Breaking Down the Barriers to Anti-Retroviral Therapy Programs

Medicins Sans Frontiers

Dr Mary Moran (MSF-Australia) acknowledged that the obstacles to ARV access are the high ARV price, poorly adapted programs and poor infrastructure in the resource poor settings (RSP). The discussion then turned to TRIPS (trade related intellectual property rights), which dictates that name brand drugs must be used and that generic drugs can't be produced, imported, or prescribed for 20 years. All countries that are in the WTO, must sign TRIPS, and this will be enforced in 2005/2006. There is a vaguely worded health safeguard to allow RPS countries get around TRIPs compliance (if they need to) by parallel importing and compulsory licensing. The patent holder still gets a royalty. However countries like the USA and Switzerland have retaliated against countries that have tried to implement these safeguards. The European Union has chosen not to do this. Generic branding has lead to large price reductions in ARVs but only for drugs in the spotlight. The price reductions by PHARMA Pharmaceuticals have been to lead to greater than 90 percent price drops, but have many restrictions and conditions attached which limits their availability and use.

Dr Greg Dore (Australia NCHECR) suggested that better infrastructure is needed in the RPS and recommends that all countries only use triple ARV therapy as the standard of care. He emphasised that research should not be done on substandard of care, such as with dual ARV Therapy. Research is needed into simpler regimens - given once daily, STI, when to start and timing of TB/ARV among others. ART resistance is not a problem in the RLS as less than one percent of people are on Therapy in the RLS. ART toxicity is a large spectrum problem and will be different due to underlying illnesses. There will be more immune reconstitution illness as patients are starting ARV with lower CD4 counts. Monitoring of clinical course and labs are critical. Programs should be evaluated with epidemiological bias.

Dr Stephano Vella (IAS/Italy) began by saying that price issues must be addressed but emphasised that Pharma must be involved. Dr Vella is running a large trial testing for STI in Italy with 600 patients. Dr Wai Lin Oo (MSF-Thailand) described his program in the Surin province of Thailand. He outlined the current situation such as the HIV prevalence of 1.4 percent in pregnant women in Surin. In Dec 2000 they started large scale ARV program, where they use HAART have CD4 counts but no viral load. They spend USD 140,000 per year on therapy or about USD 220 per month, per patient. They start ARV if CD4 counts are less than 250 cells or a child if immune category two or three. They now receive an 80 percent price reduction from PHRAMA Pharmaceuticals or used GPO generic drugs. Their doctors follow routine labs, PE and QOL (yearly).