Independence

The committee members of the CCMO are appointed by the minister on the basis of expertise. They carry out their work for the CCMO alongside their regular positions and also regularly offer expertise to other bodies. If a member has various roles and contacts it does not necessarily have to pose a problem for their activities for the CCMO. However, their interests, conflicting or not, must be transparent.

The KNAW code

The code to prevent influence through conflict of interest of January 2012 is an initiative of the Royal Dutch Academy of Sciences (Koninklijke Nederlandse Akademie van Wetenschappen (KNAW)), amongst others. This code is endorsed by many organisations, including the CCMO. Together with the Medicines Evaluation Board (CBG/MEB) and the National Institute for Public Health and the Environment (RIVM), the CCMO has set up a document further explaining (in Dutch) the specific nature of these organisations in the light of the code. The basic principles of the KNAW, that is transparency, proportionality and responsibility, are leading in the CCMO’s policy on conflict of interests.

Procedure for committee members

Before a CCMO member can take part in the committee’s activities, he/she must sign a declaration: the Declaration of interests and (sideline) activities (Opgave van belangen en (neven)functies). This is updated periodically and can be found on the CCMO’s website on the page of the (deputy) committee members. Each committee member must also check if there is a possible conflict of interest or relations for each specific agenda item, in such that it could influence the decision on that item. The committee member must also avoid what could be perceived as a conflict of interest. The criteria from the KNAW code can be used in making this consideration.

Committee members must give prior notice to the committee chair of relations and interests which could form a possible impediment to the decision making concerning one or more agenda item. It is then determined if, and to what extent, there is a conflict of interests and which procedure must be followed. This is mentioned at the beginning of the meeting to all those present and is noted in the minutes.

As is stated in the KNAW code, the procedure to be followed must be proportional to the gravity of the possible conflict of interest (proportionality principle). The most extreme measure is that the committee member does not act as referent, and does not take part in the discussion and decision making concerning a particular protocol. In that case, the committee member must leave the meeting until that particular agenda item has been discussed. The committee member must also refrain from all interference with regards to the content of that protocol, both within and outside the realms of the meeting.

If the conflict of interest is considered to be less extreme then participation in the general discussion may take place, as long as the exception is well motivated. This procedure applies in particular to cases whereby exclusion from the discussion would mean blocking expertise which is deemed to be essential. In such a case the committee member in question can answer general questions on the concerned agenda item, if necessary. The chair and other committee members must pose those questions as directly and objectively as possible. The member must then leave the meeting prior to the decision being made. This procedure must be noted in the minutes.

Procedure for external advisors

If there is a conflict of relations or interests pertaining to an external advisor, then an attempt must be made to find an alternative advisor. If one cannot be found and the conflict is deemed to be less extreme, the advisor can be asked to give (written) advice, as long as the exception is well motivated. This procedure can be followed in particular if expertise is limited, such as for research with very specialist technology or procedures. In such a case, the chair and other committee members must pose all questions as directly and objectively as possible to the advisor. The advisor must afterwards not be involved in the decision making, has no voting rights and is not contributory to the content of the CCMO’s decision.

The committee chair is responsible for the policy concerning interests and relations. If there is any doubt as to how to act in a specific case, the chair comes to a decision after he/she has discussed the matter with at least one of the two vice-chairs.

Confidentiality

The CCMO members are obliged to confidentiality with regard to all information to which the committee has access for the purpose of carrying out its activities, and which is explicitly marked as being confidential or which is evidently so due to the nature of the information.

The confidentiality obligation also applies to others involved in the execution of one or more of the CCMO’s tasks, such as external experts or anyone sitting in on the meeting. They must also first sign a declaration of confidentiality.