History of the Australian Drug Evaluation Committee
August 2003
The Australian Drug Evaluation Committee was established in 1963 following the Thalidomide experience. The Thalidomide experience had brought home to Australian health officials that there were not only benefits but potential risks from the use of therapeutic compounds. The Commonwealth Department of Health and senior Australian clinicians discussed ways to deal with concerns around the use of drugs. These led to the establishment of the Australian Drug Evaluation Committee as an independent committee to advise on the safety of new drugs being imported into Australia and to formulate measures for the evaluation of possible adverse affects of drugs that were being used in Australia.
The Committee first met in late July 1963, under the Chairmanship of Dr Edgar Thomson. The functions of the Committee were to make medical and scientific evaluations of such therapeutic substances that the Minister referred to it for evaluation, to make medical and scientific evaluations of other therapeutic substances if, in the opinion of the Committee, it would be viable to do so, and to furnish such advice to the Minister as the Committee considered necessary related to the importation into, and the distribution within, Australia of therapeutic substances that were the subject of evaluations made by it.
The role of the Committee in the genesis of Australia's drug regulatory system was pivotal. It was as a result of the recommendations of the Committee that standards for submission of data for people wishing to import medicines into Australia were introduced. The Committee also sought to ensure that companies were required to provide information about risks, as well as benefits, in promotional material for health professionals, and very early in its life established a voluntary adverse drug reaction reporting scheme. It later established a sub-committee, the Adverse Drug Reactions Advisory Committee <http://www.tga.gov.au/adr/adrac.htm>, to advise on medicine safety matters.
The early Australian Drug Evaluation Committee (ADEC) made a number of important decisions in relation to individual product groups, for example - oral contraceptives and the need for medical supervision in their use and a recognition of long-acting sulphonamides, which were very widely used, and a link with Stevens-Johnson syndrome, especially in children.
The role of the Committee has evolved over time with the drug evaluation system. Australia has one of the world's leading independent regulatory systems at the present time with evaluation of the quality, safety and effectiveness of medicines based on submission of evidenced-based, internationally-derived dossiers. The role of the ADEC is to provide an important system of review for the evaluation work and to guide decision making of the TGA in regard to prescription medicines. The Committee also advises the Minister on matters relating to policy and general safety of therapeutic compounds. It continues to maintain close links with related committees such as the Pharmaceutical Benefits Advisory Committee, its own Adverse Drug Reactions Advisory Committee <http://www.tga.gov.au/adr/adrac.htm> and the National Drugs and Poisons Schedule Committee <http://www.tga.gov.au/ndpsc/index.htm>.
The Committee is now established in the Therapeutic Goods Regulations. It consists of senior clinicians, toxicologists and pharmacologists, experienced not only in the practice of medicine in the Australian context but with considerable expertise, who can contribute broadly to the Committee as collegiate members. The current Chair is Professor Martin Tattersall, Professor of Cancer Medicine at the University of Sydney.
The ADEC meets every two months for up to two days and considers carefully matters submitted to it. In respect of a new substance proposed for marketing in Australia, the ADEC would typically receive copies of evaluation reports prepared by the TGA on quality, toxicology and clinical experience, a summary of key issues document from the TGA and an unedited response from the pharmaceutical company. The Committee may also receive input from consumer organisations in relation to its consideration of items. Following careful consideration and discussion at the meeting, the Committee provides advice to the Minister and TGA, whose delegates make decisions in relation to the regulation of products.
The Committee may also be asked to comment on safety-related issues, such as products being considered for withdrawal, on extensions of indications and on complex applications where the TGA and applicants are unable to reach agreement, for example on new generic products where the TGA has concerns about registration. The expertise and advice of the ADEC is well-respected throughout the region and minutes of the ADEC are distributed to regulators in neighbouring countries where they are seen as having great importance.
In addition to ADRAC, the Australian Drug Evaluation Committee has another sub-committee, the Pharmaceutical Sub-Committee, which advises it on issues related to manufacturing and quality of medicines. This sub-committee, in its own right, is recognised for its expertise in this area.
The ADEC has formed ad hoc working parties at various time. In particular, an ad hoc working party has published a Medicines in Pregnancy <http://www.tga.gov.au/docs/html/medpreg.htm> categorisation, a unique Australian categorisation of the risk of medicines in pregnancy. The book is designed to assist health professionals in counselling women who may have exposure to medicines during pregnancy or who may require treatment during pregnancy.
The model of ADEC has worked so successfully that the TGA has expanded its system of expert committees and now has committees specifically advising it on the areas of over-the-counter medicines, complementary medicines and medical devices. The system of expert advisory committees has served Australia well and is one that continues to serve the needs of the Australian public in ensuring medicines and other therapeutic products are of a acceptable standard before they reach the market in Australia while at the same time facilitating early access by Australians to new and important advances in treatment.