Bio-Terror Legislation (2004)

BIOTERRORBIBLE.COM: The following news and events are in respect to bio-terror and pandemic related legislation which occurred within the calendar year of 2004. The American government, more than any other nation, has been systematically preparing its population for an upcoming bio-terror related pandemic by passing draconian bio-terror legislation in the wake of the 9/11 attacks.

Bio-Terror Legislation (2001), Bio-Terror Legislation (2002), Bio-Terror Legislation (2003), Bio-Terror Legislation (2004), Bio-Terror Legislation (2005), Bio-Terror Legislation (2010), Bio-Terror Legislation (2011),  and Bio-Terror Legislation (2012).

Title: Technology Transfer Debate In The Biodiversity To Consider Impediments Such As Export Controls
February 21, 2004
Sunshine Project

Abstract: Governments meeting in Kuala Lumpur today decided to begin discussions on technology transfer that include consideration of obstacles that are imposed by developed countries, such as export controls. Early this morning, Parties to the nearly-universal* Convention on Biological Diversity established a Programme of Work on Technology Transfer and Cooperation that includes consideration of systems that "present obstacles that impede transfer of relevant technologies from developed countries", a reference to, among other impediments, the Australia Group, the controversial "informal arrangement" by which developed countries, citing non-proliferation concerns, deny transfers of microbiological production and safety equipment and knowledge to many developing countries.

Developing countries and non-governmental organizations worked over the course of the last two weeks to insert export control studies into the decision. Earlier this week at the meeting's Ministerial Segment, a joint statement by dozens of NGOs attending the meeting called for government action to reform Australia Group export controls. As initially tabled, the decision was heavily biased against developing countries and in favor of rich ones and the biotechnology industry, which generally aims to export biotechnological products - not technology - to developing countries. Through cooperation between Asian, African, and Latin American countries together with NGOs, elements were added to the decision that corrected some of the imbalances.

Under the Programme of Work, the Secretariat of the Biodiversity Convention, working with a regionally-balanced group of experts, will prepare informational and technical studies of developed country obstacles to technology transfer, such as export controls. The decision also provides for the participation of international organizations in this process, which should enable the participation of NGOs. The results of these studies will be presented for political consideration at future meetings of the Convention, beginning with its 8th Conference of the Parties in Brazil in 2006.

Sunshine Project-US Director Edward Hammond, in Kuala Lumpur, is cautiously optimistic about the decision. The key objective of the Biodiversity Convention's work should be implementing a system of multilaterally-facilitated, safe technology transfer that ensures that the objectives of both the Biological Weapons Convention and the CBD are upheld. "The CBD and Biological Weapons Convention contain parallel obligations for developed countries to transfer biological technologies to the developing world," says Hammond, "Yet, in neither case, have developed countries fulfilled their obligations. We are hopeful that in-depth consideration of export controls by the CBD will result in strides forward that will enable safe, multilaterally-facilitated technology transfer consistent with the objectives of both Conventions. That will simultaneously enhance international security and provide for the conservation and sustainable use of biodiversity, and a fair sharing of benefits arising from its use. The replacement of the Australia Group with a treaty-based mechanism that, unlike the present regime, enjoys the support of the developing world will, in turn, enable efforts to strengthen the Biological Weapons Convention."

 * The Convention on Biological Diversity (CBD) almost universal. The only major non-parties are the United States and Iraq, along with the much smaller states of Andorra, Brunei, and the Vatican (Sunshine Project, 2004).

Title: United Nations Security Council Resolution 1540
Date: April 28, 2004
Source: Wikipedia

Abstract: United Nations Security Council Resolution 1540 was adopted unanimously on April 28, 2004 regarding the non-proliferation of weapons of mass destruction. The resolution establishes the obligations under Chapter VII of the United Nations Charter for all Member States to develop and enforce appropriate legal and regulatory measures against the proliferation of chemical, biological, radiological, and nuclear weapons and their means of delivery, in particular, to prevent the spread of weapons of mass destruction to non-state actors.

It is notable in that it recognizes non-state proliferation as a threat to the peace under the terms of Chapter VII of the United Nations Charter, and creates an obligation for states to modify their internal legislation.

Furthermore, the resolution requires every state to criminalize various forms of non-state actor involvement in weapons of mass destruction and its related activities in its domestic legislation and, once in place, to enforce such legislation. By virtue of its universal scope and mandatory nature, resolution 1540 marks a departure from previous nonproliferation arrangements and adds a novel layer to the nonproliferation regime. Before the resolution was adopted, the non-proliferation regime was based on many partly overlapping arrangements, none of which established universal mandatory obligations (Wikipedia, 2012).

