Annexes to COM(2023)9 - Feasibility study of an active-substance-based review system (‘monographs’) and other alternatives for the environmental risk assessment of veterinary medicinal products - Main contents
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| dossier | COM(2023)9 - Feasibility study of an active-substance-based review system (‘monographs’) and other alternatives for the environmental risk ... |
|---|---|
| document | COM(2023)9  |
| date | January 13, 2023 |
In theory, both alternative systems (AhE and Access VetMed) could be put in place without a revision of the current legal framework. However, in practice, the success of both systems would depend entirely on the willingness of the CAs to conduct the necessary work. In the absence of a clear legal framework imposing a timeline, a common approach and prioritisation of the effort by the CAs, both proposals are likely not to work.
All three systems proposed would thus require a revision of the current legal framework for VMPs.
6.Conclusions
The active-substance-based monograph system and the two alternatives that have been evaluated could to varying degrees contribute to improving environmental protection.
The monograph system would best optimise, improve and consolidate hazard data on active substances for ERA, improve knowledge about relevant environmental risks, avoid duplication of tests on vertebrate animals and thus contribute to the 3 R’s (Replace, Reduce, Refine), lead to a higher quality of ERA data, allow environmental information to be gained more efficiently and give environmental authorities, experts and the public access to ERA data. In the long term, the administrative burden on the authorities and industry is expected to be reduced. However, this effect of reducing the administrative burden is not guaranteed 20 .
The monograph system would enhance the protection of the environment thus supporting one of the main objectives of Regulation (EU) 2019/6 21 . Moreover, the monograph system could ensure a consistent assessment of VMPs containing the same active substances.
The two alternative proposals remain centred on product evaluation. Therefore, they would not address some of the drawbacks of the current system, such as inconsistent assessments, limited availability of environmental information, and the remaining difficulty to identify harmful active substances. These alternatives would not result in significant improvements regarding protection of the environment and of animal and human health. Moreover, both proposals lack clarity on the timeline, the legal enforceability, how a harmonised approach between the CAs can be ensured and how the work should be prioritised.
Therefore, only the monograph system would contribute to meeting the general objectives of Regulation (EU) 2019/6 (except for the envisaged reduction of administrative burden, at least initially) and support the EU Strategic Approach to Pharmaceuticals in the Environment 22 and the ‘one substance, one assessment’ approach as specified in the Green Deal 23 and the Chemicals Strategy for Sustainability 24 .
The monograph system represents a significant shift in the VMP authorisation process. The changes needed for the implementation of a monograph system (including of legislative nature), would be a major challenge for the veterinary regulatory network (CAs, EMA and the Commission) and the industry.
During the implementation phase, the monograph system and the two proposed alternatives would give rise to additional costs for already authorised VMPs and are likely to be more cost- and resource-intensive than the current system of a complete ERA evaluation for each individual VMP application. The costs for applicants of new MAs of VMPs could be higher under the monograph system in comparison with the current system and the two alternatives proposed. Consequently, a negative impact on availability of VMP cannot be excluded and cost pressure on SMEs could increase.
The implementation of Regulation (EU) 2019/6 is still developing. It calls for the adoption of some 25 delegated and implementing acts, about half of which needed to be adopted before or by the date of application, 28 January 2022. The next package of acts the Commission will focus on are mostly due by 2025, with one act due by 2027. Apart from the legislative work, since the adoption of the Regulation in 2018, the resources and effort of the CAs and the industry have been directed at implementing the new legal framework on the ground. This has been and continues to be very demanding and burdensome for the network and the industry. Moreover, the effects of the current system in relation to ERA, such as the impact of Article 18(7) on generic applications and Article 72 on legacy products that have not been subject to an ERA, will need time to materialise. Therefore, introducing the monograph system or any of the two proposed alternatives, in addition to the measures and approaches that would need to be put in place in order to implement Regulation (EU) 2019/6, would seem to be premature at this point in time and would impose excessive demands on already overstretched resources.
