Legal Entities as Governance Tools
The government’s sponsorship meant that the political status of herbal medicines shifted from a cultural heritage to a subject of innovation. The government’s efforts to transform Korean medicines opened up a political and epistemic space where professional boundaries and the ontology of drugs are renegotiated and redefined.
At the discursive level, a recurring theme was that the two systems of knowledge were incommensurable, which by definition meant that medical and pharmaceutical principles and practices in Korean medicine could not be translated into those in biomedicine. For instance, in 2000, the government enacted laws pertaining to “laws to propel research and development of natural drugs” in order to nurture the innovative pharmaceutical industry capable of producing international blockbuster drugs. A legal definition of a natural drug[802] is “a medicinal product that is made of an entity with a chemical structure or composition not previously approved in a drug by the KFDA or a complex medicinal product that contains a new entity as an efficacious component not previously approved in a drug by the KFDA”.[803] With the enactment of special laws to label the legal category of natural drugs as prescription drugs, the government also granted regulatory favoritism to the relevant industrial sectors to facilitate the development of natural drugs.In 2003, the Korean government passed a law stipulating the safety, quality, and functionality of foods with health claims under the Health Functional Foods Act.[804] Health Functional Food is legally defined as a product intended to enhance and preserve human health with one or more functional ingredients or constituents. Health functional foods are very much akin to functional food or functional health products in international contexts, in that they are consumed to prevent nutrition-related diseases and increase physical and mental well-being.
As a minimum measure to secure the safety and quality of foods with health benefits (in distinction both from pharmaceuticals and from nutritional/dietary supplements), the government required manufacturing companies, including pharmaceutical companies, to submit scientific andClassification as a Technology 229 historical evidence for review, as most functional food ingredients are derived from natural products. Consumers tended to consume health products for purposes of boosting the immune system, which constitutes the largest functional foods market.[805] Thus, the government stepped in to assess, evaluate, and regulate foods with health claims, requiring them to go through a degree of review processes.
Naturalendotech co., Ltd (NeT) is a biotechnology company founded in 2001 with concentration on research and development and commercialization of natural ingredients. Looking into the domestic market structure, where health products targeted at middle-aged and older women were insufficiently developed, the company strategically focused on the development of health products for women. From the beginning, the company adopted the triple helix innovation model, although not intentionally, because a significant portion of R&D funds came through government research grants. As a small-sized biotechnology company, it strategized to get ahead of competing manufacturing or pharmaceutical companies by reutilizing natural resources and turning them into commercially marketable products via the means of techno-scientific innovations. By partnering with academia and research institutes, the company was successful in acquiring a series of patents for products that claimed to have significant effects on symptoms associated with women’s diseases starting in 2003. The company sought both domestic and international patents almost simultaneously, targeting international clientele, too.
On the other hand, the changes in governmental actions opened a long- seated conflict, in particular over natural drugs, between the two professional organizations, Western biomedicine and Korean medicine. Under the current laws, Korean medicine doctors are not permitted to prescribe or administer prescription drugs, for the reason that such drugs are based on biomedical and scientific knowledge and methods. The underlying understanding was that Korean medicine and Korean medicines (han yak) were holistic without differentiating theoretical principles from diagnostic and therapeutic practices, nor telling the body from mind. This was translated into the understanding that Korean medicines did not differentiate prescription drugs from generics or over-the-counter drugs. Consequently, the legal and regulation action that natural drugs were labeled as prescription drugs incited a jurisdictional boundary
war between Korean medicine doctors and the Western medical circle, including the pharmaceutical industry.
VI.
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