RFP_SOL-121-17-000005_SAFEMed.pdf

Request for Proposals (RFP) No.: SOL-121-17-000005 Issue Date: February 2, 2017 Questions Due: February 10, 2017 at 17:00 Hours Local Kyiv time Closing Date: March 6, 2017 at 17:00 Hours Local Kyiv time

SUBJET: Request for Proposal (RFP) No. SOL-121-17-000005

REFERENCE: Safe, Affordable, and Effective Medicines for Ukrainians (SAFEMed) Activity

Dear Sir/Madam:

The United States Government, represented by the U.S. Agency for International Development (USAID), Regional Mission for Ukraine, Belarus and Moldova, contemplates award of a five year Cost-Plus-Fixed-Fee (CPFF) Completion contract to implement the “Safe, Affordable, and Effective Medicines for Ukrainians (SAFEMed)” Activity. The estimated price range of the contract is $12-$15 million, subject to the availability of funds.

This procurement will be conducted under full and open competition procedures, pursuant to Part 15 of the Federal Acquisition Regulation (Far) (48 CFR Chapter 1). USAID encourages your organization to indicate its interest in this solicitation by submitting a proposal in accordance with the instructions in Section L - Instructions to Offerors. USAID will evaluate the responsive proposal in accordance with the evaluation factors provided in Section M – Evaluation Factors for Award.

USAID encourages the participation to the maximum extent possible of U.S small business (SB) in this activity as prime or subcontractors in accordance with Part 19 of the FAR.

Offerors are encouraged to read the entire solicitation. Special attention should be paid to Section L – Instructions to Offerors and Section M – Evaluation Criteria. Offerors must comply with FAR Clause 52.204- 7, System for Award Management and adhere to the requirements set forth in Section K- Representation, Certifications, and Other Statements of Offerors.

Any amendments to this solicitation will be made available through the Government homepage at http://www.fbo.gov. It is the offeror’s responsibility to check this site periodically for official updates and amendments of the solicitation.

Only electronic responses are required (See Section L). Please submit your proposals to the email addresses below by 17:00 Hours Local Kyiv Time, March 6, 2017. Receipt time is when the proposal is received by AID/Washington internet server. The addresses for the receipt of proposals are:

llomonosova@usaid.gov and rroe@usaid.gov. Hand delivered proposals (including commercial courier) and facsimile transmission will not be accepted.

The Technical Proposal has a strict sixty (60) page limit including annexes. Offerors are advised that any pages exceeding this limit will not be evaluated. Offerors are reminded that evaluators have to be able to read the proposals, so presentation and legibility are crucial. The Statement of Work (SOW) is provided in Section C.

This RFP does not obligate the United States Government to pay any cost incurred in preparing and submitting your proposal. In addition, the Government reserves the right to reject any and all offerors, if such action is http://www.fbo.gov/ mailto:llomonosova@usaid.gov mailto:rroe@usaid.gov considered to be in the best interest of the Government. Furthermore, the Government reserves the right to make an award without discussions.

Thank you for your interest in USAID programs.

Sincerely, /S/

Eduardo Elia Supervisory Contracting Officer

Regional Contract Office U.S. Agency for International Development Ukraine, Moldova, Belarus and Cyprus

1. THIS CONTRACT IS A RATED ORDER RATING PAGE OF PAGES

UNDER DPAS (15 CFR 700)

2. CONTRACT NUMBER 3. SOLICITATION NUMBER 4. TYPE OF SOLICITATION 5. DATE ISSUED 6. REQUISITION/PURCHASE NUMBER

SEALED BID (IFB)

NEGOTIATED (RFP)

7. ISSUED BY CODE 8. ADDRESS OFFER TO (If other than Item 7)

NOTE: In sealed bid solicitations "offer" and "Offeror" mean "bid" and "bidder".

9. Sealed offers in original and _____________________________ copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if hand carried, in the depository located in until local time _______________________ (Hour) (Date)

CAUTION - LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All Offers are subject to all terms and conditions contained in this solicitation.

A. NAME B. TELEPHONE (NO COLLECT CALLS) C. E-MAIL ADDRESS

AREA CODE NUMBER EXT.

(X) SEC. DESCRIPTION PAGE(S) (X) SEC. DESCRIPTION PAGE(S)

PART I - THE SCHEDULE PART II - CONTRACT CLAUSES

A SOLICITATION/CONTRACT FORM I CONTRACT CLAUSES

B SUPPLIES OR SERVICES AND PRICES/COSTS PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

C DESCRIPTION/SPECS./WORK STATEMENT J LIST OF ATTACHMENTS

D PACKAGING AND MARKING PART IV - REPRESENTATIONS AND INSTRUCTIONS

E INSPECTION AND ACCEPTANCE

F DELIVERIES OR PERFORMANCE

G CONTRACT ADMINISTRATION DATA L INSTR., CONDS., AND NOTICES TO OFFERORS

H SPECIAL CONTRACT REQUIREMENTS M EVALUATION FACOTRRS FOR AWARD

K REPRESENTATIONS, CERTIFICATIONS AND OTHER

STATEMENTS OF OFFERORS

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted within _180_ calendar days (60 calendar days unless a different period is inserted by the Offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT 10 CALENDAR DAYS (%) 20 CALENDAR DAYS (%) 30 CALENDAR DAYS (%) CALENDAR DAYS (%) (See Section I, Clause No. 52-232-8)

