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Table 3 Policy development and implementation; decision-making process

From: Decision-making process for introduction of maternal vaccines in Kenya, 2017–2018

Sub-theme Quotes
Problem identification First you need, first we do an analysis, situation analysis, to identify whether there’s a need or if there’s a gap. Once we identify if there’s a gap for this policy, specific policy, we write to our permanent secretary... We make a request to start the process of developing a policy towards the either maternal or child health... Once we get that approval, we constitute a steering technical committee that understands very well on that area that will work on that mmmmmm policy document. And there will be steering meetings to inform and in those, there will be public participation, there’s partners’ participation. So for maternal policy I think, applies just like any other, any other policy, in the ministry or the division. (R05, national level)
Considerations for vaccine introduction We have epidemiological data which guides the ministry on the rationale behind introducing vaccines. We also have general directions globally from the World Health Organization of what is required. We also use authority bodies like the Pharmacy and Poisons Board where we get licensed vaccines into the country. We do all these in consultations with research institutes such as KEMRI polio lab and KEMRI measles lab. Collating this data helps us to tell the worth of a vaccine and its cost. (R01, national level)
We must also consider our capacity to deliver the vaccines. We have to determine the side effects of the vaccine as well. You understand that vaccines are just like any other drug with side effects. We have to establish that the benefits outdo side effects. We also take into consideration the population which is at risk. What is the magnitude of the burden of diseases in question? (R02, national level)
Well, of course involves both the division of disease surveillance and the division of vaccines at national level. I have not been engaged in the policy development process but the best of my knowledge at county level is we would look at disease prevalence, we would look at some of the conditions that are affecting our mothers, we would look at availability of vaccines that are effective globally, uh WHO …WHO approved and then look at possibly what is the cost of that disease …uh in terms of life, …so the Disability Adjusted Life Years (DALYs) …look at the cost of the vaccine and then do a cost effectiveness analysis. (R05, county level)
The need for a vaccine is driven by certain factors about diseases. For example, the prevalence of the diseases, ability to control the disease, is the vaccine available, is the vaccine desirable, safe and all other basic sciences about the vaccine. However, bottom line is that after doing baseline issues such as the need for a vaccine, the cost is always a factor. (R07, county level)
The first thing is it must be safe. Its pros must outdo its cons; what it protects from should be more than what it could cause us because vaccines also have their negative impacts…
It should also be able to do what we are saying it can do. Safety alone does not guarantee that it is effective…
Safety, effectiveness, accessibility and other factors along that line. (R06, national level)
Monopolized engagement of national level entities in vaccine policy recommendation When the government has an intention of rolling out a vaccine.
… they seek justification first to decide for or against rolling out a vaccine. We (KENITAG) therefore, adduce the evidence and submit it to the ministry by collating information and discussing it with the aim of unearthing the pros and cons. These will lead us into making recommendations based on scientific facts, our own studies and experiences. We collate information from all these sources and pass it to our client, ministry of health. They do not have to take our advice. (R07, national level)
KENITAG is comprised of experts in different fields. These include pediatricians, researchers and professors who look at the diseases and they are able to delve deeper. They find out more issues about the disease to create understanding that helps shape the direction of a vaccine policy. They also look at the justifications for introducing a vaccine or not. (R04, national level)
The final decision is at the discretion of the government since it considers several angles. On our part, we are guided by the scientific dimension of the vaccines. (R07, national level)
Since we are mostly at the county level, we pick the national policy and domesticate it at our level; we rarely come up with our own policy… We then call our stakeholders, pick the policy issues relevant to us from the national policy, and put in our own policy document. (R20, county level)
Complexity of decision-making process …before it (vaccine policy) reaches endorsement, there is a lot of technical deliberations and fact finding about the vaccine. As a unit, we (Unit of Vaccines and Immunizations) are mandated to take charge of that. I can therefore say that there is no policy which can be made without our involvement. We are the only program (National Immunization Program) with the authority to handle immunization issues in the country. (R08, national level)
It is the cabinet secretary of health who makes the final decision. He has his technical officers at the Division of Vaccines and Immunization (DVI) who advice the cabinet secretary (CS) who then pass that on the decisions. Even as they deliberate on that, there are financial implications which the CS must consider when tabling vaccination recommendation at the cabinet. There must be a round table where you explain the money to be allocated. (R07, county level)
Policy implementation process (systematic implementation) Once the policy has been drafted, tried and passed, then it is the ministry to cascade it down. Remember we now have a devolved system with forty-seven governments. The bigger role of the central government is policy-making then cascade it down to the devolved units to make it in to practice. (R03, national level)
The ministry makes policy documents to the people who will implement the policies. (R16, county level)
What I have seen is there is a launch, normally there would be a launch, an introductory launch. At county level we normally would get sensitized, invited to the launch get a sensitization package on the new policy, get introduced to it and then the national would actually roll it out to us then it would be our responsibility at the county to ensure that we have implemented that policy. So what would happen is we would have meetings with our sub-county teams, sub-county would have meetings with facilities introduce that then would see how to now roll it out to the community with the sensitization through our community health structures and through our health promotion officers and ensure that the information goes round but the implementation really falls on us at the county, how we do procurement, what we administer then would be at the county level. (R20, county level)
Policy evaluation We also support the counties with policy guidelines on immunization in soft and hard copies for their reference during practice. We also organize several trainings, so that we update new issues, discuss observed challenges and possible solutions. (R02, national level)
…as a country, and as a county, we have adopted the performance approach. So each person has their set targets, so if you don’t meet, your supervisor will ask you why haven’t you met your targets, you will explain. (R08, county level)