Regulatory Policies

Guiding Principles

A national drug policy called "Tanzanian National Drug Policy" was written and approved in 1991 and is still functioning. The policy covers all aspects relating to drug regulatory control, drug registration, drug procurement and quality assurance. There is a plan "The Master plan for the Pharmaceutical Sector, 1992-2000, Tanzania, Mainland” developed in 1991. The country is in the process of implementing the policy[1].

However, the policy is outdated — dating back to 1991 — and a revised/ updated National Drug Policy and Pharmaceutical Master Plan is still awaited. Although the National Essential Medicine List/ Treatment Guidelines were revised in 2006, the list is far too long, containing over 700 items. This provides minimal protection for local pharmaceutical industries as there are many internationally produced products to choose from.

The overall objective of the existing Tanzania Drug Policy of 1991 is to make available to all Tanzanians ‘essential pharmaceutical products, which are of quality, proven effectiveness and acceptable safety at a price that the individual and the community can afford’. It aims to develop and support national pharmaceutical industries to increase local production and thereby encourage self-reliance. The policy contains provisions for:

1) Drug selection: the policy aims to select pharmaceutical products in accordance with the concept of essential drugs to be distributed as generic drugs.

2) Procurement: the policy prioritises essential drugs and preferentially supports local manufacturing companies (who have 15% leeway on prices over international suppliers), and aims to achieve self-reliance by shifting away from imports.

3) Distribution: essential medicines should always be available to those who need them and should be distributed in the most cost-effective manner.

4) Quality assurance: facilitated by the TFDA providing free technical support and regularly inspecting industries (although this is limited due to budget constraints). Local industries must register all drugs produced every year after showing that they have achieved GMP.

The policy also requires all drugs to bear their generic International Non-Proprietary Names

(INN) even when available under brand names only.

Privatization

The healthcare system in Tanzania is privatized. The aim is to minimize government expenditures and apply private sector managerial skills. Privatization of Tanzanian pharmaceutical industries has taken the forms of:

1)      Liquidation: government sold shares of state-owned industries to the private sector;

2)      Indirect subsidization: using tenders for international and local procurement to distribute essential medicines free-at-point-of-use for strategic medicines (e.g. ARTs and TB drugs) with resources from the Global Fund and PEPFAR);

3)      Contracting-out by tendering: MSD contracts the private sector to supply medicines[2].

[1] http://apps.who.int/medicinedocs/en/d/Jwhozip43e/26.1.13.html

[2] Robert M. Mhamba and Shukrani Mbirigenda, The Pharmaceutical Industry and Access to Eessential Medicines in Tanzania, Institute of Social and Economic Research, Rhodes University, Southern and Eastern African Trade Information and Negotiation Institute (SEATINI), Training and Research Support Centre in the Regional Network for Equity in Health in East and Southern Africa (EQUINET), July 2010, pp.9-10.