Consultancy to support the development of WHO report on access to medicines for hepatitis C

1. INTRODUCTION

Few people living with HCV infection in low- and middle-income countries access new Direct Acting Antiviral (DAA) medicines and diagnostics.  This situation is likely to change as prices of these medicines become lower with the introduction of generic formulations, through pilot projects, access programs and when governments initiate treatment programmes. In 2014, Egypt was the first middle-income country to negotiate a reduced price for sofosbuvir of US$900 for a 12-week treatment as compared with a price of US$84,000 in the US or Euro 25,000–57,000 in Europe.  Due to the lack of applicable patents, some countries, for example Morocco, will be able to procure (or locally produce) generic DAAs. However, a lack of market transparency delays access to treatment including in high burden countries.  This applies to the regulatory-approval status and patent status of medicines and the availability and quality of generic formulations.

To address these concerns, the HIV/AIDS Department-Global Hepatitis Programme and the Department on Essential Medicines and Health Products is producing a report documenting the barriers to access to HCV treatment in countries where treatment programmes are starting and how these barriers are being surmounted.  The main objective of the report is to document how countries are improving access to the new DAAs and HCV diagnostics, including lessons learnt on how major challenges were surmounted and highlighting market information to contribute and advocate for improving global access to HCV treatment. The report will also share up-to-date market information on prices, sources, including local production of generics, and regulatory and patent status to complement existing HCV medicine landscapes and analyze how market dynamics impact drug availability in low and middle income countries. The purpose is to support advocacy for the introduction of HCV treatment and provide countries with critical information that will facilitate their program development.

2. DESCRIPTION OF THE ASSIGNMENT

I. Purpose of this assignment

The main aim of this consultancy is to collect and consolidate updated information on the status of access to new hepatitis drugs in ten selected countries; to document “country case-studies” as well as global market information on individual drugs or drug combinations and diagnostics. Information will be collected from a variety of sources, including ministries of health/national hepatitis programmes/policy makers, innovator and generic pharmaceutical companies, procurement and supply organizations, non-governmental organizations, such as Medicine Patent Pool, UNITAID, and others. Information will be validated and consolidated for inclusion int the WHO Report “Surmounting challenges in access to HCV treatment and diagnostics”.

II. Scope of Work

The assignment is from 1^st September 2015 to 29 February 2016, for a maximum of 90 days.

III. Outputs

• Design data collection tools and questionnaires (milestone 30 September 2015)
  • Identify sources for collection of information for country case studies, including decision-making process in engaging in hepatitis C response, role of civil society and opinion leaders, collaboration with implementing partners, number of sites and patients, diagnostic and regimen used, patent situation and license agreements, registration, procurement options, local production, dispensing policy, drug and lab cost policies and prices in various health sectors, success and constraints
  • Identify sources for collection of information on global markets for individual Hepatitis C drugs and combinations and diagnostics: sources and prices, status of prequalification and regulatory authority approved, innovator and generic producers, API availability, patent situation, registration status.
  • Draft collection tools and questionnaires for collecting information on country case studies and global market information, from a variety a partners and sources of information including ministries of health/national hepatitis programmes/policy makers, innovator and generic pharmaceutical companies, procurement and supply organizations, non-governmental organizations, partners such as Medicine Patent Pool, UNITAID, and others.

• Conduct data analysis and quality assurance of data received from selected countries for documenting case studies and market data on individual drugs /combinations – By 15 December 2015
  • Participate in data collection interviews (countries selected by WHO)
  • Assess quality and consistency of collected information:
• Review all contributions for technical accuracy and provide comments to contributors in consultation with WHO
• Cross check for complementarity of sections, identify gaps
• Ensure technical consistency across all sections of the case studies and global market information
• Ensure technical consistency with WHO treatment hepatitis guidelines and other published references on hepatitis drugs and treatment in consultation with WHO

• Prepare tables and graphs and draft text describing country case-studies and summary spotlights By 15 January 2016
  • Prepare tables and graphs for country case studies and global market data (both quantitative and qualitative data)
  • Organize and present data into final tables and graphs Draft sections of case studies and summary spotlights on market data

• Produce a quality assured document, internally consistent and aligned with WHO global guidance and standards – By 29 February 2016

IV. Timeframe & Deliverables

• Deliverable 1 : List of sources for information and data collection tools and questionnaires developed, due by 30 September 2015
• Deliverable 2: Information from countries and global pharmaceutical data collected and validated, due by 15 December 2015
• Deliverable 3: Tables and graphs, and drafted sections on country case studies and spotlight on individual drugs/combinations for insertion into WHO report, due by 15 January 2016
• Final document, due by 29 February 2016

V. Performance monitoring

The contractor’s work will be supervised by the Technical Officer, Responsible for Toxicity Monitoring (first-level supervisor), and by the Team Lead, Global Hepatitis Programme (second-level supervisor), both in the HIV/AIDS Department.

The detailed timeframe above includes deliverables and milestones, against which performance will be monitored on a monthly basis.

VI. Location and Travel

The contractor is expected to work remotely, with regular communication with the WHO technical focal points for this work.

Physical presence in Geneva may be required 2-3 times during the assignment, encompassing 2-3 weeks. Any duty travel related to this assignment will be organized separately, following the WHO Rules and Regulations on duty travel (not to be included in the proposal budget). The Contractor shall verify that all Contractor Personnel is legally entitled to travel to the country or countries where the work is to be carried out, including Switzerland.

3. REQUIREMENTS FOR THE ASSIGNMENT

I. Education

Essential: Master in Pharmaceutical Sciences, Medicine, or Public Health

II. Experience

Essential: At least 3 to 5 years’ experience in public health of which at least 1 year experience in the field of HIV and/or viral hepatitis

Desirable: Experience in HIV or Hepatitis data management and analysis with demonstrated ability to reach out key stakeholders, international partner collaboration, excellent communication and writing skills in English, familiarity and experience with the International Organizations.

Previous work experience with WHO or other international institutions in the field of HIV or Hepatitis would be an asset.

4. SUBMISSION OF PROPOSALS       

No later than 10 August 2015, 12:00 CET the bidder shall submit by email:

1.  A letter of motivation outlining relevant experience as mentioned under section 3. This letter also need to indicate the daily consultancy rate. Any cost related to the assignment need to be reflected into the daily rate except for travel as indicated under section 2.
2. An updated CV.

Email for submissions of proposal:        pdifin@who.int (use subject: Bid Ref 2015/HTM/HIV/008)

Mailing address for submission of proposal:

World Health Organization

Mrs Elleanie TEWOLDE

HQ/HIV-SIP, D45031

Bid Ref: 2015/HTM/HIV/008

20, Avenue Appia

CH-1211 Geneva 27

Switzerland

• Web Site: http://www.who.int/hiv/en/

• Keywords: Hepatitis, Direct Acting Antivirals, Access

• Documents to be attached:

• NONE