Friday, July 28, 2006

US ROK FTA - Why the Pharma dispute is a public health issue not just trade

For those who think the US is automatical wrong in sticking to its guns on Korea's planned changes to its drug purchasing system should consider this:

Police on Thursday arrested five people on charges of producing cosmetics containing heavy metals, such as mercury, and selling them to hospitals and skin clinics across the country. 

Another 53 people, including hospital directors, were booked without detention for selling the fake cosmetics to customers. They sold the cosmetics, saying the products were efficacious against atopic dermatitis and pimples, a police officer said...

 ... According to the Food and Drug Administration's examination, Vasheti cream contained about 71-98 times as much mercury as the authority's limit for heavy metal in cosmetics. White cream had 33-2,150 times the mercury limitation.

Just think those types of things could be included as part of the positive list scheme since they are cheaper than normal imports. Think I am over stating my case? Consider the following citation from an Op-ed in the Korea Times:

In reality, South Korea has no fair and transparent process for evaluating efficacies and bioequivalence of medicines, thus making it difficult for the national health insurance to cover only cost-effective drugs. 

In April, the Korea Food and Drug Administration (KFDA) announced that four bioresearch centers falsified test results for 10 genetic drugs, each produced by 10 local pharmaceutical firms. 

The KFDA said the 10 firms had obtained approval for their genetic medicines after presenting test results which were manipulated in collaboration with the research center

You read that right 10 "generic" manufacturers sold drugs with falsified effectivity reports. And these are only the 10 caught, imagine how many more.

I mention this so you can remind yourself any some idiot wants to lecture how the US government is lobbying for the "greed" of big pharma. There are other issues involoved here one should know about.


At August 01, 2006 11:51 AM, Anonymous R. Walsh said...

Interesting...I worked for a US biotech company that was trying to get its drug into registration in Korea back in 1999...the KFDA had brought in a new set of regs in 1998 that were actually a bit more stringent than the EU or USFDA's...

We had to shell out some money to Korean research facilities, quite a bit, and for results that they themselves couldn't seem to properly interpret. These were for tests & assays "unique to Korean requirements", they said.

Now our competitors in Jeil Sugar, Green Cross, Dae Woong, were of course not subject to this sort of foolishness.

Then we see our Korean biotech friends going all over China, buying up small lots of material (cytokines, vaccines), labeling it as their own, and then using it to beat us on government bids in S. America...

When we blew the whistle on them to the KFDA we got a rather dismissive 'fuck-you'.

It comes as no surprise that these research institutes were all in on the take...

At August 01, 2006 2:50 PM, Blogger Dram Man said...

The war stories we could share over a cup of coffee Mr. Walsh...

Incendently there is another aspect to all this you may know, but will add here for the uninitiated. In Korea you cannot patent a chemical unlike most countries. Under Korean law a chemical is a naturaly occuring thing (no matter how unatural the production method) and therefore cannot be patented. So in order to patent a drug in Korea you need to patent the use of the chemical/drug for a speific ailment.

To make a longer exposition short, basicaly this means that any company can make the drug as long as they market it for something the patent does not cover. This is another reason why generics proliferate in Korea.


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