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.
The overall purpose of this short-term consultancy is to support the MOH in the implementation of new medicines safety standards, to provide an independent assessment of laboratories that conduct bioequivalence studies, and to recommend a long-term strategy for the development of laboratories network in accordance with EU standards.
It is expected that the Consultant will work with the Key Stakeholders, including but not limited to, the MOH (Pharmaceutical Directorate), State Expert Center, national laboratories, and associations of pharmaceutical manufacturers to build a better understanding of the current situation in Ukraine and to develop a set of evidence-based recommendations. Such recommendations in order of priorities will be used by the MOH to further stimulate compliance with EU bioequivalence requirements for generic medicines in Ukraine.
- Define current EU and Ukrainian requirements for laboratories to conduct bioequivalence studies of medicines.
- Identify clear and detailed criteria to be used in assessing laboratories for their compliance with established requirements with focus on the European integration of Ukraine.
- Conduct an assessment of up to 10 Ukrainian laboratories that conduct/potentially can conduct bioequivalence studies of medicines and document its learnings.
- Design options and recommendations for gradual transition of the national network of bioequivalence laboratories to be fully in line with EU requirements and standards.
- Propose relevant existing EU-funded programs (or other), that can be useful in the adaptation process.
- Discuss the assessment findings and recommendations with key stakeholders.
- Conduct up to 10 site visits to the laboratories located across Ukraine.
- Comprehensive report in English in SAFEMed standard format (will be shared) that contains but is not limited to:
- Comparative list of EU and Ukrainian requirements for laboratories that conduct bioequivalence studies.
- List of detailed criteria to be used in assessing laboratories.
- List of ISO standards that are recommended to be adopted in Ukraine.
- Finding of the assessment of Ukrainian laboratories that conduct / can potentially conduct bioequivalence studies and recommendations on how to bring national network of Ukrainian laboratories in line with EU requirements and standards.
- Slide deck for the round table discussion with stakeholders.
- Round table discussion with key stakeholders with the support of SAFEMed.
Total number of working days: 40 days in March – May 2020
It is expected the Consultant will spend:
- 15 working days to Ukraine (March – April 2020) in one trip;
- 25 working days remotely (5 days – preparing for a Ukraine visit, 15 days – drafting the report, 5 days – finalization of the report after discussion with SAFEMed and key stakeholders).
Duties performance location
Consultant will partially work remotely and will require travel to several cities of Ukraine during the course of consultancy, partially work at home.
Qualifications and Experience
- Solid understanding of bioequivalence issues and pharmaceutical markets.
- At least 10 years of experience and an in-depth knowledge of EU pharmaceutical regulations; experience of European countries in bioequivalence is a plus.
- Strategic thinking, outstanding written and oral English-language communication skills; no Ukrainian is required for this consultancy – English-Ukrainian Ukrainian-English translation/interpretation will be provided by SAFEMed.
- Extensive experience in conducting clinical studies and/or evaluating research laboratories.
About the Organization
Management Sciences for Health, an international nonprofit organization, is dedicated to closing the gap between what is known and what is done about public health problems. MSH saves lives and improves health by helping public and private organizations throughout the world to effectively manage people, medicines, money, and information. Working from more than 30 country offices and our US headquarters, our staff from 65 nations is highly regarded for its technical expertise, integrity, and commitment to making a lasting difference in health.
Management Sciences for Health (MSH) is a nonprofit international health organization composed of more than 2,000 people from 73 nations. Their mission is to save lives and improve the health of the world’s poorest and most vulnerable people by closing the gap between knowledge and action in public health. Together with their partners, they are helping managers and leaders in developing countries to create stronger management systems that improve health services for the greatest health impact.
MSH takes an integrated approach to building high-impact sustainable programs that address critical challenges in leadership, health systems management, human resources, and medicines. Simply put, they support stronger health systems for greater health impact.
Their expertise in these areas falls into the broad categories of management functions—for example, leadership and governance or pharmaceutical management—and health areas like tuberculosis or maternal, newborn, and child health. They apply their expertise by
- Partnering with governments, local organizations, and communities in developing nations to build their own capacity for long-term health impact;
- Providing global leadership in critical areas of health management and health care delivery;
- Bringing the best of MSH from around the globe to the people we serve, working as One MSH with a focus on lasting health system improvements.
Leadership, Governance, & Management
They work with in-country partners to build stronger health systems to improve:
- the management and leadership of priority health programs, health organizations, and multisectoral partnerships such as The Global Fund to Fight AIDS, Tuberculosis and Malaria, developing a critical mass of managers at all levels of the health system who can lead and inspire teams to achieve results;
- the management systems of health organizations in the public and private sector, transferring practical approaches and skills to ensure that management structures contribute to sustainable organizational success;
- the governance and management of health organizations and multisectoral partnerships, facilitating change and transferring knowledge to enable organizations to administer their resources efficiently and scale up their services.
Health Service Delivery
MSH combines extensive public health expertise, proven service delivery approaches, and evidence-based interventions in five critical areas:
- HIV & AIDS
- Maternal, newborn, and child health
- Family planning and reproductive health
- Other communicable diseases, including malaria and pandemic and avian influenza
Human Resources for Health
MSH helps governments develop multisectoral strategies and policies to plan and manage their health workforces. We use a comprehensive approach that addresses all the facets of human resources for health needed to achieve an adequate supply of well-trained and motivated health workers. MSH offers capabilities in leadership, human resource management, education, partnerships, policy, and finance to achieve these goals.
Vital to our success is a participatory approach to project design and implementation, which cultivates broad-based support from all stakeholders. We also build and improve infrastructure and local capacity to effectively purchase, store, deliver, and use quality essential medicines.
Health Care Financing
MSH helps governments and NGOs assess their current financial situation and systems, understand service costs, and develop initiatives to use existing funds more effectively and generate additional revenue—all with the goal of supporting a nation’s health priorities.
MSH has developed proven methods for rapidly strengthening the analysis and use of existing health data—normally at the province, district, and facility levels—without revising existing recording and reporting requirements. With an emphasis on learning through action, district teams undertake assessments of health services, identify gaps in performance, and design solutions to support better decision-making and, therefore, better management of improved services.
MSH has worked closely with the Health Metrics Network of the WHO to develop a comprehensive approach for enhancing the performance of health information systems and data by employing a practical, strategic planning process that can be carried out by national working groups.