14. ACKNOWLEDGEMENT OF AMENDMENTS AMENDMENT NO. DATE AMENDMENT NO. DATE

(The offeror acknowledges receipt of amendments to the SOLICITATION for offerors and related documents numbered and dated:

CODE FACILITY 16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER 15A. NAME AND

ADDRESS OF

OFFEROR

(Type or print)

15B. TELEPHONE NUMBER 17. SIGNATURE 18. OFFER DATE

AREA CODE NUMBER EXT. 15C. CHECK IF REMITTANCE ADDRESS IS DIFFERENT FROM

ABOVE - ENTER SUCH ADDRESS IN SCHEDULE

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT 21. ACCOUNTING AND APPROPRIATION

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION: 23. SUBMIT INVOICES TO ADDRESS SHOWN IN ITEM (4 copies unless otherwise specified)

10 U.S.C. 2304(a) ( ) 41 U.S.C. 253(c) ( )

24. ADMINISTERED BY (If other than Item 7) 25. PAYMENT WILL BE MADE BY CODE CODE

26. NAME OF CONTRACTING OFFICER (Type or print)

Eduardo Elia

27. UNITED STATES OF AMERICA 28. AWARD DATE

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

(Signature of Contracting Officer)

(REV. 9-97)

10. FOR INFORMATION CALL:

11. TABLE OF CONTENTS

STANDARD FORM 33

SOLICITATION, OFFER AND AWARD N/A

SOLICITATION

OFFER (Must be fully completed by Offeror)

AWARD (To be completed by Government)

SOL-121-17-000005

X

02/02/2017 REQ-121-17-000007

USAID/Ukraine/Regional Contract Office Department of State 5850 Kyiv Pl.

Washington D.C. 20521-5850

17:00 (Kyiv LT) 03/06/2017

Ms. Larisa Lomonosova Acquisition Specialist llomonosova@usaid.gov

See Attached Table of Contents

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X 4-6

X 7-17

X 18-19

X 20

X 21-34

X 35-38

X 39-67

X 68-84

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USAID/Ukraine/Regional Contract Office

USAID/Ukraine/Office of Financial Management

Request for Proposal SOL-121-17-000005 Safe, Affordable, and Effective Medicines for Ukrainians (SAFEMed)

PART I - THE SCHEDULE

SECTION B - SUPPLIES OR SERVICES AND PRICE/COSTS

B.1 PURPOSE

The purpose of this contract is to strengthen the pharmaceutical system in Ukraine through the activity entitled “Safe, Affordable, and Effective Medicines for Ukrainians (SAFEMed)” as described in detail in Section C. STATEMENT OF WORK.

B.2 CONTRACT TYPE

This is a Cost-Plus-Fixed-Fee (CPFF) Completion Contract. For the consideration set forth in the contract, the Contractor must provide the results, deliverables and results described in Section C and Section F (to be incorporated at contract award). The Contractor must also comply with all other contract requirements.

B.3 ESTIMATED COST, CEILING PRICE, FIXED FEE, AND OBLIGATED AMOUNT

(a) The estimated cost for the performance of the work required hereunder, exclusive of fixed fee, if any, is __________ [ TBD ]. The fixed fee, if any, is _________ [ TBD ]. The estimated cost plus fixed fee, if any, is ___________ [ TBD ].

(b) Within the estimated cost plus fixed fee (if any) specified in paragraph (a) above, the amount currently obligated and available for reimbursement of allowable costs incurred by the Contractor (and payment of fee, if any) for performance hereunder is _________ [ TBD ]. The Contractor shall not exceed the aforesaid obligated amount.

(c) Funds obligated hereunder are anticipated to be sufficient through _________ [ TBD ].

B.4 PRICE SCHEDULE

(a) Cost Category Amount Total Estimated Cost TBD Fixed Fee TBD

Total Estimated Cost Plus Fixed-Fee TBD

(b) The inclusion of any costs in the above cost categories does not obviate the requirement for prior approval by the Contracting Officer of cost items designated as requiring prior approval by any of the terms and conditions of this contract, including the applicable cost principles (see FAR § 52.216-07, “Allowable Cost and Payment”); nor does it constitute a determination of allowability by the Contracting Officer of any item of cost, unless specifically stated elsewhere in this contract.

Also, these amounts may not be adjusted without a written modification signed by the Contracting Officer. The Contractor will not bill any amounts against this contract in excess of the amounts specified for each line item.

(c) The Contractor agrees to furnish data that the Contracting Officer may request on costs expended or accrued under this contract in support of the budget information provided herein.

B.5 INDIRECT COSTS

(a) Pending establishment of revised provisional or final indirect costs, USAID will reimburse allowable indirect costs on the basis of the following negotiated provisional or predetermined rates and the appropriate bases pursuant to the Contractor’s current executed Negotiated Indirect Cost Rate Agreement:

Description Rate Base Type Period

% 1/ 1/ 1/

1/Base of Application:

Type of Rate:

Period:

(b) The Contractor will make no change in its established method of classifying or allocating indirect costs without the prior written approval of the Contracting Officer.

