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Following the introduction of Directive 2024/3019, pharmaceutical companies are deploying new resources. This regulatory change redefines priorities in environmental sustainability reporting for the entire industrial sector. Among the most impactful changes is the introduction of the principle of Extended Producer Responsibility (EPR), which represents a profound innovation in the methods for reassessing authorisations and the responsibility for treating micropollutants. Below, we outline the main changes introduced:
Extended Producer Responsibility:
The new regulation introduces an innovative approach by requiring pharmaceutical companies to actively participate in a centralised organisation for the collective management of EPR obligations. This means assuming financial responsibility for several critical aspects:- Investments in quaternary wastewater treatment
- Operational management of plants
- Micropollutant monitoring systems
- Data collection and verification processes
New monitoring standards
The directive introduces more stringent monitoring requirements that include:
- Analysis of concentrations of specific pharmaceutical substances
- Evaluation of the effectiveness of removal processes
This new monitoring system will require companies to implement standardised analysis methodologies, thus ensuring greater transparency and comparability of data.
Quaternary treatment
A key element of the directive is the introduction of quaternary treatment, with ambitious objectives:- 80% removal of at least six target substances
- Phase-by-phase implementation from 2033 for large plants
- Phase-by-phase extension until 2045.
This phased approach allows companies to plan and implement the necessary technological changes without compromising operational continuity.
Protection for Small Businesses
A key aspect of the directive is its focus on small production facilities. The exemption for those producing less than 1 ton per year demonstrates a balanced approach that protects SMEs while maintaining high environmental standards. This preserves innovation and diversity in the pharmaceutical sector, avoiding insurmountable barriers for smaller companies.
Preparing for the Future
Pharmaceutical companies have a clear timeline ahead of them:
- 2027: Definition of technical criteria for exemptions
- 2028: Implementation of EPR systems
- 2033-2045: Gradual introduction of quaternary treatment
This timeframe allows for strategic planning of investments and necessary operational changes.
Impacts and Opportunities for the Sector
The implementation of Directive 2024/3019 is opening up new scenarios in the pharmaceutical sector, bringing with it both significant challenges and interesting opportunities for innovation and growth. Companies are facing a crucial moment that requires a profound transformation of existing processes.
From an operational perspective, companies will have to completely rethink their environmental management systems. This means not only implementing new traceability technologies, but also reconsidering the entire product life cycle. In some cases, certain drugs may need to be reformulated to make them more environmentally friendly, a process that requires time, resources, and specific expertise.
On the economic front, the impact is expected to be significant. The investments required to comply with the new regulation include not only the implementation of cutting-edge monitoring and control systems, but also significant investments in research and development to create more sustainable products. This could lead to a temporary increase in production costs, with possible repercussions on the final prices of medicines. However, in the long term, these investments could translate into greater operational efficiency and a substantial competitive advantage.
But it is on the strategic level that the most interesting prospects are opening up. The directive is accelerating the development of "green by design" drugs, an innovative approach that integrates environmental sustainability from the early stages of product design. Companies that position themselves as leaders in this field will benefit from a significant reputational and market advantage. Furthermore, the need to collaborate more closely with water management companies is creating new opportunities for partnerships and cross-sector innovation.
Particularly interesting is the emergence of new collaboration models between different players in the sector. Some companies are already exploring the possibility of creating consortia for the joint management of treatment plants, while others are investing in programs to develop innovative solutions to reduce environmental impact.
Finally, the aspect of communication should not be underestimated: companies that effectively communicate their commitment to sustainability will be able to significantly strengthen their market position, responding to the growing environmental awareness of consumers and stakeholders.
Conclusions and Outlook
Directive 2024/3019 represents a turning point for the European pharmaceutical industry. Companies that anticipate these changes, investing in innovation and sustainability, will not only comply with new regulatory requirements but will also be able to build a significant competitive advantage.
The future of the pharmaceutical sector will be characterised by greater attention to environmental impact, from design to production to product disposal. This transition toward greater sustainability, while challenging, is crucial to ensuring a future where pharmaceutical innovation goes hand in hand with environmental protection.
Companies that embrace this change as an opportunity rather than a requirement will be the ones leading the industry toward a more sustainable future, meeting the growing environmental expectations of consumers and society as a whole.
In this context of profound transformation, Veolia is positioning itself as a strategic partner for pharmaceutical companies, offering comprehensive, cutting-edge solutions to address the challenges of new regulations. With over 160 years of experience in water treatment and proven expertise in the pharmaceutical sector, Veolia has innovative quaternary treatment technologies and advanced micropollutant monitoring systems. Our integrated approach, combining proprietary technologies, digital services, and specialised support, enables pharmaceutical companies to anticipate regulatory requirements, optimise operating costs, and pursue their sustainability goals with maximum efficiency.
