Egypt : Complete Profile - What is GIS - World Health Organization

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Health Systems Profile- Egypt Regional Health Systems Observatory- EMRO Control Technical Committee (MCTC) establishes guidelines for provincial inspection services for drugs and medical devices. The national quality control organization, in cooperation with MCTC is setting up guidelines for quality assurance for drugs and medical devices. Clinical trials of drugs are carried out in compliance with good clinical practice pricing To promote the availability of safe and effective drugs at the lowest possible price, cost is achieved by rationalizing the drug pricing system in the public and private sectors, and by promoting the use of generic drugs selection. The selection of drugs on the national multi-level EDL is based on the following criteria: − must meet the health needs of the majority of the population − sufficiently proven scientific data must be available regarding the effectiveness of any such product − products should have a substantial safety and risk to benefit ratio. The National Organization for Drug Control and Research (NODCAR) represents the empowered national regulatory authority for quality control. NODCAR is entrusted with the quality control of pharmaceutical and biological products, raw materials, cosmetics, veterinary products, medical devices, household insecticides, medical plants and natural product as well as raw materials, and packaging and filling materials. In the last few years, the counterfeit medicine and smuggled drugs are considered an international problem. To combat this phenomenon the Egyptian government implements the following measures. − appropriate legislation that identifies the import, national transit, and export of counterfeit or smuggled goods into across and out of their customs − new legislation that strengthens the penalty for persons who are involved in this activity − inspection and enforcement of control − laboratory facilities for analytical tests of the products. Reforms over the last 10 years The Pharmaceutical Sector is an important component of the Health Sector Reform Program (HSRP). Over the last two years, several activities have been completed as part of reform of the Pharmaceutical Sector. The following is a summary of them: Develop new organogram for Pharmaceutical Sector. Develop new organogram for the National Organization for Drug Control and Research (NODCAR). Establish a new building for the MOHP Pharmaceutical Sector. Develop PHC Essential Drug list. Introduction of the new pharmaceutical system in MOHP facilities Introduction of clinical pharmacy service in MOHP hospitals Develop Essential Drug List manual for family health facilities. Complete national survey for drug consumption at MOHP facilities. 95
Health Systems Profile- Egypt Regional Health Systems Observatory- EMRO Review the national drug list. Develop job description for pharmacists working in the primary health care facilities. Establish training programs for pharmacists working at the five pilot governorates. Develop achievement indicators for staff working at the MOHP Pharmaceutical sector. Provide registration and pricing system program, recommended by WHO (SLAMED). Globalization Egypt has signed of the TRIPS agreement and became a full member (with no exemption) since January 2005 . this implies putting on additional burden in introducing new generic medicine specially with the long potency period given to the new pharmaceutical inventions Fortunately TRIPS agreement contains solutions for some problems under certain condition s The number of newly inverted drugs that needed till new is very few Egypt should not sign for the TRIPS plus agreement otherwise the breakthrough points with the TRIPS agreement will no longer exist Privatization The international trend of merge between the multinational pharmaceutical companies represents an extra burden on the smaller national companies Egyptian local manufactures should find way to overcome this challenge Planned reforms Pharmaceutical sector reform and the National Drug Policy (NDP) aim to make drugs affordable, safe, efficient, and available to the entire population based on the real needs at the time needed. The pharmaceutical sector reform strategies focus on the following. a. National Drug Policy b. Essential Drug List c. Legislations and regulations d. Rational drug use e. Pharmaceutical industry f. Human resources development (A) National Drug Policy The NDP was formulated and issued in 2001 an is integrated into the overall National Health Policy. The NDP must continue to evolve over time, therefore the following tasks must be accomplished; 1. Dissemination of NDP strategies and concepts among individuals in the health sector .and other stockholder 2. Monitoring implementation of the NDP in terms of presenting approaches to achieve the goals of the policy, and ensuring commitment by institutions and health professionals. 3. Periodical review of the NDP and strengthening the updating process. (B) Essential Drug List (EDL) The national EDL was approved in 1998. The drugs included in the EDL are quoted in generic terms, and are classified according to type of providers. The list of essential drugs needed for the basic package of services have to be made universally available. The 96
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