safemed activity annual progress performance report

SAFEMed Activity

Annual Progress Performance Report

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

PY3 PROGRESS REPORT (1 October 2019 – 30 September 2020)

Award No: AID-121-C-17-00004

Prepared for USAID/Ukraine

C/O American Embassy

4 Igor Sikorsky St.,

Kyiv, Ukraine 04112

Prepared by

Management Sciences for Health

4301 Fairfax Dr, Suite 400,

Arlington, VA 22203, USA

Submitted on October 24, 2020

SAFEMed Annual Report: October 1, 2019 – September 31, 2020 ||1

Table of Contents

I. ACRONYMS AND ABBREVIATIONS 2

II. CONTEXT UPDATE 3

III. EXECUTIVE SUMMARY 3

IV. KEY NARRATIVE ACHIEVEMENT 7

1.0 Policy Priority Setting: HTA and Essential Medicines List (EML) 8

2.0 Advancing Public Procurement Instruments and Operations 13

3.0 Strengthening NHSU Pharmaceutical Policy 18

4.0 Optimizing PEPFAR Supply Chain Contributions 22

5.0 Bioequivalence 25

6.0 Strategic Communications 27

V. MONITORING, EVALUATION AND LEARNING 28

VI. LESSONS LEARNED 30

VII. ENVIRONMENTAL MONITORING 30

VIII. PROGRESS ON LINKS TO OTHER ACTIVITIES 30

IX. PROGRESS ON LINKS TO HOST GOVERNMENT 31

X. FINANCIAL INFORMATION 31

XI. SUB-AWARD DETAILS 31

XII. ACTIVITY ADMINISTRATION 32

XIII. LIST OF LEGISLATION DEVELOPED WITH SAFEMed SUPPORT 35

XIV. SUCCESS STORIES 38

Figure 1. Proposed Process with a Positive List 9

Figure 2. Progress of the e-Catalogue Use Over Time 14

Figure 3. Survey Summary of the e-Catalogue Enhancement Features 15

Figure 4. CPA's COVID-related Procurements Delivered with the SAFEMed Support 17

Figure 5. Proposed Reimbursement Program Logic Framework 18

Figure 6. Summary of Insulin Price Setting in Four Models 20

Figure 7. Decentralized Drug Distribution Model via Private & Municipal Pharmacies 22

Figure 8. Analysis of the 2019 Reimbursement Program 26


I. ACRONYMS AND ABBREVIATIONS

ARV antiretroviral drug

CMU Cabinet of Ministers

COVID-19 Coronavirus disease

CPA Central Procurement Agency

CPH Center of Public Health

DDD Decentralized Drug Distribution

DTG Dolutegravir

EML essential medicines list

ERP external reference pricing

EU European Union

GDP Good distribution practice

GOU Government of Ukraine

HIV human immunodeficiency virus

HRS Health Reform Support

HTA health technology assessment

INN International Nonproprietary Name

IO international organization

KPI key performance indicator

MEA Managed Entry Agreement

MIS Management Information System

MMD multi-month dispensing

MOH Ministry of Health

MSH Management Sciences for Health

NHSU National Health Service of Ukraine

OSC Overseas Strategic Consulting, Ltd

PEPFAR President's Emergency Plan for AIDS Relief

PPE personal protective equipment

PPP Public Private Partnership

PrEP pre-exposure prophylaxis

PY project year

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

SEC State Expert Center

SKU stock-keeping unit

TAPAS Transparency and Accountability in Public Administration and Services

TB Tuberculosis

TLD tenofovir/lamivudine/dolutegravir

UAH Ukrainian hryvnia

USAID United States Agency for International Development

WHO World Health Organization


II. CONTEXT UPDATE

During Project Year 3 (PY3) – October 1, 2019 through September 30, 2020 – the health

care and procurement systems in Ukraine continue to undergo a lengthy and complicated

reformation process breaking status quo and fighting corruption. Changes in the Ministry

of Health (MOH) administration and its respective agencies bring uncertainties and shift

priorities. Initial buy in and close interactions between the project and the MOH are

necessary to increase awareness and support implementation of project activities in

Ukraine. It takes time and additional efforts to create a common understanding and vision

among new and existing stakeholders.

The COVID-19 outbreak became a pandemic in March 2020 which followed by a national

quarantine, challenged day to day lives as well as the implementation of many activities

planned. Despite all challenges, SAFEMed remained committed to supporting Ukraine and

continuing with planned activities to the most extent possible.

III. EXECUTIVE SUMMARY

A. Key Narrative Achievements

SAFEMed aims to improve transparency and cost-efficiency of pharmaceutical public

procurement that will foster increased access to safe, affordable, and quality medicines for

Ukrainians. In pursuit of our goal through close collaboration with the MOH, the Central

Procurement Agency (CPA), the National Health Service of Ukraine (NHSU), Center of

Public Health (CPH), and State Expert Center (SEC), SAFEMed is guided by three project

objectives:

1. Strengthen governance within the pharmaceutical sector of Ukraine;

2. Optimize the financing of

the pharmaceutical

sector; and

3. Increase the availability

and appropriate use of

medicines in Ukraine.

All project activities are

implemented via technical,

financial, and legal assistance

(See Section XIII for the list of

legislation and normative acts)

in the following work streams—

health priority setting, public

16pharmaceutical sector

legislations adopted by the

Government of Ukraine

as a result of USG Support

84%Proportion of e-prescriptions

f i l led under Affordable

Medicines Program

1.026 BillionHryvna 86% 85.40%

81.50%76.10%

Baseline PY 1 PY 2 PY 3

SAFEMed Project Year 3 Key Performance

Indicators Update

saved by the healthcare system

through central procurements


102 millionHryvna

saved by the healthcare

system through regional

procurements via EPR


Proportion of OOP spending on medicines out of total

spending on medicines


procurement, reimbursement program, and supply chain—as well as quality assurance

with a focus on bioequivalence. When combined, work streams and activities collectively

strengthen the system from all angles, from medicines selection to forecasting to actual

procurement to assuring quality.

1.0 Policy Priority Setting: Health Technology Assessment (HTA) and Essential

Medicines List (EML)

In spite of COVID-19 limitations, while building capacity of the HTA department at the SEC,

SAFEMed has continued its efforts in promoting HTA to be included in all relevant

processes to ensure evidence-based health policy making as well as supported

implementation of the existing EML policy. To this end, this reporting period SAFEMed:

Developed an electronic demand quantification tool for EML and introduced it across all Ukrainian regions with the help of a user-friendly instructional video.

Demonstrated 102 million Ukrainian hryvna (UAH) savings in the regional procurement of medicines from the EML as a result of price capping.

Jointly with CPA and NHSU, held an anti-corruption training event in Lviv for 81 participants. Training offered practical understanding of the EML policy and operational changes in Ukraine’s health care system – from the introduction of tariffs by NHSU and EML demand quantification to procurement law changes and establishment of CPA – all designed to improve access to medicines for the Ukrainian patients.

Collaborated with the NHSU, the HTA Department of the SEC, and clinical experts to develop clear criteria and process for the inclusion of medicines in the health benefit packages with key considerations given for ensured transparency; as well as supported the MOH on rationalizing the process and ensuring use of evidence-based medicine principles and HTA for selection of medicines for the nomenclature.

Revisited previously drafted legislation that outlines a legal framework that sets the rules for the execution of the robust HTA function in Ukraine and establishment of the independent HTA agency in 2022. New HTA Decree is expected to be signed by the Cabinet of Minister (CMU) in October 2020.

Was actively engaged in the MOH HTA Working Group with a focus on two subgroups: identification of priority conditions and development of the positive list concept.

Developed 6 evidence summaries using HTA principles. Conducted a series of HTA capacity building events. A total of 430 HTA user and

doers benefited from targeted learning events developed specifically for the Ukrainian counterparts in the effort to advance the HTA function.

Joined efforts with the MOH to lead the second National HTA Forum with 117 participants attending the event online and offline that built consensus around key HTA issues.


2.0 Advancing Public Procurement Instruments and Operations

In PY3, SAFEMed continued to support CPA to ensure the newly formed agency continues

to grow and perform adequately in its preparation for taking over the procurement of life-

savings medicines from the international organizations (IOs). To this end, SAFEMed:

Supported the CPA in holding its official office opening, a significant milestone that indicated how far the agency has progressed since its inception in October 2018.

Provided a number of practical trainings led by various experts that enhanced the skills of CPA staff, and provided information about the dynamics of the pharmaceutical market and changes in the Law of Public Procurement.

Led development of key internal CPA policies and business. Provided continuous communications and outreach support to assure focused and

coordinated introduction of the CPA to its target audiences and clients. Continued to provide the MOH and CPA with legislative support in advancing public

procurement instruments, including introduction of Management Entry Agreements (MEA) and support to the IOs. As a result, with the support from the project in June 2020, the CPA was tasked to procure nearly 500 items for a total of 14 out of 38 central programs with a budget of 225 million dollars allocated from public funds. These are vital programs such as but not limited to HIV/AIDS, respiratory disorders of newborns, cardiovascular diseases, and hemophilia.

Continued to support the recruitment of consultants seconded to the CPA. Supported scale up of eCatalogue with content building and targeted promotions to

the regions and health care facilities: the number of health care facilities that used eCatalogue services increased significantly since its launch in January 2020; a total of 200 product categories with 2,891 products were added to the eCatalogue platform; and sales from January until September 2020 reached 13 million UAH.

Developed and introduced a Business Intelligence (BI) tool that includes a dashboard with easy-to-use graphic visualization that facilitates fast and effective decision-making for CPA’s category manager to analyze and define market opportunities.

Supported the MOH and the CPA in the distribution of COVID-19 commodities and Personal Protection Equipment (PPE) procured with special State Emergency funds. CPA has successfully procured and delivered an estimated 6 million units with a value of $1.6 million, while SAFEMed supported the cost of logistics services at $35,000 as part of CPA’s learning how to work with the private GDP-certified logistics company.

3.0 Strengthening NHSU Pharmaceutical Policy

This reporting period, SAFEMed continued to support NHSU in the roll out of the robust

state reimbursement program. More specifically, SAFEMed:

Developed a comprehensive logic framework along with key performance indicators (KPIs) to measure the progress and the impact of NHSU’s reimbursement program.