Project Bioshield Act
Date: July 21, 2004
Source: Wikipedia

The Project Bioshield Act was an act passed by the United States Congress in 2004 calling for $5 billion for purchasing vaccines that would be used in the event of a bioterrorist attack. This was a ten-year program to acquire medical countermeasures to biological, chemical, radiological and nuclear agents for civilian use. A key element of the Act was to allow stockpiling and distribution of vaccines which had not been tested for safety or efficacy in humans, due to ethical concerns. Efficacy of these agents cannot be directly tested in humans without also exposing humans to the chemical, biological, or radioactive threat being treated. In these cases efficacy testing follows the FDA Animal Rule for pivotal animal efficacy.

Since the 2001 terrorist attacks, the United States government has allocated nearly $50 billion to address the threat of biological weapons. U.S. funding for bioweapons-related activities focuses primarily on research for and acquisition of medicines for defense. Biodefense funding also goes toward stockpiling protective equipment, increased surveillance and detection of biological agents, and improving state and hospital preparedness. The increase in this type of funding is mainly for this Project BioShield. Significant funding also goes to BARDA (Advanced Research and Development Authority), part of HHS. Funding for activities aimed at prevention has more than doubled 2007 and is distributed to 11 federal agencies. Efforts toward cooperative international action are part of the project (Wikipedia, 2004).

Title: President Bush Signs $5.6 Billion Bill To Strengthen Bioterror Defenses
Date: July 21, 2004
Source: PBS

: President Bush signed legislation Wednesday designed to help protect the United States against biological and chemical attacks by encouraging development of drugs and vaccines.

The $5.6 billion, 10-year Project BioShield program provides the drug industry with incentives to research and develop responses to bioterrorism. The legislation also speeds the approval process of antidotes and will allow emergency government distribution of certain treatments before the Food and Drug Administration has approved them. "We know that the terrorists seek an even deadlier technology, and if they acquire chemical, biological or nuclear weapons we have no doubt they will use them to cause even greater harm," President Bush said in the Rose Garden.

"The Department of Health and Human Services has already taken steps to purchase 75 million doses of an improved anthrax vaccine for the Strategic National Stockpile. Under Project BioShield, [Health and Human Services] is moving forward with plans to acquire a safer, second generation smallpox vaccine, an antidote to botulinum toxin, and better treatments for exposure to chemical and radiological weapons," the president continued. The bill tries to guarantee a market for bioterror defenses by buying and stockpiling the new drugs and vaccines to treat or protect people against such diseases as anthrax, smallpox or the plague, or against such toxins as ricin. Without such assurances, the private sector would probably be reluctant to invest millions in products that may never be needed.

The legislation received bipartisan support in Congress. It passed the House on a 414-2 vote July 15 and the Senate passed it 99-0 in May. "Modern terrorist threats come not just from explosions, but also from silent killers such as deadly germs and chemical agents," Sen. Ted Kennedy, D-Mass., an author of the bill, said in a statement. "Project BioShield creates a lifesaving partnership between our government and the private sector to develop the vaccines needed to project our citizens from this bioterrorism. This bill could save millions of lives." Some critics of the bill said it did not provide adequate protection against lawsuits for the companies creating the drugs and vaccines. Sen. Joseph Lieberman, D-Conn., and Sen. Orrin Hatch, R-Utah, proposed a bill known as BioShield II that would provide litigation protection and additional "incentives designed to stimulate private sector biotechnology firms," Hatch said June 9 at the Senate Judiciary Committee (PBS, 2004).

Title: President Bush Signs Project Bioshield Act Of 2004
Date: July 21, 2004
Source: White House

Abstract: THE PRESIDENT: Thank you, all. Mr. Speaker. Please be seated. Thanks. Good morning, and welcome to the Rose Garden. On September the 11th, 2001, America saw the destruction and grief terrorists could inflict with commercial airlines turned into weapons of mass murder. Those attacks revealed the depth of our enemies' determination, but not the extent of their ambitions. We know that the terrorists seek an even deadlier technology. And if they acquire chemical, biological or nuclear weapons, we have no doubt they will use them to cause even greater harm.

