Drug delivery
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
www.worldpharmaceuticals.net 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
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 high- volume 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.
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