Designed four pricing models for the inclusion of life-saving insulins into the reimbursement program. Nearly 210,000 insulin-dependent patients are expected


to benefit from it once the program is set in motion in 2021 nationwide, in spite of COVID-related delays.

Jointly with NHSU and the MOH, led two national Reimbursement Forum with extensive participation from public and private pharmacies, family doctors, patients’ organizations and industry representatives.

Conducted an assessment and produced "Fraud Prevention and Detection Functionalities for State Reimbursement Program in Ukraine" technical report that served as a springboard for future joint actions by NHSU and SAFEMed.

4.0 Optimizing PEPFAR Supply Chain Contributions

This reporting period, as part of the overall improvement of the HIV and TB supply chain

continuum, SAFEMed jointly with local counterparts at the MOH, CPH and CPA:

Designed a business case and developed an innovative Decentralized Drug Distribution (DDD) models to increase access to antiretrovirals (ARVs) and pre-exposure prophylaxis (PrEP) through private and municipal pharmacies as well as family doctors at the primary health care service delivery level.

Unlocked a political dialogue and developed draft changes in the legislation in support of proposed DDD models to mitigate COVID-19 interruptions in HIV/AIDS service delivery and distribution of medicines.

Completed “last mile” ARV and TB therapies Public Private Partnership (PPP) pilot in Odesa region with over 80 service delivery points participating and developed a set of practical recommendations for a national “last mile” pilot to go to scale in 2021.

Provided technical support to increase access to TLD for Ukrainian patients by removing market access barriers and offering other practical solutions based on the latest evidence available.

Offered hands-on support to the CPH to strengthen national ARV quantification and forecasting efforts with a seconded quantification and visualization expert from the project.

Supported Ukraine's response to COVID-19 through legislative, procurement, and logistical support.

5.0 Bioequivalence

In spite of COVID-19, in PY3 SAFEMed has been able to make headway in the

bioequivalence work stream. More specifically, SAFEMed:

Completed an analysis of the 23 INNs participating in the 2019 reimbursement program from the bioequivalence perspective. The analysis showcased that a significant number of generic SKUs in the reimbursement program registered at the SEC do not have proven bioequivalence.

Jointly with the MOH developed draft CMU decree which was released for public discussion on the MOH website on February 28, 2020. Adoption of this decree will provide open access to the information on the bioequivalence of generic medicines in the Ukrainian market.


6.0 Strategic Communications

Throughout the project year, SAFEMed communications activities included:

Production of instructional videos (e.g. EML demand quantification tool and MedData for COVID-19 demand quantification), short promotional activity-specific video bites, infographics, 12 monthly newsletters, three success stories, and other visual materials that provided the MOH, CPA, and NHSU with high-caliber communication support.

Development and implementation support of targeted communication strategies for CPA and the HTA department of the SEC.

Presentation of SAFEMed progress and achievements in local and international fora to share lessons learned in HTA, reimbursement, and bioequivalence workstreams.

IV. KEY NARRATIVE ACHIEVEMENT

SAFEMed applies health system-strengthening best practices to create evidence-based

interventions and strengthen Ukraine’s pharmaceutical system in line with the MOH’s

health care reform objectives. It aims to improve access to appropriate, quality medicines

to maximize availability within MOH’s budgetary constraints. In pursuit of its goal,

SAFEMed has three project objectives: (1) Strengthening governance within the

pharmaceutical sector of Ukraine; (2) Optimizing the financing of the pharmaceutical

sector; and (3) Increasing the availability and appropriate use of medicines in Ukraine.

All project activities are implemented via technical, financial, and legal assistance (See

Section XIII) in the following work streams—health priority setting, public procurement,

reimbursement program, and supply chain—as well as quality assurance with a focus on

bioequivalence and verification. When combined, work streams and activities collectively

strengthen the system from all angles, from medicines selection to forecasting to actual

procurement to assuring quality.

In addition, SAFEMed is contributing directly to two PEPFAR goals which aim to maintain

life-saving treatment for individuals, and to accelerate progress toward controlling the

pandemic through optimization of ARV regimens for adults and pediatrics, including

transition to Dolutegravir (DTG)-based regimens, and phase out of legacy regimens;

adoption and implementation of differentiated service models including multi-month

dispensing (MMD) and DDD. In utilizing a thorough consultative process and through close

collaboration with the MOH, CPA, NHSU, CPH, SEC, patient groups, other USAID

implementing partners, and the private sector, SAFEMed interventions work to

institutionalize evidence-based medicine selection, strengthen and systematize public

procurement of pharmaceuticals and commodities, support sustainable public sector

pharmaceutical financing, and strengthen the pharmaceutical supply chain. SAFEMed’s

approach relies on direction from its government counterparts and aligns with Ukraine’s


National Health Care System Reform and the partnership agreement between Ukraine and

the European Union (EU) that requires pharmaceutical reforms to align with EU standards.

The project is guided by the robust transformative vision of Ukraine’s pharmaceutical

system that is more transparent and cost efficient with more medicines of better-quality

available to the Ukrainian public, contributing to the Government of Ukraine (GOU) goal of

a health care system that produces better health outcomes and sustained epidemic control.

1.0 Policy Priority Setting: HTA and EML Establishment of an HTA function in Ukraine has been a top priority to ensure evidence-

based health care policy-making and aid decision-makers to select health technologies that

provide the best value for the Ukrainian health care system. Frequent changes in the MOH’s

administration have brought uncertainties on whether the interest and dedication to

develop an HTA function will continue, or more and closer interaction will be necessary to

increase awareness and support implementation of HTA in Ukraine. In PY3, SAFEMed

worked to communicate the need for HTA and the successful steps completed towards a

well-established HTA function in Ukraine to MOH’s various administrations. In addition,

SAFEMed performed various capacity-building activities to ensure a strong understanding

of HTA.

In spite of COVID-19 limitations, while building capacity of the HTA department at the SEC,

SAFEMed has continued its efforts in promoting HTA to be included in all relevant

processes to ensure evidence-based health policy making as well as supported

implementation of the existing EML policy. To this end, SAFEMed:

Developed an electronic demand quantification tool for EML and introduced it across all Ukrainian regions with help of a user-friendly instructional video.

Held an anti-corruption training event in Lviv for 81 participants to offer practical understanding of the EML policy and operational changes in Ukraine’s health care system – from the introduction of tariffs by NHSU and EML demand quantification to procurement law changes and establishment of CPA – all designed to improve access to medicines to the Ukrainian patients.

Collaborated with the NHSU, HTA Department of the SEC, and clinical experts to develop clear criteria and process for the inclusion of medicines in the health benefit packages with key considerations given for ensured transparency.

Supported the MOH on rationalizing the process and ensuring use of evidence-based medicine principles and HTA for selection of medicines for the nomenclature.

Revisited previously drafted legislation that outlines a legal framework that sets the rules for the execution of the robust HTA function in Ukraine and establishment of the independent HTA agency in 2022.

Was actively engaged in the MOH HTA Working Group with a focus on two subgroups: identification of priority conditions and positive list creation.


External Reference Pricing (ERP) to Reduce Costs

To eradicate opaque processes around regional drug tenders and high prices by

wholesalers, SAFEMed applied ERP to cap prices for 19 medicines (out of 427 medicines

from the EML) that constitute over 50 percent of the value of the drugs bought by public

healthcare facilities regionally. Thus, Ukrainian hospitals and other healthcare facilities

now see set prices for these drugs in Prozorro, and wholesalers will no longer be able to

drive up unfair markups in different regions. This measure was approved by Ukraine's

Prime Minister in May 2019 and was brought into action with supportive normative acts in

February 2020 by the MOH. As of August 2020, data analysis demonstrates 102 million

UAH savings in the regional procurement of medicines as a result of price capping.

Revision of the National List of Medicines for Public Coverage: Evolution towards a Positive List

There is a need in Ukraine to rationalize the lists of medicines and to create a single

Positive List that will combine all lists, with a rationalization process based on evidence

that is HTA-informed. A recent analysis SAFEMed completed showed a significant overlap

between the EML and the nomenclature for the central procurement. This clearly shows a

need to improve processes of determining the lists as well as highlights the risk of double

funding, and disconnection with registration, which might negatively affect availability of

medicines. A Positive List specifies medicines selected for public coverage, whereas a

negative list explicitly identifies medicines excluded from the public coverage. All countries

in the WHO European Region have at least one reimbursement list, usually in the form of a

Positive List. All countries in Central Eastern Europe have Positive Lists.

Currently, access to

medicines in Ukraine can

be realized through

decentralized (which

includes local programs,

EML items, other

medicines included in the

guaranteed package, as

well as other medicines

once EML needs are met

at 100%), and central

procurement

(nomenclature). The

reimbursement program

that includes a small number of medicines from the EML can be accessed through

pharmacies, while the rest is accessed via health care facilities. SAFEMed, upon request

from the MOH, presented the limitations of the existing system and the benefits of a single

Figure 1. Proposed Process with a Positive List


Positive List, and proposed an overview of a potential process (Figure 1). The proposed

Positive List can:

Clarify roles of individuals & entities Improve evidence-based decision making through HTA Streamline & standardize the process Improve transparency and trust Improve stakeholder engagement and public support Allow managing and monitoring drug utilization which can lead to rational revisions

in the list Improve public access to value providing drugs with clear control on funding the

drugs that have clear evidence on improving clinical outcomes Improve efficiency in using resources and qualified professionals.

Discussions are underway on the transition from the EML to the Positive list under

ownership and leadership of the MOH with SAFEMed’s support.

Developing Evidence Summaries with HTA

Globally, the uncertainties in prevention and treatment of COVID-19 make it extremely

difficult for health care decision-makers. There is a need for immediate action, yet evidence

is scarce. Policy makers as well as health care professionals encounter challenges in

obtaining, understanding, and putting the right information into practice. The need for

evidence-based decisions and close intergovernmental collaboration is more important

now than ever before. SAFEMed experts, in close collaboration with the NHSU and

Ukrainian clinical experts, developed four Evidence Summaries on select treatment

approaches and broad international practice.

1) Remdesivir

2) Chloroquine and hydroxychloroquine

3) Lopinavir/Ritonavir combination

4) Convalescent plasma.

