Australian Pharmaceutical

The consumer movement, particularly the Consumers Health Fomm, also has considerable political influence. As a result of political pressure exerted by HIV/AIDS pressure groups and industry, the DRA was reviewed, new legislation introduced and new committees established to ensure that the regulatory authority responded more efficiently to public and political needs. Professional associations, especially the Pharmacy Guild of Australia, have traditionally played an active role in decisions related to pharmaceutical regulation. The Australian Pharmaceutical Advisory Council was established by the Australian Government to advise the Commonwealth Minister for Health on pharmaceutical policy. 

Australian Pharmaceutical Manufacturers Association Association of South-East Asian Nations... 

The Australian Pharmaceutical Advisory Council (APAC) provides the primary forum for the engagement of all stakeholders in discussion, debate and resolution of issues arising from the application of the National Medicines Policy, facilitating cooperation between stakeholders and addressing specific issues brought to it for deliberation. 

Australian Pharmaceutical Manufacturers Association ( ) (1990), The Control of Microbial Contamination in Nonsterile Pharmaceutical Products for Human Use, , Canberra, Australia. 

Henry, D. A., S. Hill, and A. Harris. 2005. Prescription Drug Prices and Value for Money. The Australian Pharmaceutical Benefits Scheme. JAMA 294 (20) 2630-2632. 

Sainsbury, P. 2004. Australia-United States Free Trade Agreement and the Australian Pharmaceutical Benefits Scheme. Yale Journal of Health Policy Law Ethics 4 387-99. 

The Australian Pharmaceutical Publishing Co. Ltd 35 Walsh Street, West Melbourne 3003 Canada... 

The Australian pharmaceutical industry represents approximately 1 percent of the world market for pharmaceuticals. It comprises approximately 120 companies and is dominated by subsidiaries of some of the largest multinational companies. The small number of Australian owned companies includes Paulding, Sigma, AMRAD, CSL and Blackmores. In 1994, the Australian industry made up around 1.3 percent of total employment, 1.9 percent of total turnover and 2.1 percent of total value added across the manufacturing sector. In the same year, total sales, including exports, were around 3.8 billion, of which the over-the-counter (OTC) component was around 26 percent. The industry employs approximately 12,000 persons (Owens 1996). 

Carmen Langley is a pharmacist with over 15 years experience in the Australian pharmaceutical industry, mostly in regulatory affairs. She is principal of La Rosa Langley Pty Ltd., a Sydney-based regulatory affairs consultancy. She also has had a number of teaching interests in the pharmaceutical industry. Ms. Langley has been president of ARCS (Association of Regulatory and Clinical Scientists) since 1997. 

Australian Pharmaceutical Advisory Council. National Guidelines to Achieve the Continuum of Quality Use of Medicines Between Hospital and Community, ISBN 0642272646 Commonwealth Department of Health and Family Services Canberra, Australia 1998 1-11. Australian Pharmaceutical Advisory Council. Integrated Best Practice Model for Medication Management in Residential Aged Care Facilities, ISBN 0642415390 Commonwealth Department of Health and Aged Care. Canberra, Australia 2000 1-17. 

Australian Pharmaceutical Advisory Council. National Guidelines to Achieve the Continuum of Quality Use of Medicines Between Hospital and Community. Canberra Publications Production Unit, Commonwealth Department of Health and Family Services, 1998. 

Quality Assurance is presently recognised in the Australian pharmaceutical industry to include the following duties ... 

S. Hill, A.S. Mitchell and D.A. Henry, Problems with the interpretation of pharmacoeconomic analyses A review of submissions to the Australian pharmaceutical benefits scheme, JAMA 283 (2000), 2116-2121. 

Australian Pharmaceutical Handbook and Formulary, 13th edition. The Pharmaceutical Society of Australia, Canberra (1983). 

The Pharmaceutical Society of Australia, The Australian Pharmaceutical Formulary, 8th ed., (1955). 

The Australian and Malaysian governments currently do not undertake pharmaceutical manufacturing. Formerly, the Australian Government owned the Commonwealth Serum Laboratories, but it privatized this operation in the early 1990s. Similarly, the Malaysian Government ended its role in pharmaceutical manufacturing in 1993. In view of the trend towards privatization of public enterprise, more governments can be expected to follow the examples of Australia and Malaysia. 

Langley, P. (1996), The November 1995 revised Australian guidelines for the economic evaluation of pharmaceuticals , PharmacoEconomics, 9, 341-52. 

