EU abdressions: Generics prices could increase by 875 %!

EU abdressions: Generics prices could increase by 875 %!

The Austrian Generalic Association warns of considerable consequences of the amended municipal wastewater directive (Karl) of the EU. This measure is intended to reduce micro -pollutants, especially pharmaceutical residues in the wastewater. The introduction of a mandatory fourth cleaning level in large sewage treatment plants is planned, the costs of which are primarily to be borne by the manufacturers of human medicinal products and cosmetics. According to the association, the generic industry, which is 70 % of all drugs in Europe, will have to cover around 60 % of the costs incurred, which could lead to a serious risk of access to vital drugs, such as Gesundheits-adhoc.de reported.

Wolfgang Andiel, President of the Austrian General Association, expressed that the environmental tax to be paid could exceed the margins of many preparations, which would potentially lead to a retreat from the market. The association calls for a solution that takes into account both environmental and health goals. Almost 60 % of the generic packs cost less than the prescription fee of 7.55 euros, and the average package price in Austria is only 2.83 euros.

challenges due to high costs

The financial burdens of the new guideline are alarming model calculations. For example, the costs from the Netherlands could lead to price increases of up to 875 % in metformin, a widespread standard preparation for diabetes treatment. In Austria, the generic share of metformin is even 98 %. The EU Commission estimates the annual costs for the introduction of the additional cleaning levels at 1.18 billion euros. According to alternative estimates, however, these costs could be up to 11 billion euros.

In order to address this situation, several companies in the generic industry support complaints against the directive at the European Court of Justice (ECJ), including well-known member companies of Pro Generika such as Accord, Fresenius Kabi, Sandoz, Teva, Viatris and Zentiva. This lawsuit is involved in the general criticism of the directive, which is considered discriminatory and disproportionate, since it only takes pharmaceutical and cosmetics companies responsible for pharmaceutical residues, while others, such as agriculture, are not in focus.

Danger for the supply of drugs

Experts warn that the introduction of the fourth sewage level and the associated costs could be a serious danger to the supply of drugs in Europe. The industry has already struggled with the problem that rising costs cannot be transferred to consumers, which endangers the profitability of many medications. According to an estimate, the manufacturing costs for the antibiotic amoxicillin could increase by up to 116 % and even by up to 446 % for diabetes. The association therefore appeals to the federal government to work to ensure the supply of drugs and to work on a solidarity model, as it exists in Switzerland.

Members of the generic industry are concerned that the framework conditions set could result in a decline in availability of important drugs. Critical drugs are often generic that make up 90 % of critical drugs in Europe. Some members argue that drug residues primarily come from human excretions and not from production, which is why the distribution of the costs is not justified. The future of pharmaceutical supply in Europe will continue to be questioned, while the EU member states have to decide by mid-June whether they want to join Poland's lawsuit against the guideline. It remains to be seen how the clarification of this topic will take place on the part of politics and the judiciary.