Justification and Approval EPP SAFEMed.pdf.pdf

JUSTIFICATION AND APPROVAL (J&A)

TO: Daniel Harter, Regional Supervisory Contracting Officer

CC: Deborah Broderick, Agency Competition Advocate

FROM: Alina Yurova, Senior Health Project Management Specialist, Office of Health

DATE: 06/09/2020

SUBJECT: Justification and Approval (J&A) for Other than Full and Open Competition for

Contract No. AID-121-C-17-00004, Safe, Affordable, and Effective Medicines for Ukrainians activity

We request approval of this justification for use of other than full and open competition pursuant to the authorities under the Expedited Procedures Package (EPP) for programs managed by USAID for the Prevention, Care, and Treatment of HIV/AIDS under the President’s Emergency Plan for AIDS Relief (PEPFAR), approved on December 31, 2019, with the extension of the authority through December 31, 2024. Your approval of this J&A constitutes the justification for other than full and open competition as required by Tab 1 (D&F for the Authorization of Less than Full and Open Competitive Procedures in the Modification or Award of Contracts) of the

EPP.

a) Nature and/or description of the action being approved.

This is a request to approve the use of other than full and open competition to increase the total estimated cost (TEC) of Contract No. AID-121-C-17-00004, ‘Safe, Affordable, and Effective Medicines for Ukrainians activity’ (SAFEMed) activity by $7,000,000 from $12,434,000 to $19,434,000. The contract is currently implemented by Management Sciences for Health (MSH) (“the contractor”).

The additional funding will allow USAID to augment and expand the existing efforts to achieve PEPFAR goals under the SAFEMed Statement of Work (SOW) to support the Government of Ukraine (GoU) in securing an uninterrupted supply of antiretroviral drugs (ARVs) through building transparent and cost-efficient procurement processes in the pharmaceutical sector at the national and sub-national levels. If approved, this action will contribute significantly to overall health reform effectiveness, it will scale up Ukraine’s response to the HIV/AIDS epidemic, and it will strengthen USAID’s collaboration and partnership with the GoU and other key stakeholders, including the private sector.

4, Igor Sikorsky Street, Kyiv, 04112, UKRAINE; Phone: +380 44 521 5000; Fax: +380 44 521 5155; http://ukraine.usaid.gov

b) A description of the supplies or services required to meet USAID’s needs (including the estimated value).

A $7,000,000 TEC increase will allow USAID to continue supporting key activities in the Ministry of Health’s (MOH’s) reforms to further align with the PEPFAR goals for uninterrupted supply of drugs and commodities. The activities envisioned in this TEC increase also align and fall within the SOW’s original objectives.Specifically, the $7,000,000 increase will allow the following supplemental activities under the contract’s current objectives:

Objective 1: Pharmaceutical sector governance strengthened

● Support HIV/AIDS procurement through strategic development and building the capacity of the Central Procurement Agency (CPA). Capitalizing on USAID’s prior investment, SAFEMed will continue providing technical assistance to the CPA. Established in October 2018, the CPA was tasked with managing state public procurements. With additional funding, the contractor will support the shift from launching the CPA to fully operationalizing the organization’s capacity to procure and manage essential drugs, including HIV and TB commodities, and deliver them to patients on time;

● Improve central distribution of publicly procured medicinal products, including ARVs and other HIV-related drugs and commodities. The contractor will work to align central level distribution with current best practices, remove legislative and normative bottlenecks, and identify opportunities to engage Ukrainian private logistics companies;

● Provide technical assistance to the Health Technology Assessment (HTA) agency on the selection of medicines and other commodities to ensure HIV/AIDS remains a priority disease for the GoU;

● Support the GoU’s implementation of a revised, consolidated Positive List of medicines to include the most effective and evidence-based HIV/AIDS drugs in the state guaranteed package;

● Support the GoU to optimize evidenced-based standard treatment guidelines for HIV/AIDS and set protocols for rational drug procurement and use.

