From the Hill – Spring 1998

Clinton’s proposed big boost in R&D spending faces obstacles

President Clinton’s FY 1999 budget request, which projects the first surplus in nearly 30 years, calls for increased R&D investments, especially for fundamental science, biomedical research, and research aimed at reducing greenhouse gas emissions.

Under Clinton’s plan, federal R&D support would total $78.2 billion, which is $2 billion or 2.6 percent more than in FY 1998. Nondefense R&D spending would rise 5.8 percent to $37.8 billion, and defense R&D would decline by 0.3 percent to $40.3 billion.

Although the president’s proposed R&D budget request is the largest in years, there are obstacles to achieving it. First, the administration will have to convince Congress to buy into its plan to increase discretionary spending above a cap that was set as part of last year’s balanced budget agreement. The administration has established three special funds, or groups of high-priority nondefense programs, that Congress must now consider supporting. One of these, the Research Fund for America, would include most but not all nondefense R&D. (The other two funds would cover transportation and natural resources and environment programs.) The Research Fund for America would get $31.1 billion in FY 1999, up 11 percent from the previous year.

To get around the discretionary cap, the budget would fund $27.1 billion of the $31.1 billion from discretionary spending that is subject to the cap. The remaining $4 billion, essentially representing all of the requested increases for nondefense R&D, would come from new offsetting revenues outside the cap.

One problem with this approach is that $3.6 billion of the additional $4 billion for the Research Fund for America is projected to come from revenues resulting from tobacco legislation, which is a highly contentious issue in this Congress. Thus, in order to fund the requested increases for nondefense R&D programs, Congress will have to do one of four things: enact tobacco legislation that would allocate a portion of the settlement for research programs; increase discretionary spending, thus breaking last year’s agreement; increase discretionary spending and taxes to compensate; or allocate the spending under the current caps, thus requiring offsetting cuts in non-R&D programs.

The president’s nondefense R&D budget has four priorities. First, biomedical research would get a big boost. The National Institutes of Health (NIH) would receive $14.2 billion, up 8.1 percent. Of this amount, the National Cancer Institute would receive $2.5 billion.

Second, the National Science Foundation (NSF), the primary supporter of basic research in most nonbiomedical fields, would receive $2.9 billion, up 11 percent. NSF’s research directorates would each receive double-digit percentage increases, led by a 16.5 percent increase for research in the Computer and Information Science and Engineering directorate.

Third, energy research in the Department of Energy (DOE) would get increased funding, largely because of the U.S. effort to reduce greenhouse gas emissions in response to last year’s Kyoto Protocol on climate change. DOE’s nondefense R&D funding would jump by 11.1 percent to $3.8 billion, with the increase focused on developing energy-efficient technologies. DOE’s defense R&D would rise by 10.4 percent to $3.3 billion, largely because of more spending for the Stockpile Stewardship Program, which is developing computer models to measure the reliability of the nation’s nuclear weapons.

Finally, basic research spending would rise to $17 billion, up 7.6 percent. NIH would get nearly half of this ($8 billion, up 8.4 percent). The Department of Defense basic research account would increase by 6.6 percent to $1.1 billion.

Tobacco deal could be a boon to biomedical research

Members of Congress are less than optimistic about enacting comprehensive tobacco legislation this year. But if a deal is reached, it’s likely that biomedical research will be a big winner.

In June of 1997, various states and the tobacco industry negotiated an agreement that, if approved by Congress, would settle a number of lawsuits and provide the industry with future legal immunity. In exchange, cigarette and smokeless tobacco companies would pay $368.5 billion to federal, state, and local governments over 25 years. Five Senate bills that were introduced in October and November of 1997 would use the tobacco industry’s billions to support biomedical science.

In S. 1411, Sen. Connie Mack (R-Fla.) and Sen. Tom Harkin (D-Iowa) propose to increase funds for medical research by eliminating the ability of tobacco companies to deduct any lawsuit settlements from their taxes. Those funds, estimated at $100 billion, would be used to establish a National Institutes of Health (NIH) Trust Fund for Health Research. Under the terms of the bill, which is cosponsored by nine Democrats and six Republicans and supported by more than 175 organizations, NIH would decide how most of the money would be spent.

