Várhelyi not ‘deaf or blind’ to pharma's concerns over Wastewater Directive
Health Commissioner says he will do ‘everything in his power’ to correct unfair burden embedded in the legislation
Speaking at the opening of a new EGIS plant, in Kőbánya, Budapest, the EU’s Health Commissioner Olivér Várhelyi said that he hoped that the Biotech Act would be published before the end of the year and equally that he thought negotiations on the Pharmaceutical Package should also be completed in the coming weeks.
The pharma plant, which represents an investment of €78 million, is a welcome addition to API (active pharmaceutical ingredient) production in the EU, where around 80% of APIs are currently imported from India or China. It is one of two identical plants, the other one recently opened in Normandy, led by the Servier group.
“We are convinced that API manufacturing contributes significantly not only to competitiveness but also to security of supply,” said CEO of Egis Pharmaceuticals PLC, Csaba Poroszlai. “Egis is a vertically integrated European company - meaning that here in Europe we conduct research and development and manufacture both pharmaceutical active ingredients and finished products, which we then market worldwide.”
Urban Wastewater Treatment Directive
In his speech, Várhelyi said he was far from “deaf or blind” to the mounting problems, raised unanimously across the pharmaceutical sector, about issues that go beyond healthcare regulations. He said that environmental rules were coming to the forefront.
He said that he would do “everything in his power” to carry out a rebalancing, saying that it was unacceptable that the obligations of the Urban Wastewater Treatment Directive fall disproportionately on the pharmaceutical sector.
He insisted that this was the moment to reassess rules not yet in force and to correct the unfair burden embedded in existing legislation, before the imbalance becomes irreversible. He pledged to use every tool available to help restore that balance.
Commission's cost study
The Czech government has added the matter of the ‘Urban Waste Water Treatment Directive – Cost Study’ to the agenda for next Tuesday’s (2 December) Health Council. The study was requested by ten member states at the last Health Council in June.
Czech officials have welcomed the Commission’s ongoing efforts to prepare its study, but say the analysis should go beyond environmental and infrastructural costs and include the financial consequences for national health system budgets.
“While the introduction of extended producer responsibility for pharmaceutical residues is expected to enhance environmental protection, it may also have significant repercussions on medicine pricing, reimbursement frameworks, and patient access to essential treatments.”
They say that the study should take into account the dual objectives of environmental sustainability and equitable access to healthcare.
Medicines for Europe, which represents the generic and biosimilar pharma sector, has called for an urgent pause in implementation until the Directive is properly reviewed. It is also supporting a case brought by the Polish government that argues the legislation is disproportionate to its objective and contrary to the principle of equal treatment, by placing the burden on removing micropollutants solely on the producers of cosmetics and pharmaceuticals.
The question now is whether the Commission will try to change the rules ahead of what many in the sector view as an unsustainable burden.