During this week I have been attending the 45^th Annual Conference of Japanese Society of Toxicology (JSOT) in Osaka, Japan. I have learned about the origin of Japanese medicines and visited the birth place of the pharmaceutical industry in Doshomachi area in Osaka. I have also visited together with EFPIA Executive Director on International Affairs Koen Berden our colleagues from EFPIA Japan in Tokyo. Lastly, and the reason I was invited here, I gave a presentation at the conference on “New Phase on the Environmental Risk Assessment of Human Medicine” about the European pharmaceutical industry’s initiatives under the Eco-Pharmaco-Stewardship.

Ecotoxicology focuses on understanding the exposure and effects of environmental contamination on organisms including human health. Pharmaceuticals in the Environment (PiE) is a global issue, where thousands of ecotoxicologists and non-clinical scientists all over the world are contributing to filling the knowledge gaps in science and developing tools and methods to help pharmaceutical industries, regulators and academic community to better predict the environmental impact of pharmaceuticals. While we await for the European Commission to publish their strategy on PiE, the world (thankfully) keeps turning around and regions in which the issue has not been in the burning focus also develop.

In Japan, the initial research “Study on environmental Pharmaceutical assessment” was started a decade ago by the Ministry of Health, Labour and Welfare (MHLW) and has ever since evolved into a “Guideline on the Environmental Risk Assessment in new drug development”. It among other things promote the voluntary actions of pharmaceutical industry and takes the risk-based and prioritised approach how many and what kind of studies need to be conducted for a new active pharmaceutical ingredient (API). Japanese Pharmaceutical Manufacturers Association (JPMA) and National Institute of Health Sciences (Japanese-NIHS) are actively conducting research on ecotoxicology and the collaboration between the companies and research communities is flourishing, it appears. The valued European perspective was brought into the discussion here also by the representative of European Medicines Agency (EMA). Comparing the regions, it is clear that Europe has moved more to the playground of the precautionary principles and the planned update later this year on the guideline of Environmental Risk Assessment looks like making the requirements event stronger, although introducing much needed clarity on certain topics as well.

From European industry’s perspective, I’m always proud to present our proactive Eco-Pharmaco-Stewardship which is the framework that looks at the whole lifecycle of a medicine and focuses on the actions, where the industry can play an active role; Research and Development (better predicting environmental impact early), manufacturing (best practices in effluent management), extended Environmental Risk Assessment scheme (going beyond the current legal requirements) and promoting the correct disposal of expired and unused medicines (#medsdisposal). The story is strengthened by the fact that in Europe we collaborate tightly between originators, generics and self-medication industries, which makes the audience “wow” even in the other side of the world. This was the message I wanted underline here in Japan – the multi-stakeholder engagement is required to address the concerns of PiE. While we protect the environment, we must bare our societal responsibility and not impact the access of the patients to the life-saving treatments.