Justification and Approval SAFEMed under Pandemic EPP COVID April 2021.pdf

JUSTIFICATION AND APPROVAL (J&A)

TO: Daniel Harter, Supervisory Contracting Officer

CC: Deborah Broderick, Agency Competition Advocate

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

DATE: April 7, 2021

RE: Contract No. AID-121-C-17-00004, Safe, Affordable, and Effective Medicines for Ukrainians (SAFEMed) activity

SUBJECT: Justification for Other than Full and Open Competition under the Expedited Procedures Package (EPP) for Responding to Outbreaks of Contagious Infectious Diseases

You are requested to approve this justification for use of other than full and open competition pursuant to the authorities under the EPP for Responding to Outbreaks of Contagious Infectious Diseases (the “Expedited Procedures Package”), approved on March 24, 2020. Your approval of this J&A constitutes the justification for other than full and open competition as required by Tab 1 (Determination and Findings (D&F) Authorization for the Use of Other than Full-and-Open Competition in the Award or Modification of Contracts) of the EPP.

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

This is a request to approve a contract modification to increase the total estimated cost (TEC) and provide a one-year time extension to Contract AID-121-C-17-00004, Safe, Affordable, and Effective Medicines for Ukrainians activity (SAFEMed), implemented by Management Science for Health (MSH). The proposed modification will increase the TEC by $8,000,000 from $19,434,000 to $27,434,000 and extend the period of performance from August 31, 2022, to August 31, 2023.

The additional ceiling and time extension will allow USAID to meet the original contract objectives, whose achievement has been delayed or postponed due to the COVID-19 pandemic, as well as respond to emergency needs related to the COVID-19 outbreak. This ceiling increase will significantly improve Ukraine's capacity to build effective procurement and supply chain systems for proper quantification, selection, procurement, storage, warehousing, and distribution of critically needed medical supplies and commodities, including vaccines and TB drugs.

If approved, this action will enable USAID to mitigate opportunities for corruption and increase the overall effectiveness of health care service delivery by improving the control of infectious diseases. Program expansion and extension will strengthen USAID’s collaboration and partnership with the GOU and other key stakeholders.

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

An $8,000,000 ceiling increase and time extension will allow USAID to advance anti-corruption goals, and to support key activities in the MOH’s pharmaceutical sector reforms in the context of COVID-19 epidemic. The sudden COVID-19 outbreak has affected health service delivery in many ways, making essential medicines and commodities - including personal protection equipment (PPE) - less accessible to providers and patients. The activities envisioned in this TEC increase and extension align with the SOW’s original objectives. Specifically, the $8,000,000 increase will allow for an expanded effort toward the achievement of these objectives.

Illustrative additional activities under the contract’s current objectives are outlined below:

Objective 1: Pharmaceutical sector governance strengthened

Additional effort under this objective will extend SAFEMed’s efforts to address policy and legislative barriers that hinder efficient, cost-effective, free-of-corruption health procurement management and administration in Ukraine, including efforts to respond to new stresses or needs brought on by the COVID-19 epidemic. Illustrative activities include, but are not limited to:

● Legal support to the MOH to address gaps in the cold chain for COVID vaccine distribution (1st stage of vaccination per MOH road map).

● A seconded technical advisor to the MOH to advise on supply chain planning and implementation for COVID-19 vaccination, including supporting the organization and coordination of initial Covax deliveries to the regions.

● Review current legislation, identify and address barriers and bottlenecks for COVID-19 vaccines procurement, ensuring price confidentiality and the use of managed entry agreements as instruments to reduce opportunities for corruption.

● COVID-19 supplies and commodities procurement support through strategic development and building the capacity of the Central Procurement Agency (CPA) to meet national needs and avoid supply interruptions.

● Technical assistance to the Health Technology Assessment (HTA) department at the State Expert Center (SEC) on the selection of health technologies, medicines, and other commodities to ensure an appropriate response to the COVID-19 pandemic and to support the restoration of essential services post-COVID.

● Support the GOU to optimize evidenced-based standard treatment guidelines for COVID-19 and set protocols for rational drug procurement and use.

● A situational analysis of pharmaceutical system preparedness for new health tools such as innovative TB treatments or COVID-19 vaccines. The analysis would be used to strengthen the pharmaceutical system, including TB medicines policy and market authorization; organization and structure to manage the program; distribution principles and plans; cold chain; access; and proper administration to population and safety monitoring.

● Analysis of the implications of ongoing health service reforms and decentralization on access to medicines and vaccines, and optimal delivery network models in the regions, including involvement of family doctors in dispensing/distribution.

