Last week, I promised that I would discuss the Industry Panel held at the Meeting of Experts on Tuesday, August 19. The panel comprised speakers from two pharmaceutical companies (Astra Zeneca and GlaxoSmithKline) and two biotechnology companies (the J Craig Venter Institute and the Association of Biotechnology Led Enterprises of India).
The pharmaceutical industry representatives asserted that the industry is already highly regulated, particularly in terms of good manufacturing and good laboratory practices, and that their business survival requires them to have extensive safety and security procedures in place. This is a valid point, in my opinion, though of course these practices and procedures did not just emerge full-blown overnight and without contentious debate. Moreover, the participants said, the pharmaceutical industry is dominated by global corporations and thus has a strong business interest in seeing that whatever rules or standards are adopted be globally harmonized. The industry is particularly interested in the development of global frameworks for risk management and governance, as such frameworks would allow companies to manage all of their operations effectively across the multiple regulatory systems in which they operate.
The flip side of this strong support for global approaches is, of course, that industry is likely to work against approaches which it believes are not risk based, are not “proportionate” to risk, and do not “avoid unnecessary burdens.” One industry participant was blunt in stating where this may lead, remarking that decisions to put local (i.e. national) regulatory frameworks into place will have a global impact, and that countries which do so may put themselves in a disadvantageous position unless and until global regulatory frameworks are developed. This sort of argument is used all too often to undermine positive actions by individual nations who choose to take on a leadership role.
The biotechnology industry is much less regulated than the pharmaceutical industry, and thus there is less of a foundation upon which to build biosecurity measures. Indeed, small, unregulated biotechnology companies which have not yet established a strong product line or reputation to defend may be the weakest link in the biosecurity chain within the commercial sector. The biotechnology industry is also globalizing rapidly. For this reason, the pharmaceutical and biotechnology industry representatives all stressed that transfers of biological materials across borders are essential to their operations. One of their major concerns today is that export and import controls lack harmonization and are placing a heavy burden on industry. Thus, both industries are very interested in seeing new controls developed which would ease global trade in biological materials while maintaining biosecurity.
It is important that, in spite of their various qualification, none of the industry panelists argued against the development of stronger safety and security measures for life sciences activities. For industry, the key is that such measures be universal in nature, so that there is a level playing field for all involved. Now, if only industry showed a little more understanding of the problem. According to one participant, “it’s the individual who creates the risk, not the technology.” Well, no, it’s the intersection of both.
But that’s better than where industry was at in 2005, when it largely asserted that there was no problem at all. In the final analysis, this was a good session with hard-hitting comments that cut through much of the delicate language and pussyfooting that often surrounds discussions of biosafety, biosecurity and the oversight of science. The industry representatives got right to the point and made clear where industry stands.
As for the overall meeting – although I missed the last day, it appears that I did not miss too much. Out of a total of 79 statements or presentations made at the meeting (excluding 22 opening statements and 11 statements by NGOs) only 14 statements were made on the last day. These focused on education (6 statements) and codes of conduct (8 statements). The numbers confirm what was already apparent in the meeting room by the time I left: there are now significant activities underway to enhance biosafety and laboratory security (though there is a long way to go, as the presentations made clear), but the broader range of efforts needed to build an effective “web of prevention” lag far behind. That is the only reasonable explanation for the fact that there were 52 statements and presentations, some of them quite detailed, on the relatively narrow topics of biosafety and laboratory biosecurity, but only 27 statements and presentations on oversight of research, education and awareness raising among life scientists, and codes of conduct (and as I noted earlier, some of these presentations were off-topic).
Now, all eyes will be on the December Meeting of States Parties, to see how the States Parties use the information shared last week to fulfill the goal for these annual meetings that was laid down at the Sixth Review Conference at the end of 2006: to “promote common understanding and effective action.” This will be difficult, since the Sixth Review Conference in 2006 did not provide the Annual Meetings with any decision-making authority. Yet, as Richard Guthrie noted in his final report for the BWPP, such authority is necessary if States Parties are to do anything more than to individually “accept or reject [the ideas raised at the meetings] as they see fit.” Thus, I agree with Guthrie’s assessment that the Meeting of Experts was “a success within the terms of its remit,” but that “much more could have been done, had it been allowed.”
