The UK and EU propose bans on 'forever chemicals' (PFAs) – Great for the environment but what about the medical industry?

'Forever chemicals', which are used in countless industries worldwide, have been linked to a range of health issues.

The EU and UK are now exploring bans in a bid to tackle the issues that these chemicals may present - but with the medical industry heavily reliant upon them, how do we balance protecting the environment with the immediate needs of healthcare? 

In February 2023, five EU countries submitted a proposal to ban more than 10,000 PFAs. PFAs most commonly known as 'forever chemicals' comprise a group of thousands of synthetic chemicals which are degradation, heat and oil resistant. These properties make PFAs useful in the medical industry, in both products and production processes.  They are used in an extensive list of medical devices and supplies including implants, ventilators, surgical meshes and protective gowns. Moreover, they can be used to extend the shelf life of many pharmaceuticals and are used in special paints which allow hospitals to use strong cleaning chemicals to sterilise rooms. Many PFAs have limited or no alternatives and as such they are arguably a critical, albeit microscopic, part of how our medical industry functions. 

However, the fact PFAs do not break down over time means that they accumulate in the environment, animals and humans for decades. The Norwegian Environment Agency (involved in the draft EU proposal) stated:

"You can find PFAs in penguins in the Antarctic, in polar bears in the Arctic, even in the rain water in Tibet". 

According to the European Environment Agency these 'forever chemicals' can lead to problems such as:

"liver damage, thyroid disease, obesity, fertility issues and cancer"

As people become increasingly aware of possible associations between PFAs and health issues, there has been an increase in litigation. For example, in the US a class action brought against Thinx, a manufacturer of period underwear, resulted in a huge settlement at the beginning of the 2023. A further class action is being pursued against a similar producer of menstrual underwear, Knix Wear, which advertised its products as free of 'forever chemicals'. 

Discussions by regulators around the banning of PFAs are gaining traction globally. In September 2022, California banned the sale of many consumer items containing intentionally added PFAs. More recently, the EU's proposed ban aims to reduce the presence and continued accumulation of PFAs in the environment. Last April, the UK Health and Safety Executive (HSE) followed suit and published an assessment of the use of PFAs in the UK, which includes recommendations to ban hundreds of PFAs.  

Global steps towards a ban on PFAs may present a difficult challenge for manufacturers in the medical industry in considering whether there are alternatives that can be used. The five  EU countries behind the EU proposal stated that: 

"In many cases, no such alternatives [to PFAs] currently exist, and in some they possibly never will."

Major manufacturers in the healthcare industry are looking to change their product strategy, for example, by investing in sustainable coatings for medical devices, and phasing out the use of PFAs where alternatives are available. However, for other medical devices, where there are no available alternatives to PFAs, further research and investment will be required. 

Finding the way to regulate the use of PFAs, particularly in the healthcare industry will be crucial. Differentiating the essential nature of its use in that industry, which saves lives, from other industries where suitable alternatives may be readily available is key.  

The Johner Institute, a consultancy which supports medical device manufacturers with research around product development and regulatory compliance, believes a solution is to develop a risk-based regulation in which the amount of PFAs any product contains, along with the type of exposure, and the inherent risks of the substance used, are determined. The Johner Institute considers that "risk acceptance must again depend on benefits". 

So, does the risk posed by PFAs depend on the benefits of its use? In the medical industry, perhaps the answer is that it does. An outright ban of PFAs before suitable alternatives are identified could have a significant impact on the lives of vulnerable people who depend on those products. Careful consideration must therefore be given to any regulation developed to ensure the rights of patients are protected.