Pharma is one of the most heavily regulated sectors in the global economy. Patient safety is paramount, and every part of the development and production process must meet stringent standards, which can vary from country to country.
At the same time, pharma companies, like other businesses, are faced with growing pressure from governments, global regulators, customers and supply chain partners to make sure that their products are sustainable. Optimising drug delivery systems so that they comply with sustainability regulations without compromising patient safety is, however, a challenge both for pharma companies and regulatory bodies such as the US Food and Drug Administration (FDA) that have not traditionally regarded sustainability as part of their remit.
Regulations covering sustainability vary from jurisdiction to jurisdiction. The EU’s 2019 Green Deal, a package of measures and directives designed to reduce carbon emissions, has been particularly influential in the drive to improve sustainability, underpinning and driving related legislation that includes targets for the use of recycled and recyclable packaging, as well as the removal of micropollutants and the restriction of environmentally harmful chemicals.
The US too has a number of environmental regulations that apply to pharma, enforced by agencies such as the Environmental Protection Agency (EPA) under laws like the Clean Air Act and Clean Water Act, which require companies to manage emissions and waste. While Good Manufacturing Practice (GMP) focuses on product quality and safety, it does not directly govern environmental emissions and waste management in line with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.
Pressure also comes from customers, says Michaela Fuetsch, head of PT chemical and environmental legislation at Roche: “There is an emerging trend of taking sustainability criteria, with up to 30% weight, into consideration in pharmaceutical tenders; for example, in the UK, France and Norway. In other countries like Spain, there are requirements to provide waste and waste management information for all drugs used in the hospital setting.”
Medicines regulators are slowly starting to consider sustainability
Medicines regulators are only slowly beginning to integrate sustainability into their frameworks, however. The FDA has encouraged environmental assessments for certain drug products, especially combination products involving devices. The European Medicines Agency (EMA) is currently developing environmental quality standards (EQS) for pharmaceutical companies. André Gagnon, a spokesperson for Health Canada, says that the regulator supports manufacturers in considering the use of recycled, reusable, compostable and sustainable materials in the development of medical devices or systems – but that “sustainability considerations are not part of the regulatory basis for authorising the sale of drug delivery devices or systems”.
In the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) has a requirement in every marketing application for a human medicinal product to include an environmental risk assessment (ERA). “This obliges an evaluation of the potential risks of that product alongside mitigation measures. Where a delivery system is integral to the product, such as an inhaler or pre-filled injection device, this is also in scope of that assessment,” an MHRA spokesperson says.
Packaging and delivery materials are a prime target
So what steps are pharma companies taking to improve sustainability in drug delivery? The focus so far has been on the materials used in packaging and delivery, including primary packaging, propellants and additives. But most now understand the need to look at the bigger picture, which entails assessing the impact of the product across its life cycle from concept development right through to design, manufacture, transport, patient use and end-of-life disposal. The greatest potential for impact comes in higher-volume products and common drug delivery technologies used in multiple drug products. For example, pressurised metered-dose inhalers (PMDIs) have come under scrutiny because historically they have used greenhouse gases such as hydrofluoroalkane as propellants. Meeting environmental regulations set by the EU and other regulatory bodies requires pharma companies to reduce the use of hydrofluorocarbons gases in their products.
Some drug companies are now delivering alternatives. AstraZeneca, for example, has created a low-carbon version of its Trixeo Aerosphere inhaler for chronic obstructive pulmonary disorder (COPD), which recently received approval from the MHRA. The inhaler uses a propellant that, according to AstraZeneca, has a 99.9% lower global warming potential (GWP) compared with propellants used in other PMDIs. Autoinjectors are another highvolume product that offer an opportunity to address sustainability concerns. Disposable autoinjectors are typically made of non-biodegradable materials such as polyvinyl chloride (PVC), so replacing them with reusable injectors ought to be an easy win. In recent years, however, the trend has been away from reusable items in favour of single-use disposables, which are easier for patients to use, less likely to spread infection and often cheaper to manufacture. The recent growth in demand for GLP-1 weight loss drugs has inevitably been matched by the rapid growth in numbers of single-use autoinjectors to deliver them, potentially leading to an increased carbon footprint.
Pharma companies have therefore been looking for ways to reverse the trend while keeping their products safe, patient-friendly and environmentally sustainable.
This is not straightforward, however. “The primary packaging in direct contact with the drug product is highly regulatorily binding,” says Fuetsch. “Any change to the primary packaging will require a sound scientific data package to support compatibility, integrity of the drug product quality at release and over its shelf life. Any product-specific characteristic will need to be maintained; for example, sterility and container closure integrity for sterile product.”
Another challenge is the requirement to regularly assess extractable and leachable studies, she adds. “Testing every recycled batch is prone to significant pharma operation impact and potential supply issues.”
