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Minister announces review of drug evaluation

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Minister for Aged, Family and Health Services Hon. Peter Staples M.P.


Parliament House, Canberra Phone (06) 277 7220 Fax (06) 273 4146



Professor Peter Baume, of the School of Community Medicine at the University of New South Wales, is to head a review of the processes of approving new drugs for the Australian market,

Federal Aged, Family and Health Services Minister, Peter Staples, announced today.

Mr Staples made the announcement addressing the Drug and Medical Device Regulation - Towards Global Co-operation Conference at the Hilton Hotel in Sydney.

"Professor Baume's background as a consultant physician, together with his long and distinguished career in Federal Parliament and his considerable interest in the drug evaluation process, make him an ideal person for the task," Mr Staples said.

"I am most grateful that Professor Baume has accepted the role when he has the competing pressures of a new career.

"The purpose of drug evaluation is to protect the public from unsafe, ineffective and poor quality drugs. However, this needs to be balanced against the public's interest in gaining access to new and possibly life-saving medications. The industry, too, must be

saved from over-regulation."

Mr Staples emphasised the review will not be just another inquiry into drug evaluation, but has a charter to make specific recommendations on how the Australian system might be improved for the benefit of all.

"Questions need to cover such issues as whether Australia needs to re-examine drugs which have already been approved overseas, how much use can be made of evaluation reports from other countries, and the level and nature of information drug companies should be

required to submit to authorities," he said.

"The task is to be completed quickly, with Professor Baume reporting by July 1, 1991. I am urging those who have criticised the existing system to get behind this review in a positive way."


Portfolio of Community Services and Health


The Minister also announced former National Heart Foundation Director Dr Robert Hodge, Australian Consumers Association member Louise Sylvan, and the Managing Director of the Commonwealth Serum Laboratories, Dr Brian McNamee, will comprise a reference group

for Professor Baume.

"The review is not aimed at passing judgement on Australia's existing drug regulation system, but at finding ways to improve it and still provide appropriate public protection," Mr Staples said.

"In calling for this review the Government is not seeking to avoid its decision making responsibilities, but rather acknowledging that highly complex and technical issues are involved on which the best possible advice needs to be available. I'm confident Professor Baume will provide that."

Specifically, the Review will examine:

the need for Australian evaluation of drugs approved in other countries;

the extent of opportunities for greater international co-operation on drug evaluation;

the responsibility of manufacturers to bring new drugs onto the Australian market;

whether manufacturers should have greater freedom to make minor changes to existing products;

the detailed arrangements for the drug evaluation process, and the extent to which they can be simplified and improved;

the resources available for evaluation of drugs for the Australian market;

the role and processes of the Australian Drug Evaluation Committee (ADEC);

arrangements for reporting adverse reactions to drugs;

the access of terminally ill patients to drugs; and,

in the light of the Review's other recommendations, whether consideration needs to be given to changes to the system of granting listing on the Pharmaceutical Benefits Scheme.

Detailed terms of reference for the inquiry are available from the Department of Community Services and Health in Canberra.

Contact: Howard Conkey (06) 2777 220

Date: 4 March 1991


Bo m : 30 January 1935 Educations Narrabeen Public School, North Sydney Boys High School, Sydney Grammar School.

Sydney University:

MB BS 1962

MD 1969

FRACP 1972

Medical Appointments:

Resident, Medical Registrar and Research Fellow in Gastroenterology, Royal North Shore Hospital of Sydney 1958-62

Research Associate, Nutritional and Intestinal Unit, the General Hospital, Birmingham, UK 1963

Postgraduate Medical Federation Course in Gastroenterology, London 1963

Smith & Nephew Fellow (UK) 1963

Fellow in Gastroenterology, Vanderbuilt University Hospital, Nashville, Tennessee USA 1964-65

Research Associate, Thayer Veterans Administration Hospital, Nashville, Tennessee, USA 1964-65

US PHS Fellow 1964-65

Roche Research Fellow RACP 1965-67

Honorary Assistant Physician, Royal North Shore Hospital of Sydney, 1966-74

Member, Board of Medical Studies, Royal North Shore Hospital of Sydney, 1967-69

Clinical Supervisor (Medical), Royal North Shore Hospital of Sydney, 1967-69

Member, Reference Committee of the Medical Board, Royal North Shore Hospital of Sydney 1967-69

Consulting Physician in Private Practice 1967-74

University of Sydney $

Part-time Lecturer in Physiology 1970-74

Clinical teacher 1967-74

More than 75 articles published in various medical journals.

. . . /2



Senator for New South Wales 1974-91

Government Deputy Whip 1977-78

Government Whip 1978-80

Minister for Aboriginal Affairs 1980-82

Minister for Health 1982

Minister for Education 1982-83

Shadow Minister 1983-87

Resigned 1987

Resigned from Parliament 1991


Councillor Cumberland College of Health Services Councillor Australian National University


Professor and Head, School of Community Medicine, of New South Wales University

Chair Australian Sports Drug Agency (Commonwealth), Chair Drug Offensive Council (New South Wales), Health Advisory Council (New South Wales)