Considerations of Genetic 1
Running head: GENETICS AND POLICY-MAKING
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Considerations of Genetic Research on Policy-Making
Michelle Schoonover
Creighton University

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Abstract
Current health policies are outdated due to the emergence of genomic research. Health policies, such as the United States’ HIPPA and Canada’s PIPEDA were enacted to ensure the civil liberties and rights of their citizens. The protection of health information is a major concern of the federal government since public health records would result in rampant discrimination. New policies pertaining to genetic research need to remain consistent with current policies, but also consider the international ramifications. This paper will discuss the future of policy-making in terms of the following: (a.) current health information policy (b.) theories on genetic policymaking (c.) consumer involvement in policy-making (d.) commercialization of genetic material.

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Considerations of Genetic Research on Policy-Making
The field of genetic research is blooming into an international and multi-billion dollar corporation. The discoveries of genomic research have implications that reach far beyond the bounds of a single nation; rather they effect mankind. Currently, health policies of one nation do not affect the civil rights of citizens from another. Therefore, every nation can independently form their own policies concerning the rights of their citizens. However, with the emergence of genetic health care, new health policies concerning both individuals and research need to be forged. The human genome is not the property of a single person or nation due to the common heritage of humans that is evident in the genome. Therefore there is an international component to policy-making. Federal laws should reflect the convictions of the citizens that are impacted by the laws, while concurrently observing the international standard that maintains the dignity of the human being. The rights and responsibilities of the patient are often addressed when making health policies. The civil rights of the patient should not be disregarded when forming genetic health policies.
Governments acknowledge that the health information of its citizens should be confidential due to potential discrimination if the information were public despite the fact that genetic tests are not good indicators of the health of a person. Genetic tests indicate genotype not phenotype; therefore, the results of a genetic test can not be used to consider a person’s health.
For example, just because a woman possesses the BRAC1 allele she will not necessarily develop breast cancer. In fact, the woman is more likely to take more preventative measures, such as yearly mammograms, if she knows that her risk of breast cancer is high. Current laws do not address the forthcoming issues of genetics; therefore, new policies need to be enacted to protect

Considerations of Genetic 4 civil rights. However, the method and policy contents that will best serve society and the individual is heavily debated.
Current Health Information Policies
The medical health of a person is confidential to employers, insurance companies and family members unless there is explicit consent by that individual. In fact in 2003, the federal government revised the laws ascribing the rights of a patient. The “Health Information Patient
Privacy Act” (HIPPA) insures that every patient will receive confidential treatment, without the fear that his or her insurance, employer and family will receive notification (“ HIPAA,” 2004
).
Confidentiality is important because open medical records could be a source of discrimination in the workplace. HIPPA was enacted in order to restore the civil rights of a patient (“ HIPAA,”
2004 ).
It is not only in the United States that federal government is realizing the necessity to maintain the medical confidentiality of its citizens. In Canada, prescription records could be sold without consent as long as direct identifiers such as name, address, telephone numbers, health card number were removed, despite the fact that 69% of the patients could be identified
(Zoutman, Ford, & Bassili, 2004). Therefore, on January 1, 2004, the Canadian government issued the Personal Information Protection and Electronic Documents Act (PIPEDA). The act requires informed consent before any personal information can be released to ensure the confidentiality of the patient (Zoutman et al, 2004).
Genetic policy-making
Currently, there are four different approaches concerning policy-making regarding genetic material. They are (a.) the human rights approach, (b.) statuary approach, (c.) administrative approach, (d.) market driven approach (Knoppers, Hirtle & Glass, 1999).

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(a.) Human Rights Approach
The human rights approach relies on the court system to prevent discrimination and assert the right to privacy in accordance with the current values of the public. However, this approach does not address potential problems until they have already developed and the litigation associated with this policy style is costly and lengthy (Knoppers et al , 1999).
(b.) Statuary Approach
The statuary approach is concerned with the implication of scientific advances and seeks to limit the potential problems through bans and restraints. The statuary method is advantageous in that it is indicative of political values and offers immediate answers when problems arise.
However, this style limits the consumer involvement in policy-making (Knoppers et al , 1999).
Consumer involvement in genetic policy making is essential because the consumer is most directly affected by the results.
(c.) Administrative Approach
The administrative approach to policy-making gives sole control to the government; the public has little influence on decisions. This approach “allows for the gradual development of self-regulatory codes of conduct” (Knoppers et al, 1999) and self-regulation of ethics, licensing and monitoring of research group activities. Individual corporations are responsible for drafting the codes of ethics and these codes do not necessarily reflect the values held by the public nor do these corporations need to justify their standards to the public (Knoppers et al, 1999). This approach is the most liberal in that it does not have public intervention. The companies are free to perform any experiment as long as it does not violate the set of standards that it set for itself.
The company is also free to change its policy when it deems appropriate. The administrative

