International Drug Regulatory Mechanisms

Albert I. Wertheimer

• Publisher: CRC Press
• Year: 2022
• eBook ISBN:
  9781000156843
• Topic: Medicine
• Subtopic: Pharmacology

Learn how international governments have committed themselves to improving access to quality health care!

International Drug Regulatory Mechanisms explores the environment, organization, structure, functioning, and finance of health systems and pharmaceutical markets in 19 countries. Local experts describe each country's experiences with and lessons learned from the regulation of pharmaceutical products. This book will help government officials, pharmacy educators, and pharmaceutical industry leaders from around the globe identify and develop successful methods for controlling pharmaceutical drug prices and utilization.

In International Drug Regulatory Mechanisms, you will learn about the health care system of each country and each government's measures to control drug costs. This text shows you what government interventions are feasible as well as effective, and the impact of these measures on consumers, government agencies, and the pharmaceutical companies and distributors. Drug policies, reimbursement concepts, and health insurance companies are all examined to give you a better working knowledge of the methodology and guidelines involving drug control in nations such as:

• Iceland
• Canada
• Israel
• Malaysia
• Argentina
• Taiwan
• Mexico
• Italy

International Drug Regulatory Mechanisms is an extensive text that shows how pharmaceuticals are regulated throughout the world. This book examines howdespite similar goalsprice controls, utilization controls, record keeping, and quality requirements differ greatly between countries. Using numerous graphs, tables, and figures, this one-of-a-kind resouce provides you with new insight into which strategies are superior and how to implement these strategies in your own country.

R_X Price Control Methods in Mexico

Jaime Kravzov-JinichMarina Altagracia-MartínezMartha Elena Yamasaki-LópezHector Salgado-SchoellyClaudia Cardona-Carlín

Jaime Kravzov-Jinich, Doctor Honoris Causa, is Professor, Department of Biological Systems, Universidad Autónoma Metropolitana-Xochimilco, Camino Real al Ajusco #121 casa 11, Prol. Tepepan, México DF, México 16029 (E-mail: [email protected]).

Marina Altagracia-Martínez, Ph.D., is Professor, Department of Biological Systems, Universidad Autónoma Metropolitana-Xochimilco, Calzada del Hueso # 160 Depto. 601-A, Col. ExHacienda de Coapa, México DF, México 04850 (E-mail: [email protected]).

Martha Elena Yamasaki-López, Q.F.B., is Subdirector, Hector Salgado-Schoelly, Q.F.B., is Director, and Claudia Cardona-Carlín, Q.F.B., is Head of the Department, Drug Division, Mexico D.F., Ministry of Health, Av. Jardín #356, Colonia del Gas, Delegación Azcapotzalco, México DF, México, c.p. 03500.

Address correspondence to: Dr. Marina Altagracia-Martínez at the above address.

SUMMARY. The current Mexican health system was founded in 1943. At the end of the 1960s, the model reached its limits and in the 1980s, the Mexican government began the creation of the National Health System (SNS). The reasons to establish such a system, its objectives, and composition of SNS are discussed in the article. In 1992, the federal Law Office for Consumers (PROFECO) was empowered to watch and verify the Mexican officials’ measures and norms. This article also provides a general description of the factors that characterize the Mexican pharmaceutical industry. A comparison of pharmaceutical expenditure both in the public and in the private sector is also detailed. [Article copies available for a fee from The Haworth Document Delivery Service: 1-800-HAWORTH. E-mail address: <[email protected]> Website: <http://www.HaworthPress.com> Ó 2003 by The Haworth Press, Inc. All rights reserved.]

KEYWORDS. Mexico, pharmaceutical expenditure, national health system, generic drugs

INTRODUCTION

Since its beginning (1943), the Mexican Health System has been related to the work force and has included drug endowing in the health services (consultation, hospitalization, laboratory tests, etc.). Therefore, drugs and their price controls are closely linked to the health system. This means that the non-employed population is not considered in that system (1).

In 1975, the first presidential resolution was published, establishing that each Public Health Institution should have an essential drug list (EDL), that they should revise it periodically, and that its use was obligatory in the Public Health Institution (PHI) (2,3). In 1977, the Mexican government proposed a unique essential drug list for the PHS, containing 444 chemical entities and 636 pharmaceutical presentations (4). In 1984, the first unique essential drug list (EDL) was published and adopted for the public sector (PS), including the Mexican Social Security Institute (IMSS), the Social Services & Security Institute for State Workers (ISSSTE), the Ministry of Health (SSa), and the National System for Integral Family Development (DIF) (5). This publication stated that the EDL should be obligatory for the PS. Its main objective is to clearly, precisely, and concisely orient the physicians’ most encompassing action, drug prescription. Since 1984, there have been continuous revisions (about 8 in all) (6-11). For the first time, in 1997, it was divided into two big sections: the first one is for primary care (first care level), and the second one is a catalogue for second and third care levels and highly specialized care (12). The 1999 edition is the most recent publication. Its first section (Primary Care Level) includes 201 chemical entities and 275 pharmaceutical presentations. The catalogue section (Other Care Levels) includes 462 chemical entities and 588 pharmaceutical ones (13).

Mexico has adopted the EDL, partially based on the World Health Organization (WHO) essential drug list. Drugs included in the Mexico PS list are selected by the Interinstitutional Commission of Essential Drug List (CICBI); its general secretary is the Health Minister (Federal), and titular members represent each of the public health institutions. Since 1988, members of the Medical and Academic Societies assist in the EDL revisions. Most members are clinical pharmacologists, and there are also representatives from industry. University faculties, pharmacists, and consumer groups are not represented (2).

Criteria for the drug selection include:

1. Drug efficacy and safety.
2. Elimination of drugs lacking approved quality and the inclusion of new therapeutic products with proven therapeutic value.
3. Restriction of duplicate drugs with the same pharmacological action.
4. Exclusion of non-scientific drug combinations (polypharmacy) (5).

These criteria concur with those recommended by WHO and do not necessarily apply to the catalogue section.

All decisions related to the CICBI are required to be explained and published in the official gazette. Nevertheless, the CICBI does not always give logical or therapeutic reasons for the decisions.

Cost is considered an important criterion, and, parallel with the EDL, in 1984, Mexico developed a government drug...

Table of contents

• Cover
• Half Title
• Title
• Copyright
• Contents
• Foreword
• Interventions to Curb Rising Pharmaceutical Costs in Iceland
• Canadian Public Policies and Practices Related to Drug Prices, Utilization and Expenditures
• Drug Policy in the Czech Republic
• Drug Policies and Pricing Mechanism: The Malaysian Perspective
• Drug Pricing in South Africa–Policy and Praxis
• Drug Price Control in India–An Overview
• Pharmaceutical Benefit Scheme and Cost Containment in Taiwan’s National Health Insurance
• RX Price Control Methods in Mexico
• Financing Pharmaceutical Care in the Dutch Health System
• Drug Pricing Policy in Hungary
• Germany’s Attempts to Control Drug Prices and Expenditures: Success or Failure?
• Regulating the Prices and Costs of Medicines in the United Kingdom
• The Controls of Prices of Medicines in Israel
• Pharmaceutical Services in Slovenia
• Pricing and Reimbursement of Medicinal Products in Denmark
• Drug Prices in Argentina
• Drug Pricing and Reimbursement System in Turkey
• Medication Expenditure and Utilization in Morocco
• Pharmaceutical Expenditure: Aspects of Cost Containment in Italy
• Organization of Health Care Systems and Financing of Pharmaceuticals in Norway, Including Cost Containments
• Index