It appears that the study, which is due to commence shortly after April 2016, promises to be a relatively comprehensive one. Furthermore, the Commission has already recognised that the existing SPC system in the EU has a number of shortfalls, and it has actually identified some of these in its tender paper. It will therefore come as a great relief to innovators in the life sciences industry that this process for improvement and change has finally begun in the EU.
The study might also have a wider impact outside Europe - for example, in Canada, there are proposals to introduce a new SPC system and it remains to be seen whether the draft Canadian legislation will be based on legislation already introduced in the EU (as opposed to other regions of the world, such as the US or Japan).
In relation to timings, the call for tender is just the first step in what will inevitably be a very long process towards the European Commission evaluating what amendments it believes need to be made to the current SPC regime. It will therefore be some time before any changes to the existing legislation are actually implemented.
Whilst we eagerly await further announcements from the European Commission on the next steps following the study, the good news is that industry players and users of the SPC system have plenty of time to provide their input on how any proposed changes to the SPC system should be achieved.In addition to some of the issues already mentioned above, there may be other areas on which innovators and other companies wish to comment - for example, whether a formal SPC opposition procedure should be available; variations to the maximum term provisions (currently capped at 5 years); and/or whether a transition period might be appropriate (bearing in mind the UPC and UP transition period proposals).Watch this space for further developments.