Action Point 1 - Strategy to support capacity building
One of the main objectives of SEARN is dedicated to ‘facilitate and support regulatory capacity development to enhance regulatory skills and competencies and strengthen regulatory systems in the region’. Capacity building was also one of the most common demands from the working groups during their meetings in January 2022 and from the Steering group in its March 2022 meeting.
To address this need, the Assembly adopted on 8 June 2022 the SEARN Work Plan 2022-2023 which includes the action point 1, led by Working Group 2 (WG2) Regulatory Strengthening: ‘Draft a strategy to support capacity building for SEARN members’.
Scope and definitions
While the concept of capacity building (later replaced by capacity development) has often been used synonymously with training and technical assistance, these are only some of several approaches to developing capacity (1).
The United Nations Sustainable Development Group (UNDG) defines capacity as ‘the ability of people, organizations and society as a whole to manage their affairs successfully’ and the United Nations Development Programme (UNDP) has defined capacity development as ‘the process through which individuals, organizations and societies obtain, strengthen and maintain the capabilities to set and achieve their own development objectives over time’ (2,3).
The UNDP identifies 3 inter-related levels to capacity development (2):
- Individual—improving individual skills, knowledge and performance through training, experiences, motivation and incentives;
- Organizational—improving organizational performance through strategies, plans, rules and regulations, partnerships, leadership, organizational politics and power structures, and strengthening organizational systems, processes, and roles and responsibilities
- Enabling environment—improving policy framework to address economic, political, environmental and social factors including economic growth, financing, labour markets, political context, policy and legislative environment, class structures, and cultural aspects in a coherent and mutually reinforcing fashion.
Specifically, the World Health Organization (WHO) has established a Regulatory System Strengthening (RSS) programme which uses the Global Benchmarking Tool (GBT) to identify strengths as well as areas for improvement, and develop Institutional Development Plan (IDP). In this context, this strategy generally encourages the Members of SEARN to use the GBT to strengthen their regulatory systems for all medical products. Of interest, the GBT defines competency as follows: ‘Competency combines knowledge, skills and attitude. Competencies describe how the work is to be carried out while objectives indicate what must be accomplished. They also provide a sound basis for consistent and objective performance standards by creating a shared language for what is needed and expected by the organization’.
This strategy focuses on:
- Individual capacity development
- Organizational capacity development, in complement to the WHO Regulatory System Strengthening (RSS) programme.
To support the SEARN member countries in strengthening their regulatory capacity.
- To identify and prioritize the needs of the SEARN members in terms of capacity building
- To create an environment supporting capacity development of SEARN members in order to strengthen regulatory systems in the region.
UNDP levels for capacity development
Please see above (Scope and definitions)
Global Benchmarking Tool
The Global Benchmarking Tool (GBT) represents the primary means by which the World Health Organization (WHO) objectively evaluates regulatory systems, as mandated by WHA Resolution 67.20 on Regulatory System Strengthening for medical products (4). The tool and benchmarking methodology enables WHO and regulatory authorities to:
- identify strengths and areas for improvement;
- facilitate the formulation of an institutional development plan (IDP) to build upon strengths and address the identified gaps;
- prioritize IDP interventions; and
- monitor progress and achievements.
As part of this tool, all regulatory functions include sub-indicators related to the existence and implementation of guidelines, procedures, and tools, the development of which may be supported by collaboration and information sharing between the Members of SEARN.
Further, all regulatory functions include an indicator related to Human resources, containing several sub-indicators.
Global Competency Framework
The draft WHO Global Competency Framework for Regulators of Medical Products outlines competence criteria for pharmaceutical regulators and investigators. The global competency framework is designed to identify critical gaps in the professional development and capacity of regulatory personnel. The framework provides performance indicators across a variety of national regulatory functions, including the regulatory governance framework, marketing authorization/ reviewers, regulatory inspection, vigilance and surveillance, and laboratory analysis.
The competency framework’s provides means to evaluate NRAs development and a range of its capabilities to perform critical regulatory functions. Thus, the global competency framework allows competency modeling by individual NRAs across the maturity levels, in particular, levels 1 to 3, aligning individual capabilities with the organizational strategy and business processes.
The framework is organized around the competencies of an individual regulatory professional linked to the practice activities, which is used to define staff responsibilities. The defined practice activities are observable regulatory work inputs and outputs, integrating multiple competencies ,and the knowledge, skills, and behaviors for that activity. Practice activities are either core activities that are linked to the organizational regulatory system as defined in the WHO GBT or role-specific practice activities for reviewers, pharmacovigilance, laboratory analysts, and inspectors.
