The editorial below was written by Camilla Beech, Regulatory Affairs Manager, Oxitec Ltd, UK, partially as a response to a recent editorial by Guy Reeves, on regulatory aspects of GM mosquitoes.
Having spent over 10 years developing novel genetic approaches to control insect pests, we’re acutely aware of the importance of proceeding with caution, of doing so in a transparent and open manner, and of engaging in the most effective way possible with the diverse communities who have an interest in the development and use of these new technologies.
Getting this right is essential: over 50m people currently suffer from Dengue fever each year; the incidence of the disease is growing, and it’s increasing in severity. As well as tackling this growing problem, the technology which has been developed also offers a solution to agricultural pests, as well the potential to tackle other mosquito-borne diseases, including malaria. Realising this enormous potential will rest upon public and political acceptance, so the right approach to public engagement is unquestionably of paramount importance. The key question then - for us, for the academic community, regulators and politicians – is what the right approach looks like, and how to manage it.
A successful programme of public engagement needs to cater for diverse audiences
Openness and transparency must be our watch-words. But to be effective, communication must be appropriate to the situation and the audience at hand; it must be practicable; and it must be timely. That transparency in the regulatory process is a laudable objective is hardly in doubt, but that ‘transparency’ necessarily constitutes an exhaustive reproduction of the evidence base regulators have assessed is more questionable.
It may instead be more useful to consider what is the aim of a successful programme of public engagement. Broadly, product developers, whether in the public or private sector, need to ensure that communities which have an interest in or which may be affected by a proposed intervention are aware of the proposal, understand the essential characteristics of the technology in question, and are well versed in the potential risks, and the potential benefits. To achieve that, developers need to reconcile the particular requirements of a diverse range of interests. Without attempting to be exhaustive, they might be listed as follows:
• Members of the public: in particular those of local communities likely to be directly affected, but also concerned members of the public from elsewhere
• The media: both local and international
Regulatory authorities are well versed, and indeed are accountable for, the decision-making process surrounding the approval of a new technology, and in assessing the diverse evidence base that must be assembled to facilitate this process. But this comprehensive assessment is likely to remain the domain of specialists: dogmatically reproducing and disseminating that assessment is neither necessary to a successful public engagement programme, nor the most effective means of approaching it.
Similarly, while peer reviewed publications should remain an important route through which information can be disseminated to the academic community, there are significant practical barriers to ensuring that information pertinent to the approval of a new technology is exhaustively reproduced through this route: foremost among these are the long time delays involved, and the disparity between what constitutes questions of interest for regulators or local communities affected by a new technology, and what is deemed of wider scientific import by the academic publishing industry.
Successful public engagement will therefore rest upon a much broader, more comprehensive approach. Ensuring that local communities are kept fully informed will always rely to some extent upon the approach taken by local government and/or regulators, and the measures which they deem to be appropriate. However, there is undoubtedly much that technology developers can do themselves to engage with communities. In Brazil, for example, Oxitec’s partner Moscamed Brasil has worked with local radio and T.V., organised community meetings and school programmes, as well as an extensive programme of one-to-one discussions with residents in the affected area. The overwhelmingly positive feedback received thus far from the programme is perhaps testament to the impact which proactive efforts by technology developers can have on the public engagement process.
Finally, open and willing engagement with both local and international media is likely to remain the litmus test for transparency. For this reason, we believe it is crucial that technology developers maintain an ‘open-door’ policy to media interests (at Oxitec, we have never turned down a radio, T.V. or press interview). It is undoubtedly the case, as Oxitec has found, that such openness will occasionally expose developers to negative coverage from both press and NGOs. But ultimately, that openness is likely to do more than any other measure to garner public trust and confidence.
Can companies be open?
Of course, none of these suggested measures will carry much weight if one starts from a position that commercial interests, or indeed any interest which favours a particular outcome, will necessarily preclude openness. There are two key considerations here:
In the first instance, the development of any new technology will almost inevitably involve commercial drivers. Furthermore, it is naive to think that, even in the absence of commercial motivations, the proponents of a given intervention – be they political or academic – will be entirely without bias regarding its successful implementation.
The second point is that, while a company may indeed have a profit motivation, this by no means precludes a drive to maximise public benefit from the technology they are developing. It is true that a business at the cutting edge of a new science will have some proprietary technology which it will not wish to share with potential competitors: businesses could not survive on any other basis, and without such protection, promising new technologies would languish in the absence of competitive businesses or investors willing to take them forward. But the need for commercial protection should not be seen as indistinguishable from a wider predisposition towards secrecy. Businesses like our own strive to realise public benefit from our work; it would be inconceivable to deliberately mislead the very people we aim to work with, or to keep from them important information regarding our products. Moreover, as Guy Reeves has noted, the future of a novel technology depends on widespread public and political acceptance; it makes perfect business sense for developers to take with utmost seriousness their duty to engage with and inform the public at every step.
This is a debate which could influence millions of lives currently affected by dangerous insect pests. Public and political acceptance is vital: the challenge for developers, academics and governments, is to establish the characteristics of successful public engagement programmes which are realistic, and achievable.