By Michael Green and Paul Davies
A coalition of medical and environmental groups has called upon the European Commission (EC) to propose specific legislation that will address pollution, in particular, by active pharmaceutical ingredients (APIs). This political development highlights the complex debate currently taking place over how to identify and address the effects of APIs.
An API is the biologically active component of a pharmaceutical drug. Other ingredients, known as “excipients”, are the inert substances present in a pharmaceutical drug. For example, if a product is in syrup form, the excipient is the liquid being used.
The coalition has raised the concern that APIs make their way into groundwater, rivers, lakes, oceans, and even drinking water after being disposed, with potentially harmful effects on the environment and human health. APIs are specifically designed to trigger a biological process (unlike most other chemical pollutants). As such, if APIs are present at significant-enough levels, biological processes in humans and/or animals may be unintentionally activated with potentially harmful effects. For example, some evidence suggests that the environmental presence of antibiotics contributes to developing antibiotic-resistant strains of bacteria, and that synthetic hormones found in contraceptive pills cause infertility in fish. Moreover, the effects on humans of inadvertent long-term exposure to low levels of APIs in drinking water, particularly given the potential for the presence and interaction of multiple APIs, are relatively unknown.
The occurrence of APIs in the environment was first reported in the 1970s. Although significantly more data is available today, this information primarily comes from small-scale investigations regarding a restricted number of drugs. Therefore, scientists still know little about the environmental risks of pharmaceutical pollution. Statements about the behaviour of pharmaceuticals in the environment are largely speculative.
Stakeholders are divided over how to address the effects of APIs. Advocates for lessened, or maintenance, of current regulation of pharmaceutical pollution argue that there is a need to better understand and assess actual impacts on the environment, human health, and animal health. Conversely, campaigners for tighter regulation of pharmaceutical pollution cite the precautionary principle. This European legal principle states that when an activity could harm the environment or human health, precautionary measures should be taken — even if some cause-and-effect relationships are not fully established scientifically.
In response, the EC has launched a consultation on potential policy options to curb the impact of pharmaceuticals in the environment. The EC is seeking feedback and further information from stakeholders on their perception of the problem, the need for action, and possible, high-priority responses.
Latham will continue to track developments involving the regulation of pharmaceutical pollution. Clearly, there is an important balance to be struck between protecting the environment (and possibly environmental effects on human health), and safeguarding all-important access to effective and appropriate pharmaceutical treatments for both human patients and animals.
This blog was prepared with the assistance of Tegan Creedy in the London office of Latham & Watkins.
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