Send In The Clones

=”article_text”>

Introduction

The birth of Dolly1 in 1997 initiated the debate on human cloning.2 Recently, a panel of international scientists requested that the United Nations to adopt a ban on human reproductive cloning, but panel members disagreed on whether therapeutic cloning or cloning for research should be banned also.3 France, Germany and the Royal Society in Britain advocate bans on human reproductive cloning.4 The United States and Vatican desire a ban on the cloning of all human cells,5 and Raelians will clone anyone for a price.6 Therapeutic cloning will likely provide remedies to some of the most devastating human diseases,7 but some feel therapeutic cloning and reproductive cloning are morally wrong because of the destruction of embryos in the process.8 With various interest groups at odds, governments are compelled to come compromises.

The focus here is on the Canadian and American approaches to cloning regulation and stem cell research. The paper gives an overview of stem cell research, cloning, and their relation. Then, discussion follows that describes the federal legislative, administrative, and executive policies from both countries as well as province and state laws. Finally, the paper presents a model approach.

Cloning and Stem Cells

Stem cells are unspecialized cells that renew themselves for long periods of time through cell division.9 They can be induced to become specialized cells.10 Pluripotent stem cells may give rise to many types of cell types, multipotent stem cells can give rise to certain types of cells, and unipotent stem cells can give rise to single cell types.11 However, current research suggests that multipotent and unipotent stem cells may also have the ability to be induced to form other types of cells.12 Tolipotent stem cells are stem cells that can become an organism.13 Stem cells can be derived from embryos, fetal tissue, umbilical cord blood, and adult tissue.14 Most ethical objections to stem cell research revolve around the use of embryonic stem cells or fetal tissue stem cells.15

Cloning is the process of creating a precise genetic copy of any organism including cells, plants, animals, or humans.16 The three methods of cloning are genetic, blastomere separation or twinning, and somatic cell nuclear transfer.17 Genetic cloning replicates genetic or cellular material by making copies of DNA fragments (molecular cloning) or replicates cellular material (cellular cloning).18 Molecular and cellular cloning are widespread and have produced advances in the treatment of human disease.19

Blastomere separation or twinning, involves the splitting of a human embryo by attempting to get an early embryo to divide into multiple embryos.20 This process sometimes happens naturally when identical twins, triplets, or quadruplets are produced.21 The undifferentiated nature of the cells that get up early embryos create the possibility to separate the blastomeres and have them continue to develop as separate genetically identical organisms.22

Somatic cell nuclear transfer (hereinafter “SCNT”) cloning transfers the nucleus from a cell that has two sets of genes into an egg from which the nucleus has been removed.23 SCNT can use a nucleus from an undifferentiated embryo or a differentiated adult cell.24 SCNT also makes the transfer of animal nuclei into human cells or vice versa possible. The cloning debate is about SCNT. SCNT procedures are distinguished as being for therapeutic or reproductive purposes.25 Therapeutic cloning refers to using SCNT techniques for medical or research purposes.26 Reproductive cloning refers to using SCNT to develop a genetically identical human.27

Stem Cell-Cloning Relationship

In order for scientists to clone genes, cells, or organisms, they must have a set of originals. Stem cell lines provide sources of originals for further stem cell research using SCNT.28 Adults may donate stem cells to science. Embryo surplus from assisted reproductive facilities are also sources of stem cells for research.

Ethical Concerns

Opponents of SCNT procedures major objections are the employ of human embryos and infringements on human dignity.29 Problems with these arguments arise from an inability to understand the difference between pluripotent stem cells and tolipotent stem cells and an inability to understand that the same DNA does not form the ’same’ person. Both types of stem cells are undifferentiated and thus apt of becoming any type of human cell, but pluripotent stem cells are incapable of becoming human beings.30 The argument that the exercise of pluripotent stem cells destroys potential human life is therefore moot. Similarly, opponents of reproductive cloning argue the process would violate the uniqueness of humans.31 The assumption this argument makes is that DNA is the only determinable factor of who a person is and fails to consider that human development is both social and biological.32

The Canadian Approach

The Canadian advance to stem cell research and cloning regulations recognizes the importance of governmental involvement in both the public and private sector. Although its proposed use of criminal sanctions for those violating the proposed Assisted Human Reproduction Act has been criticized, the House of Commons has preserved such sanctions to promote governmental goals. Federal legislation has been in process for several years. The current draft bill in the House of Commons has completed the second reading.

