Sustainability: Multiple Approaches Exist to Reduce Pharma’s Environmental Footprint

Pharma’s environmental footprint almost equals that of the automotive sector—but the pharmaceutical industry is seeking to reduce it. Ever since the Kyoto protocol was ratified in 1997 to address the effects of climate change and escalating greenhouse gasses, sustainability has become an important component of a corporation’s strategy. Sustainability programs are most commonly deployed under the umbrella of Environmental, Social and Governance (ESG) frameworks intending to address the larger issue of being a good corporate citizen, and ESG standards have trended upward. A record $649B was poured into ESG-focused funds worldwide in 2021.¹ With stakeholders putting money into companies with sustainability plans in place, more businesses are prioritizing ESG programs. ESG factors are a subset of nonfinancial performance indicators that include ethical, sustainable, and corporate governance issues making sure there are systems in place to ensure accountability.² The considerations measured as part of an ESG program are shown in Figure 1. 

Looking closer at the ESG challenges in pharma, several areas emerge: 

• Reducing waste 
• Cutting carbon emissions and greenhouse gas pollution 
• Reducing pharma in the environment through multiple vectors 
• Addressing energy and water consumption, including fossil fuel usage rates 

Reducing Waste 

The pharmaceutical industry generates significant waste across its entire value chain, starting with manufacturing chemical precursors for active pharmaceutical ingredients (APIs) and ending with the pharmacies, hospitals, and clinics that serve patients. Pharma companies are investing in processes and materials derived from “Green Chemistry” in an effort to diminish the amount of solvent and other toxic by-products generated by conventional chemistry in the manufacture of APIs. The Twelve Principles of Green Chemistry³ provide excellent guideposts for designing a process with sustainability in mind, thanks to its focus on three main principles: Design for Energy Effi ciency, Prevention (of waste), and Inherently Safer Chemistry for Accident Prevention. The green chemicals market is expected to grow at a CAGR of 11.6% from 2022 to 2029 to reach $217.18B by 2029 and doesn’t show any signs of slowing down.⁴ 

Industry organizations also are playing a role in driving down waste. The Pharmaceutical Supply Chain Initiative (PSCI) works to achieve positive safety, environmental, and social outcomes across the entire global pharmaceutical and healthcare supply chain. Sustainable packaging solutions continue to improve with drug sponsors and manufacturers having access to recently developed environmentally friendly packaging materials including bio-derived substrates that can be broken down by microorganisms innocuously into the environment. Bioderived plastics are manufactured using renewable agricultural sources instead of those synthesized from fossil fuels, and monomaterials that use only material for construction to enhance recyclability and reduce energy use. 

Carbon Footprint and Greenhouse Gas Reduction 

According to the World Health Organization (WHO), climate change is now the biggest health threat facing humanity and is projected to cause an additional 250,000 deaths every year between 2030 and 2050.⁵ The pharmaceutical industry produces 4.4% of the world’s carbon emissions, with the footprint forecast to triple by 2050 if countermeasures are not taken. In 2019, the pharmaceutical industry produced 48.55 tons of CO2 for every million dollars in sales — actually higher than the automotive industry, which generated only 31.5 tons for every million dollars in sales.⁶ A recent study compared the ESG performance of the top 100 pharma companies based upon their own reporting since 2015.⁷ The results are shown in Figure 2. Industry has focused its reduction efforts on three major areas: direct emission as a result of manufacturing, facilities operations, and company cars/transportation (Scope 1); purchasing electricity from renewable energy (Scope 2); upstream and downstream activities such as purchased goods and services, end-of-life treatment of products, business travel and distribution (Scope 3). Of these, Scope 3 factors constitute more than 96 percent of carbon emissions, but exhibit the least amount of reduction. 

Reducing Pharma in the Environment 

Pharma in the Environment (PIE) looks to reduce the amount of pharmaceutical products and byproducts in the environment. Medications enter the environment through leaks and improper disposal by consumers and from waste discharge as a byproduct of manufacturing. A recent study⁸ that monitored more than 258 rivers in 104 countries found that the presence of pharmaceutical contaminants posed a threat to the environment and human health in more than 255 of the sites studied. Pharma firms are partnering with sustainability organizations, such as the European Federation of Pharmaceutical Industries and Associations (EFPIA). EFPIA is working closely together with the self-medication industry and generic and biosimilar manufacturers. 

