Review of the management of adverse effects associated with ...

eference to improvements in transparency
and communication.
A report is to be provided by Professor Horvath to
the Parliamentary Secretary for Health and Ageing
by 28 February 2011.
2.3 Matters outside the
Terms of Reference
The following matters have not been addressed
in the Review as they are outside the Terms of
Reference:
• issues specific to WA, including the
interactions within the WA health
department and between the department
and the public health units;
• the debate in the media as to the need
for vaccination of the population, and
children in particular, with pandemic H1N1
containing vaccines; and
• the perceived conflicts of interest of experts
in providing vaccination advice and of the
TGA in post market surveillance.
2.4 Method of the Review
Professor Horvath:
• reviewed the data, documents and
communications detailed in Appendix I;
• wrote to all the Chief Health Officers in
Australia to advise them of the Review and
ask them to provide input if they wished;
• wrote to the European Medicines Agency and
the national medicines regulatory agencies
of Canada, Ireland, New Zealand (NZ), Japan,
Singapore, Switzerland, United Kingdom (UK)
and the United States of America (US), asking
for information about their adverse events
monitoring systems; and
• interviewed the key informants listed in
Appendix II. The interviews were semistructured
and covered a range of aspects,
including: how the current system works;
its strengths and weaknesses; the roles
played by key organisations; the processes
involved in identifying and managing
a safety signal; the analysis required to
identify signals; reporting arrangements;
communications between jurisdictions
and the TGA; communications with health
professionals and consumers; lessons
learned from the 2010 influenza season
experience; and views on safety monitoring
system improvements.
The Review was also informed by the outcomes
of a Meeting of Experts convened by the Chief
Medical Officer, Professor Jim Bishop AO, on
1 December 2010.
Administrative support to the Review was
provided by Dr Bronwen Harvey, Medical
Adviser with expertise in immunisation policy
and programs, and Mr Joel Willis, Departmental
Officer with experience in seasonal and pandemic
influenza vaccine programs.
2.5 Structure of the Report
The Report describes the Australian regulatory
system for drugs and vaccines (Section 3.0) and
how the post-marketing surveillance component
compares with international systems (Section
3.4). The Report then outlines the National
Immunisation Program and its governance
structures (Section 4.0). Information about influenza
and influenza vaccination is presented Section 5.0.
The Review findings on the response to the 2010
seasonal influenza vaccine adverse events and
on potential improvements to the vaccine safety
monitoring system are presented in Section 6.0 and
the Review recommendations in Section 7.0.
Introduction 3