Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA) - Hong Kong, China, 24 - 27 June 2002
(2002; 166 pages) View the PDF document
Table of Contents
View the documentAbbreviations and acronyms used in this report
Open this folder and view contentsOpening ceremony
Open this folder and view contentsHerbal medicines
Open this folder and view contentsKeynote address
Open this folder and view contentsSafety of blood-derived products
Open this folder and view contentsAntimicrobial resistance - new initiatives
Open this folder and view contentsHarmonization I
Open this folder and view contentsHarmonization II
Open this folder and view contentsProtection of trial subjects in clinical trials
Open this folder and view contentsRegulating biotechnology products
Open this folder and view contentsRegulatory challenges: health sector reform and drug regulatory capacity
Open this folder and view contentsAccess to drugs and vaccines I
Open this folder and view contentsAccess to drugs and vaccines II
Close this folderCounterfeit pharmaceutical products
View the documentCounterfeit pharmaceutical products
View the documentThe fight against counterfeit drugs in the Russian Federation
View the documentCounterfeit medicines
View the documentRecommendations
Open this folder and view contentsHomoeopathy
Open this folder and view contentsSafety monitoring
Open this folder and view contentsE-Commerce
Open this folder and view contentsCurrent topics
Open this folder and view contentsRegulatory challenges of new technologies
View the documentList of participants
View the documentBack cover
 

Counterfeit medicines

Mr Steve Howells, Australia

In Australia, counterfeiting is a crime. Goods are defined as counterfeit if the label or presentation of the goods, or any document or record relating to the goods or their manufacture, or any advertisement for the goods, contains a false representation of any of the following:

• the identity or name of the goods;

• the formulation, composition or design specification of the goods or of any ingredient or component of them;

• the presence or absence of any ingredient or component of the goods;

• the strength or size of the goods (other than the size of any pack in which the goods are contained);

• the strength or size of any ingredient or component of the goods;

• the sponsor, source, manufacturer or place of manufacture of the goods.


The above law applies to all therapeutic goods including medicines, such as prescription drugs, over-the-counter drugs, herbal medicines, vitamins, minerals, traditional medicines, sunscreens and homoeopathic medicines, and devices such as artificial organs, prosthetic devices, surgical instruments, bandages and condoms. It also applies to ingredients and components used in the manufacture of medicines and devices respectively. Goods for use in humans and animals are treated in the same way.

Counterfeiting can also involve substituting a cheaper unapproved product, switching labels, misrepresenting ingredients, source, place of manufacture, dosage, etc. in documentation, and false trial and/or test data. The import, export, manufacture and supply of counterfeit goods are all treated as criminal offences. All counterfeit imports and exports can be seized and destroyed without prosecution in Australia.

The above offences carry a penalty of AUS$ 55 000 fine and/or 5 years of imprisonment if committed by an individual, and AUS$ 275 000 fine if committed by a corporation.

A number of specific measures are needed to combat counterfeiting:

• adoption of the WHO guidelines;
• making counterfeiting a specific crime;
• an effective licensing and registration system;
• strengthened export controls;
• use of criminal investigators to carry out investigations;
• enhanced cooperation between local police, customs and health agencies;
• increased cooperation of drug regulatory authorities and agencies in different countries;
• support from the pharmaceutical industry.

 

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