Taiwan: Pharma at the Tipping Point - Pharmaceutical Executive


Taiwan: Pharma at the Tipping Point

Pharmaceutical Executive

The need for an improvement in Taiwan's translational research capacity has not only been recognized by those institutions solely concerned with the pharmaceutical sector; rather, this is a train of thought present across the entire Taiwanese academic community. Dr. Chi-huey Wong, president of Academia Sinica, the cornerstone of Taiwan's basic research capacity, underlines the importance of creating this bridge between science and industry: "We need to build a capacity and capability to link basic research to industry. Many basic discoveries are not getting translated into commercial opportunities, so Taiwan needs to have a component there to identify the important early-stage discoveries and move them into industry. In order to do this, the country needs to have a good investment team to identify key projects, and good legislation in place to encourage the translation into industry. The government's Diamond Action Plan for Biotech Takeoff was designed for such a purpose. It shows that we have a good understanding of the problem, and are trying to move in the right direction." Wong believes that Taiwan's current strategy of focusing on drug discovery is playing to the strengths of the country, but that a successful biotech industry can only be created when academia works hand in hand with industry: "Taiwan is very focused on discovery, and Big Pharma has more experience in development; most Big Pharma companies have shifted their focus from early stage to development in recent years. Moving from discovery to development costs from US$300 million to US$1 billion—60 percent percent of which is spent on marketing. Taiwan cannot afford to focus on late-stage development in this moment of its industrial development; we lack the requisite experience and skill. Hence, collaboration is very important."

Jin-fu Chang, Minister in Charge of Taiwan's Diamond Action Plan for Biotech Takeoff.
As well as improving the level of translational research, another key element of the Executive Yuan's Diamond Action Plan was the creation of a US-style Food and Drug Administration. In January 2010, four existing agencies were combined to create the Taiwan FDA (TFDA), a great achievement for the industry. However, because of Taiwan's unique political situation with China, creating an internationally recognized agency was made a little more difficult. Jaw-jou Kang, director general of the TFDA, explains that "Taiwan has a unique political situation that means it cannot join a lot of international organizations, which makes it very difficult to communicate with other countries. The way that the TFDA has approached this problem is through bilateral cooperation—in April 2010 we signed a memorandum of understanding with the TGA in Australia for example. We also have exchanged letters with US, Switzerland, and EU for information exchange of medical devices. Further to Exchange of Letter, we established the Technical Cooperation Program with 12 Europe-notified bodies to share GMP inspection reports as acceptable evidence for submitting Quality System Documentation applications to the TFDA." This will speed up the approval process for many companies in Taiwan.

The cause of these issues in the international community is Taiwan's relationship with China, which is something of a double-edged sword: While it makes international collaboration and harmonization a delicate issue, it also allows for Taiwan to act as a stepping stone to the vast Chinese market. On Sept. 11, the Economic Cooperation Framework Agreement (ECFA) came into effect. ECFA aims to reduce commercial barriers between the two countries and help to grow bilateral trade, which currently stands at US$110 billion. Although the strengthening of bilateral relations is a contentious issue in Taiwan, the general feeling among the pharmaceutical community is that it makes Taiwan a more attractive investment destination. No longer will the country be confined to its market size of 23 million consumers; companies operating in Taiwan will now have increasingly easier access to the 1.3 billion Chinese consumers waiting just across the strait.


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