Objective 2: Pharmaceutical sector financing optimized

● Technical assistance to expand access to HIV/AIDS medicines and pharmaceutical services through the use of existing financial resources;

● Technical and legal assistance to expand access to HIV/AIDS medicines through private sector pharmacies and institutions;

● Technical assistance to the MOH, CPA, Center for Public Health (CPH) and National Health Service of Ukraine (NHSU) to analyze and assess cost structures and legal barriers that may affect distribution of HIV/AIDS medicines;

● Support to expand the Affordable Medicines Program to include distribution/reimbursement of ARVs through public and private pharmacies with the use of e-prescriptions. Together with CPH, the contractor will explore opportunities for distribution of ARVs via pharmacies, participating in the state reimbursement program as a means to further expand access to HIV treatment. This approach will improve prescribing practices for ARVs and will eliminate the likelihood of stock-outs of ARVs;

4, Igor Sikorsky Street, Kyiv, 04112, UKRAINE; Phone: +380 44 521 5000; Fax: +380 44 521 5155; http://ukraine.usaid.gov

● Initiate and support a pilot to distribute ARVs in private pharmacies; and

● Continuously build the capacity of NHSU staff to expand, manage, and evaluate HIV programs and their participation in the reimbursement program.

Objective 3: Availability and appropriate use of essential medications increased

● Support the quantification and forecasting of HIV essential medicines for prevention, treatment, and care;

● Provide technical assistance to CPH and AIDS Centers’ staff to collect and consolidate demand for HIV treatment;

● Support the CPH and the MOH to improve prescribing practices for ARVs, including multi-month scripting and distribution (MMS/D), and eliminate the likelihood of stock outs of ARVs;

● Support the GoU to design and implement innovative approaches that utilize technological advances to address HIV supply chain management issues. Delayed and unpredictable deliveries of HIV supplies have been identified as an important barrier to effective supply chain management and a driver of provider practices, such as a reluctance to provide Monthly Months Dispensing (MS/D). SAFEMed will work with government partners to identify opportunities for efficiencies and improved data management;

● Improve logistics and distribution of ARVs and HIV-related drugs and commodities:

○ The contractor must fully understand the bottlenecks of the in-country distribution, identify and improve linkages between key functions of forecasting, procurement, coordination and distribution and will help establish effective and smooth operations between MOH, CPA, CPH;

○ The contractor must assist the GoU to remove legislative and normative bottlenecks that prevent effective private sector participation in the HIV/AIDS logistics and warehousing space, specifically, engagement of private logistics companies to deliver HIV commodities to the sites;

○ The contractor must engage private logistics and warehousing companies, and identify opportunities to effectively outsource key elements of the supply chain to improve on-time delivery of quality medicines;

○ The contractor must provide innovative solutions to last mile distribution for centrally procured ARVs, which may include delivering drugs through pharmacies, by mail, and other options;

● Support development of bioequivalence standards to use generics for public purchases at the central and regional levels. The contractor must work to establish legal and operational frameworks to assure that public purchases of HIV commodities (handled by CPA, international organizations, or sub-nationally/regionally by health care facilities via Prozorro) fully meet bioequivalence requirements for generics. This will build more public trust toward government procurements of medicines.

Through these augmented and expanded activities, USAID expects to achieve better access to quality and safe ARV, TB, and medication-assisted therapy (MAT) drugs for HIV and TB/HIV patients, optimization of treatment regimens and more trust towards affordable generic drugs.

4, Igor Sikorsky Street, Kyiv, 04112, UKRAINE; Phone: +380 44 521 5000; Fax: +380 44 521 5155; http://ukraine.usaid.gov

c) Identification of statutory authority permitting other than full and open competition.

AIDAR 706.302-70(b)(3) and 40 U.S.C. §113; See Action Memorandum entitled “Expedited Procedures Package (EPP) for Programs Managed by the U.S. Agency for International Development (USAID) for the Prevention, Care, and Treatment of HIV/AIDS under the President’s Emergency Plan for AIDS Relief (PEPFAR)” approved on December 31, 2019.

The PEPFAR EPP provides the authority for exceptions to full and open competition in the award or modification of contracts and assistance agreements under PEPFAR as well as a general source-and-nationality waiver for goods and services for PEPFAR-funded programs. The EPP includes three specific authorities:

● Tab 1: Determination and Findings (D&F) authorizing the use of other than full and open competition in PEPFAR contracts.

● Tab 2: A Blanket Determination for restricting eligibility of assistance instruments under the revised ADS 303.

