[VIEWPOINT]The Biotech Boom Requires Cooperation

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[VIEWPOINT]The Biotech Boom Requires Cooperation

Over the last two years there has been a biotechnology boom in Korea. Last October, President Kim Dae-jung, the prime minister and 10 cabinet ministers met to discuss how to promote Korea's biotechnology industries. In February, the government announced that the biotechnology budget would double to 320 billion won ($244 million). The private sector has also seen surging investment in biotech industries.

But in the boom, one important thing has been forgotten: the laws and procedures relating to the approval and registration of new medicines and food.

Globally, medicine accounts for 50 percent and food for 20 percent of all biotechnology products. One of the reasons for the worldwide excitement at the completion of the mapping of human genome was its profound import for the pharmaceutical industry.

In Korea, as in most developed countries, there are strict rules concerning the registration and approval of medicines to be used by humans. The organizations in charge of this include the Ministry of Health and Welfare and the Food and Drug Administration. All new medicines must follow the necessary procedures regardless of how they are developed. After being given the initial go-ahead, new medicines must go through years of clinical trials and then a final evaluation. So the final destination for new medicines, after billions of won have been spent on an average of eight years of development, are agencies such as the Food and Drug Administration.

Over the last two years, these agencies have made considerable progress in testing and approving domestically developed medicines, but there is still long way to go. The most serious problem is the lack of highly skilled professional workers at the agencies, and, as a result, an inexpert approach to assessing and approving new medicines.

The main responsibility of public workers at the agencies is to evaluate specialized data, but each worker has too large a workload and is responsible for too wide an area. Workers are also paid too little for their duties. This situation often results in a lack of expertise and confidence, and a tendency to implement rules too uniformly.

Furthermore, there is mistrust between the public workers and pharmaceutical companies. The public workers are suspicious that they are being misinformed by the companies. The companies regard the public workers as little more than bureaucrats trying to hamper the progress of a new product. With a situation like this, it will be difficult for Korea to be a leading nation in biotechnology.

The attitude of the public and the media to these agencies makes the problem worse. Each set of clinical trials carries an inevitable risk. Last October, when an 18-year-old boy died during the clinical testing of a new medicine in the United States, most of the media described the young man as a hero who sadly died during the development of a new treatment. The boy's father accepted his son's tragic death. None of the public workers related to the incident was fired or demoted, and instead a stringent investigation of the causes of the incident followed.

Here, it is likely that emphasis would have been put on finding a scapegoat - and perhaps not on finding out exactly what went wrong.

The development of new medicines - which make up 50 percent of biotechnology markets - works best when the public, the media, companies, the government and individuals all cooperate in the development process.

It is most important to recruit professionals who are specialized in the approval and registration of new biotech medicines, and to foster a rational and flexible attitude among public workers.

Without radical reform in the organizations and agencies which have the final say in the commercialization of newly developed medicines, the government's rallying cry to build a nation with strong biotechnology will leave behind nothing but a bitter echo and wasted budget.


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The writer is a professor of genetic engineering at Seoul National University.

by Kim Sun-young

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