S. 1530, proposed by Sen. Orrin G. Hatch (R-Utah), citing the industry’s past “reprehensible” marketing of tobacco, calls for higher punitive damages-$398.3 billion over 25 years. Most of the money would go to various kinds of health-related research and activities at NIH. Hatch also wants a National Tobacco Research Agenda to be prepared annually by the Food and Drug Administration, the Centers for Disease Control and Prevention, NIH, and others. The agenda would outline research concerning the role of tobacco products in causing cancer, genetic and behavioral factors related to tobacco use, the development of prevention and treatment models, the development of safer tobacco products, and brain development in infants and children.

S. 1415, proposed by Sen. John McCain (R-Ariz.), would establish a Public Health Trust Fund and a National Cessation Research Program. McCain’s bill would restrict research funding to the development of methods, drugs, and devices to discourage individuals from using tobacco products and would provide financial assistance to individuals trying to quit using tobacco products.

Sen. Edward M. Kennedy (D-Mass.), in S. 1492, has proposed establishing a National Biomedical and Scientific Research Board to make grants and contracts for the conduct and support of research and training in basic and biomedical research and child health and development. In a companion bill, S. 1491, Kennedy proposes an excise tax of $1.50 per pack on cigarettes, which would bring in $20 billion a year, including $10 billion a year to fund research. Kennedy’s approach differs from other bills in that yearly revenues over an unlimited time period would be generated-$650 billion over the first 25 years. Equivalent legislation has been introduced in the House by Rep. Rosa DeLauro (D-Conn.).

Sen. Frank R. Lautenberg (D-N.J.) has introduced S. 1343, which proposes to increase the cigarette excise tax rate by $1.50 per pack. The revenues would be deposited in a public health and education trust fund. The Lautenberg bill would allocate much less money to research than would the Kennedy bill. Rep. James V. Hansen (R-Utah) has introduced a House version (H.R. 2764S) of the Lautenberg legislation.

Sensible, coherent, long-term S&T strategy sought

With the end of the era of federal budget deficits in sight, House and Senate members from both parties are calling for a doubling of federal nondefense R&D spending during the next 5 to 10 years. At the same time, however, key congressional leaders are warning that future science budgets, in the words of Rep. F. James Sensenbrenner, Jr. (R-Wisc.), “must be justified with a coherent, long-term science policy that is consistent with the need for a balanced budget.”

Last fall, Sensenbrenner, chair of the House Science Committee, and House Speaker Newt Gingrich launched a year-long study to develop “a new, sensible” long-range science and technology (S&T) policy, including a review of the nation’s science and math education programs. They tapped Rep. Vernon Ehlers (R-Mo.), vice chair of the science committee, to lead the study.

Since the end of the Cold War, many policymakers have called for a reconsideration of the role of government, industry, and academia in supporting S&T to better reflect the environment we live in today. Although numerous scholarly reports have recommended various options for a post-Vannevar Bush science policy, the House Science Committee study is the first time that Congress has attempted to address this issue since the mid-1980s.

Ehlers has stated that his goal is to prepare a “concise, coherent, and comprehensive” document by June 1998 in order to obtain the legislative support needed to move ahead. In an effort to maintain bipartisan interest, congressional staffers from both parties have been assigned to assist Ehlers.

Ehlers launched the study by conducting two roundtable discussions. The first involved almost 30 renowned scientists and policy experts; the second included young, early career scientists. During the roundtable discussions, Ehlers and his staff posed a long list of questions on topics such as encouraging industry investment; enhancing collaborative research partnerships among government, industry, and academia; and contributing to international cooperation in research. Readers can contribute to the study by providing their own answers to the questions posed to the experts. To do so, visit the science policy study Web site at <http:www.house.gov/science/science_policy_study.htm>.

Cloning debate heats up

A year after the world learned that an adult mammal had been successfully cloned, the issue of human cloning continues to be a major concern in Congress. After the initial excitement about cloning died down last year, it appeared unlikely that any legislation would be passed soon. But earlier this year Congress was spurred into action after Chicago physicist Richard Seed said he would set up a lab to use somatic cell nuclear transfer, the cloning technique used to create Dolly the sheep, to clone human beings. Seed claimed that he had some financial backing as well as an infertile couple willing to participate in the procedure.