Considerations of Genetic 6 approach effectively avoids lawsuits and prohibitive legislation due to its self-regulation
(Knoppers et al, 1999).
(d.) Market Driven Approach
The market-driven approach is based on the principles of capitalism. The development of technology is dependent upon public and private investments. In theory, the projects that result in the greatest financial gain by investors will be supported. Those projects that are not supported by consumers will have little financial recompensation and therefore will have little fiscal support by investors (Knoppers et al, 1999). This method gives the public a voice in terms of its financial ability. This method does not give equal voice to everybody. Only those of significant financial security can express their view, through either direct investment and/or the utilization of scientific advancements by consumer means.
Consumer Involvement in Policy Making
While in the past, professionals’ testimonies were sufficient to form legislative acts concerning public health, the modern concern of genetics requires that the professional model be disbanded and the public voice resonate (Ard & Narowicz, 2001). This model believes that consumers possess neither sufficient knowledge nor ability to deserve an influence on policymaking (Ard & Narowicz, 2001). In the four different approaches the degree of public involvement differs significantly, from direct involvement to scientific autonomy. All four approaches acknowledge that the public should have a moderate amount of authority on policymaking but none refute that the expertise of professionals in public health and medicine is also necessary. The humanistic approach takes precedence when policy-makers argue that those who are most affected by the implementation of policies should also have a strong voice in the generating of these policies. The capitalist approach also asserts that the public voice should be

Considerations of Genetic 7 present in committee hearings since public funds largely support genetic research (Ard &
Narowicz, 2001).
While it is acknowledged that the public should have a voice, research has shown that the public actually only has a modicum of influence. While both the humanistic and market driven models directly support public involvement, the reality of policy-making is still centered on the professionals. Before making a decision concerning public policy, the federal government devises an advisory committee to determine the potential implication of genetic research (Ard &
Narowicz, 2001). The composition of these committees contains individuals from industry, academia, the government and consumers, although each groups’ representation is not proportional to its actual percentage in the general public. For example 44% of the committees have been from academia, while only 11% have been consumers research. There is also overlap between individuals from industry and academia, giving these groups a higher percentage of influence (Ard & Narowicz, 2001).
It is important to distinguish between the general public and consumers. Consumers are individuals who might use the genetic services and therefore the policy concerns these individuals. The general population is composed of all citizens (Ard & Narowicz, 2001). The individuals from industry are predominantly from medical institutions and health insurance companies. Of the individuals from academia, several institutions were over-represented. The decisions concerning policy reflect the values of these organizations more than the values of the general population (Ard & Narowicz, 2001). Although policy-makers acknowledge that consumers should have an influence on the formation of health policies, including those involving genetic research, there has been little evidence demonstrating the application of this belief.

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Commercialization of Genetic Material
It is universally accepted that the commercialization of genetic material is not ethically permissible. “Turning tissue, cell lines and DNA into commodities ‘violates body integrity, exploits powerless people, intrudes on human values, distorts research agendas and weakens public trust in scientists and clinicians’”(Knoppers et al, 1999). The General Conference of
UNESCO (United Nations Educational, Scientific and Cultural Organization) adopted the
Universal Declaration of the Human Genome and Human Rights on November 11 th , 1997. This document asserted the universal rights of every individual. “Article 1 states: ‘The human genome underlies the fundamental unity of all members of the human family, as well as the recognition of the inherent dignity and diversity. In a symbolic sense, it is the heritage of humanity”’(Salter
& Jones, 2002, p. 328). This declaration does not dictate the status of an individual’s genetic material, but does maintain that financial gains should not be made from genetic material.
Regional institutions such as the European Directive on the Legal Protection of Biotechnological
Inventions and the Convention of Human Rights and Biomedicine have acknowledged that human genetic material is part of the person and is not property that can be sold (Knoppers et al,
1999). This is analogous to the selling of organs on the “black market.” It is a lucrative and unsavory practice because it is viewed as undignified to the humanity and value of a person.
Health policies concerning genetic material should also reflect the position of the United
Nations and regional health advisories: genetic material is not for sale. Informed consent forms are currently used to ensure the privacy of a patient and also to release results for research studies. Policy-makers need to modify current policies concerning informed consent. New policies should limit the financial compensation of DNA donors. This proposed informed consent would also guarantee the right for scientists to reuse the genetic material under the