B.6 CEILING ON INDIRECT COSTS (if applicable) [determination to include this clause in the contract will be made at the time of award in accordance with FAR 42.707(b)(1) ]

(a) Reimbursement for indirect costs shall be at the lower of the negotiated final (or predetermined) or the following ceiling rates:

Description Rate Base Type Period

% 1/ 1/ 1/

1/Base of Application:

Type of Rate:

Period:

(b) The Government will not be obligated to pay any additional amount should the final indirect cost rates exceed the negotiated ceiling rates. If the final indirect cost rates are less than the negotiated ceiling rates, the negotiated rates will be reduced to conform to the lower rates.

(c) This understanding will not change any monetary ceiling, obligation, or specific cost allowance or disallowance. Any changes in classifying or allocating indirect costs require the prior written approval of the Contracting Officer.

B.7 COST REIMBURSABLE

The U.S. dollar costs allowable will be limited to reasonable, allocable, and necessary costs determined in accordance with FAR § 52.216-7, “Allowable Cost and Payment,” FAR § 52.216-8, “Fixed Fee,” FAR § 52.232-20, “Limitation of Cost,” and FAR § 52-232-22, “Limitation of Funds,” if applicable, and AIDAR 752.7003, “Documentation for Payment.”

B.8 PAYMENT OF FIXED FEE

USAID will pay a proportion of the contractor’s fixed fee each month pursuant to FAR § 52.216-8, “Fixed Fee,” upon the receipt of an invoice deemed proper by the Office Financial Management (OFM) located in USAID/Ukraine.

B.9. MULTI-YEAR CONTRACT AND CANCELLATION CEILING

This contract is considered non-severable, and is therefore a multi-year contract as defined in FAR 17.103.

Therefore, this contract is subject to the requirements of FAR 17.106.

Performance under this contract during the second and subsequent program years is contingent upon the appropriation of funds. All program years except the first are subject to cancellation. Cancellation shall occur by the dates specified below if the Contracting Officer:

1. Notifies the Contractor that funds are not available for contract performance for any subsequent program year; or

2. Fails to notify the Contractor that funds are available for performance of the succeeding program year.

Cancellation Ceiling:

This is a CPFF type contract where the Contractor is authorized to be reimbursed for all costs which are allowable in accordance with FAR 52.216-7, “Allowable Costs and Payment.” Therefore, the Contractor will not incur any costs which would have been amortized over the life of the contract should the contract be cancelled in accordance with FAR 52.217-2.

The Government's liability for cancellation charges shall not exceed $0. This amount will be reduced in accordance with FAR 17.106-1(c)(1) at the conclusion of each program year, as follows:

Program Year Cancellation Date Cancellation Ceiling Year 1: 2017/2018 N/A N/A Year 2: 2018/2019 March 31, 2018 $0.00 Year 3: 2019/2020 March 31, 2019 $0.00 Year 4: 2020/2021 March 31, 2020 $0.00 Year 5: 2021/2022 March 31, 2021 $0.00

[END OF SECTION B]

SECTION C - DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

SAFE, AFFORDABLE, AND EFFECTIVE MEDICINES FOR UKRAINIANS (SAFEMED)

ACTIVITY

I. SUMMARY

Title: Safe, Affordable, and Effective Medicines for Ukrainians (SAFEMed) Activity

Purpose: The purpose of the Safe, Affordable, and Effective Medicines for Ukrainians (SAFEMed) activity is to strengthen the pharmaceutical system in Ukraine to ensure transparency and cost-efficiency for desired health outcomes. This contract will 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, the contract will provide technical assistance in support of USAID/Ukraine, other USG agencies in Ukraine, the Government of Ukraine (GoU), civil society, and the private sector to improve public procurement of medicines and health commodities. In addition, the contract will contribute to the creation of sustainable health pharmaceutical financing, and strengthen rational pharmaceutical management and the pharmaceutical supply chain. This contract will build on the achievements of the USAID-funded Systems for Improving Access to Pharmaceuticals and Services (SIAPS) Ukraine program and offer state of the art technical solutions to currently inefficient and corrupt pharmaceutical financing and procurement systems, and inefficient supply chain management practices. The solutions will support decentralization and integration of health services across national and sub-national levels and sectors, and secure a stable supply of essential HIV, MAT, TB, HCV drugs and commodities at best prices.

Objectives: Objective 1: Pharmaceutical sector governance strengthened

Objective 2: Pharmaceutical sector financing optimized Objective 3: Availability and appropriate use of essential medications increased

II. BACKGROUND

Ukraine’s health care system struggles to meet the needs of its population. Despite becoming an independent state in 1991, the system retains key features of the Soviet Semashko system: highly centralized and vertically organized; over-reliance on expensive hospital-based curative care, with outdated medical standards and practices; and weak outpatient primary health care and community-based care. The current input-oriented, rather than results-oriented system is expensive and inequitable. There are no incentives to provide or track quality of care, leading to inefficiencies and poor patient outcomes. The system cannot operate effectively since the massive resources required to keep it functioning as it is currently organized far exceed the economic capacity of the state. Additionally, the health sector is crippled by pervasive corruption, most notably in the area of pharmaceutical procurements.

