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Considerations of Genetic
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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Considerations of Genetic
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Current health policies are outdated due to the emergence of genomic research.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
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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
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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
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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 11th, 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
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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
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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
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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). (page
numbers unknown).
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.
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