I thought I would open my first posting by updating something I published a while back, in my own blog, on one of the less obvious problems of being a developing country scientist.
The obvious things? Oh, not enough funding; no local agents for expensive capital equipment; long and sometimes erratic supply chains; higher prices for commonplace lab supplies – all well known, and something we live with every day and have learned to deal with.
The less obvious? Try bumping up against an orchestrated policy of not allowing developing countries to order custom-made genes that appear on what seems to be an ever-growing list of proscribed agents – or dealing with journals that ask all sorts of alarming questions about the bug you are attempting to publish something on.
Around two years ago I was moved to write a piece on my teaching blog, ViroBlogy, about the inequity that had suddenly developed in the synthetic DNA arena. This had followed the publication of two articles in the Nature stable; this one here by Erika Check Hayden, and one here by Ali Noury and Christopher Chyba. Both articles had made the apparently quite reasonable point that:
“the way that the industry screens orders for hazardous toxins and genes, such as pieces of deadly viruses and bacteria…could be crucial for global biosecurity.”
At the time, I wrote:
Yes. Well. They would say that, wouldn’t they?? “They” being anyone in the developed world who has a paranoid fantasy about bearded extremists in caves (or crew-cut extremists in leafy suburbs) gleefully unwrapping their couriered DNA and brewing up a nice little necrotising poxvirus, or an airborne Ebola, or possibly an H5N1 variant that spreads human-to-human better than the present versions.
I wrote the following comment to the Check article, published online:
While “all right-thinking people” – for which, read “those easily scared by the unrealistic prospect of mail-order killer bugs” may agree that some kind of limitations are required on what synthetic DNA is sent out, and to whom…there is a baby being thrown out with the bathwater here.
My laboratory has just, despite many previously successful orders from the same company, been denied permission (or told to obtain clearance from the relevant government, which amounts to the same thing) to have a coat protein gene synthesised for a bluetongue virus (BTV) strain now found all over western Europe. Because, apparently, BTV is on the Australia Group prohibited list of biological agents – and South Africa is not a signatory to this group, which started out for arms control but has apparently ramified somewhat.
….
The ways of limiting spread of genes that are being proposed are first, unnecessary; second – discriminatory in the extreme.
And may just provide a good deal of business for firms operating in developing countries who otherwise would have been ignored because of quality issues. Imagine that: a lab in Pakistan, or South Africa, or Indonesia, using home-made genes to make a vaccine.
Because that is a LOT more likely than using them to make a pathogen.
So DO let’s keep things in perspective, shall we?? And let reputable labs doing reputable work order the materials they need to work with.
And what would I say now, two years later? Pretty much the same thing, sadly. Despite contact with one of the companies named in Check’s article, during which they tried to reassure me that “reputable laboratories” would not be much inconvenienced, the policy remains a large, blunt object with very little flexibility. It also remains discriminatory. Sadly, however, our science in the developing world is not important enough to force it to change.
There is hope, however: a year or more ago, George Church was quoted as saying that the cost of DNA synthesis was falling as quickly as DNA sequencing – at around a factor of 10 a year. This means that the technology will probably outstrip policy pretty soon, and the genie will be well and truly out of the bottle – and in the developing world. Making DNA for us poor people, to do things like make vaccines that affect developing countries only.
Bring it on…!
Thanks for this relevant and interesting ethical problem. I am wondering whether you can comment upon another type of barrier that can block the production and commercial introduction of generic medicines or crops (or the use of formerly patent protected traits in crops) by poor countries or small companies. I am referring to the ownerships regulations with respect to biosafety dossiers concerning patented traits. These ownerships regulations are not limited to the restricted period of patent rights concerning the same traits. In fact responsibility regulations regarding biosafety dossiers do not have any time limit and this can have a blocking effect in further innovatory activities, in particular for poor countries and small companies. So it is not only that the normal provisions of the Cartagena Protocol on Biosafety can restrict, as Andrew Bennett director of the Syngenta Foundation for Sustainable Agriculture argues: “There is a growing constraint arising from the provisions of the Cartagena Protocol on Biosafety, which add stewardship responsibilities and liability and risk considerations that the technology ‘giver’ must take into account when entering into a partnership or granting licenses,” (https://www.ifpri.org/blog/can-public-and-private-sectors-work-together-poor?print). Bennett is right that the cost of developing biosafety dossiers can be huge. However, there is more, because of the lack of a time limit and the duty to make public the biosafety dossiers, companies even can destroy the dossiers after the patent regarding the patented trait has been expired. The strict stewardship regulations regarding biosafety dossiers without time limit can in my view have monopolizing effects. Can that indeed be the case?
@MK I’m not 100% sure about all your questions but I’ll try and shed some light on the issue.
1) 1) Yes, it is expensive to develop a comprehensive regulatory dossier and, yes, it has become another tool through which a particular company could get a competitive advantage. But… all but what is considered to be confidential business information (CBI) is publicly available in South Africa (SA), so the dossier can’t be “destroyed”. Also, the regulatory “unit” is the GM event, so any subsequent use of the event (under licence or potentially later, off patent) by other companies will fall under the original safety assessment/”dossier”, so “generic GM companies” theoretically won’t have to develop a complete new dossier. Generic medicine regulations are a good comparator but we just don’t have the systems in place for GM products yet. Finally, in my opinion even some of what was originally considered to be CBI could be made public once the trait is off patent, but it’s too early to know if this could be feasible/allowed – policies still have to be developed.
2) 2) Liability is a different story… SA doesn’t have an official “off patent policy” in place yet but I would guess the sentiment would be that the originator of the trade will remain liable… which of course opens a can of worms like all liability issues do…
3) 3) I agree with your last statement re the possible negative impacts of excessive stewardship and liability policies. Unfortunately in many developing countries GM technology is currently seen as an “outside” technology from which it should “protect” itself (including economically) and many regulatory systems are developed on this premise, making the local development of relevant technologies almost impossible…
To our considerable satisfaction, that which I predicted has come to pass: it is now possible to get anything we want synthesised and sent to us, no questions asked. For genes as diverse as those encoding human papillomavirus L1 and L2 and E7 proteins; African horsesickness VPs; beak and feather disease virus coat proteins; HIV Env proteins, and several more.
I stress we are using these for making candidate vaccines and reagents; however, if we were in a developed country, we would almost certainly not have to worry.
And some Chinese and Korean companies are getting a lot of business B-)
Topic now further covered here: https://rybicki.wordpress.com/2015/12/10/online-recipes-for-bird-flu-virus-add-to-bioterrorism-threat-no-no-they-dont/