● Tab 3: A Source-and-Nationality Waiver renewing Geographic Code 935 (which includes any source except those prohibited by U.S. law or regulation or otherwise determined to be ineligible for Federal funding) for the procurement of goods and services for activities and programs under PEPFAR.

Tab 1, the EPP D&F, is attached to this J&A.

d) A discussion of the proposed contractor’s unique qualifications or the nature of the acquisition that requires use of the authority cited.

Ukraine has the second-largest HIV epidemic in Eastern Europe and Central Asia with approximately 240,000 people living with HIV. Improving access to safe, quality and affordable ARVs, HIV diagnostics, and other HIV-related commodities is a top priority of the GoU and is essential to achieve and sustain epidemic control in Ukraine. However, poor management of the centrally controlled supply chain processes, lack of tools and professional expertise, compounded by endemic corruption, prevent the GoU from effective management of the HIV/AIDS commodities supply chain and hinder achievement of PEPFAR goals.

The contractor’s (MSH) technical assistance has significantly contributed to achieving the PEPFAR objectives. Introduction of modern health reforms policy mechanisms, such as the health technology assessment and establishment of the HTA department at the State Expert Center, has facilitated the process of identifying HIV/AIDS as a priority disease for Ukraine with the potential to focus more government resources to fight the epidemic. MSH’s establishment and capacity building of the CPA has created a transparent and effective instrument for ARV procurements, demonstrating substantial cost savings and value-add through end-to-end supply chain management.

SAFEMed initiated revision and setting of bioequivalence standards based on European best practices to make generic drugs more accessible to patients. In addition, a public private partnership (PPP) was piloted in Odessa to improve the ARV supply chain and facilitate scale-up

4, Igor Sikorsky Street, Kyiv, 04112, UKRAINE; Phone: +380 44 521 5000; Fax: +380 44 521 5155; http://ukraine.usaid.gov of multi-month scripting. The contractor has provided legal support to institutionalize evidence-based practices at the national level and build sustainability of the GoU initiatives.

MSH’s strategic vision and successful problem-solving efforts have resulted in quick and timely adoption of decrees and orders critically needed to reach PEPFAR goals.

The key to many of these successes is MSH’s technical expertise, strategic leadership and collaborative partnerships established with key government stakeholders. Specifically:

● MSH recruited a world-renowned expert in health technology assessment, to help the NHSU develop the methodology for pharmaceutical selection as part of the health benefits package for the second wave of Health Financing Reform. Additionally, an international sourcing and procurement expert with a pharmaceutical background was recruited to assist with the transition of the state procurements from international organizations to the newly formed CPA. The expert trained the CPA staff in pharmaceutical procurement management, sourcing, supplier relations and other areas -an expertise not readily available in Ukraine. Furthermore, a well-connected and knowledgeable team of local experts in pharmaceutical reform, supply chain, legal and government relations effectively augmented the international expertise.

● MSH has shown strong strategic leadership with an astute sense of timing to contribute to a broader vision of a sustained HIV/AIDS supply chain through actions that support USAID’s New Partnership Initiative (NPI), which seeks private sector engagement and underutilized partners. A dynamic leadership team is effectively leveraging political timing with international and in-country resources, always seeking opportunities to promote PEPFAR goals through successful public private partnerships, and collaborations with pharmaceutical, distribution and technology companies.

● MSH has created strong and effective relationships with key Ministry stakeholders that have been sustained throughout political changes. The team was able to help create the CPA that will now buy, manage, and distribute state procured ARVs. They have also started working with the CPH to improve ARV drug forecasting capacity. The team has embedded one of its senior technical advisors at the Deputy Minister of Health’s office.

These relationships take years to foster and change of players would be disruptive to the PEPFAR goals to ensure an uninterrupted supply of HIV/AIDS commodities.

Lastly, as the second wave of the Health Financing Reform is launched in 2020, many systemic changes are not yet foreseen by the GoU, or by health care providers. The GoU has specifically requested additional technical assistance in this regard. Thus, the need for continuity is especially relevant in this political climate as successful implementation of health reform is required to ensure an uninterrupted supply of HIV/AIDS commodities.

