The theory behind Dr. Wilmut's technique is that all body cells contain the exact same genetic information as the initial fertilized egg cell (or embryo).(7) As an embryo develops, parts of the genetic message "switch off" through the process of differentiation.(8) This causes the cell to become a specific tissue or organ (the cell is now considered to be differentiated).(9) Dr. Wilmut's trick was to make the DNA of the differentiated donor cell act like the DNA of a sperm or unfertilized egg.(10) He and his team "starved" the mammary cell into a dormant stage by reducing the nutrient-laden serum to the cell,(11) which made it capable of duplicating the entire organism (like an undifferentiated cell).(12) An electrical current was then administered which caused the "starved" mammary cell to fuse, in a process called renucleation, with an unfertilized egg from which the nucleus had previously been removed through enucleation.(13) The resulting embryo was then implanted into a surrogate mother and brought to term.(14) Dolly became an exact genetic duplicate (a clone, or twin) of the mammary cell donor.(15) However, her long-term health is still an uncertainty because her cells may act like the cells of a sheep six years older--the age difference between Dolly and her mother.(16)

When asked about the applications of this new technology, Dr. Wilmut told Britain's Press Association news agency it would be used "to produce more health care products. It will enable us to study genetic diseases for which there is presently no cure and track down the mechanisms that are involved."(17) Cloning technology, in general, holds the promise of tremendous benefits in agriculture and medicine,(18) and could help save endangered species such as the Hairy Nosed Wombat and China's Giant Panda.(19) Medical advances include "revolutionary medical treatments and life-saving cures for diseases such as cancer, hemophilia, cystic fibrosis, sickle cell anemia, and emphysema."(20) It can also further understanding of developmental biology and allow physicians to repair and regenerate human tissue in burn victims and those suffering from spinal cord injuries.(21)

One medical application relates to tissue and organ transplants.(22) There is a greater medical need of transplantable organs than is currently available from any source.(23) It is possible using cloning techniques to grow a replacement organ with the same genetic make-up of the patient to receive it.(24) If organs are derived from the person in whom they will ultimately be transplanted, immune rejections of the implant would be prevented.(25)

Although scientists have been able to clone animals since the 1950's, Dolly represents two important breakthroughs. Scientifically, she proves that differentiated cells can be "turned back on" and induced to grow into a complete animal.(26) Douglas Foster, an animal science professor at the University of Minnesota, said the event was "mind-boggling because everybody thought you could never de-differentiate cells."(27) Ethically, Dolly represents the possibility of asexual human reproduction--a woman could reproduce without the involvement of a man. "She merely provides her own DNA, her own unfertilized egg, and her own womb."(28)

Dolly's entrance onto the world stage re-ignited an on-going global debate regarding the ethics of genetic research, and in particular, the cloning of a human. In the United States, President Clinton charged the National Bioethics Advisory Commission to report back to him in ninety days about the moral, scientific, and ethical ramifications of cloning a human being.(29) On the same day, the Foundation of Economic Trends said that it had organized 400 religious and health organizations worldwide to push for new laws banning human cloning.(30) Three bills were introduced in Congress regarding this issue (S. 368 on 2/27/97, and H.R. 922 and 923 on 3/4/97),(31) and the President proposed his legislation on June 9, 1997.(32) As of August 1997, at least thirteen states have also drafted bills to prohibit human cloning.(33)

Internationally, the Vatican was one of the first to take a public stand on the issue arguing that people have a right to be born in a human way and not in a laboratory.(34) An emergency debate in the European Parliament on March 11, 1997 generated support for a formal Europe-wide prohibition.(35) Many other countries followed suit and banned or introduced legislation to ban human cloning (i.e. Malaysia, China, Japan, etc.).(36) The World Medical Association, the World Health Organization, and UNESCO were among many international organizations who also condemned the practice.(37) The issue was even addressed at the Summit of the Eight held in Denver, CO in June.(38)

With all the international attention this little sheep has generated, many scientists, lawyers, and members of the pharmaceutical industry are concerned that important research will be thwarted, and life-saving medical breakthroughs frustrated by ill-conceived laws.(39) Although there is no mention in the U.S. Constitution or in U.S. case law of a specific right to freedom of scientific inquiry, the First Amendment free speech clause and the Fourteenth Amendment due process clause support this concept.(40) Justice McReynolds stated in Meyer v. State of Nebraska that "It]he American people have always regarded education and acquisition of knowledge as matters of supreme importance which should be diligently promoted."(41)

