戻る
Japan’s Plasma System:
How to Best Meet Patient Needs
Prepared for:
Plasma Manufacturing System Study Council
Ministry of Health, Labour and Welfare
Tokyo, Japan
By:
Christopher Healey, PPTA Executive Director
November 5, 2002
Role of National Authority
- Address patient health needs
- Safety and availability of plasma therapies
- Secure, Safe and Stable Supply
Self-Sufficiency is a legitimate
objective only after patients’ health
needs are adequately addressed.
|
Meeting Patient Needs?
Key: “?” indicates skepticism regarding claim of self-sufficiency for coagulation factors.
Data Source: Dr. Albert Farrugia, Head of Blood and Tissue Services, Therapeutic Goods Administration, Australia
Japan’s Blood Supply
- Aging population and fewer donors
- Declining blood donations
- Active recruitment of young donors
- Young donors are higher risk
- Increasing future unmet need
PPTA案 Proposal:
Path to Full Patient Care
Safety Considerations
- Access to therapy is a safety issue
−Without lifesaving therapies patients die
−With inadequate treatment patients suffer
- Safety standards are imperative
−QSEAL and IQPP are “state-of-the-art”
−Technology advances must be utilized
- Diversity of supply increases safety
−Example: BSE and vCJD in the UK
|
Safety Considerations
- Leading technologies make plasma therapies safe
| − | Domestic and non-domestic plasma is collected and manufactured under well-regulated standards |
- Domestic and non-domestic plasma meet the KENKETSU standard
| − | All plasma is freely donated |
| − | Compensation is appropriate for travel and inconvenience |
- Patient access is hindered by labeling that suggests differences in safety
|
Proposal for Safety Forum
Proposal:
- Plasma Safety Forum in January 2003
| − | Held in Tokyo |
| − | Scientific presentations on product safety |
| − | Demonstrate safety of domestic and non-domestic products |
| − | Avoid mischaracterizations of product safety |
|
Conclusion
- Patient health comes first.
- Self sufficiency limits patient access.
- Diverse supply increases safety and availability.
- Safety results from high standards and new innovative technology.
|
トップへ
戻る