Healthcare, Regulatory and Reimbursement Landscape - Republic of China (Taiwan) , New Report Launched

Taiwan’s increasing elderly population and declining birth rate pose a demographic challenge for its government. Good access to health insurance, a growing healthcare burden and government initiatives are expected to drive market growth, although periodic price cuts present a major challenge.

In 2013, the number of people above the age of 65 years accounted for 11.5% of Taiwan’s total population (NDC, 2013b). This is increasing significantly and given the association between elderly populations and increased prevalence of all kinds of disease, it is associated with a growing disease burden for Taiwan’s healthcare system. Medical expenditure for chronic diseases has also increased, although the government is attempting to reduce the financial burden this presents through comprehensive healthcare reforms. The overall population increased slightly between 2008 and 2013 from 23.0 to 23.4 million, mainly due to a rising life expectancy. However, the birth rate decreased at a negative Compound Annual Growth Rate (CAGR) of 0.04% between 2008 and 2013 (National Statistics R.O.C., 2012; NDC, 2013b).

In 2013, although Taiwan’s pharmaceutical market was smaller compared to Japan’s, China’s, India’s and South Korea’s, totaling $5.7 billion, its per-capita expenditure on medicines was significantly higher, being $245.7 in 2013. The pharmaceutical market grew at a CAGR of 6.9% from 2008 to 2013. The Taiwanese government is taking various steps to ensure investment and growth in the pharmaceutical industry. In line with the Act for the Development of Biotech and New Pharmaceuticals Industry introduced in 2007, the Taiwanese government provides incentives for new pharmaceutical companies to establish themselves in Taiwan, such as a reduction in income tax. However, the country’s Global Budget Payment System was implemented in 2002, following which the price of National Health Insurance (NHI)-funded drugs reduced seven times, impacting both domestic companies and their foreign counterparts. The Office of the US Trade Representative estimates that on average, pharmaceutical prices in Taiwan are 28% of the price of the equivalent product in the US (USTR, 2013). The continual price cuts are a major challenge for the growth of the pharmaceutical market.

The market for medical devices in Taiwan is one of the largest in Asia due to the country’s growing elderly population and the subsequent increase in the demand for healthcare products and services. It was valued at approximately $1.7 billion in 2008 and grew at a CAGR of 4.6% to $2.2 billion in 2013. By 2020, it is expected to have reached $3.1 billion.

Universal healthcare coverage and access to healthcare facilities and reimbursement are the distinguishing features of the Taiwanese healthcare system.

The Republic of China (Taiwan) has a compulsory NHI system with universal coverage and covers approximately 99.9% of the population (NHI, 2014a). In 2013, the NHI system saw many changes – the second-generation NHI system was implemented in January, and in July the name of the Bureau of NHI (BNHI) was changed to National Health Insurance Administration (NHIA). Due to the reforms in the NHIA system, the organization no longer has a deficit in funding (NHI, 2014a). In 2013, approximately 93.7% of all healthcare facilities in Taiwan were contracted by the NHI system. The government receives funds for health insurance from general tax revenue.

The Taiwanese regulatory authority provides a transparent and efficient regulatory system to facilitate the approval of pharmaceutical products and medical devices with a relatively short approval time.

Drugs for marketing must be approved by the Taiwan Food and Drug Administration (TFDA), an agency of the Department of Health (DoH), following the evaluation of a New Drug Application (NDA) by the Center for Drug Evaluation (CDE). The fee incurred for the approval of a new drug is $20,338 (CDE, 2012g). The CDE completes the NDA review and sends the assessment reports with recommendations to the DoH within 100 days, which is significantly less time when compared to the regulatory authorities of other developed countries.

The Ministry of Health and Welfare (MoHW) is the healthcare authority responsible for regulating the importation of medical devices through TFDA under the Pharmaceutical Affairs Law. Pre-market registration from TFDA is required before medical devices can be manufactured locally or imported into the Republic of China (Taiwan). All foreign suppliers must obtain approvals through their Taiwanese importers or through a Republic of China (Taiwan)-registered subsidiary.

Although the economy continues to be strong and stable, rising unrest due to a free trade agreement with China and Taiwan’s long-standing diplomatic isolation are acting as obstacles for economic development.

The trade agreement with China in June 2013 has had a negative effect on President Ma Ying-jeou’s popularity, as many in Taiwan fear this may be a strategy that could lead to reunification of the two countries, to Taiwan’s disadvantage. Additionally, some believe that the free trade pacts will destroy local small business in the Republic of China (Taiwan). Elections at the end of 2014 are expected to cause a major change in the political environment of Taiwan.

Taiwan has formal diplomatic ties with only 24 countries in the Pacific, Latin American and African regions, due to China’s insistence that nations cannot have official relations with both China and Taiwan.

Taiwan has a large trade surplus and its foreign reserves are the fourth largest in the world behind those of China, Japan and Russia. Taiwan's GDP per capita increased from $17,372 in 2008 to $20,930 in 2013 (IMF, 2014a). The country’s per-capita income has always been significantly higher than that of China and India. In 2013, the total government gross debt was 41.0% of GDP, which is lower than countries such as India (66.7% of GDP), Thailand (45.3% of GDP), and Malaysia (58.2% of GDP) (IMF, 2014f).

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