Hopes rise for legal medical reform

December 01, 2022 | 11:00
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While Vietnam has made improvements in the rules for medical devices, international pharma groups are proposing extra refinements.

The Ministry of Health (MoH) is to work on a law on medical devices to increase efficiency of state management and create more favourable conditions for businesses. The focus is expected to be market authorisations (MAs) and drug tenders.

Some legal barriers are expected to be settled imminently when in early November, Deputy Prime Minister Vu Duc Dam signed Resolution No.144/NQ-CP on ensuring drugs, medical equipment, and reimbursement of healthcare costs and health insurance.

The government asked the ministries of health, finance, and planning and investment to quicken amendment and supplementation of legal documents related to purchasing, tenders, manufacturing, and import of drugs and medical devices to deal with the legal barriers.

Hopes rise for legal medical reform
Decree 98 will affect medical devices from various major markets, Le Toan

The MoH is asked to work with the Ministry of Justice and other relevant ministries and agencies on preparation for building of draft amendments to the Law on Pharmacy towards simplifying administrative procedures related to granting of licences, renewal of MAs, and others; as well as revision of Decree No.98/2021/ND-CP dated November 2021 on management of medical devices.

The MoH is also requested to work with the MoF and the Ministry of Planning and Investment (MPI) as well as other relevant ministries and agencies on amending, supplementing, or issuing new documents about purchase and tender of medical devices; rental of properties; supply of devices; management and use of public assets; and use of state funding.

A representative of the US-ASEAN Business Council told VIR, “Reforming the law will create a breakthrough in the field, creating a firm legal foundation for state management, tenders, and purchase of medical devices in the local market. Businesses are expecting that the law will be quickly drafted and enacted.”

Some key issues the council expects the law will cover include continuous recognition of MAs, increased transparency in tenders.

According to health experts, joint venture mechanisms related to medical devices, equipment rentals, and supply of diagnostic testing equipment are among the legal barriers in the prevailing rules, causing many difficulties for both domestic and international players. At present, there is no law comprehensively governing activities and state management about medical equipment in Vietnam. The country only has circulars and decrees to guide the issue, which sometimes overlap with other legal documents.

Taking effect in early 2022, Decree 98 acknowledges international MAs. Accordingly, medical equipment acknowledged and licensed by international management agencies will be recognised in Vietnam, or named in the list to speed up MA licences. Medical devices from the United States, the EU, Australia, and others will be subject to this acknowledgement.

Decree 98 sets out new regulations on registration numbers of medical devices and a fast-track approval process for registration of Class C and D devices. It also sets out new regulations on import licences, product classification, price management measures, adverts, clinical trials, and post-market management.

However, problems in the implementation of Decree 98 as well as Circular No.14/2020/TT-BYT from 2020, which regulates the bidding process of medical devices for public health establishments, and other legislation have caused a recent shortfall in devices.

For instance, Circular 14 regulates that when estimating the contract value, the health facility shall examine the successful bids within 12 months – a regulation deemed inappropriate with market price rules.

Minister of Planning and Investment Nguyen Chi Dung, after receiving comments from deputies of the National Assembly about the draft amendments of the Law on Public Procurement, said that together with amending of decrees and circulars guiding the law, the draft amendments will add some regulations to deal with the current problems in tenders of drugs and medical equipment.

Tenders and joint venture mechanisms related to devices and equipment rentals have been an issue of special concern among international pharma firms, including members of the US-ASEAN Business Council and the European Chamber of Commerce (EuroCham) in Vietnam’s Medical Devices and Diagnostics sector committee.

Earlier, EuroCham proposed that the government and competent authorities should examine the public-private partnership model for the healthcare sector, while increasing transparency and ensuring a level playing field and fair competition in public procurement of medical devices and diagnostics.

Currently, 90 per cent of medical equipment is imported from foreign countries, of which public hospitals hold 70 per cent of the market share.

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By Bich Thuy

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