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Pharmaceuticals in the Environment – Industry contribution to a strategic approach (Guest blog)

While waiting for the publication of European Commission strategy for Pharmaceuticals in the Environment, it is a good time to look back and refresh our memories on how pharmaceutical industry in Europe became truly active on the topic.

In 2012 EFPIA established a Task Force in response to the developing focus of pharmaceuticals in the environment (PIE) from industry, and externally from the EU Commission, academic scientists and NGOs. This prospective decision enabled the pharma industry from the outset of these discussions to speak with one voice. While keeping the interest of patients for maintaining access to medicines in the view of any environmental regulatory strategy, a clear, proactive concept was developed and presented during the upcoming years to address the concerns of many stakeholders.

Not long after, the other major European trade associations, AESGP and Medicines for Europe, joined this initiative and the “Inter-association Initiative Task Force on PIE” (IAI PIE TF) was developed as the focal point for European pharma industry to deal with environmental policy and science issues on human pharmaceuticals.  Subsequently, PIE  has gained wider interest within the European Water Framework Directive, within the United Nations under SAICM (Strategic Approach to International Chemicals Management) as an emerging issues (Environmentally Persistent Pharmaceutical Pollution). In addition, PIE has become a hot topic at the national level in many EU member states.

The IAI PIE TF has developed three major strategic areas,
  • addressing an improved regulatory framework for the environmental risk assessment of human medicinal products in context with the requirements of the authorization for human medicines,
  • developing research based methodology for prioritization of legacy compounds for environmental risk assessment,
  • providing guidance for the effluent management for production and formulation sites.
These concepts provide a framework of stewardship for medicinal products over the whole life-cycle, and consequently are known now as “Eco-Pharmaco-Stewardship (EPS)” concept (https://www.efpia.eu/media/288586/pie-brochure.pdf). 

EPS includes a clear process description on how the present regulation on the environmental risk assessment for human medicines can be further developed to cover the full life-span of an active pharmaceutical substance (“extended Environmental Risk Assessment”).

Additionally, industry has initiated together with the EU Commission a research project under the Innovative Medicines Initiative (IMI) to develop sound scientific methodology for prediction and screening of environmental hazards and risks of pharmaceuticals, which will help to prioritize the large number of legacy compounds which have incomplete environmental information for a proper risk evaluation. The project also provides models for supporting the internal environmental risk assessment of new pharmaceutical molecules under development in pharma companies (http://i-pie.org/).

Under EPS, a risk-based approach was developed and shared with pharmaceuticals producers for managing and controlling the manufacturing effluent emissions. This approach was disseminated via a number of webinars under the PSCI initiative, and many member companies have set up their management plans for production sites world-wide to monitor and improve effluent management (https://pscinitiative.org/news#bulletin44).

Last but not least, a media campaign was developed to inform European citizens in their respective country or region how to dispose unused medicines (http://medsdisposal.eu/).

Improper disposal of unused medicines was identified by many stakeholders as a source for avoidable environmental contamination with pharmaceutical compound residues.

The EPS concept is an excellent example of how the pharma industry is staying proactively engaged with regulatory and policy developments and how to engage and act under the increased stakeholder expectations. The clear and concrete proposal developed by the industry is providing a relevant contribution which has been discussed already with many stakeholders. If many parts of the EPS concept will be incorporated into a future PIE strategy in Europe, this will additionally help our industry to make significant progress towards a sustainable use, production, and disposal of medicines, while safeguarding the access to medicines for all patients. It also helps to reassure the patients taking these life saving medicines that the environmental impact of their medicines is effectively managed. 

Dr Reinhard Laenge

Head of Ecotoxicology Research & Development, Pharmaceuticals Bayer AG Co-chair of Inter-Association Initiative...
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