Harmonized clinical governance regulatory framework for Africa

-Solomon Sackitey

We need a harmonized clinical governance regulatory framework for Africa. Why or why not? And whose responsibility should it be?

Should African governments and private institutions fold their arms and rely on the major pharmaceutical companies in the industrialized world to develop and implement such frameworks for them? My opinion is a “big no, no”.

Local African community leaders, the national Regulatory Agencies and students in the universities, colleges and nursing schools must form partnerships with foreign national and international healthcare institutions to have this accomplished.

Recall these dreaded historical events that we no longer want anywhere on the planet?:

1.  In a more recent Nigeria v. Pfizer case, it was alleged that Global Pharmaceuticals giant, Pfizer, conducted Trovan vaccine tests on 200 children in Kano, Nigeria, without obtaining informed consent from their parents. Eleven children died in these tests, it was alleged.

o Retrieved from Pfizer settles remaining Nigeria, U.S. Trovan suits.

o Retrieved from Nigeria: Pfizer VS Kano Trovan Victims – U.S.$75 Million Settlement Exposed

2. Tuskegee Syphilis Study (1932-1972)  involving 600 African-American men in Alabama in which case 400 of them were infected with syphilis and they were not made aware of the fact that their wives and children could be infected.

o See also Research at UNLV.edu 

3. During World War II, German physicians conducted medical experiments on thousands of concentration camp prisoners without their consent.

o Also  from Research at UNLV.edu 

4. Thalidomide drug experimentation of the 1950s, where about 12,000 babies had birth defects and deformities during the experimental drug’s use in Europe and in the US. Most of the women were not aware of the fact that this drug was experimental.

o Retrieved from UNLV

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