The project is expected to strengthen and make more competitive the European healthcare industry by positioning it at the forefront of the development of medical technologies, products, and services of the future - those that generate less waste, require less waste treatment, have reduced carbon footprints, increased circularity, and other approaches that reduce the environmental impact of healthcare.

It aims to promote the development of new health products by integrating the principles of the safe & sustainable by design (SSbD) framework¹, from the earliest design stages, and notably for packaging and device design including the end-of-life of a product. In the context of this call, packaging includes primary packaging in direct contact with products (e.g. drugs, medical devices, in vitro diagnostic reagents, etc.) and secondary packaging made of plastic polymer materials – excluding secondary and tertiary cardboard packaging. Medical devices refer to single-use plastic pharmaceutical and medical devices used for the administration of medicines such as pens used for insulin injection or devices used for surgeries such as trocars and staplers. They may contain additional components such as metals and electronic components as is the case of smart staplers, for example.

The project should as a minimum have all of the following impacts:

• Developers of health products (e.g. drugs, medical devices, in vitro diagnostic reagents, combination devices, etc.) are able to draw general lessons and best practices for their current research, and integrate research results on packaging and devices that generate less waste, make more efficient use of materials, and minimise the use of single-use components.
• Alignment with the European Green Deal objectives for healthcare systems, especially in the field of waste management and CO₂ reduction, as well as an improved competitive position for healthcare companies.
• Improving the recyclability of medical devices, independent of whether the material of construction (e.g. plastic, metals) is classified as non-hazardous or infectious waste².
• Reduced carbon footprint of health products in alignment with the Paris Agreement on climate change and the European Green Deal (55 % by 2030, NetZero by 2050).
• Propose new solutions that are holistic in nature, and which do not create additional adverse ESG (environment, social & governance) issues.
• New solutions should facilitate circularity even if the end points are not a closed loop back into the healthcare sector and instead are used for other applications.
• Identify a range of physical, mechanical, chemical and/or composting recycling infrastructures such that packaging materials and single-use medical devices (e.g. pens used for insulin injection, surgical trocars) can be recycled.

_{1 https://publications.jrc.ec.europa.eu/repository/handle/JRC128591}

_{2 https://www.who.int/news-room/fact-sheets/detail/health-care-waste}

The project should contribute to the following outcomes:

1. Paradigm shifts in standard materials to shape products of the future (e.g. reduced material usage by pushing the boundaries on material specifications such as down gauging foils/films, blending virgin and recycled polymers, inclusion of more sustainable materials as newly proposed from material suppliers, etc.).
2. Development of new and effective technologies, products and innovations that generate minimal waste from packaging and enable the recycling of used devices (including devices which have been in contact with human tissues, i.e. infectious waste¹) throughout their lifetime of use in healthcare systems, by applying the principles of the safe & sustainable by design (SSbD) framework.
3. Alignment with the European Packaging and Packaging Waste² and Ecodesign of Sustainable Products³ Directive proposals.
4. Such innovations – i.e. packaging materials & single-use medical devices (e.g., pens used for insulin injection, surgical trocars) are easily accessible in sufficient quantities to healthcare providers (e.g., hospitals, medical analysis laboratories, caregivers, and patient associations/organisations).
5. Environmentally-friendly packaging and device materials are designed from sustainable raw components and manufacturing processes with minimal carbon footprint.
6. Selective sorting procedures, implementable by healthcare providers.
7. The creation of short circuits for recycling packaging and device waste from healthcare providers’ locations.

Healthcare systems more widely adopt a lifecycle assessment approach, enabling healthcare to become a more sustainable industry with closer and more circular recycling loops for packaging as well as single-use devices, including those which may have been contaminated (i.e. infectious waste).

Solutions should include a holistic approach such as:

1. adoption of biomass balanced materials that reduce environmental impacts, and
2. inclusion of advanced recycling technologies such as various chemical recycling technologies (hydrolysis, pyrolysis, solvolysis, etc.) if improvements to environmental impacts can be properly documented.

