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Improving capacities for access to medicines (ATM) in Thailand

แผนงานวิจัยพัฒนาขีดความสามารถสำหรับการเข้าถึงยาของประเทศไทย;
Date: 2558-03
Abstract
The main purpose of the research project, “Improving Capacities for Access to Medicines (ATM) in Thailand” is to analyze national mechanisms and local-level situation for ATM and to propose policy recommendations for an improved ATM with regard to the following issues: (1) use of the compulsory licensing (CL) measure for innovative drugs; (2) national mechanisms for improved ATM; (3) access to drugs in National Lists of Essential Medicines (NLEM), Sub-list Ngor; and (4) monitoring of purchasing prices and reimbursed prices of medicines under sustainable financing. Based on literature review of the ATM context, the main issue for Thailand is about getting access to innovative medicines, of which various factors on intellectual property and international trade play important roles. This resulted in unaffordable prices for most developing countries due to market exclusivity of the patented, branded originator products, coupled with the delayed competition of generic drug industry. Lessons learnt from international community that could be applied to Thailand include (1) counteracting the evergreening patents by India using Sections 3(D) and 3(E) and by Australia using information on minimal therapeutic values of the evergreening patented medicines; (2) regional pooled procurement by Pan- American Health Organization (PAHO) for drugs used for non-communicable diseases (NCDs) additional to antiretrovirals, drugs used for tuberculosis and malaria; (3) country’s integrated policies toward strengthening domestic drug industries in Brazil and Argentina; (4) strong networks of civil societies that were synergetic with public sectors in incorporating social value judgement additional to technical support in making policy decision. Success in the use of CL by the Thai government in 2006 shed light on the following critical success factors, including (1) collaboration with civil societies and academia to counteract the reaction from original drug industry, (2) availability of the clear and easily accessible patent databases, and (3) secured sources of generic drug supply plus available information on production process and finished product quality. Other alternatives including price negotiation and use of TRIPS flexibilities should be considered as well. For management of ATM at the national level, the Thai government by Ministry of Public Health (MOPH) has focused on drugs covered by National Lists of Essential Medicines (NLEM), which have been established since the first National Drug Policy (in 1981). In early versions, the NLEM covered mostly basic essential drugs. At present, several drugs were included and ranged from sublist Gor for the basic essential drugs to sublist Jor(2) for the very expensive drugs. An innovative policy for improved ATM in the Universal Health Coverage (UC) scheme has been implemented through National Health Security Office (NHSO)’s Drug Fund. Drugs that have been managed by the NHSO included those in the NLEM sublist Jor(2), chemotherapy or hormones for outpatients, drugs for thalassemia and hemophilia, clopidogrel, orphan drugs, methadone, drugs of opportunistic infections in patients with HIV/AIDS, inhaled corticosteroids and long-acting bronchodilators, antituberculosis, immunosuppressants, morphine, psychiatric drugs (risperidone and sertraline until 2013). Use conditions for certain drugs might not be in accordance with those Indicated by the NLEM due to different committees. However, this issue has now been being resolved. Apart from medicines, NHSO managed vaccines under the Expanded Program for Immunization (EPI) and those under campaigns such as influenza virus vaccine and Japanese encephalitis vaccine. In implementing the national policies at the health care service level, because the three major insurance schemes used different payment methods and mechanisms, pharmacists and hospital personnel had to shoulder administrative burdens, such as separation of drugs and patients according to eligibility criteria. Changes in the policies and practices from MOPH, NHSO and Government Pharmaceutical Organization (GPO) required timely adaptive measures at the health care level and caused job stress to implementers. Thus, a recommendation would be to reconcile fragmented administrative methods that factor in limitation of the concerned parties. For drugs in the NLEM sublist Ngor, of which several are for non-communicable, chronic diseases such as diabetes (pioglitazone, repaglinide, insulin aspart, insulin glargine), epilepsy (sodium valproate, lamotrigine, levetiracetam) and high-cost, broad-spectrum, injectable antibiotics for the hospital-discharged patients, there existed the issues for the UC patients living in the district or sub-district levels. Therefore, financing mechanisms of health insurance schemes should be available at the provincial or regional levels (estimated budget for 240 million Baht). To reduce budget constraint, these drugs should be negotiated for the lower prices using the national mechanism similarly to those in sublist Jor(2). In addition, capacities of health professionals on proper use of these medicines should be built in order that patients could be referred back to district hospitals where the medicines could be easily accessed. For health financing to be sustainable, monitoring of purchasing prices and reimbursement prices is a crucial mechanism. The quarterly provider price index during 2010-2013 had a decreasing trend for an overall and for almost all therapeutic classes (166 items in 11 classes). This would make room for fiscal space to support the ATM in hospitals. Controlling drug prices are the major role played by various committees, whereby the focal point is MOPH (for the purchasing prices) and Civil Servant Medical Benefit Scheme (CSMBS) (for the reimbursement prices). Medium prices for lipid modifying drugs announced publicly in 2014 which relied on methods other than mode or median is a stepping stone for controlling the purchasing prices; whereby lessons learnt from Taiwan’s National Health Insurance on market survey-based price adjustment shed light on technical feasibility for controlling the reimbursement prices despite limited administrative feasibility in Thailand. Finally, delay in implementation of the CSMBS’ new reimbursement rates and controversy on cost structure as a required condition for drug registration in the new Drug Act are the latest unsettled issues.
Copyright ผลงานวิชาการเหล่านี้เป็นลิขสิทธิ์ของสถาบันวิจัยระบบสาธารณสุข หากมีการนำไปใช้อ้างอิง โปรดอ้างถึงสถาบันวิจัยระบบสาธารณสุข ในฐานะเจ้าของลิขสิทธิ์ตามพระราชบัญญัติสงวนลิขสิทธิ์สำหรับการนำงานวิจัยไปใช้ประโยชน์ในเชิงพาณิชย์
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