The bill I am about to sign is an important element in our response to that threat. By authorizing unprecedented funding and providing new capabilities, Project BioShield will help America purchase, develop and deploy cutting-edge defenses against catastrophic attack.

This legislation represents the collective foresight and considered judgment of United States senators and members of the House of Representatives from both political parties -- many of whom experienced bioterror firsthand when anthrax and ricin were found on Capitol Hill. It reflects 18 months of hard work and cooperation by many dedicated public servants in Congress and in the White House. It sends a message about our direction in the war on terror. We refuse to remain idle while modern technology might be turned against us; we will rally the great promise of American science and innovation to confront the greatest danger of our time.

I want to thank the Vice President for his hard work. He was the point man in the White House on this piece of legislation and did an excellent work. I appreciate Secretaries Tommy Thompson and Tom Ridge for their leadership on this important piece of legislation, as well. I appreciate the Speaker and Leader Frist for making this bill a priority.

I want to thank Senator Gregg and Senator Kennedy and Senator Cochran for working on this bill. I appreciate the efforts. I appreciate Congressmen Barton, Billy Tauzin, Chris Cox and Henry Waxman, as well, for their hard work.

I appreciate the members of my administration who are here, thanks for coming. These will be the implementers of this important piece of legislation.

Project BioShield will transform our ability to defend the nation in three essential ways. First, Project BioShield authorizes $5.6 billion over 10 years for the government to purchase and stockpile vaccines and drugs to fight anthrax, smallpox and other potential agents of bioterror. The Department of Health and Human Services has already taken steps to purchase 75 million doses of an improved anthrax vaccine for the Strategic National Stockpile. Under Project BioShield, HHS is moving forward with plans to acquire a safer, second generation smallpox vaccine, an antidote to botulinum toxin, and better treatments for exposure to chemical and radiological weapons.

Private industry plays a vital role in our biodefense efforts by taking risks to bring new treatments to the market, and we appreciate those efforts.

By acting as a willing buyer for the best new medical technologies, the government ensures that our drug stockpile remains safe, effective and advanced. The federal government and our medical processionals are working together to meet the threat of bioterrorism -- we're making the American people more secure.

Second, Project BioShield gives the government new authority to expedite research and development on the most promising and time-sensitive medicines to defend against bioterror. We will waste no time putting those new powers to use. Today, Secretary Thompson will direct the NIH to launch two initiatives -- one to speed the development of new treatments for victims of a biological attack, and another to expedite development of treatments for victims of a radiological or nuclear attack. Under the old rules, grants of this kind of research often took 18 to 24 months to process. Under Project BioShield, HHS expects the process to be completed in about six months. Our goal is to translate today's promising medical research into drugs and vaccines to combat a biological attack in the future -- and now we will not let bureaucratic obstacles stand in the way.

Third, Project BioShield will change the way the government authorizes and deploys medical defenses in a crisis. When I sign this bill, the Food and Drug Administration will be able to permit rapid distribution of promising new drugs and antidotes in the most urgent circumstances. This will allow patients to quickly receive the best available treatments in an emergency. Secretary Thompson has directed the FDA to prepare guidelines and procedures for implementing this new authority. By acting today, we are making sure we have the best medicine possible to help the victims of a biological attack.

Project BioShield is part of a broader strategy to defend America against the threat of weapons of mass destruction. Since September the 11th, we've increased funding for the Strategic National Stockpile by a factor of five, increased funding for biodefense research at NIH by a factor of 30, secured enough smallpox vaccine for every American, worked with cities on plans to deliver antibiotics and chemical antidotes in an emergency, improved the safety of our food supply, and deployed advanced environmental detectors under the BioWatch program to provide the earliest possible warning of a biological attack.

The threat of bioterrorism has brought new challenges to our government, to our first responders and to our medical personnel. We are grateful for their service. Not long ago, few of these men and women could have imagined duties like monitoring the air for anthrax, or delivering antibiotics on a massive scale. Yet, this is the world as we find it; this nation refuses to let our guard down.

Tomorrow, the 9/11 Commission will issue its findings and recommendations to help prevent future terrorist attacks. I look forward to receiving the report. I will continue to work with the Congress and state and local governments to build on the homeland security improvements we have already made. Every American can be certain that their government will continue doing everything in our power to prevent a terrorist attack. And if the terrorists do strike, we'll be better prepared to defend our people because of the good law I sign today.

It's my honor to invite the members of the Congress to join me as I sign the Project BioShield Act of 2004. Thanks for coming (White House, 2003).