In many countries around the world, an environmental risk assessment must be conducted and submitted to regulatory authorities as part of an official marketing approval or a new substance notification.
Because Merck markets products globally, our new products are assessed in a manner consistent with applicable global regulatory requirements.
We put our human drug substances through a battery of environmental “fate and effects” tests, which evaluate the potential impact of pharmaceutical residues in the environment. Tests are performed in independent research laboratories officially accredited to perform regulatory testing, follow protocols issued by the Organization for Economic Cooperation and Development (OECD) and are in full compliance with Good Laboratory Practice regulations. The European Medicines Agency (EMA) publishes detailed information on the human drug products it assesses in European Public Assessment Reports, which now include the results of environmental risk assessments.
Merck scientists also collaborate with other pharmaceutical companies, government agencies and universities to increase awareness and apply scientific methods to assess the potential impact of pharmaceuticals in the environment, and to increase the understanding of such impacts. For example:
- Merck joined with other pharmaceutical companies, Swedish stakeholders with environmental interests, and the Swedish Association of the Pharmaceutical Industry in establishing an environmental classification system for pharmaceuticals in Sweden. We voluntarily provide environmental risk data on our products to the Swedish system, which is publicly available online and updated on an ongoing basis.
- Merck scientists are working with government and university scientists from Canada on the Canadian Environmental Impact initiative. This initiative is developing environmental assessment regulations aimed at addressing risks to the environment and to human health posed by products regulated under the Canadian Food and Drug Act.
- Merck scientists participated in a multi-stakeholder group that provided recommendations and research ideas related to the potential impacts of pharmaceuticals to support environmental sustainability in the Baltic Sea region in Europe.