Guidelines on Good Pharmaceutical Trade Practice (GPTP). 2015 - Malaysia
(2015; 4 pages)


The Malaysian National Medicines Policy (MNMP) which was revised in 2012 aims to promote equitable access and rational use of safe, effective and affordable essential medicines of good quality to improve the health outcomes of the people. Being a crucial commodity in healthcare, medicines have to be duly regulated and managed to ensure that the wellbeing of the public is safeguarded. Malaysia has a dichotomous healthcare system where public healthcare expenditure is almost fully subsidised by the government while private healthcare spending is covered either through private health insurance, employers or out-of-pocket (OOP) payments. In the public health system, there is an indirect price control mechanism through the Ministry of Finance (MOF) policies and directives.

However, in the private sector medicines are priced according to market forces and competition. It has been reported that the prices of medicines in Malaysia are among the highest in the region despite the fact that medicines imported into the country are non-taxable. A prominent reason to this is the monopoly of new single source medicines which leads to high drug prices set by registration holders to recoup some or all of their initial investment. This has a direct impact on affordable access to new medicines.

However, high price of medicines is not the only issue in the private sector. The pharmaceutical market failures mainly in the form of information imbalance and failure of competition has led to price disparities within and between distribution channels. Price cutting between giant chains and independent pharmacies, market monopoly, creation of artificial demand, unfair bonusing, discounts and rebates and bundling of unwanted medicines has created an unhealthy and dysfunctional market and business environment.

Thus, it is timely for the introduction of a guideline on “Good Pharmaceutical Trade Practice (GPTP) for Private Sector” towards ensuring best trade practices across the pharmaceutical distribution chains. All pharmaceutical trade practices should be in line with existing laws and regulations and this guideline will address the finer details not spelt out under current legislations.

This guideline aims:

  • To harmonize the current trading practices between/within all pharmaceutical distributing channels towards fair pricing and equitable access to quality medicines.
  • To allow public to get the benefit from price discounts/ rebates thus increase their access to affordable medicines.
  • To promote transparency in price information.
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