Policy and regulation
The pharmaceutical sector is guided by a National Drug Policy (NDP), which was developed in 1993 G.C in line with the National Health Policy (3). There is no specific NDP implementation plan that set responsibilities, budget and timeline although some elements of the NDP are incorporated in the Health Sector Development Plan of the country.
The sector is regulated by the "Drug Administration and Control Proclamation No. 176/199, which was promulgated on 29 June 1999 G.C. This proclamation has superceded the former regulation called "Pharmacy Regulation No. 288/ 1964", which formed the legal basis for official establishment of drug regulation in Ethiopia. "The Pharmacy and Laboratory Department" was the first drug regulatory body established under the Ministry of Health by the Pharmacy Regulation No. 288/ 1964. The department performed drug regulatory activities as well as the registration of pharmacy personnel.
Following the passage of proclamation No 176/ 1999, the pharmacy department was transformed to an independent drug control authority named "Drug Administration and control Authority (DACA)" which became operational on September 2001 G.C.
DACA inspects manufacturers, wholesalers, drug retail outlets as well as pharmacy units in health care facilities. It issues certificates of competence to private manufacturers, wholesalers and drug retail outlets while trade licenses are issued by the Ministry of Trade. DACA has different written guidelines and inspection check lists.
According to the above proclamation, DACA can establish its own branch offices in the regions. But, so far, no branch office is opened. Instead, the Regional Health Bureaus are delegated to undertake inspection and licensing of drug retail outlets.
Proclamation No. 176/ 1999 defines the objectives, powers and duties as well as organization of DACA. Products covered by the proclamation include human and veterinary drugs, traditional medicine, pesticides, animal food additives, poisons, blood and blood products, vaccines, sera, radio active pharmaceuticals, cosmetics, sanitary items, medical instruments and Medical supplies.
The proclamation has provisions for regulatory activities such as drug registration, inspection, quality control, post marketing surveillance, control of clinical trial, drug information and advertisement, packaging and labeling of products. It also states the need for obtaining license for import, manufacture, wholesale and retail activity. But, it does not include requirements for obtaining such licenses. Regulations based on the proclamation have been drafted and submitted to the council of Ministers for approval.
The proclamation stipulates that any form of drug advertisement must be approved in advance by DACA. A drug information and Adverse Drug Reaction (ADR) monitoring unit has been established and ADR monitoring as well as dissemination of drug information to health professionals is recently initiated. Generic prescribing is advocated in both public and private sector but it is not obligatory. Generic substitution is also being practiced but has neither legal support nor prohibition.
Drug evaluation and registration system exists. The process involves assessment of the safety, efficacy and quality of products through clinical and Pharmaco-chemical data evaluation as well as laboratory quality control. Submission of WHO-type certificate is a requirement for products to be imported. There is a written guide line indicating the above and other requirements. However, the registration process is not linked to Good Manufacturing Practice (GMP) inspection of manufacturing plants.
According to article 16 of the proclamation, "no drug, whether produced locally or imported, shall be put to use unless it is duly registered by the Authority" (4). However, in practice, the registration focuses on products imported by the private sector. Locally manufactured products and those imported by the public sector are not subject to registration.
Delay in the registration process is a problem often mentioned by clients. The registration system is computerized and to date 3258 products are registered. But there is no list of registered products accessible to the public domain.
Quality assurance of pharmaceuticals
Following the promulgation of proclamation No. 176/1999, the old established drug quality control and toxicology laboratory was structured under DACA. It undertakes Physico-Chemical tests, Pyrogen tests, sterility test and toxicological tests. In 2001 G.C, a total of 294 samples were received by the laboratory: 2 taken from private pharmacies, 16 for public procurement, 31 for GMP inspection and 246 for registration purpose. 213 samples were tested the same year out of which 15 have failed the test.
Selection
There is a "List of Drugs for Ethiopia (LIDE)", July 2002 G.C edition, and it is further classified by level of health care facility. The list consists of international non proprietary (generic) names of drugs that can be imported or locally produced and it is also the basis of drug registration (5).
A National Essential Drugs list (EDL) containing 234 chemical entities was prepared in 1987 G.C. as an extract from the LIDE which was called "National Drugs List (NDL)" at the time. But, the EDL has never been revised and published since then (6).
