The EU Green Deal: the challenge of greening medical technologies

Introduction

No day passes by in Brussels without hearing buzzwords linked with the European Union (EU) ‘Green Deal’ agenda, such as ‘Chemicals Strategy for Sustainability’ or ‘Toxic-Free Environment Strategy’ [1].

The goal of this ambitious EU policy agenda is to gear up Europe’s efforts to become the first climate neutral continent by 2050, in line with the Paris agreement on climate change [2]. To achieve this, a swathe of EU policies are currently under major review and revision, and new initiatives are being proposed too, with the effect of mainstreaming environmental and sustainability considerations across EU policies and regulations.

What’s in the EU Green Deal for Europe’s laboratory professionals, and for the medical technology industry that supplies these laboratories with the tools they need to help patients?

At a basic level, what’s in it for us all is an invitation to contribute what we can (alongside all other sectors, within and outside healthcare) to the goal of a healthier planet.

The launch last year by the EFLM of its “Green Labs” task force shows laboratories’ determination to improve their sustainability performance across Europe and beyond.

It does not mean however that a “one-size-fits-all” approach must or can be taken to help contribute to the EU Green Deal Agenda. Nor that it can all happen in a day. The EU Green Deal agenda is a transition agenda, and it certainly poses a number of specific challenges to the in vitro diagnostic (IVD) community.

The Chemicals Strategy for Sustainability (CSS): from political discourse to reality

One important example is the so-called CSS. Under this pillar of the EU Green Deal, the European Commission aims to accelerate existing efforts to reduce the use of the most hazardous chemical substances. Key categories of substances targeted here are listed in the European Commission’s communication of October 2020: Substances of Very High Concern (SVHCs), Endocrine Disrupting chemicals, Carcinogenic, Mutagenic and Reprotoxic chemicals (CMRs), sensitisers, and Persistent, Mobile and Toxic chemicals (PMTs) [3].

It is through this lens that various EU Directives and Regulations dealing with chemicals such as Regulation on the Classification, Labelling and Packaging of hazardous substances (CLP)” [4] and the EU Regulation on the “Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) [5] and Restriction of Hazardous Substances Directive. (RoHS) are currently being revised [6].

The idea is to reserve the use of the most hazardous substances where there is a real, serious, need and “case” to do so, and only after an assessment has been made as to whether there are other suitable, less harmful alternatives available [7].

In the case of medical technologies such as in vitro diagnostics (IVDs), this can pose complications. For instance, octylphenol ethoxylates (OPE) such as Triton X-100 are widely used as surfactants or detergent in all sorts of products, including reagents and other chemical mixtures needed to run IVD assays. Yet through the lens of the CSS and EU chemicals legislation in general, these substances are also seen as posing concern to the environment.

A key challenge facing the EU is how to balance its laudable environmental ambitions against the citizenry’s expectation and need for seamless, modern healthcare, including continued, reliable availability of diagnostic services.

IVDs are strictly regulated by sectorial EU legislation – notably the Regulation (EU) 2017/746 on in vitro Diagnostic Medical Devices – to ensure health and safety, not only of patients but also of laboratory professionals who use IVDs [8]. Managing the interface between this sectorial legislation and the rapidly changing EU legislation dealing with chemicals is a delicate exercise. The current timelines for restricting or authorising chemicals under legislation like the EU REACH Regulation can clash with the (longer) timelines needed to (re-)design and (re-)validate the chemical composition of reagents, buffers and so on, in compliance with the EU’s sectorial IVD legislation.

The ambition of the EU to phase out chemicals of concern even faster than they are today therefore challenges the IVD industry to contribute to this goal while delivering safe and high-quality tests to Europe’s laboratories and healthcare systems.

Consider for instance the following facts:

1. Laboratory professionals routinely and deliberately use hazardous chemicals, and precisely for their hazardous properties. It may take a great many years (and potentially even an eternity) before IVD assays can rely on reagents or buffers that can trigger the desired reaction with human samples while only comprising inert chemicals.

2. These hazardous chemicals are not always used in isolation, one by one, but rather tend to be used as part of complex mixtures where each chemical performs a specific function, often at very low volumes.

3. If a laboratory professional has the right set of chemical(s) for performing the right test, (s)he need not look elsewhere, and can instead use what (s)he has and which works well.

4. Engaging in research does not mean one will necessarily succeed in identifying suitable and viable alternatives at the end of the process. Indeed, one can expend considerable resources (both financial and in terms of professional time) over years to find no viable alternative to the chemical formulation of today’s commonly used reagents.

5. Finally, in those cases where alternative formulations can be found, and are successfully validated under the EU’s sectoral legislation, this will take time, and it may lead to changes to the way in which laboratory professionals may use the reagent.

Fifty shades of green

Looking at the future, new technologies such as Artificial Intelligence (AI), quantum computing, supercomputing might help and deliver more safe and more sustainable chemicals and materials by design, as shown by the many examples described in the editorial of the Clinical Chemistry and Laboratory Medicine (CCLM) journal on AI in clinical laboratories [9].

The question that is on the table is how far the European Commission is ready to confront potential trade-offs between the different policy objectives of the EU Green Deal where these are conflicting with, for instance, the realities of Europe’s diagnostic labs.

The above-referenced example of octylphenol ethoxylates (such as Triton X-100) shows that this remains a bumpy road at the moment, considering that alternatives to these substances exist on the market, but they are also intrinsically hazardous and are therefore also candidates for EU regulatory restrictions in the future.

Even if these substances are ultimately allowed to remain in certain IVD reagents, buffers and so on in the future, the EU will still likely look at whether the environment is exposed to these substances via the use and disposal phase of the IVD lifecycle. This means potential future scrutiny in terms of how laboratories collect and dispose of wastewater as it exits IVD analysers, as in many cases today this wastewater (containing dilute quantities of octylphenol ethoxylates) goes down the drain.

There are alternatives, of course, but whether they are feasible and balanced is a question needing careful consideration. For instance, if laboratories were to collect and incinerate their wastewater, this would avoid exposure to the environment. On the other hand, many analysers create very large masses of wastewater, which would emit impressive quantities of carbon dioxide to incinerate, not to mention the financial costs for the laboratories to install and run incineration infrastructure.

Clearly, the EU needs to step carefully in pursuing the Green Deal, so that it does not save the planet on the one hand while rendering it technologically or financially unfeasible for laboratories to maintain diagnostic services to patients on the other. Or, to use the EU’s own frequently employed legislative jargon: when establishing new requirements in the environmental space, the European Commission should take into account the need to not negatively affect the health and safety of patients and users.

Balance is clearly needed. Striking the right balance is not an option. Rather, it is something the EU must do.