The Inter-Association Task Force on Pharmaceuticals in the Environment combines the expertise of the Association of the European Self-Medication Industry (AESGP), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and Medicines for Europe (former EGA) to address emerging and ongoing environmental concerns. EFPIA, AESGP, and Medicines for Europe collaborated to produce the Eco-Pharmaco Stewardship (EPS) Initiative, which strives to protect patient access to medicines while considering environmental aspects, strengthening the environmental risk assessment process, and considering the entire lifecycle of the medicine. The industry is looking closely to deploy environment impact assessment milestones as part of the overall drug development lifecycle, with a goal of designing APIs and finished drug formulations with little or no long-term environmental risk. 

Addressing Energy and Water Consumption 

Optimizing energy consumption in pharmaceutical manufacturing is complicated. Energy drives nearly all drug manufacturing processes. Simply maintaining a controlled manufacturing environment via preheating, reheating, cooling, filtration, humidification/ dehumidification, and fanning/ blowing/ air drying for newer, more potent molecules can result in a 50–60% increase in overall energy consumption at the plant level. 

Today all equipment has some level of intelligence and can provide performance data. Using this data to create a digital model of the factory to identify opportunities and optimize the energy usage in the facility is one way to understand the potential energy demands of a facility. This digital twin can be used to establish an energy baseline that can then be used to simulate alternate conditions to optimize energy usage. 

Alternate manufacturing platforms, such as pharmaceutical continuous manufacturing (PCM), when compared to batch processes, align very well with sustainability initiatives, generate less waste, and require less manufacturing space, energy, fewer personnel and support facilities. Currently, continuous direct compression technology is available for making tablets, designed to replace the existing state-of-the-art processes that typically use a granulation step that adds more energy to the process. You can do it dry, or you can do it wet, but either way, the continuous manufacturing method allows for a much smaller footprint for both equipment and energy. 

When combined with complementary technology—like adding a digital twin to a system as mentioned above, it is possible to simulate experimental designs virtually during the process development stage and avoid the consumption of additional materials and energy altogether. Pharma’s heavy dependence on water for cooling, processing, and cleaning is another significant threat to the environment as fresh water availability has become a global issue. To curtail the devastating consequences of pharmaceutical waste in the environment, the industry has adopted alternative strategies and processes to reduce its water dependency, identifying technologies where water can be reclaimed and reused and deploying systems that use less water to operate. 

Conclusion 

The pharmaceutical industry may be described as being late to the ESG and sustainability movement. But the industry has not remained on the sidelines. Successful sustainability initiatives that demonstrate environmental, social, and financial benefits attract many investors and stakeholders who prefer to focus on organizations with a strong sustainability mindset. The industry’s contribution to remediating climate change may even be more significant than the automotive industry and, as a result, the opportunity for a positive impact is proportionally larger. While there has been some movement by the industry toward reducing global carbon emission levels, the bulk of the work is still ahead. Focused industry organizations collaborating to measure and collect data that can be used to drive changes across the pharmaceutical value chain are an essential component of the sustainability ecosystem. Adopting digital models to anticipate and address energy and water waste are an effective means of reducing energy and water usage without extensive capital investment. Focusing on renewable energy sources as a source of power is one way to extend the positive impact of a plant’s energy footprint. Sustainability in pharma extends well beyond renewable packaging, touching almost every piece of the healthcare value chain. The industry will have to focus in earnest if our global efforts to reverse the devastating effects of climate change are to succeed. 

References 

1. https://www.forbes.com/sites/ forbesbusinesscouncil/2022/06/23/ how-to-make-sure-your-esg-strategy-ismaking- a-difference/?sh=7b11694550bc 

2. https://marketbusinessnews.com/ financial-glossary/esg-definition-meaning/ 

3. P.T. Anastas, J.C. Warner,Green Chemistry: Theory and Practice, Oxford University Press, New York (1998) 

4. https://www.globenewswire.com/en/ news-release/2022/05/25/2450449/0/ en/Green-Chemicals-Market-Worth-217- 18-Billion-by-2029-Market-Size-Share- Forecasts-Trends-Analysis-Report-with- COVID-19-Impact-by-Meticulous-Research. html 

5. https://www.who.int/news-room/factsheets/ detail/climate-change-and-healt h?msclkid=8018c226d13b11ec9710a785 08b88375 

6. https://www.weforum.org/ agenda/2022/11/pharmaceutical-industryreduce- climate-impact/#:~:text=While%20 it%20may%20not%20get,by%20 2050%20if%20left%20unchecked. 

7. https://www.iqvia.com/blogs/2023/01/ is-pharma-on-track-to-reduce-carbonemissions 

8. https://www.pnas.org/doi/10.1073/ pnas.2113947119