This video lecture by Christoph Spennemann, Legal Expert at UNCTAD's Intellectual Property Unit, discusses local pharmaceutical production in East African countries, in particular Ethiopia, Kenya and Uganda. It shows the need for policy coherence in diverse areas such as drug regulation, procurement, trade, and intellectual property (IP) rights.
The past few years have shown a number of important and encouraging developments in the pharmaceutical sector in East African countries. The inauguration of the first regional bioequivalence center in Addis-Ababa/Ethiopia in November 2012 will facilitate the approval of local quality generic medicines. The 2012 East African Community (EAC) Medicines Registration Harmonization Project aims at harmonizing drug regulatory standards and pooled procurement of medicines on a regional scale, providing incentives for regional trade in quality generics.The 2013 EAC Regional Intellectual Property Policy, which is based on recommendations from UNCTAD, provides important guidance to EAC Partner States on the implementation of IP flexibilities that are essential to generic production.
On the other hand, legitimate concerns about counterfeit drugs have been used in countries like Kenya and Uganda to launch legislation that could potentially limit the legitimate activities of generic producers in the guise of fighting counterfeit drugs. The basic flaw with these approaches is that they do not target issues related to drug regulation but IP issues, which have no bearing whatsoever on the safety, efficacy and quality of medicines.