The start of the fourth day of the Meeting of Experts saw yet more discussion of biosafety and biosecurity, even though the Meeting was supposed to have been well into discussions of its second agenda item: “oversight, education, awareness raising, and adoption and/or development of codes of conduct with the aim of preventing misuse” of the life sciences and biotechnology. Not much to report on here, except that Cameroon, who is not a member of the treaty, gave a presentation on its biosafety and biosecurity efforts. That is important because it is a sign that Cameroon will soon join the BWC as the push to achieve world-wide membership continues to make slow but steady progress (currently 162 of the world’s 195 nations are members). Cameroon also noted that while it has a rich body of laws relating to biosecurity, efforts to implement the laws in practical ways lags far behind due to capacity deficits. France noted that developed nations face some of the same challenges (though they have many more resources available to meet those challenges, should they choose to).
When the discussion finally turned to oversight of dual-use research, the United States led off with a presentation about the National Science Advisory Board for Biosecurity. Some of my thoughts on the NSABB proposed system are here (take home message – it has a lot of problems, my comments address just one them). Japan then made a presentation about the Aum Shinrikyo cult and its unsuccessful attempts to employ biological weapons in the 1990s. The speaker, reviewing the background of the scientists involved in this program, asked whether we should be concerned about creating scientists who have relatively low future prospects – not a comforting thought given the structural crisis in biomedical research funding here in the United States. Japan went on to describe its nascent oversight and educational efforts.
Germany described its procedures for security vetting of personnel, which is based on checks on identity, references, qualifications, employment history and criminal record, but did not discuss any additional oversight measures. The UK discussed its approaches to the oversight of emerging technologies, with a focus on nanotechnology and synthetic biology.
In the afternoon, the US National Academies spoke about its work related to oversight, noting that most US scientists prefer self-governance by the scientific community following guidelines set by the federal government (no surprise there, that’s the NSABB proposal). Pakistan spoke about its nascent efforts to strengthen dual-use research, being built on a foundation of an existing biosafety oversight system (a common theme throughout the meeting has been the preference for building new safety and security measures into existing mechanisms whenever possible). Cuba discussed its laws and mechanisms for biosafety regulation, including mechanisms to ensure compliance with regulations, and its system for biosafety training
Brazil was the last to speak on oversight, and took an approach that was reminiscent of that taken by the NSABB, focusing on first on not unduly impeding scientific research and then on establishing an oversight mechanism. Brazil said it favors a combination of institutional and governmental control – but did not really describe its oversight mechanisms, which it suggested would be found in Working Paper 28 of the Meeting (not yet available).
The discussion then turned to education and awareness raising, by which most mean education about the risks associated with the life sciences, the BWC and other laws meant to reduce these risks, and professional responsibilities. For a topic that has been recognized for several years now as being very important for success in efforts to mitigate dual-use risks, there has been remarkably little progress. This was evidenced by the fact that Germany and France both talked more about codes of conduct than about education. The United States and the United Nations 1540 Committee (named after UN Security Council Resolution 1540) largely talked about issues other than education, as did two of the four panelists on the final Chairman’s panel discussion.
Who did talk about education? Switzerland talked about its initial educational efforts and brought along a simple but useful fact sheet that it is distributing to all universities and associations. The United Kingdom also talked about education and awareness raising, as well as oversight and codes of conduct, in a paper that is well worth reading. I reproduce the conclusions of the paper here (emphasis mine):
The UK recognises that codes of conduct for scientists and awareness raising campaigns do not offer a foolproof defence against the misuse of the life sciences for hostile purposes. But what they can do – along with measures on oversight and education – is to heighten the levels of awareness in the academic and research communities of the need for care; highlight the nature of the Convention.s legal prohibitions; and promote the need to address issues such as technology governance on a continuing basis. Such issues cannot be dealt with quickly; sustained efforts by a broad range of stakeholders are required over an indefinite period of time.
Measures taken in this context should not be seen in isolation: improved biosafety and biosecurity in laboratories, enhanced disease surveillance, effective national implementation of the Convention, improved investigative mechanisms for cases of alleged use and practical oversight of dual-use R&D all have a role to play in strengthening the BTWC. The UK believes that progress is required in all these areas, since they are mutually reinforcing.
Friday is the fifth and final day of the Meeting of Experts. The discussion of education will continue, to be followed by a discussion of codes of conduct. Unless something goes terribly awry, the final report has already been all but formally agreed – it is a factual report only, relating what the various participants in the meeting said. I will be flying home and so will miss the last day, but will keep up with developments from afar. Look for my final posting on the meeting next week – along with my promised discussion of the industry panel held on Tuesday.
The third day of the BWC Meeting of Experts was devoted exclusively to the issues of biosafety and biosecurity, broken into three topics: concepts, capacity building, and risk management.
