Background
Ukraine has made significant strides in digitalizing the state and its functions. Successes of the Prozorro system, implementation of the national interoperability system for state registries (Trembita), increasing the transparency of public sector through open-data initiative, development of digital public services under "State in smartphone" initiative are well-known and documented. The Ministry of Digital Transformation (MDT) created in 2019 aims to continue and expand this trend. Most recently, the Government-launched the "Diia.gov.ua" e-services delivery web-portal and its namesake mobile application. These digital products embody the newest trends of digitalisation for citizens.
With support from its partners, MDT aims to rapidly develop new and improved e-services that will offer an enjoyable and secure experience. Recently Ukraine saw the development and implementation of several high-profile e-services in different spheres – business registration, construction, birth related services (eMalyatko), and others. At the very end of 2020, MDT launched a mechanism for individual entrepreneurs to apply for state support in the most battered economic sectors. E-service expansion, especially throughout the COVID-19 pandemic, helps citizens get no-contact access to governmental services. Such services also cut state administrative costs, bringing about more transparency into government-citizen interactions and slashing petty corruption.
Rapid development of e-services poses new challenges – cybersecurity threats and risks of personal data leak. To address this challenges MDT is constantly working on improvement of the Diia infrastructure (data centre, a set of web-portals and mobile application) information security, organizes “Bug bounty” challenges and performs data protection audits. In august 2021 MDT launched second “Bug bounty” challenge for the Diia application, this bug bounty is the first public bug bounty launched by MDT.
On 1 January 2021, UNDP launched its new Digital, Inclusive, Accessible: Support to Digitalisation of State Services in Ukraine (DIA Support) Project. The project is made possible due to support of the Government of Sweden and is carried out in close collaboration with the Ministry of Digital Transformation of Ukraine (MDT) and other government stakeholders.
The project builds on extensive UNDP experience in two areas: administrative service reform and reengineering and digitalising public administration processes with broad citizen and expert engagement. As part of the project, UNDP will help the government partners – primarily MDT – select several service clusters in use by citizens representing vulnerable groups. Services will be packaged to accommodate everyday needs and transposed into a fully digital format. While working on creation of new digital services, the DIA Support Project will certify the software systems developed under Ukrainian regulations and in line with international cybersecurity practices.
Following the outbreak of the full-scale war in Ukraine on 24 February 2022, the Government of Ukraine together with the President’s Office approached UNDP with a request to support creation of the state register of medical devices to enable better service provision to the citizens of Ukraine, including those most vulnerable affected by the war. In this context, UNDP is seeking services of a qualified professional to provide business analysis services for development of the state medical devices register.
Duties and Responsibilities
2. Objectives of the assignment / Scope of services
Following the Law of Ukraine "On Medicines", a system of registration of medicines have been created, which consists of a few subsystems: the registration service itself with the administrator's office, the national medicines list system and the public website of the register. However, this system needs to be substantially updated. The MVP of the project has already taken the first step and the first version of the register was created, but the absence of Electronic Common Technical Document (eCTD) compliance leads to the impossibility of harmonizing the legislative field with the European Union, which becomes very important after the President of Ukraine signs an application for EU membership.
The ultimate goal of this assignment is to create the grounds for development of a national State Medicine Register (SMR) system covering processes related to medicines at all stages of their life cycle - from applying for registration to market control, ensuring a single information space for data exchange and interoperability between all participants in the industry.
The main objective of this assignment is to conduct business analysis for processes connected with the SMR in part of harmonizing with eCTD, and medicines registration process, and reimbursement process which will be transformed to the technical requirement.
3. Description of responsibilities / scope of work
The Consultant will be responsible for conducting the following activities in order to achieve the overall goal of the assignment:
- Conducting interviews with stakeholders in frames of their current functions, further functional requests and potential user-experience.
- Review and analyse national and international legislation which regulates end-to-end processes for the system.
- Work with stakeholders to define business processes, stakeholder needs and their flow.
- Describe and analyse “as is” business process.
- Suggest and describe “to be” business process for the Register target model.
- Compilate requirements, description of back-end logic.
- Provide recommendations for the legal changes of the Register's and related processes regulation.
- Estimation of projects cost using appropriate systems, tools, and techniques.
- Planning and prioritizing projects backlog and development for the systems.
- Compilate technical requirements for development of the Register as procurement documentation.
- Support preparation of procurement procedures (if necessary).
4. Measurable outputs of the work assignment/deliverables
It is expected that the National consultant to provide business analysis services for development of the state medicines register will deliver the following services (non-exhaustive list):
Deliverable # | Deliverable essence | Deadline* |
Deliverable #1 | Analysis of EU Regulations: Regulation (EC) No 726/2004 in frame of Register functioning. Expected result: Developed regulations overview document which covers medicinal products:
| In 20 working days after signing the contract |
Deliverable #2 | Overview of SMR logical data model and functional structure Expected results:
| In 20 working days after acceptance of Deliverable 1 |
Deliverable #3 | Function requirements for SMR in part of compliance with eCTD and registration, estimation for project. Expected result: Developed technical requirements which covers medicines registration and related sub-registers for reimbursements procedures and includes:
| In 20 working days after acceptance of Deliverable 2 |
* The consultant should provide his/her proposal regarding the quantity of working days needed for each deliverable, based on the tentative deadlines indicated above, and indicate in the financial proposal amount distribution by deliverable section.
5. Management arrangements
The National consultant to provide business analysis services for development of the state medicines register will be primarily responsible for achieving the objectives of the assignment. He/ She will be responsible for all personal administrative expenses associated with the assignment.
