BACKGROUND: This paper discusses national programs implemented in India, Pakistan, Malaysia, and Philippines to generate and apply evidence in making informed policy decisions on the approval, pricing, reimbursement and financing of medicines, diagnostics, and medical devices. APPROVAL: In all countries, the Ministries of Health are generally responsible for approval of health technologies through various agencies like the Central Drugs Standard Control Organisation in India, Bureau of Food and Drugs for medicines and Bureau of Health Devices and Technology for medical devices in the Philippines, the National Pharmaceutical Control Bureau, Health Technology Assessment Unit and Medical Device Bureau in Malaysia, and the Drug Control Organization in Pakistan. Product dossiers are evaluated while taking decisions. PRICING CONTROL: India has a strong price control mechanism through the National Pharmaceutical Pricing Authority. In the Philippines, the Essential Drug Price Monitoring System monitors prices of 37 essential drugs monthly from all drugstore outlets nationwide. In Malaysia and Pakistan registration pricing of new drugs is negotiated/fixed by the government with the vendor. REIMBURSEMENT: A mix of social, voluntary private and community-based health insurance plans are available in India while the Philippine Health Insurance Corporation is responsible for reimbursement of drugs and medical devices in the Philippines. In Malaysia no formal reimbursement system is being practiced, and in Pakistan the government reimburses medical claims of its employees. FINANCING: In both India and the Philippines the bulk of health expenditure is out of pocket while the government pays for 20% and 28% respectively in both countries. The public health care services in Malaysia are heavily subsidized by the government with minimum fee being charged to the public. The government of Pakistan gives free medicines to its citizens at the public health facilities. CONCLUSIONS: In the region under discussion, one of the priority areas that the different regulatory agencies would benefit from is human resource development to facilitate the process of evidence based assessment of health technologies. Higher budgetary allocation and stronger legislation is also needed along with interagency and international coordination and cooperation to harmonize.
BACKGROUND: This paper discusses national programs implemented in India, Pakistan, Malaysia, and Philippines to generate and apply evidence in making informed policy decisions on the approval, pricing, reimbursement and financing of medicines, diagnostics, and medical devices. APPROVAL: In all countries, the Ministries of Health are generally responsible for approval of health technologies through various agencies like the Central Drugs Standard Control Organisation in India, Bureau of Food and Drugs for medicines and Bureau of Health Devices and Technology for medical devices in the Philippines, the National Pharmaceutical Control Bureau, Health Technology Assessment Unit and Medical Device Bureau in Malaysia, and the Drug Control Organization in Pakistan. Product dossiers are evaluated while taking decisions. PRICING CONTROL: India has a strong price control mechanism through the National Pharmaceutical Pricing Authority. In the Philippines, the Essential Drug Price Monitoring System monitors prices of 37 essential drugs monthly from all drugstore outlets nationwide. In Malaysia and Pakistan registration pricing of new drugs is negotiated/fixed by the government with the vendor. REIMBURSEMENT: A mix of social, voluntary private and community-based health insurance plans are available in India while the Philippine Health Insurance Corporation is responsible for reimbursement of drugs and medical devices in the Philippines. In Malaysia no formal reimbursement system is being practiced, and in Pakistan the government reimburses medical claims of its employees. FINANCING: In both India and the Philippines the bulk of health expenditure is out of pocket while the government pays for 20% and 28% respectively in both countries. The public health care services in Malaysia are heavily subsidized by the government with minimum fee being charged to the public. The government of Pakistan gives free medicines to its citizens at the public health facilities. CONCLUSIONS: In the region under discussion, one of the priority areas that the different regulatory agencies would benefit from is human resource development to facilitate the process of evidence based assessment of health technologies. Higher budgetary allocation and stronger legislation is also needed along with interagency and international coordination and cooperation to harmonize.
Authors: Noordin Othman; Agnes I Vitry; Elizabeth E Roughead; Shaiful B Ismail; Khairani Omar Journal: BMC Public Health Date: 2010-11-30 Impact factor: 3.295