April 23rd, 2007
Alex Jones/Honduras This Week
Generic drugs such as these flu medicines are used in public hospitals in Honduras.Narcotics in Honduras are too expensive for many, including the government. As a result the state cannot fulfil its constitutional duty to provide enough free or adequate healthcare to Honduran citizens. In an attempt to approach this problem and decrease the cost of drugs, some companies illegally make generic copies of patented original molecules. As they don’t have to fund research, they are able to sell at lower prices. These illegal generic drugs thus play an absolutely crucial role in Honduran health. “Currently the government buys mostly generics for the public hospitals, because by doing so they can afford to buy significantly more drugs,” says Dr. Jacobo Andonie, technical director at Andifar Laboratories, a manufacturer of generic drugs. Individuals make the same decisions, as “at a private pharmacy the difference between a patented and generic drug might be the difference between L.1000 ($50) and L.100 ($5).” With 60% of the population living below the poverty line, this may mean the difference between life and death in the case of an easily treatable disease. Whilst it is clear that cheap, generic drugs play a vital role in Honduran health, there are major problems with coupling the need to provide cheap healthcare with the need to provide good quality drugs.
You can’t make generics of original drugs unless they have run out off their patent or your company buys patent rights, “in theory,” says Andonie, “but the world is not working that way. There are two big players in the east – China and India – and as soon as a new US or European drug comes out they have their chemists study the molecule and make the raw material.” This may take up to a year, but sometimes takes less than three months. “This raw material is then available to the manufacturer who has the guts to make the drug.”
This is illegal, and “the big companies don’t turn a blind eye towards generic companies when they break the patent laws, but for them it is such a small market that sometimes to fight it is not really worth it. The (Honduran) pharmaceutical market is between $110 and $130 million per year. But then you have so many drugs in that market, so to fight each little bit doesn’t really make sense. If you were in Mexico I am sure they would fight it, they have 90 million people there. In Brazil they fight it for sure.”
Indeed last year Novartis, a Swiss pharmaceuticals multinational corporation, challenged an Indian law that denies patents for minor or trivial improvements on already known drugs. The legal challenge came after a patent was denied for the new cancer treatment, Glivec/Gleevec. The challenge was dismissed in a high court ruling, and this decision that was welcomed by health activists around the world, including Medicins Sans Frontieres, The Berne Declaration Group and the All-India Drug Action Network.
Similarly, last year Brazil’s president had to authorise the country to sidestep the patent on an AIDS drug manufactured by Merck, a US pharmaceutical giant, after they refused to supply the drug to Brazil at the same cheap price they do to Tailand, citing the size of the Brazilian economuy. Brazil now imports a cheaper, generic, Indian made version of the patented Efavirenze drug.
These are just two examples of where a developing market has become large enough such that it is worth fighting the patent laws. Novartis cited India’s “booming middle class” in an open letter to the NGO community justifying its action in India, and Merck justify their policy towards Brazil by claiming that “as the world’s 12th largest economy, Brazil has a greater capacity to pay for HIV medicines than countries that are poorer or harder hit by the disease.” However, as these countries do seem to have two markets within one economy, they also seem, so far, able to fight off the pressure. Many people are worried that as small economies enter free trade agreements with each other they are creating large markets of small economies. This may mean that they create markets large enough for research based pharmaceuticals to earn a profit upholding patent laws or pushing for more stringent patent laws, but made up of governments that are individually too weak to stand up for their citizens as the Brazilian and Indian government have shown an ability to do so.
Another down side of being a generics company in a developing country is that you hold very little power in the international arena, especially compared with the major research based pharmaceuticals. It is thought that these big pharmaceuticals use their strength to suggest international regulations in such a way that makes it hard to produce cheap equivalents of what they do. A lot of the time it appears that these pressures are exerted in the form of new standards, procedures and laws demanded through the World Health Organization (WHO). Thus many standards are put into place and advised upon through WHO, but are incompatible with a need to produce affordable drugs.
“For example, since 2000, WHO – through each government in Central America – have required that every manufacturer complies with the Good Manufacturing Practice (GMP).” This is a series of criteria that regulate the quality of the equipment and methods used to make the drugs. “It is a great tool, and it definitely helps us to improve our service, but I am sure a lot of the smaller generic companies went bankrupt over it.”
Similarly, “you can no longer use published data to register new molecules…but that is exactly what you have to do if you are a generic company. The US doesn’t want us to use their data. They want us to do our own clinical trial. That both raises our cost and delays our launch into the market.”
“In developed countries a generic has to be bioequivalent with the original. In Honduras this topic of bioequivalence is gaining force, but it is still not the same.” For two things to be bioequivalent means that they act the same in a test tube. It is an analysis that should be carried out with tablets to test the rate at which they dissolve, for example, or quantity of medicine that will end up in the right place after being filtered through the liver. Syrups and vaccines however don’t need to be tested for bioequivalence.
The status of bioavailability is similar in the developed world, but, because of its high price, less practiced even than bioequivalence in developing countries. Bioavailability signifies the extent to which two medicines act the same in humans, and so needs live human testing. “However bioavailability and bioequivalence are hard and expensive to do, so the industry has focused on GMP instead.” For this reason, according to Andonie, you will hear stories of drugs which didn’t have the full affect, or had to be taken in double doses etc... “Once you comply with the GMP, if you have the time and the money, you comply with bioequivalence. Then you are providing a 95% similar drug. Once you have done that you may do bioavailability, and that is perfect, but then you are way off the charts…nobody would be able to afford your products…the whole point of generics in Honduras is to have low prices.” For this reason, in Honduras, generics often fall short of qualities desired in the developed world, and are not necessarily the same quality as the original drug.
After all this, “generics do provide a better option, particularly for poor countries.” But it is not enough to just continue in a balance between of breaking the law and being an insignificant player in the international arena. There needs to be a change such that developing countries can legally provide adequate and affordable healthcare. “In a fairer world these companies (research based pharmaceuticals) should offer a different price for poorer nations.”
