Mexico: Healthcare System and Drug Regulatory Overview

Introduction

While universal healthcare has yet to be accomplished in Mexico, the government believes it is achievable in 2012. The country also plans to raise regulatory standards to that of the US FDA by 2012, through improving the intellectual property environment and eliminating similares. Pharmaceutical companies also stand to gain from the relatively unrestricted drug pricing environment in Mexico.

Features and benefits

* Assess the key factors facing pharma in terms of healthcare expenditure, regulatory issues, pricing and reimbursement
* Review the insurance and healthcare system in Mexico including recent health reforms.
* Gain insight into regulatory and intellectual property issues in Mexico.

Highlights

Healthcare provision remains fragmented in Mexico, and public healthcare accounts for just half of Mexico’s total healthcare costs. However, the government has shown its support for healthcare by implementing its Seguro Popular de Salud program and now believes that universal healthcare is achievable in 2012.
Also on the agenda for 2012 is the plan by the regulatory agency (COFEPRIS), to raise regulatory standards in Mexico to that of the US FDA, by continuing to eliminate similares, creating a framework for biologics and removing domestic manufacturing requirements.
Mexico boasts a higher degree of protection than many other countries in Latin America. Nevertheless, despite its requirement to provide 5 years of data exclusivity, the government has been criticized for failing to guard against the inappropriate disclosure of confidential data submitted with application dossiers.

Your key questions answered

* What have been the main drivers of healthcare expenditure in Mexico?
* How have healthcare reforms in Mexico shaped the efficiency of the public healthcare system?
* How has Mexico made progress in raising its regulatory standards to that of the US Food and Drug Administration and the European Medicines Agency?
* How is the drug pricing environment advantageous to pharmaceutical companies in Mexico?
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Executive Summary
Mexico – Introduction
Mexico – Strategic scoping and focus
Mexico – Key findings
Healthcare expenditure
Insurance and healthcare system
Regulatory issues
Pricing and reimbursement
MEXICO – HEALTHCARE EXPENDITURE
Mexico – The majority of healthcare costs are met out-of-pocket
MEXICO – INSURANCE AND HEALTHCARE SYSTEM OVERVIEW
Mexico – The Ministry of Health controls all levels of the country’s health system
The social security institute is the main healthcare program
Establishing universal healthcare through the SPS is a top priority of the government
The proportion of people with private health insurance is increasing
Mexico – Healthcare provision remains fragmented
Centralized healthcare services offer cheaper services than decentralized healthcare services
MEXICO – DRUG APPROVAL AND REGULATORY PROCESSES
Mexico – COFEPRIS is the main regulatory body
Pharmaceutical classification in Mexico
Approval procedures – the requirements in Mexico are similar to those in the US and Europe
Approval times have increased since 2008
Pharmacovigilance is improving in Mexico
Mexico – Intellectual property and data exclusivity
Intellectual property is positively regarded in Mexico
Mexico – Drug counterfeiting
Counterfeit drugs are a persistent problem in Mexico
MEXICO – PRICING AND REIMBURSEMENT
Mexico – Key pricing regulatory bodies
Mexico – Pricing issues
Pricing reforms have attempted to control the high price of drugs in Mexico
Price setting in the private market
Mexico – Reimbursement issues
There are two formularies for reimbursed drugs in Mexico
MEXICO – BIBLIOGRAPHY
Mexico – Publications and online articles
APPENDIX
Exchange rates used in this report
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