Objective 2: Pharmaceutical sector financing optimized

Additional effort under this objective will extend SAFEMed’s work to guarantee the purchase of quality-assured essential medicines and to more efficiently use available resources in response to the COVID-19 pandemic. Illustrative additional activities include, but are not limited to:

● Strengthen the online national medicines management platform for forecasting, quantification, supply planning, and early warning system (EWS) for TB and other medicines.

● Support the MOH in reconfiguring the supply chain to fit the characteristics of upcoming COVID-19 vaccines and therapeutics, such as shelf-life, vaccine volume, cold-chain capacity, and distribution networks, in close collaboration with UNICEF.

● Provide technical assistance in developing and implementing the best feasible options in Ukraine for prioritization of new medicines, regimens, and diagnostics through the MOH HTA mechanism.

● Strengthen information management for procurement decision-making at the Center for Public Health (CPH) and CPA by improving the efficiency of national forecasting and quantification systems, and enhancing it to include TB medicines and other health commodities.

● Support the MOH and CPH in quantification and forecasting of COVID-related drugs and commodities.

● Develop optimal information solutions for data visualization, preparing analytical materials and dashboards for COVID-19 management.

Objective 3: Availability and appropriate use of essential medications increased

Additional effort under this objective will extend the implementation of innovative approaches to address supply chain management issues and to support challenges related to COVID-19 vaccines, TB, and other commodities distribution. Illustrative additional activities include, but are not limited to:

● Technical assistance to the MOH on the implementation of an Immunization Roadmap for COVID-19 vaccination coverage.

● Logistics support to the MOH.

● Improvements to the central and regional distribution of publicly procured medicinal products, including COVID-19 commodities and TB drugs by aligning distribution levels with current internationally recognized standards.

● Expansion of GOU private sector engagement (PSE) through identification and engagement of Ukrainian private logistics companies to support COVID-19 vaccine supply.

● Support for COVID-19 vaccines stock and consumption management, including tools to reduce expiration risks and utilization of unused stocks.

● Support systems for tracking COVID-19 supply chains to ensure rapid response and investigation of adverse reactions to the vaccine.

As a result of the augmented and expanded activities to strengthen national supply chain systems, including in the context of MOH COVID-19 immunization campaigns for 2021-2022, USAID expects that the SAFEMed activity will achieve the objectives originally expected under the subject award and will address additional challenges related to the COVID-19 pandemic and recovery.

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 the “Expedited Procedures Package for Responding to Outbreaks of Contagious Infectious Diseases” approved March 24, 2020. The D&F is attached to this file in Tab 1. The EPP can only be used for an Infectious Disease Outbreak, as defined in paragraph 2 of the D&F (Tab 1). The COVID-19 outbreak was declared a Public Health Emergency of International Concern by the World Health Organization (WHO) on January 30, 2020, and therefore the class D&F applies to COVID-19 emergency response activities.

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

With the sudden COVID-19 outbreak in March 2020, it has become evident that the GOU does not have sufficient resources and capacity to undertake immediate action to stop the spread of infection and protect healthcare workers. SAFEMed’s technical assistance to the CPA has been critical to Ukraine’s procurement and distribution of personal protection equipment, as well as for quantification of needs and demand collection from the regions during the pandemic.

SAFEMed has also expanded the use of MedData, an effective information-analytical system based at CPA and developed with USAID support. SAFEMed produced an instructional video on how to use the MedData tool to enter the current stock, and the expected supplies of medicines, medical devices, personal protective equipment, and medical equipment necessary to combat

COVID-19.

Building efficient logistics and supply chain systems are becoming a greater priority for the MOH in preparation for vaccine procurement and the country’s largest-ever vaccination campaign. In December 2020, the MOH Vaccine-Preventable Infections Task Force approved a Road Map to introduce SARS-CoV-2 caused COVID-19 vaccine and to carry out a large-scale immunization campaign in response to the COVID-19 pandemic, in 2021-2022. According to the COVID-19 Road Map, at least 50% of the population of Ukraine will receive a vaccine in 2021-2022, and its implementation requires coordinated efforts of national and international partners.

MSH has been a reliable partner with strong technical skills and expertise in the area of logistics, procurement and supply chain coordination, and medicines quantification. They are best positioned to provide this type of support to the MOH in response to COVID-19 for the following reasons:

(i) Complementarity with Existing Programming: MSH is the current implementer of the SAFEMed activity, and an increase in funding will allow MSH to continue vital support without interruption of activities that have already been initiated. For example, SAFEMed is already engaged in the implementation of the first stage of a COVID-19 vaccination campaign, in accordance with the MOH Road Map, including direct logistical support to receive initial COVID vaccines from the Covax facility.

