Knowledge on rare diseases and orphan drugs

Orphan drugs in Singapore

The orphan drugs policy in Singapore is based upon a Medecine Order ('Orphan drugs Exemption'). The legislation, which came into force at the end of 1991, gave a definition of orphan drugs and of the legal framework for imports in Singapore.

A rare disease is defined as a life threatening and severely debilitating illness.

An orphan drug is a medicinal product which has been identified by any doctor or dentist as an appropriate and essential remedy with no effective substitute for the treatment of a rare disease.

The product should not hold a previous product licence under the Medicine Act and should be approved by the competent Health Authorities either from the country of origin or from any other country where the orphan drug has been used.

Orphan drugs importers must maintain proper records, including:

• The quantity imported or supplied
• The date of reception or supply
• The name and address of the person for whom the orphan drug is provided

In addition, any other drug imported shall be kept in a hospital and be under the charge and control of a ' custodian ' who must be a physician, dentist or pharmacist appointed by the hospital

Any doctor or dentist who requires an orphan drug for the treatment of their patient suffering from a rare disease may request the custodian to provide them with the drug.

So far, there has been no other incentive, such as marketing exclusivity or subsidies in the orphan drug policy.