A proposed restriction on the use of fluorinated substances in Europe would have an “irredeemable impact” on the continent’s life sciences sector, the European Federation of Pharmaceutical Industries and Associations (EFPIA) warns.
Specifically, supplies of more than 600 essential medicines would be at risk and manufacturing would “grind to a halt” in Europe in less than three years if the wide-ranging chemical ban is put in place, EFPIA said in a press release this week.
The chemical ban is being floated by authorities in Germany, the Netherlands, Sweden, Denmark and Norway in a bid to limit risks to the environment and human health from the production and use of a wide-range of Per- and Polyfluoroalkyl substances (PFAS), EFPIA explained.
PFAS are a large class of thousands of synthetic chemicals used "throughout society," according to the European Chemicals Agency. They contain carbon-fluorine bonds, which are one of the strongest chemical bonds in organic chemistry. That makes them resilient, but it also means PFAS can accumulate in the environment, where they've been found to contaminate groundwater, surface water and soil.
The proposed restriction covers up to 10,000 substances, which would make it one of the “widest ever put in place,” EFPIA said. In its current form, the restriction would have an “irredeemable impact on many industrial sectors, including the essential health products and technology sectors,” the EU pharma group added.
The pharma industry is concerned about the impact of PFAS on the environment and “does not oppose the close consideration of certain harmful PFAS,” EFPIA said.
Crucially, however, not all PFAS have hazardous properties, with some considered of low concern, EFPIA argues. The chemicals are used widely in the production of medicines, but those used in actual therapeutics have “no or low identified risk," the group adds.
“Therefore, while there is a need to minimize emissions, the approach should ensure the continued production and availability of medicines for patients in Europe,” EFPIA said.
To further its claims, EFPIA ran a patient impact analysis, which found that if the proposals go ahead in their current form, at least 47,677 global marketing authorizations would be affected, with a “significant number of critical medicines no longer available.”
More than 60% of critical medicines in Germany, France, Sweden, Finland and Norway would be affected, the federation argues.
Meanwhile, Europe has been trying to get ahead of drug shortages in recent months and years. For instance, a group called the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) has been keeping tabs on Europe’s antibiotic shortage since November.
With partners in government and industry, the group is working to boost capacity and resolve supply shortfalls.
In addition, a group of 19 European countries recently launched an effort to reduce the bloc’s supply chain reliance on outside countries.
The proposed European Critical Medicine Act would follow in the footsteps of similar acts such as the Critical Raw Materials Act and support European “green, digital” manufacturing for essential meds and ingredients.