Guests discuss the opportunities that UKVFTA unlocks for UK pharmaceuticals. — VNS Photo Lê Việt Dũng

HÀ NỘI — UK pharmaceutical exports to Việt Nam witnessed a strong growth rate of 32 per cent in the first nine months of 2022, according to British Ambassador to Việt Nam Iain Frew.

The ambassador was speaking at the workshop 'UKVFTA commitments and implications for the pharmaceutical sector in Việt Nam' on January 10.

He said under the UK-Việt Nam Free Trade Agreement (UKVFTA), UK pharmaceutical companies enjoy lower tariffs, increased access to the public procurement market for pharmaceutical products, and enhanced protection of intellectual property rights in Việt Nam.

"UKVFTA has helped deliver regulatory changes that have allowed British pharmaceutical companies to obtain foreign-invested enterprise (FIE) status in the country," said Iain Frew.

The ambassador expressed his appreciation for the Ministry of Health's efforts to revise the legal regulations on pharmaceutical registration and management, especially the issuance of Circular 08 which removed additional requirements on the certification of pharmaceutical products.

He also appreciated the decision by the National Assembly to allow the extension of the expired marketing authorisation until 2024. He hoped that the ministry would be able to issue the list of pharmaceutical products under this resolution soon to ensure the continuity of supply and patient treatment.

Đỗ Xuân Tuyên, deputy minister of Health, revealed that the National Assembly had approved a resolution, under which the marketing authorisation (MA) of certain drugs and medicinal ingredients is extended to December 31, 2024. 

He said his ministry had been working on the above-mentioned list of pharmaceutical products and would soon publish it to avoid a disruption of medical supply chains.

He also said his ministry had drawn up a revised version of the Law on Pharmacy 2016 and submitted it to the Government for approval. The version offers five big changes to the original law.

One of the changes involves the replacement of five-year-periodically approved extensions of MA by automatic extensions of MA. Another change centers around the reduction of clinical trial requirements in favour of developed countries.

"Another change involves the decentralisation of MA to local pharmaceutical authorities," said Tuyên.

The deputy minister expected the version to be approved and sent to the National Assembly for discussion in October 2024.

Harry Rawicz-Szczerbo, head of Trade & Investment, British Embassy in Hà Nội, underlined several opportunities for UK pharmaceutical products under UKVFTA.

The first opportunity involves preferential tariffs, with more than 71 per cent of UK pharmaceutical products enjoying tariff-free access to Việt Nam immediately. The remainder is slated to benefit from tariff elimination in the next four to nine years.

The second opportunity involves the access to Vietnamese public procurement market. After a transitional period of two years from the entry into force of UKVFTA, UK suppliers will secure access to a pre-determined portion of the market. 

The third opportunity is about the FIE status. The free trade agreement will allow UK pharmaceutical companies to set up FIE status, which entitles them to build warehouses and facilities, hire health experts, and carry out marketing activities in the country.

The fourth opportunity is the improvements in intellectual property rights. For example, Việt Nam will provide regulatory data protection to pharmaceutical products every five years.   

"Competitors are prohibited from relying on submitted test data in support of an application for MA for at least five years," said Rawicz-Szczerbo.

The fifth opportunity centers around clinical trials. Under UKVFTA, Việt Nam will withdraw existing clinical trial requirements that are not in line with international norms and standards, including the International Conference on Harmonisation of Technical Requirements for Registration. — VNS