Genetics’ role in healthcare of patentsadmin / January 13, 2019
There have been major revolutions in the genetic world in the 21st century, which have directly affected health care policies. Some of the major issues that have come with genetic revolution include the policies applied when administering genetic tests, genetic privacy, and education on genetics, their standardization and regulations as well as gene patenting.
Genes as the basic unit of heredity are responsible for the passing of characteristics from one generation to the other and this is where healthcare comes in. This passing on of characteristics is enabled by the presence of sequential DNA or RNA that bring about similarities or differences in individuals.
If the genetic revolution is not well safeguarded, instances of their misuse can surface and that is why care must be taken during genetic testing. Regulations governing these procedures require implementation to ensure that DNA sequences are not monopolized (Ojha and Thertulien, 2005). This paper focuses on genetics role in healthcare of patents and defines the language of genetic manipulation, its safety, legal and ethical issues, as well as mandatory screening and the role of the healthcare providers in gene therapy.
Genetics’ role in healthcare of patents
Healthcare has benefited largely from biotechnology and genetics and that is why there has been a necessity to ensure the safety of patents. For a genetic to be declared patentable, it must be unique in all sense and must have been modified, isolated, or purified to attain this status.
Intellectual property rights is an issue that has taken center stage in genetic innovations for decades. There have been numerous debates on how some genetic inventions have been licensed and used in the health care sector. The set rules seemed to impede the genetic processes due to their complexity thus flawing the whole process (OECD, 2006).
The OECD (Organization for Economic Cooperation and Development) is a body comprised of 30 countries that deals with the social, economic, and environmental issues brought about by globalization. This body resolved to put up clear guidelines that would govern the use of patents in genetic inventions for the health care sector.
This move led to the formation of the Council of the Recommendation on the Licensing of Genetic Inventions in 2006. Healthcare professionals must ensure that genetics meet some conditions before they are presented for patenting. They must be very specific on how the gene functions, must identify its sequence, and must be user friendly to others in the field.
Gene tests are carried out in humans with potential of developing some diseases. The owner of the disease gene patent has all legal rights and that is why they license their use.
This makes them owners of the royalties and no one can touch the tests not unless they are licensed to do so. However, there is still a lot of controversy on the patenting of human stem cells that are used in the health care sector to cure and control some diseases (OECD 2006).
Genetic manipulation is also referred to as genetic modification or genetic engineering and it refers to the treatment of genetic material artificially using recombinant DNA. This process encompasses the creation of heritable material outside the organism and this is followed by fusing it with the host. This fusing is made possible through microinjection, micro encapsulation, a vector system or through macro injection. The final product of this genetic manipulation is referred to as a genetically modified organism (GMOs, 2001).
The reasons behind genetic manipulation include choosing a phenotype of a baby, curing genetic diseases such as cystic fibrosis, infertility, increasing immunity, metabolism and intelligence as well as altering the physical appearance of individuals (Singers and Kuhese, 2000).There are ethical implications that come with genetic engineering and recently, President Obama’s government decided to do away with the limitations previously imposed on embryonic stem cell research by the previous regime. This has reopened the discussion that questions the ethics applied.
Altering the natural functions of a human being is seen to interfere with the work of creation though scientists have put a strong fight citing that this could be the only way to correct gene defects that limit people’s productivity. It is also seen as the only way to have individuals who are above average thus making them more productive in the society. Genetic engineering is prohibited in many countries of the world due to the potential risks it presents to people’s health. It is also seen as a sure way of affecting future generations with its outcomes that are yet to be fully verified according to Mir and Morgan (2009).
Canada for instance is one of the countries that have put strict prohibitions on genetic engineering as they are in high doubt of its effectiveness, safety, appropriateness, and the technology in use. Bioethics are the competing factions here and they argue that it is ethical to improve the quality of people’s lives if there is a way of doing so. They support this by providing facts that go towards treating people with genetic diseases and this makes genetic engineering a therapeutic process.
Improving the quality of people’s lives is quite alluring since genetic modifications will ensure that people are above average. In this case, people will live longer, age slowly, be more intelligent, and have high immunity to diseases. Since this process is still undergoing rigorous tests, its efficacy and safety is highly doubted as scientists try to piece workable facts together. The principle of non-maleficence is however against the bioethical approaches since it advocates for zero harm in the employed therapies.
The trial and error genetic modification process for humans could be very detrimental to people’s lives and many could be lost in the process. It is thus seen as an insult to human dignity as it cannot be justified morally. The harm that such genes would present to human beings remain unknown though they are feared to be fatal since this has been tried on animals and many of the offspring are variable making it even more questionable (Mir and Morgan, 2009).
