
Article 31 – paragraph 1 – point a
(a) there is no other satisfactory method of treatment, prevention or diagnosis authorised or sufficiently available in the Union or, if such method is already available, the temporary emergency marketing authorisation of the medicinal product will contribute to address the public health emergency;
Amendment 226 #
Proposal for a regulation
Article 31 – paragraph 1 – point b
Article 31 – paragraph 1 – point b
(b) based on the scientific evidence available, the Agency issues an opinion concluding that the medicinal product could be effective in treating, preventing or diagnosing the disease or condition directly related to the public health emergency, and the known and potential benefits of the product outweigh the known and potential risks of the product, taking into consideration the threat posed by the public health emergency.
Amendment 234 #
Proposal for a regulation
Article 37
Article 37
Amendment 235 #
Proposal for a regulation
Article 39
Article 39