Proposed Legislation

Although Canadians agree a need for a legislative framework to manage assisted reproductive technologies exist,33 Canada has no official laws governing cloning and stem cell research. The Canadian Institute of Health Research and Ethics in Research (CIHR) introduced guidelines for stem cell research and cloning, but no federal legislation has been passed. The House of Commons attempted legislation with Bill C-47, The Human Reproductive and Genetic Technologies Act.34 The act would have prohibited definite applications of human reproductive and genetic technologies, but it was tabled in June of 1996.35

By February 2000, the government finalized discussions with provinces, territories, and other alive to groups to set up parameters of a legislative regulatory framework, and in May of the following year the Minister of Health submitted draft legislation to the Standing Committee on Health in Parliament.36 The draft legislation was to ensure Canadians could use assisted reproductive technologies without health or safety risks and to promote promising research that could result in treatments for serious conditions.37 A modification of the draft legislation became Bill C-56, the Assisted Human Reproduction Act.38 The first session of the 37th Parliament progressed the bill through the committee meetings after the second reading, but no further.39

During the second session of the 37th Parliament, the Assisted Human Reproductive Act was reintroduced as Bill C-13. Bill C-13 is printed in the same form as Bill C-56 and is currently before the House of Commons.40 The bill prohibits assisted reproductive procedures deemed ethically unacceptable, allows other procedures so long as they are carried out in accordance with a license and regulations, and creates the Assisted Human Reproduction Agency of Canada.41

The Assisted Human Reproduction Act42

The Assisted Human Reproduction Act declares and recognizes important benefits of assisted human reproduction, defines necessary terms old-fashioned throughout the act, and binds the queen to the provisions of the Act.43 The parliament acknowledges six fundamentals critical to the drafting of the legislation.44 They are that 1) benefits of assisted human reproductive technologies can be secured through appropriate measures to promote human health, safety, dignity, and rights; 2) the health and well-being of children born through the technologies have priority; 3) women are more affected than men by the application of the technologies; 4) free and informed consent must be promoted and applied as a fundamental condition of the use of such technologies; 5) trade in reproductive capacities of persons raises health and ethical concerns and is prohibited; and 6) human individuality and diversity as well as the integrity of the human genome must be preserved and protected.45

The Agency and its Functions

The Act creates the Assisted Human Reproductive Agency of Canada (hereinafter “Agency”), which consists of no more than a 13 member board and an agency president.46 The Act grants the Agency power to give advice to the Minister, monitor and evaluate developments concerning assisted reproductive technologies, and collect, analyze and manage health reporting information related to controlled activities.47 The Agency also must provide information to the public, issue and revoke licenses, and designate inspectors for the enforcement of the Act.48 The Act further authorizes the Agency to “do anything that is reasonably necessary or incidental to achieving [its] objectives.”49 This broad power enables the Agency to make regulations for carrying out purposes and provisions of the Act.

Prohibited and Controlled Activities

Prohibited activities listed in the Act are divided into for categories: prohibited procedures, payment for surrogacy, purchase of gametes, and use of reproductive material without consent. The purpose is to prohibit reproductive materials in trade and exercise of such materials without informed consent. These activities are also prohibited to preserve and protect the ‘integrity of the human genome’.

Prohibited Procedures

The Act prohibits several procedures under allotment five. The most important being a prohibition of human cloning.50 In addition to cloning, the part prohibits creating an in vitro embryo for anything other than creating a human being or providing instruction in assisted reproduction procedures. Other prohibitions include creating an embryo from a cell or part of a cell taken from an embryo or fetus, maintaining an embryo outside of a woman after the fourteenth day of development, increasing the probability of the embryo’s gender, altering the genome of a human in vitro embryo so that the alteration could be transmitted to descendents, transplanting sperm, ovum, embryo or fetus of a non-human life into human and vice versa, creating or transplanting chimera, and creating or transplanting hybrids. Under the statute, a chimera means an embryo into which a cell of any non-human life form has been introduced or an embryo that consists of cells of more than one embryo, fetus, or human being.51 A human clone is an embryo with the same DNA sequence found in the cell of a living or deceased human being.52 A hybrid means a human ovum that has been fertilized by a sperm of a non-human life get, an ovum of a non-human life form that has been fertilized by a human sperm, a human ovum into which the nucleus of a non-human life form has been introduced, or a non-human ovum into which the nucleus of a human cell has been introduced.53 The importance of protecting human individuality and diversity as well as the integrity of the human genome is exemplified in this portion.

Controlled Activities

The controlled activities are prohibited unless performed by a licensed party in accord with the regulations.54 These sections specify that the human reproductive material to create an embryo, the creation of hybrids, and reimbursement for such procedures can only be performed by licensed entities or individuals on licensed premises. Because of some of the allowances in the Controlled Activities Sections, Critics say the bill allows human cloning.55

Offences

Violators of any of the prohibited activities are liable, on conviction on indictment, to a fine of at most $500,000, imprisonment for a term of 10 years or less, or both.56 Violators of a summary convictions are liable for fines up to $250,000, up to four years of imprisonment, or both.57 Violators of other parts of the Act are liable for fines between $100,000 and $250,000, a prison term of two to five years, or both fines and imprisonment.58 Courts may order the forfeiture and disposition of material or information in relation to the offense committed or order persons not to engage in any activities that may lead to the commission of an offense (emphasis added).59 The Attorney General of Canada must consent to any prosecutions under the Act, and the Agency may notify any fervent authorities i.e. professional licensing boards or disciplinary bodies.60

Administrative Policies

While the Parliament polishes the Assisted Human Reproduction Act, the Canadian Institute of Health Research and Ethics in Research (hereinafter “the Institute”) has established guidelines to be followed.61 The Canadian government found the Institute in 2000 to ensure that research involving humans or human biological material meets the highest ethical standards.62 The ethical standards applied by the Institute are found in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS), which applies to all research funded by CIHR and all research conducted at institutions that receive CHIR funding.63 After its formation the CIHR created an Ad Hoc Working Group of scientists, clinicians, philosophers, and lawyers to guide to the CIHR on whether human stem cell research should be eligible for CIHR funding.64

