Health-related biotechnology in Africa: managing the legislative and regulatory issues.

The challenges that most African countries face in an attempt to join the ongoing quest for the development and transfer of the products derived from health biotechnology are threefold: High research costs, inadequate regulatory capacity and unfavourable intellectual property arrangements. It is argued in this paper that these challenges are representative of the legislative and regulatory issues that require proper management in order to enable African countries to focus on the key research areas that are related to the burden of diseases that are prevalent in the region and to harness the products of such research for the benefit of the region. This paper discusses the challenges involved in managing the legislative and regulatory issues in health biotechnology and proposes specific ideas on the way forward for Africa. The methodology used is a review of the manner in which three African countries, Cameroon, Kenya and Nigeria, have encountered and dealt with such regulatory challenges. The review is carried out from policy and legal analysis perspectives.