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 pharmaceutical products

Mr Stephen Leung, Hong Kong SAR, China

According to WHO, US$ 34 billion dollars worth of medicines were counterfeit in 2001, accounting for 15% of total world output. Every country is affected and countries with weakly regulated pharmaceutical markets tend to suffer the most.

In 2001, the pharmaceutical industry invested US$ 30 billion in research and development. R&D of new drugs is a costly, lengthy process, and is also very risky: a single new medicine normally takes more than 10 years and US$ 800 million to develop. However, pharmaceuticals do provide solution to escalating health care costs, since they are potentially the most cost-effective means of saving life and preventing disease, minimizing the need for surgery, hospitalization, physician visits and nursing care. Counterfeit pharmaceuticals not only deny all these benefits but put people’s health and even life at risk.

According to WHO, the most common counterfeits are the “lookalikes”, which physically resemble the genuine drug in appearance and packaging, but which have little or no active ingredient, and may even contain harmful substances.

There are several approaches to reducing the harmful effects of counterfeit pharmaceuticals:

• Detection - inspectors should be better trained to differentiate genuine medicines from counterfeits.

• Prosecution - law enforcement agencies should be empowered.

• Execution - collaboration is needed between companies and national and international authorities.

• Penalties - these should be severe enough to serve as a deterrent.

• Education - both professionals and consumers need to be better informed and to play an active role in the fight against counterfeit pharmaceuticals.


Better communication among all parties, such as international and national regulators, the pharmaceutical industry, health care professionals and customers, is key to combating counterfeit drugs; regulatory bodies should be at the centre of the communication network.

There are no “quality counterfeits”. All are unsafe and ineffective and can even be life-threatening. Through CARE, which stands for communication, alliance, responsibility and elimination, from all involved parties, the challenge of counterfeits can be dealt with.

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