Memorandum 16
Submission from Universities UK
Universities UK is pleased to submit written
evidence to the Innovation, Universities, Skills and Science Select
Committee on the issue of biosecurity. This note makes some general
points about the current regulatory regime and how universities
fit into this, and some of the issues that arise.
INTRODUCTION
The need to secure substances or technologies
that could have the potential to be misused or harm the public
is taken very seriously by universities. There are already a number
of pre-existing frameworks that either directly or indirectly
regulate this area, covering universities and other research labs.
It is also an area of regulation that is not static, with revised
or additional requirements encouraging more advanced procedures.
The former Science and Technology Committee visited this issue
in 2003 and since then there have been a number of new developments.
Regulation in this area is often not a straightforward
issue. Any controls that prevent misuse or spread of substances
or technologies can also potentially impact upon legitimate scientific
activity. In many cases the substances, knowledge and technologies
in this area are termed "dual use". The "dual use"
dilemma faced by policy makers is that compared to hostile applications
there are a large number of peaceful purposes. Universities are
also large diverse organisations, which have a significant number
of regulatory requirements placed on them, and it is important
to bear in mind the burden this creates. Getting the regulatory
balance right can therefore be difficult.
CURRENT REGULATORY
LANDSCAPE
Health and Safety at Work Act 1974, whilst
primarily designed to enhance safety in the workplace does, for
example, give detailed guidance on handling dangerous pathogens,
and therefore has benefits for security purposes. The Health and
Safety Executive (HSE) regulate the condition of containment facilities
and university labs are required to meet definitive standards.
The HSE will undertake inspection on application
of a license, or every 3-4 years. Recording of materials is covered
under the H&S Act, though there may be some merit in exploring
how this can be improved upon. The processes for logging materials
under the Human Tissues Act may provide an example of good practice.
Biosecurity training is currently limited within
the sector, though there is currently a course run by the University
of Sussex, jointly with the Medical Research Council (MRC). Universities
UK would support the expansion of such training schemes within
the sector, both for academic and relevant non-academic staff.
2001 Anti-Terrorism Crime and Security Act
The aim of this legislation is to provide oversight
of the possession and transfers of technology, so as to stop its
application for illicit purposes. The 2001 Anti-Terrorism Crime
and Security Act amended the Biological Weapons Act 1974,
and placed new legal obligations on the scientific community to
ensure that technologies are not misused or misappropriated.
The Act is enforced through the police force.
The police from a local constabulary will check security measures
in universities. A recent study undertaken by the Science Policy
Research Unit (SPRU), at University of Sussex, shows that legislation
in this area has been well implemented and has not had any significant
negative impact on research activity.[21]
BTWC (Biological and Toxic Weapons Convention)
The Foreign and Commonwealth Office (FCO) leads
for the UK on the Biological and Toxic Weapons Convention (BTWC)
1972, which is implemented in UK law by the Biological Weapons
Act 1974. There are regular international meetings that explore
how the Convention can be strengthened.
There is currently no verification mechanism
for countries signed up to BTWC, unlike the Chemical Weapons Convention,
which has validation and enforcement through the Organisation
for the Prohibition of Chemical Weapons (OPCW). OPCW do regular
inspections and compile returns. Universities have to submit reports
to BERR, which it then submits to OPCW. There is an inventory
of classified chemicals, and usually, communication with BERR
lies with university safety officers.
Guidance from MRC, Wellcome Trust and BBSRC
In September 2005 the UK's three leading bioscience
research funding agencies published a joint policy statement on
reducing the risk of the research they fund being misused for
harmful purposes by terrorists, or others. The Medical Research
Council (MRC), the Wellcome Trust and the Biotechnology and Biological
Sciences Research Council (BBSRC) issued the statement in light
of public concerns that bioscience research could be misused in
the development of bioweapons.
Following consultation across the organisations'
funding and advisory committees the MRC, Wellcome Trust and BBSRC
examined how existing procedures might be strengthened to heighten
awareness amongst the scientific community and identify and assess
risks of misuse at the initial grant application stage.
This process has led to a series of common changes
to each organisation's policy statements, guidance and procedures.
These include changes to funding application forms, the development
of clear guidance for funding committees and modifications of
organisational guidelines on good practice in research.
Export control regulations
The Export of Goods, Transfer of Technology
and Provision of Technical Assistance (Control) Order 2003,
implemented under the Export Control Act 2002, contains controls
on biological weapons and regulates the transfer of intangible
technologies. The new controls (and indeed the old ones) have
significant implications for scientists working in HEIs.
Universities UK worked with the DTI as the regulations
developed to help to ensure that the rules were effectively communicated
and understood within the academic scientific community. However,
there remains some uncertainty about the extent to which the academic
community is fully aware of the new regulations and obligations.
The then DTI developed an explanation note for scientists (with
input from Universities UK, Royal Society and Medical Research
Council). This was circulated to all members of Universities UK.