A cartridge-based injector pen, which can deliver up to four doses, for example, potentially creates a patient safety risk because of the need to set the dose, the existence of an exposed needle and the steps the patient needs to take in disposal.
Thinking outside the box
Nonetheless, some companies in the pharmaceutical and medical device sectors are rising to the challenge by reimagining traditional drug delivery systems. For example, certain autoinjector platforms are being developed with reusable components and disposable cassettes to reduce environmental impact. These devices often feature patient-friendly designs, incorporating visual and audio cues to guide users through the injection process and confirm dose completion. Connectivity options like Bluetooth and RFID are increasingly being integrated, allowing for automated sharing of dosing data with mobile health applications. Additionally, innovative refill systems are emerging, enabling patients to return used autoinjectors to centralised hubs where automated processes handle disassembly, cleaning, syringe replacement, quality control and relabelling – supporting both sustainability and patient convenience.
There has also been some striking thinking-outsidethe- box innovation. Roche has developed a new drug delivery system for treating patients with diabetic macular oedema or diabetic retinopathy. Normally, these patients would receive monthly intravitreal injections of ranibizumab. Roche’s Susvimo, however, is a surgically implanted port delivery system (PDS) that continuously releases ranibizumab into the eye and requires refilling only every six or nine months. As well as being more sustainable, it benefits patients. “It significantly reduces the burden of frequent invasive procedures and the associated travel while maintaining comparable vision outcomes,” says Fuetsch.
Secondary packaging also offers potential for greater sustainability. Because it doesn’t touch the drug directly, the regulatory requirements are less strict. Nonetheless, says Fuetsch, secondary packaging “still needs careful assessment and validation. This is due to the complexity of protecting contents during transport and storage, especially when temperature controlled.” And while Roche is ahead in the transition of reuse targets for transport packaging, Fuetsch adds that “implementation and standardisation is a two-year cycle from development to qualification and regulatory approval, assuming no major challenges in the meantime”.
The final challenge involves assessing the sustainability of a drug delivery system across its life cycle, because while an innovation may, on the face of it, be more sustainable than the system it is replacing, a more rigorous analysis may show that not to be the case. For example, while a reusable device may appear more sustainable than a disposable one, if patients need to switch to a different dosage, they may have to replace a device that hasn’t reached the end of its natural life. Roche, in common with other pharma companies, uses life-cycle assessment (LCA), which looks at sustainability at every stage of the process.
Collaboration is key to improving sustainability
In a sector where regulators understandably prioritise patient safety, how can pharma companies make sure that their products and processes also meet sustainability targets? The solution requires regulators to collaborate more closely, both with manufacturers and with each other, to reach a consensus on how sustainability principles could be integrated into drug development. As Fuetsch says, regulators “play a crucial role in aligning global regulations with sustainable drug delivery practices”. Roche, she says, encourages regulators “to foster a flexible, global framework that supports innovation, patient access and sustainability simultaneously”.
Ideally, the future will see greater harmonisation of environmental standards across the regions covered by the ICH, as well as integration of sustainability metrics in regulatory submissions. Fuetsch argues that a harmonised global framework is crucial for a smooth transition to avoid conflicting requirements across the EU and international legislations, making the framework too complex to navigate: “Sustainability rules should be aligned and developed in consideration of existing pharma and adjacent frameworks impacting the healthcare sector.”
This collaboration is already starting to happen. There has been increasing interest in adopting LCA standards for evaluating environmental impacts across a product’s life cycle. Fuetsch particularly welcomes the upcoming British Standards Institute (BSI) standard, PAS 2090:2025, which is designed to establish product category rules (PCRs) for conducting LCAs of pharmaceutical products. Expected to be the first such specification publicly available and globally applicable, it aims to harmonise environmental evaluation.
“Previously, a lack of such a standard led to inconsistent results for similar products,” says Fuetsch. “This collaboration shows how industry and regulators can effectively create unified sustainability frameworks.”
New BSI standard could transform pharma sustainability reporting
PAS 2090:2025, a new specification from the British Standards Institute (BSI), is the first publicly available framework designed specifically for conducting life-cycle assessments (LCAs) of pharmaceutical products.
At its core, PAS 2090 establishes product category rules (PCRs) – detailed guidelines that ensure LCAs are conducted consistently across different products and companies. By defining what data should be collected, how impacts should be measured and how results should be reported, the standard aims to bring transparency and comparability to sustainability assessments in pharma.
Previously, LCA results for similar products could vary widely due to inconsistent methodologies. PAS 2090 addresses this by setting a globally applicable benchmark – a major step towards harmonised environmental evaluation in the life sciences sector.
Why it matters
- enables evidence-based sustainability claims
- supports regulatory alignment and global harmonisation
- facilitates informed procurement decisions in tenders where environmental impact is a factor
Source: BSI PAS 2090:2025 – Product Category Rules for the pharmaceutical industry
