China Looks At Innovation, Quality Policies As Chronic Diseases Rise

Maximizing innovation and focusing on product quality should be prioritized in China’s next Five-Year Plan for the pharma industry, representatives proposed at a recent government meeting. Meanwhile, data from the national health regulator have indicated a sharp rise in chronic diseases and obesity in the country.

BEIJING – China’s pharmaceutical market, ranked among the largest in the world along with the U.S. and Japan, is now facing strong downward pressure and its international competitiveness is waning, representatives at a recent meeting organized by China’s Ministry of Industry and Information Technology warned.

Current official policies are deterring innovation and not helping the situation, pointed out government and industry experts attending the June 4 meeting, held in the eastern city of Liangyungang, Jiangsu province.

First, there is a lack of clear policies for drug innovation, current financing, the drug review process, tenders and reimbursement, while patent policies are geared towards generic drugs rather than encouraging new drug innovation.

Secondly, China’s pharma market is highly fragmented, with multiple agencies issuing regulations, sometimes in contradiction of each other. Drug firms must spend the bulk of their time on meeting various regulatory demands and dealing with cut-throat price competition, leaving little time for research and development, the meeting heard.

Meanwhile, heavy local protectionism within China makes large-scale, cross-regional mergers and acquisitions nearly impossible, resulting in a low level of industry concentration on a national scale.

Given all these issues, policy makers thus need to focus in the next Five-Year Plan on product quality and enhancing top-level policy design, proposed the meeting participants. In particular, transitional medicine measures should be prioritized to facilitate the transfer of more basic research results into actual drug products, it was suggested.

Through previous Five-Year Plans for the industry, China has poured billions into drug and device innovation, hoping to generate products with their own intellectual property rights. However, the impact has been limited and the number of truly breakthrough new drugs has been low so far (Also see "China To Reimburse Biologics Under Five-Year Plan, Push Domestic Development" - Scrip, 15 Jan, 2013.).

One successful example is the rare lymphoma treatment chidamide, developed by Shenzhen Chipscreen Biosciences Ltd. (Also see "INTERVIEW: Chipscreen CEO Bets Big On Chinese Innovation" - Scrip, 14 Jun, 2015.).

Quality/Chronic Disease Issues

Innovation challenges aside, product quality has long been an issue in China. For instance, in a recent China FDA inspection, nearly half of Gingko extracts, a widely manufactured and used traditional medicine to treat hyperlipidemia and other conditions, were found to be substandard (Also see "China Gingko Crackdown Reveals Broad Quality Problems" - HBW Insight, 29 Jun, 2015.).

To that end, China is now putting resources behind a campaign to renew the meaning of “Made in China”, the broad goal being to improve quality driven by innovation and to transform China from the world’s largest factory to be one of the strongest quality manufacturers in 2025.

The need to reassess policies for innovation and quality healthcare products has also been thrown into sharp relief by data showing fast growth in cases of chronic diseases in China.

In 2012, when the latest data were released, nearly one in 10 Chinese adults were obese, the figure being more than double the rate in 2002, according to health statistics from China’s National Health and Family Planning Commission.

And according to new official data released on June 30, one in four people over 18 have high blood pressure and one in 10 is diabetic, making China the country with the largest diabetic population in the world.

Due to air pollution and environmental change, respiratory diseases are also on the rise. Among people over 40, the incidence rate of chronic obstructive pulmonary disease is 9.9%, for instance.

In fact, chronic diseases now account for 86.6% of all mortality in China, with cardiovascular disease, cancer and chronic respiratory conditions the major causes of death. The mortality rate for coronary heart disease and lung cancer is continuing to increase, the report noted.

[Editor's note: This story was contributed by PharmAsia News, which provides in-depth coverage of Asia business and regulatory developments.]