Ewan Townsend, Co-chair of Arnold & Porter’s Sustainability Committee, discusses the pharmaceutical sector’s shift towards environmentally friendly green chemistry
There are several aspects of the pharmaceutical industry’s potential environmental footprint. Research and development require sophisticated equipment, controlled environments, and specialised materials. Manufacturing processes can sometimes be energy, water and resource-intensive. Numerous regulatory requirements govern the processing and disposal of waste from manufacturing processes, used packaging and expired medicines. Complex global supply chains ship raw materials and finished products around the globe. Legions of consultants, service and technology providers travel and consume resources to support their clients. To improve sustainability, many in the industry adopt a holistic approach that considers the entire life cycle of each pharmaceutical product.
Green chemistry: Key considerations
The guiding principles of ‘green chemistry’ encourage using greener chemicals, processes, and products where appropriate to maximize efficiency and find new ways to reduce waste, conserve energy, and eliminate the use of hazardous substances. From an environmental perspective, green chemistry analyses all stages of a product’s life cycle (from design and manufacture to its use and disposal).
However, transitioning to green chemistry in the pharmaceutical sector poses a number of unique challenges and considerations:
- Patient safety remains paramount: Developing greener medicines cannot compromise safety. New medicines undergo rigorous testing to assess their risks and benefits before they are placed on the market. While green chemistry may be used to find efficiencies, there is limited scope to avoid the resource requirements associated with thoroughly evaluating new medicinal products.
- Restraints on changing existing products: In addition to infrastructure upgrades, moving to greener manufacturing processes and packaging for existing products often requires additional testing to generate additional safety data for regulators. This may have significant consequences from cost and resources perspectives, which can be challenging to address, even considering the cost-benefit analysis over the entire life cycle.
- Uncertain landscape and risk of competing interests: Medicines are typically developed and brought to market globally, often using global supply chains. Priorities can differ depending on position in the value chain. The legislative landscape continues to emerge locally and at different speeds, and stakeholder trends are evolving. Shareholder and investor views can also differ. All of this could cause competing interests in investment decisions and the prioritisation of greener medicines.
- Restraints on collaboration: The medicinal products supply chain is complex, and no one entity has oversight of or control over the entire product life cycle. This makes collaboration and information sharing critical amongst supply chain stakeholders. However, this must be balanced against the need to protect IP and navigate restrictions on sharing competitively sensitive information. Collaborating on sustainability initiatives can and should be encouraged, and regulators have a role to play in highlighting acceptable practices. In a neat demonstration of how industry and regulators can work together to navigate these thorny issues, the UK CMA recently helped the industry identify a safe way of sharing data around supplies of combination products.
Despite these challenges, life sciences companies can often drive progress internally and with their stakeholders. Simple steps can have a ripple effect when applied across the product life cycle. For example, by embedding green chemistry principles in decision-making when engaging new providers and including meaningful sustainability clauses with independent certification and monitoring in all of its partnering agreements, each life sciences company can, where appropriate, positively impact its complex network of partners and collaborators.
