Abstract
Market exclusivity and drug expenditures: the effects of Thailand New Drug Registration RegulationsThe effects on hospital drug expenditures of the market exclusivity granted to innovator products by means of Thailand regulations on new drug registration were assessed. Self-administered questionnaires were distributed by mail to 292 public and private hospitals in February 2001 to collect data on purchase volume and value of 11 generic-approval new drugs containing 4 active chemicals, namely fluconazole, clozapine, ondansetron, and ofloxacin (injection form). The questionnaires were returned by 166 settings (56.9%). It was found that during the first two years of generic entry, 1999 to 2000, unit prices of generic versions of all products purchased by the hospitals were lower than the prototypes’ but prices of the originals did not change significantly. Due to lower price of generic products and generic substitution in the hospitals, substantial decreasing in drug expenditures of totally 103.5 million baht has been observed. Tremendously increased purchase volume of some drugs, particularly fluconazole, among these healthcare settings when generic entered the market while there was no increasing in health needs, indicates significantly improved accessibility to drug. To potentiate the magnitude of the positive effects of generic entry on drug cost containment among hospitals and the increased accessibility to drugs, promoting drug price competition and encouraging generic substitution are recommended.