The implementation of a monograph system could be reconsidered once Regulation (EU) 2019/6 is completely implemented and its impacts in practice (i.e., availability of VMPs, administrative burden, impact of SPC harmonisation etc.) become clearer. This would then also require more certainty on the costs linked to the implementation of such an active-substance-based system and its further impacts on the availability of VMPs.
In order to have a comprehensive and coherent system, the monograph system must be considered in a broader context, beyond the VMP sector. In light of the overall number of APIs in medicinal products on the EU market 25 , a system collecting the environmental data of those used in VMPs would only cover a small portion of the APIs on the market and result in an incomplete database.
The ongoing work on a future Commission proposal to revise the general legal framework for human medicinal products would likely include new ERA requirements. Therefore, it is appropriate to wait for the outcome of this process before considering implementing the monograph system for VMPs.
In the meantime, the Commission will explore, in close cooperation with the CAs, the possibilities to improve and harmonise the current system as much as possible. Measures could be agreed upon to facilitate the potential future implementation of a monograph system, without impacting the workload of the CAs nor requiring any change to the existing legal framework.
LIST OF ABREVIATIONS
AhE AnimalhealthEurope
AMR Antimicrobial Resistance
API Active Pharmaceutical Ingredient
CA Competent Authority
EICaquatic Environmental Introduction Concentration in water
EMA European Medicines Agency
(E)PAR (European) Public Assessment Report
ERA Environmental Risk Assessment
MA Marketing Authorisation
MAH Marketing Authorisation Holder
PECSOIL Predicted Environmental Concentration in soil
PBT Persistent, Bioaccumulative, and Toxic
RMM Risk Mitigation Measures
SPC Summary of Product Characteristics
UPD Union Product Database
VICH Veterinary International Conference on Harmonisation
VMP Veterinary Medicinal Product
(1)
Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43)
(2)
European Commission, Directorate-General for Environment, Kümmerer, K., Options for a strategic approach to pharmaceuticals in the environment: final report, Publications Office, 2019, https://op.europa.eu/s/wEcR
(3)
Commission Directive 92/18/EEC of 20 March 1992 modifying the Annex to Council Directive 81/852/EEC on the approximation of the laws of Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (OJ L 97, 10.4.1992, p. 1)
(4)
Ibid., Section 5.3 of the Annex.
(5)
Ibid., Section 5.4 of the Annex.
(6)
Committee for Medicinal Products for Veterinary Use (CVMP), Guideline on Environmental Impact Assessment (EIAs) for Veterinary Medicinal Products – Phase 1 (CVMP/VICH/592/98-FINAL), available at: https://europa.eu/!ytmMgd
(7)
Committee for Medicinal Products for Veterinary Use (CVMP), Guidelines on Environmental Impact Assessment for Veterinary Medicinal Products Phase II (CVMP/VICH/790/03-FINAL), available at https://europa.eu/!bRyWpH
(8)
Committee for Medicinal Products for Veterinary Use (CVMP), Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 (EMA/CVMP/ERA/418282/2005-Rev.1), available at: https://europa.eu/!fQjmTC
(9)
Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1)
(10)
Ibid.
(11)
Regulation (EU) 2019/6, Article 18(7).
(12)
Ibid., Article 72.
