Sessional Paper No. 04 of 2012 on National Pharmaceutical Policy

Abstract

Kenya adopted the first National Drug Policy (KNDP) in 1994, concurrently with the Health Policy Framework (KHPF), to guide much- needed reform on pharmaceuticals. However implementation of the KNDP was severely hampered by subsequent lack of the requisite legal, administrative and financial support. Over the years, the urgency to reform the sector steadily increased, as documented in extensive sector reviews and assessments.

The process of developing this pharmaceutical policy started in 2006, informed by the existing evidence and guided by global technical norms; and was characterized by extensive stakeholder consultations and consensus building at multiple levels. The draft policy was adopted by national stakeholders in August 2007, and subsequently, in response to the renewed momentum of political and constitutional reforms in the country, it was further reviewed and adopted in April 2009. Subsequently, this Sessional Paper was developed and aligned to the new Constitution; and approved for presentation to Parliament at the Cabinet meeting held on 19th January 2012.

The scope of the Policy encompasses medicines and other health products and technologies – for human and veterinary use - whose development, production, sale and distribution are the mainstay of the pharmaceutical and allied sectors. It provides for the legal and institutional reforms necessary to radically improve the performance of the pharmaceutical sector in Kenya, in particular to enhance governance of pharmaceuticals across sector, regional and international arenas; restructure national institutions for the procurement, supply, regulation and quality control of medicines and other health products; develop adequate human resources for the diverse needs and functions, and enhance partnerships and collaboration aimed at universal access to Essential Health Products and Technologies.