The Sunshine Project has recently learned of an initiative to develop a voluntary international biosafety standard for biological laboratories. The initiative will being with a meeting in Brussels in April.
The Sunshine Project supports international laboratory biosafety standards; but this particular initiative is very problematic. Our concerns include undermining of WHO, a "pay-to-play" process that requires 800 Euros to simply view the working documents, and undue private sector influence with potential conflicts of interest.
The initiative should be reconceptualized, opened to civil society, and conducted within the framework of the United Nations. A letter that we have sent today to the Chair and to the Canadian Minister of Health is below, along with a description of the initiative.
We hope that you will share this with interested organizations and persons and that we can together redirect this initiative into a more appropriate institutional framework and ensure that it is conducted with more transparent and genuinely participatory methods.
Mr. Stefan Wagener
Scientific Director
Office of Biosafety and Environment
Canadian Science Centre for Human and Animal Health
Public Health Agency of Canada
Winnipeg MB
Dear Mr. Wagener:
This letter in relation to Health Canada's planned role in the International Biosafety and Biosecurity Laboratory Standard Development Initiative (described below), to start this April in Brussels. We note that you are the presumptive Chair of the initiative, aided by a representative of AstraZeneca.
Let me begin by recalling that the Sunshine Project has publicly favored the development of international lab biosafety standards since 2002.(1) In collaboration with civil society partners from South and North, in that year we began to assess international processes that are potentially relevant, including the Convention on Biological Diversity and enforceable standards-settings bodies in the WTO framework, specifically, the IPPC and SPS agreements. We have also followed WHO's biosafety program, including participation in discussions at the World Health Assembly.
Although the Sunshine Project favors international lab biosafety standards, we have a number of serious reservations about the approach that Health Canada appears to be taking. Here are some of them:
First, prior to opening the initiative to discussion or holding any public consultation, you have determined that the standard will be prescriptive and voluntary. This is not, we believe, an approach that will result in an effective standard because it will be unenforceable and may be inadequately described.
Secondly, Health Canada should be reinforcing the role of WHO in these matters rather than undermining it. While you are taking WHO's Laboratory Biosafety manual as a reference point, it does not appear that your process is in any way under the UN's umbrella. We firmly believe that efforts to develop international biosafety standards should take place within the UN system, and count on the supervision and participation of UN bodies including the World Health Organization, Convention on Biological Diversity, and the Food and Agriculture Organization.
Thirdly, you have also apparently already decided on a single standard. For many reasons, we believe that multiple enforceable standards are probably appropriate. Given the uneven international distribution of infectious disease burdens (and endemism), and the large disparities of health laboratory infrastructure between countries, there is little reason to believe that a "one size fits all" approach will work. This will undermine potential adoption and adherence to the standard.
Fourthly, your process appears to be effectively closed to civil society. While it has been announced within the biosafety profession, you have made no effort that we are aware of to inform other sectors, even at this late stage in your process. You have also required a payment of 800 Euros in order to participate. This exorbitant fee is well beyond the means of many civil society organizations and, we suspect, interested individuals.
Fifthly, we have many concerns about undue influence of the private sector and conflicts of interest in the initiative. We note that you propose a certification scheme for laboratories that would presumably operate on a commercial basis. We are very concerned about potential improprieties involving participants in the process potentially exerting influence on the standard in ways intended to financially benefit for-profit firms. We note that a primary partner is a private Norwegian firm and that your Vice-President will be from AstraZeneca. We also believe that the potential commercial interests of these and Winnipeg's International Centre for Infectious Diseases, or its employees and leaders in that and other non-governmental initiatives, should be clarified.
These are some of our concerns.
International biosafety standards are a good idea; but the International Biosafety and Biosecurity Laboratory Standard Development Initiative is the wrong way to go about addressing the issues.
We submit to the leadership of Health Canada that the Ministry should step back and reassess both its participation in this initiative and if it should move forward at all. The Sunshine Project and, we believe, other civil society organizations would welcome cooperating with Health Canada in the development of international biosafety standards under a more appropriate institutional framework and by more transparent and genuinely participatory methods.
Sincerely,
Edward Hammond
Director
The Sunshine Project
PO Box 41987
Austin TX 78704 USA
+1 512 494 0545
http://www.sunshine-project.org
cc: The Honourable Tony Clement, Minister of Health Partner organizations
(1) I understand the term "biosafety" to encompass the unfortunately named concept of "biosecurity", which is not internationally accepted and, we believe, is more properly understood as a security-subset of biosafety
issues. I also use the term biosafety here to refer to laboratory biosafety, and not its arguably better-known usage in reference to safety of genetically-modified organisms outside of containment.
