LHSS Vietnam Consultancy – Technical assistance to draft the national plan to promote local production of ARV drugs in Vietnam

1. Beneficiaries

The beneficiary organization is the Ministry of Health of Vietnam.

1. Contracting Authority

The representatives of Abt Global, as the primary implementer of the Local Health System Sustainability Project (LHSS) Vietnam Activity, will sign the contract for this consultancy.

1. Background and Context of the Assignment

Background

The global United States Agency for International Development (USAID) LHSS Project helps low- and middle-income countries transition to sustainable, self-funded health financing systems that support high-performing overall health systems. The Activity in Vietnam works with the Government of Vietnam (GVN) to advance greater local ownership of HIV and TB prevention and control. Led by Abt Global, the four-year activity supports Vietnam in increasing its domestic financing for HIV and TB services in the context of declining donor funding, using government resources more efficiently, and assuming local ownership of HIV and TB prevention and control activities. Specific objectives are: (1) Support the GVN to strengthen its public financial management systems for the public health sector and find greater efficiencies in social health insurance (SHI); (2) Increase the availability and improve the efficiency of domestic financing of HIV prevention and treatment services; (3) Strengthen the capacity of Vietnam’s supply chain management system; and (4) Integrate TB services into SHI.

Context 

The GVN has put a national program on developing pharmaceutical industry and domestic production of herbal ingredients in place to guide Vietnam’s pharmaceutical industry development and local production by 2030 with a vision towards 2045.[1] This program outlines the country’s goal of establishing a domestic pharmaceutical industry elevated to WHO level 4 classification.[2] As a result, the program set out specific development goals until 2030 in which local production shall make up 80% of domestic usage and 70% of market value. It envisions the locally produced drugs to not only meet the local demand but also help enhance the export value and remarkably participate in the global supply chain.

This development program was based on the three principles/viewpoints as following:

1. Prioritizing domestic pharmaceutical production: Implement policies and incentives to promote the development of the pharmaceutical industry, particularly the domestic production of raw materials for medicines, in accordance with legal frameworks.
2. Attracting investment in pharmaceutical industry: Focus on attracting both domestic and foreign investment, particularly in the development of innovative, high-tech generic drugs, specialty treatments, vaccines, biosimilars, and other high-value pharmaceutical products. The state will also prioritize investment in scientific research and the production of new, high-quality medicines, including national-brand herbal medicines.
3. Leveraging domestic medicinal plant resources: Capitalize on the potential of local medicinal plants, especially rare, endemic, and economically valuable species, to support the growth of the pharmaceutical industry.

With the aims to ensure a sustainable pharmaceutical industry and ensure an effective drug supply chain system to address the domestic demand and international market participation, the GVN shall focus on various solution groups including: (1) Enhancing policy environment; (2) Investment and improvement of market competitiveness capabilities, (3) Science and Technology, human resources and training, (4) Medicine and herbal ingredient market monitoring (5) International cooperation and integration, and (6) Information and Communication.

The national program shall be the foundation for the governmental related agencies such as Ministry of Health, Ministry of Planning and Investment,… enterprises and other related entities in the pharmaceutical industry to have a clearer vision to mobilize their internal resources for planning the development plan, contributing to the overall targets of the national program and strategy.

As of May 2024, 282 drug manufacturers in Vietnam met Good Manufacturing Practice (GMP) standards, meaning that they are eligible and capable of manufacturing all dosage forms, e.g., tablets, capsules, and other forms. However, to date, Vietnam enterprises who produce ARVs have been relying on external sources from countries like India, China, Pakistan, and Bangladesh to procure the materials required to manufacture the drugs. Importantly, domestic produced ARVs have just addressed around 10% of treatment needs while the remaining relies on imported ARVs. While the demand for ARV is stable and increases across the year, the country is approaching 2030 with the goal of producing more drugs locally. Therefore, in line with targets for the broader pharmaceutical industry, the country requires a specific plan to promote local production of ARV drugs in Vietnam. 

