Page 5 - Pharmacy History 22 Mar 2004

of industry representatives. The government indeed amended the Act in December 1953 to overcome a number of problems.14 The committee was expanded to six by the addition of a practising physician and a pharmacist. This remained the case until the end.
Most of the industry’s proposals were rejected but a requirement of the original Act to have packages labelled with the words ‘Registered under the Health (Patent) Medicines Act 1942’ was dropped and replaced with the abbreviation Reg Vic followed by
the registration number. The word
being second-guessed.
In 1985 and 1986 there were changes to the law allowing medicines that
had been granted marketing approval by the Commonwealth (after an evaluation by the Australian Drug Evaluation Committee), to be registered without further evaluation by the Proprietary Medicines Advisory Committee15-16 Labels, however, had to be submitted.
The PMAC continued to operate and in order to accommodate the large number of applications, especially
for sunscreens, it met every fortnight for half a day. In the late 1980s, new applications were placed on the computer using a fairly simple but reasonably successful program.
The Social
Development
Committee’s inquiries
In 1983, the Victorian Government introduced a Therapeutic Goods
and Cosmetics Bill which sought
to expand the existing regime to include licensing of manufacturers.25 The alternative medicines industry opposed the Bill and obtained a petition with 200,000 signatures,
the largest petition in the State’s history. The Minister referred the
Bill to the all party Parliamentary Social Development Committee.
This Committee recommended a two tier registration scheme that would allow vitamins, minerals and herbal substances to be sold without the need for any therapeutic claims on the label but if claims were made, the product would have to be fully evaluated
for quality, safety and efficacy. The whole subject obviously interested the Committee because it set up another more general inquiry into alternative medicine and the health food industry.26
The Industries
Assistance
Commission
The PMAC’s position was not helped when, in 1985, the Industries Assistance Commission (IAC)
at the behest of industry, called
for the PMAC to be dismantled. Remember, this was a time when the age of deregulation had just started.
The IAC shot itself in the foot. The Commission, despite calling for the scheme to be discontinued, admitted that it did not know much about the subject. This admission enabled the Premier of Victoria to rebuke the IAC which amended its final report to recommend that a federal registration scheme be set up.
Therapeutic Goods
Act 1989
In 1989, the Commonwealth Parliament passed the Therapeutic Goods Act 1989 which came into operation on February 15, 1991 when regulations were passed by the Senate. Victoria ceased to enforce
its legislation from this date. Over the 43 years that the Reg Vic scheme operated, about 30,000 medicines were registered in large blue leather bound registers designed for the purpose.
Under section 9 of the Therapeutic Goods Act 1989, the federal Minister could enter into arrangements with the appropriate State/Territory Minister for the State/Territory to provide evaluation services for a fee. Such an arrangement was entered into with Victoria and the members of the PMAC (or technically, the Victorian Department’s Chief General Manager) to act as the evaluator. The improved funding from the Commonwealth enabled the Victorian Department to set up a Therapeutic Goods Unit, consisting of appropriately qualified staff to prepare detailed written evaluation reports on applications made to the Commonwealth by sponsors of non- prescription medicines. The reports would accompany the applications to the committee. After the committee deliberated, a recommendation was made to the Therapeutic Goods Administration in Canberra.
In 1994, the State Parliament passed the Therapeutic Goods (Victoria) Act 1994 to complement the federal Act and repeal the Victorian registration system. The Victorian Minister for Health then created the Medicines Evaluation Committee (MEC) under section 24 of the Health Act 1958. The MEC was to consist of eight members but attempts to obtain the services of a paediatrician failed.
All members were chosen on the basis of their professional qualifications,
Victorian registration.
proprietary replaced patent. Although everyone called the committee the Proprietary Medicines Advisory Committee (PMAC), it never had a statutory name and its objectives were never legislatively stated.
The definition of proprietary medicine remained virtually unchanged
from the 1942 Act and the number
of exemptions contrasts with the therapeutic goods regime
of today.
When the Health Commission replaced both the Department and
the position of Chief Health Officer in the late 1970s, the Act was again amended to require the Commission to consult a person (not being a member of the committee) qualified in pharmacology or materia medica
or otherwise suitably qualified to give advice on proprietary medicines before deciding to register or not to register a proprietary medicine.
I think this was done in recognition
of the fact that the Commission itself would not have the expertise although you wonder why an expert committee should be placed in the position of
volume 2 ■ no 23 ■ July 2004
Pharmacy History Australia ■ 5