Christos Gallis leads industry position on EU water law
Pause implementation, consider the best-available evidence, and repair the legislation was the key message delivered by STADA EVP Eastern Europe, Christos Gallis, on behalf of the off-patent medicines industry during a panel discussion on the Urban Wastewater Treatment Directive (UWWTD) during the Medicines for Europe Annual Conference.
Addressing around 250 delegates in his home city of Athens, Christos appealed for a coherent set of EU policies that would improve patient access to medicines. At a time of uncertainty when Europe was trying to reinforce medicines supply through legislation such as the Critical Medicines Act, he pointed out that the UWWTD was taking Europe in exactly the opposite direction.
If implemented as it stood, the Medicines for Europe executive board member told the audience, the Directive would severely damage healthcare systems and patient access to medicines.
Stressing the industry’s commitment to be “part of the solution” on caring for the environment, Christos highlighted several key problems with the Directive and its Extended Producer responsibility (EPR) scheme that puts most of the cost of additional water treatment onto off-patent medicines suppliers.
“Not all polluters will pay,” he stated, highlighting a new Greek study presented during the conference which showed that pharmaceuticals caused just 8% of the toxic load in waste water, far less than household chemicals such as surfactants or personal-care products which will not be subject EPR fees.
“Those that do pay, will pay disproportionately,” he continued with estimated costs from governments and the water industry up to five times higher than those projected by the European Commission. “The fees will be based on product volumes, but also toxicity, but toxicity has not been clearly defined. This is the definition of a mess.”
Outlining the challenge to patient access to medicines, Christos warned that “products will become economically unviable, and will leave the market”. Taking the example of metformin, one the active ingredients likely to be worst hit by EPR fees, he pointed out that this could affect treatment for around five million diabetes patients in each of Italy and Spain. “We don’t have one problem, we have millions,” he added.
“Companies are facing a sizeable, but uncertain and uncapped, financial burden at a time when we are facing competition from the US, and China is 15 years into its Biotech Act while we are still working on it in Europe,” Christos told the audience. “We started with a laudable ambition, but ended up compromising access and industrial resilience.”
Responding to a question on what industry could do, Christos highlighted a recent referral by Ireland to the European Court of Justice, as well as an advocate-general opinion in a Polish case that is expected in early September. Nearer term, an EU Parliament vote this week could demand a new analysis of the Directive’s impact or pause implementation.