In March 2002, the Institute released the guidelines for funding for stem cell research. The guidelines allowed funding for stem cell research when the cells are derived from human embryonic stem cells subject to certain restrictions, fetal tissue, or adult stem cells.65 Under the guidelines, human embryonic stem cell may be used for research if the cells approach from existing human embryonic cell lines or from a surplus of embryos created for assisted reproductive technologies with free and informed consent and no compensation.66 The guidelines banned research leading to human cloning, reproductive and therapeutic cloning, research involving the creation of embryos strictly for research, and research combining non-human stem cells with a human embryo or fetus and human stem cells with a non-human embryo or fetus.67 In addition to the guidelines, the CIHR was working on establishing a Stem Cell Oversight Committee that would include members from the public as well as experts and creating a national registry of human embryonic stem cell lines generated in Canada.68

Provincial Approaches

While some provinces are considering passing laws concerning cloning, the majority of the provinces seem to be waiting for federal legislation concerning the topic. Many provinces already have some sort of legislative or regulatory scheme in state for assisted reproductive measures, but lack guidelines concerning cloning or stem cell research. The Act contains a section covering equivalency agreements, the section defers to provincial legislation.69 Quebec is the only province that has issued a ban on certain types of research.70 In January 2002, the province banned all destructive research involving human embryos.71 The guidelines banned also public and private research, all human cloning, and the creation of animal-human hybrids, chimeras.72 The Quebec government does support stem cell research when the stem cells are taken from adults using non-destructive means.73

Constitutional and Charter Concerns

The possibility of criminal sanctions for violations of the proposed legislation could lead to assertions of charter rights violations similar to those raised in Canadian abortion and assisted suicide cases. Despite criticism for the use of such sanctions, the House of Commons was most likely attempting not to violate the Constitution. The Canadian Constitution specifically allocates health issues to the provinces, but criminal provisions descend under federal powers. By the imposition of criminal sanctions for violations of the Act, the Canadian Parliament can regulate health through its broad criminal powers.

The American Approach

The American approach is a combination of restriction and laissez faire.74 While human embryo research is severely restricted at the federal level, professional self regulation governs the provision of clinical services.75 Like Canada no formal legislation currently exists in the United States, though numerous administrative bodies have various guidelines concerning stem cell research, and cloning. While Congress continues attempts to draft a suitable federal framework for these recent technologies, administrative bodies like the NIH and the Food and Drug Administration have drafted policies in the meantime. Several states have also enacted laws concerning assisted reproductive technologies, stem cell research and cloning.76

Proposed Legislation

Unlike the Canadian model which recognizes a relationship between cloning, stem cell research, and assisted reproductive technologies, proposed American legislation has focused mainly on the prohibition of human cloning and stem cell concerns separately from assisted reproductive technologies. After the announcement of Dolly, Congress scrambled to draft some sort of legislation concerning new technologies to prohibit human cloning. In 1997, three bills were introduced.77 In the Senate, Bill S. 368 (U.S. Senate 1997) called for a permanent ban on federal funds for cloning an individual.78 A major argument was that human cloning should be off limits, though plant and animal cloning were acceptable.79

In the House of Representatives, two bills were introduced. The first bill was H.R. 922 (U.S. House 1997b) and would have prohibited federal funds to support any research projects involving the use of a human somatic cell for producing a human clone.80 The second bill, H.R. 923 (U.S. House 1997c) or the Human Cloning Prohibition Act of 1997, made cloning a human being through SCNT illegal and imposed a $5,000 radiant for any violations.81 All three early bills introduced after Dolly had permanent bans on cloning.82 Later, President Clinton proposed the Cloning Prohibition Act of 1997, which proposed to ban attempts to create a baby through SCNT, thus limiting the ban to SCNT procedures transferred to a woman’s uterus.83 The bill allowed other SCNT research, had a duration of three to five years with NBAC oversight.84 Despite numerous congressional hearings in the Senate and House as well as recommendations by the NBAC, Congress has yet to pass legislation concerning cloning or stem cell research.

Current Cloning and Stem Cell Bills

Currently, the Senate and the House of Representatives are considering bills concerning cloning and stem cell research. Several committees and subcommittees in both houses have held hearings so that eager parties could squawk their views. Both houses are considering versions of the Human Cloning Prohibition Act of 2003 and the Cord Blood Stem Cell Act of 2003. In addition to those bills, the Human Cloning Ban and Stem Cell Research Protection Act of 2003 is before the Senate. Brief descriptions of the bills and hearings follow.