Overview of the draft Global Competency Framework for Regulators of Medical Products
The Framework expresses competency requirements for regulatory personnel of medicines and vaccines at two levels, each further broken down into activities and knowledge/skills
Meta-competencies – Competencies essential for the whole organization’s work environment; and are essential to performing the specific regulatory functions. They form the foundation for organizational success and include the following aspects: communication, compliance, critical and analytical thinking, evidence-informed practice, lifelong learning, operating with integrity, problem-solving, produces results and teamwork.
Core organizational activities – Activities that are required for the regulation of medical products, that are common to all regulatory functions in this domain. These include leadership, organizational awareness, preparation of reports to support regulatory decisions, quality management system (QMS), regulatory framework, policies, and process, surveillance and enforcement, and talent development.
Core knowledge and skills – Knowledge and skills that support the core activities aligned to each regulatory function and specific to that function.
Functional Competencies-underpins the understanding of the role of the NRA in terms of regulations including the statutes, regulations, guidelines, and processes, supervision of others, quality management system, regulatory inspections, and product quality.
Role-specific activities – Tasks that are specific to a regulatory role, which contribute to the NRA’s regulatory functions.
Role-specific knowledge and skills - Knowledge and skills that underpin the performance of role-specific practice activities.
Survey on capacity building needs of SEARN members
Based on the above frameworks, a survey was designed, discussed, and user-tested in the drafting group to capture the needs of the members of SEARN in terms of capacity building, at the individual and organizational levels. The draft survey was further discussed in WG2 during its meeting on 20 March 2023, and the comments were incorporated.
The questionnaire asked the respondents tree sets of questions:
- General information about the respondents, including which type of products they work with
- Capacity building needs at the individual level, based on the draft Global Competency Framework for Regulators of Medical Products (a short introduction was presented, as well as links to the document), and also asking about the preferred means of capacity building. The two last questions were open questions to cover any other aspect, one of them based on the GBT and explicitly asking about the 5 identified types of products.
- Capacity building at the organisation level, based on the global benchmarking tool, and highlighting the type of needs required. This part also asked about the preferred means of capacity building, and included one open question to cover any other aspect.
MTaPS supported an in-depth analysis of the results from the survey.
The results showed that for meta-competency domain on collaboration and core-competency domains on Regulatory framework, policies, and process and Surveillance and enforcement domains had the highest percent response and thus need for capacity building at an individual level both in the all-inclusive NRA responses and the country group responses.
Capacity building needs for role specific competencies domains showed preference for intermediate/advanced training vs. foundation training, which could be explained either by more difficulties in accessing advanced training resources or by the profile of the respondents. Below are the capacity building domains identified from the survey for each role:
- Reviewer role specific competency: Product Quality (Intermediate/Advanced) was identified as the highest capacity building need across all NRAs and country group responses.
- Inspector role specific competency: Regulatory decision-making (Intermediate/Advanced) domain was selected as the top capacity building need across all NRAs and country group 2 and 3 responses; however, it was the third domain identified for capacity building need for country group 1.
- Laboratory analyst role specific competency: Laboratory systems and equipment (Intermediate/Advanced) domain was selected as the top capacity building need across all NRAs and country group 2 and 3 responses. However, the outcomes of capacity building needs for country group 1 were: Analytical methods and reports, Work environment safety and Analytical methods and reports all at 23.81%, all below 50%. Analytical methods and reports domain was selected for capacity building recommendations for group 1.
- Vigilance Personnel role specific competency: post-market surveillance (Intermediate/Advanced) was chosen as the highest capacity building need across all NRAs and country group responses.
The outcomes of the other regulatory needs mapping for the key GBT indicators show that Regulatory System, Regulatory Inspections and Laboratory testing were the top areas that require capacity building for Medicines, Traditional, and Vaccines Products across all NRAs.
The outcomes of the organizational level capacity building needs mapping showed that regional collaborative/work-sharing mechanisms, Good regulatory practices, Guidelines and Transparency / Information Sharing are domains for capacity building for the following GBT regulatory functions: Regulatory System, Marketing authorization, Vigilance and Laboratory testing.
There was also a general preference for in person vs. virtual capacity development for all competency areas, which was more pronounced for role specific competencies for inspectors and laboratory analysts.
Prioritization of the needs
The Network decided to prioritize piloting the development of the preferred domains from each dimension of the draft Global competency framework based on the results of the survey:
- Meta-Competencies (Collaboration),
- Core-Competencies (regulatory framework, policies, and process),
- Role-specific competencies for reviewers (Product quality),
- Inspectors (Regulatory decision-making),
- Laboratory analysts (Laboratory systems and equipment)
- Vigilance personnel (Post-market surveillance).
