Consultant

Job Description

Title: Consultant

Company Name: United States Pharmacopeial Convention (USP)

Vacancy: --

Location: Anywhere in Bangladesh

Salary: Negotiable

Experience:
∎ At least 5 years

Published: 5 Nov 2024

Education:
∎ Master’s degree in Pharmacy/Microbiology/ Development Economics/ or related field of study.

Requirements:

Additional Requirements:
∎ Minimum five years of practical experience in economic research and regulatory area
∎ Advanced knowledge and practical understanding of interpreting and implementing WHO Agreement in general and especially the TRIPS Agreement and international transactions
∎ Advanced understanding of international trade law and treaties and their implication to domestic laws, such as the trade law of BGD, and vice-versa when applied.
∎ Advanced university degree in international relations or law or Economic
∎ Solid comprehension of the interpretation and implementation of the exception of Articles 3, 4, and 5 of the TRIPS, the potential implication of a country withdrawing from the TRIPS waiver.
∎ Practical understanding of the Bangladesh Patent Act 2022, the National API Policy 2018 as well as the roadmap for promoting local production of APIs in Bangladesh.
∎ Advanced university degree in public health or health economic
∎ Working knowledge and understanding of regulatory systems and the pharma sector in Bangladesh or abroad.
∎ Skills: Logical and analytical capabilities and comfort with handling data; very strong communication skills including the ability to write in English clearly and concisely; ability to work effectively across a broad range of stakeholders and administrative levels; project management.
∎ Willing: Handle multiple tasks and be flexible to respond to changing needs and travel.
∎ Period of Performance: From the time of initiation till May 25th, 2025. Maximum allowable 80 days.
∎ Legal documents: Valid Business Identification Number (BIN) and Proof of Submission Return (PSR).
∎ Payment Terms: Payment will be made in the next 30 days after submission of invoice and monthly progress report/assigned deliverables confirmation. VAT will be added and TAX will be deducted as per the government policy.
∎ Minimum five years of practical experience in economic research and regulatory area
∎ Advanced knowledge and practical understanding of interpreting and implementing WHO Agreement in general and especially the TRIPS Agreement and international transactions
∎ Advanced understanding of international trade law and treaties and their implication to domestic laws, such as the trade law of BGD, and vice-versa when applied.
∎ Preferred qualifications:
∎ Advanced university degree in international relations or law or Economic
∎ Solid comprehension of the interpretation and implementation of the exception of Articles 3, 4, and 5 of the TRIPS, the potential implication of a country withdrawing from the TRIPS waiver.
∎ Practical understanding of the Bangladesh Patent Act 2022, the National API Policy 2018 as well as the roadmap for promoting local production of APIs in Bangladesh.
∎ Advanced university degree in public health or health economic
∎ Working knowledge and understanding of regulatory systems and the pharma sector in Bangladesh or abroad.
∎ Skills: Logical and analytical capabilities and comfort with handling data; very strong communication skills including the ability to write in English clearly and concisely; ability to work effectively across a broad range of stakeholders and administrative levels; project management.
∎ Willing: Handle multiple tasks and be flexible to respond to changing needs and travel.
∎ Period of Performance: From the time of initiation till May 25th, 2025. Maximum allowable 80 days.
∎ Legal documents: Valid Business Identification Number (BIN) and Proof of Submission Return (PSR).
∎ Payment Terms: Payment will be made in the next 30 days after submission of invoice and monthly progress report/assigned deliverables confirmation. VAT will be added and TAX will be deducted as per the government policy.

