Budny 10:00
L19
THE ETHICS OF PATENTING A MEDICAL PROCEDURE
John Passerini (jlp189@pitt.edu)
REGENERATIVE MEDICINE
Many scientists and biomedical engineers are working to
further the developments in regenerative medicine.
Regenerative medicine is a fairly new branch of medicine that
attempts to use the natural regenerative nature of organs,
tissues, and cells to “change the course of chronic disease and
in many instances regenerate tired and failing organ systems
lost due to age, disease, damage, or congenital defects” [1,2].
In response to recent problems with shortages in organ
donations for transplantation, researchers have made great
efforts to unveil the science behind regenerative medicine [1].
Doing this would allow for the creation of a naturally
functioning organ replacement for the patient [2]. An organ
created through regenerative medicine is a more natural and
medically preferred replacement as opposed to the
implantation of a donated organ. An antirejection drug such
as immunosuppressant drugs must be taken for the body to
accept the implanted donor organ [3].
These drugs
significantly compromise the ability of the immune system.
Therefore, patients who have taken immunosuppressant drugs
have a reduced ability to fight off infections and viruses,
making it all too easy for them to contract a common cold or
flu [3].
researchers are currently perfecting the process of taking adult
stem cells and coaxing them into their embryonic state [3].
Adult stem cells are mature cells taken from a fully formed
human [3]. These cells can be obtained from various areas of
the body including bone marrow [3]. These cells are then
isolated using medical technologies and injected into
damaged areas of the body for treatment [3]. These cells have
been proven to be able to heal broken bones, replace skin
damaged by burns, and treat leukemia [3]. Multipotent and
unipotent stem cells can differentiate only into a limited
amount of cell types, and therefore are not commonly used in
the research of regenerative medicine [2].
The Process
The growth of new organs using stem cells involves a
tedious medical process.
Scaffolds, three-dimensional
structures of micro vascular networks, must be either
biologically derived from a mammal or produced
synthetically so that they matches the size of the organ needed
[4,3]. Once this is complete, the stem cells are grafted onto
the scaffold and grown either in a laboratory environment or
in another controlled area outside the human’s body [3].
Upon reaching a predetermined threshold of maturity, they
are then transplanted into the human [3].
Stem Cells
ETHICS OF OBTAINING A PATENT
The basis for regenerative medicine is stem cells, both
embryonic and adult stem cells [3]. Stem cells are the basic
cells that make up our body [3]. They are rapidly reproducing
within the human body and have the capability to differentiate
into other cell types [3]. They can grow into nerve cells,
organs, and skin [3]. There are four subcategories of stem
cells: totipotent, pluripotent, multipotent, and unipotent stem
cells [2]. Totipotent stem cells, which are found in the early
stages of embryo development, are the cells in which
embryonic stem cells are isolated [2]. Embryonic stem cells
are considered pluripotent since they can differentiate into
cells of the germinal layers ectoderm, mesoderm, and
endoderm but not trophectoderm [2]. The way in which these
stem cells are harvested is the main reason for the controversy
over the ethics of their use [3]. Many believe life starts at
conception and therefore destroying an embryo in order to
harvest stem cells is destroying a life. Once harvested, they
can be genetically programmed through human intervention
to become any form of the human body [3]. Thus, embryonic
stem cells have a great chance in repairing damaged organs or
other physical bodies because of their great ability to
differentiate into many cell types [3]. In an effort to bypass
the ethical issues surrounding embryonic stem cells, medical
University of Pittsburgh, Swanson School of Engineering 1
Submission
Date
2013-1029
It is almost unanimously agreed upon that the scientific
process accompanying regenerative medicine will be
perfected sometime in the future [3]. Although, the ethics
surrounding the patenting of this medical procedure is much
more controversial. Many researchers and organizations have
been funded and have supported funding to further research
in regenerative medicine. The legality of the ownership of
their work and discovery has tremendous health care and
patient significance.
Code
The National Society of Professional Engineers states in
its Code of Ethics for Engineers that “engineers shall hold
paramount the safety, health, and welfare of the public” and
furthermore that “engineers shall at times strive to serve the
public interest” [5]. More directly related to this topic, the
Biomedical Engineering Society Code of Ethics states that
biomedical engineers shall “consider the larger consequences
of their work in regard to cost, availability, and delivery of
health care” [6]. These codes must be given adequate
John Passerini
consideration when considering the ethics of patenting a
medical procedure such as regenerative medicine.
patents being available for medical procedures because of the
more individualistic approach and less dialogue between
organizations. The idea of individualistic research goes
against the nature of successful research: the sharing and
educating of knowledge leading to discovery and the
refinement of science.
