AESGP and its members consider it crucial to address the issue of reducing the environmental impact of self-care products in Europe, while ensuring that people still have access to effective treatment and wellness options.
New legal proposals on water effluents that impact medicines
To ensure that healthcare goals are aligned with environmental concerns, AESGP has been closely monitoring policy developments, particularly related to the European Commission’s legislative initiatives on the Urban Waste Water Treatment Directive (UWWTD) review and the amending Directive for the Water Framework, Groundwater and Environmental Quality Standards Directives. This includes providing accurate data on the impact of pharmaceuticals on the environment while also ensuring regulatory pathways for patients to have access to the necessary products.
To better understand the provisions of the water directives, AESGP met with officials from the Directorate-General for Environment. These meetings also served to provide the point of view of pharmaceutical products producers, and the intricacies of their regulatory aspects, and to challenge the applicability of Extended Producer Responsibility (EPR) at the molecular level.
AESGP has published a Position Paper on the revision of UWWTD in which it outlines that, given the provision of medicines is in the overall public interest, the legal proposals should therefore consider:
- application of EPR to manufacturers of micro-pollutants based on the risk they pose to the environment and/or human health,
- recognition of all sources of hazardous micro-pollutants irrespective of sector,
- avoidance of exceeding administrative burdens where they are not justified while ensuring that funds collected through EPR schemes are used in the most cost-effective manner,
- acknowledgement that environmental policies promoting the development and use of products with negligible potential environmental impacts must be considered alongside the societal and health benefits of pharmaceuticals,
- and, ultimately, not jeopardizing access to any category of medicines for people who need them, particularly those in smaller markets.
AESGP has also worked together with EFPIA and Medicines for Europe on providing feedback on the Commission’s proposals mentioned above as well as on the call for evidence on the Polluter-Pays Principle.
AESGP has been participating in the European Commission’s and Committee of the Region’s Zero Pollution Stakeholder Platform through Bengt Mattson (LiF – the Swedish Association of the Pharmaceutical Industry) as a dual representative of both AESGP and EFPIA. This platform aimed to facilitate the implementation of flagship initiatives under the Zero Pollution Action Plan by bringing together experts and establishing a shared vision on how to achieve the defined goals. The pharmaceutical industry representative showcased the reality of healthcare products and highlighted unintended impacts of the Zero Pollution Actions on pharmaceuticals and how to work on solutions that can deliver on the objectives of the Action Plan.
Activities under the Inter-Association Task Force on Pharmaceuticals in the Environment
Following the in-depth review of the Eco-Pharmaco-Stewardship programme, the Industry’s Inter-Association Task Force on Pharmaceuticals in the Environment (IAI PiE TF) kept up their work in the different areas: investing in research projects, reducing discharges from manufacturing plants, promoting the proper disposal of medicines, proposing an extended Environmental Risk Assessment and reflecting on the application of Extended Producer Responsibility.
Through initiatives like PREMIER – Prioritisation and Risk Evaluation of Medicines in the Environment, which started in 2020 under the Innovative Health Initiative, the IAI PiE Task Force has contributed to advancing the knowledge on pharmaceuticals in the environment. These scientific projects play a crucial role in collecting reliable data to identify and prioritize the active pharmaceutical ingredients that are most likely to pose a risk to the environment.
Reducing discharges from manufacturing plants
The European pharmaceutical industry has taken steps to decrease discharges from their manufacturing plants by sharing best practices among themselves. This involved adopting a risk-based approach to identify areas for improvement and creating a “maturity ladder” that culminated in the document ‘Technical Guidance for the Responsible Management of Manufacturing Effluents’. This tool will assist companies and their suppliers in evaluating their performance and making continuous improvements to their processes to ensure environmental compliance.
Extended Environment Risk Assessment
Under current legislation on Environment Risk Assessment (ERA), pharmaceutical companies are required to evaluate the potential environmental risks posed by their medicines before they are approved and launched, as well as when they are used in new combinations or for new indications. The European pharmaceutical industry advocates for a review and potential update of the ERA throughout the product lifecycle to ensure it reflects the most up-to-date information on a medicine’s impact on the environment. To achieve this, the IAI PiE Task Force has developed a document on Policy Options for an extended ERA (eERA), suggesting a model that utilises modern technology and contemporary data collection to improve the system.
Promoting the proper disposal of medicines
AESGP has kept the management leadership of the MedsDisposal initiative, assisting the communication and awareness efforts regarding the appropriate use, storage, and disposal of unused and expired medicines. This effort has resulted in an extensive update of the dedicated website and other virtual materials that provide information on current medicine disposal systems in Europe.
Extended Producer Responsibility
The new stream of work created with the Extended Producer Responsibility (EPR) has led to the production of a White Paper, ‘Balancing challenges on Environment with Access to Medicines in Europe’. This document serves as an Impact Assessment of policy options for Pharmaceuticals in the Environment and the use of EPR applied to human medicines found in wastewaters after excretion or wash-off.
For the purposes of bringing these inputs to policy makers, the IAI-PiE advocacy team has drafted smaller abridged documents summarising the key ideas of the different work streams, also to include them as annexes to the Eco-Pharmaco-Stewardship brochure.
Global activities: promoting the Charter for Environmentally Sustainable Self-Care
Internationally, AESGP co-chairs the Environment Working Group of the Global Self-Care Federation (GSCF). This working group has kept on promoting the 2021 initiative on the Charter for Environmentally Sustainable Self-Care, which calls on GSCF members to commit to concrete pledges in three priority areas: “Plastics & Packaging”, “Pharmaceuticals in the Environment” and “CO2 Footprint”. A number of AESGP members have joined the initiative by submitting a pledge.
The Charter aims to maximise the actions of individual companies by enabling them to work together to accelerate the green transition of industries in line with the United Nations Sustainable Development Goals (SDGs) and the objectives of the European Green Deal.