The discussion of biosafety and biosecurity concepts actually began yesterday. It continued today with presentations from professional and scientific associations. Three biosafety associations (American Biosafety Association (ABSA), Asia-Pacific Biosafety Association (APBA) and European Biosafety Association (EBSA)) presented their activities. APBA noted that there is no shortage of information to support good biosafety and biosecurity programs. The challenge for its members relates to the limited resources and infrastructure in place to support systematic and sustainable implementation. The discussions later in the day on capacity building aimed to address this issue, with the World Health Organization and many developed nations laying out their efforts to promote capacity building in other nations (some discussed building capacity at home as well), and many developing nations laying out their activities to build their capacity. It is clear that there is much more interest and activity in this area today than there was a few years ago. That’s good for both safety and security, as well as for bridging some of the divides between developed and developing nations. Much remains to be done, and it is not clear that all current efforts are yet being designed to build sustainable capacity.
One of the more interesting presentations was that of the Inter Academy Panel for International Issues (IAP). The IAP is a network of national science academies from 98 countries around the world. In 2005, an IAP working group on biosecurity – comprising the Dutch, Chinese, Cuban, Nigerian, UK, and US academies, drafted a Statement on Biosecurity that has since been endorsed by nearly 70 national academies. The Statement is a general set of principles that academies and others could use to develop codes of conduct for life scientists. Though general in nature, it is interesting to compare to another set of general guidelines for a code of conduct, prepared by the US National Science Advisory Board for Biosecurity (NSABB). Only the IAP statement explicitly and clearly states that “scientists have the obligation to do no harm.” Only the IAP statement clearly says that scientists “have a responsibility to use good, safe and secure laboratory procedures, whether codified by law or by common practice.” Only the IAP statement makes reference to national and international law and regulations. And only the IAP statement makes explicit reference to the BWC and says that scientists have a responsibility to notify appropriate individuals or authorities if they become aware of activities that violate the BWC.
Given the challenges of getting a diverse group of countries to agree on anything, it is striking that the NSABB principles for a code of conduct are in many ways significantly weaker than a statement which has been endorsed by our own National Academies. Surely we can do better.
The afternoon saw a second Chairman’s Panel Discussion, this time focused on the topic of biosafety and biosecurity risk assessment. In my opinion, many of the presentations were over-the-top, making risk assessment for biosafety and biosecurity into a much more complicated undertaking than necessary. Hopefully the diplomats took home a couple of core messages – simple methods will often suffice, especially in an area such as biosecurity where there is very little underlying knowledge to guide understanding of the risks; taking into account the human component of risk assessment is crucial, risk is not just about the pathogens; transparency of the risk assessment process is key to acceptance of the conclusions drawn; and that adequate controls must be developed and implemented to mitigate risk if the risk assessment process is to have any value.
Day 2 of the Meeting of Experts
Traditionally, meetings of the BWC are closed to NGOs except for the first and last plenary sessions. On Tuesday, for the first time ever to my knowledge, NGOs were allowed to remain in the room during all working sessions. This is a positive development that will hopefully continue for the rest of the week. One result is that I can report on the day’s events from first hand knowledge.
The day started out with a a poster session on the topics of biosafety and biosecurity – a second new development for the BWC. Poster sessions, long familiar to scientists, are informal gatherings at which individuals (in this case primarily governments, intergovernmental organizations, and non-governmental organizations) present their work, in the form of a poster, to other attendees who can view and discuss the information at their leisure. The session was well attended and received. I have been told that many of these posters should ultimately be available on the BWC website.
The formal sessions started off with a presentation by the World Health Organization (WHO) on their efforts since 2005 to enhance biosafety and laboratory biosecurity globally. WHO noted that several cases of laboratory acquired infections with the SARS virus in 2003 triggered their latest efforts on biosafety, while the anthrax attacks of 2001 triggered their efforts on biosecurity. WHO further noted that it considers laboratory biosafety to be the best foundation on which to build laboratory biosecurity. As noted previously, efforts to promote greater biosafety are of great interest to developing nations in particular.
WHO also noted that, as in the United States, a proliferation of biosafety level 3 and biosafety level 4 laboratories is underway around the world. WHO asked whether this proliferation is actually increasing or reducing the risks of infection?
The answer may be some of both. Certainly many of these laboratories are needed – many countries have had little or no level 3 capacity in spite of the fact that they routinely face outbreaks of diseases caused by pathogens best studied at level 3. But without adequate safety equipment and procedures, there is a significant risk of accidental disease outbreaks. There are also concerns that perhaps there is an over-proliferation occurring (i.e. proliferation beyond actual needs) in some cases. Georgia (the nation) pointedly asked why, for instance, Brazil is building 12 new biosafety level 3 facilities, noting that the US government is funding efforts in Georgia to consolidate high-risk pathogens into fewer facilities. Brazil of course responded that they did not have enough capacity before, and might in fact add a biosafety level 4 facility too. I have no way to judge this statement – it may well be true. But there is clearly the potential here for the proliferation of high containment labs to get out of control. One wonders how much of this is driven by the proliferation in the United States. Georgia’s question also points to one of the internal contradictions in our own policy – we are funding consolidation overseas but proliferation at home.
