A blog post by Luna Dayekh, Safer Pharma Project Officer
In response to global supply chain disruptions, shortages of essential medicines, and the trade turmoil unleashed by President Trump’s new tariff policies, countries across Europe and beyond are reevaluating their reliance on offshore pharmaceutical production. Notably, around 80% of the active pharmaceutical ingredients (APIs) needed for medicines produced in the EU, along with 40% of the final products, come from India and China.
Therefore, a growing number of governments and institutions are now advocating for reshoring, bringing the manufacturing of medicines and their key ingredients back to Europe. The motivation is clear: boosting resilience, reducing dependency on distant suppliers, and improving control over essential medicines.
But as this shift gains attention, one critical dimension risks being overlooked:
What are the environmental consequences of reshoring medicine production? Is this an opportunity to green the pharmaceutical industry? And are we ready to change medicine production in ways that will help to build a sustainable pharmaceutical industry for the long term?
Why reshoring is on the rise
The COVID-19 pandemic exposed the vulnerabilities of globalised medicine supply chains. Reliance on a handful of countries outside the EU for the production of APIs, often thousands of kilometres away, created bottlenecks that delayed or blocked access to essential treatments. In response, European governments are pushing for domestic or regional manufacturing to ensure supply security and strategic autonomy. From new policy initiatives to dedicated funding schemes, reshoring is being framed as a solution to health system fragility. But supply security is only one piece of the puzzle.
Environmental considerations
In major pharmaceutical-producing regions, weak enforcement of environmental standards means that waste from manufacturing plants is often improperly managed. As a result, APIs seep into local water sources, contaminating rivers, soil, and groundwater. This not only jeopardises the health of nearby communities (contributing to conditions like birth defects or skin diseases, among others) but also disrupts ecosystems. Aquatic life is particularly vulnerable; traces of pharmaceuticals in water can alter reproductive systems in fish, damage biodiversity, and destabilise entire food chains. Soil contamination further compromises agricultural productivity.
Antimicrobial resistance (AMR) is often described as a ‘silent pandemic’— one of the biggest global health crises that could surpass cancer in annual deaths by 2050 if left unaddressed. One of the lesser-known but significant drivers of AMR is the environmental release of antibiotics and resistant bacteria from pharmaceutical manufacturing facilities. When wastewater from these plants contains high concentrations of antibiotics or other antimicrobial agents, it creates ideal conditions for resistant bacteria to emerge and proliferate (Lübbert and colleagues, 2017). These resistant strains can then spread to human populations through water systems, food, and direct contact. Despite its urgency, this environmental pathway remains critically under-regulated in many production hotspots, particularly in low- and middle-income countries supplying global markets.
Reshoring presents an opportunity to raise environmental standards in pharmaceutical production. Compared to some offshore facilities, where pollution controls are often poorly enforced, manufacturing in Europe or other highly regulated regions can reduce air and water pollution and ensure better waste management.
However, it’s not that simple.
Infrastructure costs and environmental impact
Building new manufacturing plants or upgrading old ones carries a significant carbon and material footprint and requires investment from the pharmaceutical industry. However, the political and economic context often complicates the green promise of reshoring. Pharmaceutical companies are not always willing to invest in costly upgrades unless there's a clear return on investment. Governments, in turn, may feel pressure to subsidise or incentivise reshoring efforts with public funds, often without demanding strong environmental commitments in return. There is also a risk here to fast-track or water down environmental impact assessments, permitting procedures and monitoring requirements to speed up the process and supply resilience.
1. Energy
Pharmaceutical production is highly energy-intensive. The sector’s greenhouse gas emissions are 55% higher than those of the automotive industry, for example, highlighting the carbon cost of manufacturing.
While pollution controls in the EU are generally stricter than in many offshore production sites, reshoring production could lead to a rise in local emissions, particularly if manufacturing is not powered by clean energy. This makes it essential to maintain and even strengthen strict environmental controls within the EU. At the same time, it presents an opportunity to reinforce EU pharmaceutical procurement policies.