Considerations of Genetic 9 guidelines of presumed consent. New consent laws would also ensure that donators would retain confidentiality (Kerr, 2003).
The right to patent any component of the human body, including an individual’s unique genes is not universally accepted because a patent implies ownership. Since the human genome is a vestige of humanity’s common link, the ownership of a particular sequence is contrary to the dignity of man. The ability to patent a particular sequence is neglectful of the fact that not one person can own the rights to the genetic make-up of another person. The patenting of genetic material is incompatible with the notion that genetic material is not for profit.
The right to patent genetic material however does not have an international standard or policy, which has caused two different practices to develop concerning the same issue. Although largely restricted to European nations, who typically have a more conservative approach to genetics, there is a belief that the human body is not a “patentable invention” (Knoppers et al,
1999). Therefore patents should not be allowed. The second approach is market driven. In order to make a profit, companies patent their discovered sequences prematurely and/or attempt to encompass a broad range of genetic material in their patents. However, this method can lead to overlapping and incomplete patents because institutions attempt to increase their profits
(Knoppers et al, 1999). The patenting of genetic material is a double-edged sword. While patenting allows for scientific collaboration, it prevents different scientific groups from utilizing the data and information discovered by other research groups. On the other hand, if patents were abolished, research groups would be unwilling to share information. The patenting of genetic sequences has led to a problem concerning public health on an international scale in terms of its obstruction in the prevention of diseases.

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In order to combat patents that are not in accordance with the best interest of society, the
European Patent Convention amended their patent laws to include an “ethical filter.” This morality clause enables the government to deny a patent if it seems contrary to the benefit of the public (Knoppers et al, 1999). This step would be in accordance with the United Nations stance on the exploitation of genetic material for a profit. The market-driven approach to policy-making is in direct conflict with the assertions made by the Universal Declaration of the Human Genome and Human Rights because it assumes a free market that is directed by profit. While the patenting of genetic material may be contrary to the dignity of man, national patent offices must first forbid the patenting of genetic material. This however will prevent the capitalist approach from dominating the market. Scientific collaboration and advancement will continue using the ethical filter to prevent the capitalist approach from dominating (Knoppers et al, 1999). The
European Patent Office has been urged by the European Parliament to deny the Myriad Genetics biotech firm the breast cancer genes BRCA1 and BRCA2. This act symbolizes the growing national conviction that genes are not patentable (Salter & Jones, 2002). However, this patent has been accepted by the United States Patent office (Bonetta, 2000). In accordance with the growing dilemma concerning the patenting of genetic material, the United States Copyright Office maintains that an individual’s unique DNA sequence is not an “original work of authorship” and therefore cannot be patented (Pearlstein, 2001). The United States patent office maintains that while an individual’s DNA cannot be patented, the discovery of DNA sequences of a population is patented.
Current health policies do not address the merging issue of the status of genetics, both in the form of genetic tests and genetic research. Current policies are only concerned with the immediate problems of health information. They neglect that genetics is the future of the health

Considerations of Genetic 11 care industry. Policy-makers in the genomic era must consider the societal implications when fashioning new national policies. Health policies should reflect the current values of the citizens, not only the medical and industry professionals that currently compose a majority of health policy advisors. While there remains an inequality among representation in the demographic concerning policy-making, it is important to note that there is currently more of a consumer voice in policy-making than in the past. The increasing consumer voice in policy-making has been a step forward in recent years. Also, genomic health policy-making on an international level is currently being addressed. The future of patenting genetic material is extremely controversial due to the common lineage of all human beings. Patenting is in direct violation of the Universal
Declaration of the Human Genome and Human Rights , which asserts that to maintain human dignity, profiting from genetic material is prohibited. However, the ban on patenting requires international cooperation and standard federal laws in all nations. In the age of genomic research, to maintain order and international scientific collaboration, an international policy concerning available avenues of research (i.e. cloning, stem cells, etc.), the legality of patents, patient confidentiality, standard of ethics and future implications of current research might prove to become necessary. This ensures the dignity of the human race does not diminish.

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References
Ard, C., & Narowicz, M. (2001). A seat at the table: membership in federal advisory committees evaluating public policy in genetics. American Journal of Public Health, 91,
787-790.
Bonetta, Laura. (2000). Raising the bar for gene patents. Current Biology, 11(4).
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Kerr, A. (2003). Genetics and citizenship. Society, 40, 44-55 . Retrieved March 8, 2004, from
Academic Search Premier database (10770518).
Knoppers, M., Hirtle, M. & Glass, K. (1999). Commercialization of genetic research and public policy. Science, 286, (page numbers unknown). Retrieved March 8, 2004, from
Academic Search Premier database (00368075).
Pearlstein, J. (2001, October). How to protect your DNA from unauthorized use. Red Herring.
Salter, B. & Jones, M. (2002). Regulating human genetics: the changing politics of biotechnology governance in the European Union. Health, Risk & Society, 4, (page numbers unknown). Retrieved March 8, 2004, from Academic Search Premier database.
United Medical Center. (2004, January) HIPAA-Patient Privacy Act . Retrieved March 9, 2004. http://www.umcwy.org/Services/HIPPAA.htm

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Zoutman, D., Ford. B., & Bassili, A. (2004). The confidentiality of patient and physician information in pharmacy prescription records. Canadian Medical Association Journal,
170(5), 816-817.