Despite the government’s strong request for facilitation of marketing authorisation renewal, foreign drugmakers are still waiting for the renewal of expired authorisations, triggering concerns over a possible future shortfall of drugs.
|Drugmakers yearning for MA clarity
According to a reliable source from the International Quality Medicines, Generic and Biosimilar Sector Committee under the European Chamber of Commerce in Vietnam, the deadline of May 25 set by Deputy Minister of Health Do Xuan Tuyen in Official Letter No. 2328/BYT-VPB1 referring to Decree 29/2022/ND-CP, instructing the Ministry of Health (MoH) to publish the list of extended marketing authorisations (MA) has not been met.
Van Ho, chairwoman of the committee, told VIR, “We hoped for this long-awaited release of the list because more and more medicines are unavailable to patients every day. Hospitals report lack of medicines caused by significant delays in tenders due to lack of valid (extended) MA. Patients’ health and lives are at risk, while businesses – both local manufacturers and importers – are faced with financial loss.”
“While waiting for the emergency solution and extension of the expired or soon expiring MA, at the same time there is no progress on DAV side in the regular 5-years extensions of MA. The industry is completely powerless. For the sake of Vietnamese patients, we beg the government for immediate action,” she added.
The list, much anticipated by the pharmaceutical industry, is supposed to let the manufacturers and importers of medicines continue supplying the hospitals and pharmacies with drugs which had been already registered in Vietnam for years and proved their safety and efficacy for patients’ treatment.
In mid-May, a list of 156 foreign-made pharmaceuticals got MA renewal in Vietnam when the Drug Administration of Vietnam (DAV) issued Decision No.265/QD-QLD, enabling them to continue trading in the local market amid the growing demand. They include drugs from many famous groups such as Adamed, GlaxoSmithKline, Astellas, B. Braun, and Novartis Pharma.
However, due to the procedural delays, lack of resources and pandemic impact on the MoH, over 12,000 medicines will disappear from the Vietnam market until December 31, 2022 if the government doesn’t take immediate action.
According to the MoH, at the end of 2022 nearly 9,800 MA numbers will expire. Thus far, more than 7,700 files have been sent to the ministry for renewal. Industry insiders forecast that in the second half of 2022, the healthcare sector is likely to face a lack of drugs if the barriers related to congestion of MA renewal files at the MoH are not solved.
Van Ho noted that since Vietnam is now more attractive to international drugmakers due to the EU-Vietnam Free Trade Agreement, it requires stable and clear legal framework, with timely regulations aligned with international practice. If this is not provided and respected, the country’s attractiveness for the foreign investors will be affected.
Last week’s missing announcement followed the government’s request in April to amend existing drug registration rules in order to facilitate business operations. Accordingly, the MoH worked with the General Department of Vietnam Customs to deal with the problems related to customs clearance procedures for imported drugs, while working with the Ministry of Finance and other relevant agencies on the completion of a draft decree guiding the implementation of Resolution No.12/2021/UBTVQH15.
Among the biggest expectations among international pharma firms in Vietnam is announcement of the list and amendment of Circular No.32/2018/TT-BYT on drug registration and MAs in line with international practices which the MoH is working on. They now expect establishment of a mechanism for MAs to remain valid throughout the product lifecycle, similar to the practice in other countries, instead of being subject to renewal every five years.
The DAV said that going forward, the MoH will revise the Law on Pharmacy towards making the MA renewal automatic, as seen in Europe.
At present, under the existing rules, pharmaceuticals and ingredients must get an MA from the MoH before being used in treatment or pharmaceutical production activities in Vietnam. The first MA provides a product with a registration number and validity of 3-5 years. After that, it will then have to be renewed for further use.