– Local affiliates may play an important role in the PICO simulation and scoping process : EU teams will rely on Nordic affiliates to provide local market information for PICO simulation and preparation.
Moreover, local affiliates may become an important point of influence for ‘health technology developers’ (HTDs) in the PICO process.
Involvement of the HTD in the scoping and PICO creation process, as currently drafted, is very limited.
If this set-up prevails local impact will become very important.
Nordic affiliates can educate local stakeholders which will probably be consulted by the HTA agencies when drafting their PICO suggestions.
-The workload regarding local submissions is likely not reduced much: HTA submissions in the Nordic countries require health-economic analyses, which are not part of the JCA.
Thus, there will be a large chunk of work left to be done for a local submission in the Nordics.
More work may be done on a global /EU level: Many companies will opt to strengthen their global or EU-level teams to be able to meet the challenges posed by the JCA, especially the data-time challenge: a range of analyses that must be informed, designed, produced, checked and summarized in a dossier in a short period of time.
Once those teams are established they may take on other tasks such as adapting the CE models to local markets.
As anyone working with JCA knows these are educated guesses, they may be true for some but not for all pharmaceutical companies – leave your own thoughts below!