27 Amendments of Fulvio MARTUSCIELLO related to 2023/0132(COD)
Amendment 315 #
Proposal for a directive
Recital 69
Recital 69
(69) The pollution of waters and soils with pharmaceutical residues is an emerging environmental problem, and there is scientific evidence that the presenclevels of some of thoese substances inmay pose a risk to the environment from their manufacturing, use and disposal poses a risk to the environment and public health. The evaluation of the legislation showed that strengthening of existing measures to reduce the impact of medicinal products' lifecycle on the environment and public health is required. Measures under this Regulation complement the main environmental legislation, in particular the Water Framework Directive (2000/60/EC50 ), the Environmental Quality Standard Directive (2008/105/EC51 ) the Groundwater Directive (2006/118/EC52 ), the Urban Wastewater Treatment Directive (91/271/EEC53 ), the Drinking Water Directive (2020/218454 ) and the Industrial Emissions Directive (2010/75/EU55 ). _________________ 50 Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1). 51 Directive 2008/105/EC of the European Parliament and of the Council of 16 December 2008 on environmental quality standards in the field of water policy, amending and subsequently repealing Council Directives 82/176/EEC, 83/513/EEC, 84/156/EEC, 84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of the European Parliament and of the Council (OJ L 348, 24.12.2008, p. 84). 52 Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the protection of groundwater against pollution and deterioration (OJ L 372, 27.12.2006, p. 19). 53 Council Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment (OJ L 135, 30.5.1991, p. 40). 54 Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (recast) (OJ L 435, 23.12.2020, p. 1). 55 Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (recast) (OJ L 334, 17.12.2010, p. 17).
Amendment 323 #
Proposal for a directive
Recital 70
Recital 70
(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures where medicinal products are demonstrated to pose a risk to the environment according to the ERA. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment, the marketing authorisation should be refused. The ERA should be updated when new data or knowledgand fails to address short- comings indicated by the Agency or competent authority, the marketing authorisation shall be provisional while not prohibiting or delaying patient access to medicines. The ERA should be updated when new data that changes the ERA conclusions or evidence about relevant risks become available.
Amendment 331 #
Proposal for a directive
Recital 71
Recital 71
(71) Marketing authorisation applicants should take into accountconsider the relevance of environmental risk assessment procedures of other EU legal frameworks that may apply to chemicals dependent on their use. Further to this Regulation, there are four main other frameworks: (i) Industrial chemicals (REACH, (Regulation (EC) No 1907/2006); (ii) Biocides (Regulation (EC) No 528/2012); (iii) Pesticides (Regulation (EC) No 1107/2009); and (iv) Veterinary medicines (Regulation (EU) 2019/6)). As a part of the Green Deal, the Commission has proposed a ‘one-substance one- assessment’ (OS-OA) approach for chemicals56 , in order to increase the efficiency of the registration system, reduce costs and unnecessary animal testing while not prohibiting or delaying patient access to medicinal products. _________________ 56 Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions, The European Green Deal, Brussels (2019), COM(2019) 640 final.
Amendment 335 #
Proposal for a directive
Recital 72
Recital 72
(72) The emissions and discharges of antimicrobialbiotics to the environment from manufacturing sites may lead to antimicrobialbiotic resistance (“AMBR”), which is a global concern regardless where the emissions and discharges take place. Therefore, the ERA scope should be extended to cover the risk of AMR selection during the entire life cycle of antimicrobials, including manufacturingantibiotic resistance selection during manufacturing of the antibiotics.
Amendment 337 #
Proposal for a directive
Recital 74
Recital 74
(74) For medicinal products authorised prior to October 2005, without any ERA, specific provisions should be introduced to set up a risk based prioritisation programme for the ERA submission or update by the current market authorisation holders for those medicinal products that present a serious risk to the environment.
