Taiwan and other regional players are finding it difficult to compete on the same scale as China when it comes to hosting clinical trials. Over the years, Taiwan has developed a strong reputation in the field of healthcare. It is now looking to leverage its advantages to position itself as a regional biomedical hub and a viable location for conducting clinical trials for promising new drugs.
Taiwan’s strengths in this area include solid IPR protection, well-run hospitals, excellent health professionals, and favorable government policies, which have contributed to creating a positive infrastructure for biomedical industry startups. Unfortunately, Taiwan seems to be losing ground to regional rivals when it comes to clinical trials. Despite being known as a reliable and cost-effective environment for such trials, it is facing stiff challenges from competitors – particularly from China.
In a presentation this August, Dr. Chern Herng-der, executive director of Taiwan’s Center for Drug Evaluation (CDE) under the Ministry of Health and Welfare, outlined the change in the competitive landscape for clinical trials in the region between 2016 and 2018. Chern’s talk to the Taiwan Society of Regulatory Affairs for Medical Products noted that of the six countries surveyed, China showed the strongest, most sustained growth in the number of clinical trials registered during that period.
Click on the source link to see Dr. Chen’s charts.
Changes in China
Despite China’s obvious advantages, many companies in previous years doubted the cost-effectiveness of conducting clinical trials there when considering the quality of the data. The country’s hospitals often fell short when it came to good clinical practice, and political interference, complex and confusing regulatory requirements, and underdeveloped medical systems made carrying out trials extremely burdensome.
In addition, the time it took to authorize clinical trials could be exceedingly long, preventing Chinese testing centers from being incorporated into the worldwide release of many drugs. Over the past four years, however, the Chinese authorities have made it a priority to address some of these longstanding issues. The country’s drug evaluation agency continues to increase the number of personnel and drug reviewers on its staff. In addition, China has adopted a U.S.-style approach to clinical trial applications, which has decreased the time needed to authorize a trial from a year to about 60 days.
The improvements in China’s regulatory system and manufacturing capacity have had a dramatic overall effect on the number of clinical trials being sponsored there, but have also impacted its regional competitors, as Chern indicates. In Taiwan, for example, only 51 clinical trials were held in the first six months of 2019, as opposed to 172 in China during the same period.
Taiwan first introduced a clinical trial system in 1993, and the quality of the trials steadily improved over the years, helped by an effectively coordinated set of relevant laws and regulations, Chern says. Taiwan became an early regional leader, partly because China was so far behind the curve. The Taiwanese clinical trials system at that time was so successful that it served as a model for South Korea’s KoNECT (Korean National Enterprise for Clinical Trials), established in 2007. Chern notes that KoNECT did so well in applying the information gleaned from Taiwan’s experience that it eventually overtook Taiwan in the number of clinical trials conducted.
Boon Huey Ee, general manager of Merck Biopharma Taiwan & Hong Kong, describes herself as upbeat about Taiwan’s long-term prospects as a base for conducting clinical trials, provided more is done to ensure that Taiwan stays competitive and increases its appeal to the major pharmaceutical companies, the main drivers of investment.
She suggests some changes to improve Taiwan’s image as a good place to conduct clinical trials and to better facilitate interaction between the government and pharmaceutical companies. One is to provide more incentives to reward innovation when new drugs are launched in Taiwan. “There are some incentives available, but these are mostly directed at local companies,” Ee says. “Those for multinational companies perhaps do exist, but they need to be better promoted and the details clarified.”
Another key step would be to get major pharmaceutical companies more involved in the rules-making process. Providing a platform for them to work with government ministries and the local biomedical industry would encourage collaboration and contribute to the development of Taiwan’s biopharma ecosystem.
CDE’s Chern says the Taiwan authorities are well aware of China’s recent gains in attracting clinical trials and intend to start making changes based on the experiences of neighboring countries. He cites four main factors determining the competitiveness of clinical trials: “quality, timeliness, cost, and market,” all of which Taiwan can excel at. Taiwan’s “scientific capabilities and excellent infrastructure” could make it a “global powerhouse in the biopharma arena,” Chern says.
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