5. I note Professor Skerritt is currently Vice-Chair of the International Coalition of Medicines Regulatory Authorities and Chair of the Scientific Advisory Council of the Centre for Innovation in Regulatory Science – do these organisations receive money from pharmaceutical companies? If so, then isn’t there a conflict of interest in Professor Skerritt holding these positions? 6. I note that a number of members on the TGA’s Advisory Committee on Vaccines work for organisations that receive significant funding from big pharmaceutical companies. How is this not a conflict of interest?

Question Number: 153
PDR Number: SQ22-000522
Date Submitted: 21/11/2022
Department or Body: Department of Health

5. The International Coalition of Medicines Regulatory Authorities is self funded through in kind contribution of time and other costs of the 33 participating regulatory authorities – there are no contributions from any external party. As the Senator indicated Prof Skerritt is chair of the Scientific Advisory Council of the Centre for Innovation in Regulatory Science. Each of the world’s top regulators are members of this Council, and the chair has typically been rotated between regulators – for example, the previous chair was the Chairman of the UK medicines regulator while Australia is the current chair. As the title of the Council indicates, it is scientific (i.e. not focussed on commercial issues, and does not discuss or review specific products or research conducted by particular companies) and advisory (i.e. it does not have a role in the management or board-type governance of the research centre). In keeping with its scientific and advisory role the Council has no visibility of the accounts of the centre as this would be inconsistent with a purely scientific and advisory function. Any questions regarding the centre’s funding would therefore need to be addressed to the UK-based management of the centre.

6. Members of the Advisory Committee of Vaccines are appointed in their individual capacities and not as representatives of their employing organisations. Applicants must submit a ’declaration of interest in support of application’ when seeking membership to a statutory advisory committee. In addition, the Therapeutic Goods Regulations 1990 expressly require the disclosure of direct or indirect material personal and pecuniary interests by members of the statutory advisory committees. A written ‘disclosure of interest declaration’ is also required at various times during a committee member’s term of appointment including on appointment, annually during their term of appointment, prior to each committee meeting (including any interest in relation to specific agenda items), and at the commencement of each meeting. Members are also required to notify the Chair and secretary, in writing, of any additional interests as soon as reasonably practicable, during the term of their membership. Enquiries regarding funding of the organisations that employ committee members should be referred to the respective organisations as the Department does not hold information on funding of these organisations. Please note that many of the employers of TGA Advisory Committee members are organisations such as universities, hospital systems and state government departments, which may have tens of thousands of staff and thousands of funding sources.