Human Cloning Prohibition Act of 2003

H.R. 534

The bill is identical to the Human Prohibition Act of 2001 introduced in the 107th Congress, H.R. 2505.85 The Subcommittee on Criminal Justice, Drug Policy and Human Resources held hearings on stem cell research (July 2001) and cloning (May 2002) during the 107th Congress.86 No such hearings were held during the 108th Congress.87 The hearings consisted of the testimony of various alive to parties including religious leaders, scientists, doctors, and persons with disabilities or diseases that may be treated through stem cell research or cloning.88

After defining human cloning, asexual reproduction, and somatic cell, the House version of the Act prohibits public and private attempts to manufacture human cloning, to participate in an attempt to perform human cloning, or to ship or receive an embryo (or products derived from an embryo) produced by human cloning.89 The bill includes criminal and civil penalties. Criminal penalties of up to 10 years imprisonment and a civil penalty of no less than $1 million or the scandalous glean of violations involving pecuniary gain multiplied by two, if that amount is greater than $1 million.90 The bill does not restrict nuclear transfer or cloning techniques to produce molecules, DNA, cells other than human embryos, tissues, organs, plants, or animals (other than humans).91 After the General Accounting Office consults with the National Academy of Sciences, the General Accounting Office may conduct a study to decide whether amendments of the prohibition of human cloning are necessary.92 The GAO is to submit a characterize to Congress two years after the enactment of the Act with recommendations for legislative or administrative actions.93

The Committee on the Judiciary passed the bill without amendment.94 One proposed amendment was to exempt the importation of products derived from embryos if such products could not become human beings.95 A second amendment was proposed to exempt prohibitions on SCNT used for further scientific idea or pursue treatments so long as such transfers were not used to initiate pregnancy.96 Both amendments were defeated 19 to 12.97 The dissenters objected to the report arguing the proposed bill would prevent U.S. citizens from benefiting from ongoing stem cell research and that the failure to conduct hearings during the present congressional term was a disservice to the Committee, Congress and the American people.98 The House of Representatives passed the bill on February 27, 2003.99

S.245

Several Senate committees and subcommittees held hearings on cloning and stem cell research.100 In 2002, a Subcommittee of the Committee on Appropriations, the Committee on the Judiciary, and the Committee on Health, Education, Labor, and Pensions held such hearings.101 Like House hearings, these hearings allowed interested parties to speak on the issues.102 The Senate version of the Act, S.245, was introduced on January 29, 2003 and closely resembles the House version.103

Cord Blood Stem Cell Act of 2003

Both houses have a proposal for the Cord Blood Stem Cell Act, the purpose of which is “to establish a National Cord Blood Stem Cell Bank Network to prepare, store, and distribute human umbilical cord blood stem cells for the treatment of patients and to serve peer-reviewed research using such cells.” 104 Bills to establish this Act were introduced in the House in January and in the Senate in October of this year.105 With the exception of the findings in the House version of the bill, bills H.R. 2852 and S. 1717 are almost identical with only minor changes.106

The Act proposes to create a National Cord Blood Stem Cell Bank Network.107 The purpose of the banks would be to acquire, test, and store human cord blood acquired with informed consent of the donor, build blood units collected available to transplant centers for stem cell transplantation, and allocate cord blood for research.108 The Act establishes the eligibility of donor banks, which requires Federal and State licensees, donor screening to prevent the transmission of harmful infections, strict confidentiality, encouragement of ethically diverse donors, and adequate communication with other banks.109 The network would be administered by a board of directors.110 The Act also creates a blood stem cell registry and appropriates $15 million for 2004 and $30 million for 2005.111

Human Cloning Ban and Stem Cell Research Protection Act of 2003

This bill defines human cloning, human somatic cell, nuclear transplantation, nucleus, oocyte, and unfertilized blastocyst.112 The definitions of human cloning in this bill are different than those in the Human Cloning Prohibition Act (HCPA).113 This definition is limited to transplantation of the product of SCNT into a uterus or functional equivalent, while the HCPA definition includes all SCNT procedures.114 This Act prohibits cloning and attempts to clone.115 It also prohibits shipping products of nuclear transplantation in interstate or foreign commerce for purposes of cloning and exporting unfertilized blastocyst to countries that do not prohibit human cloning.116 Like the HCPA, there are criminal penalties of no more than ten years, but the civil penalties are slightly different in that they call for $ 1 million fine or three times the depraved of pecuniary gain.117 This bill also requires forfeiture of any property derived from or used to commit a violation or attempted violation of the Act.118

The bill further requires the Comptroller General to submit a report to the Committee on the Judiciary of the Senate and the Committee on the Judiciary of the House of Representatives describing actions taken by the Attorney General to enforce the Act as well as the personnel and resources used.119 A recount that describes similar state laws and actions by state attorney generals is also required.120 A report on coordination of enforcement among federal, state, and local governments is also required as well as a report on International laws relating to cloning.121

The bill goes on to describe ethical standards for nuclear transplantation research.122 This fragment prohibits SCNT into oocytes that have been or will be fertilized, maintaining unfertilized blastocyst longer than 14 days (unless they are frozen), purchase or sale of human oocyte or unfertilized blastocyst, and conducting SCNT in laboratories where ART is also conducted.123 Violations of the ethical standards are subject to a civil penalty of no more than $250,000. 124

Administrative Policies

Some agencies have issued policies concerning cloning and stem cell research. Presidential advisory boards have provided recommendations on how the federal government should regulate new biomedical technologies. Administrative agencies like the Food and Drug Administration and the Department of Health and Human Services have issued regulations for these research techniques while Congress polishes legislation.

