Nov 22, 2002 (CIDRAP News) – In passing a bill to create a Department of Homeland Security (DHS) this week, Congress left the Department of Health and Human Services (HHS) in charge of most bioterrorism preparedness and civilian biodefense research programs—to the relief of medical research and public health groups.
Just a week before signing off on the bill, Congress also added a measure to help pave the way for a potential smallpox immunization campaign: protection for healthcare workers and organizations that administer smallpox shots against lawsuits over vaccine side effects.
The Senate passed the nearly 500-page bill Nov 19, a few days after it won House approval. The legislation will combine 170,000 federal workers from 22 agencies into a single department responsible for protecting the nation from terrorists. The measure is considered the biggest federal reorganization since the Department of Defense was established in 1947.
The Bush administration's original homeland security bill would have transferred bioterrorism-related medical research, now administered by the National Institutes of Health and the Centers for Disease Control and Prevention (CDC), from HHS to the new department. The bill also would have shifted the main responsibility for promoting state, local, and hospital bioterrorism preparedness from CDC to DHS.
But opposition from public health and research groups prompted the House to drop those provisions when it passed an earlier version of the homeland security bill in July. The version that was finally enacted preserved those changes.
"We're just glad that HHS will continue to do the public health and research programs," Janet Shoemaker, public affairs director for the American Society for Microbiology, which had lobbied for that outcome, told CIDRAP News.
DHS will have a say
The DHS will still have a role in shaping the direction of the preparedness and research efforts, however. The new legislation, HR 5710, says in Section 304 that the HHS secretary must collaborate with the DHS secretary to set priorities, goals, objectives, and policies for "human health-related research and development activities relating to countermeasures for chemical, biological, radiological, and nuclear and other emerging terrorist threats."
"I would imagine that would be for things like prioritizing that we need an anthrax vaccine, and that's already being done, so I don't see any change from what we were doing before Jun 18 when this was introduced," Shoemaker said. "That was certainly expected, and we agree with that."
The legislation includes very similar language concerning the program to support state, local, and hospital preparedness: the HHS secretary must collaborate with the DHS secretary to set goals and strategy and to measure progress. The CDC this year awarded roughly $1 billion in grants to state and local health agencies and hospitals for bioterrorism preparedness.
While HHS held onto the public health research and preparedness programs, it did not come away entirely unscathed. The DHS will take over the National Pharmaceutical Stockpile (which the bill calls the Strategic National Stockpile), the supply of drugs, vaccines, and medical equipment that the CDC maintains for public health emergencies. The stockpile is stored at secret sites around the country.
Shoemaker said she wasn't sure of the reasons for changing the management of the stockpile. "We had a lot of questions about that," she said. "Now it's done and we're all going to have to live with it. We would've preferred to have everything kept at HHS in collaboration with Homeland, but some things were bound to go."
Also moving from HHS to DHS are three other offices that deal with emergency preparedness: the National Disaster Medical System, the Metropolitan Medical Response System, and the Office of Emergency Preparedness (OEP), according to Section 503 of the legislation. The OEP is part of HHS's Office of Public Health Preparedness, the rest of which apparently is staying within HHS.
Protection for smallpox vaccinators
Shoemaker said the provision on smallpox vaccine liability was added to the House bill at the last minute—Nov 12—and she was unsure where it came from. The measure would protect individuals and healthcare "entities" that give smallpox shots from liability for harmful side effects. The federal government would defend against any lawsuits over adverse events, and plaintiffs could receive compensation for injuries but no punitive damages. The liability shield also covers vaccine manufacturers. The protection would apply only during and 30 days after an emergency declared by the HHS secretary.
"Covered individuals and entities would receive U.S. Justice Department Defense in the case of suits brought by injured parties, as long as defendants cooperate fully with Justice Department officials," says the "Washington Report" of the Council of State and Territorial Epidemiologists (CSTE). Parties eligible for the protection include licensed healthcare workers and anyone else authorized by state law to give smallpox shots, according to the law.
The CSTE report notes that the law does not provide for compensating healthcare workers who have adverse reactions to smallpox shots or have to miss work after receiving a shot because of the risk of transmitting the vaccinia virus to patients. (The federal Advisory Committee on Immunization Practices recently said this risk is low and recommended against furloughing healthcare workers after vaccination.)
The new legislation has several other provisions that may have implications for bioterrorism preparedness. Some examples:
- The "select agent" program, for tracking dangerous pathogens used in research, will remain in HHS, but HHS must collaborate with DHS on the list of agents and on security measures, according to Shoemaker.
- A new Homeland Security Advanced Research Projects Agency will fund research on "revolutionary changes in technologies that would promote homeland security," the law states. The law authorizes $500 million for the agency for fiscal 2003.
- Within a year, the DHS must establish a university-based center or centers for homeland security.
- The new department will appoint a Homeland Security Science and Technology Advisory Committee, which will advise the DHS undersecretary for science and technology. The committee will have 20 members representing fields such as emergency response, research, business, product development, and management consulting. The National Research Council may be asked to choose the members.
- The DHS will take over the US Department of Agriculture's Plum Island Animal Disease Center, but the USDA will still conduct research there.
"There's going to be a lot of work now to figure out how this is all going to fit together and function over there," Shoemaker said.
Text of Homeland Security bill on Library of Congress's Thomas Web site: search HR 5710