January 24, 2018
The long-awaited Delegated Acts Register has arrived but that doesn’t mean an end to the usual opacity, as we can see with files like formaldehyde and the on-going reform of supplementary protection certificates (SPC). The latter is an IP tool that extends patent rights by 5 years, helping manufacturers of pharma and plant health products to cover the extremely high cost of R&D and market authorisation.
Last year, the Commission began an impact assessment on modernising the EU law on SPCs. In October it launched a public consultation. However, only a few days after the consultation closed officially on 4 January 2018, DG GROW indicated it plans to fast-track a legislative proposal introducing a ‘manufacturing waiver’ that would permit a manufacturer to produce a generic of an original product still under SPC protection and export it outside the EU. This means profound changes to the delicate balance between free competition and the attractiveness of investing in research.
The Commission is effectively disregarding the feedback submitted during the public consultation by not taking sufficient time to analyse the contributions and rushing through its final initiative. In other words, it is effect using the impact assessment and public consultation to validate a decision already taken, treating them as boxes to tick off a list. This shows a lack of respect to experts, stakeholders and civil society.Daniel Gueguen