The economic and social effects of needle-stick injuries and syringe reuse have raised heightened awareness and immense concern prompting governments and healthcare organizations worldwide to implement new legislations and regulations to combat the problems :

WHO & International Initiatives

• World Health Organization (WHO), the United Nations Children's Fund (UNICEF) and other international agencies have begun an aggressive campaign to halt global epidemic of lethal diseases spread by contaminated needles. The plan calls for phasing out use of all standard disposable and reusable syringes in developing countries and replacing them with a new generation of safety syringes that can only be used once.
  - Excerpt from: http://www.needlestick.org
• WHO, UNICEF and UNFPA urge that, by the end of 2001, all countries should use only auto-disable syringes or syringes which are designed to be sterilized. Standard disposable syringes should no longer be used for immunization. (Courtesy: Safety of injections WHO-UNICEF-UNFPA joint statement on the use of auto-disable syringes in immunization services)
• UNICEF announces that, as of January 1st, 2001, no procurement service contracts for standard disposable syringes will be entered into.
  
  Courtesy: WHO-UNICEF-UNFPA joint statement on the use of auto-disable syringes in immunization services

Laws and Government Regulations Enforce Use

• The Needle-stick Safety and Prevention Act, passed by U.S. Congress in November 2000, mandates hospitals to evaluate and adopt safety injection devices that help prevent the spread of infection by contaminated blood. Hospitals that fail to use safety injection devices where appropriate are subject to a $10,000 fine, per incident.
• The Bloodborne Pathogens Standard (BPS) revised by Occupational Safety and Health Agency (OSHA) in 2001, to clarify and emphasize the requirement to use safety devices to reduce bloodborne pathogen exposure risk. Healthcare institutions can be fined up to $7,000 for each violation of the BPS, and up to $70,000 for each willful violation from outright failure to use safety devices.
• Conventional disposable syringe has been prohibited in the U.S. since July 2003, with a "grace period" expiring in 2005. By April 1st, 2005, all self-administered syringes sold in the U.S. are required by law to include safety features.
• In Canada, the province of Saskatchewan and Manitoba have mandated the use of safety-engineered needles in healthcare facilities. The Service Employees International Union (SEIU) is lobbying for similar legislation to be implemented in Ontario.

China's Efforts in Promoting Conversion to Safe Needle Devices

• On December 28th, 2001, the State Food and Drug Administration in China issued a statement which restated the 14th Directive released by the State Economic and Trade Commission in 1999, which prohibits the construction of new disposable syringe factories, while permitting the establishment of Auto-Disable syringe production facilities.
• The Foreign Investment Industrial Guidance Catalogue issued in March 2002, placed the conventional single-use syringe within the restricted foreign-investment category, while placing Auto-Disable syringe within the preferred foreign-investment category.
• China's Ministry of Health, working in collaboration with UNICEF, is mandating the use of Auto-Disable syringes for children's immunization campaigns in a number of cities and provinces in China.
• The Safety of Injections Association was formed in Beijing on April 20th, 2004. This organization was formed to aggressively promote safe injection behavior throughout China.

Market Potential

Since the Needle-stick Safety and Prevention Act was enacted by U.S. Congress in 2000, conversion from standard syringes to safety-engineered devices has substantially increased in the developed world. Whilst the United States is a pioneer in enforcing legislation to mandate usage of safer needle devices, the dangers of cross infection through the transmission of bloodborne pathogens are clearly global. During the next five years, we expect many other countries to adopt safety-engineered devices as the standard form of pharmaceutical delivery.

Moreover, increasing global awareness of cross infection through syringe reuse has also prompted regulations being implemented in developing countries like China to mandate the use of safety needle devices.

Current Bird Flu Epidemic

• The U.S. Senate passed legislation authorizing $4 billion for additional purchases of anti-flu medication.
• U.S. President George Bush called together the heads of major vaccine companies "to press ahead, and to expand our manufacturing capacity for a vaccine to address this risk.".
• This means a major sales opportunity for Otter, as each vaccine will need to be paired with an Auto-Disable syringe.