JAPAN: INFORMED CONSENT AND CLINICAL TRIALS
Informed consent is a concept that requires physicians to share decision-making power regarding medical treatment with their patients. This concept originated in the U.S. and there is no history of informed consent in Japan. Thus, the vast majority of Japanese are not aware of the importance of informed consent. In Japanese, informed consent is translated as “explanation and consent.” This translation does not fully explain the right of patients to be active decision makers in deciding their course of treatment.

However, even if Japanese physicians and patients were to fully understand the concept of informed consent, traditional relationships between Japanese patients, physicians, and family members may be the strongest barrier to the application of this principle. Physicians in Japan have a “doctors know best” mentality. Family members also want to protect their loved ones. Once a family member becomes ill, they are often treated as incompetent and incapable of making their own decisions regarding treatment. Paternalistic physicians and protective family members would often counteract informed consent and try to make medical decisions to promote a patients’ well being independent of his/her wishes and values.

A survey conducted by the Ministry of Health and Welfare (MHW, now the Ministry of Health, Labor and Welfare - MHLW) revealed that 40% of 1600 physicians deemed it appropriate to decide how much medical information should be given to patients while only 26% felt that patients should be given as much information as they want.

Due to the lack of informed consent and patient decision-making power, patients are often unaware of their eligibility to participate in clinical trials. Those that do participate may not be aware of the full implications of the study or its purpose. The Japanese government has taken steps in recent years to educate the public regarding the benefits of clinical trials and the importance of patient participation. However, without proper informed consent during clinical trials, it is unlikely that significantly more Japanese patients will choose to participate in such clinical research.

The following are some general recommendations to carry out effective informed consent for clinical trials:

• Clearly and simply explain the purpose of the study
• Distinguish the investigational treatment from standard care
• Avoid overstating the potential benefit of the investigational treatment
• Keep focus on the physical and non-physical risks associated with the investigational treatment as a whole
• Broadly estimate the likelihood of the risks associated with the investigational treatment
• Provide supplementary and readable documents that are culturally sensitive and provide these materials throughout the lifetime of the study

CHINA: NEW SDA REGULATIONS FOR DRUG PRODUCT REGISTRATION
Authorities at the State Drug Administration (SDA) in China announced earlier this year that they are planning to implement nine new complementary regulations and methods for drug product registration in the country. These new regulations will be implemented from the end of 2002 into 2003. After the promulgation of the Implementing Methods for China’s Pharmaceutical Administration Law, the nine new regulations and methods will be implemented successively.

The SDA has in recent years been trying to address the problems and issues of drug registration in China. Some of the problems of the current drug regulatory system in China include: (1) non-integration of drug standards into China’s national regulation of drug products, (2) unclear and substandard regulations regarding drug packaging and inserts, (3) decentralized administration of drug evaluation, resulting in low quality generic drugs and counterfeits, and (4) imported drug registration regulations do not conform to WTO requirements.

On September 15, 2002, a new definition for new drugs was introduced into China. Instead of “drugs not previously manufactured in China” the definition for new drugs has been changed to “drugs not previously marketed in China.” This change in definition places foreign and local drug manufacturers on a more level playing field. New indications for drugs manufactured locally would be treated in a similar fashion as imported drugs. In addition, the SDA plans to implement the Methods for Regulating Drug Product Registration (Methods) on December 1, 2002.

SOUTH KOREA BANS HUMAN CLONING AND STEM CELL RESEARCH
The South Korean government announced the passing of a new bill banning the cloning of human cells starting next year. The bill that was finalized on September 24, 2002, will restrict the cloning of human cells as well as somatic cells. The Life Ethics and Safety Measures bill will also prohibit embryonic stem cell research, artificial hybrid fertilization between human beings and animals, and genetic treatment of fertilized eggs, embryos, and fetuses. Those convicted of violating the bill can face up to 10 years in prison.

Many scientists and researchers are opposed to the bill believing that the new regulation will only slow South Korea’s progress in scientific research. Stem cell research is believed to hold the answers to cures for diseases such as Parkinson’s disease and Alzheimer’s. In response to the outcry by many scientific experts, the Korean Health Ministry stated that the bill would be reviewed in three years time to take into account any scientific and technological developments and changes.

Clonaid, a U.S. cloning company headquartered in Nevada and founded in 1997, plans to continue its research regardless of the new regulations. The company has already implanted a cloned embryo in a South Korean woman. The woman is expected to give birth early next year. Clonaid’s branch office in Korea claims it will continue with research despite government warnings.

DRUG RETAILERS IN CHINA PREPARE FOR FOREIGN COMPETITION
On January 1, 2003, China’s retail pharmaceutical market will be open to foreign competition for the first time since the establishment of the People’s Republic of China. Previously, foreign medical retail companies were only able to do business in China through joint ventures. As a result of WTO entry, these restrictions will be lifted and foreign companies will be able to compete in the Chinese market beginning early next year.

Presently, domestic pharmaceutical companies are gearing up to prepare themselves for the increased and formidable competition from abroad. Recent statistics show that China has 196 pharmaceutical enterprises with retail chain stores with annuals sales of approximately RMB 8 billion (US$967 million). Domestic drugstores are far from being able to compete with their foreign counterparts on equal footing. Unlike foreign drugstore chains, local companies do not have adequate IT or management skills. These inadequacies will serve as a huge disadvantage once restrictions are lifted next year. Experts predict that in the not too distant future, foreign and joint venture companies will grab a significant portion of the market share while domestic companies will hold on to approximately 15% of retail pharmaceutical sales.

However, a number of domestic companies are increasing their investments in chain stores and are planning to open stores prior to January 2003 in order to prepare themselves for greater competition. Sanjiu Enterprise Group, one of China’s largest pharmaceutical companies, is planning to open between 8,000-10,000 stores, spending about RMB 1.3 billion (US$157 million).