In our earlier article, we discussed the implications of the European Commission’s legislative proposal from 26 April 2023 for the environmental risk assessment (ERA) as included in the proposal for the renewed EU pharmaceutical legislation. Since then, the European Parliament adopted its position on the proposal on 10 April 2024, including several amendments.[1] We will discuss the amendments related to the ERA introduced by the European Parliament.

Under the directive as proposed by the Commission, companies are required to submit an ERA, including risk mitigation measures, when applying for a marketing authorization. The concept of an ERA has already been used since 2006, but will in the new legislation be updated. The amendments introduced by the Parliament make the grounds for refusal of a marketing authorization based on an incomplete or insufficiently substantiated ERA somewhat less strict compared to the original proposal by the Commission. The new wording allows for explanations as to why the ERA might be incomplete, indicating a shift towards a ‘comply or explain’ approach. However, under the position adopted by the Parliament a marketing authorization can still be refused if the risks identified in the ERA are not sufficiently addressed. The amended text adopted by the Parliament explicitly states that identified risks can be addressed by the risk mitigation measures.[2]

Following the proposal of the Commission for generic medicinal products or biosimilars, the market authorisation applicant may refer to studies conducted for the reference medicinal product when preparing the ERA. However, under the adopted text by the Parliament, if an applicant refers to a reference medicinal product that received its first marketing authorization before 30 October 2005, the authorisation can be refused if the ERA is deemed incomplete or insufficiently substantiated and the product is potentially harmful to the environment.[3]

The Parliament adopted the broadened scope of potential risks to be assessed as part of the ERA as proposed by the Commission. However, the European Parliament included stricter requirements:  risk mitigation measures with regard to preventing and limiting emissions to air, water and soil submitted with the ERA should cover the entire life cycle of the medicine.[4] This is reflected in the amendments: the Parliament clarified in proposed Article 22, paragraph 3 that the ERA must include measures to avoid or limit emissions to air, water, and soil during the manufacturing, use, and disposal of the medicinal product. This is a very broad scope, compared to the current situation, but also considering the proposal from the Commission. 

For ERAs conducted up to 18 months after the proposed directive’s entry into force (the transition period), the text adopted by the Parliament requires updates not only in case of missing information – as in the proposal - but also unconditionally to include risk mitigation measures covering the entire life cycle (manufacturing, use, and disposal). Under the adopted text, if information is missing, the competent authority will actively request marketing authorization holders to update the ERA.[5]

Furthermore, the Parliament added a paragraph stating that the Commission will issue guidelines on conducting the ERA specifically for antimicrobials other than antibiotics within twelve months of the Directive’s entry into force.[6]

The Parliament also added two paragraphs stating that the outcome of the ERA assessment, including data submitted by the marketing authorization holder, will be made public by either the EMA or the competent authority of the respective member state. When disclosing information about the ERA, including antimicrobial stewardship and access plans, commercially confidential information will be omitted.[7]
 

[1] European Parliament legislative resolution of 10 April 2024 on the proposal for a directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC (COM(2023)0192 – C9-0143/2023 – 2023/0132(COD)), Texts adopted - Union code relating to medicinal products for human use - Wednesday, 10 April 2024 (europa.eu).

[2] Article 47, paragraph 1, point d adopted text EP proposed directive.

[3] Article 47, paragraph 1, point da adopted text EP proposed directive.

[4]Text adopted by the European Parliament, 1st reading/single reading 2023/0132(COD) – 10/04/2024 (Summary), https://oeil.secure.europarl.europa.eu/oeil/popups/summary.do?id=1782753&t=e&l=en. 

[5] Article 22, paragraph 6, subparagraph 2 adopted text EP proposed directive.

[6] Article 22 paragraph 4a adopted text EP proposed directive.

[7] Article 22, paragraphs 7a and7b adopted text EP proposed directive.