(13)
Schwonbeck, S., Breuer, F., Hahn, S., Brinkmann, C., Vosen, A., Radic, M., Vidaurre, R, Alt, J., Oelkers, K., Mezler, A., Floeter, C., Feasibility Study of an Active-substance-based Review System (‘Monographs’) and Other Potential Alternatives for the Environmental Risk Assessment of Veterinary Medicinal Products, EW-06-21-127-EN-N, European Union, Luxembourg, 2021, ISBN 978-92-76-42335-5, doi: 10.2875/94477, available at https://op.europa.eu/s/wvC9
(14)
Rönnefahrt, I., Experiences with environmental risk assessment in the authorization procedure of Veterinary Medicinal Products, in International Workshop on Eco-Pharmacovigilance of Veterinary Medicinal Products. 2013, Federal Environment Agency, Dessau-Roßlau: 4.-5. December 2013, Berlin. p. 1-27, available at: https://www.umweltbundesamt.de/sites/default/files/medien/378/dokumente/roennefahrt_vortrag_veroeffentlichung_2.pdf , accessed on: 9 September 2022;
Rönnefahrt, I., Monograph system of active pharmaceutical substances: necessity, challenges and perspectives, in Workshop „Monograph system on active pharmaceutical substances“. 2014, Federal Environment Agency, Germany: Brussels, Belgium. p. 1-17, available at: https://www.ecologic.eu/sites/default/files/event/2015/4_monograph_system_workshop_2014_roennefahrt.pdf , accessed on: 9 September 2022
Rönnefahrt, I., N. Adler, and S. Hickmann. Paradigm shift - Towards a substance-based environmental risk assessment of pharmaceuticals. in SETAC Europe Annual Meeting 2016. Nantes, France: Federal Environment Agency, abstract available at: https://cdn.ymaws.com/www.setac.org/resource/resmgr/abstract_books/setac_europe_abstractbook_na.pdf , p. 305, accessed on: 9 September 2022
Rönnefahrt, I. and N. Adler, Harmonised environmental information of pharmaceutical substances – the essential base for risk assessment and risk management in International Conference on Risk Assessment of Pharmaceuticals in the Environment (ICRAPHE). 2016, Federal Environment Agency: 8–9 September 2016, Paris, France. p. 1., abstract available at: https://www.acadpharm.org/dos_public/ICRAPHE_abstract_book_VF.pdf , p. 129, accessed on 9 September 2022
Rönnefahrt, I., The ERA master file concept, in Workshop „How to achieve an appropriate Environmental Risk Assessment of Veterinary Medicinal Products”. 2017, Federal Environment Agency, Germany: Brussels, Belgium, p. 1-14, available at: https://www.umweltbundesamt.de/sites/default/files/medien/362/dokumente/05_era_master_file_system_ronnefahrt.pdf , accessed on: 9 September 2022.
(15)
Schwonbeck, S., Breuer, F., Hahn, S., Brinkmann, C., Vosen, A., Radic, M., Vidaurre, R, Alt, J., Oelkers, K., Mezler, A., Floeter, C., Feasibility Study of an Active-substance-based Review System (‘Monographs’) and Other Potential Alternatives for the Environmental Risk Assessment of Veterinary Medicinal Products, p. 348, EW-06-21-127-EN-N, European Union, Luxembourg, 2021, ISBN 978-92-76-42335-5, doi: 10.2875/94477, available at https://op.europa.eu/s/wvC9
(16)
Regulation (EU) 2019/6, Articles 44(10), 47(3), 49(11) and 52(11) read in combination with Article 55(2)(a)(v).
(17)
The public assessment report in the case of marketing authorisation procedures other than the centralised one and the European public assessment report in the case of the centralised procedure is a document or set of documents describing the scientific evaluation and reflecting the conclusion reached by the regulators at the end of the evaluation process. It provides a summary of the grounds for approval (or refusal) of the marketing authorisation for the specific veterinary medicinal product. It is made available to the public, after the deletion of commercially confidential information.
(18)
Coordination group for mutual recognition and decentralised procedures veterinary medicinal products established under Article 142(1) of Regulation (EU) 2019/6.
(19)
Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters, United Nations, Treaty Series, vol. 2161, p. 447, https://unece.org/DAM/env/pp/documents/cep43e.pdf
(20)
See section 4.2 – Administrative burden and cost for CAs.
(21)
See section 4.1 – Guaranteeing the highest level of protection of public and animal health and of the environment
(22)
COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE European Union Strategic Approach to Pharmaceuticals in the Environment (COM/2019/128 final)
(23)
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 (COM/2019/640 final)
(24)
COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Chemicals Strategy for Sustainability Towards a Toxic-Free Environment. COM(2020) 667 final
(25)
See Background section.