REVISED PHARMACEUTICAL LAW ON THE LEGISLATIVE AGENDA

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Lawmakers Discuss Pharmaceuticals, Tax, and Trade Unions

The 15th session of the National Assembly (“NA”) resumed in mid-June, with legislators discussing a wide range of regulations. Of particular note for foreign enterprises and international investors during the fourth week of the 15th session (17-21 June) was the Law on Amendments and Supplements to the Pharmaceutical Law, the amended Trade Union Law, and the Law on Value-Added Tax (“VAT”).

The proposed revisions to the Pharmaceutical Law aim to address several issues identified since the legislation was last updated in 2016. In particular, the government has highlighted some positives in raising pharmaceutical regulations to international standards. However, it has also pinpointed issues such as time-consuming administrative procedures on pharmaceutical and raw material circulation and a continued lack of development of the domestic sector. 

The amendments and provisions proposed in the NA aim to streamline administrative procedures. For instance, it proposes that domestic pharmaceutical companies not be required to submit clinical dossiers during the application for the authorisation of new drugs intended to prevent or treat so-called ‘Group A’ diseases (except for vaccines). The new proposals also suggest a ban on the sale of pharmaceutical goods on social media platforms.

That same week, the government proposed three new laws for discussion in a ‘thematic lawmaking’ session on 13 June in Hanoi. This 26th thematic session on law building of the current legislative term – and the fourth of 2024 so far – proposed regulations including a new Data Law, an amended Law on Health Insurance, and a Law on Disease Prevention. The session also discussed other regulations, including the Law on Chemicals and amendments to the Law on Advertising and the Law on Standards and Technical Regulations.

NA Deputies also highlighted an urgent need to reform administrative procedures during sessions late last month, following new business registration figures showing that more companies had closed than opened in the first four months of 2024. While 81,000 new businesses had started trading, 86,000 ceased operations during that period, according to the Minister of Planning and Investment. Legislators highlighted the need to streamline administrative procedures and speed up approvals to reduce bureaucratic bottlenecks and increase innovation.

Meanwhile, as we covered before, the draft Land Law has now been implemented ahead of schedule. In a recent cross-ministerial meeting with representatives from all 63 provinces to discuss the drafting of implementing regulations, the Ministry of Natural Resources & the Environment (“MONRE”) was tasked with working with other ministries and stakeholders to ensure that the new law would be consistent with and avoid conflicts with other regulations.

APFL Partners will continue to monitor these regulations and ensure that our clients are kept up to date with how these could impact on their commercial operations and investment projects. For more information about these or other upcoming legislative changes, just email us on: contact@apflpartners.com


Disclaimer: This article and its content are for information only and are not given as legal or professional advice. they do not necessarily reflect all relevant legal provisions with respect to the subject matter. Readers should seek legal or professional advice before taking or refraining to take any action.

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