Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Counterfeit drugs in industrialized and developing countries - A comparison ***

Sebastian Strobl (Abschlußjahr: 2011)

Counterfeit drugs have a long history. As early as 400 B.C. there have been warnings of their presence and Dioscorides, a Greek physician, pharmacologist and botanist living from 40 90 AD, wrote in his MateriaMedica about the detection of counterfeit drugs. The threat of counterfeit medicines therefore hardly is a new one and it persisted through the ages.The modern issue of counterfeit medicine emerged in the 1980s when more and more member states of the WHO reported counterfeit medicines. It was first brought to a greater attention on an international conference on the rational use of drugs in Nairobi 1985.

The WHO defines counterfeit medicines as a subset of substandard medicines which are deliberately and fraudulently mislabelled with respect to identity and/or source.Counterfeit drugs can contain the wrong ingredients, not enough or no API at all. Counterfeit of Packaging and/or PIL are also commonly seen.
Besides the risk of not receiving the correct medicines and therefore not the correct treatment for their diseases, patients taking counterfeit drugs also have the risk that the wrong ingredients these drugs often consist of are harmful themselves. These harmful substances included in counterfeit drugs in the past include for example diethylene glycol in cough syrup.

Both branded and generic drugs are counterfeited, however patent and high priced medication is more likely to be counterfeited.

Counterfeit medicines are present in industrialized and developing countries.The extent of the problem and several other factors concerning the counterfeited drugs however differ significantly between industrialized and developing countries.Of course the extent depends on the drug regulation control and enforcement and on the quality and the prices in the legal supply chain.In most industrialized countries like the USA, Japan or the members of the EU the extent of counterfeit drugs is below 1% share of the total medicines market value. An exemption is the former Soviet Union where up to 20% of the market may consist of counterfeit drugs.In contrast in great parts of Africa, Asia, Parts of Latin America between 10 and 30% of the available medicines are fakes.

Not only the extent of the problem differs between wealthier and poorer countries but also the types of medicines counterfeited.In industrialized countries often lifestyle medicines like slimming pills and anabolic drugs are faked. The best known symbol of counterfeit drugs is of course the widely known medicine against erectile dysfunction Viagra®.In developing countries however often more crucial medicines are faked. This includes antibiotics and drugs against very prevalent diseases like malaria, HIV/AIDS or tuberculosis.

The aim of this master thesis is to present a current, compact and accurate view of the problem of counterfeit drugs on a worldwide basis. It should especially address and list the differences of the problem in industrialized and developing countries to be able to make a comparison. It should furthermore address the reasons of these differences.

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