FACULTY OF LAW

Department of Private and Judicial Law

Dissertation presented and defended publicly for the award of the degree of Doctor of Law

By

Adolphe KUMBA SHINDANO

Graduate of advanced studies in law

Professor AMISI HERADY, Promoter

January – 2023

SUMMARY

Substandard and counterfeit medicines constitute a global scourge whose trafficking continues to grow, in all countries, particularly in the Democratic Republic of Congo, where multifaceted harm is caused to patients who cannot benefit from access to quality medicines for effective treatment.
In view of this phenomenon affecting public health, due in particular to the lack of transparency and appropriate accountability mechanisms in pharmaceutical governance, there are countless challenges to be addressed by both decision-makers and thinkers, the actions of the latter having to illuminate the path of the former.
It is therefore with this in mind that this doctoral study intervenes,
consisting of the quest for good pharmaceutical governance with regard to the need for compensation for damages caused by substandard and counterfeit pharmaceutical products under Congolese law. It recommends both preventive and restorative measures for adequate protection of the patient consumer.
It highlights the urgency of adopting strong, repeated and sustained communication on the risks posed by substandard and counterfeit medicines to the public.
Keywords: Protection, consumers, good pharmaceutical governance,
compensation, damages, substandard and counterfeit pharmaceutical products, Congolese law.

SUMMARY

Sub-standard and counerfeit drugs are a global scourge, the trafficking of which continues to grow, in the Democratic Republic of Congo. In the Congo, where multifaceted harm is caused to patient who cannot benefit from Access to quality drugs for effective treatment.
In view of this phenomenon affecting public health, due in particular to the
absence of transparency and appropriate mechanisms of accountability in pharmaceutical governance, there are countries challenges to ne met on the part of both decision-makers, the action of these to light the way for them.
It is also in this perspective, that the present doctoral study intervenes, consisting of the quest for good pharmaceutical governance, whith regard to the need for compensation for the damage caused by sub-standard or counterfeit pharmaceutical products in Congolese low. It recommended both preventive measures for adequate protection of the consumer patient.
It stresses the urgency of adopting strong, reparated and on going communication on the risks posed by sub-standard and countefeit medicines to the public. Keywords: Protection, consumers, good pharmaceutical governance, compensation, damages, sub-standard and countefeit pharmaceutical products, congolese law.