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Fifty years of independent expert advice on prescription medicines

12 February 2014

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Evolving committee structure

The original committee

From 1963 to 1991, ADEC only consisted of six or seven members eminent in the fields of clinical medicine and pharmacology.

Findings were often communicated to other health professionals by publications in the Medical Journal of Australia.

ADEC set up its first subcommittee in 1970, the Adverse Drug Reactions Advisory Committee (ADRAC), to deal with the increasing reporting of adverse reactions.

Later, other subcommittees were formed with specific briefs to provide the necessary expertise in specialist areas, particularly in emerging areas of medicine with new regulatory concerns.

Professor Mervyn Eadie

Professor Mervyn Eadie AO, MD, PhD, FRACP, FRCPEd, fifth chair, 1985-1993

Professor Eadie is one of the University of Queensland's most highly regarded academics, having been professor of clinical neurology and neuropharmacology since 1977. Following retirement in 1997 Prof Eadie has continued to publish at a prolific rate, particularly in the area of the history of neurology, as well as continuing in medical practice and university teaching.

Expanding ADEC membership

In the eighties various reviews came to the common conclusion that there was a need for a comprehensive national approach to the regulation of therapeutic goods.

The Commonwealth focus shifted from the point of import to the point of supply with the passing of the Therapeutic Goods Act 1989, and the relevant parts of the then Department of Health, Housing and Community Services were named the Therapeutic Goods Administration, or TGA.

photo of the TGA building

The States and Territories remained responsible for the control of the retail supply of therapeutic goods, scheduling and the regulation of wholesalers.

And from the beginning of 1992 the membership of ADEC was increased, so that in addition to the core members there were also between ten and twenty associate members, each with complementary expertise.

Reforms to separate pre- and post- market regulation

In 2009 reform processes began to separate premarket and postmarket regulation. The aim was to prevent any possible conflict of interest that might arise from the same experts being involved in both premarket and postmarket assessment of medicines and to ensure that sufficient resources were directed towards postmarket regulation.

This change was in line with international trends, and involved changes to the committees as well as the internal structure of the TGA. New committees were formed with the word 'advisory' in the names. This emphasises the advisory nature of the committees, with the decisions being made by the TGA.

ADEC met for the last time in December 2009, and its successor, the Advisory Committee on Prescription Medicines (ACPM) was formed in January 2010. The ADEC subcommittee that dealt with postmarket issues (the Adverse Drug Reaction Advisory Committee) was replaced by the Advisory Committee on the Safety of Medicines (ACSOM).

Professor Susan Pond

Professor Susan Pond AM,MD DSc, FTSE, sixth chair, 1994-1996

Professor Pond's influence spans innovation and entrepreneurship in the fields of science, medicine, and biotechnology in Australia and internationally.

Currently, she is Chair of the Australian Initiative for Sustainable Aviation Fuels, Vice President of the Academy of Technological Sciences & Engineering and board member of the Australian Nuclear Science and Technology Organization and Innovation Australia.

Consumer perspectives

ADEC initiated the production of consumer-oriented information about medicines. Today, this is known as Consumer Medicine Information and is commonly provided by community and hospital pharmacists when they dispense medicines, as well as being available on the TGA website.

With the changes in 2010, the Therapeutic Goods Regulations were amended so that all the statutory committees, including ACPM, also contain an expert in consumer issues.

Publication of committee advice

The TGA has been publishing ADEC and ACPM advice since December 2009, together with the information provided to the committee, the final decision and a summary of any appeal (Australian Public Assessment Reports - AusPARs).

The TGA publishes the approved Product Information and Consumer Medicine Information on its website. This information is examined and commented on by ACPM.

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