(ii) Operations: MSH has an office in Kyiv that can accommodate the growing needs required for additional activities. MSH has built a strong team with sound technical and management expertise. MSH has excelled in bringing in worldwide experts in procurement, supply chain, and health technology assessment. This expertise has helped the activity to achieve a high standard of performance. The activity has also initiated a Young Professionals program and has enlarged the team to include talented young public health professionals, who provide day-to-day operational support to the technical staff, making the activity more efficient and sustainable. The contractor has established working contacts with a local legal organization that supports project operations across all key workstreams.

(iii) Technical Expertise: MSH has world-class technical expertise that can adjust to the changing political environment and immediately respond to health reform challenges in the context of COVID-induced stresses on the health system. MSH technical consultants demonstrate sound knowledge in procurement and supply chain and provide direct support to the MOH, the National Health Service of Ukraine (NHSU), and the Center for Public Health (CPH).

SAFEMed has actively helped establish the first independent national health procurement body (CPA), and the Health Technology Assessment (HTA) department at the State Expert Center.

Working closely, and building the capacity of these newly established government entities, the project team has gained unique experience in addressing health reform needs and a valuable understanding of barriers to the successful transition to the new standards. MSH, and its subcontractors, have solid and diverse expertise to respond to the GOU’s requests for technical assistance in implementing vaccination plans to mitigate the risks of COVID epidemic, and help to optimize and stabilize the supply of medicines, including TB drugs.

(iv) Relationships with Key Stakeholders: MSH has successfully collaborated with government institutions, such as the MOH, State Expert Center, and the CPH, as well as the private sector. The activity has built links and cooperation with pharmaceutical industry representatives, the European Business Association, the American Chamber of Commerce, and the World Bank. Civil society organizations and patient groups have partnered with the activity to advocate for reforms in medical procurement. SAFEMed took the lead in developing a Procurement Strategy for the MOH in collaboration with the Kyiv School of Economics.

Despite the fluid political environment and multiple staff changes at the MOH, the activity has established and maintained productive relationships with new teams and regularly updates the MOH on both progress, and key health reform messaging. These factors give MSH, the current SAFEMed implementer, an overall comparative advantage to continue this activity with increased funding. This approach exceeds the benefits of a competitive process encouraged by law and required by Agency policy, considering the unique needs of the Mission in the context of the COVID emergency. It is unlikely a new implementer would have equivalent or sufficient depth of understanding of procurement and supply chain issues and would face additional barriers to timely start-up, which would impact the GOU’s vaccination efforts. Building extensive linkages with GOU counterparts and the pharma industry would require considerable time and effort and could delay urgent country requests for the COVID response.

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 needed services described herein are within the original scope of the contract’s current objectives. This requirement to meet the GoU’s needs is based on MSH’s unique qualifications and proven work under the current contract to ensure rapid support during the ongoing COVID-19 outbreak.

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

The estimated budget is based on historical costs for similar services. The Contracting Officer has determined that awarding this TEC increase will cost substantially less and be of shorter duration than competitively procuring a new contract. The Contracting Officer, by signing this document, certifies that the estimated costs to the U.S. Government, as required by the independent government cost estimate, for the award under the subject contract, represent the best value to the Government and that such an acquisition is appropriate and reasonable. 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 that 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. MSH was competitively selected as the contractor through a full and open procurement in 2017. Since the purpose of the proposed TEC increase is to support the GOU’s COVID-19 response, it is not feasible to select another contractor that would be able to undertake these activities promptly given the needs for technical assistance, as well as the contractor’s established relationships.

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

Publication of a notice is not required per the determination at AIDAR §705.202(b) and no sources submitted a written expression of interest in this acquisition.

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 based on the GOU’s specific needs for continuity of support for access to safe and affordable medicines. Any subsequent or future need of support will be procured through full and open competition.

RECOMMENDATION

It is recommended that you approve this justification for use of other than full and open competition pursuant to the “Expedited Procedures Package for Responding to Outbreaks of Contagious Infectious Diseases,” approved on March 24, 2020. 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.

Ecl. Tab 1- EPP D&F for the Authorization of Less than Full and Open Competitive Procedures in the Modification or Award of Contracts.

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 D&F Authorization for the Use of Other than Full-and-Open Competition in the Award or Modification of Contracts under the Expedited Procedures Package for Responding to Outbreaks of Contagious Infectious Diseases” approved on March 24, 2020. (attached in Tab 1)

The Contracting Officer is the Approving Official based on the authority given under the EPP.

However, a separate Contracting Officer certification is not required per AIDAR 706.302-70(c)(1).

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, Date Contracting Officer Representative for SAFEMed

APPROVAL:

Daniel Harter, Date Regional Contracting Officer

CLEARANCE:

Randy Ali, Date

Resident Legal Officer