Patients In China Denied Innovative New Medicines, Says E.U. Pharmaceutical Group
June 30, 2010
SHANGHAI – A group of major European drug developers said Chinese patients are being denied innovative new medicines, according to press reports covering the most recent meeting of the pharmaceutical working group of the European Union Chamber of Commerce in China.
Drug makers that are part of the European chamber said during a recent meeting in Beijing that China’s goal of becoming an innovative society by 2020 is being jeopardized by long and unnecessary approval processes for clinical trials, plus difficulties in maintaining quality across the market.
The working group includes approximately 30 European pharmaceutical companies with operations in China; more than 20 have established factories that produce not just for China, but also for export throughout the region or even globally. The total investment by European pharmaceutical companies in China is about €700 million.
During the meeting, delegates said continued problems with current pharmaceutical regulation could create new barriers for Chinese patients seeking access to innovative new medicines, according to press reports.
The slow regulatory process for clinical trial applications in China creates challenges for drug makers. In China, it normally takes between nine and 12 months to obtain approval for a clinical trial, compared to only 60 days in Europe; hence, a sizable time lag between drug registration in China and Europe exists, the working group noted.
There is an array of major difficulties facing international drug firms that aim to conduct clinical trials in China, according to Ivy Teh, managing director of the Singapore-based healthcare consultancy Clearstate.
“It is a time-consuming process to apply for clinical trials of new drugs. The application process generally takes six to 12 months before a final approval is obtained and this is strictly supervised by the healthcare authority,” Teh told PharmAsia News. “As this application process may vary from international standards, it may confuse multinational companies that are not familiar with China’s regulations.”
“In addition, the trial period typically lasts for a long time for most drugs, except for those drugs under the expedited approval process,” said Teh. “The long trial period may result in multinational companies missing the best timing to launch new products into the market.”
The low number of registered clinical trial facilities in China, with all these facilities being level three hospitals, is a major difficulty, Teh noted.
“Up to 2009, there were only 236 clinical trial facilities registered in China to support the demand of clinical testing for innovative drugs,” Teh said. “Consequently, this increases the difficulty for drug manufacturers to find registered clinical trial organizations nearby their factories. This scarcity is even more prominent as the distribution of clinical trial facilities is fairly uneven across China.”
“For instance, nearly 30 percent of these organizations are centralized in only three metropolises: Beijing, Shanghai and Guangzhou,” she explained. “In addition, clinical trial organizations are only able to conduct specific types of trials approved by the State Food and Drug Administration and the Ministry of Health. In particular, Beijing, Shanghai and Guangzhou clinical trial facilities are able to conduct two to three times more categories of drugs testing compared to other cities in China.”
Thus, international drug firms with operations outside of tier one cities might be drastically limited in the choice of facilities to clinically test their innovative drugs. These firms might need to refer to clinical trial hospitals located in Beijing, Shanghai or Guangzhou for some of their new drugs, Teh added.
Government support for local drug manufacturers is another great barrier for international firms, according to Teh.
In many provinces in China, the government encourages and supports clinical trials of innovative drugs from local pharmaceutical companies rather than from multinational firms, she said. “This might include the faster new drug clinical trials application approval of local drug manufacturers by authorities.”
International drug firms are thus placed in a rather disadvantaged position in some regions in China.
The European Union Chamber of Commerce pharmaceutical working group said the failure to enforce the Ministry of Human Resource and Social Security’s stipulation in 1999 on updating the National Drug Reimbursement List at least once every two years is a further restriction on Chinese patients’ access to innovative medicines.
In China, only medicines that are included on this list are eligible for reimbursement under the national health scheme. At the provincial level, province-level health authorities establish their own list on the basis of the national list.
Last November’s update of the central list increased the number of Western drugs to which Chinese patients can gain access through the healthcare system; however, the last update before that was in 2004.
The E.U. has raised concerns about this issue with China’s Ministry of Commerce several times in the past, but has been rebuffed each time.
Due to the high cost of research and development of innovative drugs, along with numerous layers of supply chain intermediaries between the manufacturer and the patient, these medicines are typically priced at a premium when launched, which also limits the average Chinese patient’s ability to afford innovative drugs, according to Teh.
- Ying Huang (pharmasia@elsevier.com)
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