Cheaper AIDS drugs coming

THE number of life-prolonging HIV-AIDS drugs on the Namibian market may increase by 75 per cent, giving patients more and cheaper options, the international AIDS conference was told at the end of last week.

Addressing the conference in Toronto, Canada, Dawn Pereko from Namibia told delegates that the growing demand for anti-retroviral drugs (ARVs) was met by a huge backlog of registration applications for medicines awaiting marketing approval, caused by inefficient procedures and a lack of skilled staff. In September 2004, about 1 000 applications were pending.At that time, 49 ARVs were on the market, but the backlog prevented access to valuable fixed-dose combinations and paediatric products.Namibia’s pharmaceutical registration process is administered by the Medicines Control Council (MCC).However, since the Rational Pharmaceutical Management (RPM) Plus Programme intervention began in April 2005, 1 392 applications for new medicines have been evaluated.Of those, 14 ARVs have been reviewed and approved and 24 generic ARVs are awaiting approval.That may increase the number of ARVs on the market by 75 per cent.Pereko told the conference that the 14 approvals included much-needed paediatric dosage forms and fixed-dose combinations that could help increase adherence, as the addition of generic products helps decrease prices.Pereko addressed the conference on the topic ‘Improving the availability of ARVs in Namibia by using policy change to streamline the drug registration process’.She said the Rational Pharmaceutical Management (RPM) Plus Programme worked with the Namibian Government on interventions to streamline the registration process.She said the key was a policy change allowing the MCC to give priority to ARVs for registration.The new policy permits the MCC to accept certain quality requirements that have already been approved by recognised authorities.She said barriers to accessing ARVs could come at different levels in the pharmaceutical system.”In Namibia, an administrative backlog was keeping ARVs and other medicines off the market.A combination of policy and managerial interventions streamlined the drug registration process and made way for vital additions to HIV-AIDS treatment,” Pereko said.She called on countries to monitor and evaluate all aspects their pharmaceutical policies and procedures to find “hidden” obstacles to access.As the conference ended on Friday, scientists, clinicians, people living with HIV-AIDS and others called for care and treatment programmes to be scaled up.In September 2004, about 1 000 applications were pending.At that time, 49 ARVs were on the market, but the backlog prevented access to valuable fixed-dose combinations and paediatric products.Namibia’s pharmaceutical registration process is administered by the Medicines Control Council (MCC).However, since the Rational Pharmaceutical Management (RPM) Plus Programme intervention began in April 2005, 1 392 applications for new medicines have been evaluated.Of those, 14 ARVs have been reviewed and approved and 24 generic ARVs are awaiting approval.That may increase the number of ARVs on the market by 75 per cent.Pereko told the conference that the 14 approvals included much-needed paediatric dosage forms and fixed-dose combinations that could help increase adherence, as the addition of generic products helps decrease prices.Pereko addressed the conference on the topic ‘Improving the availability of ARVs in Namibia by using policy change to streamline the drug registration process’.She said the Rational Pharmaceutical Management (RPM) Plus Programme worked with the Namibian Government on interventions to streamline the registration process.She said the key was a policy change allowing the MCC to give priority to ARVs for registration.The new policy permits the MCC to accept certain quality requirements that have already been approved by recognised authorities.She said barriers to accessing ARVs could come at different levels in the pharmaceutical system.”In Namibia, an administrative backlog was keeping ARVs and other medicines off the market.A combination of policy and managerial interventions streamlined the drug registration process and made way for vital additions to HIV-AIDS treatment,” Pereko said.She called on countries to monitor and evaluate all aspects their pharmaceutical policies and procedures to find “hidden” obstacles to access.As the conference ended on Friday, scientists, clinicians, people living with HIV-AIDS and others called for care and treatment programmes to be scaled up.