The article discusses the impact of a new directive on the generic pharmaceutical industry in Europe. According to the European generic medicines association, this sector is disproportionately affected by the directive as it supplies the majority of essential medicines for patients with serious illnesses. Generic medicines represent a significant portion of the medicines dispensed in European healthcare systems, with 70% of medicines, 90% of critical medicines, but only 19% of the pharmaceutical value being generics.
Medicines for Europe has expressed concerns that producers of generic medicines will be burdened with financing the costs of wastewater treatment, including those from industrial and agricultural sources. They have voiced their support for companies like Accord, Adamed, Fresenius Kabi, Insud, Polpharma, Sandoz, STADA, Teva, Viatris, and Zentiva who have filed a lawsuit against the directive.
The directive aims to promote the development of medicines in a more environmentally friendly manner, but the industry argues that it overlooks the unique nature of pharmaceutical products, which are chemically based and cannot be redesigned without compromising their effectiveness. A model created by the association demonstrates the significant impact of the directive on medicine supply across Europe, with cost increases of up to 875% for diabetes treatment, 368% for amoxicillin, and 321% for epilepsy medication.
The article highlights the disproportionate burden placed on the generic pharmaceutical sector by the directive, with expectations that they will bear up to 60% of the costs despite representing only 19% of the market value. The estimated annual cost of water treatment under the directive is 1.180 million euros, which could jeopardize the economic viability of many vital medicines. Some member states anticipate this cost to be five to six times higher, with the German government suggesting it could reach 5,000 to 11,000 million euros annually.
The industry warns that the directive could lead to a shortage of generic medicines, with catastrophic consequences for patients and the sustainability of European healthcare systems. They criticize the directive for unfairly targeting cheap medicines and the pharmaceutical and cosmetic sectors without sufficient evidence to support their responsibility for water pollution. The industry also raises concerns about the flawed impact assessment of the directive, which could increase bureaucracy and create unnecessary uncertainty.
Medicines for Europe is seeking legal action against the directive, believing it to be discriminatory and disproportional, particularly impacting low-cost and essential medicines for public health. They hope that the European Court of Justice will consider their case and are open to discussions with EU institutions to resolve the matter outside of court. However, they emphasize the need for legal action to protect access to healthcare and prevent the imposition of unsustainable taxes that could hinder medicine accessibility.
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