Such Evidence Summaries can assist in complex decision-making processes, so that

patients have access to safe and effective medical care. SAFEMed shared Evidence

summaries with the SEC, NHSU, and MOH for consideration in distribution to a broader

clinical community, during the protocol development process. As a result, the MOH

requested that SAFEMed develop an additional Evidence Summaries for a costly treatment

option (Idursulfaze) for a rare condition. The HTA department, at the SEC, prepared a

second Evidence Summary, with guidance and oversight from SAFEMed, on the treatment

of Hepatitis B as part of the HTA capacity building and establishment of stronger HTA

function in Ukraine.


Comprehensive HTA Capacity Building Efforts

Since 2017, SAFEMed’s HTA activities have helped generate a better understanding of the

HTA function and advanced an open dialogue among core HTA actors in Ukraine. To

continue supporting the HTA learning and institutionalization process, SAFEMed launched

the HTA webinar series "HTA around the Globe.” The series aimed to provide Ukrainian

stakeholders with an international perspective from recognized HTA thought leaders.

In May – July 2020, SAFEMed supported six successful HTA webinars, with up to 75

participants per session. Webinar participants received a detailed account of the following

HTA topics:

Germany - HTA activities with Alric Rüther, MD, PhD. Turkey’s pricing system and reimbursement of medicines with Prof. Rabia Kahveci. Sweden – an overview of the HTA bodies and their influence on health care policy-

making decisions with Dr. Sophie Werkö. The Netherlands – Universal Health Coverage and the HTA role by Wim Goetsch. Managed Entry Agreements (MEAs) with Dr. Héctor Castro. HTA for Medical Devices with Jamie Erskine and Richard Charter.

One feature that distinguishes USAID SAFEMed webinars: a knowledge-based component

for the participants. Each session began with a brief survey, in which each participant

answered three to four questions. The survey is a function of the webinar interface

allowing participant answers to be available instantly. At the end of each session,

participants completed a closing poll or questionnaire—based on the information that the

presenter delivered. The satisfaction surveys issued after each learning session evaluated

the overall quality of the webinars, speakers’ presentations, and topic relevance. Using a

scale of 1 to 5 (5 being the highest rating), sessions received a 4.8 to 5 rating, resulting in a

4.92 median score. The first round of webinars is evidence that the development of HTA

and other country-specific experiences from recognized HTA thought leaders is of great

interest in Ukraine.

As part of SAFEMed’s capacity building efforts, HTAi Regional Meeting virtually hosted by

Ukraine was organized on September 8-11, 2020 with simultaneous translation to facilitate

attendance of HTA stakeholders from Ukraine and other neighboring countries. A total of

120 people from 20 countries attended the event. Four panels and 3 courses were

conducted under HTAi leadership with active participations from Ukraine, and welcome

remarks from Ukraine's MOH. A total of 23 speakers from 16 countries contributed to the

regional event. In addition to the attendance of the HTAi regional conferences, many

representatives from Ukraine were able to attend a number of learning/training events by

HTA thought leaders free of change including

Training Course: Principles of Pharmaceutical Pricing Policies by Zoltán Kaló,

Professor of Health Economics, Hungary;


Training Course: Introduction to Health Technology Assessment – HTA101. It was

recorded and posted on HTAi webpage is open for all HTAi members. All HTAi

regional event participants were provided a free access; Live Q&A Session HTA101

Hosted by HTAi Board Members Iñaki Gutierrez Ibarluzea, HTAi President, Spain

and Jani Mueller, HTAi Director, South Africa;

Training Course: Health Technology Assessment of Medical Devices by Richard

Charter, Co-Chair of HTAi Medical Devices Interest Group; Rabia Kahveci, Senior

Technical Advisor on Pharmaceutical Policies and Governance, SAFEMed project,

Ukraine; Adriana Velazquez Berumen, Senior Advisor and Focal Point of Medical

Devices at WHO; Jamie Erskine, Health Technology Assessor King’s Technology

Evaluation Centre.

Overall, 430 HTA user and doers benefited from targeted learning events developed

specifically for the Ukrainian counterparts in the effort to strengthen an HTA function. See

summary table below:

Participants/Organizations TOTAL SEC MOH NHSU CPA CPH Patients

Groups

Clinicians

&

academe

Other,

incl.

industry

HT

A I

nte

ract

ive

On

lin

e

We

bin

ar

Se

rie

s

HTA in Germany 53 12 - 10 - - - 10 21

HTA in Netherlands 40 12 - 1 - - - 12 15

HTA in Turkey 43 8 - 4 - - - 10 21

HTA in Sweden 47 10 - 2 - - - 9 26

MEA 72 11 1 5 1 - - 10 44

Overview of

different HTA

functions in Europe

39 8 - 2 1 - - 8 20

HTA and medical

devices 38 8 - 2 - - - 9 19

HT

Ai

Re

gio

na

l

Co

nfe

ren

ce

Co

urs

es

Course 1: Pricing of

Pharmaceuticals 35 5 - 2 1 - 1 2 24

Course 2: HTA for

medical devices 35 9 - 2 - - 1 2 21

Course 3: HTA 101

trainings 28 11 - 2 1 1 1 2 10

TOTAL* 430 94 1 32 4 1 3 74 221

Second National HTA Forum

Led by the Ukrainian MOH with technical support from SAFEMed, the second National HTA

Forum took place on September 24-25, 2020. The Forum outputs assisted policymakers in

making the best decisions about how to allocate scarce public resources to have the largest

impact on health. A total of 117 participants, including policymakers, doctors, pharmacists,


industry representatives, and patients' organizations, tuned in to learn about the most

recent HTA developments in Ukraine and ask tough questions in the interactive online

Forum.

In addition, the second National HTA Forum offered a series of interactive workshops for

stakeholders and experts to enhance their skills in the establishment and strengthening of

an HTA function in Ukraine. The Forum concluded with a strong consensus regarding the

need to establish an independent agency. The Forum created a vital platform for open and

transparent dialogue among the many actors involved in putting HTA into policy and

practice – the MOH and its agencies, doctors, pharmacists, health economists, patients’

organizations, pharmaceutical industry partners, and international organizations.

2.0 Advancing Public Procurement Instruments and Operations In PY3, SAFEMed continued to support medical CPA, in collaboration with USAID’s

Transparency and Accountability in Public Administration and Services (TAPAS) and

Health Reform Support (HRS) Projects and in coordination with a larger donor community,

to ensure the newly-formed agency continues to grow and perform adequately in its

preparation for taking over the procurement of life-savings medicines and devices from the

IOs. To this end, SAFEMed:

Supported the CPA in holding its official office opening, a significant milestone that indicates how far the agency has progressed since its inception.

Provided a number of practical trainings and learning events led by recognized local and international experts that enhanced the skills of the CPA staff and consultants and provided information about the dynamics of the pharmaceutical market and changes in the Law of Public Procurement.

Led development of key internal CPA policies and business processes in line with international best procurement and jurisprudential practices, including establishment of the Supervisory Board.

Provided continuous communications and outreach support to assure focused and coordinated introduction of the CPA to its target audiences and clients across Ukrainian regions.

Continued to provide the MOH and CPA with legislative support in advancing public procurement instruments. As a result, with the support from the project in June 2020, the CPA was tasked to procure nearly 500 items for a total of 14 out of 38 central programs with a budget of 225 million dollars allocated from public funds. These are vital programs such as but not limited to the HIV/AIDS, respiratory disorders of newborns, cardiovascular diseases, and hemophilia.

Continued to support the recruitment of consultants seconded to the CPA.


Scaling up CPA’s Medical

eCatalogue System

With joint support from

the SAFEMed and TAPAS

projects, in 2019 the CPA

launched an electronic

catalogue solution on

ProZorro, the official

electronic public

procurement platform in

Ukraine. Since January

2020, CPA's eCatalogue

has expanded rapidly,

providing health care

facilities with a quick, easy, and innovative solution for smaller purchases that fall under

the 200,000 UAH threshold. By design, the eCatalogue expands access to medicines and

medical supplies, helps health care facilities save time and money, and significantly reduces

opportunities for corruption. For the eCatalogue to work, local and foreign suppliers

teamed up with the CPA and SAFEMed to create categories and products in demand, while

the CPA promoted its new tool at health departments and healthcare facilities with bespoke

outreach efforts, infographics and videos, and ProZorro provided the platform and the

ongoing technology support. As a result, nine months into its rollout, the number of

healthcare facilities that used eCatalogue services increased significantly.

SAFEMed, in collaboration with CPA, has focused on increasing the availability of relevant

products and active suppliers in the system based on constant feedback and

communication with the regions and in direct coordination with suppliers. Since the launch

of the eCatalogue, with support from SAFEMed CPA successfully created 200 product

categories with a total of 2,892 products on the eCatalogue platform. eCatalogue has

achieved success with year to date sales reaching nearly 13 million UAH. (See Figure 2)

To learn clients’ perspective, SAFEMed and the CPA created and distributed an online

customer survey that received over 120 responses from procurement-related staff across

healthcare facilities in Ukraine, to garner feedback on their satisfaction with the eCatalogue

system. Respondents with prior experience using the tool were asked to rate from a list of

nine available benefits which ones they prefer the most and as a result – Easy to find

products, User-friendly interface, and Easy ordering processes, 55%, 45%, and 36%

respectively, were selected. Additionally, 37% of potential customers that visited the tool in

the past but did not end up making a purchase indicated that it was because they could not

Figure 2. Progress of the e-Catalogue Use Over Time


find the products they

needed. The results are

indicative that in order to

retain existing and attract

new customers, the

eCatalogue should

continue to focus on

making relevant and high-

quality products

available. Looking into

expanding features of the

system, when all 120

respondents were asked

‘How would you

recommend improving the eCatalogue tool further? The result also revealed that in

addition to broadening the range of available products customers were also looking to

enhance the tool further in a number of areas as seen in Figure 3.

Advancing MEA as a procurement tool

SAFEMed provided technical and legal support to the MOH for the introduction of MEA into

the process of public procurement of medicines. These arrangements between

pharmaceutical manufacturers and the MOH will allow for coverage of new medicines

while monitoring their effectiveness and safety in the best possible commercial conditions

for the state. The tool is widely used in the EU and best practices for its implementation

were evaluated and selected for the development in Ukraine. Such approach minimizes

risks at the implementation stage, as well as ensures further sustainability of the use of

innovative procurement tools.

