16 Amendments of Sirpa PIETIKÄINEN related to 2023/0131(COD)
Amendment 238 #
Proposal for a regulation
Recital 25
Recital 25
(25) In certain cases, shortcomings in Member States’ system of supervision and related enforcement activities could risk to substantially hinder the achievement of the objectives of this Regulation and those of revised Directive 2001/83/EC which could even lead to the emergence of risks to public health or to environment. To address these challenges, harmonised inspection standards should be ensured through the establishment of a joint audit programme within the Agency. This joint audit programme will also further harmonise the interpretation of good manufacturing and distribution practices on the basis of Union legislative requirements. Moreover, it will support further mutual recognition of inspection outcomes between Member States and with strategic partners. Within the joint audit programme, the competent authorities are subject to regular audits conducted by other Member States to maintain an equivalent and harmonised quality system and to ensure an appropriate implementation of relevant good manufacturing and distribution practices into national laws and equivalence with other EEA inspectorates.
Amendment 328 #
Proposal for a regulation
Recital 77
Recital 77
(77) The development of antimicrobial resistance is a growing concern and the pipeline of effective antimicrobials is obstructed due to a market failure whereby access dynamics at Member State level constitute a significant disincentive for companies to invest in the development of novel antibiotics; it is therefore necessary to consider new measures to promote the development of priority antimicrobials that are effective against antimicrobial resistance and to support undertakings, often SMEs, which choose to invest in this area.
Amendment 355 #
Proposal for a regulation
Recital 79 a (new)
Recital 79 a (new)
(79 a) The fight against antimicrobial resistance will only be addressed through push (R&D focused) and pull (access focused) incentives at EU and national level. In order to provide the right signal on which products to incentivise at both EU and national level, the creation of an AMR Designation is needed. Such AMR Designation would allow the EU to identify all products which could contribute to the fight against antimicrobial resistance and would provide the necessary focus to coherently target R&D and access incentives.
Amendment 458 #
Proposal for a regulation
Recital 134
Recital 134
(134) In the area of medicinal products, a high level of protection of inter alia citizens, consumers, health, the environment, as well as legal certainty, a level playing field and fair competition always need to be ensured and existing levels of protection need to be respected.
Amendment 475 #
Proposal for a regulation
Recital 137
Recital 137
(137) To achieve a better security of supply for medicinal products in the internal market and to contribute thereby to a high level of public health protection, it is appropriate to approximate the rules on monitoring and reporting of actual or potential shortages of medicinal products, including the procedures and the respective roles and obligations of concerned entities in this Regulation. It is important to ensure continued supply of medicinal products, which is often taken for granted across Europe. This is especially true for the most critical medicinal products which are essential to ensure the continuity of care, the provision of quality healthcare and guarantee a high level of public health protection in Europe. To combat certain shortages, medicinal products prepared for individual patients in a pharmacy according to a medical prescription “magistral formula”, or according to the pharmacopoeia and intended to be supplied directly to patients served by the pharmacy “officinal formula”, may be used.
Amendment 671 #
Proposal for a regulation
Article 15 – paragraph 1 – point f a (new)
Article 15 – paragraph 1 – point f a (new)
(f a) there is an equivalent product on the market with less negative environmental impacts.
Amendment 715 #
Proposal for a regulation
Article 19 – paragraph 3
Article 19 – paragraph 3
3. Conditional marketing authorisations or a new conditional therapeutic indication granted pursuant to this Article shall be subject to specific obligations, such as the obligation to conduct a post-authorisation environmental risk assessment study. Those specific obligations and, where appropriate, the time limit for compliance shall be specified in the conditions to the marketing authorisation. Those specific obligations shall be reviewed annually by the Agency for the first three years after granting the authorisation and every two years thereafter.