Amendment 500 #
Proposal for a directive
Article 4 – paragraph 1 – point 26
Article 4 – paragraph 1 – point 26
(26) ‘combination of a medicinal product with a product other than a medical device’ means a combination of a medicinal product with a product other than a medical device (as defined by Regulation (EU) 2017/745) and Regulation (EU) 2017/746) and where the two are intended for use in the given combination in accordance with the summary of product characteristics;
Amendment 523 #
Proposal for a directive
Article 4 – paragraph 1 – point 33
Article 4 – paragraph 1 – point 33
(33) ‘environmental risk assessment’ means the evaluation of the potential risks to the environment, or risks to public health, posed by the release of the medicinal product in the environment from the use and disposal of the medicinal product and the identification of risk prevention, limitation and mitigation measures. For medicinal product with an antimicrobialbiotic mode of action, the ERA also encompasses an evaluation of the risk for antimicrobialbiotic resistance selection in the environment due to the manufacturing, use and disposal of that medicinal product;
Amendment 528 #
Proposal for a directive
Article 4 – paragraph 1 – point 35 – point c
Article 4 – paragraph 1 – point 35 – point c
(c) of undesirable effects on public health due to the release of the medicinal product in the environment including anti- microbialbiotic resistance;
Amendment 623 #
Proposal for a directive
Article 22 – paragraph 3
Article 22 – paragraph 3
3. TWhen the ERA indicates a risk to the environment, the applicant shall also include in the ERA risk mitigation measures to avoid or where it is not possible, limit emissions to air, water and soil of pollutants listed in Directive 2000/60/EC, Directive 2006/118/EC, Directive 2008/105/EC and Directive 2010/75/EU. The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment.
Amendment 634 #
Proposal for a directive
Article 22 – paragraph 4
Article 22 – paragraph 4
4. The ERA for antimicrobialbiotics shall include an evaluation of the risk for antimicrobialbiotic resistance selection in the environment due to the entire manufacturing supply chain inside and outside theof the active substance or medicinal product within the European Union , use and disposal of the antimicrobialbiotic taking into account, where relevant, the existing international standards that have established predicted no effect concentration (PNECs) specific for antibiotics.
Amendment 640 #
Proposal for a directive
Article 22 – paragraph 6 – subparagraph 1
Article 22 – paragraph 6 – subparagraph 1
The marketing authorisation holder shall update the ERA with new information without undue delay to the relevant competent authorities, in accordance with Article 90(2), if new information pertaining to the assessment criteria referred to in Article 29 becomes available and could leads to a change of the conclusions of the ERA. The update shall include any relevant information from environmental monitoring, including monitoring under Directive 2000/60/EC, from eco-toxicity studies, from new or updated risk assessments under other Union legislation, as referred to in paragraph 1, and environmental exposure data.
Amendment 656 #
Proposal for a directive
Article 23 – paragraph 1 – subparagraph 1
Article 23 – paragraph 1 – subparagraph 1
By [OP please insert the date = 30 months after the date of the entry into force of this Directive] the Agency shall, after consultation with the competent authorities of the Member States, the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA), establish a programme for the ERA to be submitted in accordance with Article 22 of the medicinal products authorised before 30 October 2005 that have not been subject to any ERA and that the Agency has identified asto potentially harmfulcause a risk to the environment by risk-based prioritisation in accordance with paragraph 2.
Amendment 660 #
Proposal for a directive
Article 23 – paragraph 2
Article 23 – paragraph 2
2. The Agency shall set the scientific criteria for the identification of the medicinal products asthat potentially harmfulcause a risk to the environment and for the prioritisation of their ERA, using a risk based approach. For this task, the Agency may request from marketing authorisation holders the submission of relevant data or information.
Amendment 665 #
Proposal for a directive
Article 23 – paragraph 3
Article 23 – paragraph 3
3. The current marketing authorisation holders for medicinal products identified in the programme referred to in paragraph 1 shall submit the ERA to the Agency. The outcome of the assessment of the ERA including the data submitted by the marketing authorisation holder shall be made publicly available by the Agency.
Amendment 667 #
Proposal for a directive
Article 23 – paragraph 4
Article 23 – paragraph 4
4. Where there are several medicinal products identified in the programme referred to in paragraph 1 that contain the same active substance and that are expected to pose the same risks to the environment, the competent authorities of the Member States or the Agency shall encourage the marketing authorisation holders to conduct joint studies for the ERA, to minimise unnecessary duplication of data and use of animals, specifically to avoid unnecessary testing of vertebrate species and to follow the 3R rule.
