Published: 20 August 2014

Consultations

Response to requests for increased transparency regarding MAAC processes

About the consultation

Medsafe hosted a "Communication with Industry Workshop" on 24 September 2013. Industry representatives that attended the workshop were invited to provide feedback on Medsafe's communication with Industry and offer suggestions on how Medsafe could make improvements.

Industry representatives commented that there was a lack of communication to industry regarding the Medicines Advisory Assessment Committee (MAAC). One of the suggestions was making a meeting summary of MAAC recommendations available on the Medsafe website. It was discussed that, with greater transparency internationally regarding evaluation reports, there is less justification not to publish MAAC recommendations.

Medsafe presented the comments received from industry to the 98th meeting of the MAAC and proposed that a summary of each MAAC meeting should be published on the Medsafe website. In the meeting summary, Medsafe would publish the:

• names of Committee members and any observers
• key outcomes of the meeting

Medsafe also proposed to advertise dates of upcoming meetings to provide an opportunity for applicants with referred applications to prepare.

The proposal was discussed and the MAAC noted that some applicants may consider information typically recorded in the minutes as commercially sensitive. The MAAC requested that Medsafe should write to industry representatives and applicants, that have had applications referred to the MAAC, to seek their views on greater transparency.

Submissions received

Nine submissions were received by the deadline of 19 May 2014. There was:

• general support for the proposal to increase the transparency of the MAAC
• a request that applicants should approve the minutes prior to publication
• a concern that the MAAC minutes often contained sensitive information
• a request for guidance during the NMA or CMN evaluation as to which MAAC meeting the sponsor's application is to be referred to.

Consultation feedback

All submissions have been reviewed by Medsafe and subsequently the MAAC at their 99th meeting. The feedback from applicants was used to suggest a new business rule for the publication of the MAAC agenda and minutes.

The MAAC noted that there was general support for increasing the transparency regarding the operation of the MAAC and publication of the outcomes.

The MAAC disagreed that applicants should be requested to approve the minutes prior to publication. It noted that the applicant was not present for the entire meeting and that the published minutes should be an accurate reflection of the MAAC's recommendation. The minutes cannot be amended to include information that was not discussed at the meeting and also observers have no formal standing in relation to confirmation of the minutes.

The MAAC noted the concerns of the applicants that commercially sensitive information should be withheld. It agreed that the minutes should be prepared in two parts. One part would be prepared for publication and consist of a summary of the recommendations made. The other part would record the discussion undertaken by the MAAC. As the discussion always refers to information considered commercially confidential by the application this would be withheld from publication.

The MAAC also agreed that applicants will continue to be provided with a copy of the minutes relating to their application prior to publication. This would mean any major concerns regarding the confidentiality of the information proposed for release could be addressed by the Secretariat.

The Committee also requested Medsafe add information to the website description of the role of the MAAC to provide examples of applications that are typically referred. They also requested that evaluators signal to applicants if an application is likely to be referred as soon as possible.

The MAAC agreed to operate a new business rule for 12 months and encouraged sponsors to provide feedback on the published minutes.

New Business Rule

As of 1 January 2015, Medsafe will advertise the anticipated MAAC meetings throughout the year.

Four weeks prior to each meeting Medsafe will publish the agenda.

Seven weeks following a meeting Medsafe will publish a summary of the recommendations made and the reasons for each recommendation. The complete meeting minutes will be withheld to protect commercially sensitive information. Applicants will be informed of what will be published before it appears on the Medsafe website.

The process will be reviewed after 12 months.

Medsafe will update guidance on its website about the work of the MAAC and provide more examples of the types of applications typically referred.

Implementation

The new business rule will be implemented from 1 January 2015 for a trial period of 12 months.

Enquiries

Any questions relating to this consultation should be directed via email to:
andrea.kerridge@health.govt.nz