Two important bills were introduced in the Senate. Sen. Bill Frist (R-Tenn.), a medical doctor, and Sen. Christopher Bond (R-Mo.), a longstanding opponent of human embryo research, introduced legislation prohibiting the creation of a human embryo through somatic cell nuclear transfer. Sen. Diane Feinstein (D-Calif.) and Sen. Edward Kennedy (D-Mass.) introduced a bill prohibiting the implantation of a cloned human embryo in a woman’s uterus, thus avoiding the controversial issue of human embryo research.

The Republican leadership in the Senate, seeking to address concerns about human cloning and embryo research, brought a bill equivalent to the Bond-Frist legislation swiftly to the floor for a vote. But Feinstein and Kennedy led a filibuster that could not be broken.

The House has moved more cautiously on this controversial issue. Last year, the Science Committee passed a bill sponsored by Rep. Vernon Ehlers (R-Mich.) that would ban federal funding for human cloning research. Earlier this year, the Commerce Committee held a full-day hearing on the legal, medical, ethical, and social ramifications of cloning.

At the heart of the cloning debate is the question of whether the benefits that cloning research may yield outweigh the possible risks to human morality, identity, and dignity. Not least among the concerns about cloning is the possibility that imperfect techniques could produce damaged human embryos.

Further complicating the cloning debate are recent questions about the validity of the experiment that led to the birth of Dolly. The experiment using adult cells to clone an animal has not yet been duplicated, and skepticism is rising. Ian Wilmut, the Scottish scientist who created Dolly, has promised to prove that Dolly is the real thing.

Debate over database protection continues

A House bill aimed at strengthening copyright protection for database publishers is arousing concern among some scientists, educators, and librarians. H.R. 2652, introduced by Rep. Howard Coble (R-N.C.), seeks to address various concerns raised by database publishers. Under current law, databases are entitled to copyright protection only if the information contained is arranged or selected in an original way. The effort involved in simply compiling the data isn’t enough to justify protection. Database publishers claim that they work long and hard to compile their data, regardless of how it is organized. Current law, they say, leaves them vulnerable to others who wish to duplicate their products. “Without effective statutory protection, private firms will be deterred from investing in database production,” warns the Information Industry Association.

Coble’s bill would prohibit the use of data from a database in a way that would harm the marketability of the original database. The prohibition would apply only if the data in question represented an “investment of substantial monetary or other resources.”

The bill is the latest legislative attempt to increase database copyright protection in the United States. In 1996, then-Rep. Carlos Moorhead introduced a bill that would have created a sui generis model, or a new category of intellectual property protection for databases. In 1997, the U.S. delegation to a meeting of the World Intellectual Property Organization (WIPO) also backed a new category of protection for databases.

But academic and research interests opposed the U.S. proposal, arguing that it did not adequately protect research, educational, and other “fair uses” of data and would give database publishers too much control over the data their products contained. The new protection, they claimed, might prohibitively raise access costs and impede research in data-intensive areas such as study of the human genome and climatology. The United States subsequently dropped the proposal from consideration at the WIPO meeting.

However, the European Union approved a directive calling on its member nations to implement sui generis database protection. Because the European directive would not cover databases from nations without something akin to sui generis protection on their books, the pressure on the United States has increased, resulting in Coble’s proposed legislation.

Opponents of Coble’s bill contend that although the European directive will deny the new sui generis protection for U.S. databases, existing copyright protections will remain in place, leaving U.S. companies no worse off. In addition, Jonathan Band, general counsel of the Online Banking Association, has noted that U.S. companies could still receive sui generis protection if they established subsidiaries in Europe.

Unlike the previous proposals, Coble’s bill does not follow the sui generis model. Instead, it is based on “misappropriation” of data. Although critics acknowledge that moving to the idea of misappropriation is a step in the right direction, they argue that the Coble bill does not include a strong enough exception for nonprofit, scientific, or educational uses of data. “The difficulties of identifying and implementing a suitable balance between incentives to invest and the preservation of both free competition and essential public-good uses should not be underestimated, nor should legislation be rushed in order to meet deadlines imposed by foreign bureaucrats,” said Vanderbilt University law professor Jerome Reichman at a House hearing last fall.

The House Judiciary Committee Subcommittee on Courts and Intellectual Property, which has been considering the bill, was expected to mark it up in early March 1998.