Improving EU regulatory environment for pharma company
Our client Heel is a leading manufacturer of homeopathic medicinal products strongly dedicated to scientific research. Heel had to deal with a non-suitable regulatory environment. Existing requirements as applied by competent national authorities did not honor investments in scientific research. Alber & Geiger faced a European Commission not being open for any changes in legislation. Alber & Geiger needed to also address issues on national level and develop a strategy before relevant national competent authorities.
Providing coherent legal arguments
The strategy co-ordinated legal, ethical, medical and scientific concepts into coherent arguments. It showed the European Commission and the EU institutions but also relevant national competent authorities more broadly, the particularities of homeopathic medicinal products, as well as their effectiveness and safety and the different national approaches in the EU Member States.