NATIONAL CAPACITY FOR EVALUATION OF EVIDENCE AND DECISION-MAKING

1. NATIONAL CAPACITY FOR EVALUATION OF EVIDENCE AND DECISION-MAKING Mauro Toledo Marrelli Universidade de São Paulo

2. 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.

3. 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.

4. 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.

5. National decision to use GM mosquitoes • 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)

6. 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

7. 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

8. Taking decisions in context • Impact 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)

9. 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?

10. Decisions required

11. 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

12. 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).

13. 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