It is shameful to speculate about children's health. During the last plenary in Strasbourg, the European Parliament approved a motion for a resolution on the regulation on medicinal products for pediatric use. The text, which rightly calls for a review of the Regulation after 10 years of implementation, also presents some gray areas: the main one is the system of rewards and incentives for pharmaceutical companies set up in an attempt to promote the development and authorization of medicines for pediatric use. As there are not many medicines authorized for pediatric use, the dosages, methods of administration, adverse effects of medicines used on children are studied only on adults. European rules provide for the granting of a extension premium of six months of the drug patent (aimed at adults) even if authorization for pediatric use is denied. This award consists of an additional six months of protection of the intellectual property rights of the medicines.
To obtain it, there is the risk that pharmaceutical companies could set up the relative procedures (the pediatric investigation plan) despite knowing that the drug has limited efficacy on children or that it is not useful at all. Why might pharmaceutical companies abuse the system? Because they earn money by recovering the costs invested in the development of the drug. We want to avoid that abuse or misuse of this incentive can constitute a business on the skin of child health. To defend this principle we tabled an amendment which unfortunately was rejected. The face of healthcare must change: true innovation is not encouraged, new effective drugs are not developed against rare diseases, because these pathologies are not profitable.
The EFDD group – Movimento 5 Stelle however, it contributed to improving the final text by inserting some fundamental paragraphs for the protection of minors' health. Here they are:
– The concept of use off label in pediatric medicine (previously absent altogether).
– The reference to the almost systematic deferral of pediatric investigations.
– The reference to the small number of completed pediatric investigation plans.
– The legal obligation for the Commission to fund research for medicines for children and for Member States to provide detailed evidence on their commitment to support research.
– The need to strengthen the network for the clinical research in the pediatric field.
We don't say drug companies shouldn't make money, but we can't continue to leave public health in the hands of market logic. And this is why we renew our invitation to consider the establishment of a public and European pharmaceutical company. In closing, I would like to recall that a few days ago the Commission opened a public consultation on the experience gained. I invite everyone, pharmaceutical companies, doctors, scientists, patient groups and groups of parents with a difficult experience to send their contributions to the Commission by 20 February 2017.