Internationally, the law is even murkier. The UN adopted the Universal Declaration of Human Rights which affirms the fundamental rights to life, liberty, medical care, and to benefit from scientific progress and its uses, yet prohibits human cloning.(42) Several countries, including France, Denmark, and the Netherlands, forbid embryo research, and Germany and Spain have complete bans against human cloning.(43)

As the world attempts to harness this new technology for the benefit of all people, careful attention must be paid to the concept of scientific freedom. Historical figures such as Galileo remind us of the tragedy of encumbered scientific inquiry,(44) while Nazi doctor s are a glaring example of medical research gone awry.(45) Medical advances in this century such as heart transplants and in-vitro fertilization were also greeted with the fear and trepidation that cloning received, but thankfully for the millions of lives that have been created or saved, the world did not ban these procedures.(46)

This Comment will discuss the current threat to scientific freedom posed by absolute bans on human cloning. Parts II and III discuss the response of the United States and the international community to Dolly. Part IV discusses the legal position of scientific freedom in the U.S. and abroad. Finally; Part V will posit that a total ban on human cloning infringes on the freedom of scientific inquiry, and endangers the public by encouraging the establishment of black market cloning clinics.(47)

II. THE UNITED STATES' RESPONSE

On February 22, 1997, British scientists at the Roslin Institute made the international announcement of Dolly's birth.(48) Two days later, President Clinton requested Dr. Harold T. Shapiro, chairman of the National Bioethics Advisory Commission and president of Princeton University to have the commission undertake a ninety day; thorough review of human cloning and recommend ways to prevent abuse of the technology.(49) The eighteen member panel was composed of expert scientists, theologians, and lawyers.(50)

The science journal Nature published Ian Helmut's results on February 27, 1997.(51) On that same day Senator Christopher (Kit) Bond (R-Mo.) introduced S. 368 which would permanently ban federal funding for human cloning research.(52) It was his intent to make sure that human cloning stays in the realm of science fiction.(53) He wanted to send a clear signal that "human cloning is something we cannot and should not tolerate[,]" noting that the notion of cloning a human is repugnant to the public.(54) However, he narrowly drafted the bill so it would not affect plant and animal cloning research or the mapping of the human genome.(55)

A CNN/Time poll released on March 10, 1997 confirmed Sen. Bond's statement regarding the feelings of the public.(56) Based on interviews with 1,005 adult Americans, most thought cloning animals or humans was morally unacceptable--seventy-four percent said human cloning is against God's will.(57) When asked if they would consider cloning themselves, ninety-one percent said no.(58)

A week after his request that the National Bioethics Advisory Commission review this technology; Clinton issued a memorandum entitled "Prohibition on Federal Funding for Cloning of Human Beings"(59) In the memorandum, he made clear that because of the profound ethical issues this technology raises, no federal funds would be allocated for human cloning.(60) In his announcement to reporters about the prohibition, Clinton compared this discovery to the splitting of the atom.(61) Although this technology promises more productive strains of crops and livestock, revolutionary medical treatments and cures, and secrets of the genetic code, it carries burdens as well as benefits.(62) He urged the entire scientific and medical community to follow the Federal government's example and establish a voluntary moratorium on the cloning of humans.(63) Later that afternoon, Rep. Vern Ehlers (R-Mich.) stated on the House floor that he will be introducing two bills in the House--one that will ban the use of federal funds for human cloning research, and a second to ban the practice of human cloning in the United States.(64) On March 5, 1997, Rep. Ehlers introduced H.R. 922, The Human Cloning Research Prohibition Act, which was referred to the Committee on Science and the Committee on Commerce.(65)

One week later, on March 12, the Senate Committee on Labor and Human Resources' Subcommittee on Public Health and Safety held a hearing on S. 368 entitled "Scientific Discoveries and Cloning: Challenges for Public Policy."(66) Sen. Bond testified that his intent with this bill was to send a message that human cloning was not to be tolerated.(67) He stated, "It]his type of research on humans is morally reprehensible, and we should not be creating human beings for spare parts, as replacements, or for other unnatural and selfish purposes.(68) He questioned whether we should institute criminal penalties for conducting this type of research like Germany, Spain, and Australia have done.(69)

