Technical support to Assess the Fiji Regulatory System and develop an Implementation plan for NRA

WHO
Technical support to Assess the Fiji Regulatory System and develop an Implementation plan for NRA Request for EOI

Reference: WPRO/2020-08/PIC_NRS/TN113132/lal
Beneficiary countries or territories: Fiji
Published on: 27-Aug-2020
Deadline on: 10-Sep-2020 00:00 (GMT 13.00)
Description

BACKGROUND

Strengthening regulation of medical products contributes in the achievement of universal health coverage (UHC) by ensuring the quality, safety and efficacy of medical products before being used by the public.

Assessment of national regulatory systems is key in building the capacity of National Regulatory Authorities (NRAs). The Fiji Ministry of Health & Medical Services (MHMS) has been previously assessed in 2017 for good governance for medicines (GGM) encompassing the whole pharmaceutical systems from selection, procurement, regulation and distribution.  However, there is still a need to evaluate the current performance of NRA functions.

Considering this will be the first NRA assessment in Fiji, a list of KPI’s will be identified based on the global benchmarking tool (GBT). These KPI’s will be used to assess or measure the performance maturity level of Fiji NRA. It will be also used to monitor progress of strengthening activities until it will become an independent NRA.

 

PURPOSE/SPECIFIC OBJECTIVE OF THE ACTIVITY

  • To provide support in finalizing the key performance indicators for benchmarking process.
  • To conduct assessment of Fiji national regulatory systems for medical products and develop a regulatory plan.

 

DESCRIPTION OF ACTIVITIES TO BE CARRIED OUT

Output 1: Completion of KPI’s and assessment of NRA

  • Deliverable 1: Final tool with KPI’s and sub indicators
  • Deliverable 2: Assessment report and draft recommendations

Output 2: Development of implementation plan for NRA

  • Deliverable 3: Workshop presentations and meeting report
  • Deliverable 4: Technical report and Implementation plan

 

METHODS TO CARRY OUT THE ACTIVITY

1. Work with WHO Country Office in Fiji and MHMS to:

  • • Review the global benchmarking tool and identify indicators and sub indicators that are relevant to Fiji context.
  • • Discuss with WHO DPS on the draft KPI’s and provide recommendation on its use.
  • • Discuss the KPI’s with MHMS and finalize the tool.

2. Work with WHO DPS in planning and conduct the assessment/meeting:

  • • Organize, plan and schedule the assessment with MHMS.
  • • Conduct NRA assessment with MHMS.
  • • Organize meeting with MHMS and key stakeholders to discuss progress of NRA functions, gaps and challenges identified.
  • • Develop implementation plan based on the assessment and outcome of meeting with MHMS and key stakeholders.

 

QUALIFICATIONS & EXPERIENCE

Qualifications required:

Essential: University degree or higher in pharmacy or medicines

Desirable: Post graduate degree or training in public health law or pharmaceutical law

Experience required:

At least 5 years of relevant experience in strengthening regulations in low/middle income countries, some of which should have been obtained in an international context. Experience in conducting governance or national regulatory assessment.

Skills / Technical skills and knowledge:

Demonstrated expertise and good knowledge on pharmaceutical regulatory system and framework. Have a fair understanding about overall pharmaceutical system, procurement and management of system and medicines/profession regulatory functions and activities.  Expert in doing assessment, desk research, report writing and developing improvement plans.

Languages:

Fluent in English

 

COMPETENCIES

Teamwork, respecting and promoting individual and cultural differences, Communication, Knowing and managing yourself and producing results.

 

ADDITIONAL INFORMATION:

The consultant will need to be based in Fiji in order to conduct NRA assessment and facilitate workshop (depending on Fiji if conditions allow and travel restrictions due to COVID-19). This work will end on 11th December 2020.

 

APPLICATIONS

Qualified and interested specialists should submit their CV {for individual contractors} or Company Profile {for institutional applications} and Expression of Interest {cover letter} to the Supply Officer through WP RO UNGM at < wproungm@who.int > by 10 September 2020. 

The cover letter should outline how their experience and qualifications make them a suitable candidate for this position and should include their proposed daily consultancy fee and availability.

Please use Tender Notice No. 113132 as subject to all submission. Only successful candidates will be contacted.