Recommendations for Harmonizing Health and Sustainability: Analyzing the Intersection of EU Environmental Regulations and Pharmaceutical Legislation

In the past, the pharmaceutical industry enjoyed exemptions from most sustainability regulations. However, as sustainability gains momentum and becomes one of the top policy priorities worldwide, the pharmaceutical industry is under increasing pressure to contribute to achieving environmental objectives. The political landscape in which the pharmaceutical industry solely focused on health policy is significantly changing, with cross-sectoral legislation such as the European Green Deal poised to impact the pharmaceutical industry—

Pharmaceuticals in the Environment

Environmental pollution poses a critical vulnerability for the pharmaceutical industry. Byproducts of patient medication excretion are now commonly found in surface and groundwater across Europe, posing a threat to essential resources like irrigation, drinking water, flora and fauna. There is substantial evidence of pharmaceuticals negatively affecting the environment, including the impairment of reproduction in exposed fish populations, the impact of various antibiotics on environmental bacteria and algae, and the decline of vulture populations due to poisoning with diclofenac when feeding on animal carcasses.

The full extent of this impact is set to become better understood as the European Commission presents a new directive and regulation to revise and replace current pharmaceutical legislation which reinforces a requirement for pharmaceutical companies to conduct environmental risk assessments for their products. This involves evaluating the potential environmental impacts of a pharmaceutical throughout its lifecycle, from production to disposal. If significant risks are identified, companies may need to take corrective measures, or in some cases, redesign their products, further prolonging the drug development process.

Pharmaceuticals in Waste Water

The journey of a drug into the environment does not end with its development. One of the most common routes for pharmaceuticals to enter the environment is via patient excretion following the use of a drug. However, micropollutants such as residues from pharmaceuticals and cosmetics are not currently included in the EU Urban Waste Water Treatment Directive. This is set to change as the European Commission proposes revisions to this legislation, requiring pharmaceutical companies to drastically alter their production processes. The legislation aims to improve water quality by reducing discharge of pharmaceutical residues into water bodies by more than 365,000 tonnes by 2040. Pharmaceutical manufacturing facilities will be obligated to implement advanced wastewater treatment technologies, including investments in improved filtration and treatment methods. Furthermore, pharmaceutical companies are now obligated to trace the presence of specific substances in their products and monitor their release into the environment.

Impact on the Pharmaceutical Industry

Compliance with this new EU environmental legislation will necessitate significant investments by pharmaceutical companies. They will not only have to allocate more resources to research and develop eco-friendly formulations but also fulfill other obligations.These compliance costs can be substantial, especially for smaller pharmaceutical companies. However, this pile of new regulations will eventually drive innovation within the industry, leading to the creation of products with reduced environmental impacts. Pharmaceutical companies will need to reevaluate their entire supply chain to ensure that the production, packaging, and distribution of their products comply with environmental standards, leading to more sustainable sourcing and manufacturing practices. The pharmaceutical industry will also need to prepare for and adapt to time-limited derogations for packaging of drugs and medical devices, along with concerns in the sector over the future cost and availability of recycled materials.

As environmental policies become a top political priority for an increasing number of governments worldwide, business models will have to undergo dramatic changes. While pharmaceutical companies have generally enjoyed the status quo thus far due to exemptions, this is about to change as more . This, paired with the regulatory changes mentioned above, presents an opportunity for pharmaceutical companies to be at the forefront of the market by appealing to consumers who value eco-friendly options. Embracing this transformation offers pharmaceutical companies a unique opportunity to play a significant role in advancing climate and sustainability initiatives thus transforming their reputation.