Statement of Intervention by Asia Pacific NGO Delegate on Strategic Use of ARVs

The Delegation welcomes the Report on the Strategic use of ARVs in the treatment and prevention of HIV. This is a subject central to the success in reaching two of the three zeros. In achieving these goals there are two important factors that need to be addressed.

Diagnostics

The 2009 WHO Guidelines recognised the role of VL testing in the identification of treatment failure. With many PLHIV across LDCs and many MICs having barely one CD4 count performed a year and no VL test, many people are on failing regimens without knowing. This leads to poor health outcomes, increased and avoidable morbidity and mortality, increased community viral load, and transmission of HIV including drug resistant virus.

To address this there must be two strategies.

Firstly an investment in the roll out of existing and, as they become available, new diagnostic technologies, training in their operation, and promotion within positive communities of the need for them to be insisting on regular testing, and to be informed of the results and what they mean.

Secondly, given the inadequacy of just identifying how many people are taking treatment in clarifying how effective treatment strategies are, there must be a move to measuring viral load suppression as a measure, instead of the number of those taking pills.

Availability of second and third line ARVs

Using better and more robust first line regimens (more cost effective even though more expensive) will reduce the risk of resistance and treatment failure, however a very substantial percentage of those on treatment will still develop resistance and need to move to second and third line regimens.

A major barrier to the access of second and third line regimens is costs. Even the wealthiest countries with significant epidemics, such as the United States andothers, will face challenges under the current pricing structure in meeting the financial burden of providing treatment to every person with HIV. It is hard to imagine therefore how middle income countries will be able to bear this burden given the cost of second and third line regimens, and indeed many of those countries inLatin America and Asia that were pioneers in making treatment available for all people who needed it will find it difficult to continue this provision as requirements for second and third line grow. In my own case after living with HIV for over thirty years I now need to be on a regime that costs $30,000 a year. If I had been living in a developing country rather than a developed country I would be dead. Survival should not be a matter of geographic luck. But right now it is!

A review of the history of access to affordable HIV treatment clearly shows that it was the entry of generic ARV competition that brought prices down to affordable levels rather than market forces, negotiations or any other factor. The strict criteria of patentability in India has been an important factor in ensuring India’s supply of ARVs to the developing world. It would also help if originator pharmaceutical manufacturers would play their part by reducing prices and sharing intellectualproperty to increase access not only in low income countries but also in middle income countries, and indeed across the globe. Voluntary Licences, whether direct or through the MPP, must cover all countries and not selectedones, as is currently the case.

The WTO recognised that the patent regime on pharmaceuticals was a threat to access to essential medicines in developing countries, and reaffirmed in the Doha declaration the rights of countries to use TRIPS flexibilities as a mechanism to address this problem.However the practicability of implementing TRIPS flexibilities has been shown to be difficult and cumbersome. The use of TRIPS flexibilities is further compromised by TRIPS+ clauses in existing free trade agreements and those under negotiation, often as a result of heavy lobbying by pharma companies.These TRIPS+ requirements go way beyond the requirements of the WTO and are simply a way of further protecting the already very large profits of originator pharmaceutical companies. The current TRIPS arrangement is simply not delivering on the Doha Declaration.

The Delegation calls for renewed commitments to ensure that essential medicines and diagnostics are accessible to all countries. Clearly a different paradigm is required for delivering affordable medicines, not just for HIV but for HCV, TB, HBV and all NCDs, Until a mechanism for delivering affordable essential medicines is agreed, we call for an immediate moratorium on TRIPS, as recommended by the Global Commission on HIV and the Law.

This is a reality check. People are still dying and every day there are new HIV infections for lack of access to effective treatment. We have the science, we have the medications, We just lack the will to make them available to everyone.