“Drug lag”, absence or delay in approval of drugs that are available in other countries, has been a much debated issue. We previously reported the “drug lag” status of the US, EU, and Japan with 398 New Chemical Entities (NCEs) approved either in the three regions between 1999 and 2007. The major data such as approval date was collected from the public sources of regulatory agency of each region. In this article, the utility and limitation of public data sources are discussed.
The advantages of utilizing of public sources are that reliable, precise, and comprehensive data can be obtained cost-free. Meanwhile, the collection of the data is time and labor-consuming work and there is a limitation of data availability. However, the study suggested that the comparison of the “drug lag” status of the three regions could be done by utilizing public data and complementary commercial databases.

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The Pharmaceutical industry faces several challenges such as a series of patent expiries of major products, the slow pace of the R&D process, a decrease in new innovative compounds, generic drug penetration, and a change in drug policy, and is seeking out a new business model. To overcome these challenges, large global pharmaceutical companies have performed consolidation of companies and entered into emerging markets and generic business, whereas large domestic companies have made acquisitions of overseas companies. In Japan, generic penetration was relatively slow compared with other developing nations but many Japanese companies with a focus on domestic business face a potential sales decline risk from a potential shift to generics by the recent government action, and companies with heavy exposure to long-term listed drugs are under pressure to change their business model. To realign with these changes, there are four major points which companies undertake: 1) consolidation of pharmaceutical companies with chemical companies, 2) strengthening the emerging market business, 3) strengthening the generic drug business, and 4) strengthening the overseas business through acquisition.

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Immunization is an important tool to prevent human from infectious diseases. The purpose of immunization is to prevent individuals, and moreover it can prevent whole community. However, immunization can cause rare but serious adverse events. We should always consider the balance on the risk and benefit of immunization when we give it.

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In order to promote safe and confident use of medicine, it is essential to share information on adverse events of the product itself as well potential risks associated with the use of medicine, among the patients, family members of patients, healthcare practitioners, pharmaceutical companies and regulatory agencies. This is especially important to assure that risk communication is appropriately conducted to minimize risks.
Risk communication of medical products is usually followed four steps.
a. Planning of the content of risk communication based on collection and analysis of safety information
b. Execution of actions to share risk information among the relevant playerspatients, healthcare practitioners, pharmaceutical companies, regulatory agencies
c. Evaluation of risk communication based on monitoring of actions and its results
d. Planning and actions for improving effectiveness of communication
Nevertheless, there remain issues to be resolved in each of the four steps. Especially as no methods for evaluation of risk communication has been established yet, it is critical to prepare such guidelines quickly in order to promote standard risk communication as common practice.
As one of the practicable ways to resolve this issue, we have attempted to evaluate the results of conveying information from regulatory agencies and pharmaceuticals companies to healthcare practitioners by analyzing prescription data (National Prescription Audit data) as well as the frequency of access by healthcare practitioners to search safety information on drugs before and after the notification of revision drug precautions. The result of this analysis conducted for two products, showed evidence that of physicians prescription have changed as the frequency of access to search for safety information increase after notification of revision of drug precautions.
In conclusion, the effectiveness of risk communication must evolve quickly by initially establishing the methods and standard procedures of transferring safety information to healthcare practitioners. Simultaneously, awareness to minimize risks should be effectively built through mutual communication among the stakeholders participating in team treatment including the patient.

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Sibutramine products, which were not approved in Japan, but were the most popular anti-obesity agents on-line, were purchased through on-line brokers in 2008. Fiftythree parcels consisted of 9 products were obtained from 32 on-line brokers.
These products are prescription medicines in countries where they are approved, but no brokers informed us of this, or requested prescriptions. Package inserts were written in various foreign languages, including Polish and Turkish, or were absent. An explanatory note in Japanese on dosage and administration accompanied several parcels,but the maximum dose was described as nearly three times that in the proper package insert.
The Japanese Ministry of Health, Labour and Welfare’s guidance to patients wishing to import medicines personally is that they should not import more than one month’s supply. The majority of parcels included more than one month’s supply and the maximum was 10 times this amount. A few parcels failed content uniformity tests. One product had not been approved by any government. After the suspension of market authorization of sibtramine products in Europe and the USA in 2010, several sites continued to offer supplies.
Consumers are individually responsible for personal imports, and poor management by stakeholders puts them at risk. They should be made aware that emerging outlets such as the internet bypass the conventional protection framework, and should take great care.
Internet sales easily cross borders, and international cooperation would be indispensable to improve the situation. Personally imported pharmaceutical parcels to Japan were dispatched from several neighboring countries, including Cambodia, China, Hong Kong, India, and Thailand, and also from the Philippines, USA, and UK. Cooperation with these countries would be indispensable for the control of personal imports to protect Japanese public health.

