Revue Prescrire, article en une, Medicines in Europe October 2003
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Medicines in Europe:
Protection of drugs switched to self-medication
 
The current European draft legislation, as supported by the pharmaceutical industry, will forbid competitors from marketing generics of a switched drug for a number of years. The pretext cited is that companies' new clinical data need to be protected from exploitation by competitors. This is specious, however, as OTC switch trials are neither obligatory nor necessary.
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The term "OTC switch" (OTC = over the counter) refers to the decision by a drug company to make a prescription-only drug available for self-medication. The company also switches its promotional efforts from prescribers to pharmacists and the public, through media campaigns.

The prescription drug is often maintained on the market, while the OTC version is sold under a different name and at a higher (uncontrolled) price. In France, for example, loperamide is sold under the names Imodium° (for prescription) and Imossel° (for self-medication), and the same antacid combination is sold under the names Xolaam° (for prescription) and Maalox° (for self-medication).

The "OTC switch" is a trick commonly used to relaunch a drug whose sales are waning or will shortly face competition from new drugs or generics.

The "OTC switch" is fairly simple. The company simply has to obtain exemption from regulations governing prescription-only drugs. This exemption, granted by the national minister of health, specifies, for safety reasons, the maximal dose per intake and the maximal quantity per box for safe self-medication. The exemption may be restricted to a particular route of administration, for example local or oral but not parenteral use.

As a rule, the switched drug is granted marketing authorisation on the basis of a simple bibliographic dossier. No new clinical evaluation is required for well-known substances that have been used for many years in the same indication. The expected benefits and risks have already been assessed, and extensive follow-up data are generally available. Further evaluation is rarely necessary or requested.

Companies sometimes sponsor a small clinical trial of the drug at the exempted dose. When done by an opinion leader in the relevant indication, the data can be used to support the OTC launch campaign.

The current European draft legislation, as supported by the pharmaceutical industry, will forbid competitors from marketing generics of a switched drug for a number of years (up to 3 years according to some proposals of amendments). The pretext cited is that companies' new clinical data need to be protected from exploitation by competitors. This is specious, however, as OTC switch trials are neither obligatory nor necessary.

Prices of OTC drugs are fixed freely by the companies. Theoretically, this should be counterbalanced by free market competition. Supplementary data protection would stifle this competition.

Medicines agencies' requirements for OTC switches should be uniformly minimal across the European Union. It is up to medicines agencies to protect consumers, and up to drug companies to ensure their products are profitable, on a level playing field.

©Medicines in Europe Forum 15 October 2003