|The AmeriKat rolling over with excitement|
with the announcement of the new SPC study tender
Yesterday, the Commission emailed the AmeriKat with news of the re-launched SPC tender with a deadline for submissions of 27 July 2016. The new tender has a narrower scope than its previous incarnation, focusing on the legal issues concerning the SPC Regulation (of which there are many). The maximum amount of the tender is €180,000.
The purpose of the contract is stated as follows:
"The contracted study shall conduct an evaluation of the SPC regulation from a legal perspective. With this primary purpose, on one hand, the study shall evaluate the current SPC framework in terms of its legal effectiveness, efficiency, relevance, coherence and EU-added value, and on the other hand it shall also suggest whether the existing SPC rules need to be recalibrated given identified limitations (considering potential impact and options).
The European Commission can provide to the contractor economic data related to the current SPC framework to facilitate analyses.
The results could serve as a basis for an impact assessment for a future proposal by the Commission to recalibrate existing EU SPC rules."
The document continues that:
"The analysis of aspects related to harmonization and fragmentation of the SPC practices across EU Member States shall not exclude considering the impact of the lack of an European SPC with unitary effect."The tender also identifies emerging issues and challenges related to the SPC system in the EU. These include:
- Potential legal uncertainty or ambiguity in the current text of the SPC Regulations and jurisprudence ["Cough::CJEU::Cough", says Merpel].
- Ambiguity and need to harmonize and make transparent the grant procedures at national level.
- Need to update to reflect the innovation models of the pharma and agrochemical sectors, in particular in relation to biologics.
For issues that had been included in the previous tender such as matters outside pharmaceuticals and agriculture, term and economic impact, these will be subject to an additional tender with a more economic focus. This is still a work in progress. It is expected to be a few weeks before that study goes to tender. The AmeriKat will be back to update readers when that tender is announced.
For more information on the tender, click here.