Genetic engineering is prohibited in some states for both human and animal use. For instance, North Carolina scientists embarking on genetic engineering must hold legal permits allowing them to do so. Legal and ethical implications were highlighted again in 1997 when a sheep was cloned in Scot. The failures associated with cloning are also high and this has led to more restrictions as cloning is viewed as murder by some people. Moral, scientific, and religious issues have also taken a forefront in genetic engineering campaigns.
The success recorded have been few and short lived and this is attributed to poor immunity of the clones thus making them vulnerable to diseases. As a result, the Cartagena Protocol on Biosafety Environment on GMOs was passed in 2000 to ensure that genetic engineering processes are transferred, handled, used and disposed safely (Darvall, 1993).
Mandatory Genetic Screening
Mandatory genetic screening has been initiated in an effort to curb genetic disorders that many people are born with today. These disorders not only threaten longevity but also lead to the birth of people with physical and mental disabilities.
Other genetic disorders have been known to be the main cause of multiple malformations, stillbirths, infertility, mental illness, retarded growth, and miscarriages among others. Genetic screening is thus made mandatory especially for people with particular genotypes known to have potential for genetic disorders according to Miller (1999).
This process can therefore be defined as the systematic search for people with defective genetics that may lead to diseases that may affect the current and future generations as well. It has thus become a necessity for the public health care sector to conduct such screenings as families become more and more concerned about the plight of their family members who might be at a risk of acquiring the aforementioned conditions that affect thousands of people.
Mandatory genetic screening works towards preventing the occurrence of diseases and treating the ones that have already been diagnosed. Other objectives of this screening include medical management, enumeration, treatment of diseases, research, as well as providing people with reproductive information. The preventative nature of genetic screening makes it more appealing than the traditional forms of medication that only seek to cure the symptoms of a disease (Miller, 1999).
Role of the healthcare providers in gene therapy
Gene therapy is the introduction of genes into patient’s cells with the aim of treating diseases. The main diseases treated using this therapy include those that are acquired through heredity or through genetic anomalies.
Gene therapy has proved to be the link to cures for diseases such as cancer, hemophilia, and cystic fibrosis among others. To exploit gene therapy potential, health care providers have embarked on a research mission to improve this technology (BIO, 1999).
To ensure the protection and safety of patients in such a move, the FDA and NIH organizations that regulate drug development have become party to these studies. Unfortunately, a patient undergoing gene therapy clinical tests at the University of Pennsylvania died and this has raised questions about the efficacy of these bodies.
Healthcare providers and their patients would be key beneficiaries if gene therapy researches were successful. They have the duty of treating their patients of life threatening conditions such as AIDS, cardiovascular diseases and metabolic diseases that have spread fast in the 21st century.
This would therefore be a huge breakthrough for the healthcare fraternity. Some of the procedures adopted by gene therapy include limiting tumor growth through the destruction of blood vessels, cancer immunotherapy, and anti-angiogenesis as well as angiogenesis interventions.
Other technologies in use include retrovirus, adenoassociated virus and plasmid delivery systems. Healthcare professionals thus have the role of conducting clinical trials to find out which system works for what condition.
They also focus on the safety of the patient during such trials to avoid the risk of exposing them to serious illnesses or even death. Healthcare professionals also have the duty of ensuring that the vector being investigated is well guarded to avoid contamination that could lead to inaccurate outcomes.
They also work hand in hand with researchers to ensure that the vector exhibits the desired biological effect. Healthcare providers thus not only administer gene therapy to patients but also work towards its development (BIO, 1999).
In addition, healthcare providers have the duty of understanding their fields well in order to discover new ways and improve on the existing ones used in gene therapy. For instance, those dealing with cancers have to learn more about tumor cell biology to be able to come up with remedies for the condition.
Many of these diseases are sometimes accelerated by the types of lifestyles that people live and thus healthcare professionals have the duty of advising patients on diet and exercise. This helps cut down on these diseases and gives hope to those affected through healthy living (Science Daily 2010).
This paper looks critically at the issues of genetics role in healthcare of patents, defines the language of genetic manipulation, its safety, legal and ethical issues as well as mandatory screening and the role of the healthcare providers in gene therapy.
The aforementioned processes all aim at improving the health of patients by ridding them of various life threatening diseases. However, legal, ethical, and safety concerns are not absent since these processes if mishandled can cause more harm than good.
That is the reason why ethical, legal, and safety measures are implemented. On the other hand, the role of healthcare providers in gene therapy is clearly laid out and it is evident that they not only administer gene therapy but also aid in its development.
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Mir, H. & Morgan, C. (2009). Ethical implications of germ line genetic engineering. UWO Medical Journal, 78(3), 1.
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