Patient outcomes and the safety/performance of medical products should not be compromised by the environmentally-friendly packaging and device solutions to be developed by the project.

Notably, these packaging solutions should be compliant with existing standards (e.g. primary packaging with sterile barrier: ISO 11607) to guarantee the safe use of medical products, i.e. maintenance of the safety and performance levels that are claimed throughout their intended shelf life.

• Depending on the use cases selected by the project, they must provide a sterile barrier, maintain controlled humidity, protect against light, etc. throughout their shelf life, including shipment from manufacturing site to end users.
• When used as a sterile barrier, they should be compatible with common sterilisation processes (e.g. steam, gas sterilisation such as hydrogen peroxide; radiation treatments such as e-beam, gamma irradiation, X-rays, etc.).
• When used as medical products for use in humans, existing safety & biocompatibility standards are met such as European Pharmacopeia (EP) compendia, ISO 10993, etc. (e.g. not generating extractible and leachable harmful products during the full shelf life of the products).
• The chemical and physical properties of the new material formulations should also guarantee the intended shelf life of the medical products (e.g. up to 5 years).
• Work with regulators (e.g. European Chemicals Agency (ECHA), European Directorate for the Quality of. Medicines & HealthCare (EDQM), European Pharmacopeia (EP), US Pharmacopeia (USP), American Chemical Society (ACS), etc.) to create new or revised standards/monographs for new materials that are used in health products. By extension, this engagement should contribute to the generation of future product eco-design labels / green claims.
• For example, the use of packaging composed of biodegradable, recyclable and/or environmentally benign ingredients is favoured if the claimed performance and safety of the medical products are maintained.
• Improved and simplified protocols for the management, collection, and recycling of medical device waste (packaging and devices) to reduce waste management costs for healthcare providers and minimise the environmental impact of the medical waste generated by medical devices.
• Protocols for the collection of single-use devices and their packaging to drive circularity should be easily implementable by healthcare providers. Their adoption must be possible for the greatest number of healthcare providers, regardless of their location. They may potentially include the decontamination of products if they have been in contact with human tissues to allow their sorting and recycling under the safest conditions.
• Improved and simplified protocols for supply chains and logistics for sorting of packaging waste of health products for healthcare providers with a minimised carbon footprint.

The outcomes must be as cost-effective as possible so as not to burden health systems with prohibitive additional costs.

Overall, the project is expected to yield strong results from the use cases. The results should be taken as evidence to collaboratively shape European legislation on packaging and packaging waste and the eco‑design of sustainable products for health technology industries.

_{1 https://www.who.int/news-room/fact-sheets/detail/health-care-waste}

_{2 https://environment.ec.europa.eu/publications/proposal-packaging-and-packaging-waste_en}

_{3 https://environment.ec.europa.eu/publications/proposal-ecodesign-sustainable-products-regulation_en}

Product development

The project should accelerate the implementation of alternative eco-packaging and device materials through collaborative work by including policy makers, regulators, and standards bodies. It should identify, characterise, and test new replacement materials according to specifications and in compliance with existing standards (e.g. primary packaging with sterile barrier: ISO 11607).

The project should examine the European landscape of materials, whether commercially available or under development, which may be acceptable as components of sustainable packaging and appliance solutions, from different perspectives, regulations, possibility to recycle with current and future waste management processes, and sustainability of industrial supply. Such a review can benefit from and partner with the European Partnership for the Assessment of Risks from Chemicals (PARC) and with the successor partnership of the M.ERA-NET III and the AMI2030 initiative. In addition, synergies with projects funded in the Horizon Europe Cluster 4 addressing SSbD could be envisaged (HORIZON-CL4-2023-RESILIENCE-01-21: Innovative methods for safety and sustainability assessments of chemicals and materials (RIA); HORIZON-CL4-2023-RESILIENCE-01-22: Integrated approach for impact assessment of safe and sustainable chemicals and materials (RIA); HORIZON-CL4-2023-RESILIENCE-01-23: Computational models for the development of safe and sustainable by design chemicals and materials (RIA)).

