BIO's Recommendations for National Privacy Legislation
A. No. BIO is strongly opposed to legislation that separates genetic information from other medical information.
At a fundamental level, there is no clear scientific distinction between "genetic" disease and "non-genetic" disease. Information which is typically not classified as "genetic" may, in fact, be genetically influenced (e.g., cholesterol) or even purely genetically determined (e.g., gender). Thus, it is impossible to draw a clear distinction between "genetic" medical information and "non-genetic" medical information.
Most, if not all, diseases contain a genetic component. Some genetic tests can be used to diagnose the presence of disease. Other tests can provide information that can be used to reduce the risk of future disease and enable earlier and more effective treatment if and when disease occurs. Genetic information forms part of the continuum of medical information that is necessary for health care professionals to provide comprehensive care across the lifespan of an individual or a family.
Indeed, even if one were to arbitrarily separate "genetic" and "non-genetic" medical information, "non-genetic" medical information would deserve no less privacy protection than "genetic" medical information. For example, information about infectious ("non-genetic") conditions (such as HIV-positive status) may be even more sensitive than some "genetic" information. Therefore, it would be insufficient to legislate special safeguards that single out a portion of personal medical information.
Q. Should discriminatory misuse of medical information be addressed in legislation?
A. Yes. BIO believes that medical information must be treated responsibly, and safeguarded against discriminatory misuse, if new advances in medical knowledge are to achieve their full potential for improving human health.
BIO strongly supported the inclusion of genetic information in the new federal health insurance reform law, the Health Insurance Portability and Accountability Act of 1996, which prohibits insurance companies from refusing health insurance coverage to individuals on the basis of their medical history. This new law demonstrates the inseparability of genetic information from other types of medical information. BIO supports further responsible anti-discrimination legislation and suggests the development of separate legislation to address discrimination and privacy protections.
The development of genetic diagnostic tests is merely the first step in identifying new treatments for disease. Many biotechnology and pharmaceutical companies are using genetic information to develop new medicines to treat and cure diseases. Any such legislation must ensure that companies can continue to identify and develop new diagnostic tests and treatments using valuable medical information, including genetic information.
BIO believes that people should have the option of using diagnostic tests that can help them recognize early warning signs of disease and seek proper treatment for disease. This option would be jeopardized if medical information were used to discriminate unfairly.
For example, genetic tests that indicate a person's predisposition to breast or colon cancer are important diagnostic tools for better health. They inform people about their health status in advance, and enable them to receive earlier and more aggressive surveillance and monitoring in hopes of detecting disease at an earlier and more treatable stage. BIO recognizes that many people at high risk for cancer do not avail themselves of this potential life-saving information because of fear of potential discrimination.
Q. Should informed consent be obtained before disclosing medical information?
A. Yes. Informed consent should be obtained before disclosing medical information that identifies a particular individual, unless the disclosure is authorized by law or the individual has previously consented to disclosure of the information for medical research or patient care. In many instances, the FDA requires the receipt of certain medical information, and routine disclosures are necessary in order to seek reimbursement from third party payors. BIO believes any changes to the requirements for obtaining informed consent for research purposes should be made to existing consent regulations and the IRB approval process in the context of federal oversight of research, rather than through new privacy legislation.
Medical information that does not identify a particular individual should not be subject to the same consent requirements, as it does not raise privacy issues. In fact, many research results are stripped of personal identifiers or replaced with a protected alphanumeric code in an effort to preserve confidentiality. In many instances, it would be difficult, and sometimes impossible, to re-link medical information to personal identifiers in order to request authorization for subsequent disclosures.
Q. Does establishing ownership rights in medical information and samples afford greater privacy protection?
A. No. Establishing ownership rights in samples and medical information is not an appropriate mechanism for protecting confidentiality. If ownership rights were created in samples and medical information, it would be highly detrimental to medical research, to the development of new health care products, to the confidentiality of patient information, and even to the operation of blood banks and organ transplant programs.
