Pharmaceuticals Australia

W orld annual production of bismuth and its compounds has hovered around 4000 tonnes of contained Bi for many years and a similar amount of secondary (refinery) Bi is also produced. Production has been dominated by China, Japan, Peru, Bolivia, Mexico, Canada, USA and Australia which, between them, account for almost of all supplies. Prices tor die free element have fluctuated wildly since the 1970s, from < 4 (Xl/kg to > 44.00/kg at die end of 1990 it was 6.30/kg Consumption of the metal and its compounds has also been unusual, usage in the USA dropping by a factor of 2 from 1973 to 1975, for example. The mam uses are in pharmaceuticals, fusible alloys (including type metal, p. 547), and metallurgical additives. 

The Global Harmonisation Task Force (GHTF) was conceived in 1992 to address similar issues for medical devices. It has a broader regional base than its pharmaceutical counterparts in that it includes representatives from Canada and Australia in its core group, in addition to those from the EU, US and Japan. In some ways, it also faces a stiffer challenge in that there is more divergence in the regulatory... 

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. 

In terms of the influence exerted by the public and the private sectors on dmg regulation, these 10 countries can be placed along a continuum, as depicted in Figure 3.3 below. Cuba, where the Government has exclusive power over regulatory decisions, is at one extreme, and Australia, where consumers and the pharmaceutical industry have official representation and make recommendations to the TGA, at the other. 

This means that Australia, Malaysia and Venezuela have to invest significant human and financial resources in inspections of the supply channels in their respective countries in order to ensure compliance with the requirements of good distribution practice (GDP) and the provisions of the pharmaceutical laws. Arranging human resources and schedules for inspection is even more arduous when the distribution outlets are widely dispersed through the rural areas. 

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. 

In many countries, the national dmg policy defines public policy relating to the pharmaceutical sector, including regulation. However, of the 10 countries studied, only four (Australia, the Netherlands, Uganda, Zimbabwe) have a written national dmg policy document. 

Countries that developed their dmg regulation more recently generally began with one or more relatively comprehensive pieces of legislation, which covered a larger number of fiinctions relating to control of the pharmaceutical sector than legislation developed earlier. The dmg laws of Australia, Malaysia and Zimbabwe are examples of such development. 

As mentioned above, significant changes in dmg regulation in Australia, Cypms and the Netherlands, were made as a result of the thalidomide disaster that occurred in Europe in 1961. This is a classic example of a crisis-led change. The disaster increased public concerns about pharmaceutical safety governments responded by imposing more stringent controls on the pharmaceutical sector, and with less resistance from the industry than would normally have been the case. 

Australia has a formal process for adopting European guidelines for drug development and evaluation, including the ICH guidelines. It also has bilateral agreements with a number of countries, and its membership of the Pharmaceutical Inspection Convention allows it to exchange GMP information with other members. 

Membership of committees Australia is the only country in the group with a system for including pharmaceutical industry representatives on committees which have the power to consider applications. 

In terms of qualifications, Australia appears to have the most demanding recruitment requirements for GMP inspectors. The TGA s GMP auditors need to have worked in industry before their appointment and undergo 6-12 months formal training after appointment. Similarly, GMP inspectors in the Netherlands must have acquired experience in the pharmaceutical industry. 

The difference between the monthly salary of a GMP inspector and of a head of production in a private pharmaceutical plant is considerable. The salary of a head of production is 3.3 times greater than that of a GMP inspector in Tunisia, and double that of a GMP inspector in Uganda. In these two countries, the gap between the monthly salary of a distribution-channel inspector and that of a pharmacist working in a retail pharmacy is smaller, but still significant. In Australia and the Netherlands, salaries for pharmaceutical professionals in the public and private sectors are comparable. Only in Cypms are GMP and distribution-channel inspectors better paid than their private-sector counterparts. 

For non-prescription and generic dmgs, the documentation required is simplified and is mostly concerned with chemical and pharmaceutical data. In general, the documentation required for registering products containing new chemical entities is more extensive than that for products in other categories (see Table 8.2). Countries that have the capacity to make an independent assessment of the safety, efficacy and quality of products, such as Australia, Estonia and the Netherlands, do not request the WHO-recommended Certificate of Pharmaceutical Product. Only Cyprus and Tunisia request price information. 

Secondly, stmctural features in dmg regulation in countries operating a federal system of government affect the ability of the DRA to monitor dmg distribution throughout the entire country. In Australia, authority over distribution channels is fully delegated to the individual states. As a result, the TGA does not have the authority to assess and control the dmg distribution situation for the whole country. In contrast, the Pharmaceutical Services Division in Malaysia appoints a deputy director of health in each of its 13 states with power to issue licences, carry out inspections and submit reports. Under this arrangement, command and control may be exercised and an official channel established for information flow between the federal and state governments. 

This study has found that dmg regulation does not meet these requirements in all the countries studied. In some countries, legislation omits or exempts certain areas of pharmaceutical activity from the scope of control. In Australia, Malaysia and the Netherlands, legislation requires traditional/herbal medicines to be assessed and registered. But this is not the case in Cypms, Uganda or Zimbabwe. As a result of such gaps, dmg regulation provides only partial protection for consumers. 

Pharmaceutical Association of Malaysia Proprietory Medicines Association of Australia... 

Barrie C. Finnin, Ph.D., Department of Pharmaceutics, Victorian College of Pharmacy, Monash University, 381 Royal Parade, Parkville, Victoria 3052, Australia, Telephone +61399039520, Fax +613 9903 9583, E-mail barrie.finnin vcp.monash.edu.au... 

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