Amendment 733 #
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1 – point a
Article 20 – paragraph 1 – subparagraph 1 – point a
(a) conducts a post-authorisation safety study if there are concerns about the risks of an authorised medicinal product to the environment or to public health. If the same concerns apply to more than one medicinal product, the Agency shall, following consultation with the Pharmacovigilance Risk Assessment Committee, encourage the marketing authorisation holders concerned to conduct a joint post-authorisation safety study;
Amendment 793 #
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 environmental and health risks of the product, taking into consideration the threat posed by the public health emergency.
Amendment 887 #
Proposal for a regulation
Article 40 a (new)
Article 40 a (new)
Article 40a AMR Designation 1. All AMR medicinal products developed to address a priority pathogens should be granted an AMR designation through an open and transparent Community procedure. 2. A medicinal product shall be designated as an AMR medicinal product if its sponsor can establish: a) That it is intended for the diagnosis, prevention or treatment of a pathogen included in the ‘WHO priority pathogens list for R&D of new antibiotics’, or an equivalent list established at Union level. b) That there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in the Community or, if such method exists, that the medicinal product will be of significant benefit to those affected by that condition. 3. In order to obtain the designation of a medicinal product as an AMR medicinal product, the sponsor shall submit an application to the Agency before or at the moment of the application for marketing authorisation is made. The application shall be accompanied by the following particulars and documents: a) name or corporate name and permanent address of the sponsor; b) active ingredients of the medicinal product; c) proposed therapeutic indication; d) justification that the criteria laid down in Article x(y) are met, the indications expected and the relevant preclinical and clinical data. The Agency shall verify the validity of the application and ensure that an opinion is given within 90 days of the receipt of a valid application.
Amendment 891 #
Proposal for a regulation
Article 40 b (new)
Article 40 b (new)
Amendment 957 #
Proposal for a regulation
Article 45 – paragraph 2 – subparagraph 2
Article 45 – paragraph 2 – subparagraph 2
The marketing authorisation holder shall without undue delay inform the Agency and the Commission of any prohibition or restriction imposed on the marketing authorisation holder or any entity in contractual relationship with the marketing authorisation holder by the competent authorities of any country in which the medicinal product is marketed and of any other new information which might influence the evaluation of the benefits and risks, both health risks and environmental risks, of the medicinal product concerned. The information shall include both positive and negative results of clinical trials or other studies in all indications and populations, whether or not included in the marketing authorisation, as well as data on the use of the medicinal product where such use is outside the terms of the marketing authorisation.
Amendment 1109 #
Proposal for a regulation
Article 68 – paragraph 2
Article 68 – paragraph 2
2. Medicinal products designated as orphan medicinal products under the provisions of this Regulation shall be eligible for incentives made available by the Union and by the Member States to support research into, and the development and availability of, orphan medicinal products and in particular aid for research for small- and medium-sized undertakings and not-for-profit entities provided for in framework programmes for research and technological development.
Amendment 1457 #
Proposal for a regulation
Article 115 – paragraph 1 – subparagraph 1
Article 115 – paragraph 1 – subparagraph 1
The regulatory sandboxes shall not affect the supervisory and corrective powers of the competent authorities. In case of identification of risks to public health or environment or safety concerns associated with the use of products covered by a sandbox, competent authorities shall take immediate and adequate temporary measures in order to suspend or restrict their use and inform the Commission in accordance with Article 113(2).
Amendment 1580 #
Proposal for a regulation
Article 122 – paragraph 4 – point e a (new)
Article 122 – paragraph 4 – point e a (new)
(e a) specify the systems and procedures to ensure the European Shortages Monitoring Platform (ESMP) includes accurate information on available critical medicinal stocks in legal entities that are authorised or entitled to supply medicinal products to the public including pharmacies supplying hospitals and hospital pharmacies.
Amendment 1625 #
Proposal for a regulation
Article 125 – paragraph 1 – point f
Article 125 – paragraph 1 – point f
(f) inform the Agency of the causes and of the end date of the critical shortage.