Categories
Law

Laws governing home tests for HIV can bolster prevention efforts in sub-Saharan Africa

Laws that encourage people to test themselves for HIV can bolster efforts to eliminate AIDS-related deaths in sub-Saharan Africa.

That’s the conclusion of a report published Wednesday by the Thomson Reuters Foundation and the South African AIDS Trust, a nongovernmental organization that coordinates efforts to counter HIV and AIDS in South Africa, Tanzania, Malawi, Mozambique, Zambia, Zimbabwe and Botswana.

The report examines laws relating to home or self-testing in the seven countries where the South African AIDS Trust operates as well as in the USA, United Kingdom and France. Though about 24.7 million people live with HIV in sub-Saharan Africa, only about half know whether they have contracted the virus, according to the United Nations.

Michael Sidibe (l), executive director of UNAIDS, meets on January 18, 2013 with President Jacob Zuma of South Africa. (Photo courtesy of UNAIDS)
Michael Sidibe (l), executive director of UNAIDS, meets on January 18, 2013 with President Jacob Zuma of South Africa. (Photo courtesy of UNAIDS)

The compendium, which the law firm Arnold & Porter produced pro bono in tandem with law firms in each of the countries covered, examines whether self-testing is legal, the regulations that govern distribution of devices that make such tests possible, and protections for privacy.

“One of the key critical success factors in fulfilling the UNAIDS and global goal of zero new infections, zero deaths and zero discrimination is people knowing their own HIVsero-status and having the ability to act on the knowledge,” writes Jonathan Gunthorp, the South African AIDS Trust’s executive director, in a preface to the report.

Self-testing for HIV creates opportunities for people to access HIV treatment and prevention services. The opportunity is especially great in sub-Saharan Africa, where fewer people know their HIV status compared with people elsewhere in the world. More than 1.1 people in the U.S. live with HIV infection but about 84% of them know they have the virus, according to the Centers for Disease Control and Prevention.

All of the countries surveyed by the South African AIDS Trust provide citizens who have HIV with antiretroviral drugs that suppress the HIV virus and halt progression of the disease.

Among countries surveyed, the U.S. is the only one that has a home HIV test in the market. The Food and Drug Administration approved the kit, which is manufactured by OraSure Technologies, in 2012. Though the U.K. also has endorsed self-testing for HIV a test that satisfies the European Union’s standards for medical devices has yet to appear on shelves.

According to the report, South Africa, Malawi, Mozambique, Zimbabwe and Zambia all would permit device makers to market home tests, although South Africa currently prohibits pharmacies from selling them. (Presumably the test could be sold over-the-counter.) By contrast, Botswana and Tanzania require that HIV tests be supervised by a trained professional.

Protections for privacy vary by jurisdiction as well, the report finds. Though France and Mozambique shield test results completely, most countries permit disclosure of test results pursuant to a court order or to guardians or partners, as well as in situations where a person is charged with a sexual offense or a disclosure is necessary for purposes of medical treatment.

Constitutional privacy protections exist in South Africa, Malawi, Mozambique, Zimbabwe, while Mozambique, Botswana and Tanzania all have laws that protect HIV tests results specifically. The U.K. and France adhere to privacy protections enshrined in the European Convention of Human Rights. In America, rules governing the confidentiality of HIV tests vary by state.

Depending on the jurisdiction, people who test positively for HIV may have a legal duty to disclose such information to sexual partners and insurers. Though none of the countries requires an employee to disclose his or her HIV status to an employer generally, the U.S. and U.K. require disclosure instances in which an employee’s HIV status ties directly to the job.

All of the countries surveyed offer counseling in connection with testing for HIV. For example, Tanzania requires counseling before and after testing for anyone who receives a test in a state-sponsored testing center. In France, counselors must discuss the limits in reliability of so-called rapid tests. Counseling that follows tests tends to give guidance on such topics as notifying partners, connecting with care and maintaining a healthy lifestyle, depending on the test result.

“HIV self-testing is not a magic bullet,” adds Gunthorp. “In combination with other innovative thinking, however, it may hold the key to increasing reach of testing, opening new options for hard to reach communities, making life easier for semi-discordant couples, and supporting both prevention and treatment.”

The report also examines laws that govern the liability of manufacturers for harm to consumers from devices themselves or from failure of a test to diagnose someone correctly.