Following consultations with the industry and international thought leaders, SAFEMed

provided critical technical support to the MOH on the development of a pivotal draft

legislative document that defines MEA, their governance procedures, and implementation

plan as a new and innovative procurement tool in Ukraine. The draft Decree of the CMU

was developed in coordination with leading international experts on MEA and represented

the best global practices and recommendations that were adjusted to the legislative context

in Ukraine. The document also contained a detailed MEA regulation procedure, a draft

contract template agreement, and a negotiation procedure that was approved by the MOH.

Additionally, SAFEMed supported MOH in the development of a communication strategy

that targeted key stakeholders such as the public, industry groups, patient groups, and

policy decision-makers to highlight the benefits of MEA as an innovative procurement tool.

Figure 3. Survey Summary of the e-Catalogue Enhancement Features


Data-Driven Decisions through BI

SAFEMed, in coordination with CPA, has been leading a targeted activity aimed at

developing best practice tools and techniques in the area of BI. Such activity encouraged

collaboration and a culture of innovation with the objective to create practical tools that

enable CPA to make data-driven decisions. Phase 1 of BI introduced in September 2020

includes a dashboard with easy-to-use graphic visualization that facilitate fast and effective

decision-making. Some key capabilities include:

Ability to understand market, suppliers, and INN dynamics which include key growth segments and trends for all items in scope for CPA across the Ukrainian market;

Ability to quickly identify savings opportunities through the ability to compare prices for individual items across different sales channels and manufacturers in Ukraine;

Ability to accurately estimate each tender price through the ability to analyze pricing dynamics for each product dosage type within each INN across a number of years.

Phase 1 of the BI includes data on all the nomenclature that is in CPA’s scope of

responsibilities for 2020 and has become one of the key tools used by category managers to

analyze and define market opportunities.

An Overview of the Pharmaceutical Market

During this reporting period SAFEMed held two educational events for key government

counterparts in order to build better understanding of the current trends in the

pharmaceutical market. Leading legal experts and pharmaceutical market analysts

presented pivotal changes of the pharmaceutical market as whole and in Ukraine, areas

that are most influenced by COVID-19 epidemic, and falsification of medicines in Ukraine.

SAFEMed presented an analysis of the state reimbursement program from a

bioequivalence perspective, highlighting potential new approaches of its use as a non-price

criterion in public procurement processes. Both events were well attended, offline and

online, with up to 30 participants from CPA and NHSU.

Regional Outreach

Due to COVID-19 measures, namely, travel restrictions and social distancing requirements,

CPA secured a spot to present at an online forum organized by NHSU Academy together

with HRS. The online format evidently enhanced their geographical reach with staff

attending from across multiple regions in Ukraine. SAFEMed, in collaboration with CPA,

created a detailed agenda that covered pivotal aspects of the new legislative landscape and

related procurement best practices available through CPA. The attendees rated the agenda

and the presentation itself very highly with a total of 500 participants attending the live


webinars. Recordings were made available in addition to an instructional video for

eCatalogue users for further distribution.

Additional targeted outreach activities were conducted by CPA staff throughout the project

year through short regional trips alone or together with NHSU and/or Verkhovna Rada

Health Committee members in order to promote CPA and its new tools.

Supporting the COVID-19 Response in Ukraine

The fast spread of COVID-19 has forced Ukraine to make quick decisions about how to

prevent and treat the disease. SAFEMed has supported Ukraine's response to the COVID-19

by contributing to the development of emergency procurement-related legislation that

would put in place measures against COVID-19. SAFEMed supported the development of

The Law of Ukraine No. 530-IX “On Amendments to Certain Legislative Acts of Ukraine

Aimed at Preventing the Occurrence and Spread of Coronavirus Disease COVID-19)”

approved on March 17, 2020. The Law on COVID-19 opened the door to a wide range of

legislative acts to enable undertaking measures, aimed at preventing the occurrence and

spread, localization and elimination of outbreaks, epidemics, and pandemics of COVID-19.

The Law on COVID-19 that went into effect immediately after approval allowed for:

Importation of medicines, medical devices and/or medical equipment necessary to carry out measures against COVID-19 into Ukraine and be temporary exempted from VAT.

Medicines, medical devices and/or medical equipment necessary to be used against COVID-19 to be temporarily exempted from import duties and payment for completing customs formalities outside the location of the customs authorities or outside working hours. Customs clearance of such goods will be carried out as a matter of priority and may be made based on preliminary or provisional declarations.

Support to COVID-19 Response by Building

Stronger Logistics

Total value

of COVID-19 PPEs

procured by medical CPA

with the GOU

Emergency Funds

1,589,328 USD

4,647,040

MASKS

June –

September 2020 DELIVERY OF COVID-19

PPEs COVERED24 REGIONS & KYIV

CITY34,786 USD

Total cost of PPEs logistics

by SAFEMed funds

1,233,810

RESPIRATORS

18,500

GLOVES

14,783

SHIELDS

OANDA Mid period average: 1 USD = 27.710827 UAH

Figure 4. CPA's COVID-related Procurements Delivered with the SAFEMed Support


Procurement contracts at the expense of budgetary funds may be concluded with up to 100% advance payment for the goods, works, or services necessary to carry out measures against COVID-19.

In addition, SAFEMed provided technical support to the CPA during all stages of the procurement cycle including but not limited to analyzing proposals, qualifying suppliers, and managing supplier performance. MedData has also continued to be the main tool to collect real-time demand from 512 hospitals, 29 laboratories, and 25 emergency departments across the 24 regions of Ukraine for all COVID-19 related commodities. Moreover, with State Emergency funds CPA has successfully procured and delivered an estimated 6 million units with a value of $1.6m across various PPE’s, which has resulted in the delivery of approximately 50% of all quantities ordered by MOH to date. SAFEMed supported the cost of logistics services at $35,000 as part of CPA’s learning how to work with the private GDP-certified logistics company.

3.0 Strengthening NHSU Pharmaceutical Policy

Development of the Logic Framework and KPIs for the Reimbursement Program

This reporting period, SAFEMed supported NHSU in developing a comprehensive logic

framework along with a set of KPIs to measure the progress and the impact of the

Reimbursement Program. These deliverables are especially important to have now, at a

time when NHSU is considering the expansion of the Reimbursement Program.

A logic framework depicts

core components of the

intervention; what they

do; how they interact to

produce changes; how

they lead to long-term

outcomes; and what

resources are in place to

ensure implementation. It

allows NHSU to make

clear assumptions about

complex interventions. In

addition, a logic

framework ensures a

common understanding

of the Reimbursement

Program across diverse

stakeholders; exposes

weak links between Figure 5. Proposed Reimbursement Program Logic Framework


activities and outputs; identifies potential unintended consequences of the program so they

can be avoided; and helps monitor the progress and evaluate the implementation. Along

with the logic framework, SAFEMed developed a set of key performance indicators to

measure consistently and correctly the outputs, the outcomes and the impact of the

Reimbursement Program. (See Figure 5).

Supporting NHSU’s Reimbursement Forum Connecting Public and Private Sector

In October 2019, the NHSU with support from SAFEMed hosted a national forum on the

reimbursement program. The forum brought together more than 150 representatives of

pharmacies, distribution companies, doctors, government agencies, and international

projects, demonstrating a great example of fruitful cooperation between public and private

sector for the benefit of Ukrainian patients.

To support the NHSU in the expansion of the reimbursement program, SAFEMed conducted

a series of in-depth consultations and panel discussions with key informants including the

MOH, endocrinologists, primary doctors, industry representatives, and public

organizations. With the aim to improve cooperation and health services for more than

200,000 patients in Ukraine that dependent on insulin, representatives of the NHSU shared

their vision for the insulin reimbursement program as well as proposed business processes

to deliver insulin to patients. Clinical experts supplemented existing directions with

practical experience and exchanged opinions about the upcoming changes and overall

vision for the program, and family doctors stressed the importance of learning how to

manage diabetic patients at primary health care service delivery points. In addition, in

December 2019 the NHSU and the MOH with support from SAFEMed brought together over

160 pharmacists, industry representatives as well as thought leaders from the medical

community, patient organizations and government agencies to discuss expansion of the

existing reimbursement program with insulins and to provide updates to stakeholders on

the status of the program expansion. Moving forward, SAFEMed will continue working side

by side with NHSU and other key counterparts to provide timely technical, financial, and

legal support during the transition period.

New Pricing Mechanism for Insulin

Under the terms of the planned transition of the insulins program from the SEC to NHSU's

Affordable Medicines program, NHSU aims to optimize public funding for the program by

introducing more effective insulins pricing aligned, where feasible, to the existing

reimbursement program. Due to unique nature of the insulin prescribing practices, and in

line with international experiences, prices and ePrescription need be set up by the trade

names. This approach is different to the general reimbursement program rules where

pricing and ePrescription are both INN-based. In order to advance transitioning of the

insulin program to NHSU, SAFEMed cooperated with the representatives from the Kharkiv


National Pharmaceutical University, family doctors, endocrinologists, and other relevant

stakeholders to develop four pricing models for the inclusion of insulins into the

reimbursement program:

Model 1 processes pricing calculations based on dividing all registered medicines

by three categories such as insulin type, form of its primary package and duration of use. For domestically manufactured medicines, currently declared prices were used as internal reference pricing. For the medicines manufactured internationally, an external reference pricing was applied.

Model 2 introduces equal rules of price setting for both domestic and international pharmaceutical manufacturers using same categories as Model 1.

An ATC-based price setting Model 3 uses a different approach to the selection of reference countries as well as the number of price positions, number of reference groups and number of the lowest prices for drugs. To formulate reference prices for insulins, they were divided into reference groups according to the INN, 5th level ATC classification and form of primary package.

The algorithm of price selection depending on the presence or absence of insulin medicines in the reference countries, as well as the quantity of reference prices was tested for pricing in Model 4. For this Model, vials and cartridges were modeled as those provided free of charge for the registered patients and syringe pens free of charge for the some identified categories of patients. At the same time for co-payment categories, the amount of reimbursement is defined as the cost, recalculated from the cost of the 1 IU of vial where the rest is paid by the patient.

In order to provide NHSU with the best scenario for the insulin pricing in a variety of

settings, measurements, approaches and limitations, SAFEMed summarized

recommendations and recommended NHSU to pick Model 1, Model 3, or their combination.

