The National Assembly of Vietnam passed the much-awaited Law on Tender on June 23, 2023, marking a significant milestone in the regulation of the instrument placement model. The law, officially promulgated on July 10, 2023, addresses issues that arose due to the lack of a legal framework for this model. The instrument placement model has been a focus of the EuroCham Medical Devices and Diagnostics Sector Committee’s advocacy efforts since 2018.
The absence of a clear legal framework surrounding the instrument placement model created numerous difficulties in the bidding process and reimbursement for tests conducted on instruments placed over the past six years. This issue reached a critical point in mid-2022 when the Ministry of Finance and Vietnam Social Security issued official letters dismissing the instrument placement model. In addition, they halted health insurance payments for tests performed with placed instruments. Consequently, this caused shortages of medical supplies and disruptions in testing, diagnostics, and treatment at public hospitals in Vietnam during the fourth quarter of 2022 and the first quarter of 2023.
In response to these challenges, the EuroCham MDDSC launched extensive advocacy activities and campaigns in 2022. These efforts involved gathering voices from various stakeholders, including the private and public sectors, patients, associations, media outlets, and embassies. The EuroCham MDDSC worked closely with the drafting committee, offering valuable comments and sharing best practices from other countries. The culmination of these efforts led to the development of short-term and long-term solutions aimed at definitively resolving the issue.
The short-term solution materialized in Government Resolution No. 30/NQ-CP, dated March 4, 2023. This resolution allowed health insurance reimbursement for technical services performed using machines supplied by winning contractors.
For the long term, the new Tender Law was crafted and approved by the Vietnam National Assembly on June 23, 2023. Following its approval, the law was officially promulgated on July 10, 2023. Effective from January 1, 2024, the new law encompasses six accepted models, including the instrument placement model, cost per test, equipment and consumable procurement, equipment procurement only, consumable procurement only, and outsourcing lab services. It is noteworthy that these models were recommended by EuroCham MDDSC.
The successful implementation of both short-term and long-term solutions by the government underscores the significance of EuroCham’s advocacy efforts and the strong collaboration between the private and public sectors in shaping policies within the medical devices sector. This outcome showcases how the collective voice and cooperation among various stakeholders can greatly influence and shape the regulatory landscape, ensuring a more robust and inclusive environment for the medical devices industry in Vietnam.