Import and distribution
Import and wholesale are done by the public sector, private sector, NGO's and international organizations.
The Pharmaceutical Administration and Supply Service (PASS) of the Ministry of Health and the Pharmaceutical and Medical Supply Import and Wholesale Share Company known as PHARMID (semi-governmental organization) are responsible for import and distribution to the public sector. PHARMID has eight wholesale distribution branches (2 in Addis Ababa and 6 in different regions). The public procurement is done through international and local tenders as well as by direct purchasing or negotiation. It is limited to the LIDE. Guideline on drug donation is prepared in the local language.
In the private sector, the total number of importers /wholesalers has increased from only 11 in 1993 G.C to 42 in 2002 G.C. Procurement in the private sector is done by direct order to manufacturers abroad and it is also limited to the LIDE.
The drug retail activity is done by the public sector, private sector, city councils, and the Red Cross society of Ethiopia. This sub-sector has also shown significant growth in number of outlets during the last decade. In 2000/ 2001 G.C, there were 311 pharmacies (run by pharmacy degree graduates), 249 drug shops (run by pharmacy diploma graduates or equivalent), and 1971 rural drug vendors (run by nurses or health assistants or pharmacy technicians). Moreover, each health care facility has its own pharmacy unit / dispensary.
According to the Ministry of health, the potential coverage, defined as percentage of the population within 10 km of a health station (walking distance), is estimated at 51.2 % in 1993 E.C (2000/01 G.C). Indirectly, this shows that the percentage of the population which has geographical access to essential medicines is more than 51.2 %. (7)
Production
In 1993 G.C, there was only one local pharmaceutical manufacturing plant and it was owned by the government. Currently, drug production activity is being under taken by 13 local pharmaceutical manufacturing plants: One government owned, eleven private (unaffiliated with multinationals) and one private (affiliated with multinationals). Three of the factories are engaged in medical supplies production, one on empty gelatin capsule production and nine on finished product formulation using imported raw materials. However, only one of them has a certificate of competence from DACA.
There is no price control on pharmaceuticals. Both finished products and raw materials are subject to taxation, except anti retro viral drugs.
Drug financing
Sources of drug financing include government finance, private expenditure (i.e. user charges or out of pocket payments), external assistance, loan, and private health insurance. There are no updated figures on the contribution of each source although the National Health Accounts exercise in 1995/ 96 indicated that the private expenditure on drugs accounts for the largest share of the total estimated drug expenditure in the country.
In 2001/ 02 G.C, the total government drug budget was about 104 million ETB (US$ 12.1 million) which is approximately 19% the recurrent government health budget and represents a per capita drug budget of ETB 1.6(US$ 0.18). This is very low as compared with the target set in HSDP I (US$ 1.25) and WHO's recommendation of US$ 1.00 (8).
According to PASS, the total drug expenditure* of the Ministry of Health in 2002 G.C. was estimated at ETB 257.9 million (USD 30 million) representing a per capita drug expenditure of ETB 3.8 (US$ 0.44). No reliable data is available on the drug expenditure of the private sector and other sectors. According to the National Bank of Ethiopia (9), the total value of import of "medical and pharmaceuticals" in 2001/02 G.C was ETB 421.3 million (US$ 49 million). However, this category includes non-drug items as well and the value for drugs alone is lower than this figure.
* Includes: Regular MOH’s drug budget of 104 million ETB, Loan 47.7 million ETB, and donation of 106.2 million ETB.
The government owned health facilities provide free health care including drugs to poor patients upon submission of letters from local administration offices. Anti-TB drugs are also provided free of charge to all patients.
Rational Drug use
The Ministry of Health has prepared Standard Treatment Guidelines (STG) for six types of diseases and has distributed them to health care facilities. A national formulary based on the LIDE (2001G.C) is under preparation by DACA.
The concept of essential drugs is part of the basic curricula of pharmacists and pharmacy technicians. Public education on rational use of drugs is being given by DACA through the mass media. There is no mandated continuing education program for health professionals, except that pharmacy and medical associations occasionally organize continuing education programs for their members.
