Kenya Health Bill 2012 Audit and Medicines

 The proposed Health Legislation 2012 seeks to:

  1. Consolidate all the laws relating to health in Kenya
  2. The Bill also seeks to provide for regulation of health care services and health care service providers
  3. Provide for the establishment of national regulatory institutions
  4. Consolidate the inter relationship between the national and county health institutions
  5. Establish a  coordinating agency of professionals within the health industry and
  6. Provide for attainment of the basic right to health

The consolidation of all health laws into one document is an important aspect and has the advantage of certainty and allows for ease of finding provisions relating to health in one Act if the Bill is passed.Nonetheless, this also poses a serious challenge given that issues relating to health are numerous and varied. An attempt to consolidate the law might lead to a very bulky Act which will be rigid and difficult to amend. A risk of omitting certain key provisions remains a very real risk in the endeavor to consolidate the law; leaving such aspects to be covered instead by regulations as opposed to being covered in the Act.

The Aids Law Project in collaboration with various other organizations working in the Health Sector has had several discussions to discuss the proposed Bill. As a result of the said meetings, the Organization has come up with a Memorandum that draws to the attention of the draftsman various provisions in the Bill that are problematic or that may pose a great challenge in the implementation of the same. These include the below:

Clause 57-Procurement and supply of Medicine
This is covered in part 10 of the Bill. Clause 57(4)-states that notwithstanding sub-section (3), counties shall have the right to procure these items incidentally from other sources where the Kenya Medical Supplies Agency is unable to supply them in good time or at a competitive price.

It is our considered view that it is easier and cheaper to monitor and evaluate one procurement agency. Notwithstanding the spirit of the Bill in appreciating devolution, we would much rather that life saving medication such as those used in the treatment of TB, HIV & AIDS, Cancer and Malaria remain centralized at National level while other drugs can be procured at county level. This will ensure that the qualities of medicines available especially to combat the above maladies are standardized.

Clause 23-Kenya Health Service Authority
Part 4 of the Bill makes provisions for the creation of a Kenya Health Service Authority. Clause 23 proposes that the authority shall perform the advisory functions to the national and county governments on issues such as formulation and implementation of necessary policies and measures; development of health regulations, health research, provisions of health care, arbitration in disputes involving institutions within the health sector, human resources among others. The organizational structure of the authority is intergovernmental yet the functions are surprisingly already dominated within the national government. While we appreciate the role the Authority will play, we advocate for the composition of the Authority to comprise of independent experts who have no vested interest whatsoever that may hinder the execution of their duties.

Clause 63(1)-Traditional and Complementary Medicine
Part 13 of the Bill makes provisions on traditional and complementary medicine in Kenya. This is an attempt to recognize the value of such medicine and how they can play a role in the wider medical scheme. As much as we are elated that this is a first attempt by government to regulate this sector, we deem it fit that Kenya should come up with a comprehensive separate legislation on traditional and complementary medicine as has been demonstrated to be quite effective in countries such as South Africa and Zimbabwe to effectively regulate the sector.
The power of the National Minister for Health to identify and document issues appertaining to traditional medicine is an extremely weak provision that needs to be beefed up by the formation of a fully fledged authority or regulatory agency.

Clause 102-Regulations and Access to Medicine
The clause empowers the cabinet secretary to make regulations generally for the better carrying out of the proposed law. The clause needs to be strengthened to allow the cabinet secretary to have powers to issue compulsory licenses and/or grant them powers to allow for parallel importation of medicine. In the event that this is not agreeable, we further recommended that the cabinet minister for health be allowed to initiate the process of compulsory licensing with the cabinet minister for trade.

Intellectual Property Issues
The Bill fails to make any provision on generic medicine. We recommend that the Bill should not leave such vital provision to be dealt with by other statues. The same should be addressed in the proposed law.

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  2. The bill should also look at the pharmacy and poisons board to stop its bias on registering the pharmacist.Registration should be done on merit and the body should stop acting as examining body but a regulating body.Thanks

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