Short Term Consultant for Feasibility Study Pharma Regulation

Purpose of the Consultancy

To conduct a feasibility study on a sub-regional platform for regulatory pharmaceutical system strengthening and cooperation in the Pacific

Background

Access to safe, effective, quality and affordable essential medicines is important in achieving universal health coverage (UHC) and the Sustainable Development Goals. However, Pacific island countries (PICs) face 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. During the Technical Workshop on Strengthening Regulatory Framework for Pharmaceutical Systems in the Pacific which was held from 12 to 14 March 2018 in Denarau, Fiji, Member States discussed steps and strategies to strengthen regulatory frameworks in the Pacific and one of the meeting resolutions was to consider establishing a sub-regional platform for regulatory system strengthening and cooperation. Hence, a feasibility study is proposed to guide member states and WHO if such mechanism is feasible and can strengthen regulatory capacity in the Pacific with commitment from both sides.

Planned timelines (subject to confirmation)

Start date:  01 June 2018
End date:    30 November 2018

Work to be performed

The consultant will conduct a feasibility study on a sub-regional platform for regulatory pharmaceutical system strengthening and cooperation in the Pacific.

Method(s) to carry out the activity

Phase 1

• Develop project plan including study scope, methodology and assessment tool
• Review existing medicine policies, legislative and regulatory systems for pharmaceuticals in Pacific Island Countries or elements thereof
• Review pharmaceutical profiles, market structures and key pharmaceutical activities  of each of the selected Pacific Island Country

Phase 2

• Interview key stakeholders in each selected country using the assessment tool
• Collect relevant information and data from selected countries
• Analyse countries regulatory framework and mapping of each regulatory elements
• Identify areas of convergence between countries based on findings

Phase 3

• Submit final report on the feasibility of a sub-regional platform including overall recommendations on:

       a. Options for institutional arrangements
       b. Sustainability
       c. Costing estimates
       d. Barriers and facilitating factors for political acceptance
       e. Policy options for countries to facilitate collaboration at the sub-regional level

Output/s

Output 1: Feasibility study on a sub-regional platform for regulatory pharmaceutical system strengthening and cooperation in the Pacific

Deliverable 1.1: Project plan including study scope and methodology

Deliverable 1.2: Final feasibility study report

Technical Supervision

The selected Consultant will work on the supervision of:

Responsible Officer: Asaeli Raikabakaba, Techncial Officer, PHS/ EMT, raikabakabaa@who.int with guidance from EMT, WPRO, escalantes@who.int;

Manager: Martina Pellny, Team Coordinator Health Systems and Policy, PHS, WHO/ DPS

Specific requirements

- Qualifications required:

Essential:  University degree in pharmacy or medical sciences, or relevant health discipline and background in law or regulations.

Desirable: Postgraduate qualification in any of the following areas: medicine, public health, business management, law from a recognized university

- Experience required:

Essential: Minimum of seven years of experience in pharmaceutical related fields, such as pharmaceutical regulation, quality assurance, procurement and supply chain management and experience in setting up platforms or in working in the area of  regulatory convergence and cooperation

Desirable: Experience in undertaking feasibility studies in the area of institutional or organizational development

- Skills / Technical skills and knowledge:

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

- Language requirements:

Fluent in English

Competencies

• Communicating in a credible and effective way
• Producing results
• Moving forward in a changing environment
• Fostering integration and teamwork
• Knowing and managing yourself

Place of assignment
Suva, Fiji and place of residence of consultant

Medical clearance

The selected consultant will be expected to provide a medical certificate of fitness for work

Travel

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

Payment

Payment will be made in instalments and discussed upon issuing of contract.

Detailed cost and budget breakdown
Please quote your fee for a maximum of 60 working days over the indicated period.

Applications
Qualified and interested individuals should submit an application letter and CV  to wpfjidpsprocurement@who.int by 29 May 2018. Please use Tender Notice No.  71989 as subject to all submissions. Only short-listed applicants will be contacted