Implications
The cost a patient or health insurance company must incur
when a patient receives a vital medical treatment, such as an
organ replacement, must be a price in which “the safety,
health, and welfare of the public” is upheld if the code for
engineers is to be supported [5]. A patent is the sole
ownership of something by a single individual or group.
Patents generally cause an increase in the cost of something
as compared to an un-patented good or procedure [7].
Economics states that when one and only one entity has full
ownership of something, their ability to control and their drive
to maximize their profits causes the price of the patented item
or procedure to greatly increase [7]. The American Medical
Association House of Delegates condemned the patenting of
medical and surgical procedures in the mid-1990s [8]. One of
the reasons for their condemnation is “a possible increase in
the cost of healthcare” [8]. In an attempt to maximize profits
by raising prices, patentees would therefore compromise the
availability of the medical procedure, limiting its long term
impact on the general population [9].
Availability is another area in which biomedical engineers
are morally bound to consider when acting according to the
Biomedical Engineering Society Code of Ethics [6].
Biomedical engineers develop devices and processes unlike
what other engineering fields develop. Biomedical engineers
develop devices and procedures that aid in and/or determine
the fate of one’s life. Therefore, biomedical engineers must
be held to a higher moral standard than all other engineering
fields when considering their direct affect and importance to
people’s lives and well-being. Biomedical engineers have a
moral obligation to perform work and procedures that allow
for cost-effective treatments so that no patient is deprived of
the right to health. Large fees and an involved legal process
surrounding the issuing of licenses for the ability to perform
the medical procedure of regenerative medicine would hinder
the availability of this technology to patients [9]. Several
health care groups who would have otherwise been
performing the procedure, may decide not to obtain a license
due to fees and the legal process. On the flip side, patentees
of a thriving medical procedural discovery may be reluctant
to issue licenses to others, as this will diminish their profit
margins [7]. The sharing of research and developments
between separate entities researching regenerative medicine
would slow or possibly cease if a patent, sole ownership, was
at stake [9]. As stated by law, public use of a procedure, or
publication of a description of a procedure prior to applying
for a patent may invalidate the application [9]. In addition,
engineers and scientists alike would not risk losing any and
all return on their efforts to share information with another
group if they could not profit in any way from that other
group’s success [9]. Discovery and developments in the area
of research would move at a much slower pace in the case of
Right to Health
A patent being held for the procedure of regenerative
medicine would violate the right to health, in part because of
both cost and availability [10]. The phrase “right to health”
has several different interpretations. But at its most basic and
agreed upon level, it consists of the right to a decent minimum
level of health care [10]. Many nations such as the United
Kingdom contain legal clauses that portray “a strong moral
requirement” to have medical procedures be unable to be
patented [10]. In the Unites States, under the Medical
Procedures and Affordability Act of 1996, physicians and
health care groups are given immunity from law suits
involving patent infringement, and patents for medical
procedures are available [10].
Christian moral law states, “Let each of you look not only
to his own interests, but also to the interests of others”Phillippians 2:4 [11]. The interests of self must be detached
from the thought process of a biomedical engineer when
dealing with a patient’s health. A patient’s quality of life or
life itself is tremendously more important than any possible
financial gain. “Do not withhold good from those to whom it
is due, when it is in your power to do it”-Proverbs 3:27-28
[11]. As explained above, patenting a medical procedure such
as regenerative medicine would withhold good from
individuals and society. The lack of organ donation compared
to the great number of organ failures presents a huge problem
to society that would be solved through the perfection of
regenerative medicine. Obtaining a patent for this procedure,
which would decrease the availability of the treatment to
patients, is morally unjust.
Patent Protection
Some economists and legal authorities believe patent
protection for medical procedures would help society [10].
They believe the purposes of a patent, namely the incentive
for an inventor to freely disclose information and continue to
innovate and invent, applies to medical procedures in the
same way it would to all other situations [10]. Patent
protection allows inventors to reveal their information and
discoveries, knowing that they are protected from this
information being stolen from them [10]. Without patent
protection, many argue, inventors may keep their discoveries
secret through actual or legal trade secrecy [10]. Through this
secrecy, a greater monopoly would occur than if the
innovation was patented and known to the public [10].
