The Federal Ministry of Health now invites eligible consulting firms ("Consultants") to indicate their interest in providing the Services, Interested Consultants should provide information demonstrating that they have the required qualifications and relevant experience to perform the Services
ministry of Health
REQUEST FOR EXPRESSION OF INTEREST (REOI)
(Re-Advertised]
(CONSULTING SERVICES-FIRMS SELECTION)
Country: Federal Democratic Republic of Ethiopia
Name of Project: AFE Health Emergency Preparedness, Response, and Resilience MPA project
Loan No /Credit No./Grant No.: P180127
Assignment Name: Consultancy for In-depth legal analysis of national laws and other applicable rules on manufacturing, storage, distribution, and products liability; ownership, control, and autonomy of institutions responsible for - manufacturing of human vaccines and pharmaceuticals in Ethiopia. Reference No. ET-MOH-465961-CS-QCBS
The Federal Democratic Republic of Ethiopia has received financing from the World Bank for AFE Health Emergency Preparedness, Response, and Resilience MPA
HEPRR project (P180127) and intends to apply part of the proceeds for procurement of Consultancy services for In-depth legal analysis of national laws policies and strategies on manufacturing, storage, distribution, and products liability; ownership, control, and autonomy of institutions responsible for manufacturing of human v AFE Health Emergency Preparedness, Response, and Resilience MPA Vaccines and pharmaceuticals in Ethiopia.
The consulting services ("the Services") include conducting a comprehensive legal analysis of national laws, policies and strategies in relation to;
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- Regulation of manufacturing, storage, distribution, and product liability A (related to design defects, manufacturing defects and failure to warn about potential risks associated with the use of defective products) for human vaccines and pharmaceutical products, ensuring compliance with safety and quality standards; Ownership structure, governance, and operational independence of institutions tasked with human vaccine and pharmaceutical manufacturing;
- Assess the intellectual property laws in light of providing best standard of > protection to manufacturing human vaccines and pharmaceutical products.
- Determine the adequacy of the technical, legal, and regulatory framework, Th its alignment with international best practices;
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- Assess the legal and regulatory measures ensuring the integrity of supply chains for human vaccines and pharmaceuticals, including counterfeit prevention, import/export regulations and transportation standards.
- Examine the regulatory oversight of clinical trials, ethical approval T processes, and patient protection mechanisms to ensure compliance with 3 international standards.
- Asses the legal institutional framework for monitoring adverse effects, recall mechanisms, and reporting obligations for vaccines and pharmaceuticals.
- Assess laws and policies that ensure equitable access to essential medicines, i affordability mechanisms (such as price controls), and protections against monopolistic pricing.
- Assess impact of vaccine and pharmaceutical manufacturing, including waste management and carbon footprint reduction is compliant with environmental laws.
- Identify any gaps, and propose gap-filling measures including implementation plan on how to fill gaps identified.
The consultant should have a team of experts and experience in conducting legal, technical and regulatory analysis of industries and understanding of international standards is also critical. The detailed TOR for the assignment can he obtained at the address given below. The consulting firm should make efforts to ensure that all stated outstanding obligations are confirmed to have been satisfactorily met by the Ministry of Health (MOH) and the World Bank. The estimated implementation period for the study 2 months.
The Federal Ministry of Health now invites eligible consulting firms ("Consultants") to indicate their interest in providing the Services, Interested Consultants should provide information demonstrating that they have the required qualifications and relevant experience to perform the Services. Accordingly, the consultancy firm and its experts should have the following desired competency and experience.
The consultancy firm
Should have the expertise and practical experience in the conduct of the study indicated in the scope of services with testimonial statements from at least one similar project it handled before.
Should have a minimum of 3 years of experience as a registered legal firm.
Consultants may associate with other firms to enhance their qualifications but should indicate clearly whether the association is in the form of a joint venture and/or a sub-consultancy. In the case of a joint venture, all the partners in the joint venture shall fulfill the requirement as they are jointly and severally liable for the entire contract, if selected.
Required Qualifications and Work Experience of Experts
The consultancy firm should have multidisciplinary experts at least with the following qualifications:
- A PhD degree in law with at least 5 years of relevant experience, a Master's degree in law with at least 8 years of relevant practical experience in analyzing legal frameworks preferably related to manufacturing of health products or with Bachelor's degree and at least 10 years of relevant experience.
- At least Master's degree in pharmacy and having experience in pharmaceuticals manufacturing, with at least 8 years of relevant experience or with Bachelor's degree and at least 10 years of relevant experience.
- At least Master's degree in Pharmacy and 8 years of experience in GMP and regulatory of pharmaceutical products or with Bachelor's degree and at least 10 years of relevant experience. Any international experience is a plus.
- And other relevant non-key experts required for the task
- Fluency in English.
The shortlisting criteria are core business and years in business, relevant experience in conducting similar studies, technical and managerial capability y of the. firm. The Qualifications and Experience of Key Experts shall not be it included in the shortlisting criteria. Key Experts will not be evaluated at the shortlisting stage.
The attention of interested Consultants is drawn to Section III, paragraphs, 3.14, 3.16, and 3.17 of the World Bank's "Procurement Regulations for IPF Borrowers" November 2020 ("Procurement Regulations"), setting forth the all World Bank's policy on conflict of interest.
In addition, please refer to the following specific information on conflict of, interest related to this assignment: as per paragraph 3.17 of the Procurement Regulations.
Consultants may associate with other firms to enhance their qualifications but should indicate clearly whether the association is in the form of a joint venture with and/or a sub-consultancy. In the case of a joint venture, all the partners in the joint venture shall be jointly and severally liable for the entire contract, if selected.
A Consultant will be selected in accordance with the Quality and Cost Based selection (QCBS) method set out in the Procurement Regulations. Further information can be obtained at the address below during office hours in the morning from 08:30 am to 12:30 pm and in the afternoon from 01:30 pm to 05:30 pm at the address stated below.
Expressions of interest must be prepared in English and delivered in a written in person, or the form to the address below on or before 9April, 2025 at 3:00 pm by e-mail or by any electronic application, either in hard copy, soft copy or firms both. The soft copy version, which should be a scanned copy of the original vices, signed proposal with all signing details, signatures and stamps fully visible, they must be submitted along with a copyable / searchable PDF, or Word version m the of proposals on a CD or a USB in the address below.
Ministry of Health
Procurement Lead Executive Officer
P.O. Box 1234
Wereda: Lideta Subcity, Kebele 07/14 House: Sudan Street City: Addis Ababa, Country: Ethiopia
Tel. Landline:+251-11-515 0993
Procurement expert, Mr. Gemechisa Olani
Email: gemechisa.olani@moh.gov.et
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