As previously covered in this blog, on 26 April 2023 the European Commission published a set of proposals for the reform of EU pharmaceutical legislation.
One of the most significant aspects of the reforms is that measures to protect the environment are core. For the first time, protection of the environment will be brought to the fore of the pharmaceuticals industry, and are embedded and enshrined throughout the package. Our ESG expert within our Brussels office will be publishing a full, informative and discursive review of the environmental measures included within the package on this blog, but in the meantime here’s a quick overview:
- Some of the key measures to protect the environment include imposing reinforced environmental risk assessment (ERA) to marketing authorisation holders at the time of authorisation, and post-authorisation environmental studies. An ERA will have to be carried out in relation to medicines that contain or comprise of genetically modified organisms (GMOs), in order to assess their potential harmful impact on the environment and on human health. Moreover, the process of conducting ERA assessments on investigational medicinal products will be centralised, therefore addressing the fragmentation that currently exists on a national level. The importance of the need to protect the environment is highlighted by that fact that an incomplete or insufficient ERA may be a ground for the refusal of a marketing authorisation.
- In another demonstration of how much higher up the priority ladder the environment is in the proposed legislation, the reforms envisage that should the potential risk posed to the environment be high enough from an over the counter product, its use can be limited by upgrading it to prescription-only status.
Keep an eye on our blog for the more in-depth analysis post of these reforms to come.
For further information please contact Julia Gillert, Els Janssens or Magda Tovar.