Advisory Boards

President Clinton established the National Bioethics Advisory Commission (hereinafter “NBAC”) in 1995.125 Clinton asked the NBAC to consider suitable and ethical issues surrounding coning.126 Duties of the commission included providing advice and making recommendations to the National Science and Technology Council, identifying broad principles to govern ethical conduct of research, and accepting suggestions of issues for consideration from Congress and the public.127 The NABC published a report in 1997 with conclusions about cloning.128 Those conclusions were using SCNT to generate babies was morally unacceptable, the government should conclude a carefully written law forbidding attempts to create a child through reproductive SCNT, suggesting government encouragement of deliberations on reproductive cloning, and cooperation of federal agencies to inform the public.129

President Bush itsy-bitsy federal funding of stem cell research involving stem cell lines created prior to August 9, 2001. Later that year, he established a Council on Bioethics to advise on consequential issues from advances in biomedical science and technology.130 The President’s Council on Bioethics published Human Cloning and Human Dignity.131 The mission of the Council was to undertake fundamental inquiry into the human and moral significance of developments in biomedical and behavioral science and technology, to survey related ethical and policy questions, to provide a forum for national discussion, to facilitate a greater understanding of bioethical issues, and to eye possibilities for useful international collaboration.132 A majority of the Council recommended a ban on cloning to produce children and a four year moratorium on cloning for biomedical research.133 The minority recommended a ban on cloning to perform children with regulation of the use of cloned embryos for biomedical research.134

Administrative Agencies

The FDA has asserted authority over SCNT and has published non-binding guidance documents for researchers in the field of biotechnology.135 FDA authority only extends to investigating products proposed to be introduced on the market that topple under specific categories designated by statute, which include interstate commerce and clinical trails of human subjects.136 The broad interpretation of biologics, one of three medical products regulated by the FDA, has enabled the body to include somatic cell therapies and gene therapies.137 The process for FDA approval requires a level of safety and effectiveness before human tests are performed.138 FDA approval for SCNT procedures to reproduce people is unlikely, because of the current risks involved.

Congress prohibited the Department of Health and Human Services from using any of its appropriated funds for creating embryos for research or research where embryos are destroyed or discarded.139 While this limited government funding for stem cell research and cloning from DHHS, General Counsel for DHHS found that the NIH could still fund research using human pluripotent stem cells.140

The NIH has established guidelines for research using Human Pluripotent Stem Cells.141 The NIH according to the opinion of the DHHS may fund research using stem cells from both embryonic and fetal tissues.142 The NIH Director formed a working group from the Advisory Committee to the Director (ACD) to assert the ACD on guidelines for research involving pluripotent stem cells.143 The guidelines allow funding using human pluripotent stem cells derived from fetal tissue or early human embryos that are surplus products of in vitro fertilization.144 Further, to receive funding, the cells must not be implanted into a woman’s uterus nor be at the stage when the first major tissue type is formed.145

State Approaches

By 2001, six states had passed laws to limit human reproductive cloning.146 Other states are no doubt struggling with the issue. California the first state to enact a law in 1997 limits forms of nuclear transfer, but maintains the protection of research.147 Like California, legislation in Michigan, Virginia, Rhode Island, and Louisiana contains a research protection clause.148 Michigan’s cloning ban makes reproductive cloning a felony.149 Rhode Island imposes fines between $250,000 and $1 million depending on whether the violator is a corporation or an individual.150 Virginia’s fines for human cloning are no more than $50,000.151 The Missouri law is more vague and bars any use of status funds for research with respect to human cloning.152

Many states that do not directly tackle the cloning issue have laws that regulate fetal or embryo research.153 Most of these laws were enacted in the 1970’s in response to Roe v. Wade or in the 1980’s with due to the rise of IVF.154 South Dakota enacted laws to prevent embryonic stem cell research.155 Other state laws cover the area of assisted reproductive technologies setting forth conditions for ART practices such as consent requirements for the expend of gametes and embryos.156 To say the least, state practices vary and many of the laws are vague, which raises questions of which procedures if any are restricted.

Constitutional Concerns

One notable constitutional concerns about the outlawing of SCNT is that these laws violate procreative liberty, which is protected by the Constitution.157 In Eisenstadt v. Baird, 405 U.S. 438 (1972), the Supreme Court stated the right to privacy was the right of the individual to be free from unwarranted government intrusion into matters concerning the individual’s decision to bear or beget children.158 Opponents of this view argue that SCNT is not reproduction, but rather recycling and does not drop under constitutional protection.159 Another possible constitutional question is whether laws prohibiting SCNT violate the right to acquire useful knowledge.160 Supreme Court dicta from 1923 suggested liberty under due process included acquiring knowledge.161 These and other constitutional questions are likely to arise with the passing of federal legislation on SCNT and stem cell research. .

A Comparison of the Approaches

Both governments oppose reproductive cloning. The president and the House of representatives also oppose therapeutic cloning, but the Senate has not weighted in on whether therapeutic cloning should be allowed. The Canadian government supports therapeutic cloning.