Responsibilities & Context:
∎ Review national and international policies as well as the agreements related to TRIPS, WTO, and Bangladesh’s LDC graduation.
∎ Identify existing registered patented medicines, patented but to lapse soon from the patent list, off-patent medicines, potentially new and patented molecules,
∎ Assess the current situation and potential implications of TRIPS waiver withdrawal on Bangladesh’s pharmaceutical sector, focusing on local production, access to patented priority medicines, and public health.
∎ Collaborate with key stakeholders to gather insights, identify challenges, and assess readiness for the transition.
∎ Conduct a quick review of relevant experiences from other countries with similar economic, health, and pharmaceutical development conditions as Bangladesh, and draw the main lessons learned in the assessment report.
∎ Develop/update an action plan to address challenges post-TRIPS waiver, ensuring continued access to essential/priority medicines.
∎ Organize consulting meeting/s with relevant stakeholders as applicable.
∎ An assessment report addressing the current situation and potential implications of TRIPS-waiver withdrawal on selected medical products
∎ Dissemination of the report findings among the relevant stakeholders.
∎ Purpose of the Assessment
∎ The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement allows Least Developed Countries (LDCs) certain flexibilities, including waivers on patent rules, compulsory licensing, and parallel importation of pharmaceuticals, ensuring access to affordable medicines. For instance, Bangladesh’s exemption from patent protection has enabled local production of generic medicines through reverse engineering, significantly benefiting its domestic pharmaceutical sector.
∎ However, as Bangladesh transitions from LDC to developing country status by November 2026, these flexibilities will be phased out, creating challenges for the local pharmaceutical industry. Currently, Bangladesh produces 98% of its medicine needs domestically, but after TRIPS waivers are removed, the country will face potential challenges of increased costs and barriers in manufacturing and accessing patented drugs. At present, in Bangladesh, there are 1757 generic medicines registered to be manufactured locally, from which some are patented, some are off-patent, and some are to be lapsed from patented lists. Patented and new drug molecules will require compulsory licensing and affordability will be highly affected by higher costs/prices.
∎ During this transition, Bangladesh may seek further TRIPS exemptions for the whole range of health products or for specific regimes of products. However, there is limited data on the number of patented medicines in use and their impact on public health, the number of off-patent molecules, on which medicines the TRIPS waiver withdrawal will have a significant impact regarding access, which medicines will need priority consideration to better access for public health protection, etc. Addressing these critical data gaps will facilitate preparation for the country through the post-TRIPS waiver landscape for ensuring continued access to essential and priority medicines for better public health.
∎ In collaboration with national stakeholders, the PQM+ Program, along with the World Trade Organization Cell of the Ministry of Commerce, the National Bureau of Revenue, DGDA, and BAPI, has already developed an action agenda to address these anticipated challenges. A key step was the implementation of the Patent Act 2022 and the National API Policy 2018. In the current program year, PQM+ will work with the Directorate General of Health Services (DGHS), DGDA and other related ministries to identify selected priority medical products used for tuberculosis and other infectious diseases, pandemic emergencies, as well as for reproductive, maternal, newborn, and child health, both patented and off-patented, and assess the current situation and potential implications of TRIPS-waiver withdrawal on selected medical products” on their availability and affordability.
∎ Responsibilities:
∎ The consultant will:
∎ Review national and international policies as well as the agreements related to TRIPS, WTO, and Bangladesh’s LDC graduation.
∎ Identify existing registered patented medicines, patented but to lapse soon from the patent list, off-patent medicines, potentially new and patented molecules,
∎ Assess the current situation and potential implications of TRIPS waiver withdrawal on Bangladesh’s pharmaceutical sector, focusing on local production, access to patented priority medicines, and public health.
∎ Collaborate with key stakeholders to gather insights, identify challenges, and assess readiness for the transition.
∎ Conduct a quick review of relevant experiences from other countries with similar economic, health, and pharmaceutical development conditions as Bangladesh, and draw the main lessons learned in the assessment report.
∎ Develop/update an action plan to address challenges post-TRIPS waiver, ensuring continued access to essential/priority medicines.
∎ Organize consulting meeting/s with relevant stakeholders as applicable.
∎ Deliverables:
∎ An assessment report addressing the current situation and potential implications of TRIPS-waiver withdrawal on selected medical products
∎ Dissemination of the report findings among the relevant stakeholders.

Employment Status: Full Time

Job Location: Anywhere in Bangladesh

Read Before Apply:

An updated CV with cover letter, and at least three (3) references

Expected daily rate to deliver the scope of work (SOW) excluding travel cost. The travel cost will be reimbursed by PQM+.

We only accept the electronic application.