EU Ombudsman wants more transparency concerning medicines for children

European Union Ombudsman Nikiforos Diamandouros has called on the European Medicines Agency to increase the transparency of its procedures for ensuring that children can benefit from new medicines.

This follows a complaint from two pharmaceutical companies which were required by the EMA to test the suitability for children of their heart failure medicine. They alleged unfair treatment because other pharmaceutical companies had been exempted from the obligation to test similar products. The Ombudsman concluded that the EMA did not properly disclose its assessments in these cases. He called on the Agency to make its procedures more transparent in the future.

The complaint was submitted on behalf of Takeda Global Research & Development Center, part of Japan’s largest pharma company Takeda Pharmaceuticals (TYO: 4502) and Anglo-Swedish drug major AstraZeneca (LSE: AZN). The complainants co-developed candesartan cilexetil (a product used to treat hypertension and heart failure marketed under the trade name Blopress). There are two other ARBs on the market, namely, losartan (Merck & Co’s Cozaar) and valsartan (Novartis’ Diovan). According to the complainants, the Agency wrongly treated an application for a waiver for candesartan, given that it treated that waiver application differently from those for losartan and valsartan.