Q（Question）

The Guidelines state that the review and supervisory committee must include "a person with independence from the company." For example, if an external expert such as an attorney reviews promotional materials in accordance with an industry self-regulatory guideline, is it permissible to designate that person as the "person with independence from the company" required for the committee?

A（MHLW answer）

From the perspective of ensuring that the review and supervisory committee's advice to the supervisory department is conducted properly, it is not permissible for a person who performs review work on promotional materials to serve as a member of the review and supervisory committee.

Therefore, when utilizing an external expert such as an attorney who is currently conducting reviews of promotional materials as a "person with independence from the company," that person should be positioned as a member of the review and supervisory committee—not of the supervisory department for promotional information activities.

So what (meaning): An external attorney or expert who reviews materials cannot simultaneously serve as the independent member of the committee. The two roles must be held by different individuals.

So why (rationale): Advising the committee on materials one has personally reviewed constitutes self-evaluation and eliminates the objective check the committee is designed to provide.

Commentary — background, application, practical notes

The prohibition on concurrent roles as reviewer and committee member shown in this Q&A is a concrete expression of the role-separation principle required to ensure monitoring effectiveness. A person who conducted the review of materials cannot simultaneously advise the committee on the propriety of that review—the result would be self-evaluation, eliminating the third-party check. An external attorney or regulatory specialist is an 'outsider,' but as long as they serve as a reviewer, they cannot serve as an independent committee member.

A typical scenario is a pharmaceutical regulatory specialist who regularly contracts to review the company's materials, and the company wishes to draw on that expertise on the review and supervisory committee as well. The practical resolution is either to assign Person A to materials review and Person B to the independent committee role, or to limit Person A to review work and appoint a separate individual as the independent committee member. Since concurrent roles are impermissible, the organizational design must ensure a sufficient pool of qualified specialists.

A common confusion is between 'advising' on a review and 'conducting' a review. An independent committee member providing general advance advice to the review team is not problematic, but if that person specifically reviews a particular material and participates in the approval/rejection decision, they become a 'person who conducts reviews.' Even a committee member observing the review process as an 'observer' may be considered to have substantively participated in the review, so it is advisable to define clear rules in the SOPs governing contact between committee members and the review process.