The Sunshine Project http://www.sunshine-project.org
Please also see:
Convention on Biological Diversity http://www.biodiv.org/default.shtml
Food and Agricultore Organization of the United Nations http://www.fao.org
World Health Organization http://www.who.int
International Biosafety and Biosecurity
Laboratory Standard Development Initiative
http://www.biorisk.eu
The Sunshine Project supports international laboratory biosafety standards; but this particular initiative is very problematic. Our concerns include undermining of WHO, a "pay-to-play" process that requires 800 Euros to simply view the working documents, and undue private sector influence with potential conflicts of interest.
The initiative should be reconceptualized, opened to civil society, and conducted within the framework of the United Nations. A letter that we have sent today to the Chair and to the Canadian Minister of Health is below, along with a description of the initiative.
We hope that you will share this with interested organizations and persons and that we can together redirect this initiative into a more appropriate institutional framework and ensure that it is conducted with more transparent and genuinely participatory methods.
Mr. Stefan Wagener
Scientific Director
Office of Biosafety and Environment
Canadian Science Centre for Human and Animal Health
Public Health Agency of Canada
Winnipeg MB
Dear Mr. Wagener:
This letter in relation to Health Canada's planned role in the International Biosafety and Biosecurity Laboratory Standard Development Initiative (described below), to start this April in Brussels. We note that you are the presumptive Chair of the initiative, aided by a representative of AstraZeneca.
Let me begin by recalling that the Sunshine Project has publicly favored the development of international lab biosafety standards since 2002.(1) In collaboration with civil society partners from South and North, in that year we began to assess international processes that are potentially relevant, including the Convention on Biological Diversity and enforceable standards-settings bodies in the WTO framework, specifically, the IPPC and SPS agreements. We have also followed WHO's biosafety program, including participation in discussions at the World Health Assembly.
Although the Sunshine Project favors international lab biosafety standards, we have a number of serious reservations about the approach that Health Canada appears to be taking. Here are some of them:
First, prior to opening the initiative to discussion or holding any public consultation, you have determined that the standard will be prescriptive and voluntary. This is not, we believe, an approach that will result in an effective standard because it will be unenforceable and may be inadequately described.
Secondly, Health Canada should be reinforcing the role of WHO in these matters rather than undermining it. While you are taking WHO's Laboratory Biosafety manual as a reference point, it does not appear that your process is in any way under the UN's umbrella. We firmly believe that efforts to develop international biosafety standards should take place within the UN system, and count on the supervision and participation of UN bodies including the World Health Organization, Convention on Biological Diversity, and the Food and Agriculture Organization.
Thirdly, you have also apparently already decided on a single standard. For many reasons, we believe that multiple enforceable standards are probably appropriate. Given the uneven international distribution of infectious disease burdens (and endemism), and the large disparities of health laboratory infrastructure between countries, there is little reason to believe that a "one size fits all" approach will work. This will undermine potential adoption and adherence to the standard.
Fourthly, your process appears to be effectively closed to civil society. While it has been announced within the biosafety profession, you have made no effort that we are aware of to inform other sectors, even at this late stage in your process. You have also required a payment of 800 Euros in order to participate. This exorbitant fee is well beyond the means of many civil society organizations and, we suspect, interested individuals.
Fifthly, we have many concerns about undue influence of the private sector and conflicts of interest in the initiative. We note that you propose a certification scheme for laboratories that would presumably operate on a commercial basis. We are very concerned about potential improprieties involving participants in the process potentially exerting influence on the standard in ways intended to financially benefit for-profit firms. We note that a primary partner is a private Norwegian firm and that your Vice-President will be from AstraZeneca. We also believe that the potential commercial interests of these and Winnipeg's International Centre for Infectious Diseases, or its employees and leaders in that and other non-governmental initiatives, should be clarified.
These are some of our concerns.
International biosafety standards are a good idea; but the International Biosafety and Biosecurity Laboratory Standard Development Initiative is the wrong way to go about addressing the issues.
We submit to the leadership of Health Canada that the Ministry should step back and reassess both its participation in this initiative and if it should move forward at all. The Sunshine Project and, we believe, other civil society organizations would welcome cooperating with Health Canada in the development of international biosafety standards under a more appropriate institutional framework and by more transparent and genuinely participatory methods.
Sincerely,
Edward Hammond
Director
The Sunshine Project
PO Box 41987
Austin TX 78704 USA
+1 512 494 0545
http://www.sunshine-project.org
cc: The Honourable Tony Clement, Minister of Health Partner organizations
(1) I understand the term "biosafety" to encompass the unfortunately named concept of "biosecurity", which is not internationally accepted and, we believe, is more properly understood as a security-subset of biosafety
issues. I also use the term biosafety here to refer to laboratory biosafety, and not its arguably better-known usage in reference to safety of genetically-modified organisms outside of containment.
The Sunshine Project http://www.sunshine-project.org
Please also see:
Convention on Biological Diversity http://www.biodiv.org/default.shtml
Food and Agricultore Organization of the United Nations http://www.fao.org
World Health Organization http://www.who.int
International Biosafety and Biosecurity
Laboratory Standard Development Initiative
http://www.biorisk.eu