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Pharmaceuticals in the Environment – Let’s Face the Concerns Together!

вечер на Уральской реке

Even when correctly used, pharmaceuticals may end up in the environment. The main source is through human excretion of substances when the body has not been able to metabolise them completely. To a lesser extent, pharmaceuticals can enter the environment through the improper disposal of medicines and as a result of manufacturing discharges.

Exciting times lie ahead, as later this year the European Commission is expected to come up with a strategy on how to manage pharmaceuticals in the environment. It is expected that the proposed activities will mostly include non-legislative changes and a robust impact analyses that will be conducted prior to implementation. It is also expected that activities will involve all stakeholders throughout the lifecycle of the medicine: patients and healthcare professionals; pharmaceutical manufacturers and wholesalers; regulators and legislators on the European level as well as in Member States; not to mention water bodies throughout Europe.

The European pharmaceutical industry recognises and understands the concerns raised by the stakeholders regarding the presence of pharmaceuticals in the environment. Beyond our mission to care and cure, and to ensure access to medicines, we wish to address concerns through open and constructive dialogue with stakeholders and policy-makers. Europe must be able to make smart decisions on what to do differently in order to decrease the exposure from pharmaceuticals in the environment. This needs to take into account public health aspects, while minimizing the environmental impact. One thing is clear – no one can succeed alone; we need to work together!

The European pharmaceutical industry, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Generic and Biosimilar Medicines Association (EGA) and the Association of the European Self-Medication Industry (AESGP) have worked hard with their members on this topic. We have developed, and want to take part in, the management of pharmaceuticals in the environment (PIE) through the Eco-Pharmaco-Stewardship (EPS) initiative, in order to reduce the amount of pharmaceuticals that end up in the environment. We suggest activities that span the life cycle of a medicinal product:

  1. Refining the existing environmental regulatory risk assessment process for medicinal products to ensure that the assessment remains up-to-date and relevant actions are taken if a risk is found, even at the post-approval stage. We call it extended ERA.
  2. Identifying potential environmental risks of existing and new active pharmaceutical ingredients through targeted assessment strategies and filling data gaps for older products through a 10-million Euro IMI project (iPIE).
  3. Compiling best industry practices to enable manufacturers to minimize even further the risks to the environment.

One thing that has kept us busy this spring, is the objective of raising public awareness with regard to the correct disposal of pharmaceuticals. Pharmaceutical waste is not just ordinary household waste!

Today’s technology provides quick and flexible opportunities to reach out to the public in an engaging way and the pharmaceutical industry, together with wholesalers, pharmacists, dentists, health care students and water bodies, plan to raise awareness across social media platforms. The exciting launch of the social media video campaign and a dedicated website will take place at the EFPIA Annual Meetings on 4th June! Come and join us and take part in this interesting discussion!

Click here to visit the official 2015 EFPIA Annual Meetings Page

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Written by

Sini Eskola__MG_3451-3

EFPIA Regulatory Affairs Director

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