Legal Framework to Fight Counterfeit Pharmaceuticals in Cambodia

Schmitt and Orlov – Morgane Issenmann and Dan Greif Phnom Penh, Cambodia

During the 14th ASEAN Health Minister Meeting held in Cambodia, on 29 August 2019, the Minister of National Defense of Cambodia, Tea Banh, warned that counterfeit pharmaceuticals are a growing problem. It was discussed how the current Cambodian laws can be used to address this serious public safety risk.

Pursuant to Article 2(1) of the Law on Management of Pharmaceuticals (1996), amended by the Royal Kram No. NS/RKM/1207/037 (2007), a pharmaceutical is a substance produced primarily from chemicals, bio-products, microbes, or plants combined:

• To use in the prevention or treatment of human or animal diseases, or;
• To use in medical or pharmaceutical research or diagnosis, or;
• To change or support the functioning of organs.

Article 2(2) of the same Law defines a a counterfeit pharmaceutical as a medication that:

• May contain inactive ingredients or inappropriate quantities of active ingredients, or;
• May not contain enough active ingredients as mentioned on the label, or;
• Has a packaging, design, identification similar to or the same as the original products, or;
• May be produced or packaged without licensing from the Ministry of Health.

The second to last point concerns pharmaceutical trademarks which help consumers identify their desired products.

Article 14 of the Law concerning Marks, Trade Names and Acts of Unfair Competition (2002) provides that counterfeit trademark goods means “any goods, including packaging, bearing without authorization a trademark that is identical to a trademark validly registered in respect of such goods, or which cannot be distinguished in its essential aspects from such a trademark, and which thereby infringes the rights of the owner of the trademark in question under the law of the country of importation”.

According to Article 12 of the Law on Management of Pharmaceuticals, any person who produces, imports, distributes, displayes or sells counterfeit pharmaceuticals shall be penalized by imprisonment from 5 to 10 years and subject to a fine of from 2,000,000 (two million) to 10,000,000 (ten million) Riels (from around 500 (five hundred) to 2,450 (two thousands four hundred fifty) United States Dollars).

The current laws of Cambodia have robust provisions for addressing the growing problem of pharmaceutical counterfeiting in Cambodia. Pharmaceutical brand owners can use these laws and the services provided by Cambodian Law Firms to address such counterfeits and further the public safety of Cambodian citizens.

We will continue to track developments on intellectual property laws related to Cambodian pharmaceuticals and will publish further updates.