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a standardized protocol and diagnostic tests accelerate the development and distribution of drugs and provide faster treatment

On July 13, the Joint United Nations Programme on HIV / AIDS (UNAIDS) has announced its ambition to provide antiretroviral therapy (ART) to 15 million people infected with HIV / AIDS to 2015 (compared to a total of 9.7 million in 2012). The new framework has been published in the back of the new guidelines recommend that patients begin treatment before the WHO.

More specifically, the guidelines have raised the CD4 threshold where art should be prescribed blood of 350 cells/mm3 and 500 cells/mm3. CD4 cells are white blood cells attacked by HIV, his account gives an indication of the state of the immune system of an individual and the progression of the disease

CD4 are essential to achieve the objective of UNAIDS, particularly in Africa, where HIV prevalence is high, but the test is not widely available in countries with poor health .

In Malawi, for example, only 10% of health centers offer CD4. The situation is very similar to other parts of the continent and millions of people are waiting for their CD4 count.

The introduction of point of care testing decentralized, which can be used in environments with limited resources for health care workers in low-skilled, could significantly increase coverage. In Mozambique, the introduction of point of care CD4 in primary care clinics has doubled the number of patients receiving antiretroviral therapy and halved the time required for patients to begin treatment.

The problem is that this kind of point of care diagnostics are kind of blind spot when it comes to regulation. "We have a very good framework for drug regulation, but there is a gap in the diagnosis," says Jani Ilesh, director of the National Institute of Sa?de (National Health Service) in Mozambique. "There is a diagnostic log, similar to the drugs, but not really a good regulatory function."

Instead, the government decided to have a diagnosis on an ad hoc basis, which leaves the sector vulnerable to lobbying and poor quality products, says Jani.

The reason for this regulatory oversight is that the point of care diagnostics is a relatively recent phenomenon, says Brenda Moon, coordinator of market dynamics with UNITAID funding for global health. Originally developed and approved in developed countries and developing countries to take. "Now there's a lot of innovation in the diagnosis specifically designed for use in the poorest countries - products that are portable, point of care, and can be used by health workers in the community," says the Moon. "The bad news is that we have a complete system to ensure the quality of these products." attempt to fill this gap, UNITAID has decided to give $ 5 million to the London School of Hygiene and Tropical Medicine to create a harmonized regulatory framework for diagnosis in Africa.

therefore contribute to the establishment of the Working Group for the Harmonization Pan (PAHWP), an organization that will create a harmonized regulatory framework among its members. Currently, there are eight Member States: the East African Community (Kenya, Tanzania, Uganda, Rwanda, Burundi), Ethiopia, Nigeria and South Africa. PAHWP held its first meeting on July 24 and a number of other Community Development in West Africa and South Africa have already expressed their interest in joining. Industry representatives were also invited to participate in discussions.
Asia

has its own regulatory body, the Working Group on Harmonization of Asia for nearly two decades, so PAHWP takes stock of the experience of its Asian counterpart. Much of the work is in the process of rationalization and standardization such as recording, post-marketing monitoring product quality audits, etc., but the heart of the negotiations is the issue of clinical trials.

"Because of the lack of regulation, even small countries insist on national approved devices' data, says Peel." The first test point service that was marketed for CD4 count had to do 60 tests, is completely untenable, "said
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