Extension eases strain on drugs management

The National Assembly in January approved a resolution allowing the extension of marketing authorisation (MA) for pharmaceuticals which expired on January 1.

A representative of the US-ASEAN Business Council, told VIR, “This is excellent news for pharma businesses and our members in particular. We have strongly supported the extension and this will facilitate their operation.”

Now, the extension of MAs will last until the end of 2024. It will contribute to loosening the backlog of pharmaceuticals and the shortfall of drugs facing medical facilities nationwide for months, and ensuring the supply for examination and treatment. MA has been an issue of concern among domestic and international pharma firms, as well as health facilities, for years. In Vietnam, drugs are subject to MA renewal every five years. Meanwhile, other nations have a mechanism for MA to remain valid throughout the product lifecycle.

According to statistics from the Ministry of Health (MoH), nearly 13,000 MAs expired between November 2021 and the end of 2022. The Vietnam Pharmaceutical Association added that hundreds of drug registration numbers in Vietnam expired and if they were not extended for use, interruption in the supply of medicine was likely.

Members of the council in Vietnam and other international business associations, including the European Chamber of Commerce, had many times called for the extension and the removal of MA renewal to facilitate their operations and to ensure the supply of medicines in the country.

Before the approval of the resolution, in an effort to help pharma firms solve their challenge, the prime minister issued in late 2022 Decision No.1661/QD-TTg approving the cut and simplification of regulations related to business activities under the management of the MoH.

Ngo Thanh Hai, lawyer at the LNT & Partners, said that the abolishment is appropriate because many kinds of pharmaceuticals in circulation globally and in Vietnam for years and prove their quality. Therefore, the regulation on extension of MA every five years is not necessary.

“International experience show automatic renewal of MA for drugs without quality violation and serious side effects is applied without submitting an application for extension of the circulation registration number,” Hai noted.

All pharma firms expect that the amendment of the Law on Pharmacy will include the removal of MA renewal to ensure its high legislation for long-term application. According to the MoH, the revision of the Law on Pharmacy will be among its focuses in 2023.

While the government’s new orientation is expected to be a driving force for the development of the industry and reinforce the interest among multinationals, some experts said that it is necessary to institutionalise legal documents to create an open legal corridor to attract investors and related parties into Vietnam.

A representative of Sanofi told VIR, “The country should strengthen public-private partnerships between the government and the pharmaceutical industry in improving health finance, and collaborate with academic institutions to improve the ability of researching and developing.”

The representative also offered some recommendations to the government on industry coordination. “Policies that support and encourage foreign direct investment and intangible benefits are needed, for example the development of medical professionals,” he said.

“There should also be encouragement to create innovation since improvement is a crucial factor to increase productivity and digital solutions to discover expectations in the medical industry; and establish a legal framework and management mechanism to assure the quality and boost market confidence.”

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