Canada and the United States also seem to agree that civil and criminal penalties are necessary to enforce their proposed legislation. Because human reproductive cloning seems to follow from current stem cell research and therapeutic cloning, such sanctions are likely to become moot in the future. The sanctions already in effect in the United States and Canada have caused an exodus of scientists and groups like the Raelians who claim they can clone people.

Both nations are currently operating under regulations or guidelines while federal legislation is pending. The CIHR and NIH guidelines allow research using embryonic stem cells in excess of assisted reproductive facilities and ban human cloning. Most states and provinces have not enacted legislation concerning stem cell research or SCNT, but may have some laws concerning embryo and fetus rights or the regulation of excess embryos from assisted reproductive facilities. Constitutional questions will arise in both nations once federal legislation is passed.

The critical difference between the Canadian arrive and the United States approach is that the United States seems to be leaning toward a ball on all cloning including therapeutic cloning and cloning procedures for research. Another distinction is the employ of government funds. Current United States policy limits government funds to research that uses existing stem cell lines. The Canadian approach does not have or propose this limit on public funding. The United States has been called hypocritical because private research is not bound by the mandate.

The Canadian proposed structure is also more appealing than the U.S. proposal. Canada categorizes assisted reproductive technologies, stem cell research, and cloning (SCNT) under one Act and one Agency. While the United States proposal would allow oversight among various agencies like the current structure. Politicians in the United States are concerned with moral and ethical objections to stem cell research and therapeutic cloning, but government involvement in these new technologies is important. A failure by the U.S. to participate in a global scientific movement is likely to be detrimental to the American public and science community. The practical Canadian proposal though moderate will not cripple the country by limiting government involvement in stem cell research or SCNT. The Senate’s Human Cloning Ban and Stem Cell Research Protection Act would be positive American legislation that would foster research in the U.S. and prohibit reproductive cloning, but with the president and House of Representatives calling for an all out ban on any type of SCNT procedure and the use of embryos, S.303 may already be doomed.

An Ideal Approach

An ideal approach to stem cell research and SCNT would assist new technological advances. Government regulation should be flexible and change with technology. Such an approach would allow stem cell research on stem cells from assisted reproductive surplus as well as adult donors. Other allowances would include the creation of new stem cell lines as well as hybrids and chimeras for research purposes only. Because of safety concerns reproductive cloning would be prohibited at first, but once no dangers existed to clones, reproductive cloning would be allowed. Therapeutic cloning would not be limited and people suffering from diseases that could be cured from stem cell research would be encouraged to donate stem cells for public and private research for cures. Such legislation would allow the manufacture of body parts for therapeutic purposes, but ban the produce of people. A liberal reach like this would enable a government to slowly educate and prepare its citizenry for the eventual cloning of humans and promote the cures for numerous diseases plaguing society.

Conclusion

Human cloning is upon us. Although not many claims have been made of cloned humans, a rising demand will result in suppliers. Bans for any type of cloning are being supported by moral and ethical reasons, safety concerns, and the protection of human dignity. The benefits of therapeutic cloning and the challenge of creating a human clone suggest cloning is here to stay. Government regulation is imperative to prevent abuses in new technologies. Canada’s moderate approach, which allows government funding for research and therapeutic cloning is better than the U.S. approach to these new technologies. Until the president and members of Congress gather that the destruction of embryos and cloning are ‘evils’ that a fresh world must live with, government funded research in the United States will suffer, and private researchers will move to countries with more practical approaches, leaving the United States lagging unhurried in new medical treatments that could be beneficial to millions of Americans.

1 See The Cloning Sourcebook 1 (Arlene Judith Klotzko ed., Oxford University Press 2001) (describing Dolly as a remarkable sheep because she was cloned).

2 See id at 94. See generally The Future Is Now America Confronts the New Genetics (William Kristol and Eric Cohen, eds., Rowman & Littlefield Publishers, Inc. 2002); The Human Embryonic Stem Cell Debate (Suzanne Holland, Karen Lebacqz, and Laurie Zoloth eds., The MIT Press 2001).

3 See Human Cloning: International Body Calls for Ban on Reproductive but not Therapeutic Cloning, OBGYN & Reproduction Week, Oct. 13, 2003.

4 Survey Vatican, Washington, stall UN Treaty on Human Cloning for At Least a Year, The Canadian Press, Nov. 19, 2002. See also Britain’s Leading Academic Institution Calls for Ban on Reproductive Cloning, The Canadian Press, Sept. 22, 2003.

5 See Vatican, Washington, stall UN Treaty on Human Cloning for At Least a Year, The Canadian Press, Nov. 19, 2002.

6 See Lori B. Andrews, The Clone Age 237 – 239 (Henry Holt and Company 1999). The Raelians area religious sect that believes humans were first cloned in the image of Elohim (aliens). With the announcement of Dolly, the leader of the sect, Rael formerly Claude Vorilhon, formed a company in the Bahamas and started Clonaid, a project to clone humans. Clonaid asserts that it has cloned at least 3.

7 Peep supra mark 1, at 65 (quoting the NBAC).

8 Cf. The Human Embryonic Stem Cell Debate 136 (Suzanne Hollad, Karen Lebacqz, and Laurie Zoloth eds. The MIT Press 2001).

