EFPIA works towards a balanced, evidence-based framework of Eco-Pharmaco-Stewardship to be utilised in addressing the emerging problem of PIE in Europe.
The pharmaceutical industry recognises and understands concerns raised by stakeholders regarding the presence of pharmaceuticals in the environment (PIE). The major source of pharmaceuticals entering into the environment is via patient excretion following use of a medicine that is taken to prevent, cure or alleviate a medical condition. A comparatively smaller contribution to PIE stems from emissions from industry during the manufacture of pharmaceuticals and from the incorrect disposal of unused or expired medicines. Industry is committed to playing a role in addressing concerns about PIE and is actively engaged in minimising the impact of its activities on the environment.
The issue of pharmaceuticals in the environment requires a balanced approach. In contrast to many other substances/chemicals in the environment medicines play an important role in human health. Today, European citizens can expect to live up to 30 years longer than they did a century ago. Huge reductions in mortality (e.g. from HIV/AIDS, many cancers or cardiovascular disease) and significant progress in terms of quality of life are the results of some large and many small steps in biopharmaceutical research. The public health benefits of pharmaceuticals are undeniable. This aspect should always be the priority when assessing the benefits and risks (including environmental impact) of pharmaceuticals.
EFPIA is working closely together with the self-medication industry and generic and biosimilar manufacturers. The Inter-Association Task Force on Pharmaceuticals in the Environment combines the expertise of the Association of the European Self-Medication Industry (AESGP), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and Medicines for Europe (former EGA) in order to address emerging and ongoing environmental concerns.
This is being done through the sound assessment of current and future actions, whilst remaining mindful of patient needs and ensuring access to medicines. Founded on the principles of product stewardship, the Eco-Pharmaco-Stewardship (EPS) initiative has been developed. It considers the entire life-cycle of the medicine and addresses the roles and responsibilities of all parties involved, including public services, the pharmaceuticals industry, environmental experts, doctors, pharmacists, and patients.
The EPS initiative is supported by three 'pillars', which have been identified as the initial key areas of focus for the pharmaceutical industry:
- Pillar 1 – IMI iPIE project: the identification of the potential environmental risks of existing and new active pharmaceutical ingredients (API) through intelligent and targeted assessment strategies. The European pharmaceutical industry has initiated a project under the Innovative Medicines Initiative (IMI), a joint undertaking between the European Commission (EC), academia and the pharmaceutical industry. The project will use all available scientific knowledge to develop tools and assays, which will prioritise and identify the pivotal areas in which more data would strengthen the understanding of a potential risk for medicinal products in use today. This will enable the most efficient and effective use of resources. It is anticipated that the output may also be applied to screen new active pharmaceutical ingredients in development to target environmental testing needs.
- Pillar 2 – Manufacturing effluents management: the compilation of best industry practices, enabling manufacturers to minimise risks to the environment. 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. However, this assumes that a good understanding of the risk to the environment and the knowledge required to limit losses are uniformly available. 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 were encouraged to exchange practices in further developing their level of effluent control systems.
- Pillar 3 – extended ERA: the refinement of the existing environmental risk assessment (ERA) process for medicinal products to ensure that they remain up-to-date and relevant. 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 to 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.
The need for diligence does not end with the EPS pillars; there are many other opportunities to minimise losses to the environment along the life-cycle of a medicinal product, such as increasing transparency and access of the environmental data, and educating the public on the correct use and disposal of unused and expired medicines. In order to promote the latter, a collaborative campaign focusing on the correct disposal of unused and expired medicines was initiated by the industry in 2015 (www.medsdisposal.eu).
The pharmaceutical industry stands ready and willing to work with other stakeholders in evaluating and working on all aspects of the medicines lifecycle that may have a harmful impact on the environment. In all of these endeavours, the key priority remains to ensure patients' access to medicines in cooperation with all stakeholders, including European and National Competent Authorities. The industry believes that the EPS approach can serve to address concerns and inform adequately the existing regulatory paradigm.