EAC Medicines Policy, Legislative and Regulatory Environment

All countries, apart from Rwanda, have distinct national medicines policies (NMPs). Rwanda’s policy is embedded in the National Health Policy. Burundi, Kenya, and Tanzania (Zanzibar) have updated NMPs. Tanzania (Mainland) has a draft policy that was presented in 2014, but has not yet been approved. Uganda is currently revising its NMP, which is expected to be completed in 2015. Rwanda started work on its NMP in 2009, but this is yet to be approved [14].

The time taken for the review and approval of NMPs is long. Timelines span 24 years, that is, 1991-2015 (Tanzania - Mainland); 13 years, that is, 2002-2015 (Uganda); 6 years, that is, 2009-2015 (Rwanda). Kenya has managed to produce three revisions over the period 1994-2012; Tanzania (Zanzibar) has produced two NMPs from 1991 to 2014; Uganda is on its third revision; and Rwanda is still developing its first policy. These timelines highlight the varying capacities and challenges faced by the Partner States in the development, review, and revision of NMPs.

The scope of existing NMPs of Partner States generally covers pharmaceuticals for human and veterinary use,¹ as well as herbal products. The updated policies of Kenya and Tanzania (Zanzibar’s) have extended scopes to also include medical devices and technologies, food products, tobacco products, cosmetics, and emerging health technologies.

Generally, the components of the NMPs in Partner States are based on the WHO- recommended components of NMPs:

• • Selection: evidence-based, focusing on morbidity patterns, EMLs
• • Supply: local production, procurement mechanisms, distribution and storage, disposal of unwanted or expired medicines
• • Rational use: STGs, Medicines Information, rational medicine use for training, education, promotion
• • Affordability: taxes or tariffs on essential medicines, pricing, use of generics, TRIPs mechanisms
• • Financing: user charges, health insurance, donor assistance
• • Human resource development: education, training, continuing education
• • Monitoring and evaluation: baseline surveys, indicators for monitoring, periodic monitoring, independent external evaluation
• • Research
• • Technical cooperation among countries
• • Legislative and regulatory framework: Drug Regulatory Authorities, good governance for medicines, legislation and regulation, medicines registration and licensing, quality assurance (inspection and enforcement), regulation of prescription and distribution

All Partner States have legislation in place to support the implementation of their policies. However, such legislation and regulations are often outdated and not enabling; in some instances, the legislation is the bottleneck for implementation. For example, in Uganda, the legislation places the National Drugs Authority as the overall body responsible for both the policy and the regulator. The situation is unique in Uganda, when in most countries the NMPs remain within the policy arm of Ministries of Health, and not with the regulatory authorities [15].

Kenya’s Pharmacy and Poisons Act of 1957 (Chapter 244) regulates both the products and the practice, while the policy calls for the separation of these functions. Kenya’s Pharmacy Practice Bill, 2012, proposed amendment to the Pharmacy and Poisons Act (Chapter 244). It also allows for the separation of the Pharmacy and Poisons Board from the Ministry of Health. However, current legislation also contributes to confusion regarding the autonomy of the regulatory body as it places the Chief Pharmacist of the Ministry of Health as the Registrar and the Director of Medical Services as the Chair of the Board. Therefore, in Kenya, the provisions in the 2012 policy to elevate the status of pharmaceutical services from under the medical directorate cannot be achieved within the existing legislation. ^[1]

In Burundi and Rwanda, existing pharmaceutical laws have to be changed to ensure semiautonomous status of the regulatory authorities, as these currently are based within Ministries of Health. Rwanda has already enacted a law in 2013 for establishing autonomous institution to regulate medical products; hence, it has not been stated here.

There is a move across the region toward the creation of semiautonomous government agencies to spearhead the national medicines regulatory affairs.

It is only in Tanzania (Mainland), through the Tanzania Food and Drugs Authority, and Uganda, through the Uganda Drugs Authority, that semiautonomous authorities exist. In the remaining Partner States, the regulatory authorities are all within the Ministries of Health. In Kenya, this is the Pharmacy and Poisons Board. In Rwanda, it is the Pharmacy Task Force. In Burundi, no actual structure exists even though registration of medicines occurs under a decree. While changes are being discussed in Partner States to establish semiautonomous structures, progress is slow. In Kenya, the Kenya Food and Drugs Authority Bill remains pending. The Rwanda Food and Medicines Authority (RFDA) Bill was approved in 2013; due to policy changes, this Bill was revoked and a new proposal is being considered where the RFDA will be an institution under the Rwanda Inspectorate and Competitions Authority (RICA) within the Ministry of Commerce.

There are three WHO prequalified drug quality control laboratories in EAC: Tanzania, Kenya, and Uganda. Across the EAC Partner States, there is a shortage of skilled human resource in NMRAs.

Table 2.2 presents an overview of pharmaceutical legislation and the agencies responsible for implementation for the EAC Partner States.

The EAC, unlike the Southern African Development region, does not have a regional mechanism for procurement of medicines. Nor does it have a regional list of essential medicines or regionally standardized treatment guidelines. These are areas for future development. Whereas, the initial focus is on regional harmonization concentrating on policy development and medicines regulation.

• [1] Normally vaccines, blood products, and other biologicals are considered to be within the framework of medicinal products for human use. This also true for herbal products for human use.