Since 2020, LHSS Vietnam has supported the GVN to promote ARV market openness, including promoting additional ARV marketing authorizations and local production. The Activity has also supported the GVN in enhancing its capacity in ARV supply chain management to effectively monitor ARV drug procurement and management. With an aim of offering solutions to the GVN to ensure a sustainable supply of ARVs, LHSS Vietnam will engage consultant(s) to draft a national plan to promote the local production of ARV drugs. The draft plan will lay out steps and actions to promote the local production of ARVs and thus contribute to toward the targets for increased domestic pharmaceutical production from now on to 2024. 

1. Objective

The overall objective of this assignment is to develop a national plan to promote local production of ARV drugs in Vietnam, in alignment with existing national plans and strategies to strengthen the local pharmaceutical industry. Increasing ARV local production will contribute to achieving the goals of pharmaceutical local production development program and ensuring the sustainable supply of the ARVs for HIV treatment.

1. Tasks

To achieve the above objective, LHSS Vietnam will conduct the following technical assistance tasks: 

• Compile international and regional best practices of ARV local production to ensure effective, sustainable, and resilient domestic provision of ARVs.
• Conduct a review of the existing regulations, policies, and procedures of Vietnam’s pharmaceutical production which will influence local ARV production using domestic resources.
• Explore, analyze, and compare local production of ARVs with the importation of ARVs based on consultations with local pharmaceutical enterprises and suppliers and relevant stakeholders. 
• Consult policymakers and related stakeholders such as the Drug Administration of Vietnam and Vietnam pharmaceutical companies association (VNPCA) to identify necessary policy framework for local ARV drug production. 
• Based on the key findings from different reviews, develop a draft plan with recommendations, opportunities, and challenges for local ARV drug production in Vietnam. 

1. Deliverables and Timeline

The service provider will work closely with relevant stakeholders, including MOH-related organizations, to conduct relevant reviews and draft the plan with the following deliverables:

Activities

Deliverables

Due date

ProtocolProtocol (including methodology, timeline and LOE)

February 21

Desk reviewSlide deck on key findings

March 7

Collect information from pharmaceutical enterprises and suppliers.Slide deck summary of interview outcomes and findings from information collection. 

April 18

Interview key stakeholders involved in the local producation of ARVs.Draft development plan of ARV local productionA development plan of ARV local production drafted

May 16

1. Management of the Assignment 

All deliverables shall be reviewed by Supply Chain Specialist, Procurement, and approved by Technical Director at LHSS Vietnam. 

The work will be carried out in Ha Noi from February 2025 through May 2024 during an estimated 40 working days.

The consultant(s) shall submit deliverables together with supporting documents to LHSS as per the agreed consultancy plan. 

1. Requirements 

Qualification requirements 

• A master degree in public health, pharmacy, or relevant discipline, or a higher degree is preferable.
• Strong knowledge of the domestic pharmaceutical market in general and ARVs in particular in Vietnam.
• Understanding of GVN policies and regulations on local production and the pharmaceutical industry.
• Knowledge of the international pharmaceutical market.
• Demonstrated ability to work effectively with government agencies, including the MOH.
• Language requirement: Vietnamese. The ability to speak and write English would be an advantage.

Equipment

The consultant(s) will use their own computer and equipment as necessary to carry out the assignment.

Note: With respect to any reports, data, or information produced by the Consultant in the course of performing tasks under this work order, Abt Associates shall have unlimited rights to use, disclose, reproduce, prepare derivative works, distribute copies to the public, perform publicly and display publicly, in any manner and for any purpose, and to have or permit others to do so. The Consultant will fully disclose, deliver, and transfer to Abt Associates and the Consultant irrevocably assigns to Abt Associates its entire right, title, and interest in and to any and all ideas, methods, inventions, devices, and improvements, originating, conceived, acquired, or developed by the Consultant, either solely or jointly with others, in connections with this Consulting Agreement. The provisions of this paragraph shall survive expiration or termination of this Consulting Agreement.

[1] Decision 376/QD-TTg of the Prime Minister dated 17 March 2021 approving the program on developing pharmaceutical industry and domestic production of herbal ingredients to 2030, vision towards 2045

[2] Classification level 4: Produce raw materials and invent new drugs

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