In close consultation with

academe, family doctors,

endocrinologist and other

external stakeholders, NHSU

selected a combination of insulin

pricing models 1 and 3 and will

work with the MOH to obtain

approval on the pricing

methodology for insulin

reimbursement. Due to COVID

and political environment,

integration of the insulins into

the reimbursement program has

being delayed until 2021.

Figure 6. Summary of Insulin Price Setting in Four Models


Fraud Prevention and Detection Functionalities

In PY3, SAFEMed conducted an assessment and produced "Fraud Prevention and

Detection Functionalities for State Reimbursement Program in Ukraine" technical

report. As the Reimbursement Program goes to scale from low-cost INNs to more

expensive pharmaceutical products many risks and opportunities for financial waste, fraud,

and abuse can emerge, therefore, jeopardizing the success and integrity of the entire

program. The assessment identified 16 specific schemes for impacting financial loss on the

reimbursement program as it expands including the following classified as high risk:

Physician detailing where manufacturer-marketing techniques are used to influence physicians into prescribing a specific trade name product;

Physicians and pharmacists collaborate to create and bill Sham Prescriptions for real, non- participating patients for medications not needed;

External and internal threats that compromise eHealth and/or MIS service providers to alter databases or transaction files to misallocate resource or exploit health care information;

Medication swap where 1) the pharmacy and patient split the difference when a higher-cost medication is billed and a lower cost medication is dispensed; and 2) the patient is told the higher cost medication is out of stock and receives the lower cost medication but the pharmacy bills the higher cost mediation.

Based upon the 16 schemes defined, a total of 21 tools and capabilities have been identified

that can support the proactive and retrospective identification and prevention of financial

loss including:

Specialists, Family Doctors, Pharmacies, and Pharmacy Chain Report Cards that compare key performance and financial measures against their peers.

Secret Code Report that identifies anomalies in how patients choose to receive their ePrescribing Secret Code including variation in the selection of print and SMS numbers.

Use of Dynamic Dosing Criteria that determines best-case medication selection, dosing, and duration based upon a patient’s individual diagnosis, weight, age, and gender.

Utilization of Step Therapy Protocols which support the use of a proven, cost-effective treatment regime before more expensive treatments are prescribed and reimbursed.

The use of Directly Observed Therapy for patients where adherence is suspect or proven to be insufficient for patient health.

Following completions of the assessment in March 2020, SAFEMed and NHSU jointly

identified two consultants seconded to NHSU to support fraud prevention and detection

activities for the reimbursement program. Works are currently underway.


4.0 Optimizing PEPFAR Supply Chain Contributions Over the past several years, the GOU has made significant strides in improving access to

ARVs in Ukraine: nearly 90% of ARVs are currently procured at the costs of the state

budget with donors` contribution gradually decreasing. However, a closer look at the

supply chain system revealed bottlenecks that had to be addressed to ensure the

unrestricted access of the patients to life-saving medicines that will contribute to the

sustained epidemic control and provide more effective patient-centered care to mitigate

COVID-19 related disruptions. This reporting period, as part of the overall improvement of

the HIV and TB supply chain continuum, SAFEMed worked closely with local counterparts

at the MOH, CPH, and CPA on a number of supply chain activities.

DDD: PrEP and ARVs in Pharmacies and Engagement of Family Doctors in HIV Diagnosis and

Treatment

SAFEMed aims to improve access to medicines for patients, including people living with

HIV. Currently in Ukraine, only AIDS centers and “Trust Rooms” are in charge of dispensing

ARVs and PrEP; therefore, SAFEMed designed a business case and developed an

innovative DDD model to increase access to ARVs and PrEP, including through

private and municipal pharmacies. The major effort during this year was to initiate the

appropriate legislative changes and obtain political support in the current volatile

Ukrainian realities. SAFEMed prepared draft changes to a number of legislative acts.

Despite COVID-related restrictions in the country, the consensus on piloting PrEP and ARVs

through pharmacies was reached with the MOH, CPH, and Parliamentarians. Hence,

endorsement of most of the required legislative changes was delayed and this activity was

rolled over to the next

project year.

In order to expand access

to HIV diagnosis and

treatment, under new

health care reform

objectives family doctors

were to provide such

services. Although

accepted as a concept by

family doctors, legislative

barriers still needed to be

addressed. With support

from the project at the

end of September 2020, Figure 7. Decentralized Drug Distribution Model via Private & Municipal Pharmacies

Alliance & AIDS Centers

Step 3.

Prescribing PrEP/ARV

Signing agreements with pharmacies based on geo locations

Step 2. Required Testing

Lab Facility

Step 1.

Medical &

non-medical

screening

Family Doctor or AIDS Center

Provides funding for PrEP in Ukraine

Global Fund

Receive PrEP

Pass to pharmacies who sign contracts


Step 4. Dispensing PrEP for 3 months

Pharmacies (public or municipal) are assigned to cover specific geo catchment area

Pharmacies

Step 5.

Social support,

follow up and

evaluation


Decentralized Drug Distribution List: Pharmacy-

based PrEP/ARV Distribution Model

Demand quantification

Verification

Delivery

Stocks monitoring

Central Procurement


the Ministry of Justice endorsed changes the MOH Order No. 585 to optimize HIV testing

and treatment service delivery, including MMD, and engagement of the primary health care

providers – all needed to launch another DDD model for ARVs distribution in Ukraine.

Public Private Partnership Logistics Pilot

In PY3, SAFEMed successfully completed its PPP “last mile” logistics pilot in the Odesa

region. After ten months of pilot implementation, SAFEMed summed its experience and

recommended to maximize the benefits of the private sector engagement in logistics:

Bundling up TB and HIV “last mile” deliveries with other medicinal products procured centrally with public funds. These can include but are not limited to vaccines, medicines and lab commodities from other central programs. The greater volume will incentivize private sector participation and result in greater savings for the MOH due to economies of scale.

Repurposing delivery trucks to bring back lab samples to the Odesa Regional AIDS Center in an effort to expedite HIV and TB testing services for a small fee. Engaging private sector companies in integrated sample transport systems offer the potential for savings and reductions in turnaround times.

Expanding to other regions is recommended due to the good results of ten months pilot in Odesa region. More regions and accordingly large logistic coverage encourage private sector participation. Different logistic companies may participate in the project, serving different regions, providing strengthening of reliability and competitiveness. This also will help to resolve the problem of “last mile” deliveries all over Ukraine, assuring access of ART and TB even the most distant sites.

In order to find best solution of cost calculation, SAFEMed also recommended reviewing

the scheme of utilizing a fixed fee instead of calculating percentages of values. The fixed fee

could include the volume of cargo, cost of one driver and truck per day plus mileage and

the number of stops made. Comparing both ways of costs calculation will allow evaluating

the best method. In addition, SAFEMed discussed with the representatives from CPH to (1)

expand the duration of the logistics pilot, (2) include additional medicines and (3) add

family doctors for the distribution chain as per new legislation. In response, CPH requested

to include Hepatitis C medicines in the logistics pilot for distribution and supported the

motion to include family doctors in the logistics pilot. All these agreements will be taking

into consideration in the PY4 as “last mile” logistics pilot goes to scale across the country.

Technical Support to Support TLD Transition

This reporting period, at the request for the CPH SAFEMed provided targeted assistance in

identifying potential solutions to increase TLD access for the Ukrainian patients. More

specifically, CPH raised a concern about DTG use in pregnant women. Considering the

recommendations in the national clinical protocols and precaution about DTG use in


pregnancy in the official labels, pregnant women have limited access to DTG treatment in

Ukraine. SAFEMed analyzed the latest literature data, reviewed international guideline

recommendations, and conducted a market overview. To address the issue, SAFEMed

recommended the following measures:

Revisit and update national clinical protocols for HIV treatment based on the latest available scientific evidence and international practices. Physicians should provide pregnant women or those who are trying to conceive with the relevant information about the risks and benefits of DTG use and possible changes of ARV. Folic acid supplementation should also be considered.

Conduct an online training on the updated national clinical protocols with special emphasis on the use of DTG-containing regimens among women of childbearing potential and pregnant women specifically, and provide physicians with the information included in the instructions for each individual DTG-containing compound with special emphasis on those that do not specifically recommend against the use of DTG in pregnancy.

Work with individual manufacturers to consider updating their instructions in accordance with the latest evidence.

Removing Market Access Barriers for TLD in Ukraine

To accelerate progress, while making changes in the current legislation to extend the terms

of existing fast track registration certificates for TLD, SAFEMed activities this reporting

period have also included mapping the market and engaging with TLD manufacturers to

encourage registration of ARVs as part of the treatment optimization and TDL transition

plan. Because of bespoke outreach efforts and formal discussions, Hetero Labs Ltd, Mylan

Laboratories and Sun Pharmaceutical initiated submission of the documents to have TLD

registered in Ukraine. See current status of the registration in the table below.

* In early October 2020, Hetero Lab Ltd and Mylan Laboratories Ltd were declared as successful winners of the CPA-led transparent and open

procurement of ARVs with 2020 public funds, producing substantial savings.

Manufacturer name

Type of registration TLD registration terms in Ukraine

WHO prequalified

USFDA approved

Macleods Pharmaceuticals Limited

Regular procedure 04.04.2019 - 04.04.2024

Yes No

Aurobindo Pharma Ltd

Regular procedure 14.11.2019 - 14.11.2024

Yes Yes

Hetero Labs Ltd.* Regular (info on formulation not yet available)

In progress Yes Yes

Sun Pharmaceutical Industries Limited

Fast track registration for TLD30, TLD 90 (WHO PQ pack sizes)

In progress Yes No

Mylan Laboratories Ltd.*

Fast track registration for TLD 30 (WHO PQ pack size). Regular procedure of registration for TLD30, TLD90, TLD180

TLD 30 08.07.2020 – 31.03.2022

Yes Yes

Emcure Pharmaceutical

Regular procedure 08.07.2020 – 08.07.2025

No No


Quantification Support to the CPH

SAFEMed continued close collaboration with the CPH through a seconded expert that

supported CPH's activities in ARV quantification and forecasting. The expert provided

technical assistance related to ARVs and TB drugs stock level monitoring such as the

development of user-friendly and visual tools for modelling different scenarios of TLD

transition together with CDC experts, and preparing an analytical note on the potential risk

for ARVs availability taking account substantial delays in deliveries due to COVID-19

restrictions. In order to improve CPH’s quantification and forecasting efforts, SAFEMed also

provided support in the analysis of the existing MIS HIV to assess the possibility of its

potential integration with a modern quantification e-tool that will allow triangulating

patient data with commodities data and improving quality of monthly reports and

proactive reactions for potential stockout/overstock risks.