Sen. Bill Frist, chair of the Subcommittee on Public Health and Safety and the only physician in the U.S. Senate,(70) encouraged the world to address this issue in a calm, reasoned, and rational way.(71) The purpose of the hearing was to examine the benefits of this new technology to agriculture, research, and medicine, and to cool down an overheated public debate.(72) He reminded Congress that many scientific advances that were at first vilified are now considered commonplace.(73) For example, in the 1960's society viewed the idea of cutting out a diseased heart and replacing it with a heart from someone else as terrifying and unethical.(74) Today, heart transplants are a modern miracle.(75) In October, 1997, Sen. Frist published an article which described the task of the Senate as striking "the delicate balance of regulating science in order to ensure that this technology is harnessed for good, without trespassing on the liberties of the research community."(76) He also said that as elected leaders "we must resist the temptations of knee-jerk politics and carefully sift facts from among the chaff of many fictions."(77)

R. Alta Charo, J.D., member of the National Bioethics Advisory Commission, warned that proposals to ban human cloning research could be challenged under First Amendment claims of freedom of inquiry.(78) Although these claims would be novel, they would nonetheless be possible to make.(79) She stated that several states, such as Arizona and Michigan, have laws that prohibit experimentation on embryos or restrict research on fetuses.(80) She also noted that Alabama, California, Florida, and New York recently introduced bills that would restrict or prohibit cloning.(81) The constitutionality of these efforts has yet to be determined.(82)

Professor George J. Annas, J.D., M.P.H. also testified at the hearing.(83) He suggested three basic models for regulating scientific/medical policy-making: 1) the market (which our society tends to worship), 2) professional standards (which we distrust), and 3) legislation (which we disdain).(84) Because the market has no morality, we can't leave important values such as human rights and human dignity to its whim.(85) Mr. Annas concluded with a recommendation to legislate the establishment of a Human Experimentation Agency with both rulemaking and adjudicatory authority in the area of human experimentation.(86) The Agency would put the burden of proof on the researchers to provide a compelling reason to use cloning technology.(87)

Finally, Mr. James A. Geraghty; president and CEO of Genzyme Transgenics Corporation, reminded the committee that the biotechnology industry has been very careful not to engage in research that is unacceptable to the American public.(88) The industry observed a voluntary moratorium on cloning bacteria until the practice was determined to be safe, and it currently observes a moratorium on germ-line therapy.(89) He urged Congress not to rush to produce legislation that might restrict "widely accepted technology with great potential therapeutic benefits."(90)

On Wednesday; April 9, 1997, the Hon. Lee H. Hamilton of Indiana inserted his Washington Report for Wednesday, March 26, 1997 into the Congressional Record.(91) He reminded legislators of the medical and agricultural applications of cloning, such as developing animals whose organs can be used for human transplants, developing animal milk proteins used to treat disease, creating improved breeds of livestock, and potential applications for growing new skin for burn victims, culturing bone marrow for treating cancer patients, manipulating genes to cure sickle cell anemia, and treating infertility.(92)

On June 7, 1997, the National Bioethics Advisory Commission submitted its report, "Cloning Human Beings," to President Clinton.(93) The Commission concluded that the cloning of DNA, cells, tissues, and non-human animals using somatic cell nuclear transfer technology and other cloning techniques is not ethically problematic.(94) While they found human cloning to be repugnant, they were also repulsed by the prospect of restricting scientific inquiry.(95) The panel basically "hung its hat" on the safety issue.(96) Henry Shapiro, chairman of the Commission, stated, "[i]t seems clear to all of us, given the state of science in this area, that any attempts to clone human beings via somatic cell transfer techniques is uncertain in its prospects, is unacceptably dangerous to the fetus, and is morally unacceptable at this time."(97) The Commission feared the risk of horribly deformed and suffering babies.(98) It took some 277 failures before Dolly was born healthy and normal.(99) The report concluded that some research could continue without risking deformed babies if the embryos are never implanted in a woman's womb.(100) Fearing legislation might interfere with other kinds of cloning research holding the promise of medical breakthroughs, the Commission did not recommend an all-inclusive ban.(101) The report cautioned that laws should be carefully written to avoid restricting potentially beneficial research.(102) "[A]ny legislation should be temporary and subject to review within a [three]-to [five]-year period...."(103) Additional recommendations included:

