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The intersection of science and law.

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The law in Canada, with its origins in British law, has historically been described as a living tree. This description is meant to reflect that the law is not stagnant and fixed. Instead, the law is continually evolving to reflect the changes in acceptable norms and standards of behaviors.

How do science and the law interact? As scientific developments often change our behaviors and activities, including sometimes creating new ones not previously possible, it is not surprising that the law must evolve to address concerns raised by scientific developments.

Scientific developments encompass a broad range from the commonplace use of cell phones, to the development of new life forms such as the Harvard mouse, and the ongoing developments in stem cell research. Different scientific developments create different impacts on society, from affecting the risk of individual personal safety and health to raising ethical and moral concerns. Thus, scientific developments often impact society, requiring the evolution of the law to address societal concerns.

Banning Cell Phone Use While Driving

Today, cell phone use is so ubiquitous it is difficult to recall the time when we did not have a phone literally at our fingertips day and night. Indeed, our 16-year old children likely do not have any memory of the time before cell phones or even before cordless phones. At the other end of the spectrum, even my 70-something mother acquired and learned to use a cell phone as effectively as anyone else. And yet, even ten years ago, cell phones were still generally the size of a cordless phone and certainly not in widespread use. This scientific development in technology has now created a society where it often feels as if every man, woman, and child routinely carries a cell phone.

The combination of the ubiquitous cell phone and the increased pace and multi-tasking of our current society has led to the common use of the cell phone while driving. This is an example of an issue that causes science and the law to interact. Specifically, the legal debate surrounding cell phone use focuses on whether legislation should be created to ban their use while driving. Research has shown that any distraction while driving increases the risk of collision by four to six times. Similar to driving while impaired with a blood-alcohol level over the legal limit, cell phone use impacts driver reaction time by 18% and makes it ten times more likely that the driver will fail to stop at stop signs. Clearly, cell phone use while driving has a significant potential effect on the risk of injury or death of the driver and/or other motorists and passengers.

In Canada, three provinces have already passed legislation to restrict cell phone use while driving: Newfoundland, Nova Scotia, and Quebec; while other provinces such as Alberta are considering implementing similar legislation.

Cell phone technology has advanced to include text messaging and Internet access. Developments in wireless communications have led to the widespread use of iPhones and BlackBerrys. All of these wireless communication devices affect driver distraction.

Should Patents Be Available for New Life Forms Created by Science?

Scientific developments involving biotechnology have led to the controversy of ethics versus economic benefits, which in turn leads to a legal debate. An example of a development in biotechnology resulting in legal ramifications is the invention of a new life form called the oncomouse or the Harvard mouse.

The Harvard mouse is a genetically engineered mouse designed for cancer research using a technique designed by Philip Leder and Timothy A. Stewart of Harvard University in the United States (U.S.). They created a laboratory mouse that was susceptible to developing cancer, thereby making it an invaluable research tool. The Harvard mouse is created by injecting a gene known to cause cancer into a fertilized animal egg and then surgically implanting the egg into the mother so it can be brought to term. When born, the result is a "transgenic" animal (meaning a transfer of genes from one animal to another) because the mouse has traits attributable to the injected gene. Therefore, the transgenic mice have been genetically modified, constituting a new life form.

As the transgenic mice are susceptible to developing cancer, it is invaluable for use to research the sources and causes of cancer, which may lead to developing treatments. Consequently, the design of the scientific technique to create the Harvard mouse raises ethical questions: whether scientists should use biotechnology to create new life forms or alter existing ones. The debate consequently revolves around the sanctity of life versus the commodification of life. There are also ethical concerns regarding possible developments of cloning and issues of cruelty to animals. Intertwined with these ethical concerns is a debate about whether inventors of such techniques should profit financially by being awarded patents under the law.

The legal debate involving the Harvard mouse is primarily focused on whether life forms can be patented (or put another way, whether patent protection should be granted with respect to life forms). Due to the nature of patent law (the patent protection as a right granted to the inventor), the viewpoint in favour of granting patents invariably rests on economic arguments. The economic argument in favor of expanding the law to allow patents to be granted for a scientific development such as the Harvard mouse center on the assertion that patents stimulate the growth of industry. From the economic perspective, transgenic animals have great commercial value in the related fields of biotechnology and medicine, in the pharmaceutical industry, and in agriculture. In addition, the economic argument asserts that biotechnical advances benefit public health by reducing costs. The required research is expensive and therefore the availability of patent protection acts as an incentive to researchers.

The economic and ethical controversies of scientific developments such as the invention of a new life form like the Harvard mouse directly resulted in a new development in U.S. patent law. It was based on analyzing three tenets: novelty, utility, and nonobviousness. The doctrine of "products-of-nature" operated to bar patents from being issued where there was no invention, which was interpreted to mean inventions involving living matter. But, in 1980, the U.S. Supreme Court rendered a decision in a case (Diamond v. Chakrabarty) relating to the patentability of a bacterium capable of breaking down crude oil. The U.S. Supreme Court ruled that the language of the relevant U.S. patent legislation was broad and therefore included living micro-organisms, which effectively expanded U.S. patent law to include living matter.

