Legal Consultant

Statement of Work

Date: 4 May 2021

Project Name: USAID Medicines, Technologies, and Pharmaceutical Services (MTaPS)

Area: Drafting of Drug Act, regulations and guidelines in Nepal

Title: Consultant – Legal Assistance

Period of Performance: June 1st, 2021 to July 31st, 2022

Background:

Drugs Act of Nepal was promulgated in 1978 to establish a regulatory authority for the regulation of drugs. The major objective of the Act is to prohibit the misuse and abuse of drugs, prohibit false and misleading information on drugs and to regulate and control the production, import/export, sales and distribution, storage, and administration of drugs which are not safe for use, efficacious and of standard quality. The Government of Nepal established the Department of Drug Administration (DDA) in 1979 as per the provision of section 5 of the Act. The DDA has been made responsible to carry out all the functions related with the control of drugs under the Act and the rules framed thereunder.

MSH is seeking a consultant for the MTaPS program in Nepal to support the DDA in preparing a final draft of drug law and preparing regulations.

Description of Services to be provided

The consultant will support the work in the Ministry of Health and Population (MOHP) formulated working group involving representation from the DDA and other stakeholders and review all the existing draft Drug Acts. "The consultant will also review the gap analysis report prepared by an international consultant. In collaboration with the international Consultant and the working group, the consultant will prepare a final draft of Medicines and Medical Products Act for Nepal. The consultant will present the draft and facilitate consultative meeting(s) with stakeholders, which will be organized by MTaPS/DDA and the working group. The consultant will incorporate the recommendations/suggestions from such consultations for submission to the MOHP. The consultant will support the DDA and in collaboration with DDA and MTaPS update regulations and guidelines to become in line with the new Medicines Act and the WHO best practices.

The consultant will undertake the following activities:  

• Support the establishment of a legal working group 
• Review the four existing drafts of the Drug Act and the gap analysis report
• Collaborate with the International Consultant, DDA and MTaPS to prepare one final draft of the Medicines and Medical Products Act that takes consideration to already existing laws and regulations
• Draft the final Medicines and Medical Products Act both in Nepali and English versions
• Facilitate consultative meetings with stakeholders
• Finalize the draft in collaboration with the International Consultant for submission to the MOHP
• Address the feedback received on the draft law during the approval of the law by the government as necessary and appropriate
• Update the list of regulations and guidelines that need to be prepared/revised based on the final draft. 
• Support the revision and/or drafting of new regulations and guidelines in collaboration with the International Consultant, DDA and MTaPS.

Preferred Qualifications/Experiences

• Minimum of bachelor’s degree in law
• Minimum of 10 years of experience in legal field 
• Proven experience in the drafting of laws, preferably regulatory laws or regulations
• Experience in working with the Ministry of Health and Population, Nepal Law Commission and/or Ministry of Law, Justice and Parliamentary Affairs
• Ability to organize the own work with minimum supervision
• Ability to organize and facilitate working group and large consultative meetings
• Ability to write and prepare reports, documents and presentations
• Excellent written and verbal communication skills in Nepali and English

The interested candidate possessing above qualification and experiences are requested to apply with the following details at npprocurment@msh.org

• An updated CV including three references
• Budget requirement and payment terms