Supporting the COVID-19 Response in Ukraine

From the beginning of the pandemic, SAFEMed has supported Ukraine's response to

COVID-19 through legislative, procurement and logistical support. In addition, one of

SAFEMed's Senior Technical Advisors worked side by side with Deputy Minister of Health

responsible for the COVID-19 response in Ukraine on a number of different issues,

including the following:

1. Served as the Head of Delivery Group in the Ukrainian National COVID-19 Headquarters and was responsible for working with over 360 First Wave hospitals, including collection of the information about current stock levels and needs.

2. Supported Deputy Minister on all issues related to COVID-19 humanitarian aid and supply chain; worked directly and coordinated humanitarian aid with the Office of the President, Ukraine Ministry of Foreign Affairs, Ukraine Ministry of Social Policy, Customs, etc.

3. Worked with international partners, including communication with Vice Prime Minister's office in charge of European Integration, WHO, and other UN agencies on the MOH and CPH priorities for COVID-19.

4. Worked with the representatives from Embassies on COVID-19 humanitarian aids for Ukraine.

5.0 Bioequivalence In spite of COVID-19, in PY3 SAFEMed has been able to make headway in its bioequivalence

work. At the beginning of the program year, after preliminarily coordination with the MOH

Pharmaceutical Directorate and SEC the stakeholders agreed to classify all generic drugs

based on the criteria of the degree of proof of their bioequivalence:

The drug is not subject to bioequivalence proof (taking into account the requirements of the MOH Guideline on Bioequivalence); or

Data on the drug bioequivalence proof are not available; or Bioequivalence of the drug has been proven.


Additionally, for the purpose of promoting the information about bioequivalence of drugs

through the State Drug Registry, the previously developed draft CMU Decree was further

improved. In addition, there has been the progress of the draft CMU decree "On

amendment of item 4 of the Regulation on the State Register of Medicines", which was

released for public discussion on the MOH website on February 28, 2020. Adoption of this

decree will provide open access to the information on the bioequivalence of generic

medicines in the Ukrainian market.

Moreover, SAFEMed completed an analysis from the bioequivalence perspective of the 23

INNs participating in the 2019 State Reimbursement Program, which gave an

understanding of the actual situation on the pharmaceutical market. Further analysis

revealed that a substantial number of generic SKUs in the Affordable Medicines Program,

especially for

cardiovascular diseases,

registered at the SEC

have no proven

bioequivalence. These

data will serve as a

springboard for the

development of further

options related to the

purchases of generic

medicines made with

public funds. In the end,

the main purpose of the

activity is to introduce a

mandatory provision for

all public procurements

of generics to have

proven bioequivalence.

Lastly, SAFEMed’s assessment of laboratories that conduct or can potentially conduct

bioequivalence studies that was scheduled for March 2020, was postponed as a result of

travel ban. Presently, only six laboratories in Ukraine (4 private and 2 public) conduct

bioequivalence studies of medicines. Only two of them comply with Good Laboratory

Practice standards and only one of them complies with Good Clinical Practice standards. In

order to provide assessment of the bioequivalence laboratories in Ukraine, SAFEMed

selected an experienced international expert which will help to have a better

understanding of the capabilities of the existing laboratories and provide relevant

recommendations regarding its improvement.

23 INNs 254 SKUs

74%

13%

13%

Cardio-Vascular Diseases - 17 INNs

Diabetes Type 2 - 3 INNs

Bronchial Asthma - 3 INNs

77%

18%

5%

Cardio-Vascular Diseases - 195 SKUs

Diabetes Type 2 - 45 SKUs

Bronchial Asthma - 14 SKUs

Analysis of the 2019 Reimbursement Program

Most items (96%) in the Reimbursement Program are generics.

Out of those only 35% provided information of the proven

bioequivalence.

Figure 8. Analysis of the 2019 Reimbursement Program


In consequence of the COVID-19, pandemic and numerous changes at the MOH

administration during this reporting period, several bioequivalence work stream activities

were postponed. However, introduction of the mandatory qualitative criteria for state-

funded programs was agreed with CPA, as the main procurement body.

6.0 Strategic Communications Throughout the project year, SAFEMed communications activities included production of a

variety of instructional videos (e.g. EML demand quantification tool and MedData for

COVID-19 demand quantification), infographics, 12 monthly newsletters, three success

stories (See Section IX) and other visual materials that provided the MOH, CPA, and NHSU

with high-caliber communication support. In an effort to ensure information is

communicated to a broader audience, SAFEMed found that short “video bites” vs. written

or print materials are the more effective in catching people’s attention. As a result,

SAFEMed developed a series of “video bites” highlighting the following:

TB and HIV/AIDS logistics PPP pilot in the Odesa region;

CPA’s eCatalogue tool and how health care facilities can purchase medicines and

medical goods through the tool;

NHSU's success with the Affordable Medicines Program focusing on how NHSU

applied innovative solutions to roll out ePrescription, a tool used to complement

and advance the existing state Reimbursement Program;

MedData, an information and analytical system that collects data on the demand for

medicines and medical devices, pipeline supplies, and leftover stock;

Introducing medical CPA and its new tools, including e-Catalogue, to the regions;

Documenting CPA’s learning from the private logistics company while delivering

COVID-19 commodities to the regions.

This reporting year, SAFEMed also developed a Communications Strategy for the HTA

department, and medical CPA. Formed in discussions with the HTA Department, its

communication strategy stipulated clear communication goals and objectives; describes

target audiences and their profiles; outlines expected outcomes and key messages,

communication approaches, tools and channels along with a 12-month Plan of Actions.

CPA's Communication Strategy displays the transparent and patient-centered activities of

the CPA. In addition, to support and foster visual and brand identity of the CPA SAFEMed

developed a new brand-book for the agency.

In addition, SAFEMed introduced media monitoring, presented project’s HTA and

bioequivalence work at numerous local and international fora, and contributed to the

development of three joint NHSU-SAFEMed abstracts and videos for the international

conferences to showcase the achievements of the reimbursement program in Ukraine in

general, and the ePrescriptions in particular.


V. MONITORING, EVALUATION AND LEARNING

Indicator Disaggregated

by:

Unit Baseline YR1 YR2 YR3 YR4 YR5

(EOP)

Means of

Verification

Date Value Target Actual Target Actual Target Actual Target Target Data Source

Frequency

1 Proportion of out of

pocket (OOP)

spending on medicines (out of total spending

on medicines)

Type (EML vs.

non-EML)

Ratio 2016 86% 85% 85.4% 78% 81.5% 74% 76.1%1 70% 66% SMD

Database

Quarterly

Annually

2 Number of

prescriptions filled (out of total number

of medicines

prescribed under the

“Affordable Medicines” Program)

n/a Thousand

receipts

2017 11,897.2 26,154 26,155 40,249 43,396 53,343 55,3842 66,921 80,621

(aggregate)

MOH

data

Annually

n/a Ratio 2017 74.8% 81% 81% 83% 83.5% 88% 84% 92% 95%

(aggregate)

MOH

data

Annually

3 Number of people

trained in anti-corruption measures

in the pharmaceutical

sector as a result of

U.S. Government (USG) support

Gender (male,

female)

Individual,

who attend

80% of

training

2017 0 1,200 1,200 300 884

M:157

F: 727

400 81 incl.

17 male and 64

females

0 0 Project

database

Quarterly

Annually

4 Number of

pharmaceutical sector

legislations adopted by the Government of

n/a Nakaz

Strategy

Policy

2018 No data

collected

No data

collected

No data

collected

10 11 15 163 5 5 Project

database

Quarterly

Annually

1 As of October 25, 2020 SMD, data is only available through August 2020 2 Number of prescriptions are from April 2017 (beginning of Affordable Medicine program) to October 2020. 3 See more details on the legislation adopted in Annex XIII


Indicator Disaggregated by:

Unit Baseline YR1 YR2 YR3 YR4 YR5 (EOP)

Means of Verification

Date Value Target Actual Target Actual Target Actual Target Target Data

Source

Frequency

Ukraine as a result of USG support

5 Amount of money

saved by the

healthcare system through central

procurements as a

result of USG support

n/a Ukrainian

hryvnia

(millions)

Oct

2018

0 6M

UAH

6M

UAH

10M

UAH

1.026B

UAH4

10M

UAH

10M UAH CPA Quarterly

6 Amount of money saved by the

healthcare system

through regional

procurements via external price

referencing as a result

of USG support

n/a Ukrainian hryvnia

(millions)

2018 savings on 600M

UAH

spent on

20 top INNs

60M UAH

n/a 80M UAH

102M UAH5

80M UAH

80M UAH SMD Database

Quarterly Annually

7 Number of individuals who have

been newly enrolled

on antiretroviral pre-

exposure prophylaxis (PrEP) to prevent HIV

infection in the

reporting period

(PrEP_NEW)

Gender

Key populations

Individual 2019 0 200 0 400 1000 CPH data

Semi Annually

4 Savings for central programs managed by the CPA with 2020 budget funds (as of October 21, 2020) 5 As of October 25, 2020 SMD, data is only available through August 2020


VI. LESSONS LEARNED

In PY3 Ukraine’s healthcare system faced a number of challenges and as a result, SAFEMed

was forced to adjust quickly to continue carrying out the project’s planned activities. This

reporting period, the MOH leadership team changed three times which affected in term

leadership at the CPH, CPA and NHSU. Every time that a new Minister of Health was

appointed, additional level of efforts and time needed to be incorporated in order to:

Build an understanding of new priorities, challenges, and opportunities, Secure buy-in and understanding of the project activities, achievements/progress

made, and strategies moving forward, and Establish consensus and align on the essentials.

In addition, SAFEMed spent time informing the new individuals of the project's activities

and the type of support that can be provided to the MOH. This is not always an easy

process, as individuals can be reluctant to meet and often come into office with an already

planned agenda.

