The health sector has a significant impact on the environment; in OECD (Organisation for Economic Co-operation and Development) countries, it is responsible for between 3 and 8% of CO2 emissions. It also uses large quantities of water, energy, solvents and fossil fuel-based raw materials, and generates a lot of waste.
No individual organisation can solve these problems alone; they require input from many disciplines and a wide range of stakeholders, including different industries, universities, regulators, healthcare providers, and more. As a public-private partnership, IHI is well placed to build ambitious projects that bring together all key stakeholders at the scale needed to make a difference in this important area.
The first projects designed to improve the environmental performance of the sector were launched under the Innovative Medicines Initiative (IMI) programme and addressed medicines manufacture and understanding the impacts of medicines in the environment. Recent months have seen the launch of two new IHI projects with an environmental theme; one focuses on medicines manufacture, while the other addresses the impacts of single-use medical devices and their packaging. Finally, a future project, which is currently under development, is set to cut the use of PFAS (per- and poly-fluoroalkyl substances) in the health sector.
“By boosting the environmental performance of the health sector in diverse ways, these projects contribute to key EU policies such as the Green Deal,” said IHI Executive Director Dr Niklas Blomberg. “Moreover, by developing novel processes and advancing the more efficient use of energy and resources, they contribute to the competitiveness of the sector in Europe.”
CHEM21 and PHARMECO: resources for cleaner medicines manufacture
IMI project CHEM21 set out to improve the environmental footprint of drug manufacture and to identify and synthesise new catalysts which could help achieve this. The project delivered a range of tools, processes and methods to improve the sustainability of medicines manufacture. Although the project finished in 2017, the project’s results remain relevant today. For example, CHEM21 scientists accelerated the development of imine reductases (IREDs), a novel class of enzyme; these are increasingly being used in industry for the sustainable production of certain active pharmaceutical ingredients (APIs). The project’s solvent selection guide is also widely used in the industry.
Meanwhile new IHI project PHARMECO aims to trigger a green revolution in the manufacture of medicines. As a first step, the project will enhance the early stages of pharmaceutical development by integrating ‘safe and sustainable by design’ (SSbD) principles. Promising innovative technologies and process optimisations will be selected based on their potential to significantly reduce the use of solvents, substances of very high concern, energy, and water in pharmaceutical production practices.
In the next phase, the project will test how the SSbD-driven technologies and processes perform at a larger scale, such as that needed for clinical trials and transfer to standard manufacture settings. Together, the project outputs will form a comprehensive toolkit to support the development and manufacture of more sustainable pharmaceuticals and to evaluate their environmental impact along the whole life cycle.
iPiE and PREMIER: towards better environmental risk assessments for medicines
IMI project iPiE focused on getting to grips with the impacts of medicines on the environment. APIs are released into the environment in a variety of ways. The most common route is via the sewage system, when patients excrete them. APIs can also escape into the environment when people dispose of medicines incorrectly, and during the manufacturing process. APIs are, by definition, biologically active, and although their concentration in the environment is generally extremely low, there are concerns about the effect of these chemicals on wildlife and ecosystems in general.
Since 2006, new medicines have had to undergo an environmental risk assessment before they are approved for use. However, this raises the question of how to prioritise the assessment of the 1 900 or so medicines approved for use before 2006. iPiE produced a suite of data, tools and models to help researchers assess which medicines are most likely to get into the environment, and which medicines could be harmful to wildlife and ecosystems. This information is crucial for deciding which medicines should be prioritised for environmental risk assessment.
IMI2 project PREMIER builds on iPiE’s work. For example, they have developed software that can predict where in European rivers we might find pharmaceuticals and at what concentrations they are likely to be. This is a significant step forward from the ePIE software developed in iPIE, adding waterflows in additional countries and water basins, and refining the methodology to provide an easier user experience. Other PREMIER outputs include software to predict how much of a water-borne API could be found in fish and other wildlife, and software to identify which species share protein targets in common with patients and so could be more vulnerable to APIs.
PREMIER’s work could also dramatically reduce the numbers of animals traditionally used in studies on the impacts of APIs on wildlife such as fish. The team has devised a tool that can better help with the decision to conduct a fish study using information available from human studies combined with environmental laboratory studies on algae and invertebrates.
“We have already found that we can deprioritise about a third of fish studies and we are actively applying this finding in our own programme that is generating new data for 25 APIs,” explain project lead Stewart Owen of AstraZeneca and coordinator Ad Ragas of Stichting Radboud Universiteit. “Given the large data gap that PREMIER was initiated to help prioritise, this is a huge ethical win potentially eliminating hundreds of studies sparing perhaps half a million animals in the coming years in line with 3Rs principles. We also estimate that this one approach could reduce 40 million euros of testing costs.”
PREMIER is also developing an open access database and application software to hold all the available data for the environmental risk assessments of APIs. Creating a database and software is challenging; maintaining it sustainably beyond the life of the programme is critical. Under proposals from the European Commission, the medicines regulator is charged with hosting such a database. As a founding partner in PREMER, the EMA has been involved in helping to shape the database, and the team are working towards a long-term solution to make the data openly accessible as a trusted source of information beyond the PREMIER programme.
Safe and sustainable by design: the ENKORE vision for medical devices and their packaging
Medical devices, particularly single-use devices, and their packaging generate substantial amounts of waste, including plastics and hazardous materials that are challenging to manage. Applying ‘circular economy’ principles to the sector could reduce these impacts, but doing this is far from easy. Because medical devices are often used on or in the body, and must be sterile, there are very strict rules governing the kinds of materials that can be used to make them and their packaging. This makes it hard to use environmentally friendly materials, such as recycled materials, for example.
Now, a new IHI project dubbed ENKORE aims to address these concerns by developing an eco-design framework for single-use medical devices and their packaging. By integrating sustainable practices into the design and manufacturing processes, the project aims to reduce the ecological footprint of medical devices, paving the way for a more environmentally responsible healthcare sector. Ultimately, ENKORE hopes its eco-design framework will accelerate innovation and support the delivery of products that are both safe for patients and environmentally responsible.
Coming soon: a project on cutting PFAS in the health sector
PFAS (per- and poly-fluoroalkyl substances) are synthetic chemicals which play a key role in ensuring the quality and safety of a wide range of healthcare products, from medicines and medical devices right through to packaging and cleaning agents. They are also hard to break down and so build up when released into the environment. Concerns about the impacts of PFAS on both human health and the environment mean there is now wide recognition of the need to limit their use.
IHI call 10 (which was launched at the beginning of the year) included a topic on PFAS. The aim of this topic is to minimise exposure to and the emission of PFAS in the healthcare sector, while maintaining the quality and safety of products affected. It will do this by investigating alternatives to PFAS where viable. Where the replacement of PFAS is not possible, the topic will explore how the use of PFAS (and their release into the environment) can be minimised. The project resulting from this topic is still going through the standard two-stage call process.