Those accused in the VN Pharma fake cancer medication scandal at the appeal court in HCM City in October 2017. VNA/VNS Photo Mạnh Linh

The Government Inspectorate on Monday announced their conclusion over the responsibilities of the Ministry of Health and the Drug Administration in granting drug import licences for VN Pharma and a business licence for the foreign drug producer Helix.

According to the inspectors, leaders of the ministry and the drug administration must take the blame for several loopholes in Circular No 22 issued in 2009 regulating drug register and Circular No 47 in 2010 offering guidance for drug imports and exports.

Circular No 22 was “one of the management failures that resulted in untimely detection of forged papers in (VN Pharma’s) drug registry applications,” the inspection found.

VN Pharma managed to register seven medicines with the authorities using counterfeit documents.

Then-ministerial leaders and officials of the drug administration in 2009 were responsible for drafting and issuing the circular while those in office between 2011 and 2014 who failed to fix the loopholes of the circular must be called to account for negligence, the Government Inspectorate said.

Circular No 47 of the ministry, meanwhile, was concluded to be not in line with Prime Minister’s Decision No 151 in 2007 which demanded a foreign company to have a business licence in drug and drug materials in Việt Nam so that its medicines could be imported into the country.

As a result, the ministry granted a total of 607 import licences for three kinds of medicines reportedly manufactured by Canada’s Helix Pharmaceuticals Company. No copies of the company’s business licence in Việt Nam was included in the import applications.

Up to 200,000 boxes of H-Capita 500mg Caplet – branded as a cancer medicine – received the needed licences to be imported into Việt Nam and about 9,300 packages managed to get into the country before they were stopped by the authorities. 

According to Circular No 47, a foreign pharmaceutical company which wanted to apply for a business licence in Việt Nam was also spared of a thorough assessment of its medicine manufacturing facilities. Such lax regulation led to the issuance of an official business licence to Helix in 2014 – the company which was later found to be non-existent.

Health ministry scrutinised

The scandal broke in 2014 when suspicions were raised over the origin of the H-Capita 500mg medicine and authorities launched an investigation.

Nguyễn Mạnh Hùng, VN Pharma’s former general director, was the mastermind behind a plan to buy cancer medicines overseas and supply them to Vietnamese hospitals.

He ordered underlings to forge papers for the Helix company in order to get licences to bring the medicine into Việt Nam.

Tests by the health ministry concluded that 97 per cent of the H-Capita drug consisted of capecitabine – a chemotherapy medication used to treat breast, gastric and colorectal cancer.

However, the medicine was of unknown origin, subpar quality and its packaging failed to prove the drugs were safe to treat human diseases.

Up to 12 people have been prosecuted in the case so far while the authorities started looking into the responsibilities of the health ministry.

The Government Inspectorate said that the health minister as the highest official in charge of medicine management should be held accountable for the scandal along with the head of the Drug Administration who offered assistance to the minister in the field.

The ministry’s consultancy council and drug appraisers must take responsibility in approving VN Pharma’s seven drug registries and import licences for three types of medicines and a business licence in Việt Nam for Helix company.

The inspection’s conclusion was transferred to the Central Inspection Committee to scrutinise and decide on the penalties for any high-level officials under the jurisdiction of the Politburo and the Party Secretariat. — VNS