Similar to other countries all over the world, Ukraine was ill prepared to face the COVID-19

pandemic. In Ukraine, it revealed a number of health system-related issues that need to be

addressed. The release of the State emergency funding was slow and overregulated. Lack of

national pricing policy and control allowed for the distributors to escalate prices for

medicinal products and make additional profits when funding was scarce and most needed.

Procurement function is not designed to address immediate needs when acting fast is key

to get ahead of other countries “fighting” for limited supplies and commodities. Evidence-

based decision and consensus building regarding key clinical protocols and medicinal

products is not in place, and potentially life-saving decisions are made ad hoc.

VII. ENVIRONMENTAL MONITORING

SAFEMed does not have any activities that have an environmental impact and/or require mitigation measures.

VIII. PROGRESS ON LINKS TO OTHER ACTIVITIES

SAFEMed continued building stronger connections with other USAID-funded projects and

activities working across health and anti-corruption technical areas. Meetings were held

with the TAPAS project to coordinate legal and technical support to the CPA and public

procurement. In addition, SAFEMed is coordinating regional training activities with the

HRS project in order to provide comprehensive information to the regions in regards to the


ongoing health reforms and how it will affect medicines. Additional efforts were made to

identify special touch points for collaboration with USAID’s HealthLink and TBLink projects

led by 100% Life and PATH, respectively. Separate outreach activities were conducted to

identify additional opportunities for the private sector engagement.

IX. PROGRESS ON LINKS TO HOST GOVERNMENT

This reporting year, SAFEMed continued to collaborate -- both proactively and effectively --

with key host government counterparts in spite of numerous changes at the MOH

administration and its agencies, including by not limited to the NHSU, and CPH, as well as

COVID-19 related restrictions. SAFEMed successful built rapport, exercised allowed

flexibility and demonstrated continuous willingness to support the GOU changing priorities

and supply chain challenges related to global COVID-19 pandemic.

X. FINANCIAL INFORMATION

Total Budget:

$19,434,000

Current Obligations:

$14,044,121

Estimated expenditure as of Sep 30, 2020:

$9,489,117 68% of the obligations 49% of the total budget

XI. SUB-AWARD DETAILS Name Effective

Dates Total

Amount (USD)

Total Expenses

(USD)

Description

OVERSEAS STRATEGIC CONSULTING, LTD. (OSC)

01-Sep-17 to 30-Aug-22

$439,558 $238,911 Subcontractor (Small US business) is responsible to support project communications efforts with a full-time project staff

LEGAL ALLIANCE LAW FIRM

11-May-18 to 31-May-22

$832,659 $332,567 Objective of the subcontract is to provide relevant legal support to promote the sustainability of the medicine’s selection process for procurement and reimbursement as a part of the reform process.


Name Effective Dates

Total Amount

(USD)

Total Expenses

(USD)

Description

KYIV SCHOOL OF ECONOMICS (KSE)

10-Sep-18 to 31-Dec-19

(closed)

$537,890 $449,991 Objective of this subcontract is to assist the MOH in developing a strategy for public procurement reform in Ukraine, set up functionality, infrastructure and statutory elements of the CPA, based on category management approach, and support the roll out of the transformation from the existing system into the new one.

XII. ACTIVITY ADMINISTRATION

A. Constraints and Critical Issues

The GOU shifted all efforts into the fight against COVID-19. Activities such as, supply chain

in support of PEPFAR priorities, HTA, and bioequivalence have been deprioritized by the

MOH. As a result, the project was unable to produce some deliverables and unable to

produce some planned activities before the end of the project year. Supply chain activities

have been most significantly impacted because all of CPH's efforts have been focused on the

COVID-19 response. In addition, the administration of the MOH has changed three times

during PY3. With exception to the central procurement function led by CPA, it is unclear

what the priorities of the new administration will be and which of the project's work

streams the new MOH administration will support.

B. Personnel

In PY3, while remaining a small and lean team, SAFEMed made substantial changes in the

project organogram to align staffing with project deliverables. We did this by including

additional technical staff (senior technical advisor and technical advisors), incorporating

junior consultants as well as consultants seconded to CPA and CPH to provide short-term

technical assistance, and recalibrating internal responsibilities based on existing skills and

workload. In addition, project COP submitted her resignation at the end of PY3. MSH is

currently recruiting to fill in this position.

C. Contract, Award or Cooperative Agreement Modifications and Amendments

Project Year 3 brought several modifications to the SAFEMed contract:

Modification #6, dated October 30, 2019, provided for revisions to the date of the annual work plan submission to align with Procurement Executive Bulletin No. 19-02; more specifically, the "Annual Implementation Plan" reporting requirement under section F.8 "Reports and Deliverables" was revised to reflect this change in due date.

ii) Modification #7, dated November 19, 2019, provided for incremental funding in the amount of USD $2,000,000;


iii) Modification #8, dated March 24, 2020, provided for incremental funding in the amount of USD $2,734,000;

iv) Modification #9, dated August 7, 2020, approved the scope of work expansion and related ceiling increase request by increasing the Total Estimated Cost from $12,434,000 to $19,434,000 and providing for incremental funding of $1,610,121 bringing the total incremental funding amount to $14,044,121. The Scope of Work was also formally updated to include the expansion of work to take place during the remaining project years.

D. Status of Deliverables/Milestones

Deliverables6 Status

1.1 Summary report on HTA capacity building results at the end of the year Completed 1.2 Action plan for creating an independent HTA Agency Ongoing 1.3 2nd National HTA Forum Report Completed 1.4 Standard process description for the nomenclature development Completed 1.5 Strategy that outlines processes, methods, roles, and capacity needed to identify medicines for the health benefits package

Completed

1.6 100 clinical experts, NHSU, and HTA staff trained in the use of HTA Completed 1.7 Ten Evidence Summaries as samples for replications for the HTA department Completed 1.8 Optimized EML with health care reform and other changes Ongoing 1.9 Updated EML demand quantification tool Completed 1.10 Normative acts developed and submitted for approval by respective government bodies that will allow to advance HTA function

Ongoing

1.11 Calculation worksheet for ERP for select EML items Cancelled 1.12 Three EML market analysis reports Completed 1.13 Seven training courses conducted with up to 400 trained Ongoing 2.1 Business process for regional procurement; eCatalogue, framework agreements (FA) are in use

Completed for FA

2.2 Key CPA business processes and policies with quality at its core Plan of actions of the establishment of the Supervisory Board (SB)

Completed except for SB

2.3 At least two facilities are recognized as procurement Centers of Excellence Cancelled 2.4 CPA Transition Plan Checklist Completed 2.5 2 workshops conducted for at least 50 CPA and NHSU staff and consultants Completed 2.6 Dashboard for business intelligence and market expertise Completed 2.7 Normative acts endorsed and approved by respective government bodies in regards to CPA and public procurement functions

Completed

2.8 All regions are covered with outreach efforts (priorities are given to 7 target regions) Completed 2.9 20 consultants recruited for secondment to CPA Completed 3.1 Medicines KPI module to monitor manufacturers, pharmacies, and other providers Completed 3.2 Report on how state-guaranteed health benefits package and reimbursement effects patients OOP

Cancelled

3.3 Fraud prevention and detection functions incorporated into ePrescription Ongoing 3.4 More NHSU staff are trained in the composition and monitoring of Affordable Medicines registers

Ongoing

3.5 Affordable Medicines expansion strategy and timeline Delayed 3.6 At least three Affordable Medicines stakeholder meetings (3) Completed 4.1 Logistics pilot report with follow up recommendations and actions Completed 4.2 ARV electronic tool developed and introduced Ongoing

6 Activities are color coded as follows: Completed, ongoing, planned, cancelled/delayed


Deliverables6 Status 4.3 Consultant(s) seconded to CPH Completed 4.4 Normative acts endorsed and approved by respective government bodies Ongoing 4.5 RTK quantification tool for primary health care providers Cancelled 4.6 PrEP innovative service delivery model description Completed 4.7 PrEP pilot progress report Delayed 4.8 Normative acts for including ARVs, as well as PrEP, in private or public pharmacies Ongoing 5.1 Normative acts in regards to bioequivalence activities Delayed 5.2 List of priority medicines with rationale to participate in bioequivalence Delayed 5.3 Qualitative criteria for reimbursement program and public procurements Ongoing 5.4 Assessment report with recommendations of clinical laboratories Delayed 6.1 SAFEMed success stories (3) Completed 6.2 Monthly News Digests Completed 6.3 Communications materials or products (10) Completed 6.4 At least 2 presentations at local or international conferences Completed

E. Coordination and Partnerships

SAFEMed continued to maintain the positive relationships that it has developed during the

previous year with key government counterparts that are still in place and continues to

build relationships with newly appointed staff. In addition, SAFEMed maintain strong

relationships with other donor funded projects, patients’ organizations, and the private

sector.


XIII. List of Legislation Developed with SAFEMed Support

No. Legislative Document Status

Advancing Public Procurement Instruments and Operations

1 CMU Decree No. 1172 - On some matters to ensure effective procurement system of medicines, medical devices and auxiliaries to them and other medical products https://ips.ligazakon.net/document/view/kp191172?an=1&ed=2019_11_27

Approved November 27, 2019

2. Law No. 475-IX - On Amendments to Section IX "Final and Transitional Provisions" of the Law of Ukraine "On Public Procurement https://zakon.rada.gov.ua/laws/show/475-20#Text

Approved January 16, 2020

3. MOH Order No. 589 - On authorizing the CPA to implement programs and centralized measures in the healthcare sphere https://zakon.rada.gov.ua/rada/show/v0589282-20#Text

Approved February 28, 2020

4. Law No. 530-IX - On Amendments to Certain Legislative Acts of Ukraine Aimed at Preventing the Occurrence and Spread of Coronavirus Disease (Covid-19) https://zakon.rada.gov.ua/laws/show/530-20#Text

Approved March 17, 2020

5. Law No. 531-IX - On amendments to some laws of Ukraine aimed at increasing the availability of medicines, medical devices and auxiliaries to them, which are procured by an entity authorized to make procurements in the healthcare sphere https://zakon.rada.gov.ua/laws/show/531-20#Text


6. Law No. 532-IX - On Amendments to the Tax Code of Ukraine on Increasing the Availability of Medicines, Medical Devices and Auxiliaries to them Purchased from the State Budget and Creating Conditions for Health Procurement with the State Budget https://zakon.rada.gov.ua/laws/show/532-20#Text




