NATIONAL CAPACITY FOR EVALUATION OF EVIDENCE AND DECISION-MAKING

Mauro Toledo MarrelliUniversidade de São Paulo

Rationale There are processes in most countries for the evaluation

of a new insecticide for use in public health or the trial of a new vaccine or drug for treatment of a vectored disease.

Release of sterile or otherwise modified mosquitoes for public health objectives is starting to be adapted from the existing context.

Area-wide control of the target pest population by releasing sterile insects has a long and successful history in agriculture and livestock sectors.

Intentional introductions of self-sustaining populations of insects for biological control also offer ideas for best practice.

Overall MosqGuide Module A module (Module 3) is in development, under auspices

of WHO/TDR funding, that addresses how a national decision regarding open field testing and use of GM mosquitoes for disease vector control could be reached.

■ The objective is to highlight best practice in the national decision process regarding evaluation and possible inclusion of a GM mosquito strategy for integrated disease control.

Scope of presentation This presentation focuses on national capacity

required for decision-making. Comments on these ideas are particularly

welcome from: regulators, health decision makers, vector control personnel, environmental protection agencies, and others charged with considering inclusion of GM

mosquitoes as part of their national control programme.

First, clarify motivation Public health objectives Economic development/land use (ie expand into a new area for agricultural production) Environmental concerns/reduced pesticide use Scientific advancement Tourism Biodiversity (where invasive spp)

National decision to use GM mosquitoes

Identify target beneficiaries Urban/rural Equally distributed among vulnerable

groups/targeted to particular communities Include stakeholders

Governmental departments and agencies Agree level of public participation

National decision to use GM mosquitoes

What is the entomological objective? Eradication, containment, suppression or

prevention? Preventative where disease is not occurring, where

population is suppressed, or where immigration of mosquitoes may take place

GM mosquitoes are likely to be part of an integrated approach

National decision to use GM mosquitoes

Taking decisions in contextImpact of current measures (including

externalities)

Efficacy of current measures

Strategic planning

Opportunistic actions

Local conditions

Consider GM mosquitoes in comparison with existing cost and impact estimates (part of an integrated approach)

National capacity

Risk assessment, management capacity What is required for an evaluation?

Relevant to local conditions? Types of people needed

Technical expertise in terms of scientists in country Is there national capacity in the government? If not, in universities or other centres? Is there a regional or international expertise or laboratory, etc

that may be needed to complete capacity? Is there a mechanism for accessing this?

Decisions requiredNational or

regional questions

Is it safe? Does it work? Will it work for us?Safety in relevant populations and

conditionsImplications for costs Localization of data

Phases of introduction

Safety for

humans

Safety for Environment

/Biosafety

(GM)

Efficacy and

performance

Supply, financing

, cost-effective

ness

Relationship with

other interven

tions

Ethics, perception and social issues

Resource and

capacity needs

Delivery logistics,

opportunity for

introduction

Laboratory

Confined trials

Pilot programme

Full scale

Maintenance

Categories of decisions are related to those discussed in the WHO Guidelines for preparing Guidelines.

Why consider GM mosquitoes?Some reasons to consider: Resistance to treatment or lack of access to health care

(malaria) No treatment available (dengue) No preventive treatment (vaccine) yet available (those

coming on line are only partially efficacious) Insecticide resistance diminishes existing controls Disease control and prevention and even vector control

often accessible to those with most resources, leaving vulnerable or remote communities unprotected

Vector control often relies on participation of entire communities – one breeding site is enough to infect area

Low population of vectors/lower incidence of disease leads to less participation in community campaigns

Uncertainty with any new innovation There is a lack of familiarity, knowledge

and experience of the outcomes (efficacy of the control measure) and the possible impacts or safety, particularly unexpected or non-target impacts.

Managing the unknown in a systematic and transparent way facilitates decisions when all data is not yet available (see Module 4 on data requirements).

Module 3 In draft. Ready for public consultation early

2011. Please submit your contact details if you

want to contribute to the review process.

www.mosqguide.org.uk