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 Government of Ukraine has engaged in health sector reform efforts over the past three years. These efforts, while occurring simultaneously and not always in a coordinated way, share some common features:

• Need for systematic review and revision of existing legal and policy parameters;

• Need for more efficient and results-driven system of financing;

• Need for more transparent procurement practices;

• Need for decentralized and integrated service delivery systems supported by strong supply chain systems;

• Need for innovative solutions that support harmonization and standardization of service delivery and continuity of care.

Over the past year, progress has been made, including domestic resource mobilization efforts that resulted in increased budget levels for HIV/AIDS and TB programs. In addition, the Government has partnered with civil society organizations at every level of the system to provide more efficient and effective HIV services. The establishment of a mandatory paperless procurement platform for all public procurements – ProZorro – holds a promise of more transparent, less corrupt, and more affordable procurements. Still, much remains to be done.

Pharmaceutical Procurement

The strength of the pharmaceutical procurement system is a major determinant of commodity availability and total pharmaceutical costs. In most developing countries, pharmaceutical purchases represent the single largest health expenditure after personnel costs. An effective procurement process helps ensure the availability of the right medicines in the right quantities, at reasonable prices, and at recognized standards of quality.

In Ukraine, delays and unpredictable distribution schedules at the national level often result in stock-outs at all levels. Problems with availability are compounded by a lack of storage space and inaccurate quantification of pharmaceutical needs. Historically, outdated or contradictory government regulations have created barriers to and stalled implementation of improved pharmaceutical management practices. The lack of a common structure that bridges the various vertical reporting systems and national/sub-national levels, and non-harmonized pharmaceutical procurements make data collection and analysis difficult and greatly increase the cost of medicines.

Thus, the need for procurement reform is urgent. Recent legislation mandates that international agencies purchase health commodities for the Ministry of Health of Ukraine until March 2019, at which time Ukraine will have inaugurated an independent National Procurement Agency. Recommendations stemming from the National Supply Chain Assessment report: “this entity will require initial capitalization by either the government or donors, under the new entity, procurement should continue to be handled centrally, but with decentralized ordering and flexible delivery (it should be noted that the assessment only reviewed data from government and GLOBAL FUND procurements, and did not consider those from UNICEF, UNDP, or Crown Agents, who began some procurement on behalf of the government in late 2015). If stock is not stored in a central warehouse, then framework contracts established nationally should include contractual terms that enable entities at oblast level (and perhaps below) to order more frequently at fixed prices. This would go a long way to avoiding stock-outs, and would also reduce incentives for ordering in excess of requirements. The extremely high proportion of medicines being paid for out of pocket highlights the fact that current supplies address only a fraction of the total needs.” (S. Conesa, J. Folmsbee, O. Zhyhinas, T. Savchuk, “Ukraine National Supply Chain Assessment Results”). A primary focus of SAFEMed will to assist in ensuring this new procurement entity is prepared and empowered to function successfully.

As the health sector in Ukraine evolves and serious reforms take hold, there is a need to establish a system agile enough to adjust to changing reform environment processes. Further, in order to meet ambitious global 90-90-90 targets to end the AIDS epidemic by 2030, the SAFEMed activity would specifically contribute to the achievement of the second and third “90s”: 90 percent of people living with HIV receiving anti-retro viral treatment, and 90 percent of those on treatment adhering to the treatment and achieving undetectable viral load level by catalyzing and supporting the implementation of key reforms in pharmaceutical management to ensure access to HIV services, including effective and safe optimized regimens of ARVs, MAT medicines and laboratory commodities. The activity will contribute to the overall PEPFAR-Ukraine investment supporting health service improvements in the five highest HIV burden regions (Dnipro, Mykolayiv, Odesa, Kherson, and Kyiv City) and six medium-burden oblasts (Kyiv, Zaporizhzhya, Cherkasy, Poltava, Chernihiv, and Kirovohrad Oblasts) that contain approximately 78% of estimated PLHIV and approximately 90% of

HIV-positive PWID in non-conflict areas. Multi-drug resistant TB (MDR-TB) is a serious and increasing public health threat. The recent approval of new medicines for drug-resistant TB provides are a long-awaited opportunity to improve treatment outcomes. Introduction of this medicine will require technical assistance in a number of areas, such as registration, drug forecasting and pharmacovigilance.

III. ACTIVITY OBJECTIVES

At the end of this contract, the contractor must achieve three objectives:

Objective 1: Pharmaceutical sector governance strengthened Objective 2: Pharmaceutical sector financing optimized Objective 3: Availability and appropriate use of essential medications increased.

In order to achieve the objectives, the contractor must perform work under these three components. All of the contractor’s interventions in performance of this SOW must be approved by the Contracting Officer’s Representative (COR) via the Annual Implementation Plan (AIP). The AIP can be amended on an as needed basis with the approval of the COR.

