72012124RFI00003 RESTORE RFI 5.30.24.pdf

Subject: Request for Information (RFI) No. 72012124RFI00003 Resilient Systems for Transparent, Reliable, and Effective Pharmaceutical Governance (RESTORE)

Date of Issuance: May 30, 2024

Issued by: USAID/Ukraine

Response by: June 14, 2024, at 15:00 (Kyiv Local Time)

Attachment: (A) RESTORE RFI Questions

(B) Additional Background

I. Purpose

USAID Ukraine is in the process of designing the new “Resilient Systems for Transparent, Reliable, and Effective Pharmaceutical Governance” (RESTORE) Activity for implementation in Ukraine. We seek comments on the questions listed in Attachment A to inform the design process. Responses to this RFI are not binding on the U.S. Government and do not obligate USAID to issue a solicitation, nor does it commit USAID to pay any cost incurred in the preparation and submission of comments.

II. Brief Description

The overall goal of this proposed five-year program is to strengthen and align the pharmaceutical system in Ukraine to European Union norms and standards, enhancing transparency and cost-efficiency for desired health outcomes. This activity would support the ongoing efforts of the Government of Ukraine (GoU) and its civil society partners to transform its healthcare system to effectively meet the needs of its citizens. Specifically, it would provide technical assistance in support of the GoU, civil society, and the private sector to improve the public procurement, distribution, and availability of quality-assured medicines and health commodities. In addition, the activity would contribute to the creation of sustainable health pharmaceutical financing, strengthen both rational pharmaceutical management and the pharmaceutical supply chain, and support health system recovery and reform following Russia's full-scale invasion of Ukraine.

Building on the achievements of the USAID-funded Safe, Affordable, and Effective Medicines for Ukrainians (SAFEMed) activity, this activity would offer state of the art technical solutions to further transparent pharmaceutical financing and procurement systems, as well as to optimize

72012124RFI00003

USAID/Ukraine RESTORE RFI supply chain management practices. Implemented solutions would support decentralization and integration of health services across national and sub-national levels and secure a stable supply of medicines and medical devices, to include: commodities for the detection, treatment, and prevention of HIV, TB, Hepatitis, Syphilis, COVID-19 and other emergent threats; as well as other quality-assured essential medicines.

The activity’s draft objectives are as follows:

Objective 1: Pharmaceutical sector resilience strengthened.

Objective 2: Pharmaceutical sector governance increasingly transparent and aligned with the European Union.

Objective 3: Medicine systems increasingly patient-centered

III. Requested Information

USAID/Ukraine invites the public to submit constructive feedback and comments in response to any or all of the eight (8) questions presented in Attachment A. This includes, and is not limited to, comments on the feasibility of proposed objectives under identified critical technical areas and the identification of any potential gaps. USAID plans to take submitted RFI responses into consideration in the final activity design.

IV. Submission Instructions

Comments and responses must be submitted to USAID via email to KyivRCOHealth@usaid.gov by the date and time listed above. The subject line must read “72012124RFI00003 RESTORE Activity.” Only electronic submissions will be accepted. Responses must be written in English.

Non-compliant responses will not be reviewed. Only one submission will be accepted per organization.

All submissions should include a cover page that includes the following information:

● Organization name and address

● Organization point of contact name, SAM.gov Unique Entity ID (if applicable), telephone number, and email address

● Organization type, i.e. commercial, public sector, educational institution, NGO, etc.

● If applicable, socioeconomic status, e.g., other than small business, small business, woman-owned, veteran-owned, etc.

mailto:KyivRCOHealth@usaid.gov

● Primary field(s) of expertise/work

● Geographic presence, e.g., countries in which your organization is currently working, also noting the countries in which your organization is legally and formally registered

● North American Industry Classification System (NAICS) code, if applicable

An organization’s total response, including the cover page, should not exceed five (5) pages in length.

This RFI is issued solely for planning purposes and is published in accordance with FAR Part 10 and FAR 15.201(e). This RFI is open for comments from any interested U.S. or Non-U.S.

organization. Responding to this RFI will not give any advantage to any organization in any subsequent procurement. Likewise, organizations that choose not to respond will not be precluded from submitting a proposal in response to a subsequent solicitation, if one is ultimately issued. Any information submitted in response to this notice is voluntary. This is not a solicitation or a call for proposals. Please do not submit proposals, resumes or promotional materials, as they will be discarded. Proprietary or otherwise sensitive information must not be sent. USAID may use any information provided without incurring any obligation.

USAID reserves the right to, or not to, incorporate any, some, or none of the comments received from this RFI into any subsequent solicitations or design documents. This RFI does not restrict the U.S. Government's acquisition approach on a future solicitation, and USAID reserves the right to modify the scope, scale or other details of any planned activities.

Similarly, USAID is not obligated to modify its planned approach or otherwise incorporate the input that organizations offer.

Respondents will only receive an electronic confirmation acknowledging receipt of their response and will not receive individualized feedback on any suggestions. Questions regarding this announcement will not be answered.

We know that responding to our RFI requires time and effort on your part. We appreciate your assistance and interest in USAID/Ukraine programming!

