NA axe local clinical trials for globally tested drugs

The new law will do away with local clinical trials where global data already exists-Photo: Le Toan

The removal of the requirement, which is part of the amended Pharmacy Law approved by the National Assembly in early April, is a major achievement for the Vietnamese healthcare system and the patients it serves.

This development, as well as the “introduction of Patient Assistance Programmes, and the prioritisation of ‘Orphan Drugs’ will provide patients with faster access to the latest innovative medicines to address unmet medical needs in Vietnam,” said Jan Rask Christensen, senior director of EuroCham’s Pharma Group.

According to the Pharma Group’s White Book-2016 Edition released in early March, in order to ensure drugs are effective in all human populations, pharmaceutical companies conduct clinical trials globally to meet ethnicity requirements. Most Vietnamese people fall under the Asian ethnicity, meaning that a global clinical trial undertaken with an Asian component is satisfactory from a medical standpoint.

“Removing the local clinical trial requirement will help make the healthcare system more efficient, reducing administrative burdens for the Drug Administration Department of Vietnam (DAV) by avoiding unnecessary clinical trials. It would align with the standards applied in other ASEAN members and lead to a return of medical tourism expenditure,” Christensen stated.

Previously, Vietnam’s requirement for additional clinical trials (or waiting five years after registration in the products’ country of origin) met with strong complaints from the Pharma Group. The committee represents 22 multi-national pharmaceutical industry members, including Bayer Vietnam Ltd, Novartis Pharma Services AG, Sanofi-Aventis Vietnam, and Zuellig Pharma Vietnam Ltd.

The Pharma Group proposed on several occasions that the Vietnamese government remove the requirement, as it lengthened the wait for patient’s access to new medicines by at least 2.5-5 years.

“In fact, Vietnam was one of a few countries in the world that required a local drug registration study for long. The lack of new drugs in Vietnam predominantly stemmed from the local clinical trial requirement that the group said in its White Book-2016 Edition.

Christensen said that it was of paramount importance that these new legislative initiatives are properly implemented in order to fully benefit from the progressive amendments in the new Pharmacy Law. The changes to the Pharmacy Law outline the government’s more open policy on pharmacies and the pharmaceutical industry, management of medicines at healthcare centres, and the management of medicine quality, among other health-related items. It will take effect on January 1, 2017.