The final report of the Ad Hoc Working Group on Pharmaceuticals in the Environment, recently published by the European Commission (link), discusses the recommendations for the sustainable management of medicinal products throughout their entire life cycle.
Although it is not mandatory, the report represents a valuable working tool that has been positively welcomed by the EU Pharmaceutical Committee. Many of the proposals detailed in the seven identified lines of action are expected to be incorporated into the ongoing reforms to the EU pharmaceutical legislation. The final report also includes some Q&As in the Annexes for each line of action to further improve the comprehension of the proposed interventions.
The management of residues from pharmaceutical products released into the environment represents a key issue, as the sector is the only one (together with Cosmetics) subject to the Extended Producer Responsibility (EPR), as set out in the Urban Waste Water Treatment Directive. The resulting costs of quaternary treatment could have a significant impact on the sustainability of many pharmaceutical businesses, particularly those producing generics and biosimilars.
The Ad Hoc Working Group was established in 2020, following the 2019 Commission’s Communication on the EU strategic approach to pharmaceuticals in the environment. The Group comprised representatives from 13 member states, under the coordination of Sweden, plus the European Medicines Agency (EMA) and the EU Commission. It terminated its activities on March 2024.
The seven sub-working groups established were each responsible for a different aspect of the problem, resulting in seven actions that fall under the competence of member states. The inventory of the initial situation was integrated with a questionnaire distributed to all member states through the Pharmaceutical Committee, as well as with the exchange of views and information on experiences, national initiatives, and best practices.
The Ad Hoc Working Group also drafted a concept paper finalised in 2022 to support of the revision of the pharmaceutical legislation. The document focused on strengthening the environmental risk assessment requirements for human medicines and included a proposal for regulatory risk mitigation measures for human pharmaceutical residues in the environment.
Targeted information and training for healthcare professionals
Action 1 is focused on issuing of guidelines for healthcare professionals on the prudent use of pharmaceuticals. The existing guidelines on the rational use of antibiotics should serve as an example for extending a similar approach to all pharmaceuticals, beginning with hormones and endocrine–active substances. National competent authorities (NCAs) could also promote the use of diagnostic tests before prescription, and rational use to avoid unnecessary assumption of medicinal products and to comply to the indications contained in the Summary of product characteristics.
Mandatory training on the environmental aspects of pharmaceuticals is the focus of Action 2. This training should be implemented in higher education programmes related to healthcare and in continuous professional development programmes. Task forces appointed at the national and EU levels should define the minimum environmental aspects to be included in the curricula. Specific educational materials should be developed and freely distributed online to facilitate the dissemination of this kind of knowledge.
Advertising and prescription of medicinal products
Action 3 addresses the advertising and prescription of medicinal products. Suggested actions include communicating the environmental impact of medicines to the public and healthcare professionals by NCAs. Conversely, marketing authorisations holders (MAHs) should comunicate information about the company’s environmental policy via corporate communications only. MAHs should disseminate information on the environmental safety and appropriate waste handling of medicinal products using a mix of media, including social media.
Advertisements should not contain environmental claims that could affect how the therapeutic value of the medicinal product is perceived. Environmental claims should never represent the main message, and they should comply to relevant scientific and regulatory-approved environmental safety information relating to the active pharmaceutical ingredient (API) contained in the product. If the API is characterised as posing a risk or hazard to the environment according to the current environmental risk assessment (ERA) guideline, the suggestion of the Ad Hoc Working Group is to consider the prescription status for medicines containing it. The Group also recommended specifying the use of recycled materials used in the pharmaceutical products.
How to reduce waste of medicines
Optimisation of pack sizes is a key factor to reduce waste of medicines in the environment according to Action 4, particularly for products at high risk of antimicrobial resistance. Whenever possible, harmonisation of packaging requirements at the EU level and the use of primary and/or secondary packaging based on ecodesign and a sustainable life cycle of the materials should be promoted. Longer shelf-lives may also be considered, on the basis of targeted stability studies.
The Ad Hoc Working Group also recommended the exchange of best practices for the environmentally safe disposal of medicinal products and clinical waste (Action 5). Reusable and recyclable products instead of the disposable ones should be used to reduce waste volume, alongside improving healthcare waste segregation, destruction, and disposal practices. Whenever possible, medical waste incineration should be replaced by other types of hazardous waste treatments. Training of healthcare professionals is also important to raise awareness of the environmental risks related to healthcare waste and disseminate best practices.
Action 6 focuses on improving the collection of unused medicinal products. The first recommendation is to issue a specific guideline to support NCAs and stakeholders in designing their own take-back schemes, incorporating the Extended Producer Responsibility concept where possible. Adherence to take-back schemes should be assessed via an EU-wide survey, and collection points should be made easily accessible.
The importance of collecting unused medicinal products should be communicated to the general public through targeted campaigns, and the possible inclusion of a (harmonized) pictogram on the outer packaging or leaflet could be also considered.
Environmental expertise in the Committees and networks
Action 7 refers to the need to improve the level of environmental expertise within Committees and networks by providing regular training in addition to the modules already offered by the European Network Training Centre (NTC) at EMA. Specific EU funding should be allocated to support training on environmental risk assessment (ERA) and the relative new legislation that is coming into force.
The Ad Hoc Working Group also suggested creating a specific ERA Operational Expert Group (OEG) under the umbrella of the Non-clinical Working Party (NcWP) at EMA. This group would be responsible for organising and providing the content for ERA-training. EMA could also host an online communication platform to support ERA assessors from member states to submit questions and receive answers from experienced assessors. Experienced regulatory ERA experts could be appointed at the central level, while NCAs could hire external environmental experts.
The final recommendation is for a new ERA advisory group to be created at EMA. This could take the form of a permanent ERA Working Party (human) within the non-clinical domain, under the responsibility of the CHMP or, alternatively, a new ERA-OEG under the responsibility of the NcWP.