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This paper focused on low wages and staff shortages as causes for high turnover of care staff and examined the corresponding countermeasures. While focusing on special nursing homes, the supply behavior of nursing providers was analyzed through a detailed consideration of factors including the system, legislation, cost of establishment and operation of facilities as well as the sources of income. It was found that low wages and staff shortages are caused by: 1) a possibility that excessive facilities construction costs, largely dependent on borrowings, are leading to a squeeze in personnel costs due to the high carrying cost of loans; 2) a possibility that the nursing provider is overestimating future anticipated expenditures due to insufficient understanding of accounting rules for social welfare corporations, thus squeezing personnel costs in order to realize an excessively large surplus of income over expenditure; 3) a possibility that the owners of the nursing facility are squeezing personnel costs for private gain; and 4) a possibility that cuts in personnel costs are being implemented through an increased use of non-permanent staff and by requiring staff to take on multiple roles. In order to improve retention of care staff, proactive measures by the government and financial institutions against excessively costly facility plans, government advice in terms of appropriate levels of income over expenditure ratios, and measures to make hiring permanent care staff and improving staff retention more financially attractive for providers are necessary.

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This article compares the policy measures taken by the EU, the UK, and Japan concerning the accepting of nurses from overseas, in order to examine the consistency between regulatory purposes, means/policies, and outcomes.
As for the EU, the Treaty establishing the EU defines its purpose as promoting free movement of people, goods, capital and services. Thus, the EU promotes intra-EU mobility of nurses under the condition that the qualifications of nurses in its member states meet the minimum standards defined in the EU directive. The UK successfully managed the rules for migration, registration as nurses, and proving applicants’ language skills: it increased/decreased the inflow of oversea nurses as it intended.
While we can find consistency between regulatory purposes, regulatory behaviors, and outcomes in the case of the EU and the UK, we cannot find such consistency in Japan’s case. The government administration and ministries do not officially admit that they recruit nurses from overseas due to staff shortage, although hospitals face staff shortages and have high demand for employees. The arrangement which is set in the EPA embodies such ambivalent and conflicting interests, which leads to the imposition of additional burdens on hospitals.

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A comparison was made between the geographic distributions of physicians in Japan, the United States, and Britain. Regional variation in the number of primary care physicians per unit population was larger in Japan than in Britain. The results can probably be explained by differences in the primary care systems of the two countries. Next, we examined the effect of increased physician numbers overall on the geographic distribution of physicians in Japan and the US. In spite of constant growth in the numbers of physicians between 1980 and 2005, physicians did not diffuse according to the population distribution in both countries. Rather, US physicians seem to diffuse according to income distribution. This is probably due to the difference in health insurance systems between the two countries. In addition, physician scarcity was associated with further scarcity in US communities, while the scarcity was associated with recovery from scarcity in underserved Japanese communities. Political interventions to address the maldistribution of physicians apparently have not worked effectively in the US compared with Japan. Finally, we compared the number and distribution of specialists between Japan and the US. The lower the proportion of clinic-based physicians was, the lower the number of physicians and the lower the equity of physician distribution in Japanese specialties, while there was no association between the office-based rate and distribution equity in US specialties. In radiology, anaesthesiology, emergency medicine, and pathology, the numbers of physicians per unit population were less than half of the US values. Difficulty in being self-employed created low numbers and highly urban-biased distributions of some specialists in Japan. In conclusion, the uniqueness of the Japanese healthcare system potentially affects the geographic distribution of physicians in the country.

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