The European Union wants to eliminate from municipal wastewater drug residues excreted by people who need to take them. This is to be financed by the pharmaceutical industry. - This is a huge expense for manufacturers of inexpensive drugs, which will result in an increase in the cost of their manufacture and a decrease in availability, reports Krzysztof Kopeć, president of the National Drug Manufacturers. Today (Nov. 5), the Council will decide on the adoption of a directive on urban wastewater treatment. The Polish government opposes these regulations in the interest of patients.
Wastewater directive. What do drug manufacturers say about it?
Published Nov. 5, 2024 10:57
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Drug manufacturers are obliged to follow sound production wastewater management practices. Companies closely monitor and eliminate pollutants discharged from their plants. Trace chemical residues of drugs found in wastewater within the EU are the result of human consumption. Chemical pollution is also generated by other sectors.
Under the directive's proposed principle of extended producer responsibility, manufacturers of medicinal and cosmetic products are to pay the full cost of removing micropollutants from the residues of their products from municipal wastewater, as well as finance micropollutant monitoring, collection and verification of data of marketed goods.
The cost of the scheme in the EU ranges from €5 billion to €11 billion per year. Based on the methodology adopted by the German Environmental Agency, the impact on the Polish pharmaceutical industry will be about PLN 635 million per year.
According to Medicines for Europe, an organization of European generic drug manufacturers, this will have consequences for the stability of healthcare systems in Europe and could cause shortages in pharmacies, including of antibiotics, anti-cancer drugs, anti-diabetic drugs. It will therefore hit patients who have to take the drugs and who consequently release pharmaceutical residues.
The 15 member states of Austria, the Czech Republic, Germany, Estonia, Spain, France, Greece, Italy, Latvia, Lithuania, Malta, Poland, Portugal, Romania and Slovenia have expressed serious concern about the directive's impact on the availability of essential medicines.
Generic drug manufacturers will be particularly affected by the wastewater tax due to their large volumes and tightly constrained prices.
7 out of 10 medicines dispensed to patients in the EU are generics, and 9 out of 10 are products on the EU's list of critical medicines. Generic drugs are the backbone of European healthcare systems.
Poland's position indicated that the new directive would require long deadlines for implementation, including for investments, as well as high financial outlays. It will therefore be important to provide EU funds for the new obligations under the directive.
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