The AIP must outline the implementation process and detail activity schedules, resource requirements, roles and responsibilities, monitoring, reporting and review procedures. Quarterly monitoring of milestones, which are identified in the AWP, must be conducted by the contractor with progress being reviewed monthly and reported quarterly to the COR.

Objective one: Pharmaceutical sector governance strengthened

Governance affects all aspects of pharmaceutical systems. The high value of medicines and health technologies and the absence of data visibility, make pharmaceutical systems particularly vulnerable to problems associated with weak governance. As part of strengthening governance in the pharmaceutical sector, it is important to ensure that the principles of good governance are embodied across all pharmaceutical systems components. This contract will provide technical assistance to address policy and legislative barriers that hinder establishment of efficient, cost-effective, free-of-corruption health procurement management and administration in Ukraine.

Ineffective governance necessitates the development and adoption of evidence-based pharmaceutical laws, policies, regulations, guidelines, and standard operating procedures (SOPs) to institutionalize procedures and structures and promote accountability and prevent dysfunction and fraud.

Support under this component includes, but is not limited to, the following:

• Support the Government of Ukraine in establishment of a National Medicines Policy framework that defines the priority diseases and patient groups that will be supported with public funds;

• Support the Government of Ukraine in implementation of a revised, consolidated Essential Medicines List (EML);

• Support the Government of Ukraine in updating evidenced-based standard treatment guidelines (STGs) to set protocols for rational drug procurement and use;

• Support the Government of Ukraine in development and implementation of standard operating procedures (SOPs) where needed;

• Support the Government of Ukraine in development and implementation of guidelines for rational drug procurement.

Strengthening pharmaceutical sector governance also includes efforts to increase transparency and accountability throughout the system. Transparent systems ensure that the actions of governments, management boards, and oversight committees are recorded and publicly available. Open tender systems and clear procurement practices also thwart opportunities for mismanagement and corruption.

SAFEMed interventions to improve transparency and accountability may include, but are not limited to:

• Provide technical assistance to the pharmacy and therapeutics committees at the national, local, or institutional level that advise on the selection of medicines;

• Advise procurement boards or agencies that develop contracts and manage the tender process;

• Support human resource departments that handle recruitment, promotions, transfer and training;

• Assist committees responsible for implementing codes of conduct, conflicts of interest, and whistleblowing mechanisms;

• Support the Government of Ukraine in establishing framework contracting on national and regional levels and ensure the frameworks align with PROZORRO (Ukraine’s already established paperless procurement platform).

Lastly, an engaged, empowered citizenry creates civic action and can result in political reform. It is therefore necessary to work with country stakeholders to ensure transparency, accountability, and participation are embedded throughout pharmaceutical systems, that policies and legislation reflect these principles and delineate roles, responsibilities, and measures for accountability, and there is an engaged and invested civil society providing oversight and demanding access to and appropriate use of safe, effective, quality, affordable essential medicines and medicines-related services. In Ukraine, civil society organizations already play a key advocacy role in access to pharmaceuticals; the contractor must continue to engage these groups to demand the best use of scarce health resources, improve trust in the healthcare system, ensure the proper use of quality-assured medicines, and promote good policy making.

Objective two: Pharmaceutical sector financing optimized

Prices can be a barrier to accessing pharmaceuticals and services where people must pay directly out-of-pocket for their medications and care. In recent years, there has been increased advocacy for all countries to review their medicines pricing policies and to widely share price information from both the public and private sectors (http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(08)61762-6.pdf). Governments need to understand and monitor the components of medicines prices, and policy options should be assessed against access criteria to assure that equity concerns are addressed and priority health needs are met.

Very often, countries fail to consider the medicines implications of the basic package of essential health services, including the cost of purchasing and reimbursing for medicines and funding needed to cover medicines-related functions, such as regulatory oversight and pre-service training of the pharmaceutical workforce (e.g., pharmacists and pharmacy technicians, doctors, nurses, regulatory affairs professionals, and supply chain professionals).

Product selection and procurement are major sources of health systems inefficiency and waste according to the WHO (http://apps.who.int/iris/bitstream/10665/44371/1/9789241564021_eng.pdf); addressing these is required to guarantee the purchase of needed and quality-assured essential medicines and to make more efficient use of available resources, while supporting procurement systems and procedures that promote transparency and accountability and reduce vulnerabilities to corruption. The Government of Ukraine is already pursuing a system for reimbursement of essential medicines that aims to increase medicines affordability, decrease out-of-pocket payments, promote the rational prescription and use of medicines, increase efficiency in the public use of the state budget for medicines, and reduce the risk of corruption.

Support under this component includes, but is not limited to, the following:

• Technical assistance to the Government of Ukraine to assess pricing policies that may affect affordability of medicines and reduce financial barriers. This could include developing price-volume agreements to ensure the best prices for medicines, especially for the optimized ARV regimen, TB drugs, and HIV and TB laboratory commodities, and other health technology;

• Technical assistance to expand access to essential medicines and pharmaceutical services through the cost-effective use of existing financial resources and resource mobilization, and advocacy for supporting the registration of critically needed therapeutics, such as the new agents for MDR-TB;

http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(08)61762-6.pdf)

• Support the development and implementation of the system for reimbursement of essential medicines in Ukraine.

