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CALL FOR A LEGAL AND ECONOMIC CONSULTANT

Terms of Reference for a Legal and Economic Consultant

Background

Medicines and medicinal products are currently regulated by the Pharmacy and Poisons

Board (PPB). The Pharmacy and Poisons Act, Cap 244 is outdated and out of sync with the

current market requirements. This has resulted in the proliferation of substandard

medicines and medicinal products as documented in the BBC report in 2018 which states

that up to 30% of products in Kenya are suspected to be of substandard quality.

To remedy the situation, the Health Act, 2017 directed that a new law to regulate

medicines and medicinal products would be developed i.e. the Kenya Food and Drugs

Authority (KFDA) Bill. Section 62 of the HA states that there will be established a single

regulatory body for health products and technologies. The Ministry of Health (MoH)

together with the Ministry of Agriculture, Livestock and Fisheries (MoALF) have drafted a

proposed KFDA Bill that covers not only medicines and medicinal products, but also food.

PSK argue that the regulation of every day food should be separate from the regulation of

medicines and medicinal products.

CAP 244 regulates the profession of pharmacy and the trade in drugs and poisons. It is

administered by the Pharmacy and Poisons Board (PPB). PSK argue that Cap 244 is

outdated, and is overdue for changes as envisioned in the enactment of the Health Act

(HA), 2017. Section 62 of the HA states that there will be established a single regulatory

body for health products and technologies.

In response to the HA, the MoH together with the MoALF have drafted the KFDA Bill, 2018

which seeks to ensure that1:

  • food is safe and it is produced and handled using appropriate standards;

risks to food safety are identified continuously and addressed expeditiously;

and the labeling and marketing of food is truthful and supportive of healthy

consumer choices;

  • medicines, medical devices and biological products (therapeutic products)

are safe, perform as intended and are produced using appropriate standards;

and the benefits to human health associated with their use is favorably

balanced against the risks of harm from the use of such products;

  • veterinary medicinal products are safe, efficacious and of good quality, and

they are used in a manner that promotes human and animal health goals;

and, cosmetics are safe and are produced using appropriate standards.

 

The proposed KFDA Bill creates a bloated governance structure and a scope that is too

wide to be effective, to the detriment of the products that should be more stringently

regulated – medicinal products. The proposed Bill is not aligned to the policy imperative to

regulate health products and technologies but has expanded its scope to everyday food.

 

PSK is aware that global approaches to the combined regulation of food and drugs is

changing as seen in the USA where there is a proposal to separate the regulation of food

from drugs (medicines and medicinal products The US Food and Drug Administration

3(USFDA) is one of the bodies that the Office of Management and Budget (OMB) has

proposed for restructuring to improve efficiency, effectiveness and accountability. The

argument they have made is that food safety is now more complex than ever with the farm

to fork approaches focusing more on traceability, nutritional value, labelling, and claims

regarding health impacts. This, they argue, is so important and needs to be regulated

through a single agency, the US Department of Agriculture, and free up the USFDA to focus

on its core responsibilities of drugs, devices, biologics and tobacco.

PSK seeks to recruit a consultant to conduct a legal and economic review of the proposed

KFDA Bill and make proposals to remove the regulation of food from the KFDA Bill.

 

Objective of the assignment

To conduct a legal and economic review of the Kenya Food and Drugs Authority (KFDA)

Bill in order to inform suitable advocacy proposals to enhance the regulation of health

products and health technologies in line with the original intention of section 62 of the

Health Act, 2017, and global international best practice which proposes the separate

regulation of food from that of medicines and medicinal products.

 

Scope of Work

PSK seeks to a recruit consultant to conduct a thorough legal and economic review of the

proposed KFDA Bill. Specifically, the legal and economic consultant will be expected to:

 

A. Prepare a report on the proposed KFDA Bill which incorporates:

  1. Desk research documenting international best practice on the regulation of

medicines and medicinal products Vis a Vis the regulation of food specifically

documenting:

  • Global best practice as evidenced by regulatory impact assessments in

other countries including the U.S.A., Denmark, and other countries who

have efficient and effective systems to regulate food, and medicines and

medicinal products.

  • Conduct a review of international agreements on the regulation of food and

that of medicines and medicinal products to put forward the most suitable

policy framework that Kenya should adopt.

  • Regional approaches to regulation of food, and that of medicines and

medicinal products, specifically the East African Community.

  • Review and document the current impact on health outcomes from the

current regulation of medicines and medicinal products in the country.

 

  1. A legal review of the Health Act, 2017 and the Kenya Food and Drugs Administration

Bill, 2018 to:

  • Prepare a legal opinion on the policy imperative of the Constitution of

Kenya, 2010 and the Health Act, specifically section 62;

  • Prepare a comprehensive Bill critique of the proposed KFDA Bill, 2018; and

a memorandum to be used to advocate separate regulation of food from

that of medicines.

 

  1. Present the draft findings to the private sector to (a) understand private sector’s

position on the issue, and (b) support the development of a unified private sector

position informed by global best practice on effective and efficient regulation of food

and medicines and medicinal products.

This may require: conducting key informant interviews, focus group discussions, or

stakeholders’ workshops as may be appropriate.

  1. Along with PSK, co-facilitate relevant stakeholder engagements with the private

sector to accurately document the position of private sector on the issue.

 

The final report will be used to develop a suitable industry Policy Position Paper (PPP).

The process of developing a PPP will be supported by PSK’s Research and Policy Advisor.

 

B. Advice and support:

  1. The consultant will be required to participate in the wider consultative process to

support, and advice on the engagement of PSK with relevant government officials.

  1. The consultant may be required to make presentations of their findings to key

government officials, including, but not limited to legal departments of the MoH and

MoALF, Parliament and the Attorney General’s office.

 

Deliverables and outputs

  1. An inception report.
  2.  A draft report incorporating findings of the desk research, and a draft Bill critique

for submission to industry stakeholders. This draft report should be submitted for

review by PSK prior to presentation to industry stakeholders.

  1. A comprehensive report incorporating:
  1. Findings of the desk research
  2. The KFDA Bill critique
  3. A memorandum on the KFDA Bill
  1. Facilitation of forums where PSK is engaging private sector and key government

officials.

  1. Presentations to key government officials on the findings of the research, and the

industry position.

 

Improvement of the Terms of Reference

The Legal Consultant may advice on modalities to improve the Terms of Reference, which

he/she considers would improve the outcome of the assignment. Such proposals, if

accepted, will form part of the Terms of Reference of the assignment.

 

Consultant specifications

  • LLB Degree from a recognized University
  • Public policy degree, or a background in economics
  • A broad base of legal drafting experience
  • Previous experience in supporting the health sector be an added advantage.
  • At least five (5) years’ experience in public policy analysis

 

Proposal Submission

The proposal documents should include:

  1. Profile of the organization, staff and Lead Consultant
  2. Technical proposal outlining:
  • An explanation of the approach to be taken;
  • A proposed project work plan
  1. A detailed budget with breakdown on number of man days required to

conduct the assignment;

  1. A previous report completed on a similar project undertaken in Kenya in

the last 3 years; contracting party and contact details.

 

How to apply

The Consultant is required to submit a technical and financial proposal before CoB 16

January 2019 to:

The CEO, PSK: ceo@psk.or.ke