She told Parliaments health committee that the council was operating in much the same way as it did when it was established in 1965, yet faced a rising tide of applications to register new medicines and clinical trials. The result was a steadily mounting backlog, Hela said. Applications received by the council from pharmaceutical companies to register new drugs almost doubled in the past five years, rising from 552 in 2002 to 966 last year, she said. Fast-track applications for high-priority drugs, such as those for treating tuberculosis, HIV or bird flu, rose more than fourfold, from just 49 in 2002 to 222 last year.
To illustrate the backlog, she described how the councils capacity to approve fast-track applications had declined. In 2003, about 28% of applications were not dealt with, and by last year the figure had risen to 98%. The council was far less efficient than its international counterparts, she said. It took two to three years to register new clinical entities, 18-24 months to register generic medicines, 12-16 weeks to approve clinical trials and up to 15 months to approve fast-track applications, she said.
Mature regulatory authorities such as the US Food and Drug Administration took 12 months to scrutinise new chemical entities, three months to approve generics, four to six weeks to approve clinical trials and nine months to consider fast-track applications. Hela told MP s that delays were due to several factors, including the council lacking the means to employ its own full-time staff to assess applications. Instead, the work was contracted to part-time experts, most of whom could not scrutinise applications quickly as they had full-time posts at local universities.
These experts met to discuss pending applications every eight weeks. Their recommendations were then forwarded to the council, which was obliged to meet only six times a year, Hela said. Its a rather inefficient way of operating, she said. Hela said that the new agency envisaged by the Medicines and Related Substances Amendment Bill, now before Parliament, should address the backlog. The bill proposes replacing the council with a new entity called the South African Health Products Regulatory Authority, with the resources to employ full-time staff on the lines of South African Revenue Service.