Representatives from industry associations, companies and governing bodies yesterday said that while it is vital for the nation to participate in the Trans-Pacific Partnership (TPP) and the Regional Comprehensive Economic Partnership (RCEP), Taiwan’s biotechnology, medical and pharmaceutical sectors must first overcome several challenges before they have a chance of tapping international markets.
Taiwan’s accession to the TPP and RCEP would improve international harmonization on regulatory approval guidelines and allow the nation’s top biotechnology, pharmaceutical, and medical products and services to enter international marketplaces, experts said at a forum in Taipei.
Taiwanese companies would enjoy reduced costs of entry and risks thanks to greater levels of transparency in regulatory approval processes and assessment metrics, which are awarded to members of the trade blocs, panelists said.
As the nation vies to increase exports of active pharmaceutical ingredients and boost new drug development, which is currently estimated at less than 1 percent of the global market, domestic generic drug makers would face greater challenges, such as the more stringent intellectual property and patent laws in major markets abroad, Vice Premier Simon Chang (張善政) said.
“Due to immense development costs of developing new drugs, companies’ research findings must be protected by comprehensive patent systems to ensure their first-to-market advantage,” Savior Lifetec Corp (展旺生命科技) chairperson Sherry Ku (顧曼芹) said.
The concept of patent linkage, which prevents generic drugs from obtaining market licenses prior to the expiration of the patent term or receiving the consent of the original manufacturer is recognized in law in a number of major markets, including the US and India, and would likely be one of the conditions of joining the TPP, Ku said.
However, few Taiwanese companies are equipped to navigate the complex patent systems and obtain the required certifications, Ku said.
Taiwan’s lack of a patent linkage system has deterred foreign companies interested in the nation.
“Companies must adopt different strategies for each trade block. While innovation is vital for success in the TPP, where demand is higher for medications for mental illnesses, cost effectiveness is key in the RCEP, where the demand is focused on treating infectious diseases,” ScinoPharm Taiwan Ltd (台灣神隆) cofounder Hardy Chan (詹維康) said.
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