Regulatory measures to facilitate the development and registration of paediatric medicines: when market forces fail

Introduction. Paediatric drug development and registration are more complex than for adults and are rarely profitable. Finding solutions to improve access to paediatric medicines is a pressing global issue. A common approach is to stimulate the pharmaceutical industry with regulatory incentives, although these vary between countries. The World Health Organization is working to harmonise them. Aim. To compare regulatory measures adopted by the European Union (EU), the Eurasian Economic Union (EAEU) and the East African Community (EAC) to facilitate the development and registration of paediatric medicines. Materials and methods. Open-access regulatory databases of the EAEU, the EU and the EAC were searched for documents regulating the medicine registration process. A content analysis was conducted to identify regulatory provisions for paediatric medicines. These were categorised as either regulatory incentives or obligations. Results and discussion. Three documents were selected from the EAC, two from the EU and one from the EAEU. In the EU, 12 measures were identified in the form of incentives and obligations covering the development, registration and market placement stages. In the EAEU, one incentive measure at the registration stage was identified. No paediatric provisions were found in the EAC documents. The EAEU and the EAC may need to assess current mechanisms and expand regulation. One measure could be a requirement for international pharmaceutical companies to include the results of paediatric studies conducted under EU requirements in their regulatory dossiers. Stand-alone measures for generic medicines may also need to be developed. The principle of regulatory reliance can help regulatory authorities manage their workload effectively. Conclusion. Regulatory measures to promote the development and registration of paediatric medicines in the EU, the EAEU and the EAC are at various stages of development. The search for effective mechanisms should be intensified, taking into account the structure of the global pharmaceutical market and international experience.