The European pharmaceutical industry, represented by the Association of the European Self-Medication Industry (AESGP), the European Federation of Pharmaceutical Industries (EFPIA), and Medicines for Europe, recognises and understands the concerns raised by stakeholders as regards the presence of pharmaceuticals in the environment (PiE). For this reason, we have come together to develop the Eco-Pharmaco-Stewardship (EPS) concept, a proposal that strives to protect patients’ access to medicines while appropriately considering environmental aspects.
Environmental concerns should not overshadow public health benefits
Medicines play a critical role in ensuring a high level of public health, and we believe that political debates on PiE should not overlook the value that medicines bring to European citizens. As pharmaceuticals can enter the environment at all stages of the product’s life cycle, reducing pharmaceuticals in the environment will be the result of cooperation between the public and private sector and the consumers they serve. Therefore, all actions should strike the optimal balance between economic costs and the benefit of medicines to public health. This principle is very much part of the EPS.
The pharmaceutical industry proposes actions in areas where it has leverage
The pharmaceutical industry believes that environmental protection contributes to ensuring the health and safety of future generations. Most aspects of the EPS are readily implementable under current pharmaceutical legislation, thus avoiding the need for additional regulation. The proposal looks at three areas where the industry can most effectively reduce the potential environmental risks that might result from its activities and throughout the medicinal products life cycle:
Pillar 1 – Encouraging further research to assess the impact of PiE: The pharmaceutical industry is actively engaged in scientific research projects (independently and in partnership) aimed at filling the priority knowledge gaps for “legacy” APIs, medicinal products approved before 2006, in order to support informed science-based policy-making on PiE. The industry has initiated the iPiE project (Intelligence-led Assessment of Pharmaceuticals in the Environment) in a public-private partnership with the European Commission under the umbrella of the Innovative Medicines Initiative (IMI). This multi-stakeholder project aims at developing models for prioritising legacy products for more in-depth environmental assessment. In addition to prioritising legacy APIs, the models may also be applicable to new molecules in the early R&D stages. The project will use all available scientific knowledge to develop tools and assays, which will prioritize and identify the pivotal areas where more data would strengthen the understanding of a potential risk for medicinal products in use today, enabling the most efficient and effective use of resources. The project ended in 2019 and published the final report available here. The newly established project: IMI Premier (Prioritisation and risk evaluation of medicines in the environment) (Kick off September 2020): aims to deliver a novel assessment system for characterising the environmental risks of APIs, and which can be used to:screen and prioritise legacy APIs for a tailored environmental assessment
Identify potential hazards associated with APIs in development and explore the options to steer the design process in a greener direction;make relevant environmental data on APIs more visible and accessible to all stakeholders.
Pillar 2 – Manage pharmaceutical site effluent effectively: For the most part, the processes used to manufacture medicinal products are largely similar wherever in the world they may be used. It therefore follows that potential losses into the environment from manufacturing facilities should also be equally controllable Whilst the overall contribution of pharmaceutical manufacturing to PiE is relatively low compared with that from other sources, the pharmaceutical industry has developed and is continuously implementing initiatives which minimise API discharges from manufacturing operations through the exchange of good practices. In an effort across the industry, experts from several major manufacturers have shared experiences and developed a “maturity ladder” and associated guidance, in order to enable an enhanced understanding of the existing methods and the potential need for specific methodologies relative to the potential environmental risk posed by APIs and/or manufactured medicinal products. Manufacturing companies are encouraged to exchange practices in further developing their level of effluent control systems.
Pillar 3 – Monitor environmental impact through extended Environmental Risk Assessment (eERA): An important cornerstone of EPS is a refined Environmental Risk Assessment (ERA) process, extending beyond marketing authorisation. The ERA of a medicinal product is currently performed by companies either as part of a new marketing authorisation or when an increase in the environmental exposure is expected, e.g. with the approval of a new indication or the inclusion of a new patient population. ERA must be performed to evaluate potential risks of medicines on the environment and ensure adequate precautions are taken where specific risks are identified. The extended ERA (eERA) includes provisions to: (i) adjust exposure predictions as usage figures become available to better reflect reality, including all products with the same API, and (ii) reconsider the effects profile, as relevant and reliable laboratory findings and/or observations in the field linked to an adverse outcome become available.
In addition to these specific areas for action, the pharmaceutical industry stands ready to support European and MSs communication activities and awareness raising campaigns aimed at patients and public on the appropriate use, storage and disposal of medicines. A social media campaign #medsdisposal on the appropriate disposal of medicines was launched in June 2015. This is a joint initiative between European healthcare, industry and student organisations. Further information is available at http://medsdisposal.eu/.
Medsdisposal is an online communication campaign aimed at raising public awareness on the existing collection and disposal schemes already in place in Member States, emphasizing the fact that it is everyone’s responsibility and it is easier than one may think.
Open letter from EFPIA, AESGP and EGA addressing the public debate regarding pharmaceuticals in the environment, antimicrobial resistance and the manufacturing aspect: view here
Joint Press Statement of the Inter Associations Initiative (IAI) Pharmaceuticals in the Environment Task Force (AESGP, EFPIA, Medicines for Europe) – European Union Strategic Approach to Pharmaceuticals in the Environment: view here
Open letter from EFPIA, AESGP and EGA addressing the public debate regarding pharmaceuticals in the environment, antimicrobial resistance and the manufacturing aspect: view here
Eco-Pharmaco-Stewardship (EPS) – Pillar 1 – Research & Development: Intelligence led assessment of pharmaceuticals in the environment (iPiE):view here
