From 2027 onwards, a number of product categories sold in the EU will have to feature a Digital Product Passport (DPP) – offering standardised, accessible data to boost transparency, support sustainable practices, and empower informed decision-making across value chains. While much of this information is already provided by pharmaceutical companies through the GS1 DataMatrix to adhere to existing legislation, the sector is excluded from DPP requirements.

And yet, extending current pharmaceutical packaging information beyond existing regulatory demands offers compelling benefits to patient safety and global sustainability. While direct-to-consumer advertising is prohibited in the European prescription pharmaceutical sector, information accessible via 2D codes can still enable manufacturers to improve consumer understanding of recycling and disposal requirements, provide access to electronic patient information leaflets (ePILs), or even deliver the transparency required to enable vital medicine reuse programmes.

James Cutforth explores the value of a DPP equivalent for pharma…

Pharma’s existing product passport

In 2024 the Ecodesign for Sustainable Products Regulation (ESPR) entered into force, introducing the Digital Product Passport (DPP) for selected product groups to enhance transparency. Pharma is excluded from the requirement to provide comprehensive information about each product’s origin, materials, environmental impact, and disposal recommendations – not least because the industry is already subject to strict regulatory demands surrounding transparency and traceability. Manufacturers selling in the EU and US already use 2D DataMatrix codes to meet the serialisation and track-and-trace requirements of both the EU’s Falsified Medicines Directive (FMD) and the US Drug Supply Chain Security Act (DSCSA).

While pharmaceutical products already carry much of the same information a DPP should include, there are very notable differences. Pharma product information is built for regulators rather than patients. Medicines are prescribed rather than chosen off the shelf, removing the need for product comparison information for consumers. And, of course, unlike the other product groups that require the DPP to provide recycling information, many pharmaceutical products cannot be recycled at standard public facilities – either kerbside or local centres.

Regulatory demands aside, there are compelling reasons why pharmaceutical manufacturers should consider the value of building on the existing GS1 DataMatrix to adopt a DPP-style code. Indeed, while the GS1 DataMatrix on pharma packs is not created in line with the GS1 Digital Link standard, which means the 2D codes cannot be automatically scanned by smartphones to provide consumer communication, a recent collaboration between GS1 and Google is looking to enable consumers to use Google Lens to scan medicine packs directly. With GS1 continuing to work with manufacturers to extend the pharma-to-consumer reach, the foundation is in place for extending communication to enhance consumer understanding.

Transforming pharmaceutical disposal and recycling

The industry has a chance to play a pivotal role in reducing pharmaceutical product waste. According to the World Health Organization (WHO), 85% of the waste generated by healthcare activities is general, non-hazardous waste – yet much still ends up in landfill. The balance between recyclability and safeguarding medicine is challenging but with an estimated 150 million blister packs used by the NHS alone every year in the UK, the environmental footprint is a cause for concern.

It is even more critical to address the safe disposal of enormous quantities of unused medication. Pharmaceutical consumption continues to increase year on year, despite concerted efforts to reduce over-prescribing. While unnecessary production and transport add to CO2 emissions, the biggest concern is how individuals are disposing of the high proportion of prescription medicines that are unused after being dispensed. In the UK, 40% of people admit to throwing unused prescription medicines into general household waste, which, along with other incorrect disposal methods – including flushing down the toilet – contributes to pollution in waterways, coastlines, and ecosystems.

Lack of knowledge is a big problem that could be addressed with DPP-style codes. Raising awareness of the risks associated with healthcare waste and helping individuals with information about how to safely dispose of unwanted medicines and empty packaging – such as a link to the nearest blister pack recycling point – could make a very significant difference. Using existing on-product 2D codes to provide information about safe product disposal and packaging recycling would boost customer confidence while also reducing the risk to waterways and minimising CO2 emissions.

Acknowledging pharma fears

There are a number of legitimate concerns for pharmaceutical manufacturers considering the use of 2D codes to provide consumer information – not least the prohibition of direct-to-consumer advertising in most countries outside the US and New Zealand. Any patient-facing DPP-style code would have to be closely scrutinised to ensure it could not be deemed promotional in any way.

Pharmaceutical manufacturers and medical practitioners also share fears about patients accessing clinical data out of context. With detailed product information written for clinicians and regulators, not patients, manufacturers could also fall foul of the EU non-direct-to-consumer advertising rules that specifically call out the risk of ‘erroneous self-diagnosis’.

However, there are compelling opportunities to leverage transparency to improve health equality and better manage the distribution of medicines, including unused items. Provision of ePILs and support for prescription management to avoid over-ordering are key objectives to reduce waste. There are also a number of projects looking to reconsider the automatic destruction of expired and unwanted medicines – including an initiative in Germany to recover compounds and a project in Greece to redistribute medicines to people who would otherwise not be able to afford treatment. Working in tandem with the existing strict chain of custody and anti-tamper seals to prevent reuse once opened, 2D codes could be used to ensure products are genuine and safe to use before redistribution or recovery activity.

Conclusion: Barcodes are communicating with consumers

For pharmaceutical companies, while DPP is not a regulatory requirement, there is a powerful opportunity to evolve the current 2D codes already found on billions of medicines to provide information not only to regulators, manufacturers, and healthcare practitioners but also patients. The provision of ePILs promises to drastically reduce the need for printed leaflets. Recycling and disposal information could help consumers to understand how best to manage both used and unused medicines, reducing the risk of environmental pollution. Up-to-date information could help patients to manage their prescriptions and avoid the over-ordering that contributes to excessive drug production. And enhanced traceability could support effective and safe disposal and reuse of medicine.

Pharmaceutical manufacturers are currently not required to provide DPPs but with the support of innovation such as the GS1 programme, the provision of a DPP-equivalent is expected to become increasingly important in supporting future regulatory and market requirements.