Overall, MSH has a comparative advantage in continuing to deepen the impacts of this PEPFAR activity’s achievements. The comparative advantage of accessing this expertise and building on collaborative partnership and the continuity of activities with increased funding exceeds the benefits of a competitive process that is encouraged and required by the Agency policy. A new implementer will likely not have the same breadth and depth of technical expertise, strategic

4, Igor Sikorsky Street, Kyiv, 04112, UKRAINE; Phone: +380 44 521 5000; Fax: +380 44 521 5155; http://ukraine.usaid.gov leadership and productive relationships with GoU counterparts. Further, given the launch of a second wave of reforms, as well as USAID objectives to capitalize on the momentum to deepen impacts, the time required for a new procurement and new implementing partner to get established would be highly disruptive during this critical time.

e) A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable.

No efforts have been made to ensure that offers were solicited from as many potential sources as practicable because the GoU has specifically requested that the services described herein be provided through the USAID SAFEMed activity. This requirement by the GoU is based on MSH’s unique qualifications and proven work under the current contract.

f) A determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer, by signing this document, certifies that the estimated costs to the U.S.

Government, represent the best value to the Government and that the proposed ceiling increase is appropriate and reasonable. In addition, upon approval of this justification, the Contracting Officer will request technical and cost proposals from the contractor for the additional work requested. The Contracting Officer will conduct a thorough cost analysis of the proposal, with the same level of rigor as used with a competitive procurement, to ensure that the actual cost to the U.S. Government is fair and reasonable.

g) A description of the market research conducted (see FAR Part 10) and the results or a statement of the reason(s) market research was not conducted.

No new market research was conducted due to the nature of the authority selected and due to the GoU’s request. The contractor implementing the activity was originally selected based on a full and open competitive procedure.

h) A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

Not applicable to this action per the authority used.

i) A statement of the actions, if any, USAID may take to remove or overcome any barriers to competition before any subsequent acquisition of the supplies or services required.

The proposed modification is a specific and unique case. As stated above, if approved, the modification to increase the TEC will scale-up the SAFEMed activity based on the GoU’s specific request.

4, Igor Sikorsky Street, Kyiv, 04112, UKRAINE; Phone: +380 44 521 5000; Fax: +380 44 521 5155; http://ukraine.usaid.gov

RECOMMENDATION

It is recommended that you approve this justification for use of other than full and open competition pursuant to the Action Memorandum “The PEPFAR HIV EPP”, approved on December 31, 2019, with the extension of the authority through December 31, 2024. Your approval of this J&A constitutes the justification for other than full and open competition as required by Tab 1 (D&F for the Authorization of Less than Full and Open Competitive Procedures in the Modification or Award of Contracts) of the EPP.

CERTIFICATION:

The requirement for technical certification at FAR 6.303-1(c) is fulfilled through:

a. The signature of the Technical Officer below certifying the specific supporting data for this J&A; and

b. The EPP entitled “The PEPFAR HIV EPP” approved on December 31, 2019, with the extension of the authority through December 31, 2024. (attached).

Technical Officer:

I hereby certify that the supporting data which form a basis for the justification are complete and accurate to the best of my knowledge and belief.

_____________Alina Yurova, COR for SAFEMed________ __________________________ Date

Date:

4, Igor Sikorsky Street, Kyiv, 04112, UKRAINE; Phone: +380 44 521 5000; Fax: +380 44 521 5155; http://ukraine.usaid.gov

Alina Yurova Digitally signed by Alina Yurova Date: 2020.06.09 13:57:51 +03'00'

Technical Officer, Office of Health

APPROVAL:

Daniel E. Harter, Regional Contracting Officer

Attachment 1: Tab 1 of HIV/AIDS EPP

CLEARANCES of Justification and Approval (J&A) for Other than Full and Open Competition under the Expedited Procedures Package (EPP) for the SafeMed ceiling increase.

Drafted: Alina Yurova, SAFEMed COR

CLEARANCES:

Jeri Dible, OH ________cleared with edits____________ Date _____05/21/2020__

Pamela Strong, PCS __cleared with edits_______________ Date __5/27/2020_____

David Rush, RLO ____cleared___________________ Date __5/28/2020____

Randy Ali, Acting DMD cleared with edits Date 6/2/2020

4, Igor Sikorsky Street, Kyiv, 04112, UKRAINE; Phone: +380 44 521 5000; Fax: +380 44 521 5155; http://ukraine.usaid.gov