COUNTERFEIT DRUGS IN CHINA: SHANGHAI STEPS UP DRUG MONITORING SYSTEMS
In January 2003, the Shanghai Drug Administration Bureau announced its resolve to tighten controls over pharmaceuticals and drug distribution as well as create more efficient systems for reporting adverse reactions to medication. According to recent reports by the bureau, of 14,980 drugs inspected in 2002, 1,833 were found to be below quality standards. China is also the largest producer of counterfeit drugs in the world. Some of these imitation or counterfeit pharmaceuticals are composed of materials that do not contain proper active ingredients; some are filled with talcum powder or flour, while others contain toxic materials.

Shanghai will be the first city to implement these tighter controls. In many cities, even members of the police act as informants to medical distributors, alerting them of impending spot checks. A system is already in place in Shanghai to prevent pharmacies and drug manufacturers from being tipped off prior to inspection visits.

Greater efforts will also be made to strengthen the capabilities of the Shanghai Drug Adverse Reaction Monitoring Center. The city plans to create a more effective system of adverse drug reporting and response in order to protect the safety and health of local residents. Last year, the center received 960 calls regarding adverse reactions to medication from local medical facilities. This is three times greater than the number of calls received in 2001.

According to the Shenzhen Evening News, approximately 192,000 Chinese people have died because of fake drugs. Since China’s accession to the WTO (December 2001), the Chinese government has made concerted efforts to crack down on the counterfeit drug industry. In the first half of 2002, the government uncovered 70,000 cases of counterfeit drug production; this figure exceeds the total number of cases uncovered in the whole of 2001.

Director of the Shanghai Drug Administration Bureau, Wang Longxing, stated “In the year 2003, the bureau will spend more time monitoring the drug market following the whole process from manufacturing to selling. Moreover, we will strengthen the registration system for new medicines and appliances to control the market.”

PROMOTING TAIWAN’S MEDICAL EQUIPMENT MARKET IN THE INTERNATIONAL ARENA
With the help of University of Chicago professor Chin-Tu Chen, Taiwanese medical equipment makers are determined to strengthen their position in the international market. Dr. Chen was invited by Taiwan’s National Health Research Institute (NHRI) to assist in the development of the country’s medical equipment and biomedical instrument industries. Currently, medical equipment manufacturers are utilizing two means to establish a foothold in the international market: 1) through contract production, and 2) by aggressively promoting Taiwanese own-brand products in developing countries.

Dr. Chen believes that Taiwan’s medical equipment market has the most promise for growth of local companies. Through utilizing infrastructure that is currently available, such as industrial infrastructure for electronics, semiconductors, and telecommunications, Taiwanese companies can produce medical equipment relatively quickly. Through the integration of these infrastructures, local medical manufacturers will be able to win more contract production business from international companies.

Local medical equipment makers are heeding Dr. Chen’s advice by planning a joint international marketing company to assist them in penetrating emerging markets. Among the local companies that will be major investors in this venture are: Bioteque Corporation, President Life Sciences Company, and Apex Medical Corporation. Medical equipment manufacturers recognized the need for assistance in promoting their products in the international market due to intense competition particularly from China. Prospective shareholders of the marketing venture proposed that the company be initially capitalized at $575,000. In order to promote these ventures, the Taiwanese government has also announced that it would be subsidizing certain international marketing ventures. According to the Ministry of Economic Affairs (MOEA), the government will set aside a budget of $5.2 million for relevant endeavors in 2004.

SINGAPORE LAUNCHES STANDARDIZATION FOR MEDICAL DEVICES
SPRING Singapore (Standards, Productivity and Innovation Board) and the Economic Development board launched Singapore’s first efforts to standardize the country’s medical devices industry on January 17, 2003. The standard proposed by the governing authorities is called the Technical Reference for Medical Device Components, or TR for short. It is based largely on the US FDA Quality System Regulations (QSR). The TR is currently on a two-year trial and will be open to feedback by the medical device industry before being fully implemented. The Singaporean government hopes their initiative will bring about greater harmonization of quality standards.

The first of the technical references launched this month was the Quality System for Medical Device Components. This interim standard was developed specifically for the biomedical sector in order to cut costs and facilitate Singapore’s scheme to become a biomedical hub. Lee Suan Hiang, Chief Executive of SPRING Singapore, stated, “The Technical Reference is expected to help them [medical device multinationals] save costs, as well as facilitate audit checks on their quality systems. At present, the quality systems used by manufacturers vary and each supplier needs to have its quality system checked by its customers. With a common standard, suppliers can upgrade their capabilities independently, thus reducing the resources required to meet the different requirements of each customer.”

Singapore’s medical device industry generates approximately S$1.6 billion (US$928 million) per year and filled 3,900 jobs in 2001.

EFFECTS OF GENOME-BASED MEDICINE ON JAPANESE MEDICAL REGULATION
The advent of genome-based medicine and pharmacogenomics (the medical field that analyzes the reasons why people have different reactions to similar treatment) is expected to transform the medical regulatory environment in Japan. As the human genome is decoded, development of new medicines will be based upon individuals and their unique genetic makeup. Instead of generic drugs, designer drugs developed specifically for individuals will become the norm. Due to these reasons, the current standards for clinical testing for new pharmaceutical products will no longer apply. Instead, testing for the safety and efficacy of a particular drug product would only need to be done on specific groups of people for which the drug was designed rather than on a pool of randomized subjects. Masatoshi Ishizuka, the Director of the Research and Development Promotion Department at the Organization for Pharmaceutical Safety and Research (OPSR) believes that genome-based research will vastly increase the success rate and shorten the time of medical product development in Japan. As a result, costs will be considerably lowered.

Dr. Stefan Wohlfiel, head of Bayer Yakuhin, Ltd.’s research center in Kyoto illustrated this quickening in product development as well as lowered costs when he said, “Our research goal has been to increase yearly CDs [candidate drugs] from two in 1995 to 20 by 2004. This entails increasing productivity by 30% and efficiency by 17% per year while, at the same time, decreasing CD costs by 75%.”

Although changes are expected to occur in Japan’s regulatory environment due to the advances in genome-based medicines, these changes will not occur at a rapid pace. Hirotaka Yabuki, Vice President of The Boston Consulting Group K.K. believes that the approval process that currently averages 14.7 years “could be reduced by two to three years by a genomics-based approach, such as industrialization of target identification, pharmacogenetics and parallelization of the discovery process.” Even though the speed of regulatory approval may not decrease considerably, the differing quantity and quality of data will facilitate the job of the regulators significantly.