ACCESS TO MEDICINES - POLICY AND ISSUES MOH Botswana

MAJOR HEALTH OBJECTIVE OF NATIONAL DRUG POLICY To make drugs of acceptable safety, efficacy and quality available and affordable to all those who need them, and to promote rational use by prescribers, dispensers and consummers.

REGISTRATION OF MEDICINES According to the Drugs and Related Substances Act 1992, no drug shall be imported into or exported form Botswana or manufactured, distributed or sold unless such drug has been and is registered by the Director of Health Services The registration of a drug shall cease to be valid if any significant change has been made to the composition of the product, the dosage form or conditions of its manufacture without the approval of the Director of Health Services (DRSA)

IMPORT AND EXPORT OF MEDICINES Drugs shall not be imported or exported except by Central Medical stores or by a person duly licensed there fore in accordance with any written law requiring such licence and with the written approval of the Director for such export or import

REGULATION OF PRESCRIPTION AND DISPENSING OF MEDICINES Registered medical practitioners and dentists may prescribe all drugs including schedule 1, 2 and 3 in the exercise of their professions and the Director may in suitable circumstances authorize limited powers of prescription of any such drugs to pharmacists, registered nurses and other health personnel -DRSA 1992 section 9 (2) Dispensing of schedules 1, 2 and 3 shall be by pharmacists through pharmacies or through institutions approved by the Director, but regulations made by the Minister may provide for medical practitioners, dentists, pharmacy technicians or other health personnel to dispense such drugs ... DRSA 1992 9(2)

PROCUREMENT AND DISTRIBUTION OF MEDICINES According to the National Drug Policy the objective is to procure good quality essential medicines drugs in sufficient quantities at the lowest possible prices to meet the needs of the health service All procurement procedures shall satisfy public health needs, national legislation (DRSA, PPADB, Intellectual Property Legislation etc) Ensure a safe, secure, cost effective and efficient drug distribution system to ensure accessibility and availability of essential medicines at all health facilities

ACCESS TO MEDICINES IN GOVERNMENT HEALTH FACILITIES National Expert Committees ( Medical, Pharmacy, Allied Health Professions) are responsible for the selection of drugs into Lists access based of level of health care ( Referral, District, Clinic) Develop treatment guidelines to promote rational prescribing, dispensing and use

POST MARKETING SURVEILLANCE To ensure drugs in the Market meet set standards of safety, efficacy and quality Collection of drug samples from market for testing/ pharmaceutical analysis Adverse Drug Reaction Monitoring Drugs Regulatory Unit, National Standing Committee on Drugs, Technical Committees reviewing efficacy of drugs in the market and changing therapeutics guidelines

MONITORING AND EVALUATION Implementation of Monitoring and Evaluation to assess access to medicines Setting up targets and indicators for drug availability at Central Medical Stores, Hospitals and Clinics Conducting Surveys on Prescribing and Dispensing Practices at Health Facilities

POLICY ISSUES Patented medicines are expensive especially drugs for oncology (cancer), cardiovascular diseases, second and third antiretroviral medicines etc Harmonization of medicines and intellectual property legislation with TRIPS necessary for improving access to medicines

ISSUES Ensuring Bilateral Trade Agreements do not hinder full exploitation of TRIPS flexibilities Implementation of the SADC Pooled Procurement Strategy to increase access Strengthen Medicines Supply Chain System Strengthen the Medicines Regulatory Authority

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