7. CMU Decree No. 282 - On amendments to some decrees of the Cabinet of Ministers of Ukraine Legislation extends registration certificates for IO's procurements, introduces new (special) procedures for registration of medicinal products for CPA, and provides exemption from taxation of operations for the supply of pharmaceutical products procured by CPA. https://www.kmu.gov.ua/npas/pro-vnesennya-zmin-do-deyakih-postanov-kabinetu-ministriv-ukrayini-i150420-282

Approved April 15, 2020

8. CMU Decree No. 347 - On amendments to some CMU Decrees Ensures some preferences for the procurements of medical devices by CPA and IOs. https://www.kmu.gov.ua/npas/pro-vnesennya-zmin-do-deyakih-postanov-kabinetu-ministriv-ukrayini-347060520

Approved May 6, 2020

9. CMU Decree No. 350 - On some issues of procurement of medicines, medical devices and auxiliaries to them subject to procurement in 2020. On Approval of the List of Medicines, Medical Devices and Auxiliaries to them subject to procurement by CPA and IOs for the budgetary funds https://www.kmu.gov.ua/npas/deyaki-pitannya-zakupivli-likarskih-a350


10. CMU Decree No. 537 - On amendments to CMU Decrees No. 298 and No. 707 To prolong the delivery terms of procured products by IOs. https://www.kmu.gov.ua/npas/pro-vnesennya-zmin-do-poryadkiv-zatverdzhenih-postanovami-kabinetu-ministriv-ukrayini-vid-17-bereznya-2011-r-298-i-vid-5-veresnya-2018-r-707-i270520-537


11 CMU Decree No. 538 - On Amendments to the CMU Decree No. 622 of July 22, 2015 and No. 707 dated September 5, 2018 https://www.kmu.gov.ua/npas/pro-vnesennya-zmin-do-postanov-kabinetu-ministriv-ukrayini-vid-22-lipnya-2015-r-622-i-vid-5-veresnya-2018-r-707-i270520-538


12. MOH Order No. 1256 - On Approval of the Passport of the Budget Program for 2020 https://moz.gov.ua/uploads/4/20855-nakaz_1256_vid_27_05_2020.pdf




13. MOH Order No. 1391- On Approval of the Procedure for conducting examination concerning authenticity of registration materials on the medicine which is submitted for the state registration for the purpose of its procurement by CPA and IOs https://zakon.rada.gov.ua/laws/show/z0659-20#Text

Approved June 15, 2020 by MOH and July 14, 2020 by MOJ

14. MOH Order No. 1684 -On approval of the Procedure of selection by the MOH of specialized procurement organizations for procurement of medicines and medical devices https://zakon.rada.gov.ua/laws/show/z0746-20#Text

Approved July 28, 2020 by MOH and August 4, 2020 by MOJ

15. MOH Order No. 1917 - On Approval of the Quantities of medicines and medical devices to be procured by CPA https://moz.gov.ua/article/ministry-mandates/nakaz-moz-ukraini-vid-20082020--1917-pro-zatverdzhennja-zvedenih-pokaznikiv-100--potrebi-u-likarskih-zasobah-medichnih-virobah-ta-dopomizhnih-zasobah-do-nih-scho-zakupovuvatimutsja-derzhavnim-pidpriemstvom-medichni-zakupivli-ukraini

Approved August 20, 2020

Optimizing PEPFAR Supply Chain Contributions

16. MOH Order No. 1903 - On amendments to the MOH Order No. 585 dated July 10, 2013 https://zakon.rada.gov.ua/laws/show/z0894-20#Text

Approved August 17, 2020


IX. Success Stories

Empowering young leaders for healthcare transformation

When he enrolled into medical university, Dmytro Nestor was following his father’s footsteps, who

worked on the ambulance crew in his home city of Lviv, Ukraine. As a student, he saw the state of

Ukraine’s healthcare system and grew disappointed with the inefficient use of resources, lack of

transparency, the use of outdated treatments, inequality in healthcare access, and corruption. This

is when he made his decision to develop deeper understanding of Ukraine’s healthcare system and

committed himself to find solutions.

As the Government of Ukraine embraced a progressive health reform agenda bringing about urgent

improvements, Dmytro became a public activist, working with several government authorities and

non-governmental organizations to advocate for the uptake of the government’s ambitious reforms.

It is then that he became aware of another problem: a lack of effective leadership ready to take

responsibility and risks at the frontline of Ukraine’s healthcare reforms. So, he decided to grow as

one of such leaders and work hard for his community.

In 2019, Dmytro was selected by USAID SAFEMed to participate in the young professionals

Jumpstart initiative. Building on USAID’s long tradition of investing in young leaders, the program

places young professionals under direct guidance of more experienced development experts or

government health agencies to equip them with the skills needed to become civil servants or

development professionals in the medical field.

A year after joining the Jumpstart initiative, Dmytro has become a driver of change in his pursuit to

implement the healthcare transformation in Ukraine and a role model for other Ukrainian youth

graduating from medical programs in the country. As a Jumpstart junior consultant, Dmytro worked

in the area of Health Technology Assessment which allowed him to look at the use of medicines

from a holistic and evidence-based perspective. Dmytro is now seconded as a consultant to the

Center of Public Health where he analyzes access data for HIV medicines, creates dashboards, and

prepares literature reviews for policy-level decision makers to ensure life-saving HIV medicines

reach patients without interruptions. This work is crucial amidst the COVID-19 pandemic, as it

enables rapid response to logistical challenges and bottlenecks, recognizing the considerable

increase in demand for such services.

While working full time at SAFEMed, Dmytro is also returning to school, pursuing his studies in

public health. He believes that this will be beneficial for his current work at SAFEMed and further

professional growth.

The USAID SAFEMed program, led by Management Sciences for Health, has implemented the

Jumpstart initiative for over a year. During this period, nine young specialists have worked together

with international experts in the area of pharmaceutical and healthcare management. Many of them


have seen healthcare reform and its transformation first-hand, by working with those leading

reforms at the Ministry of Health of Ukraine, National Health Service of Ukraine, the Ministry’s

Central Procurement Agency, and the Public Health Center.

Improving Medical Public Procurement in Ukraine

Improving access to safe and affordable medicines for the Ukrainian population is a top priority of

the national government. A lack of medicines and medical supplies has long constituted a significant

barrier to treatment for patients in the country of 45 million people. Widespread corruption,

coupled with poorly managed logistics systems, inadequate medicines quality control, and

overregulated procedures, have only exacerbated the problem, leaving newly established family

physicians unable to address key health challenges, such as HIV/AIDS and tuberculosis, due to a

lack of testing supplies and medicines at the primary health care level across the regions.

Since 2015, the Ministry of Health has led ambitious and fast-paced procurement reforms aimed on

improving efficiency, cost-effectiveness, and transparency. Purchasing medicines with the help of

international organizations, reforms addressed immediate needs during times of political and

economic difficulty. By 2018, the focus had shifted to the establishment of a public transparent

procurement entity, and with support from USAID and other donors, Ukraine’s Medical Central

Procurement Agency (CPA) is learning how to take over. Established in October 2018, CPA is now

working on the development of a national procurement strategy and an operational manual for

category management, thanks to USAID’s support.

In less than six months since establishment, the newly formed agency has already demonstrated

early wins related to the use of public funds. It’s very first tender announcement for the Global

Fund Program resulted in cost savings of six million Ukrainian Hryvna on a 17 million auction

purchase of lifesaving medicines for HIV/AIDS. With technical guidance from USAID’s SAFEMed,

CPA is also poised to procure first-line treatments for Tuberculosis while working closely with the

Global Fund procurement agents and Center for Public Health.

For regional and local purchases, CPA is also exploring the use of new procurement mechanisms

such as framework agreements and an e-catalogue built for ProZorro. Such modern mechanisms

will help CPA to increase efficiency, transparency, and reduce bureaucratic burden and corruption

risks in medical procurement with public funds.

Guided by a strong vision and committed, the CPA aims to change the landscape of Ukraine’s health

procurement, accelerating access to quality, affordable health products for all.

Online application strengthens public procurement of medicines through improved

estimation and data use

The introduction of MedData, a new online application developed with support from USAID and

other donors, has improved the process of estimating quantities and costs of medicines and other

health products required for a specific period of time.


This is no small task, and mistakes are costly. Accurate quantification can be difficult if there is a

lack of reliable data, weak coordination among stakeholders, and a lack of defined roles and ability

to update and monitor forecasts and supply plans. If demands are underestimated, oncology or HIV

patients may be left without treatment; if demands are overestimated, scarce financial public

resources may be spent in vain.

Since its establishment in October 2018, the medical Central Procurement Agency (CPA) has been

tasked by the Ministry of Health to support the public procurement of more than 1,300 items under

40 national programs set to deliver medicines, vaccines, and medical devices across the country.

MedData has been used by hospitals and CPA’s category managers to collect, calculate, and verify

accurate quantification of medicines and other health products, essential for effective procurement.

“Earlier the Ukraine Ministry of Health didn’t have the right tool which enabled our specialists to

monitor procurement of medicines and calculate demand data effectively,” said Alyona Zhuzha,

CPA’s Monitoring, Analysis and Reporting Department Head.

Fast and easy to use, MedData optimizes the process of data collection and analysis. Changes made

by hospitals or by the CPA are transparent and visible online. It uses built-in formulas to improve

accuracy, so that all analysis are only a click away. It only takes minutes to estimate the demand

compared to the previous manual work that took hours, sometimes days, and often contained

human errors.

“… There are special formulas at MedData that allow you quickly and conveniently make all the

calculations to estimate your demand for medicines. From now on, we work on one platform. And

the collection of needs is online, which is also a big plus in the efficiency,” acknowledges Kateryna

Cairo, Chief Specialist from Regional Health Department in Dnipro City, Ukraine.

The tool’s functionalities continue to advance. It is set up to monitor and create red flags on

products’ shelf life, stock balances as well as reduce potential waste by the re-distribution of items

between health care facilities. It is quickly becoming popular, as data can be entered simultaneously

by authorized personnel at any hospital who have internet access. Since its roll out in 2019,

MedData is used by 144 procurement experts all many hospitals and regional health departments

across Ukraine.

safemed activity annual progress performance report

Documents