A Medical Device Daily

A new working paper published by the American Enterprise Institute-Brookings Joint Center (Washingon) says that import tariffs, duties and sales taxes on medicines, medical devices and the ingredients to produce pharmaceuticals block access to such products in the developing world.

Dr. Roger Bate of the American Enterprise Institute, co-author of the paper, said, “State-imposed barriers to access are exacerbating healthcare crises. International organizations, including the World Health Organization [Geneva, Switzerland], must use these findings as a wake-up call.”

The paper, titled “Taxed to Death: The Role That Taxes, Tariffs and Regulations Play in Denying Essential Medicines to Patients in the Developing World,” maintains that many developing countries’ governments impose “onerous” tariffs and taxes of between 30% and 60% on medicines, gauze, bandages and other medical needs.

The paper cited Brazil and India as two of the biggest offenders, maintaining average financial barriers on essential medicines of 38% and 61%, respectively.

Bate, who collaborated with Richard Tren, director of Africa Fighting Malaria (Sandton, South Africa), to write the paper, described it as “the most comprehensive examination of state-imposed barriers to essential medicines and devices to date.”

Tren added: “Countries with some of the worst health crises in the world have chosen to put these oppressive barriers in place for the sake of revenue generation, and worse protection of inefficient local industries.”

The study was released by the No Taxes on Drugs and Devices Initiative (NtDDi), an international coalition of health and development experts led by Bate. The group’s goal is to shed light on the practice of imposing burdensome taxes and tariffs on medicines and medical devices in developing nations worldwide.

“We are hoping NtDDi will raise awareness of governments hindering the treatment of infected populations by imposing excessive taxes,” Bate said. “Governments have it within their powers to remove these regressive and pernicious barriers immediately; this is a practice that must stop.”

AIDS care access in Africa

Guava Technologies (Hayward, California) and AHF Global Immunity, an international initiative of the AIDS Healthcare Foundation (Los Angeles), the largest specialized provider of HIV/AIDS medical care in the U.S., have unveiled a partnership they say is directed toward increasing access in resource-limited nations to AIDS diagnosis and treatment monitoring.

The partnership will initially focus on making Guava’s EasyCD4 system for direct, absolute CD4 T cell counts available at five sites in rural locations in Uganda and South Africa. Once the feasibility of using the Guava EasyCD4 system in these regions is demonstrated, AHF Global Immunity and Guava Technologies plan to cooperate in more broadly incorporating the system’s use in HIV/AIDS clinics around the world.

“Accurate monitoring of CD4+ T lymphocyte levels in HIV-infected individuals is a critical element for the use of anti-retroviral drugs, as it guides physicians in determining when to begin drug treatment and is a key measure of the effectiveness of that therapy,” said Henry Chang, executive director of AHF Global Immunity.

He said that with many resource-limited areas of the world now gaining access to more affordable anti-retroviral drugs, “accurate but simpler, more portable and less-costly methods of CD4+ testing are urgently needed. We are pleased to collaborate with Guava Technologies to bring such testing to several regions of Africa where the need is especially great.”

Jeff Harvey, vice president of customer solutions at Guava Technologies, added, “Until now, the cost of commercially available CD4 diagnostic testing for patient monitoring has remained very high, and access to affordable, accurate testing methods – especially in areas outside of major urban centers – very low. Multi-site clinical studies suggest that CD4 T cell enumeration conducted on the Guava EasyCD4 represents a good, significantly lower-cost alternative to approved ‘gold standard’ flow cytometry methods.”

He said his company’s assays offer comparable accuracy and reproducibility to flow cytometry-based tests, “but are much simpler and up to 20 times more affordable to use.” And, Harvey added, the Guava EasyCD4 system “offers the ability to provide a more comprehensive testing system, capable of running additional assays on its easy-to-use, benchtop instrument.”

He noted that Guava is in the process of optimizing a CD4 percent assay, as well as developing viral load assay and other clinical tests for use on the Guava EasyCD4 system.

The company said that a number of regulatory organizations around the world have indicated that new guidelines for HIV/AIDS diagnosis and monitoring will recommend the use of CD4 percent tests for monitoring pediatric HIV/AIDS patients.

Guava’s microcapillary cytometry technology enables the instrument to be “highly compact, portable and low maintenance,” the company said. It added that even novice users learn to use the EasyCD4 method in just a day or two. Testing requires only 10 microliters of whole blood per patient, making the method suitable for use in pediatric as well as adult patients.

The EasyCD4 system has not yet been cleared by the FDA for clinical laboratory use in the U.S., but the clearance process is underway.

Established in 1987, AHF is the largest specialized provider of HIV/AIDS medical care in the U.S. and under its Global Immunity program also operates free AIDS treatment clinics in Africa, Central America and Asia.

Distributor signed in Japan

Acacia Research (Newport Beach, California) said that its CombiMatrix (Mukilteo, Washington) group has entered into a non-exclusive distribution agreement with Inter Medical to distribute CombiMatrix’s CustomArray microarray products in Japan.

The new distributor will market, sell and service the CustomArray products in the Japanese marketplace. The CustomArray products are centered around a flexible and customizable DNA microarray.

Kazuo Umemura, president of Inter Medical, said, “This additional product offering will enable us to provide a complete solution when combined with our [other] product offerings for microarray users.”