JCA is optional – really?

♜ Fallacy 1: JCA is optional – really?♜

⚖️ Some people think that the submission of a JCA is optional and you can decide whether to provide it or not.

🤔 But do you really have a choice?

We say: no. In fact, the JCA submission is mandatory by European law (check Art. 10 HTAR). Anyway, there are no legal sanctions defined in the HTAR.

💡 Nevertheless, we will give you at least three strong reasons to comply with the obligation:

🔹 Evidence might be rejected in the national HTA submission if it has not included in the JCA, despite having been being requested.

🔹 You will meet again. Building up reputation is hard – restoring even more, once it is lost.

🔹 The lack of submission will also be noticed outside of Europe.