Beyond the question of the proliferation of high containment labs, other developing nations took the floor to express concerns that their needs for assistance from WHO in improving biosafety and biosecurity in their own countries are not being met. The truth is that the wealthy member states of the BWC and WHO, those who tend to be the most vocal about the need to promote biosafety and, especially, biosecurity, are simply not providing WHO with the funds it needs for this task.
The Organization for Economic Co-operation and Development (OECD) presented its efforts to enhance biosecurity “as a means of enabling innovation.” OECD discussed its Best Practice Guidelines on Biosecurity for Biological Resource Centers, adopted in 2007, which take a risk management approach to biosecurity. The problem is that nobody knows how to perform biosecurity risk assessments. OECD is now undertaking a project to develop a risk assessment methodology.
This problem became especially apparent later in the day when Norway made a presentation about the Laboratory Biorisk Management Standard developed by the European Committee for Standardization (only available by purchase!, but you can see a draft version here http://www.biorisk.eu/ – “biorisks” encompass both biosafety and biosecurity risks). Like the OECD Guidelines, the Standard relies on a risk management approach. Yet, it does not include a process for conducting risk assessments. This raised numerous questions, the answer to which was, first, that there is no such thing as “a” biological risk assessment. Instead, there are many (for facilities, for materials, for people, etc.) – this is a reflection either of the complexity of the issue, or of the problem being viewed in the wrong way. Second, there is a desperate and unfulfilled need for risk assessment methodologies. Norway noted the irony of this situation, since so many major documents (WHO, OECD, the Standard presented by Norway, etc.), and statements by governments are strongly promoting the risk management approach as the only proper approach to managing biosafety and biosecurity concerns.
I will not discuss the presentations on biosafety and biosecurity made by the other States Parties who spoke or the experts they brought to the meeting. The bottom line, as Richard Guthrie noted in his BWPP update, is that the level of detail in many of these presentations was often much greater than in previous years, indicating the increased engagement within countries on BWC related issues.
It may be of interest to US readers that our Canadian neighbors are currently in the process of developing a comprehensive biosafety and biosecurity law which will regulate the possession and transfer of all biological agents according to their level of (biosafety) risk. I may write more about this later.
A lunchtime seminar organized by the University of Bradford discussed how potential biological threats are expanding beyond pathogens and toxins to include “bioregulators” – small molecules that regulate cognition, immunity and other physiological processes – and to discuss various processes that could be used to oversee dual-use research so as to minimize the risk of harm that could arise from it.
My next report will include thoughts on a very interesting roundtable held Tuesday with representatives of the pharmaceutical and biotechnology industries, as well as on Wednesday’s events.
The 2008 Meeting of Experts opened today with statements from States Parties to the Convention. As these things go, it was the same old stuff: congratulating or appreciating the Chair for his work preparing the meeting, expressing the importance they attach to the topics being discussed this week, and looking forward to a productive discussion.
More interesting was to see where the potential differences of opinion lie between the States Parties. Not unexpectedly given the history of the BWC, the biggest differences lie between the developed, Western nations and the developing nations.
In general, the developed nations tended to focus fairly narrowly on national obligations to implement measures in the areas being discussed this week: biosafety and biosecurity; and oversight, education, awareness raising, and codes of conduct. For example, the United States pointed out that such steps will make it more difficult for terrorists and other non-state actors to divert the life sciences for malicious purposes. Moreover, the U.S. made clear its view that the implementation of effective measures in both areas serves as an indicator of compliance by States Parties with their obligations. Developed nations also often discuss the assistance they can and have provided in these areas for those who request it.
Developing nations agreed that biosafety and biosecurity measures, as well as codes of conduct, education, awareness raising, and oversight are important. But whereas the developed nations tended to emphasize biosecurity, the developing nations tended to put more equal emphasis on biosafety, which they often see as being a bigger problem in their own countries. Moreover, developing nations often emphasized the importance of scientific cooperation as a way to further enhance biosafety and biosecurity, and expressed concern that biosecurity measures and codes of conduct could be used to impede scientific cooperation or the exchange of scientific information and technologies, and to deprive states of the benefits of biotechnology.
