“Generics, Get the Facts Straight” - subject of South Africa workshop

South Africa’s National Association of Pharmaceutical Manufacturers (NAPM) held a workshop for health care practitioners at the Johannesburg Country Club earlier this month, titled Generics, Get the Facts Straight.

The workshop discussed the manner in which generic medicines were developed and registered in South Africa. One of the arguments given by detractors of generic medicines is that these medicines are not tested in human beings. Professor Jacques Snyman, former head of the department of Clinical Pharmacology at the Steve Biko School of Medicine, described how bioequivalence studies are carried out, He referred to trials which showed overall differences between standards in branded medicines and generic equivalents to be in the region of 3.5%. He also indicated that when most originator companies made improved versions of older drugs, they did not repeat the clinical trials but used bioequivalence to show non-inferiority.

Ulundi Behrtel, an attorney qualified in medical law, spoke on the ethics of prescribing medicine. She pointed out that one of the main aspects of ethics is that a professional person had the responsibility of autonomy in making the best decision for the patient. Patients had a right to be informed and communication was one of the ethical duties of a health care professional. Other considerations such as affordability were secondary to the patient’s interest. She urged the audience to become familiar with the requirements of the HPCSA, the Nursing and Pharmacy Councils when it came to the members’ ethical duties.