There are two types of pharmaceutically important derivatives (a) Compounds with a hydroxyl substituent at position 14, such as in oxycodone and the antagonists naloxone and naltrexone, and (b) Diels-Alder adducts such as etorphine and buprenorphine, where the latter compounds are all derived from another opium alkaloid, (—)-thebaine (12) (Scheme 5.10). Because thebaine is a rather scarce alkaloid, several syntheses have been investigated. Quite recently, Australian scientists have been able to modify P. somniferum in such a way that thebaine is now a main alkaloid, so that it is becoming better available [28],... 

Khan S, Ongerth J (2005) Occurrence and removal of pharmaceuticals at an Australian sewage treatment plant. Water 32 35-39... 

For a new medicine to obtain public subsidy for patients in the community, the sponsor must successfully apply for the product to be included in the Pharmaceutical Benefits Scheme (PBS). Data are required on relative cost and effectiveness, and the scrutiny of this information according to prescribed criteria is described as the fourth hurdle, that is, in addition to quality, safety and efficacy requirements that medicines must overcome, to be readily available to the Australian public. 

Australia is evident from information published by the Australian Institute of Health and Welfare (AIHW). Expenditure on benefit-paid items under the PBS is the largest single component of total expenditure on pharmaceuticals. In 2001-2 the cost to government under the PBS, not including expenditure under the Repatriation Pharmaceutical Benefits Scheme (RPBS) was AUD 4181 million. This increased to an estimated AUD 4572 million in 2002-3 with the share of total cost of the PBS met by the Commonwealth being 84.2%. 

Manufacturing sites within Australia must comply with the Australian Code of GMP for Medicinal Products - August 2002, which is based entirely on the international standard Guide to Good Manufacturing Practices for Medicinal Products, Version PHl/97 (Rev.3) 15 January 2002, published by the Pharmaceutical Inspection Cooperation Scheme (PIC/S). The ICH GMP Guide for Active Pharmaceutical Ingredients has also been adopted. 

All CTN and CTX trials must have an Australian sponsor. The sponsor is that person, body, organisation or institution which takes overall responsibihty for the conduct of the trial. It need not be a pharmaceutical company. The sponsor usually initiates, organises and supports a clinical study and carries the medicolegal responsibility associated with the conduct of the trial. 

Commonwealth Department of Human Services and Health. Guidelines for the pharmaceutical industry on preparation of submissions to the Pharmaceutical Benefits Advisory Committee including major submission involving economic analyses. Canberra (Austraha) Australian Government Publishing Service 1995. 

Tang, S. (1998), Microbial limits reviewed—Basis for unique Australian regulatory requirements for microbial quality of nonsterile pharmaceuticals, PDA, J. Pharm. Sci. Technol., 52,100-109. 

The U.S. Trade Act 1972 required AUSFTA negotiators to facilitate the "elimination of government measures such as price controls and reference pricing which deny full market access for United States [pharmaceutical] products" (USC 2002, 107-210 2102 b.8.D). Official comments supported the position that the AUSFTA would make Australian consumers pay more for the R D costs of U.S. pharmaceuticals and set a precedent for "eliminating" a pharmaceutical cost-effectiveness pricing system (Shiner 2004). 

Australian Trade Minister and U.S. Trade Ambassador Chapter 17 (Intellectual Property Rights) and Chapter 21 (Dispute Resolution Procedures) (Faunce 2005c). All of these in different ways have the capacity to impact on pharmaceutical cost-effectiveness pricing (Faunce et al. 2005). Chief amongst them, however, is Annex 2C. 

Drahos, P. and D. Henry. 2004. The Free Trade Agreement Between Australia and the United States undermines Australian Public Health and Protects US Interests in Pharmaceuticals. BM/328 1271-1272. 

Joel Lexchin is an Associate Professor in the School of Health Policy and Management at York University and a practicing emergency physician in Toronto. He has been a consultant on pharmaceutical issues for the governments of Ontario, Canada, and New Zealand as well as the World Health Organization and the Australian National Prescribing Service. 

The Australian company Starpharma has developed a vaginal microbiocide (Vi-vaGel), as the first dendrimer-based pharmaceutical to receive official approval for clinical testing from the American Food Dmg Administration (FDA). Phase 1 clinical tests have been successfully completed, and the product, which causes neither irritation nor inflammation, is expected to come onto the market... 

In 2006, the Australian authorities seized over 90 kg of ephedrine, 160 kg of pseudoephedrine and smaller amounts of norephedrine. Most of the seized ephedrine had originated in China, Malaysia and South Africa, while 60 per cent of the seized pseudoephedrine had originated in Indonesia. Seized cold and flu medications containing pseudoephedrine originated in pharmacies or had been obtained through theft or armed robbery. The situation of precursor trafficking in New Zealand remained similar to 2005 over 200 kg of raw pseudoephedrine from Asia were seized, all in the form of pharmaceutical preparations, intended for use by illicit methamphetamine laboratories in the country. 

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