Request for Assistance - legislative lobbying
Dear ESPGHAN members,
In the December Newsletter, you were informed of the progress being made in addressing the availability of paediatric medicines in the EU. However, only by joining strength and effort, it could be expected that we will achieve our mutual goal – paediatric drugs being more efficiently authorized and developed.
To summarize, respectable MEPs in Brussels, together with the ESPGHAN Liaison Officer Sanja Kolaček, and some interested members of our Society like Lissy de Ridder and Nick Croft, developed proposals for amendments to the new EU pharma law proposal. The purposes of almost 25 proposed amendments, both to regulation and directive, are to
a. retain the pediatric committee within EMA which is planned to be abolished,
b. provide further incentives for market authorization and the development of new orphan and paediatric medicines, and
c. resolve the current obstacles in accomplishing clinical studies required for the paediatric drug market authorization, by using real-world evidence and the pool of available paediatric patients more appropriately.
Our proposals, together with all other proposed amendments, are currently within the hands of the “official” rapporteurs P. Weiss (directive) and T. Wőlken (regulation), who are working on them together with the rapporteurs in shadow. Once finalized at that level, they will undergo voting first within the Committee on the Environment, Public Health, and Food Safety (ENVI), and finally voting on the EU Parliament General Assembly (probably in April).
It would be of great help if you could try to first approach the rapporteurs in shadow coming from your country, provide them with “our” amendments (available below), and lobby for their approval, and in the second stage do the same with the members of ENVI. The names, e-mail addresses, and parties that the rapporteurs in shadow and MEPs in ENVI belong to can be found below also Their names are also publicly available on the EU pages, and lobbying is a legitimate activity within such procedures.