Drug Evaluation Committee 2010-39 Procedures for Requesting a Clinical Trial by an In-Country Manager for a Clinical Trial (Part 3)
Related classification: clinical trial contracting procedures
Date of first publication: January 2011
Question
In a clinical trial agreement with an in-country clinical trial manager, do the intellectual property rights and research results obtained by conducting the clinical trial belong to the sponsor?
Background of the question
We are planning to make a two-party contract with a domestic caretaker of a clinical trial (i.e., B), and based on the opinion in question No. 2008-50, we are planning to prepare a contract by specifying the sponsor and the domestic caretaker in the clinical trial agreement. Therefore, the domestic manager of the clinical trial asked us if we can change the wording of the following contract.
(Before the change)
(Institutional form) Intellectual property rights and research results obtained through the conduct of this clinical trial shall belong to the Second Party.
(Proposed change)
"・・・・・・・・・・・・ (same as above) ・・・・・・・・・・・・・・・ shall belong to the sponsor.
Is it necessary to accept the change of wording to "the sponsor" who is not the contractor?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
No. The domestic manager of a clinical trial acts as an agent of the sponsor when conducting a clinical trial in Japan. Therefore, in general, intellectual property rights and research results obtained through a clinical trial are considered to belong to the sponsor, not to the NTA. We recommend that you confirm the attribution of the research results, etc. with the NMT and set the contents of the contract accordingly.