(submitted by Mr Roberto Gouveia)

Covers the invention of medication for the prevention and treatment of the Acquired Immunodeficiency Syndrome SIDA/Aids and the procedure for its procurement as non-patentable materials.

The National Congress decrees:

Art.
1º..........................................................................
............................................... ART. 18 of Law n.º 9.279,
of 14 May 1996, comes into force with the following additional clause IV:
"Art.18.....................................................................
....................................................
IV - the medication, together with its
respective procurement procedure, specifically
for the prevention and treatment of the Acquired
Immunodeficiency Syndrome SIDA/Aids,"
Art.2º......................................................................
.....................................................This
law enters into force on the date of its
publication.

JUSTIFICATION

In homage to ex-Deputy Eduardo Jorge, who no longer graces the floor of the Federal Legislature, we re-submit the following Bill that was introduced at his initiative during the last legislative period.

An examination of Law n.º 9.279/96 leads one to the conclusion that the protection conferred either directly or indirectly on the inventor of the product or process in articles 42,44, 68, 69, 73 in a variety of measures, is so broad that in many cases this results in economic or commercial abuse under the aegis of the law itself.

The industrial sector that is most well-placed to proceed in this manner is, without doubt, the advanced chemistry sector and most specifically the drug industry. It is not by chance that the "lobby" representing these pharmaceutical firms is highly active in both Legislative and Executive circles, as can be observed by the actions aimed at delaying to the maximum the application of Law No. 9787/99, known as the Generics Law, or at bringing influence to bear on governmental regulations for the application of the same.

At the present time, humanity is facing one of the most serious health problems of all time - the AIDS pandemic - which continues to spread and to kill millions of people every year despite all the scientific knowledge that has been accumulated to date. Currently, it is estimated that there are 30 million people infected throughout the world. Of these around 22 millions are Africans living mainly in the poor countries to the south of the Sahara. The 9th June 1999 edition of 'Veja' magazine tells of the drama through which that continent is passing. Some excerpts from that article are reproduced below as illustration:

"In the heart of Africa a time-bomb is ticking away. This will kill more that 22 million men, women and children over the coming decade. This figure is 200 times greater than all the victims of the atomic bomb that destroyed Hiroshima in 1945. Or 100 times more than the total of deaths that occurred during the Vietnam War. (...) Since the beginning of the AIDS epidemic in the early 1980s, 11.5 million people have died in southern Africa as victims of the AIDS epidemic - a number almost equal to the population of the city of São Paulo. (...) In Sub-Saharan Africa in 1997, 1.5 million children were orphaned as the result of AIDS - almost 90% of the world total (...) Not even the richest country in Africa was spared the many deaths arising from the epidemic. In little over ten years, South Africa saw 2.9 million cases of AIDS emerge from almost zero, leaving a sad trail of 360.000 deaths in their wake. (...) South Africa, with its diamond and gold mines, has an annual budget of approximately 10 million dollars to deal with AIDS but this is not sufficient even to pay fo the AZT required to reduce the chances of contaminated pregnant women passing the infection onto their babies."

The government of that country is not resigned and does not feel that it has its hands tied in its endeavor to try and revert the calamitous situation. Two years ago, a law was introduced that allows local firms to produce generic versions of patented anti-AIDS drugs or to import them from countries where they are cheaper. As can be expected, a range of reactions has been forthcoming from the multinational drug companies. As journalist Philip Shenon, in an article in "The NewYork Times", and published in Portuguese in Brazil, says:

"The United States drug industry, with the help of the Clinton administration, is trying to protect its patents, preventing developing countries that are suffering from the AIDS epidemic from producing generic versions of certain drugs which at present are too expensive for the majority of victims outside the United States. The drug companies are alarmed at the efforts being made by South Africa to allow local firms to produce generic versions of patented anti-AIDS drugs or to import such medicines from countries where they can obtain them more cheaply. (...) As the result of a series of legal battles in South Africa, American companies have succeeded to date in blocking the law that was introduced two years ago aimed at reducing the price of anti-AIDS drugs and that would have enabled them to be manufactured locally or imported without the permission of the owners of the patents. (...) In the United States, these drugs can cost an individual patient over US$ 10 thousand a year. The drugs are sold in South Africa for a similar price. (...)"

Brazil has around 600,000 carriers of the AIDS vírus, HIV. According to a World Bank forecast, back in the 1980s, Brazil was likely to have 1.2 million people infected by the year 2000. The 597,000 carriers include people who have already developed AIDS and actual deaths are excluded. Unlike the notifications of AIDS cases, the figures covering people with HIV are estimates.

In these circumstances, we cannot accept passively the exorbitant prices imposed on both the infected people and the public coffers of the drugs that are used specifically for treating AIDS. The Bill that is now before you has the same aim as the law passed in South Africa - that is, the possibility for local industries to produce interchangeable medical drugs. Interchangeable drugs are those that are the therapeutic equivalent of the innovative or reference drug. Our country needs to treat its sick people in the most efficient way possible. If local firms are permitted to manufacture generic versions, and no doubt the selling price will be lower than that of the branded drugs, this will lead to greater efficiency in the future: less expensive medicines, lower public health outgoings and more jobs available.

ROBERTO GOUVEIA
Federal Deputy PT