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Official Gazette

Monday, September 23, 2019

Revising Pharmacy Law to strictly manage drug prices

Updated: 10:17’ - 27/06/2013

The Ministry of Health has recently, in association with the World Health Organization, held a seminar to gather expert comments on draft amendments to the Pharmacy Law, aiming to improve the legal system for the development of the pharmaceutical industry.

According to Truong Quoc Cuong, head of the Drug Administration of Vietnam under the Ministry of Health, although the Pharmacy Law assigns the Ministry of Health to act as the focal agency in managing drug prices, it does not specify responsibilities of other related ministries, leading to many difficulties. Furthermore, under the Pricing Law, the Ministry of Finance is vested with the power to generally manage product and goods prices. For these reasons, the revised Pharmacy Law should assign the Ministry of Finance to formulate financial policies related to management of drug prices and to organize, in coordination with other authorities, negotiations on drug prices, Cuong suggested.

Most experts agree to the establishment of an inter-sectoral council for drug price management. However, opinions remain divergent on how such council is organized. Some propose that the council should be composed of the Minister of Finance as its head and leading officials from the Ministry of Health, the Ministry of Industry and Trade and Vietnam Social Security as its deputy heads.  Others suggest  the council be headed by the Minister of Health. The Ministry of Health supports the first option, saying that it conforms with the Pricing Law and helps assure objectivity in drug price management.

Experts also voice the need to include into the revised Pharmacy Law regulations on management of prices of new types of drug, orphan drugs, patent medicines and medicines with few registration numbers. Meanwhile, price valorization measures should be applied to essential drugs and drugs covered by the health insurance fund. The use of home-made drugs which satisfy the World Health Organization’s good manufacturing practice standards should be encouraged to promote the domestic pharmaceutical industry.   

The Ministry of Health also proposes some important amendments on the management of quality of imported drugs. Accordingly, imported drugs would be subject to quality inspection upon importation. Such inspection would be much stricter than that conducted under current regulations, including inspection of drugs’ regulation conformity assessment results, labels, standard- or regulation-conformity marks and enclosed documents, and testing of samples according to announced standards when necessary. In addition, drugs must be imported via certain border gates jointly selected by the Ministry of Health and the Ministry of Finance.- 

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