Good and cheap medicine
Gonzalo Vecina Neto
The Generic Medicines Law came into force on August 10.This gave
to the Ministry of Health the wherewithal to give to all our people
needing medical drugs, access to a fairer market in terms of health
and good value.
As the result of Law 9.787/99, conditions are now created for
the sale on the shelves of our drugstores of medical products
with specific characteristics aimed at benefiting those who to
use medicines which are both good and cheap.
The new Law effectively heralds the beginning of an era of generic
medicines in Brazil. Generics are products sold under the name
of their active component, with pharmacological ingredients matching
exactly those contained in the traditional and effective brands,
but with price reductions of up to 40% as compared to the reference
products. They are an excellent choice for consumers at the point
of sale.
A quality stamp guaranteeing the quality of the drugs will be
awarded by the Ministry of Health, through the National Health
Surveillance Agency (ANVISA). When responding to a request for
registration by ANVISA of a medical generic candidate, laboratories
should present basic tests proving that the quality is the same
as that of the usual trade-marked product in the market. Bioequivalence
tests will confirm whether or not the generic has exactly the
same absorption capacity in the human organism as the medicine
which it copies.
Once these characteristics have been verified, the product will
be considered interchangeable with the reference medicine. At
the time that generics in general were brought under an official
regulation regime, ANVISA published a list containing 99 reference
products that could begin to be copied. Other lists will be published
by the end of the current year. Once their interchangeability
is verified, such medicines will be awarded the seal of approval
of the Ministry of Health and enter the market bearing labels
with words specifying that the product is "a generic in accordance
with Law 9.787".
The other advantage of generic medicines is the low price. This
is the logical consequence of their basic features: the product
is a copy of a well-established drug, but its cost does not reflect
any of the costs incurred in the research and development of such
a drug. Development of a new drug, with an average retail life
of about 10 years, absorbs at present an investment of about $US400
million. Since the generic does not carry either a trade name
or well known mark, the generic incurs no publicity costs.
Therefore the manufacturer makes cost savings twice over - which
is clearly reflected in the lower selling price of the product.
In the United States, where the market share of generics has reached
40%, the price difference between the traditional products and
generic equivalents is 30%.
ANVISA has already begun to receive requests for registration
of new generics, but this is just the beginning of a retailing
revolution. Pharmacies and drugstores will be able to offer to
the public an enormous variety of such products, and the price
of them will obviously have a great influence on the drugs market.
The conditions have certainly been created. Brazil's Single Health
System (SUS), responsible for absorbing 25% of all the medical
drugs manufactured in this country, will purchase generics by
preference. Law 9.787 also obliges manufacturers of trade-marked
medicines to put the name of the active ingredient on the labels
of the products, together with the manufacturer's name of the
drug. The size of the lettering should be at least 50% of that
of the trade name. This is simply one more way of giving to the
consumer a choice of seeking out an alternative for the medicine
that has been prescribed.
In addition, doctors and pharmacists will play an important role
in helping this Law to work. The former will be responsible to
giving the patient a wider choice of drugs at the time the prescription
is issued. The latter will be able to offer guidance to the customer
depending on the prescription which is handed to him over the
counter.
By regulating and ensuring that the Generic Medicines Law is put
into practice, the idea of the Ministry of Health is to make available
to the customers good quality medical treatment, without which
any other effort to improve the health of the population in general
could well be undermined.
Gonzalo
Vecina Neto
Director-President of ANVISA
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