Further, it was requested to also include in the strategy a dimension based on the objectives of the Members of SEARN, to facilitate easy identification of the capacities required to reach tailored goals (e.g. ML3, ML4 or WLA).
Mapping of available resources
Initial discussion identified potential resources which could be used to support the capacity building strategy:
- SEARN NRAs: to ensure sustainability of the strategy, independence, and favour capacity building, it would be preferable that SEARN NRAs are one of the main resources used for capacity building.
- WHO may be able to offer a range of capacity building offers through various programmes, its iLearn platform, or the WHO academy.
- Partners: The WHO has established a new WHO network for regulatory systems strengthening, called the Coalition of Interested Parties (CIP), to establish and promote a unified, strategic and coordinated approach to national and regional RSS, with a view to enhancing access to safe, effective and quality medical products . The CIP aims to increase the effectiveness of collective efforts and desired impact in countries and regions, thereby contributing to the implementation of Resolution WHA67.20 as well as the common objectives of the CIP participants. The CIP Network Terms of Reference were published in December 2020 and the current list of partners is available on the website of the CIP: https://cip-network-rss.org/en/content/members. Especially, 4 partners have historically been active in the region and supported some of the Member States:
- Bill & Melinda Gates Foundation: Guided by the belief that every life has equal value, the Bill & Melinda Gates Foundation works to help all people lead healthy, productive lives. In developing countries, it focuses on improving people's health and giving them the chance to lift themselves out of hunger and extreme poverty.
- MTaPS: Funded by the U.S. Agency for International Development (USAID), the Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program implemented and led by Management Sciences for Health (MSH) provides pharmaceutical system strengthening assistance for sustained improvements in health system performance.
- TGA: The Therapeutic Goods Administration is Australia's government authority responsible for evaluating, assessing and monitoring products that are defined as therapeutic goods and has provided support to several SEARN countries as part of the Indo‐Pacific Regulatory Strengthening Program co-established by the Australian Department of Foreign Affairs and Trade.
- USP/PQM+: Funded by the U.S. Agency for International Development (USAID), PQM+ improves the quality and expands the supply of essential medical products in more than 20 countries by sustainably strengthening medicines regulatory authorities and local pharmaceutical manufacturers.
- WHO Collaborating Centres and other centres of excellence: WHO collaborating centres (CC) are institutions such as research institutes, parts of universities or academies, which are designated by the Director-General to carry out activities in support of the Organization's programmes. Currently there are over 800 WHO collaborating centres in over 80 Member States working with WHO on areas such as nursing, occupational health, communicable diseases, nutrition, mental health, chronic diseases and health technologies (5).
- Other organizations: Many other organizations provide resources for capacity building and could be helpfully considered depending on the prioritized domains, including the Asia-Pacific Economic Cooperation (APEC), the Medical Dictionary for Regulatory Activities (MedDRA), the Uppsala Monitoring Centre (UMC), the Council for International Organizations of Medical Sciences (CIOMS), the International Society of Pharmacovigilance (ISoP), etc.
Principles guiding the development of the capacity building strategy
- The outcome of the capacity building strategy should benefit all Members of SEARN
- The strategy should rely on existing resources and only develop a new capacity building offer in areas where there are unmet needs
- The capacity building offer should be sustainable and predictable so NRAs can consider it in their training strategies
- The capacity building outcomes should be documented
- Pilot the development of a sustainable capacity building offer in the prioritized domains of competency in relation with the countries’ tailored goals.
- Map capacity building actions conducted by the Network.
- Bester A. Capacity Development: A Report Prepared for the United Nations Department of Economic and Social Affairs for the 2016 Quadrennial Comprehensive Policy Review [Internet]. 2015. Available from: https://www.un.org/en/ecosoc/qcpr/pdf/sgr2016-deskreview-capdev.pdf
- UNDP. Capacity development - UNDAF Companion Guidance [Internet]. 2017. Available from: https://unsdg.un.org/resources/capacity-development-undaf-companion-guidance
- UNDP. UNDP and capacity development | United Nations Development Programme | about [Internet]. [cited 2022 Oct 23]. Available from: https://www.undp-capacitydevelopment-health.org//en/about-us/capacity-development/
- WHO. Global Benchmarking Tools [Internet]. [cited 2022 Dec 8]. Available from: https://www.who.int/tools/global-benchmarking-tools
- About WHO: Collaborating centres [Internet]. [cited 2022 Dec 8]. Available from: https://www.who.int/about/collaboration/collaborating-centres