Obligatory Use of Generic Medicines

The Minister of Health has recently released a new regulation that reinforces the obligation of governmental health care service providers to use generic medicine. According to this new regulation (No. HK.02.02/MENKES/068/I/2010), administrative sanctions will be imposed in the event that obligation is not implemented - an instrumental provision which the previous regulation failed to include.

The sanctions are included in this regulation for the purpose of endorsing the use of generic drugs in the country which lately only have a small number of consumers as oppose to the branded, expensive drugs - even though most times generic and branded drugs have no differences in their ingredients.

The obligation to use generic products not only apply to governmental health care service providers (e.g. state- and regional-owned hospitals), but also to the people working in those institutions, particularly doctors. Article 4 of the regulation explicitly addresses this obligation. The rationale behind this obligation being applied to doctors is due to the fact that doctors tend to recommend branded drugs rather than generic products in the prescriptions that they write to patients.

However, when the situation does not warrant governmental health care service providers (including the doctors) to prescribe the use of generic drugs, then branded drugs can be recommended as an alternative. According to Article 8, that situation is when generic drugs are not yet available.

The implementation of the provisions of this regulation will be overseen by the central and regional governments according to their respective tasks and functions. These tasks and functions also include their rights to impose punitive measures by way of several administrative sanctions. These sanctions consist of verbal warnings, written warnings, and ‘administrative employment sanctions.’

The regulation governing the supervision of the government (including the sanctions that the government can inflict) is dictated under the Minister of Health Decision No. HK.03.01/MENKES/159/I/2010 on Guidelines on the Development and Supervision of Generic Medicine Usage in Governmental Health Care Service Facilities which was also issued not long after the release of this regulation.

This regulation repeals and replaces the previous regulation on the same subject matter, namely Regulation No. 085/Menkes/PER/I/1989, and has been in force since 14 January 2010.