Turning point created for pharma firms in law changes

Pharma companies said that the amendments, made official on November 21, include positive and timely changes that will facilitate businesses to operate more effectively, and focus on improving service quality.

New legislation is expected to foster a better environment for all healthcare stakeholders Photo: Le Toan

“For the first time, the operation of the pharmacy chain model has been officially and specifically legalised. This is of great significance to us, affirming the recognition of the National Assembly (NA) and state management agencies for the role of pharmacy chains in supplying drugs to consumers,” Nguyen Do Quyen, executive vice president of FPT Retail, operator of the FPT Long pharmacy chain, told VIR.

“We expect that in the next phase when building decrees and circulars to guide the implementation of the new law, the government and the Ministry of Health (MoH) will receive diverse opinions and refer to the online drug sales management model of countries with similar characteristics to Vietnam to issue detailed instructions suitable for the digital economy,” Quyen added.

Legalisation of the pharmacy chain model is one of the highlights in the amended law. The others include renewal of marketing authorisation (MA), incentives, and tech transfer.

“It is a big milestone in the healthcare system, in the healthcare development journey in Vietnam. These changes were long awaited, and will foster a more transparent and a better environment for healthcare stakeholders,” said Charaf Eddine Kadri, general director of Sandoz Vietnam.

“We see that there are a lot of good incentives for local manufacturing in Vietnam, encouraging technology transfer of drugs. Our mission is to pioneer access for patients, and we know that there is still a big room to grow in terms of access in Vietnam when it comes to rural areas and when it comes to the affordability of drugs,” Kadri added.

Sandoz is now to consolidate its presence in Vietnam after setting up as a legal, independent company in Vietnam in April. Kadri said that supporting pharmaceutical companies into shortening the registration timelines of their drugs would help the whole healthcare system to better address patient needs and create more sustainability in terms of access for patients.

“When it comes to MA, we are really satisfied with the new changes, and we want to consolidate on the huge improvements that have been implemented in the recent pharma law. We would like to expand our footprint in more and more therapeutic areas, and drugs in the very near future in Vietnam,” Kadri said.

Similarly, an expert at Y Dong Pharma Co., Ltd. said that the legislation of the sale of drugs online is reasonable at this time. “Each factory and each type of drug has its own production technology, so we hope that state management authorities can be more flexible in managing drug prices. This has an impact on stimulating the development of the pharmaceutical industry.”

According to HM&P law firm, the amended law simplifies the procedures for granting MA licences to increase early access to drugs while still ensuring quality control, safety, and effectiveness, as well as compliance with international practices.

“The law reduces the number of documents required for renewing, changing, or supplementing the MA of drugs and pharmaceutical ingredients, allowing companies to maintain valid MA while awaiting renewal decisions,” said the firm. “The processing time for MA renewal applications will also be reduced from three months to less than one month for some cases.”

Vu Tuan Cuong, director general of the MoH’s Drug Administration of Vietnam, said, “With the new points of the amended law, it will fundamentally resolve the inadequacies in state management of pharmaceuticals, helping the industry continue to develop as well as ensuring timely supply of drugs with quality, safety, effectiveness, and reasonable prices.”

Pharma companies are now waiting for decrees and circulars guiding the implementation of the law to ensure its efficiency and success. Tran Khanh Thu, NA deputy representing the northern province of Thai Binh, noted, “I hope that there will be regulations from the government, as well as specific instructions from the MoH and related ministries, so that the new law can come into effect and people can enjoy the benefits of these new policies.”

Pharma law upgrades will improve effectiveness The ratification of the law amending and supplementing several articles of the Law on Pharmacy 2016 at the end of November is significant and positive news for the healthcare sector. It is expected to address key shortcomings of the current law while incorporating best practices successfully implemented in other countries.