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. 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

6. 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

7. 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

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 decision-making capacity covers a wide range of issues, requiring collaboration amongst experts from various fields. How will success be defined in the national disease and vector control strategies?

10. 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?

11. Decisions required National or regional questions Is it safe?Does it work?Will it work for us? Safety in relevant populations and conditions Implications for costsLocalization of data Phases of introduction Safety for humans Safety for Environment/ Biosafety (GM) Efficacy and performance Supply, financing, cost-effectiveness Relationship with other interventions 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.

12. 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

13. 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).

14. 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