Amendment 670 #
Proposal for a directive
Article 24 – paragraph 2
Article 24 – paragraph 2
2. The setting-up of the system of ERA monographs shall be based on a risk- based prioritisation of active substances and relevant data requirements, particularly considering vertebrate studies.
Amendment 671 #
Proposal for a directive
Article 24 – paragraph 3
Article 24 – paragraph 3
3. In the preparation of the ERA monograph referred to in paragraph 1, the Agency may request existing information, studies and data from competent authorities of the Member States and from marketing authorisation holders.
Amendment 673 #
Proposal for a directive
Article 24 – paragraph 4
Article 24 – paragraph 4
4. The Agency in cooperation with the competent authorities of the Member States shall conduct a proof-of-concept pilot of ERA monographs to be completed within three years after entering into force of this Directive taking into consideration outcomes from relevant initiatives.
Amendment 674 #
Proposal for a directive
Article 24 – paragraph 5 – point e a (new)
Article 24 – paragraph 5 – point e a (new)
(e a) risk-based prioritisation of data requirements for active substances to avoid unnecessary testing, particularly in- line with directive 2010/63/EU.
Amendment 729 #
Proposal for a directive
Article 43 – paragraph 5
Article 43 – paragraph 5
5. The competent authorities of the Member States shall draw up an assessment report and make comments on the file as regards the results of the pharmaceutical and non-clinical tests, the clinical studies, the risk management system, the environmental risk assessment and the pharmacovigilance system of the medicinal product concerned. For expedited review processes, competent authorities shall agree binding timelines with the applicants to provide a full ERA after receiving the marketing authorisation.
Amendment 742 #
Proposal for a directive
Article 44 – paragraph 1 – subparagraph 1 – point h
Article 44 – paragraph 1 – subparagraph 1 – point h
(h) to conduct post-authorisation environmental risk assessment studies, collection of monitoring data or information on use, where identified or potential concerns about risks to the environment or public health, including antimicrobial resistance need to be further investigated after the medicinal product has been marketed;
Amendment 760 #
Proposal for a directive
Article 47 – paragraph 1 – point d
Article 47 – paragraph 1 – point d
(d) tThe envirconmtental risk assessment is incomplete or insufficiently substantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant; or timelines of post- authorisation studies to further clarify environmental risk assessment, as required under Article 44, paragraph 1, point (h), cannot be agreed.
Amendment 776 #
Proposal for a directive
Article 51 – paragraph 1 – point e
Article 51 – paragraph 1 – point e
(e) is an antimicrobialbiotic ; or
Amendment 780 #
Proposal for a directive
Article 51 – paragraph 1 – point f
Article 51 – paragraph 1 – point f
(f) contains an active substance which are persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative, or persistent, mobile and toxic, or very persistent and very mobile for which medical prescription is required as an agreed risk minimisation measure with regard to the environment, unless the use of the medicinal product and the patient safety require otherwise.
Amendment 1357 #
to conduct a post-authorisation environmental risk assessment study, collection of monitoring data or information on use, if there are concerns about the risks to the environment or public health, including antimicrobialand/or antibiotic resistance, due to an authorised medicinal product, or related active substance. Such measures may be imposed at both initial marketing authorisations and as response to a review where a risk to the environment has been identified.
Amendment 1549 #
Proposal for a directive
Article 195 – paragraph 2
Article 195 – paragraph 2
2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may suspend, revoke or vary a marketing authorisation if a serious risk to the environment or public health has been identified and not sufficiently addressed by the marketing authorisation holder via conditions laid out in Articles 44(h) or 87(c).
Amendment 1558 #
Proposal for a directive
Article 196 – paragraph 1 – point f
Article 196 – paragraph 1 – point f
(f) a serious risk to the environment or to public health via the environment has been identified and not sufficiently addressed by the marketing authorisation holder via conditions laid out in Articles 44(h) or 87(c).