Objective three: Availability and appropriate use of essential medicines increased

Activities carried out in support of this objective will address both supply chain issues to ensure the availability of quality essential medicines and the supporting services required to ensure that medicines are used appropriately, that patient safety is assured, and that desired health outcomes are achieved. Together, these are the objectives of a comprehensive and integrated pharmaceutical system. The supply chain areas of product selection, quantification, and procurement are recognized as major sources of health systems inefficiency and waste. Addressing these supply chain areas is required to guarantee the purchase of needed and quality-assured essential medicines and to make more efficient use of available resources, while supporting procurement systems and procedures that promote transparency and accountability and reduce vulnerabilities to corruption. In addition, a well-managed distribution system helps ensure the condition of medicines and medical products and minimizes loss due to spoilage, theft, or expiration. When it comes to distributing medicines, the primary goal is to maintain a steady supply of pharmaceuticals and supplies to facilities. Designing systems for distributing and storing medicines, supplies, and equipment is complex particularly during times of active healthcare reform, treatment and service scale-up, and decentralization.

Having medicines available does not guarantee they are used correctly and achieve the intended health benefit. Although the availability of essential medicines and other health products is a central part of any pharmaceutical system, ensuring the appropriate use of these medicines is required to have maximum health benefit. Essential medicines are one of the most cost-effective means of saving lives and improving health, yet these medicines are often managed and used inefficiently, effectively, and irrationally (http://apps.who.int/medicinedocs/pdf/s4882e/s4882e.pdf). Approximately 50% of all medicines are inappropriately prescribed, dispensed, or sold and only half of all patients take their medicines correctly (http://apps.who.int/medicinedocs/pdf/s6160e/s6160e.pdf).

Rational drug use involves appropriate diagnosis, prescribing, dispensing, and use of medicines. Breakdowns at any point in these activities can lead to improper or irrational drug use, with potentially serious health consequences for patient and significant financial consequences for patients, institutions, or countries. As such, interventions may target physicians, pharmacists, dispensers, nurses, individual patients, insurance mechanisms, the community, drug information centers, or educational institutions. For Ukraine, two major interventions to promote the rational use of drugs are the development and use of standard treatment guidelines (STGs), and Drug Utilization Reviews (DURs). STGs establish clear standards of drug treatment for basic disease conditions, based on consensus within a health facility or health system, and also serve as sustainable improvements in pharmaceutical governance. DUR programs are used to monitor the use of the most important (high volume, high cost, narrow therapeutic margin, and significant side effect drugs, or medicines use for vulnerable members of the population) medicines in a health system and identify areas for improvement.

• Support the quantification and forecasting of essential medicines for prevention, treatment, and care (including HIV, TB, MAT, and Hepatitis C);

• Provide technical assistance in forecasting and pharmacovigilance of new TB drugs

• Support the Government of Ukraine to design and implement innovative approaches that utilize technological advances to address supply chain management issues;

• Support the Government of Ukraine to implement Drug Utilization Review (DUR) as a continuous quality improvement mechanism to analyze drug use practices and utilize this information to improve service delivery and patient treatment outcomes. Specifically, DUR contributes to increasing HIV patient retention activities, providing a comprehensive tool for focused quality improvement in AIDS centers.

The lack of accurate, relevant, and timely data that government and public health officials must use to make informed decisions to support access to quality pharmaceutical products and services continues to be a http://apps.who.int/medicinedocs/pdf/s4882e/s4882e.pdf http://apps.who.int/medicinedocs/pdf/s6160e/s6160e.pdf limiting factor hampering the development of more effective and efficient health systems. Having reliable product and patient data readily available can make the difference between an inefficient system that experiences stock outs, costly emergency procurements, and poor service utilization and an efficient system that can anticipate its needs, identify corrective, system strengthening interventions, use its scarce resources wisely, and achieve desired health outcomes. Policy and programmatic decisions that are clearly linked to available information increases transparency, accountability, and the likelihood of public acceptance.

Attention is needed at the national, regional, and global level to ensure robust data on all aspects of pharmaceutical systems is available and used to improve pharmaceutical management and health outcomes.

Pharmaceutical management information systems (PMISs) allow for the integration of product-focused logistics management and patient-specific information systems. PMIS supports the delivery of quality pharmaceutical products and services and facilitates the achievement of optimal health outcomes. An effective PMIS also complements broader health information systems (HIS) and supports the monitoring and evaluation of health system performance. Technical assistance is necessary in the development of information management strategies that are appropriate and scalable, while helping to inform decisions about the best use of human and financial resources in support of effective and efficient supply chain operations and pharmaceutical care services.

Efforts to expand essential health services coverage will rely heavily on data availability and use. Identifying areas of wastage and inefficiencies using reliable data is imperative. This includes data on the availability and prices of medicines, cost-effectiveness of health technologies, medicines use, pharmaceutical expenditures, costs of supply chain operations, budgets and operations for medicines-related functions (e.g., medicines regulatory systems), the changing burden of disease, and government health priorities. This is especially true as Ukraine pushes to implement the Health Reform Strategy. Each component of the strategy (referenced above) relies on the availability and use of timely, reliable, robust data during the planning, design, and evaluation stages of interventions.