9 See supra note 8, at xvii.

10 Observe id.

11 See Nat’l Insts. of Health, U.S. Department of Health and Human Services, Stem Cells: Scientific Progress and Future Research Directions, at ES-1 (June 2001) available at http://www.nih.gov/news/stemcell/scireport.htm.

12 Explore supra designate 7, at 131.

13 See id.

14 Study Cynthia Donley Young A Comparative Look at the U.S. and British Approaches to Stem Cell Research 65 Alb. L. Rev. 831, 832 (2002) (discussing sources of stem cell research).

15 See id.

16 Cloning and the Future of Human Embryo Research 7 (Paul Lauritzen ed., Oxford University Press 2001).

17 Id.

18 See id.

19 Id.

20 Peruse id at 8.

21 Id at 8.

22 See id at 8 (reporting that 1993 was the first year this process was successfully tried in humans).

23 Id at 9.

24 See id at 9.

25 Survey Andrea L. Bonnicksen Crafting a Cloning Policy From Dolly to Stem Cells 6 (Georgetown University Press 2002).

26 Explore id.

27 See id.

28 See id.

29 See generally Human Cloning and Human Dignity The Report of the President’s Council on Bioethics (PublicAffairs 2002).

30 See generally Ronald M. Green The Human Embryo Research Debates (Oxford University Press 2001); The Human Embryonic Stem Cell Debate 136 (Suzanne Hollad, Karen Lebacqz, and Laurie Zoloth eds. The MIT Press 2001).

31 See generally The Cloning Sourcebook 1 (Arlene Judith Klotzko ed., Oxford University Press 2001).

32 See id.

33 The Regulation of Assisted Reproductive Technology 45 (Jennifer Gunning and Helen Szoke, eds., Ashgate 2003).

34 Id at 46.

35 Id.

36 Id.

37 Id at 46 -47.

38 Peer Assisted Human Reproduction Act, C-56, 37th Parliament, 1st Session, (Can. 2002) available at LEGISINFO – The Library of Parliament, http://www.parl.gc.ca/LEGISINFO/index.asp? Lang=E&query=3077&Session=9&List=toc. See also http://www.fotf.ca/familyfacts/tfn/2003/011503.html (stating the Minister of Health introduced a modified bill in May 2002).

39 Watch http://www.parlgc.ca/LEGISINFO/index.asp? Lang=E&query=3077&Session=9&List=toc at Residence of the Bill.

40 See Assisted Human Reproduction Act, C-13, 37th Parliament, 2nd Session, (Canada 2003) available at http://www.parl.gc.ca (hereinafter “Assisted Reproduction Act”).

41 Id.

42 See Assisted Human Reproduction Act § 1.

43 Assisted Human Reproductive Act §§ 2, 3, & 4.

44 See Assisted Human Reproductive Act § 2.

45 Assisted Human Reproductive Act § 2.

46 Assisted Human Reproductive Act §§ 26 & 29.

47 Assisted Human Reproductive Act § 24.

48 Id.

49 Id.

50 Assisted Human Reproductive Act § 5(1)(a).

51 Assisted Human Reproductive Act § 3.

52 Id.

53 Id.

54 Sight Assisted Human Reproductive Act §§ 10, 11, 12, & 13.

55 See Rev. Royal M. Aamel, Editorial, Ottawa Is Deceiving Us The Hamilton Spectator, June 11, 2003.

56 Assisted Human Reproduction Act § 60(a).

57 Assisted Human Reproduction Act § 60(b).

58 Assisted Human Reproduction Act § 61.

59 Assisted Human Reproduction Act § 62.

60 Assisted Human Reproduction Act § 63.

61 See Human Pluripotent Stem Cell Research: Recommendations for CIHR-Funded Research Report of the Ad Hoc Working Group on Stem Cell Research available at http://www.cihr-irsc.gc.ca/e/publications/1489.shtml.

62 See id.

63 See id.

64 See id.

65 Glance id.

66 Gape id.

67 Look id.

68 See id.

69 Assisted Human Reproduction Act § 68.

70 See Aaron Derfel Quebec Forbids Research Using Stem Cell Embryos: Statute Could Conflict with Proposed Federal Law, National Post, Jan. 11, 2002, at A5.

71 Catholic World News Service 14 Jan. 2002 available at http://www.katolsk.no/nyheter/2002/01/17-0004.htm (discussing the Quebec ban on destructive research exciting human embryos). Seek also LIFESITE’S 2002 Year In Review -The Good News December 23, 2002 available at http://www.lifesite.net/ldn/2002/dec/02122302.html.

72 Peek Catholic World News Service 14 Jan. 2002 available at http://www.katolsk.no/nyheter/2002/01/17-0004.htm.

73 See id.

74 Look supra note 31, at 55.

75 See supra note 31, at 55.

76 See id.

77 See supra sign 23, at 32.

78 See id.

79 See id.

80 See id at 33.

81 See id.

82 See id.

83 Inspect id at 45.

84 See id.

85 H.R. Rep. No. 108-18, at 4 (2003).

86 See generally Medical Science and Bioethics: Attack of the Clones? Hearing Before the Subcommittee on Criminal Justice and Drug Policy and Human Resources of the House Committee on Government Reform 107th Cong. (2002) (recording various views on cloning); Opportunities and Advancements in Stem Cell Research Hearing Before the Subcommittee on Criminal Justice, Drug Policy and Human Resources of the House Committee on Government Reform 107th Cong. (2001) (recording various views on stem cell research).

