At the event (Photo: VNA)The ambassador was speaking at the workshop 'UKVFTA commitments andimplications for the pharmaceutical sector in Vietnam' on January 10.
He said under the UK-Vietnam Free Trade Agreement (UKVFTA), UK pharmaceuticalcompanies enjoy lower tariffs, increased access to the public procurementmarket for pharmaceutical products, and enhanced protection of intellectualproperty rights in Vietnam.
"UKVFTA has helped deliver regulatory changes that have allowed Britishpharmaceutical companies to obtain foreign-invested enterprise (FIE) status inthe country," said Iain Frew.
The ambassador expressed his appreciation for the Ministry of Health's effortsto revise the legal regulations on pharmaceutical registration and management,especially the issuance of Circular 08 which removed additional requirements onthe certification of pharmaceutical products.
He also appreciated the decision by the National Assembly to allow theextension of the expired marketing authorisation until 2024. He hoped that theministry would be able to issue the list of pharmaceutical products under thisresolution soon to ensure the continuity of supply and patient treatment.
Do Xuan Tuyen, deputy minister of Health, revealed that the National Assemblyhad approved a resolution, under which the marketing authorisation (MA) ofcertain drugs and medicinal ingredients is extended to December 31, 2024.
He said his ministry had been working on the above-mentioned list ofpharmaceutical products and would soon publish it to avoid a disruption ofmedical supply chains.
He also said his ministry had drawn up a revised version of the Law on Pharmacy2016 and submitted it to the Government for approval. The version offers fivebig changes to the original law.
One of the changes involves the replacement of five-year-periodically approvedextensions of MA by automatic extensions of MA. Another change centres aroundthe reduction of clinical trial requirements in favour of developed countries.
"Another change involves the decentralisation of MA to localpharmaceutical authorities," said Tuyen.
The deputy minister expected the version to be approved and sent to theNational Assembly for discussion in October 2024.
Harry Rawicz-Szczerbo, head of Trade & Investment, British Embassy in Hanoi,underlined several opportunities for UK pharmaceutical products under UKVFTA.
The first opportunity involves preferential tariffs, with more than 71% of UKpharmaceutical products enjoying tariff-free access to Vietnam immediately. Theremainder is slated to benefit from tariff elimination in the next four to nineyears.
The second opportunity involves the access to Vietnamese public procurementmarket. After a transitional period of two years from the entry into force ofUKVFTA, UK suppliers will secure access to a pre-determined portion of themarket.
The third opportunity is about the FIE status. The free trade agreement willallow UK pharmaceutical companies to set up FIE status, which entitles them tobuild warehouses and facilities, hire health experts, and carry out marketingactivities in the country.
The fourth opportunity is the improvements in intellectual property rights. Forexample, Vietnam will provide regulatory data protection to pharmaceuticalproducts every five years.
"Competitors are prohibited from relying on submitted test data in supportof an application for MA for at least five years," said Rawicz-Szczerbo.
The fifth opportunity centers around clinical trials. Under UKVFTA, Vietnamwill withdraw existing clinical trial requirements that are not in line withinternational norms and standards, including the International Conference onHarmonisation of Technical Requirements for Registration./.
VNA