Sincerely, Jessica R. Faber Contracting Officer USAID/Ukraine

Attachment A - Questions

USAID is interested in the following topics and specific questions related to the above background:

1. The establishment of the State Control Agency (SCA) aims to enhance and align Ukraine’s pharmaceutical regulatory standards with European Union benchmarks and best practices.

a. How can USAID best facilitate the continuous collection and incorporation of feedback from private sector pharmaceutical providers and other industry stakeholders into the development of this agency, as well as throughout the transition period?

b. How can USAID ensure that the new agency is fully aligned with the EU standards and practices?

2. As specific authorities are transferred from the State Expert Center (SEC) and State Service of Ukraine on Medicines and Drugs Control (SMDC) to the SCA, what are the main challenges in the relevant information technology systems relating to their functioning, interoperability, and/or improvement?

3. What specific steps or actions would you recommend to ensure that the decision-making processes behind Health Technology Assessments are used to inform inclusion of products in the National Essential Medicines List and the selection of products for central procurements?

a. Specifically, how can USAID better assist the GoU to ensure that these processes are clearly connected?

b. How can USAID ensure that these connections are transparent and based on data and scientific evidence?

4. How can USAID better support private sector participation and contributions to the country's healthcare reform goals and secure availability of quality-assured medicines and medical devices (in terms of innovations, investments, efficiencies, etc.)?

5. Understanding the decentralized ownership of and responsibility for HCFs (healthcare facilities) of the local government (municipalities, districts, communities) in Ukraine, what do you view as the main opportunities to improve pharmaceutical management at the regional and sub-regional levels?

6. Within the public health supply chain:

a. What are the key barriers to achieving financially sustainable regional logistics of medicines and medical products from regional to sub-regional facilities (note any unique challenges for essential medicines, vaccines, and humanitarian aid)?

b. What are the biggest opportunities and potential solutions?

7. How can USAID effectively support local pharmaceutical manufacturers in Ukraine to overcome regulatory challenges and enhance the production of essential medicines?

8. Are there any other challenges and opportunities you would like to draw to USAID’s attention to for public-private partnerships that strengthen the pharmaceutical system and ensure secure supply of medicines for Ukrainians?

Attachment B - Additional Background

Ukraine’s healthcare system faces significant challenges in meeting the needs of its population, challenges that have intensified since the onset of Russia’s brutal full-scale invasion of Ukraine.

Despite Ukraine gaining its independence in 1991, its healthcare system still reflects aspects of the Soviet model. This includes highly centralized and vertically organized governance structures, an over-reliance on expensive hospital-based curative care, outdated medical standards and practices, and insufficient outpatient primary health care and community-based care.

Ukraine aspires to align with European norms and standards and the current system sometimes leads to inefficiencies and suboptimal patient outcomes. Since the start of the full-scale invasion, the need for resources has increased while the state's economic capacity has significantly decreased. Despite notable progress and reform efforts, the health sector continues to face challenges, including issues related to pharmaceutical procurements.

However, Ukraine remains committed to combating corruption and supporting pharmaceutical system reform, reflecting its dedication to improving the health and well-being of its people.

The 2015-2025 Ukraine Health Reform Strategy calls for systemic health reform based on a European model which endorses the establishment of social health insurance, case-based provider payment systems, competitive and transparent procurement processes, empowered medical self-government, autonomously managed health facilities, and expanded and strengthened primary healthcare. These bold reforms would create a system that is outcome-oriented, meeting the country’s health care needs through improved primary care and efficient and sustainable financing.

The GOU has pursued health sector reform efforts since the 2014 Revolution of Dignity, and has made impressive progress by focusing on:

• Systematic review and revision of existing legal and policy parameters;

• More efficient and results-driven system of financing;

• More transparent procurement practices;

• Decentralized and integrated service delivery systems supported by strong supply chains; and

• Innovative solutions that support harmonization and standardization of service delivery and continuity of care.

Ukraine’s progress in health reforms includes the establishment of a central procurement agency, Medical Procurement of Ukraine (MPU), that saved the GoU more than USD $165 million (approximately 5.39 billion UAH) through the use of transparent procurement systems and a steadfast commitment to anti-corruption. The legal and functional establishment of Health Technology Assessment as a standard, transparent priority-setting process for the use of state funds for medicines and medical technologies is also a major success in health reforms.

Finally, the establishment and implementation of the Affordable Medicines Program (AMP) serves as a means for Ukrainians to access free or low-cost medicines in public and private pharmacies, leading to greatly expanded access. The AMP now supports almost 5 million Ukrainians, leading to an average reduction of 85% on co-payments for medicines to treat chronic conditions.

Building on the achievements of the USAID-funded SAFEMed activity, this activity would support the ongoing efforts of the GoU and its civil society partners to transform the healthcare system to effectively meet the needs of its citizens. Specifically, it would provide technical assistance in support of GoU, civil society, and the private sector to improve the public procurement, distribution, and availability of quality-assured medicines and health commodities by supporting state of the art technical solutions for transparent pharmaceutical financing, procurement, and supply chain management practices.