[SEOUL=Health/Medical News] As the entry into domestic market by Teva, global-level generic drug maker, is confirmed, angst in domestic pharmaceutical industry is escalating. The entry is likely to be a 'black hole' that will guzzle domestic generic drug market.
This time, again, Kim Young-jin, President of Handok Pharmaceuticals, stands amongst the vortex. He is now making various efforts to take Israel-based generic drug company into domestic market after grossly impacting domestic market through introducing France-based multinational pharmaceutical company and Switzerland-based health care provider.
Although Handok said that it was just in a preliminary negotiation over establishing a joint venture with Teva, domestic pharmaceutical industry, sure of Teva's entry, is not free from anxiety.
He also expressed his concern over the repercussions Teva will make in domestic pharmaceutical market. Teva is famous as the drug maker that most quickly develops patent-expired medication.
The problem at this juncture is the approval-patent linkage system for pharmaceutical products, scheduled to be in effect March 2015 as a result of Korean-U.S. FTA negotiation. Following a stipulation of the Korean-US FTA, Korea initiated a patent linkage system which links market approvals for generic drugs to the status of patents corresponding to the originator's product. According to the FTA, market approval for generics shall only be granted upon the consent of the patentee.
As an exception, the U.S. government grants 180-day market monoply to the first generic drug if a generic drug company files a patent nulliification suit against original drugs and wins. Korean government is also arranging similar protective system.
Industry observers agree that Teva, proficient in the patent lawsuit and the develpment of first generic drugs, is expected to make maximum use of the protective system. They worry about the possibility that the system constructed for the protection of domestic pharmaceutical companies may be used for the sake of multinational pharmaceutical companies.
A marketing representative of B drug company expressed his concern by saying, "The monopoly period for first generic drugs has been till now thought to be advantageous to domestic drug companies. But if the company such as Teva, which possesses knowhow of generic drug development and highly experienced in patent lawsuit, wins patent lawsuits and preoccupies the market for six months, domestic pharmaceutical market will have to be faced with crisis."
Lee Seung-ho, researcher of Woori Investment Securities, said, "Teva will field the strategy to preoccupy domestic generic drug market by acquiring monoply rights through patent nullification lawsuit when approval-patent linkage system is effective."
When this concern materializes, the damage will bot be limited to the problems of pharmaceutical industry that cannot release the drugs at the right time. The generic drugs, developed and released by domestic drug companies, are usually less expensive than the generic drugs of multinational pharmaceutical companies. Accordingly, in the mean time patients will have to take high-priced drugs of foreign drug companies and the burden on health insurance will increase.
Industry observers said in unison that government should as soon as as possible provide legal guideline over approval-patent linkage system to adress unpredictable future.
An official from the industry said, "Specific regulation should be arranged about the monopoly period of first generic drugs, prohibition on price collusion and approval delay automatical cessation period in a patent lawsuit. That way, the industry will be able to prepare for the situation." he also added, "Especially government should also make provision against multinational generic drug companies' use of the linkage system.
-대한민국 의학전문지 헬스코리아뉴스-