By requiring that imported pharmaceuticals comply with the same environmental standards as those produced in Europe, the EU can ensure more consistent regulation across the supply chain, helping to mitigate the overall climate impact of pharmaceutical production regardless of where it takes place.
2. API emissions
There is no EU legislation specifically targeting emissions of active pharmaceutical ingredients (APIs) into the environment from manufacturing sites. While there are broader environmental laws, there is no regulation that explicitly and comprehensively addresses the emission of APIs into water or air from production plants. APIs used in medicinal products for human or veterinary use are exempt from the REACH regulation under Article 2(5)(a), and while pharmaceutical plants fall under the Industrial Emissions Directive (IED), its Best Available Techniques (BAT) reference documents—such as those for Organic Fine Chemicals (OFC), Common Wastewater and Waste Gas Treatment (CWW), and Waste Gas in the Chemical Sector (WGC)—do not set explicit emission limits for APIs.
3. Waste management gaps
Another blind spot is wastewater treatment. Standard treatment plants are often unable to filter out pharmaceutical residues, allowing antibiotics, hormones, and other biologically active compounds to enter waterways and disrupt ecosystems. Reshoring without investing in advanced wastewater treatment technologies could perpetuate pharmaceutical pollution locally, rather than mitigating it.
4. Circularity still missing
Discussions around reshoring rarely mention circular economy principles, like reducing pharmaceutical waste, recycling materials, or using greener inputs. These should be central to any future pharmaceutical strategy.
5. Procurement and policy
Many public health procurement systems still prioritise cost over environmental impact. Even when sustainability criteria exist, they are often optional or vaguely defined, making them difficult to enforce consistently.
There are promising signs of progress. For instance, the EU’s proposed Critical Medicines Act acknowledges the need for environmental considerations in procurement. Yet, these policy efforts often fall short on providing concrete sustainability standards, timelines, and enforcement tools required to make a real impact.
Without clear, harmonised sustainability benchmarks and mandatory reporting, it's nearly impossible to compare suppliers’ environmental performance or hold them accountable, especially across borders.
What needs to happen?
Reshoring medicine production needs to be seen as an opportunity to reduce the environmental impact of the pharmaceutical sector, and not just a geographic shift. Decision-makers and industry leaders must:
- Set clear, standardised environmental metrics for pharmaceutical manufacturing (covering emissions, water usage, waste, and material sourcing) and work toward harmonising these standards across EU member states and ideally, more globally.
- Strengthen environmental oversight through rigorous environmental impact assessments and regular monitoring. Promote transparency, requiring manufacturers to report on their environmental performance as part of supply chain resilience strategies.
- Integrate sustainability into public procurement as a mandatory evaluation criterion. Countries like Sweden, Norway, and Spain offer useful models. Learning from these examples can support broader adoption.
- Invest in advanced wastewater treatment infrastructure. Build or retrofit treatment plants with the capacity to filter pharmaceutical residues, especially APIs.
- Support green innovation and circular practices, including investments in low-carbon technologies, green chemistry, and pharmaceutical waste reduction.
- Push for more collaboration between stakeholders, including governments, manufacturers, procurers, researchers, and civil society organisations. Coordinated efforts are key to aligning priorities, sharing knowledge, and driving innovation towards greener practices.
Reshoring pharmaceutical production offers a chance to rethink how and where our medicines are made. Done right, it could strengthen health systems and advance environmental goals. As governments and institutions move forward, they must ask: Are we building resilient and sustainable pharmaceutical supply chains, or just convenient ones?
Health and sustainability go hand in hand. Let’s make sure our medicine supply reflects that.
References
Lübbert, C., Baars, C., Dayakar, A., Lippmann, N., Rodloff, A. C., Kinzig, M., & S.rgel, F. (2017). Environmental pollution with antimicrobial agents from bulk drug manufacturing industries in Hyderabad, South India, is associated with dissemination of extended-spectrum beta-lactamase and carbapenemase-producing pathogens. Infection, 45(4), 479–491. https://doi.org/10.1007/s15010-017-1007-2