El Salvador’s first comprehensive pharmaceutical regulation law was passed on April 5

El Salvador’s first comprehensive pharmaceutical regulation law, which Jason Cross helped design and consulted on in the final stages, just became law on April 5. STPP postdoc Jason Cross helped to design the law and provided consulting during its final stages. He says “It will go far in assuring quality access to medicines.”

Important provisions include the following:

Creation of the National Medicine Directorate to be responsible for registration procedures and post-registration controls of pharmaceuticals, cosmetics and other drug products — modeled on our FDA. (with random surprise audits and robust conflict of interest rules)

The sale of drugs without prescription is prohibited and so is drug peddling.

Drug stores are prohibited from having internal doctors and requesting them to write medical prescriptions.

It is prohibited for laboratories, drugstores, and pharmacies to offer or give any type of gifts, fees or payments to physicians, professionals or employees related to health matters, for the preferential prescription and sale of medicines.

Prescriptions for pharmaceuticals MUST contain the generic name of a drug along with any commercial brand name.

Reference prices of medicines must be in line with costs in Central America and Panama, so that the highest price market in El Salvador should not exceed the regional average price, which price shall be no greater than three to five times the international reference price set by the World Health Organization. Generic drugs will cost 30-40% of brand-name drugs, whereas they currently average 50% of the cost.

Any person, business or state institution may import drugs directly. This will allow the Ministry of Health, as well as private hospitals and clinics, to negotiate their own prices for imported drugs.

Jason Cross be going down sometime this summer to advise on implementation of the law and the creation of the National Medicines Directorate.

Posted May 7th, 2012 in Uncategorized.

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