* the reaffirmation that no federal funds be used to clone human beings;

* the urging of privately funded scientists and clinicians to adhere to the voluntary moratorium imposed by Clinton in March;

* the finding that the new technology may have many agricultural and medical benefits; and

* the pledge to work with other countries, such as Great Britain, Denmark, Germany, Australia, and Spain, to enforce the ban on human cloning.(104)

The report also cleared up a number of misunderstandings about cloning held by the public.(105) Contrary to popular science fiction, cloning can not create an instantaneous full-grown adult, nor can it create an exact copy of an existing, or previously existing, person.(106) The report stated, "[a]lthough genes provide the building blocks for each individual, it is the interaction among a person's genetic inheritance, the physical and cultural environment, and the process of learning that result in the uniqueness of each individual human. Thus the idea that ... cloning could be used to recreate exemplary or evil people has no scientific basis and is simply false."(107)

Sen. Bond was critical of the report because it did not ban cloning outright, and he was wary of the language "at this time."(108) He preferred a statement that cloning was "wrong, period, and should be banned."(109) This concept was criticized in testimony before the commission. Randolfe Wicker of Clone Rights United Front argued, "[n]othing can prevent the age from dawning. Research is the only way to perfect the procedure, outlawing it puts it into the back alleys. Human cloning is a reproductive option, and should be available to all.(110)

   Over the past several years we have developed an interesting rhythm in                                                                 
   medical advances. A research discovery is made, it results in a   
   hue-and-cry. After some time goes by; we discover the results are not as                                                               
   dire as we feared, and we have a new and accepted treatment which assists                                                              
   infertile couples. From transplant surgery to the birth control pill, we                                                               
   have seen this cycle repeated. Fortunately, we did not outlaw organ                                                                    
   transplants or hormonal birth control. We allowed research to proceed to                                                               
   refine the techniques while we also allowed the ethics surrounding them to                                                             
   develop. Rather than give in to the initial fears, we let knowledge                                                                    
   overcome them.(137)                                               

   The vast majority of scientists and physicians in the private sector have                                                              
   refrained from using these techniques improperly, and have risen up to                                                                 
   condemn any plans to do so. But we know it's possible for some to ignore                                                               
   the consensus of their colleagues and proceed without regard for our common                                                            
   values.(172)                                                      

   Experiments clearly are a form of action, and where restrictions are based                                                             
   on the concern that experiments may result in harm to the public or to the                                                             
   environment, they are easily justified. Indeed there are ample precedents                                                              
   for such restrictions, as in the case of regulation of experiments with new                                                            
   drugs and with nuclear materials and facilities.(292)             

   The essentiality of freedom in the community of American universities is                                                               
   almost self-evident.... To impose any strait jacket upon the intellectual                                                              
   leaders in our colleges and universities would imperil the future of our                                                               
   Nation. No field of education is so thoroughly comprehended by man that new                                                            
   discoveries cannot yet be made.... Scholarship cannot flourish in an                                                                   
   atmosphere of suspicion and distrust. Teachers and students must always                                                                
   remain free to inquire, to study and to evaluate, to gain new maturity, and                                                            
   understanding; otherwise our civilization will stagnate and die.(310)                                                                  

   Public discourse in contemporary Germany is marked by an open, vibrant,                                                                
   sometimes caustic exchange of the central issues of the day. As in the                                                                 
   United States, guarantees of freedom of expression are central to the                                                                  
   constitutional order and structure of German society. Unlike speech                                                                    
   freedoms in the United States, however, German communication rights are                                                                
   carefully circumscribed by distinct textual, legal, cultural, and civility                                                             
   limits.(313)                                                      

   Given our present legal institutions and any that seem likely to emerge,                                                               
   the soundest response to a social issue posed by biomedical advance is to                                                              
   begin by assuming that no legal response is necessary. Lawyers and fearful                                                             
   persons can always conjure up catastrophes. Thus, wise jurisdictions have                                                              
   refrained from enacting legislation to solve the easily imagined, but rare                                                             
   problems.... When, occasionally, real issues have arisen, the common law                                                               
   courts have dealt with them perfectly satisfactorily. Advantage of the                                                                 
   common law--its mistakes are cheap and easy to fix. If it ain't broke,                                                                 
   don't fix it.(330)