This is becoming weighted for supply chain tenders (ie Modern Slavery Act annual statement). Stakeholders should plan to develop a greater capacity to assess an activity’s impact on local communities eg minimising water footprint during product manufacture in water stressed areas..
There is a rapidly evolving ESG-themed bond market which provides a tool for public debt investors to achieve a positive contribution to environmental or social challenges. Some pharmaceutical companies are recognising that there is an opportunity to attract significant investment through the issuance of green bonds. In September 2020, a pharmaceutical company became the first to issue a sustainability-linked bond (SLB), valued at €1.85 billion.
The roadmap for supply chain sustainability in the life sciences sector stretches from the sourcing of raw materials to the final packaging and transport of a finished product. There is increasing pressure on companies to reduce the carbon footprint of drug development – in fact it was recently reported that the manufacture of drugs contributes to more greenhouse gas emissions than the automotive industry1. Some of the key focus areas to revolutionize this challenge include:
Replacing reliance on finite and polluting energy resources to manufacture active pharmaceutical ingredients (APIs)
Transitioning from batch manufacturing to single, continuous manufacturing (separate production stages lead to significantly higher carbon emissions)
Transitioning from fossil-fuel reliant, cold chain shipping to greener alternatives
Reduction in single-use plastics for packaging
By switching from batch to continuous manufacturing, companies can achieve an economic and sustainable advantage as it allows them to rapidly adapt to changing market demand whilst reducing pressure on capital and footprint manufacturing plants and contributing to overall corporate ESG strategy. For certain classes of biopharmaceutical products upstream continuous manufacturing has always been applied: for example, unstable proteins that rapidly degrade in a culture broth.
There is potential for this universal production platform to be extended to other classes of product, such as antibodies, which are relatively stable molecules. Moreover, regulatory authorities in the three regions of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and beyond are encouraging industry to adopt new technology as supported by ICH Q8(R2), Q9, Q10 and Q11 bringing innovation to the forefront.
Notable advancements in the use of renewable energy have been made in the life science sector. For example, Schneider Electric launched its “Energize Programme” to address the need to increase utilisation of renewable energy sources across the pharma value chain in 2021, a collaboration between 10 global pharmaceutical companies to engage hundreds of suppliers in bold climate action and decarbonisation of the pharmaceutical value chain. Many big pharma companies have set targets to generate electricity solely from renewable sources within the next five years, including ambitious plans to become 100% solar powered within 10 years.
Many organisations are looking to reduce packaging and switch to biodegradable materials. Life science companies can turn to a growing number of “sustainability partners”, such as the European Federation of Pharmaceutical Industries and Associations (EFPIA). EFPIA has stated that most of its members have set sustainability goals for themselves, as they “strive to invent, produce and distribute new medicines and vaccines in a safe and environmentally responsible manner.2”
Efforts to minimise the environmental impact of chemistry is a prominent area specific to the life science sector. “Green Chemistry” focuses on the design of products and processes that minimise or eliminate the use and generation of hazardous substances in the design of medicinal products and manufacturing processes. For example, a Japanese life science company was able to develop processes that reportedly resulted in 78% less waste, 93% less organic solvent used and 46% less water whilst still being able to increase yield from their investigational drug.
Life Science companies that demonstrate a diverse clinical trial data set, to support the safety and efficacy review of drugs, will not only secure payer and regulatory approval, but also improved patient confidence medicines. Randomised Control Trial (RCT) data is the corner stone of drug development, however, patient populations are rarely homogenous in nature, and patient groups, payers and regulators are increasingly demanding that companies accurately reflect this heterogeneity in RCTs, facilitating the predictive nature of the risk-benefit profile of an approved drug, especially in underrepresented demographics.
A plethora of evidence demonstrates that race, ethnicity, age, sex and gender can influence the effectiveness of a drug v adverse drug reactions. Indeed, globally, guidance in being developed by Health Authorities to aid Sponsors either planning a prospective randomised trial using Real World Evidence (RWE) or evaluating whether a Real World Data (RWD) source is of sufficient quality to support a regulatory decision. Ideally, companies should identify the important nuances within subjects early in the drug development pathway, utilising tools available to ensure data is captured from a diverse pool of individuals.
This is underpinned by the need for stakeholders to address historical mistrust in clinical research, as evidenced by the vaccine hesitancy throughout the Covid-19 pandemic, in underrepresented ethnic groups, who also suffered disproportionately higher mortality rates. Leveraging newer technologies enabling remote monitoring became necessary during the pandemic (decentralized trials) creating an opportunity to alleviate patient burden and develop culturally specific communication, bringing the trial to the patient; increasing the diversity of participants.
The opportunity to leverage cross-border regulatory efforts, accepting more inclusive real-world trial eligibility criteria (e.g. laboratory cut-offs that disproportionality affect communities with higher incidences of co-morbidities – associated with lower socio-economic status) is now here – the onus is now on stakeholders to capitalize on this paradigm shift.
1 Lotfi Belkhir, Ahmed Elmeligi, Carbon footprint of the global pharmaceutical industry and relative impact of its major players, Journal of Cleaner Production, Volume 214, 2019, Pages 185-194,
2 Environment, Health, Safety and Sustainability (efpia.eu), 2022