Therefore, a patent implies a bargain between the inventor
and society [10]. Society benefits from the invention or
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John Passerini
discovery while the inventor benefits through the financial
gains that stem from having sole ownership of the innovation
[10]. Many economists state that sustained economic growth
can only occur when innovators feel free to openly disclose
their inventions and discoveries knowing they will see an
economic return [10]. Inventors, being unable to guarantee
return on their discoveries, would be hesitant to pursue
research and development of a possible invention [10]. For
this reason, the advancement of technology would slow [10].
More specifically to patenting a medical procedure, the
disclosure requirement that obtaining a patent entails
guarantees that the new information would become known by
all health care professionals [10].
All health care
professionals could then operate according to the new medical
procedure upon obtaining a license to do so [10]. Therefore,
upon obtaining a license to the procedure, the quality of
medical treatment for patients would increase [10].
The application of the traditional positive effects on
patents in an economic system do not necessarily apply to
medical procedures [10]. Success of those in the medical
professions differs greatly from success in most other
professional fields. Professional reputation, authorship of
medical research papers involving new information, and
increased funding from private investors are areas in which
success of a medical researcher is evaluated [10]. Profit falls
behind these characteristics of success when dealing with
those in the medical fields. There has not been any notable
evidence showing that the incentives of a patent system are
needed in order to ensure advancement in medical treatment
[10]. The incentive for a biomedical engineer to perfect the
procedure of regenerative medicine would lie in their
increased professional reputation, increased funding from
private investors for future projects, and fulfillment of their
ethical and moral obligations to society [9].
their work [6]. Therefore, in this situation, bioengineers
should not obtain a patent for the medical procedure of
regenerative medicine, even if legally permissible.
REFERENCES SECTION
[1] S. Gojo, M. Toyoda, A. Umezawa. (2011). “Tissue
engineering and cell-based therapy toward integrated strategy
with artificial organs.” MiniReview. (Online article). DOI:
10.1007/s10047-011-0578-4. pp. 171-177
[2] K. Appasani, R. Appasani. (2011). Stem Cells and
Regenerative Medicine-From Molecular Embryology to
Tissue Engineering. Humana Press. (Online book). pp. 3-18
[3] J. Ritz. (2012). “Magic from Human Regenerative
Technologies-Stem Cells.” Resources in Technology and
Engineering. (Online article). ISSN: 2158-0502. pp. 4-9
[4] C. Kleinhans, P. Kluger, E. Novosel. (2010).
“Vascularization is the key challenge in tissue engineering.”
Advanced Drug Delivery Reviews. (Online article). DOI:
10.1016/j.addr.2011.03.004. pp. 300-311
[5] National Society of Professional Engineers. (2007).
“Code of Ethics for Engineers.” (Code).
http://www.nspe.org/Ethics/CodeofEthics/index.html
[6] Biomedical Engineering Society Code of Ethics. (2004).
(Code). http://ethics.iit.edu/ecodes/node/3243
[7] J. Passerini (2013, October 23). Interview
[8] E. Robinson. (2013). “Patenting Biotechnology and
Methods of Medical Treatment.” Avvo. (Online article).
http://www.avvo.com/legal-guides/ugc/patentingbiotechnology-and-methods-of-medical-treatment
[9] World Medical Assembly. (2010). “WMA Statement on
Patenting Medical Procedure.” (Online article).
http://www.wma.net/en/30publications/10policies/m30/inde
x.html
[10] E. Ventose. (2011). Medical Patent Law: The
Challenges of Medical Treatment. Cheltenham, GBR:
Edward Elgar Publishing. (Online book). pp. 9-375
[11] (2005) Holy Bible. Belgium: Thomas Nelson Inc. (Print
book).
DECISION
The science for regenerative medicine is steadily
increasing. When the day comes in which regenerative
medicine is ready for clinical use, the judgment on whether or
not this medical procedure is patentable is paramount. The
implications for this decision will have an immense impact on
the cost and availability of the procedure, not to mention the
legal precedence it will set for future similar situations [10].
If I were involved in the successful research and development
of regenerative medicine as a biomedical engineer, I would
strongly oppose patenting this medical procedure. Doing so
would violate the Code of Ethics for Engineers and the
Biomedical Engineering Society Code of Ethics alike [5, 6].
Furthermore, it would violate Christian morality. In my view,
the primary responsibility of a biomedical engineer is to
improve the health and physical well-being of society.
Economic profit and self-gain fall second to this chief
responsibility. As the Biomedical Engineering Society Code
of Ethics states, biomedical engineers are in a position in
which they are bound to consider the larger consequences of
ACKNOWLEDGEMENTS
I would like to say thank you to the University of
Pittsburgh librarians who made the research for this paper
possible through the library’s online resources.
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