Many (but not all) developed nations do not like to discuss such matters. That’s ironic, because similar concerns that biosecurity measures and oversight will impede science are being strongly expressed by scientists in the developed nations themselves. The truth is, these issues are contentious both within and between developed and developing nations, and will remain so for a long time to come. That’s one reason why the discussions this week, which are aimed at finding effective ways to prevent the use of biological knowledge and technology for malign purposes without unduly impeding the many positive uses of such knowledge and technology, are so important.
Non-governmental organizations, which often push the issues ahead a little more than the States Parties, spoke on the floor of the Convention in the afternoon. Some of the highlights of these statements, in my opinion, were:
VERTIC pointed out that biosafety and biosecurity are “strengthened and sustained [ed. translation: require] by robust legislative and regulatory frameworks at the national level.”
The Center for International Security Studies at the University of Maryland (CISSM) argued that education, awareness raising, and codes of conduct are important but insufficient for addressing the dual-use problem. In addition, “prudent and effective oversight measures must be put in place.” CISSM suggested that the States Parties agree on six key points on oversight, including: that the activities subject to oversight be clearly defined; that oversight be carried out by independent experts; that oversight apply to all relevant research activities whether government, private sector, or academic; and that oversight arrangements must be harmonized internationally.
The University of Bradford and the National Defense Medical College of Japan pointed out that “there remains a very low level of awareness of the [BWC] and its obligations amongst many life scientists around the world.” And the Landau Network-Centro Volta and the University of Bradford reported that bioethics and biosafety education are common among 150 life science degree courses in Europe, but that biosecurity and dual use education and codes of conduct are rare.
Building on this, Brian Rappert of the University of Exeter noted that the agendas and statements from the BWC have played an important role in pushing these issues forward even to the limited extent already achieved. He urged the States Parties to agree on several specific understandings at their December meeting, including: that it is a fundamental principle that the benign intent of individuals is not a sufficient response to preventing the misuse of science; and that all those undertaking professional research careers should receive effective training or instruction related to preventing misuse of their research.
Finally, the Institute for Security Studies, an organization based in South Africa, Kenya, and Ethiopia discussed some of the issues mentioned at the beginning of this post. The ISS noted that scientific research and diagnostic research facilities remain under-resourced and under-developed in Africa, and that “improvement of biosafety procedures, rather than sophisticated and expensive biosecurity-related infrastructure, is in our view a pressing priority for the continent.” The ISS also noted that “most of the African scientists we have engaged with, once aware of the problem, are open to further discussion; recognize the importance of measures to reduce the risk associated with dual-use research; and express support for the development of appropriate oversight mechanisms.”
My personal observation is that the same can not yet be said with confidence about most scientists here in the United States.
I encourage those desiring another view and more information on the meeting this week to visit the website of the BioWeapons Prevention Project (BWPP), which is posting daily reports on the meeting. (Disclosure – we are a member organization of the BWPP.)
This morning I delivered our statement to the Meeting of Experts on the Biological and Toxin Weapons Convention.
From August 18 – 22, 2008, States Parties to the Biological Weapons Convention (BWC) and other experts will meet in Geneva, Switzerland for the annual BWC Meeting of Experts.
The BWC prohibits the development, production, acquisition, transfer, retention, and stockpiling of biological weapons in order to “exclude completely the possibility of…biological agents and toxins being used as weapons.”
This year’s Meeting of Experts will address one of the most difficult and politically contentious of issues facing efforts to prevent the development and use of biological weapons: the oversight and regulation of life sciences research.
According to prior agreement by the BWC States Parties, the two main topics for this year’s meeting will be:
1. National, regional, and international measures to improve biosafety and biosecurity, including laboratory safety and security of pathogens and toxins.
2. Oversight, education, awareness raising, and adoption and/or development of codes of conduct with the aim of preventing misuse in the context of advances in bio-science and bio-technology research with the potential for use for purposes prohibited by the Convention (translation: to help prevent the use of the life sciences and biotechnology for hostile purposes.)
Both of these topics are garnering heavy interest: the 2005 Meeting of Experts, which addressed only codes of conduct, saw the greatest level of participation ever by non-governmental organizations in a BWC meeting. Nearly 40 non-governmental organizations – including research institutes, advocacy groups, scientific and professional bodies, and academic and industry groups – participated in the Meeting.
This year’s topic goes beyond codes of conduct to cover a much broader range of issues related to science, technology, and biological weapons. Judging from the information available on the BWC website, the Meeting is generating even greater interest and participation than the one held in 2005.
Much more information is likely to start flowing on Monday. Indeed, the Meeting will likely be quite intense. States Parties will be hard-pressed to discuss the two complicated topics mentioned above in the space of just five days, in addition to hearing statements from non-governmental organizations and attending two poster sessions and a number of side events.