With funding from the United States Agency for International Development (USAID), the Safe, Affordable, and Effective Medicines for Ukrainians (SAFEMed) project implemented in Ukraine in 2017-2022 by Management Sciences for Health 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 this goal through close collaboration with the Ministry of Health (MOH), National Health Service of Ukraine (NHSU), Central Procurement Agency (CPA), Center for Public Health (CPH), and State Expert Center (SEC), SAFEMed is guided by 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.
SAFEMed activities are implemented via technical, financial, and legal assistance in the following work streams: procurement, reimbursement, policy and priority settings, supply chain, quality assurance with a focus on bioequivalence of generic medicines.
The Ukraine MOH aims to improve access to quality generic medicines through policy regulations and requirements on bioequivalence. Proven therapeutic equivalency and effectiveness of pharmaceuticals is instrumental for successful execution of public procurement of medicines, medicines reimbursement program and universal health coverage in general. Currently, Ukrainian pharmaceutical market contains numerous medicinal products – many of them are produced by local Ukrainian manufacturers – registered before 2015 without sufficient requirement to prove safety, efficiency and quality of generic products. With Ukraine going towards European integration, pharmaceutical marketing authorization dossiers should comply with European Union (EU) requirements, including those for bioequivalence. Transition period is needed to help local manufacturers to meet this important requirement. Such transition should ensure continuous access to medicines provided to patients using public funds from one side and support implementation of the MOH bioequivalence policy from another.
In 2018 USAID's SAFEMed Bioequivalence Report provided an in-depth analysis of current and future legislative requirements for better governance of bioequivalence in Ukraine. EU Guidelines on the Investigation of Bioequivalence defines cases / conditions / circumstances when bioequivalence studies are necessary and additionally formulates requirements for their design, conduct and evaluation. It stipulates that the bioanalytical part of bioequivalence trials should be performed in accordance with the principles of Good Laboratory Practice (GLP). However, as human bioanalytical studies fall outside the scope of GLP, the sites conducting the studies are not required to be monitored as part of a national GLP compliance program. The bioanalytical methods used must be well characterized, fully validated and documented to yield reliable results that can be satisfactorily interpreted. Within study, validation should be performed using Quality control samples in each analytical run.
EU Guidelines on the Investigation of Bioequivalence should be read in conjunction with the Annex I of Directive 2001/83/EC as amended, as well as European and ICH guidelines for conducting clinical trials. As bioequivalence studies are clinical phase I studies, they must be conducted in compliance with the Good Clinical Practice (GCP). Bioequivalence trials conducted in the EU/EEA have to be carried out in accordance with Directive 2001/20/EC. The test products used in the bioequivalence study must be prepared in accordance with Good Manufacturing Practice (GMP) regulations. In addition, different ISO standards are applicable, e.g. ISO 17025:2017 and ISO 9001:2015.
Ukrainian legislation establishes similar requirements for bioequivalence studies. Thus, according to bylaws planning, conducting and reporting of all clinical trials, including bioequivalence studies, are performed in accordance with the requirements and principles of GCP. The manufacture, storage and handling of the investigational medicinal product shall be carried out in accordance with the procedure established by law. Laboratories involved in pharmacokinetic studies must meet GLP requirements. The institution that conducts bioequivalence clinical studies shall submit to the MOH State Expert Center an accreditation certificate issued by the MOH (if available).
As of today, there are 6 laboratories in Ukraine (4 private and 2 public, See Annex A attached) that conduct bioequivalence studies of medicines. Only two of them comply with GLP standards, one of them complies with GCP standards. In addition there are nearly 11 laboratories that potentially can conduct bioequivalence studies provided they have necessary equipment, staff and validated procedures (See Annex B attached). In order to safeguard health and to motivate Ukrainian and other manufacturers to carry out bioequivalence studies of its generic drugs in Ukraine, the existing laboratory network should be expanded and/or adapted to EU requirements and standards. In addition, some existing laboratories may need to be upgraded and appropriately certified. Appropriate certification is time consuming and requires significant investments into the staff professional development and technical equipment.
Some CIS countries successfully developed and established Official Medicines Control Laboratories with EU-funded support. Detailed discovery of financing approach included to the consulting scope. Before starting any preparations, a fact-finding mission should evaluate the exact needs of these laboratories and the incurred costs be calculated.
To support the assignment, the USAID Rwanda Health Systems Strengthening (RHSS) Project is seeking qualified professional(s) to carry out the functional analysis of the HIGE. The consultant(s) will work closely with the RHSS Project team throughout the entire assignment. RHIC has approached the RHSS Project and requested technical assistance to carry out a functional analysis (FA) of the Rwanda HI environment and governance functions. The main objectives of the FA are to:
- Analyze how critical and essential functions of a well-governed HI national environment are currently defined, understood, assigned, and covered by the various key institutional players/actors in Rwanda;
- Identify gaps in essential functions; and
- Provide decision-makers with policy options and recommendations towards better governance of the HI ecosystem.
The assignment will involve developing a conceptual framework that clearly describes the ideal situation for a well-governed HI environment. The framework, coupled with a thorough situation analysis, will define the current HI environment in Rwanda in a structured way.
The formal setting: Clearly understand the roles and functions of concerned actors as formally defined and assigned (set up) by laws, regulations, Ministerial orders, etc. Clearly determine how key roles and functions are defined and assigned. This is to identify gaps in the formal settings definitions and attributions compared to the referenced conceptual framework retained for the FA.
Compliance with the formal setting: Assess whether formally defined and assigned roles and functions are actually assumed and exercised by the concerned actors or not; if they are, measure the extent to which they are understood and/or applied; if not applied, identify why and which institution is presumed to assume and exercise the given role and function. This is to understand actors’ degree of understanding and compliance with formal settings in place.
CONCEPTUAL FRAMEWORK DESIGN AND FA IMPLEMENTATION APPROACH
The assignment will be performed in two main phases/steps:
- Elaboration of the conceptual framework and the situational analysis: The first part of the assignment will entail consultant(s) to undertake a thorough and extensive desk review of existing HI laws, policies, regulations and existing frameworks (from the literature) to identify and adapt or develop a conceptual framework that incorporates the vision and broader functions of a well governed HI environment and how the different players relate to each other. The conceptual framework will guide the situation analysis and gaps identifications of the current HI environment. Additionally, the consultant(s) will consult key informants through interviews and focus group meetings to obtain their perspectives on the current situation, on what a well-functioning HI environment entails and the best way forward.
- Analysis of gaps and formulation of policy options and recommendations: This part of the assignment will consist in identifying the gaps in the governance of the current HI environment and formulating policy options and recommendations to address them.
Two deliverables will be prepared, one at the end of each step:
- Report - part one: conceptual framework, situational analysis of the HI environment in Rwanda;
- Report - part two: gaps analysis and formulation of policy options and recommendations.
Both reports will be subject to reviews for inputs and validation. The design and implementation of the study will be done in close consultation with RHIC and MOH. A steering committee of the FA will be set-up to guide and oversee its design and implementation. The consultant(s) will advise on the composition and establishment of the committee and contribute to the elaboration of the TORs for the committee.