martes, 6 de agosto de 2013

An Argentinian State-Owned Generic Drug Factory ( LIF )

By Guillermo Cleti

Background and introduction

In the state of Santa Fe, Argentina, it is felt that health is a basic human right as is as high a possible quality of life. The state is responsible for guaranteeing this right of the citizens. Medication is also seen as a common good and should have the attributes of: accessibility, timeliness and high-quality. It should also have therapeutic effects that are scientifically tested and be sold at a price attributed to the cost of production. Therefore, it is the common view that the entire population of Santa Fe should be granted the possibility to have access to medication.

There are numerous ways to achieve this goal. Often governments purchase drugs and then dispense them at fees below the actual costs of the drugs being subsidized for poverty populations. In other circumstances, governments have been known to impose price controls where a maximum price of the drug is determined based upon its costs of production and distribution as well as some other cost factors. The people of Santa Fe State had a different idea; they decided to guarantee access to some commonly used generic pharmaceutical products by constructing a state pharmaceutical manufacturing facility.

The Laboratorio Industria Farmaceutico del Estado (LIF) is a pharmaceutical manufacturing company in the province of Santa Fe, Argentina in which the state has full ownership. LIF was created in 1947 to provide inexpensive drug products for pharmacies in public hospitals as an answer to the new health policies of the national government at that time. It was officially created by the provincial congress. It is a state owned Corporation and has been since 1999 through provincial law number 11.657.
Today there are 94 highly specialized staff members who have been trained under GMP (good Manufacturing practice) policies and regulations. The products, production areas and quality control all meet GMP requirements. In 2012 LIF produces 38 drugs for primary health care use in Santa Fe. It provides these medicines to the national health ministry through the Remediar program. L I F specializes in beta – lactam drugs and it was the first state laboratory to have a hormonal oral contraceptive product.

"Some numbers"

It is possible to estimate the value of the L I F medicine production. The direct cost of production in US dollars for last year was 3,781,870.92. In Argentina there is a compendium that lists all of the products available on that national market and their list prices, called the Manual Farmaceutico . The corresponding wholesale price for the production from the L I F facility is US$13,920,293.98. The LIF production was 27.2% of the entire list in the Manual Farmaceutico.
During 2008 and 2009 LIF delivered four products to each of 7000 CAPS (Centros de Atencion Primaria de la Salud) or primary health care centers. Nearly 15,000,000 people receive their health care through the system. Also in 2008 they delivered over 10 million units of one product, 500 mg tablets of cephalexin. Medicine production grew 14% over production in the year 2007 and in 2009 they delivered 50 million units of four products; cephalexin, 250 mg powder for Oral suspension, cephalexin 500 mg, amoxicillin 500 mg., Paracetamol 500 mg. and glybenclamide 5mg. tablets.

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