Tuesday, April 21, 2009

Generic Drugs are Counterfeit, Say Kenyan Government

When pharmaceutical products first became available to treat HIV, they were far too expensive for most people to afford, especially in developing countries. Yet, the majority of people in need of treatment for HIV live in developing countries. So, how could pharmaceutical companies fix a price that would allow them a staggeringly high profit margin but also a large volume of sales?

HIV treatment (antiretroviral treatment or ART) is still very expensive, and that's just the drugs. It's still unaffordable to most people, but pharmaceutical companies have successfully lobbied donor governments to pay for the drugs. That gets rid of one problem, how to maximise profits for pharmaceutical companies.

But then there was another problem. Some countries who had the capacity to do the requisite research and planning and production are now producing generic equivalents of HIV drugs. These are much more affordable but this is a terrible headache for pharmaceutical companies. Of course, they are not too worried, most aid money for HIV goes to buying the branded, expensive drugs. Very little is allowed go to generics.

In Kenya, the pharmaceutical companies don't seem to have had much problem. The government produced a piece of legislation that doesn't distinguish between counterfeit products and generic equivalents. Perhaps the Kenyan government thought it was better to buy products that are tens or even hundreds of times more expensive. After all, they are not paying for them. Or perhaps someone nobbled the Kenyan government, it's hard to know. But the legislation makes sure that generics from any country can be considered counterfeit and this is very useful to the pharmaceutical companies.

There are hundreds of thousands of Kenyans in need of ART in order to stay alive and raise their families. Many of them are not on ART because the business of rolling out the drugs is slow. And because so little money is being spent on preventing new infections, the number of people requiring ART continues to increase. In fact, most of the money being spent on HIV prevention goes to programmes that have little influence on transmission of HIV or any other sexually transmitted infection.

I agree that treatment is part of prevention; people who are on treatment are less likely to transmit HIV if the treatment is working properly. But it's not good enough to spend, say, 50% of the 15 billion dollar President's Emergency Fund for Aids Relief (PEPFAR) on treatment when only 20% is going on prevention, especially as many prevention programmes have fairly dubious benefits.

It wouldn't be so bad if some of that 50% is going on something other than drugs. People on ART need more than just drugs, they need a lot of palliative care, a lot of monitoring, good health care, economic and moral support, good levels of nutrition, etc. Perhaps if pharmaceutical companies were to provide these things, donor money would be spent on them. As it is, many people get the free drugs but little else.

Those on ART who are not taking the drugs in the prescribed way, or who are not responding to the treatment for some reason, may turn out to be like the 80% of Kenyan's who don't know they are HIV positive; they could be continuing to have sex, not knowing that they are may be as infectious as people not on ART. Even worse, they may be spreading a resistant strain of HIV.

Resistance is most worrying in Kenya because it could take some time to identify people who are carrying resistant strains. Health and social facilities are not strong enough to monitor people adequately. Many get the drugs and disappear, for some reason or other. Others struggle to get the treatment they need but they don't know if they are or are not responding to the treatment until they become ill. By this time, their life and the life of their partner may already be at risk.

Resistance is a good thing, though, if you are a pharmaceutical company. People who are resistant to 'first line' drugs are usually put on 'second line' treatment. This is far more expensive, meaning higher profits. So if people fail to take their ART drugs properly, that could help the pharmaceutical companies greatly.

The Indian government is protesting because similar legislation is planned in other African countries, one of their biggest markets. And it's not just HIV drugs that are threatened, also cholera, malaria, hepatitis and malnutrition. This is not what Kenya or any other African country needs.


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