Consultant – Review and Operationalization of SMTA2 agreements for the PIP Framework Secretariat

Purpose of consultancy

To provide expert advice to help conduct the review of the terms and conditions of 15 existing Standard Material Transfer Agreements 2 (SMTA2s), as well as conduct research on, and prioritize additional manufacturers that are required to sign an SMTA2 with WHO. The Consultant will also provide technical expertise in the development of SOPs/Operational Guidance for implementation of the SMTA2 terms concerning supply and product regulation. Regarding access to diagnostics, the Consultant will draft a strategy to better engage influenza diagnostic manufacturers in order to improve supply of such products during an influenza pandemic.

Background

Building on lessons learned from the COVID-19 pandemic and to help prepare for a possible H5N1 outbreak in humans, this work is needed by the PIP Secretariat to ensure that all SMTA2 agreements can be fully operationalized at the time of the next influenza pandemic. This work will also help to ensure that products secured through the PIP Framework benefit sharing mechanisms will be supplied to countries in need at the same time as products on the market and that vaccines as well as other products will be available for donation.

Deliverables

• Task 1: Initiate and conduct the review of the terms and conditions of 15 existing Category A SMTA2s
  • Deliverable 1: Provide expert opinion on necessary changes to SMTA2 terms and conditions and produce a template of suggested changes with detailed explanations and comments.
    Expected by: 15 December 2024
  • Deliverable 2: In a cascading manner, conduct research into each SMTA2 signatory, including any changes in corporate structuring, production capacity and range of pandemic influenza products. Develop draft set of amendments for each SMTA2.
    Expected by: 30 April 2025
  • Deliverable 3: Advise on relevant issues arising during negotiations of the review of terms of an agreement, with the goal that the Secretariat could complete a review in a 6-month timeframe once negotiations begin.
    Expected by: ongoing advice until end of the contract
• Task 2: Prioritize manufacturers required to sign SMTA2s
  • Deliverable 4: Using the Influenza Virus Traceability Mechanism (IVTM) conduct research into non-GISRS entities such as influenza product manufacturers and developers that have received PIP Biological Materials but have not yet signed SMTA2s, including researching production capacity and the range and use of pandemic influenza products currently manufactured as well as being developed.
    Expected by ongoing work until the end of the contract
• Task 3: Provide Technical Expertise in the development of SOPs/Operations Guidance for implementation of SMTA2 terms
  • Deliverable 5: Advise on which terms in the SMTA2 require further operational and policy details to help ensure a coordinated and efficient roll out during an influenza pandemic of the products secured through the SMTA2s. Assist in conducting outreach with relevant units within WHO and draft relevant sections of the SOPs/operations guidance.
    Expected by 30 June 2025
• Task 4: Design a Strategy for Improving Engagement with the Diagnostic Sector
  • Deliverable 6: Develop a strategy to better engage the diagnostic sector and improve supply, during an influenza pandemic, of diagnostic products through PIP Framework access and benefit sharing mechanisms.
    Expected by 31 March 2025

Qualifications, experience, skills and languages

Educational Qualifications

Essential:

• Advanced university degree in law
• National qualification as attorney-at-law or equivalent

Desirable:

• First university degree in biomedical sciences

Experience:

Essential:

• At least 10 years of relevant experience in practicing law, preferably in the field of public health, regulatory and/or biotechnology.
• Experience in drafting and negotiating complex commercial agreements.
• Experience in practicing law in an international context.

Desirable:

• Experience working with WHO, including at WHO countries offices, or Regional Offices.
• Experience negotiating access commitments

Skills:

• Sound knowledge of corporate law, intellectual property law, regulatory law as well as knowledge of international law
• Strong interpersonal communications
• Strong writing skills
• Knowledge about ensuring equitable access to health products

Languages required:

Essential:

• Expert knowledge of English
• Intermediate knowledge of French

Location

Off site: Home-based

Travel

The consultant is not expected to travel.

Remuneration and budget (travel costs are excluded)

Remuneration:

Band C: USD 10,000 – 12,500 per month

Living Expenses (a living expense is payable to on-site consultants who are internationally recruited):

N/A

Expected duration of contract

3 months

Additional Information

• This vacancy notice may be used to identify candidates for other similar consultancies at the same level.
• Only candidates under serious consideration will be contacted.
• A written test may be used as a form of screening.
• If your candidature is retained for interview, you will be required to provide, in advance, a scanned copy of the degree(s)/diploma(s)/certificate(s) required for this position. WHO only considers higher educational qualifications obtained from an institution accredited/recognized in the World Higher Education Database (WHED), a list updated by the International Association of Universities (IAU)/United Nations Educational, Scientific and Cultural Organization (UNESCO). The list can be accessed through the link: http://www.whed.net/. Some professional certificates may not appear in the WHED and will require individual review.
• For information on WHO’s operations please visit: http://www.who.int.
• WHO is committed to workforce diversity.
• WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.
• Applications from women and from nationals of non and underrepresented Member States are particularly encouraged.
• WHO prides itself on a workforce that adheres to the highest ethical and professional standards and that is committed to put the WHO Values Charter into practice.
• WHO has zero tolerance towards sexual exploitation and abuse (SEA), sexual harassment and other types of abusive conduct (i.e., discrimination, abuse of authority and harassment). All members of the WHO workforce have a role to play in promoting a safe and respectful workplace and should report to WHO any actual or suspected cases of SEA, sexual harassment and other types of abusive conduct. To ensure that individuals with a substantiated history of SEA, sexual harassment or other types of abusive conduct are not hired by the Organization, WHO will conduct a background verification of final candidates.
• Consultants shall perform the work as independent contractors in a personal capacity, and not as a representative of any entity or authority. The execution of the work under a consultant contract does not create an employer/employee relationship between WHO and the Consultant.
• WHO shall have no responsibility whatsoever for any taxes, duties, social security contributions or other contributions payable by the Consultant. The Consultant shall be solely responsible for withholding and paying any taxes, duties, social security contributions and any other contributions which are applicable to the Consultant in each location/jurisdiction in which the work hereunder is performed, and the Consultant shall not be entitled to any reimbursement thereof by WHO.
• Consultants working in Switzerland must register with the applicable Swiss cantonal tax authorities and social security authorities, within the prescribed timeframes (Guidelines issued by the Swiss Mission are available at: https://www.eda.admin.ch/missions/mission-onu-geneve/en/home/manual-regime-privileges-and-immunities/introduction/Manuel-personnes-sans-privileges-et-immunites-carte-H/Non fonctionnaires et stagiaires.html