With the Ministry of Health’s latest pledge to improve upon medical legislation, international businesses continue to pin high hopes on marketing authorisation regulations for medical devices and distribution rights in order to drive their plans forward.
|Concerns were raised over the shortage of medical devices due to import licence expirations and other delays, photo Le Toan |
At last week’s business-to-government dialogue forum and the launch of a Whitebook by the European Chamber of Commerce in Vietnam (EuroCham), the Ministry of Health (MoH) stated that it is working on amendments to Decree No.98/2021/ND-CP on management of medical devices, with a focus on extension of marketing authorisation (MA).
“Once the government issues draft Decree 98, we will issue documents guiding the implementation,” said Bui Viet Dung, an official at the MoH. “We are also working on a law on related devices to create a full legal framework.”
Regarding distribution rights of foreign-invested enterprises (FIEs), the MoH admitted that current legal documents are not clear enough, thus causing challenges for them to perform. Under Decree No.54/2017/ND-CP guiding the implementation of the Law on Pharmacy 2016, FIEs have the right to import pharmaceuticals but, without the distribution rights, cannot sell its imported goods directly to retailers and/or consumers.
“We will work on the issues in the amendments to the Law on Pharmacy 2016 to create favourable conditions for business activities in the field,” he added.
The MoH made the statements after EuroCham’s sector committees raised their concerns over the shortage of medical devices and delays in the issuance of MA, as well as amendments of the Law on Pharmacy 2016.
MA and distribution rights have been a hot topic for years among FIEs in Vietnam. To help pharma firms solve their challenges, in January the National Assembly approved a resolution allowing the extension of MAs for pharmaceuticals that expired on January 1, changing the end date to the end of 2024.
Moreover, Decision No.1661/QD-TTg issued in late 2022 on the abolition of a number of administrative procedures approved the elimination of the MA extension process, with an implementation deadline of 2022-2023.
However, medical devices are not subject to MA extension in the new moves. Therefore, the amendment of the Law on Pharmacy is deemed urgent to realise the government’s direction.
A representative of EuroCham sector committee IQMED said, “Regulations related to the right to distribute drugs and medicinal ingredients of FIEs are only regulated in Article 91 of Decree 54. These regulations are not clear yet for implementation, and they have not been regulated in the Law on Pharmacy 2016, so they need to be added to this.”
Meanwhile, EuroCham’s Medical Devices and Diagnostics Sector Committee (MDDSC) raised its members’ concerns over the shortage of medical devices due to the expiry of Class C and D import licences and delays in the issuance of MAs.
MDDSC chairman Qadeer Raza said, “While we are glad that the MoH has considered an extension of the import licence through an amendment to Decree 98, it is still a draft and as a result, the industry is unable to ship affected devices to Vietnam.”
The committee is requesting the issuance of draft Decree 98, which includes the extension of the import licences until the end of 2023 as soon as possible. “This is so that import permits and MA numbers can be extended to resume supply of affected medical devices for patients in Vietnam,” Raza said.
Draft amendments to Decree 98 have thus far received support from the business community, including EuroCham members.
According to the MDDSC, since January 2022 only 12 per cent of submitted Class C and D devices have been approved with an MA under Decree 98. Last November, Resolution No.29-NQ/TW was issued on accelerating the national industrialisation and modernisation to 2030, with a vision to 2045. It emphasised the key role of science, technology, and innovation in helping Vietnam to address current and future challenges, and also identified pharmaceuticals as one of the priority sectors that will enable and drive innovation.
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By Bich Thuy