Safety of Imported Pharmaceuticals REF#6068

Cambodia has strict processes in place for the registration of pharmaceutical products, which mandate detailed technical specifications of both the product and its packaging to ensure safety, effectiveness, and quality. Only products that match the specifications registered with the Ministry of Health (MoH) can be imported into Cambodia. However, some pharmaceutical distributors circumvent these requirements by importing products falsely under the registration number of an authorised distributor or products that have avoided registration and testing entirely. As these products have not received import permission from the Ministry, they should be illegal for sale in Cambodia.

The registration process has become increasingly digital, with the launch of the Cambodia Pharmaceutical Online Registration System (CamPORS) in 2019, which is meant to be a digital one-stop window to register the import and use of pharmaceutical products in the country. However, unregistered products can still originate from the authorised manufacturer and meet some of the product specifications, but they nonetheless pose health risks when transported by an unofficial entity into Cambodia. Manufacturers take climatic conditions into account when designing their packaging and regularly modify their packaging for specific countries for added protection. Cambodia has a tropical climate and many of its pharmacies are not climate-controlled, requiring packaging to be adapted to prevent pharmaceutical products from spoiling in the heat.

In order to ensure that products are transported and stored under the right conditions, manufacturers require their distributors to undergo stringent audits and selection processes. Distributors that deliver products without being appointed by the manufacturer will not have undergone such controls and cannot ensure the products are safe once they reach patients. Another fundamental aspect of pharmaceutical safety is pharmacovigilance, in which a manufacturer is notified in case of an “adverse event” occurring within the market. Adverse events are negative experiences relating to the use of a pharmaceutical by a patient and are reported to manufacturers by distributors to take proactive precautions to ensure patient safety.

However, unregistered product distributors are not appointed by a manufacturer and will not report such events, increasing the likelihood that harmful pharmaceuticals will remain in distribution. EuroCham’s Healthcare Committee supports affordable treatments but emphasises that unregistered products are not a viable solution as they enter the market at cheaper prices by circumventing testing conducted by the National Health Products Quality Control Centre and the manufacturers’ pharmacovigilance processes.

While Cambodia’s existing regulations do not allow distributors the right to exclusive distribution of pharmaceuticals, to our knowledge, these regulations also do not allow the entry of products that are a variation of a registered pharmaceutical product. Companies distributing pharmaceuticals are required to apply for a variation when a registered product has been modified to ensure that its registration details are accurate and the modified variety is safe. Weak detection of unregistered products entering the market creates vulnerabilities in the distribution chain, increasing the likelihood of counterfeit and sub-standard products entering the market. Trust is reduced as there are no controls in place to certify that the active compounds match what the seller claims.

EuroCham’s primary concern on this issue is patient safety rather than the impact on revenue. Unregistered pharmaceutical products represent a serious health risk to the Cambodian population as there are no means of assuring the quality of such products. The average consumer cannot be expected to have the technical knowledge to determine whether a pharmaceutical product is spoiled or not due to inappropriate transportation or packaging, therefore responsibility must fall upon regulators to provide quality assurance through effective management of all imports.

In cases where an unregistered product is legitimate, the product manufacturer will have already registered the sale in another country and therefore does not incur any financial loss as a result of unauthorised importing. However, in the longer term, a higher presence of unregistered products in the market is likely to discourage investment by multinational pharmaceutical companies in the domestic economy. If the Cambodian subsidiary is unable to record a suitable financial performance due to lax import controls, they are unlikely to be granted a budget for activities such as education and training for patients and healthcare professionals.