Roster of Consultants Access and Regulatory Systems Strengthening for medical products in Pacific Island Countries, Suva, Fiji

Purpose of consultancy

Support WHO Pacific Health Systems (PHS) unit implementing key regulatory functions for medical products such as product registration, post-marketing surveillance and control, including pharmacovigilance, quality control and substandard and falsified medical products in identified Pacific Island Countries (PICs) and other activities related to access to quality, safe and efficacious medical products as part of the initial phases of operationalization of the Pasifika MedPro Regulatory Collaboration.

Background

The mission of the Pacific Health Systems and Policy (PHS) team is to support Member States in the Pacific to attain universal coverage of health services for better and equitable health outcomes. Health sector development acts as the foundation that both underpins and unifies public health efforts aimed at combating diseases and building healthy communities in an efficient and equitable manner, especially for high priority, excluded and underserved population groups. A strong health system foundation enables effectiveness of individual programmes and efficient use of shared system resources for all programmes.

Access to safe, effective, quality and affordable essential medicines is important in achieving universal health coverage (UHC) and the Sustainable Development Goals (SDGs) and it’s one of the pillars of every health system.

In the Pacific Island countries (PICs) there are many challenges on access to essential medicines, including, availability, affordability, and quality and safety due in part to geographical challenges and weak pharmaceutical systems. Most countries do not have fully functional regulatory systems in place and weak procurement and supply chain management often lead to low availability and wastage of essential medicines.

The Action Agenda on Regulatory Strengthening, Convergence and Cooperation for Medicines and the Health Workforce endorsed by the Member States at the 68th Regional Committee Meeting supports regulatory strengthening, convergence and cooperation in countries. The PICs can benefit from sub-regional regulatory cooperation as most are unable to build and sustain fully functional regulatory authorities due to constraints in human and financial resources.

The establishment of a subregional regulatory platform to strengthen and perform regulations of medicines, vaccines and other pharmaceuticals in the PICs was endorsed by health leaders from across the Pacific at the 13th Pacific Health Ministers Meeting (PHMM) in French Polynesia.

In February 2023, WHO DPS organized a subregional regulatory meeting, where Pacific Member States reiterated a timely, robust and effective technical support required for countries at national, cross-country and subregional level to perform regulatory functions, with a focus on product entry and post-marketing surveillance. In order to improve PICs technical support, RSS unit need to increase resources to ensure country assistance without delays.

In addition, there is also a need to support countries in other aspects related to access to medical products, such as the review and update on National Medicines Policies.

Deliverables

The contractor/s will support Member States to implement country and subregional activities related to regulation and access of medical products through the sub-regional initiative: Pasifika MedPro Regulatory Collaboration.

Under the direct supervision of the Technical Officer (Regulatory Systems Strengthening) and overall guidance of the Team Coordinator (PHS), EMT team at WPRO and other WHO teams, the consultant/s will deliver the following (individual activities/combination of some activities based on countries and/or subregional priorities):

Output 1: Country support on various aspects of Regulatory Systems Strengthening
Deliverable 1.1: Conduct analysis and revision of existing legislative, policy and governance frameworks for medical products in selected countries;
Delivery 1.2: Develop drafts for legislation, regulation and guidelines for implementation of regulation of medical products (i.e. Regulations for import control and product registration, guidelines for dossier assessment and/or verification of sameness for product registration, guidelines for reporting adverse events, etc)
Delivery 1.3: Provide specific technical support in specific regulatory functions: (i.e. product dossier assessment, investigation and causality assessment of serious adverse events, recall of substandard and falsified medical products)
Delivery 1.4: Support training in country or online related to national regulatory priority needs and guidelines.

Output 2: Support on regulatory aspects at subregional level:
Delivery 2.1: Carry out research on options to support regulatory functions at subregional level through the subregional initiative: Pasifika MedPro Regulatory Collaboration;
Delivery 2.2: Support Product Verification Process-related activities: drafting SOPs and guidelines, support revision of technical documents for selected medical products
Delivery 2.3: Support information sharing among PICs and respond to regulatory queries, when needed.
Delivery 2.4: Facilitate consultations with Member States on Medical Product regulation across the Pacific countries.

Output 3: Support on areas related to access to medicines at national and subregional level:
Deliverable 3.1: Conduct analysis and revision of existing medicines and/or health policies covering access to medical products in selected countries;
Delivery 3.2: Formulate national medicines policies, monitoring and evaluation frameworks to track progress of policy development, implementation plans and/or strategic frameworks for policy implementation

Other deliverables:
Monthly activity reports of technical support provided to countries.

Target countries to be supported based on national regulatory needs as follows: Cook Islands, Federated States of Micronesia, Fiji, Kiribati, Marshall Islands, Nauru, Niue, Palau, Papua New Guinea, Samoa, Solomon Islands, Tonga, Tuvalu, Tokelau, Vanuatu and other areas and territories in the Pacific, if requested.

Method(s) to carry out the activity
Review all the relevant documents related to medical products regulation in the respective countries and regional initiatives;
Interview key stakeholders (Chief pharmacists, procurement managers, etc.) in each selected country; collect relevant information and data from selected countries and develop databases of medical products, suppliers and manufacturers present in the PICs;
Convene meetings, consultations, workshops with all the relevant stakeholders (Virtual and/or face-to-face)

Qualifications, experience, skills and languages

Educational Qualifications:

Essential: University degree in pharmaceutical sciences, medicine, health or pharmaceutical policy or other relevant discipline with postgraduate degree in a relevant field from a recognized university.

Desirable: Postgraduate qualification in pharmaceutical regulatory affairs, public health or pharmaceutical policy or related fields.

Experience:

Essential: Minimum of seven years of experience in access and regulatory affairs for pharmaceutical and medical products regulatory aspects, including diverse regulatory functions (product registration, pharmacovigilance, quality control) and/or pharmaceutical policies and governance.
Desirable: Experience in providing technical assistance in access and regulation on medical products to developing countries, Pacific Countries and/or Small Island Developing States (SIDS). Experience in regulatory convergence and cooperation initiatives.

Skills/Knowledge:

Essential:Experience conducting multi-country studies in low- and middle-income countries
Good interpersonal skills and capable of facilitating discussion and teamwork
Good analytical thinking and writing skills

Languages and level required:

Essential: Expert knowledge of English

Location

Suva, Fiji, and/or remote work or other WHO offices in PICs, including PNG.

Travel

The consultant might need to travel to selected countries in the Pacific.

Remuneration and budget (travel costs are excluded):

a.) Remuneration: Payband level B – USD 8 000 – USD 9 980 (monthly)
b.) Living expenses: TBD

Expected duration of contract:

1 month to 11 months depending on duties assigned and the request from countries.

This roster will be valid until 31st December 2025

Additional information

The purpose of this vacancy is to develop a list of qualified candidates for inclusion in the advertised roster. Successful candidates will be placed on the roster and subsequently may be selected for consultancy assignments; however, contracting of rostered candidates is not guaranteed.

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