Then, in 1988 a patent was granted in the U.S. for the scientific technique that created the Harvard mouse, which was the first patent issued in the U.S. for a mammal. Rights to the invention were thus recognized by U.S. law. Previously, U.S. law only permitted patents for select lower life forms such as microbes and plants, and excluded higher life forms such as mammals, from patentability. U.S. patent law was therefore changed to include the scientific development of the Harvard mouse.

Soon thereafter, patent applications for the Harvard mouse were filed in Canada, Japan, and in Europe. Although Japan and Europe granted patent protection, by contrast, Canada did not.

The Supreme Court of Canada (SCC) took a different approach when a patent petition was filed for the Harvard mouse in 2002. It concluded the Harvard mouse was not patentable. In a 5-4 split decision, the majority of the SCC noted that although the federal Patent Act was broad, it was not intended to include higher life forms and therefore it failed to address the unique concerns of patenting higher life forms. The majority of the SCC concluded the Harvard mouse failed to meet the definition of invention in the Patent Act. It further concluded the patentability of higher life forms must be made by clear and unambiguous direction from the Canadian Parliament. The Court essentially invited Parliament to draft new legislation.

Like the U.S., Canada had previously permitted patents for lower life forms such as single-celled organisms or bacterium which were bio-engineered. However, unlike the U.S., Canada's top court took a different legal approach by refusing to read into the existing patent legislation the ability to patent higher life forms.

Legislating Stem Cell Research

Scientific developments such as stem cell research also create great ethical, moral, and legal controversies.

What are stem cells? Stem cells are the raw cells that develop into the 210 different kinds of tissue in the human body. Stem cells are in the pre-specialized stage and, as such, they can theoretically be developed for specific uses such as to form ceils for blood, muscle, nerves, and so forth. This potential of stem cells is the basis for the hope that stem cell research will lead to developing treatments for a variety of ailments such as Parkinson's Disease, Alzheimer's Disease, diabetes, heart disease, spinal cord injuries, and so forth, as these diseases involve either the death or dysfunction of specific types of cells. So, the theory is that if researchers can inject healthy stem cells into the patient, the patient may improve.

Why is stem cell research so controversial? There are three sources of extracting stem cells:

* from adult bone marrow;

* from the umbilical cord after childbirth; and

* from embryos from about one week old (but less than 14 days).

It is thought that embryonic stem ceils have the greatest potential for scientific research. In 1988, two research teams in the U.S. isolated and cultured stem cells from human embryos and fetuses. With respect to obtaining stem cells from embryos, the main controversy erupts from the fact the embryo must be destroyed in the process of extracting the stem cells, resulting in legal and ethical concerns.

In addition, there are three sources of embryonic stem cells: embryos donated from an in vitro fertilization process as either excess embryos determined to be unsuitable; embryos specifically created for research; and cloned embryos from human cells. Clearly, there are many legal implications arising from embryonic stem cell research.

Firstly, there is a debate about whether an embryo is entitled to the protection of the law. This is similar to the abortion debate in that the issue is: when does an embryo become a person under the law? If it is a person, then to obtain its stem cells might contravene existing criminal law.

The nature of embryonic stem cell research from embryos donated from the in vitro process necessitates new laws which at the very least regulate this new scientific process to ensure the protection of the health, welfare and confidentiality of the women donating these embryos, including the protection of vulnerable individuals and preventing the commodification of human eggs.

These new laws would need to adopt legal principles from other areas of the law, which would apply to the process of obtaining embryos by donation from the in vitro process and governing the use of such embryos for research purposes such as:

* informed consent of the donor;

* protection against conflict of interest between the donor's treatment team and the individual being granted the donor's consent;

* prohibition against any financial inducements;

* protection of donor privacy and confidentiality; and

* regulations to ensure safe procedures.

The controversy surrounding stem cell research is great, and the legal approaches taken internationally have been varied. The United Kingdom (U.K.), Belgium, and Sweden allow all forms of stem cell research. In 2001 the UK amended its legislation to permit the destruction of embryos for stem cell research but only if the research satisfied one of three conditions: it increases knowledge of the development of embryos; it increases knowledge about serious diseases; or it enables such knowledge to be applied to develop treatments for serious diseases. In addition, China has an unrestrictive embryonic stem cell research policy, but strictly forbids any research on human reproductive cloning.

Other countries have restricted various aspects of stem cell research. Countries such as Austria, Ireland, and Poland have prohibited all forms of stem cell research. Germany and Italy have criminalized only the extraction of stem cells from embryos, but permit other stem cell research. In the U.S., the debate respecting stem cell research appears to focus primarily on whether or not public funds should be used.

Conclusion

These examples illustrate how science interacts with the law. If the law is a living tree, then scientific developments can be seen as new branches and leaves, changing the structure of the law to address societal concerns.

Connie L. Mah is a lawyer practising in Edmonton, Alberta
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Title Annotation:Feature Report on Science and the Law
Author:Mah, Connie
Publication:LawNow
Date:Nov 1, 2008
Words:2093
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