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knowledge and experience rather than to represent the interests of any particular group or to be sponsored by them. This, the first version of the MEC, came into existence in December 1995.17
In July 1997, the arrangement with Victoria was concluded; the Victorian Minister for Health revoked the Order establishing the MEC and the Commonwealth took over direct control of the committee, by now having no statutory or regulatory existence. The committee was expanded slightly in November 1997 and continued to meet in Melbourne. In 1999, the committee was expanded again and its terms of reference and composition drafted, preparatory to its formal existence now found in 25 individual regulations made under the
19-20 Therapeutic Goods Act 1989.
Commentary on the Victorian Act
The Victorian Act had never been rigorously enforced and there was little enthusiasm for it among some departmental staff.21-22 Specific complaints were acted on but prosecutions were infrequent. Committee members were poorly paid, accommodation was often unsatisfactory and there was no professional departmental support until the final years of operation. Administrative staff never exceeded a secretary and a part time assistant. The Act required that proprietary medicines could be sold only when the registration details were gazetted in the prescribed manner and not before. This posed major problems for administrative staff unfamiliar with the terminology and there
was no professional supervision. Overtime had to be paid for. Poor administration in the early 1980s meant that in a number of cases,
the PMAC’s decisions were not communicated to sponsors in a timely manner.28 The committee’s public profile was low and no-one ever attempted to raise it.
The Act did not require manufacturers to be licensed despite a plea by the Chief Health Officer in 1954.24 There was little emphasis on standards, certainly in the early years.
On the other hand, it was the first legislation of its kind, not only for Australia but for much of the world;
Switzerland and South Africa were two countries that were developing
a form of product registration.12
And it provided from the outset an opportunity for aggrieved sponsors to be heard by the Committee, then
a similar opportunity to the Chief Health Officer and finally, an appeal to the Supreme Court. Interestingly, the Therapeutic Goods Act 1989, while having an appeal mechanism, does not provide for an opportunity to
be heard. In the interests of natural justice, the present Medicines Evaluation Committee does, however, continue the tradition. There were few appeals to the Chief Health Officer and no one ever appealed to the Supreme Court. There were only two kinds of fee – one for sponsors and half this amount for pharmacists who sold their proprietary medicines from their premises only. The structure was simple; something was registered or
11. Pharmaceutical Society v Piper (1893) 1 Q.B.686.
12. Landers J.G. Proprietary medicine control in Switzerland and Australia - some facts and proposals. Australus J Pharm 1952; 33: 814-824.
13. Shaw Fl I. Lessons from patent medicines legislation in Victoria .4u.stralus J Pharm 1952; 33: 824-K25.
14. Victoria. Parliamentary Debates 1952-3; 242: 1877, 2064-2080.
l5. Victoria. Health (Amendment)Act 1985 16. Victoria. Health (Proprietary Medicines)
(Amendment) Regulations 1986. 17. Australia. Therapeutic Goods
Administration. Medicines Evaluation
Committee formed. 7G l News 1995: 20: 5. 18. Australia. Therapeutic Goods
Administration. OTC’ drug evaluation - transfer fromVictoria to Canberra. TGA News 1997: 24: 22.
19. Australia. ‘Therapeutic Goods Administration. Expert committee on OTC medicines strengthened. TGA News 1999; 30: 10.
20. Australia. Therapeutic Goods Regulations 1990. regs 2ZZA to 42ZZX.
21. Pharmaceutical Society of Australia (Victorian Branch). Sale of unregistered proprietary medicines. Bulletin 19K3; 214:
6 ■ Pharmacy History Australia
volume 2 ■ no 23 ■ July 2004
it was not, and the offence centred on
selling rather than supplying. R.
I believe that we owe a considerable debt of gratitude to the legislators of the 1940s for their bold initiative.
This brief history shows that the regulation of medicines is always shrouded in controversy and forensic and technical complexity. Our present therapeutic goods and poisons laws show that this has
22. Anon. Health Department to enforce law relating to slimming preparations. Australas J Pharm 1954; 35: 330
23. Anon. British select committee into the sale of patent and proprietary medicines. .Australas .J Pharm 1914; 29: 359-361
24. Anon. Manufacturers of drugs to be registered. .Au.stralas J!’har-m 1954: 35: 752
25. Victoria. Parliament. Social Development Committee. Inquiry into Therapeutic Goods and Cosmeties 13111 1984. 1985
26. Victoria; Parliament. Social Development Committee. lnquirv into alternative medicine and the health food industrv.
not changed.
References 1986
1. Young JH.The medical messiahs: a serial history of health quackery in twentieth century America. Princeton Universitv Press, 1992.
2. Martvr P. Paradise of quackery. Macleay - Press, Sydney, 2002.
3. Beale Report. Chemist & Druggist of Australasia 1906: 21: 198.
4. British Medical Association. Secret remedies - what they - cost and what they contain. British Medical Association, London, 1909.
5. Victoria. Parliamentary l)ebates 1937; 201: 909.
6. ibid. 1937; 201769.
7. ibid. 1942:213: 194.
8. ibid. 1942; 213: 503, 514-544.
9. Anon: Patent Medicines Act. Victona.
Australas J Pharm 1948; 29 10)4.
10. Smith R.G. Patent medicines in Victoria.
Australus J Pharm 1948-129: 431.
27. Carro11 B. Completely-cured or your money back. Australus J Pharm 1968-149: 14-17
28. Anon. Vic. Govt. regulation causing big delays., Aust J Pharm 1985; 66: 438