87 H.R. Procure. No. 108-18, at 99 (2003).

88 See supra note 82 and accompanying text.

89 Human Cloning Prohibition Act of 2003 H.R. 534, 108th Cong. (2003).

90 Behold id.

91 See id.

92 Eye id.

93 See id.

94 H.R. Rep. NO. 108-18, at 6 (2003).

95 Id at 5.

96 Id.

97 Id.

98 Id at 99.

99 H.R. 534, 108th Cong. (2003).

100 See generally Status of the Implementation of the Federal Stem Cell Research Policy Hearing before a Subcommittee of the Senate Committee on Appropriations, 107th Cong. (2002); The Dangers of Cloning and the Promise of Regenerative Medicine Hearing of the Senate Committee on Health, Education, Labor, and Pensions, 107th Cong. (2002); Human Cloning: Must We Sacrifice Medical Research in the Name of a Total Ban? Hearing before the Senate Committee on the Judiciary, 107th Cong. (2002).

101 See supra note 96 and accompanying text.

102 See supra note 96 and accompanying text.

103 Compare Human Cloning Prohibition Act of 2003 H.R. 534, 108th Cong. (2003) with Human Cloning Prohibition Act of 2003 S.245, 108th Cong. (2003).

104 See Cord Blood Stem Cell Act of 2003 H.R. 2852, 108th Cong. (2003) and Cord Blood Stem Cell Act of 2003 S.1717, 108th Cong. (2003).

105 See Cord Blood Stem Cell Act of 2003 H.R. 2852, 108th Cong. (2003) and Cord Blood Stem Cell Act of 2003 S.1717, 108th Cong. (2003).

106 Compare Cord Blood Stem Cell Act of 2003 H.R. 2852, 108th Cong. (2003) with Cord Blood Stem Cell Act of 2003 S.1717, 108th Cong. (2003).

107 See Cord Blood Stem Cell Act of 2003 H.R. 2852, 108th Cong. (2003) and Cord Blood Stem Cell Act of 2003 S.1717, 108th Cong. (2003).

108 See Cord Blood Stem Cell Act of 2003 H.R. 2852, 108th Cong. (2003) and Cord Blood Stem Cell Act of 2003 S.1717, 108th Cong. (2003).

109 Watch Cord Blood Stem Cell Act of 2003 H.R. 2852, 108th Cong. (2003) and Cord Blood Stem Cell Act of 2003 S.1717, 108th Cong. (2003).

110 See Cord Blood Stem Cell Act of 2003 H.R. 2852, 108th Cong. (2003) and Cord Blood Stem Cell Act of 2003 S.1717, 108th Cong. (2003).

111 See Cord Blood Stem Cell Act of 2003 H.R. 2852, 108th Cong. (2003) and Cord Blood Stem Cell Act of 2003 S.1717, 108th Cong. (2003).

112 Human Cloning Ban and Stem Cell Research Protection Act of 2003 S.303, 108th Cong. (2003).

113 Compare Human Cloning Ban and Stem Cell Research Protection Act of 2003 S.303, 108th Cong. (2003) with Human Cloning Prohibition Act of 2003 H.R. 534, 108th Cong. (2003) and Human Cloning Prohibition Act of 2003 S.245, 108th Cong. (2003).

114 See Human Cloning Ban and Stem Cell Research Protection Act of 2003 S.303, 108th Cong. (2003).

115 See id.

116 Leer id.

117 See id.

118 Stare id.

119 See id.

120 See id.

121 See id.

122 See id.

123 Glimpse id.

124 See id.

125 See supra note 23, at 31.

126 Id at 63.

127 See id.

128 See id.

129 Contemplate id. at 43.

130 Human Cloning Human Dignity The Report of the President’s Council on Bioethics xxxv (PublicAffairs 2002).

131 Inspect id.

132 Id.

133 Id. at lviii.

134 Id. at lx.

135 See International Conference on Harmonisation; Guidance on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability 63 Fed. Reg. 50244 (FDA Sept. 21, 1998).

136 See supra note 23, at 103.

137 Id. at 100.

138 Id.

139 See National Institute of Health Guidelines for Research Using Pluripotent Stem Cells 65 Fed. Reg. 51976 (Aug. 25, 2000).

140 See id.

141 See id.

142 See id.

143 See id.

144 Explore id.

145 See id.

146 See supra note 23, at 137.

147 Id.

148 Id.

149 Id.

150 Id. at 138.

151 Id. at 139.

152 Id.

153 See id. at 139 -140.

154 Id.

155 Witness id.

156 See id. at 140.

157 Glance id. at 143.

158 See id. at 145.

159 See id. at 147.

160 See id. at 147.

161 See id. at 147.