Regulatory Developments Under pressure from severe funding restrictions caused by an aging population and a declining birth rate, the Government of Japan must establish a sustainable new healthcare system. In such difficult circumstances, preventive medical care takes on increasing importance, since it can substantially reduce medical costs and offer the Japanese population the benefits of a life free from vaccine-preventable diseases. Clearly, vaccines can be a major evidence-based and proven medical tool in Japan's future preventive medical care. Recent outbreaks in Japan of measles, Japanese encephalitis and other infectious diseases have made the public aware of the need for modern vaccines and supportive vaccine policies. The Japanese vaccine market is dominated by domestic products, representing more than 99% of the market and internationally available, cutting-edge vaccines are not in use. Japan has continuously and with increasing speed fallen behind other developed countries in terms of the vaccines available to protect the population. Vaccines widely available in the EU and US, such as MMR (Measles-Mumps-Rubella), Rotavirus, Human Papilloma Virus, IPV (Inactivated Polio Vaccine), DTPa (Diphtheria-Tetanus-Pertussis) combination vaccines that reduce needle sticks and increase compliance, pneumococcal 7v, overseas travellers' vaccines and others are still not available to Japanese risk group populations. From a public health perspective, the vaccine gap poses the risk of high outbreaks of diseases that could have been prevented by new vaccines that are not yet available in Japan. Japan's domestic-led vaccine supply policies have been based on the belief that domestic supply is the only way to secure stable and prompt supplies of vaccines essential to the protection of public health. However, domestic manufacturing capacity is not necessarily a prerequisite for securing a stable supply. Multiple suppliers, in-country stockpiles, and a strong communication network with other countries are the building blocks of a stable vaccine supply in Europe and the US. This can be achieved by a combination of domestic production and import of vaccines from abroad. Furthermore, a more attractive Japanese vaccines market would give the Japanese population access to existing and innovative new vaccines to protect their health. It would also provide an attractive climate for foreign investment in innovative biotechnology research and development. European manufacturers have seen no signs of change in the vaccine policy nor improvement of the market in the past five years. However, the MHLW has published a paper setting out a 'Vaccine Industry Vision'. The paper is the first sign that the Government is planning to make changes to improve the environment for the vaccine industry in Japan. This effort is very welcome, as the current vaccine industry should be a primary focus for reform and foreign vaccines manufacturers can contribute greatly to the improvement of healthcare for the Japanese population. Prospects for EU-Japan Economic Integration Vaccines are not included in the scope of the International Conference on Harmonisation (ICH). As a result, global harmonisation and an appropriate legal and regulatory framework for vaccines and biological products has not been achieved to bring alignment between bodies like the WHO, the EU, the US and Japan so that the quality, efficacy and safety of vaccines can be ensured in the most efficient way. The Japanese Government should be actively involved in these initiatives and the exchange of experience with other developed countries. Harmonisation with the European Medicines Agency (EMEA) could eliminate unnecessary duplication of resources. Furthermore, Japanese manufacturers and the Government should consider harmonising release specifications and quality requirements, so that foreign as well as Japanese companies can supply vaccines manufactured in Japan to worldwide markets. This would facilitate the introduction of high quality vaccines to Japan. Priorities
Key Issues and Recommendations ■ Improve availability of new vaccines Yearly status report: limited progress. Vaccines, including those from foreign manufacturers, have the potential to make a significant, positive contribution to improving the health of people living in Japan. They play a major role in public health, especially for children and the elderly - two important population groups in Japan. Yet Japanese citizens are not currently offered the same level of vaccine protection as is available to people in the US or the EU. Recommendation:
■ Harmonise vaccine standards and requirements with the EU Yearly status report: limited progress. Currently, vaccines are not included in the scope of the ICH. Since Japan has adopted independent quality requirements and specifications for vaccines, manufacturers need to undertake complicated processes to introduce Japanese vaccines to foreign markets and to bring foreign vaccines into the Japanese market. Harmonising the Japanese requirements with those of the EU and EMEA would address these issues and facilitate the development and introduction of new vaccines to Japan. Recommendation:
■ Establish national funding for new vaccines Yearly status report: limited progress. A significant increase in new vaccines for Japanese citizens will require a new system of financing. If not, there is a risk that Japan's current system of central recommendation and local funding will face difficulties in financing this new area of protective healthcare. The Government should ensure that vaccines are positioned as a cost-effective tool for reducing overall healthcare costs and serve as a good example of investing in health to achieve economic productivity. Recommendation:
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