6. Monitoring requirements / Terms of payment
The National consultant to provide business analysis services for development of the state medicines register will work under the overall supervision of the DIA Project Manager and will work closely with DIA Support Senior IT Specialist and Project Manager/Product Owner of the “SMR” Project from the Ministry of Health of Ukraine (MOH) side.
All deliverables shall be approved by UNDP in written form through e-mail after consultations with MOH representatives. No documents should be published or distributed to third parties without the approval of MOH and/or UNDP. The title rights, copyrights and all other rights whatsoever nature in any material produced under the provisions of this TOR will be vested exclusively in UNDP.
All documents should be submitted to the UNDP in electronic form (*.docx, *.xlsx, *.pptx, and *.pdf or other formats accepted by UNDP). The language of the materials and reports is Ukrainian.
UNDP will provide payment upon provision of each deliverable duly certified by UNDP in accordance with the schedule below:
Deliverable 1. 33%
Deliverable 2. 33%
Deliverable 3. 34%
Competencies
- Demonstrates integrity by modelling the UN’s values and ethical standards;
- Promotes the vision, mission, and strategic goals of UNDP;
- Displays cultural, gender, religion, race, nationality and age sensitivity and adaptability;
- Treats all people fairly without favouritism;
- Fulfils all obligations to gender sensitivity and zero tolerance for sexual harassment.
Required Skills and Experience
8. Required experience and qualifications
- At least university degree (Bachelor’s) IT, business analysis, management or other related field or relevant certificates
- At least 2 years of experience in IT as a business analyst and/or system analyst
- Knowledge of document analysis, writing user stories, functional decomposition, creating and using BPMN and standard UML tools (draw.io, Microsoft Visio or their analogues)
- Proficiency with project management tools: Jira, Confluence, Trello (or analogue) will be an asset
- The knowledge of API tools (Postman, Altova XMLSpy or their analogues) with logging/monitoring tools (Kibana and Grafana or their analogues) will be considered an asset.
- Native Ukrainian, working knowledge of English will be an asset.
9. Documents to be included when submitting the proposal
?
| Personal CV, including information about experience in similar projects / assignments, as well as the email and telephone contacts of at least three (3) professional references; |
? | Financial proposal in line with information presented in Section 4. Measurable outputs of the work assignment/deliverables; |
? | At least one example of written technical requirements, specifications of ToRs or parts of such documents if there is confidential information that cannot be shared fully. Documents have to be relevant to projects mentioned in the CV. |
?
| Duly accomplished Letter of Confirmation of Interest and Availability (template may be found at https://cutt.ly/Bzs6D4A); |
10. Financial Proposal
? Lump sum contract
The financial proposal shall specify a total lump sum amount, and payment terms around specific and measurable (qualitative and quantitative) deliverables (please, refer to Section 4 Measurable outputs of the work assignment/deliverables). Payments are based upon output, i.e. upon delivery of the services specified in the TOR. In order to assist the requesting unit in the comparison of financial proposals, the financial proposal will include a breakdown of Cost by Components.
11. Evaluation Criteria
- Educational background – 20 pts max
- 20 pts – Master degree or similar in IT, business analysis, management or other related field;
- 19 pts –Bachelor’s degree in IT, business analysis, management or other related field or relevant certificates.
- Experience in IT as a business analyst and/or system analyst – 25 pts max
- 25 pts – 6+ years of experience;
- 23 pts – between 3 and 5 years of experience;
- 17 pts – at least 2 years of experience.
- Practical experience with business analysis methods (document analysis, writing user stories, functional decomposition, creating and using BPMN and standard UML tools (draw.io, Microsoft Visio or their analogues) – 15 pts max
- 15 pts – well written and structured example ;
- 9 pts – not structured written example;
- Proficiency with project management tools: Jira, Confluence, Trello (or analogue) - 3 pts
- The knowledge of API tools (Postman, Altova XMLSpy or their analogues) with logging/monitoring tools (Kibana and Grafana or their analogues) – 2 pts
- Language Skills – 5 pts max
- 5 pts – Native / fluent Ukrainian. Working knowledge of English;
- 4 pts – Native / fluent Ukrainian.
Maximum available technical score – 70 points
EVALUATION METHOD:
? Cumulative analysis
Contract award shall be made to the incumbent whose offer has been evaluated and determined as:
a) responsive/compliant/acceptable, and
b) having received the cumulative highest score out of a pre-determined set of weighted technical and financial criteria specific to the solicitation.
* Technical Criteria weight: 70%
* Financial Criteria weight: 30%
Only candidates obtaining a minimum 70% from the maximum available technical score (49 points) would be considered for the Financial Evaluation
The maximum number of points assigned to the financial proposal is allocated to the lowest price proposal and will equal to 30. All other price proposals will be evaluated and assigned points, as per below formula:
30 points [max points available for financial part] x [lowest of all evaluated offered prices among responsive offers] / [evaluated price].
The proposal obtaining the overall cumulatively highest score after adding the score of the technical proposal and the financial proposal will be considered as the most compliant offer and will be awarded a contract.
12. Travel
In the case of unforeseeable travel, payment of travel costs including tickets, lodging and terminal expenses should be agreed upon, between the respective business unit and the Consultant, prior to travel and will be reimbursed. In general, UNDP should not accept travel costs exceeding those of an economy class ticket. Should the IC wish to travel on a higher class he/she should do so using their own resources.