10
Apr
2024
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Union code relating to medicinal products for human use - Union procedures for the authorisation and supervision of medicinal products for human use and rules governing the European Medicines Agency (joint debate - Pharmaceutical package)
Madam President, ladies and gentlemen, the legislation we are voting on today aims to support the competitiveness of the European pharmaceutical sector vis-à-vis its external competitors. For some time now, the large pharmaceutical companies have been calling for a simplification and acceleration of the procedures for the approval of new drugs by the EMA and with this legislation they are satisfied. But the main concern of the legislator in terms of health should always and above all be the protection of the health of individuals, possible only through the use of drugs properly tested and controlled before their authorization. Unfortunately, the rush to issue a license often leads to accepting risks and dangers to human health that are paid for by consumers of emergency authorized products, as we have seen in recent years. We cannot allow the prodding of competition or the bogeyman of emergency to push us to play roulette with the health and life of European citizens. I very much appreciate the ENVI amendments and the rapporteur's focus on greater transparency, but for me the proposal remains overall unacceptable.