Who Owns Your DNA?

A biotech company recently announced plans to build a gene back to sell information to drug and biotech companies conducting studies on genetic samples.

It intends to sell this information only from people who have given their consent now that the human genome- the blueprint for a human- has been decoded.

Informed consent becomes complex, given the ethical , social and legal ramifications of what the human genome can reveal. A Gallup poll take last August showed 88 percent of American adults oppose storing medical records in computerized database, and 93 percent opposed researchers studying their genetic information without their permission. But, even if privacy is assured, who holds the key to the gene vaults?

A " rough draft" of the human genome was released last February, and scientist have announced they intend to store this information in databases and develop tools for data analysis.

The database could revolutionize medicine with the possibility of tailor-made-treatments based on an individual’s unique genetic makeup and the use of gene therapy to cure, or possibly even eliminate, inherited disorder and diseases such as cancer and Alzheimer’s.

In the next few years, you might be able to deposit a blood sample at your local gene bank, find out your genetic predispositions to certain diseases and then get customized prescription drugs to match your individual genetic profile.

As this testing migrates from research laboratories to doctors’ offices, however, some serious legal and ethical privacy considerations are being raised.

Who should have access to a person’s genetic information? Can a physician, hospital, or employer perform a genetics test on a person’s blood, sputum, or other bodily fluids without that person’s consent? Can they share that medical information with others or use it in research? Who owns genetic information?

Although the issue is raised in a medical malpractice action as a rule, the concept of informed consent is broad enough to encompass the issue when a physician has a financial interest in the matter so that the professional judgment of the doctor may be affected.

The standard is an objective one: What would a prudent person in the patient’s position have decided if adequately informed of all significant perils? A California case offers some insight into the possible solutions to the thorny questions.

In Moore v. Regents of the University Of California, 271 Cal.Rptr. 146, 51 Cal. 3d 120,793 P.2d 479 (1990), cert. denied, 499 US 936 (1991), the Supreme Court of California on a motion for summary judgment held that where defendants used a patient’s cells for potential lucrative medical research without the patient’s permission, a breach of the physician’s fiduciary duty to disclose facts material to the patient’s consent occurred.

The court found that the performance of medical procedures without first having obtained the patient’s permission amounted to a lack of informed consent.

Despite strongly worded separate dissents by Justices Stanley Mosk and Allen Brossard, the majority refused to find that a viable conversion cause of action existed because "the fiduciary duty and informed-consent theories protect the patient directly without punishing innocent parties or creating disincentives to the conduct of socially beneficial research." Id., 271 Cal Rptr. at 144.

From, Moore, however, can it be logically extended that one’s genetic information also is protected under the doctrine of informed consent?

Illinois courts may be the first to decide this issue as a result of a case filed late last year against researchers on behalf o the families of dead and dying children caused by a genetic brain disease who donate tissue samples to a researcher on the premises that it would help find a cure.

Instead, the researcher intended to patent and license the results of his research for profit. Greenberg v. Miami Children’s Hospital Research Institute Inc. N.D. Ill.,docket no. 00C 6779 (filed Oct. 30,2002).

Whereas in Moore the plaintiff claimed the donated tissue was his property, the Illinois lawsuit goes further: It takes issue with the value of the information carried in the biological material of the body.

In Illinois, two statutory sources of potential protection exist: The Medical Patients Rights Act, 410 ILCS 513/1 et seq. The Medical Patients Rights Act is limited to patients involved in a research program or an experimental procedure and states that "[n]o physician may conduct any research program or experimental procedure on a patient without the prior informed consent of the patient..."

The Illinois Genetic Information Act, which became effective Jan. 1, 1998, suffers from a serious lack of definition of many terms, including "genetic information";but an even larger confidentiality problem looms.

Section 15(d) states that"[r]esults of genetic testing that indicate that the individual tested is at the time of the test afflicted with a disease, whether or not currently symptomatic, are not subject to the confidentiality requirements of this Act."

Therefore, if a person has a disease at the time of the test, his or her test results indicating the diseases are not confidential- nor is the family history of that disease. Although this may reflect sound public policy, given the decoding of the human genome and uncovering potential diseases in a person decades into the future, an individual’s medical privacy may be compromised under this statute.

To make privacy protection more meaningful, the law should make it clear that each of us owns our own DNA.

No sample should be collected without a patient’s informed consent or authorization for the purpose of DNA testing. Agreeing to do a particular test should open the door to a thousand things, some not even yet known, about which the patient has no idea and for which a research, biotechnology or pharmaceutical company may later reap billions of dollars.

Illinois and a limited number of other jurisdictions have the beginning for some meager protection regarding one’s privacy and genetic prophecy.

If Congress cannot mandate what researchers can do with research patients’ tissue and restrict the profits from that research with full and continuing disclosure of how the results will be used, it should left to the courts to determine these critical issues consonant with the law of informed consent, as well as fiduciary duties involved in conducting such medical testing.