• Work with the Ministry of Health of Ukraine and partners to develop common platforms for collecting and sharing data on supply chain management, prescribing, dispensing, adherence and patient outcomes (e.g., eHealth, ePrescription).

• Support the Government of Ukraine in planning and implementing integrated pharmaceutical management information systems that incorporate both products and patients through approaches that account for the multifaceted array of political, organizational, legal, technical, cultural, and personnel issues that must be addressed. Information systems will also support scale-up of HIV/AIDS and related services (TB, MAT, HCV) by facilitating multi-month scripting among specialized HIV/AIDS and TB service providers to relieve bottle necks and ensure continuity of services across cascade, service providers and sectors.

• Technical assistance to the Government of Ukraine to implement Pharmacovigilance Automated Information System (PAIS) a web-based application to monitor the safety of medicines

• Ensure availability and use of reliable data on medicines use and service quality to inform pharmaceutical reimbursement schemes

IV. CAPACITY BUILDING ACROSS ALL PROGRAM OBJECTIVES:

Capacity building presents a problem throughout the pharmaceutical system. In addition to a critical lack of trained personnel to support the demand for health services, human resource capacity is constrained by the limited ability of educational and training institutions to prepare staff adequately. Capacity building efforts for both individuals and institutions will span all three objectives of this program. The traditional training’s approach to address human resource capacity needs in pharmaceutical management needs to be improved.

Additionally, pharmaceutical management workers have not traditionally been acknowledged as part of the health workforce. This means that the human resource needs of the pharmaceutical management sector are commonly overlooked. The focus across all three SAFEMed objectives should be implementing short-, medium- and long-term sustainable solutions to this multifaceted human resource challenge. Interventions will target public and private sector service delivery providers and provider networks, managers, training and educational institutions, health and pharmaceutical management organizations, and the Ministry of Health.

V. TRANSITION

Of great importance to USAID is the successful transition from the existing SIAPS activity to the SAFEMed contract. To ensure a continuous provision of technical assistance and guarantee a comprehensive knowledge transfer between the incumbent and new implementing partner(s), transition will require past awardees and new contracting parties to collaborate as directed by USAID/Ukraine.

Consultations will occur between the Awardee and the incumbent to identify transition planning priorities immediately upon award.

Transition activities may include, but are not limited to, the following:

• Handover of technical assistance activities;

• Handover of any and all supply plans, warehousing and distribution plans;

• Handover of MIS systems’ documentation and data within such systems.

VI. COLLABORATING, LEARNING, AND ADAPTING

USAID/Ukraine is committed to obtaining stakeholder input to our activities, coordinating all implementing partners’ efforts for greater efficiency and effectiveness, and measuring high-level indicators in an effort to apply the following Monitoring, Evaluation, and Learning objectives:

• Evaluate the level of collaboration with other USG and other donor-supported programs (e.g., implemented by the UN agencies in Ukraine) and improve synergies.

• Use lessons learned to strengthen management systems and activity implementation.

• Provide recommendations and improvement to adapt current activities and follow-on programs.

To facilitate coordination, USAID/Ukraine may convene semiannual meetings which may include sharing of summary annual work-plans, bi-annual summary reports, best practices, and challenges. The contractor is required to attend the above mentioned meetings unless directed otherwise by the COR.

Active outreach, knowledge sharing and dissemination efforts by previous USAID-supported programs have been key to achievements in the area of pharmaceutical management. The Contractor will continue this role by effectively serving as the main resource for key health commodity issues. It will have a knowledge management and communication strategy. The Contractor will generate and communicate technical knowledge and best practices. When appropriate, the Contractor will make its tools and resources available to existing information networks.

VII. PROGRAM MANAGEMENT

Management Plan

The Offeror must include a management plan in its proposal, describing the main roles of Key and non-Key Personnel as well as the organizational relationships among staff, sub-Contractors and consultants. Ukrainian staff, advisors, contractors and grantees should be provided prominent roles in the Program. The Management Plan should detail any particular efficiency or cost-saving measures the Offeror may wish to propose. Internal financial and management controls should also be discussed to assure USAID that the Offeror, its sub-Contractors will manage U.S. taxpayers’ money with accountability.

The Offeror should include a management plan in its proposals, describing the main roles of Key and non- Key Personnel as well as the organizational relationships among staff, sub-Contractors, grantees, and consultants (including a graphical Organizational Chart). Ukrainian staff, advisors, should be provided prominent roles in the activity and offered capacity building to assume greater responsibility and deliver higher-level results. The Management Plan should detail any particular efficiency or cost-savings the Offeror may wish to propose. Internal financial and management controls should also be discussed to assure USAID that the Offeror will manage U.S. taxpayers’ money with accountability.

Grants Under Contract

The Contractor is not authorized to award Grants Under Contract.