Health tech companies are expected to design and develop new packaging and devices (e.g. insulin pens, staplers) by starting from solutions that already exist or are at an advanced stage of development (e.g. available paper-based covers / packaging seals reinforced with polyolefins, or mixtures of virgin and chemically recycled polymers for the manufacture of blisters), and/or by selecting fully compostable or recyclable materials (for example, biomass balanced polymers as currently proposed and under development by chemical companies) to generate innovative packaging and device solutions. The polymers or materials to be selected must not only be recyclable/compostable, but also manufactured with a minimal environmental footprint.

The design and development of the new packaging and devices should apply and adapt circular economy principles and be guided by the SSbD framework. It should be done in close partnership with all players of the value chain from the manufacturers of the raw materials to the end users, the healthcare providers. The packaging and device use cases of the project are highly expected to improve and enrich the current SSbD framework, through concrete feedback to the European Commission and lessons learned. It is envisioned that this will necessitate regular interactions between the project and the developers of the SSbD framework at the European Commission.

Recycling

The project should promote the management of waste from packaging and single-use devices (including complex devices) by end users, the healthcare providers, considered as key partners of the project. This should lead to the effective implementation of the sorting and recycling of waste through collaborative work, including technical, organisational, and regulatory aspects (e.g. allowing the reuse of plastics etc. after industrial disinfection and/or decontamination of infectious waste, development of new recycling processes, setting up composting units etc.). Preferably, healthcare providers should include not only hospitals, but also other end users such as nursing homes. Healthcare providers should preferably be from several EU Member States or associated countries (e.g. minimum 3 EU Member States or associated countries), given the great disparity of practices from one country to another, in terms of legislation and implementation of waste sorting and recycling.

Importantly, the project should extend existing life cycle assessment (LCA) based metrics systems to packaging and devices, by considering the life cycle of the packaging materials, from their manufacturing to their recycling / composting. The LCA study must be carried out by an independent institution. Key performance indicators are expected to come from comparing LCA metrics with the implementation of the SSbD framework, which should lead to better packaging and device recyclability and more favourable life cycle outcomes.

Another key element of the project is expected to come from an active partnership with European non-profit packaging associations, single-use plastic, and waste management associations and, possibly, standards bodies and approval bodies responsible for marketing authorisations. These institutions should work with European policy makers to support evidence-based policy making based on the findings of the different use cases of the project. The development and implementation of recyclable packaging and device solutions should also be articulated by the health tech trade associations, at the European (i.e. EFPIA, COCIR, MedTech Europe, EuropaBio and Vaccines Europe) or national levels, in particular with their working groups on sustainability and the circular economy.

General lessons / best practices and results will be shared as far as possible (e.g. peer-reviewed articles, white papers, press releases, web media, report deliverables, etc.). Communicating project results is essential to collaboratively shaping the acceptability, adoptability, and implementation of European legislation on packaging and packaging waste and the eco-design of sustainable products for health technology industries.

Besides this topic, another topic in this IHI call entitled “Sustainable circular development and manufacturing of healthcare products and their quantitative environmental impact assessment” will aim to improve the manufacturing efficiency of drug substances of chemical/biological origin (covering all chemical drug substances, proteins, oligonucleotides, vaccines or polypeptides etc.) by developing new manufacturing technologies, saving natural resources like water and fossil or fossil-based raw materials, and reducing waste in accordance with circularity principles (reduce, reuse, refine, recycle).

To jointly develop new strategies to ensure a greener healthcare industry along the whole value chain, and to avoid overlaps, a close collaboration between the two topics is essential and should be reflected by providing dedicated resources in both projects to align on common life cycle assessment (LCA) methodologies and LCA data.