ZAGREB, 16 April (Hina) - The Pharmaceutical Manufacturers Association warns that the EU Urban Wastewater Directive could threaten the sustainability of Europe's generic drug industry and healthcare systems, with 16 countries having called for a revised impact assessment. "This Directive and the massive new costs, which due to the highly regulated market cannot be reflected in the market prices of generic medicines, will endanger the supply of critical medicines for patients in Croatia as well, especially in key therapeutic areas," said Ana Gongola, president of the Association of Pharmaceutical Manufacturers, which is part of the Croatian Employers Association (HUP), on the occasion of the EU Pharma Forum, held in Zagreb on Tuesday. Gongola added that it is essential to take all necessary steps to preserve and strengthen one's own pharmaceutical production, close to patients - especially considering current geopolitical tensions that further threaten the security of global supply chains. HUP warns that the annual cost of implementing the Directive for Croatia could reach up to €23 million - nearly five times higher than European Commission estimates - with around 60 percent of the cost falling on the Croatian pharmaceutical industry. "It is particularly concerning that the financial burden of treating wastewater and removing pharmaceutical residues - which result solely from medical treatment and the natural excretion of drugs from the body, and are not related to production - is being placed predominantly on the pharmaceutical industry," warned HUP Director General Irena Weber. Therefore, the Association of Pharmaceutical Manufacturers is appealing to European institutions to revise the proposed directive to ensure sustainable and fair solutions. Generic medicines form the backbone of healthcare systems across Europe - nine in ten critical medicines in the EU are generics - and additional financial pressure could cause serious disruptions in supply, price increases, and withdrawal of certain medicines from the market. Although generics account for only 19 per cent of the EU's pharmaceutical market by value, they are expected to bear the largest share of total levies. Furthermore, these costs are related largely to medicines that are produced and consumed in large volumes but have low prices and market value, endangering their economic viability. Particularly affected are therapeutic areas such as diabetes, pain management, infections, epilepsy, bowel diseases, high blood pressure, and anesthesia.