Rapid Response Capacity

In addition to the activities described above, the Contractor must have the capacity to respond rapidly to unanticipated opportunities and obstacles as they arise, within the scope of the Program Purpose and Objectives. The Contractor will outline its approach to keeping abreast of changes in the situation on the ground and how it will maintain the flexibility to accommodate changes. In such cases, interventions may be altered, with USAID guidance and approval, to seize new opportunities. Such reprogramming may not incur additional costs, unless specifically directed by USAID. Such rapid response capacity may include, but is not limited to: rapid assessments; deployment of short-term technical advisors; logistical support to USAID or another stakeholder; training; sub-grant or sub-contract awards; or procurement of in-kind equipment, material or services.

VIII. GENDER ANALYSIS

Strengthen the Pharmaceutical System in Ukraine:

USAID requires that all activities USAID supports fully address gender considerations, ensuring that both men and women benefit from USAID support and that gender awareness is a built-in component of project activities.

Women constituted 53.7% of Ukraine population in 2016. Ukraine has made a number of commitments under key international documents in the field of elimination of discrimination against women, and particularly relating to women in political life. These include, e.g. the Convention on the Elimination of All Forms of Discrimination against Women (CEDAW) and the UN Millennium Development Goals. According to the Global Gender Gap Report 2016, Ukraine ranks 69th out of 144 countries. Ukraine ranked 108th by the level of women representation in national legislatures in early 2016. (Number one is Rwanda.) Gender equality has been stated to be the GOU priority and multiple actions have been taken to show this commitment, such as robust legal framework to support gender equality, creation of national gender equality machinery, creation of a National Program on Gender Equality.

However, several challenges and obstacles remain, which contribute to and explain Ukraine's poor gender equality rankings, including: the non-prioritization of gender equality in national policy and administrative reforms; the non-integration of gender in national statistics, planning, budgeting, and monitoring and evaluation of State programs; overt sexism in mass media, advertising, and from public officials; and lack of donor coordination and commitment to mainstreaming gender into programs and development considerations.

Health indicators reveal a disadvantaged position of men in terms of life expectancy, morbidity and communicable diseases, injuries and life-style associated health problems. Prevalence of tuberculosis and HIV-infection remains high, while the large-scale internal displacements pose the new challenge of non-controlled epidemics due to unmet medical needs of displaced people. Despite of a decline in the child and maternal mortality rates, the issues of reproductive health require additional attention to be addressed.

Finally, the progressing population ageing poses multiple challenges for the fiscal and pension systems, as well as a need in the respective adjustments at the labour market, in the systems of healthcare and life-long education.

The USG PEPFAR Interagency Team carried out a Gender Analysis in 2015. The final report was published in March 2016. Recommendations from the report must be taken into account by Safe Med Project implementer.

Public procurements are not gender-neutral. Public procurement has a gender dimension and greatly affects the process of achieving gender equality. For this very reason, it is imperative that gender perspective be taken into account in the process of a procurement of medicines and health commodities from its initial planning stage until the conclusion of the contract. It is necessary to use gender-sensitive statistics and a gender-responsive program budget that will have direct consequences on the processes and conduct of the public procurement action. Public procurement contracts should always be awarded in observance of the principles of equality and non-discrimination, transparency, and competition.

Public procurement has a great potential to promote gender equality. Whenever possible, it is important to incorporate gender equality in the subject of the contract itself. This will allow the incorporation of gender equality clauses requiring gender technical competence to the awarding entities, as well as the inclusion of gender criteria for the evaluation of the submitted proposals and for further contract implementation. This would affect any contract and would ensure that public procurement becomes an instrument for gender equality.

Decisions on purchases, the means and methods by which they are conducted, final price, and supplier -- all have a gender dimension that result in consequences affecting men and women separately. Gender-sensitive and expedient public procurement corresponds to a gender-responsive budget.

Gender equality in processes of public procurement of medicines and health commodities in Ukraine’s health sector institutions has not been duly respected. If control and accountability is to be established in the public procurement system to a full extent, it is central to recognize the impact of public procurement on women and men and the effects they produce.

Safe Med Project does not envision a stand-alone gender component. However, gender equality and gender dynamics should be promoted at all project levels. The Project implementer must place considerable focus on the integration of gender considerations throughout the project portfolio, ensuring that men and women both benefit from Safe Med Project results and are treated without discrimination; gender awareness is a built-in component of all project activities; resources are fairly distributed, taking into account the different needs of women and men.

The project should strive for at least 30/70% women/men or men/women participation in all project activities (not less 30% and not more 70% of each sex) in all aspects.

An implementer must also:

• engage local Ukrainian expert(s) as advisors on integrating gender equality and female empowerment components in project implementation;

• ensure project staff accountability for developing performance indicators for measuring program success in contributing to gender equality in Ukraine;

• include performance indicators in the Project Monitoring, Evaluation and Learning (MEL) Plan that would acknowledge the impact of gender relations on project results as well as the impact of project activities on gender relations;

• disaggregate project performance indicators data by sex as appropriate and feasible;

• clearly indicate the areas or aspects of the project in which gender is relevant and specifically show in the Work and MEL Plan how gender issues will be…