Executive summary

The regulatory system for the manufacture and distribution of medicines has four key problem areas. These problems have remained unattended to for many years, an astonishing ten years in one case, because of neglect, carelessness or inflexibility on the part of the Health Ministry, and in some cases because the Minister’s political and personal objectives have dominated.

The delays in reaching resolution on these four matters have been inordinate:

Subject                                                    Time delay

Medicines Control Council restructuring    Ten years
Prescribing powers for nurses                   Four years
A workable system for retail pharmacists  Three years
Regulations for alternative medicines         Three years

These weaknesses have consequences for both the quality of medicines available to South Africans, and their ability to access medicines. It has also led the Minister of Health into a number of scandals, including over vitamin salesman Matthias Rath, and the backyard co-called miracle Aids cure, Ubhejane.