Universities UK are currently in discussion with the BERR on how
the regulations and requirements can be promoted further.
Academic Technology Approval Scheme (ATAS)
The former Voluntary Vetting Scheme (VVS) focusing
on postgraduate research students in specific subject areas from
specific countries was reviewed by the FCO and Cabinet Office
from 2004-07. The review was initiated following concerns about
the effectiveness of the scheme as a counter-proliferation measure
raised both by HEIs and the Foreign Affairs Select Committee.
A new scheme, the Academic Technology Approval
Scheme (ATAS), has been developed and the FCO began formal operation
of the new scheme in November 2007 following a two-month trial
period. Ahead of its implementation there was considerable dialogue
between the higher education sector and the FCO to try to ensure
the new scheme operated appropriately. It is also Universities
UK's understanding that the timescales outlined for the scheme
are shorter than those in operation in a number of competitor
countries including the USA.
As at January 2008 Universities UK has not received
any significant concerns from HEIs about the new scheme. The view
from the sector appears to be that the scheme is a proportionate
response to an important national security issue. HEIs welcome
the fact that the scheme applies equally to all HEIs and all relevant
students. It is also appropriate that the UK Government controls
this vetting process rather than the situation that operated under
VVS where HEIs had to decide whether to refer applicants to the
Government or not.
Universities UK do not believe that further
vetting schemes would be required at lab level. This would prove
difficult and burdensome for institutions to manage and would
largely duplicate vetting schemes already in place at a national
level.
However, it must be recognised that the scheme
has not yet operated during the peak period for student recruitment
and admissions. If the ATAS scheme is not able to process applications
within expected timescales in June, July, August and September
it could lead to delays in students entering the visa system and
also lead to delays in the visa system. Delays in the visa system
may mean that students miss the expected start of their programmes.
Key features
— The new scheme applies to all international
(non-EEA) postgraduate research students in specific subject areas
(identified by the Joint Academic Coding System (JACS)) and a
small number of Masters programmes in specific subject areas.
— It requires students who fall into
the above category to seek and obtain "clearance" before
they can apply for a visa or entry clearance to come to the UK
or to renew a visa if they are already in the UK.
— "Clearance" is sought through
a free, online application process to the FCO.
— The student is asked to provide information
on their proposed research area in the application.
— The FCO aim to decide on most applications
within 5-10 working days and all applications within three weeks.
— Participation in ATAS has been mandatory
from 1 November 2007.
— Once "clearance" has been
obtained a student is able to enter the visa process and as part
of the visa process students are required to provide evidence
of the "clearance" in the form of a "clearance
certificate".
Issues
There remain some issues to consider around
the new scheme.
There could be difficulties for students who
are renewing visas and require "clearance" as length
of leave does not always correspond to course length so there
could be students who have progressed onto research programmes
using existing visas but then seek "clearance" and are
refused. The FCO has said that this scenario is very unlikely
but Universities UK has already been alerted to at least one case
of an ATAS refusal involving a student who was already part way
through their research programme. This scenario can cause significant
difficulties for the student involved, the HEI involved and obviously
does not reflect well on the UK.
It is still a comparatively new scheme. Work
needs to continue to ensure information about the scheme is communicated
both overseas and in the UK.
The new system does not link directly into the
existing visa system and will not link into the new points-based
immigration system.
If the turnaround time for the processing of
applications becomes longer it could present difficulties for
the recruitment and admission of international postgraduate students.
Subject areas covered by the scheme
The scheme primarily focuses on postgraduate
research students but a small number of taught Masters in certain
subject areas are included.
If the exit qualification will be a Doctorate
or Masters by Research (MRes, MPhil etc but not MEng, MPharm,
MSci) the following subject areas are included:
Subjects allied to Medicine:
JACS codes beginning:
— B1—Anatomy, Physiology and
Pathology.
— B2—Pharmacology, Toxicology
and Pharmacy.
— B9—Others in Subjects allied
to Medicine.
Biological Sciences:
JACS codes beginning:
— C7—Molecular Biology, Biophysics
and Biochemistry.
— C9—Others in Biological Sciences.
Veterinary Sciences, Agriculture and related subjects:
JACS codes beginning:
— D9—Others in Veterinary Sciences,
Agriculture and related subjects.
Physical Sciences
JACS codes beginning:
— F8—Physical and Terrestrial
Geographical and Environmental Sciences.
— F9—Others in Physical Sciences.
Mathematical and Computer Sciences
JACS codes beginning:
— G2—Operational Research.
— G7—Artificial Intelligence.
— G9—Others in Mathematical and
Computing Sciences.
Engineering
JACS codes beginning:
— H1—General Engineering.
— H3—Mechanical Engineering.
— H4—Aerospace Engineering.
— H6—Electronic and Electrical
Engineering.
— H7—Production and Manufacturing
Engineering.
— H8—Chemical, Process and Energy
Engineering.
— H9—Others in Engineering.
Technologies
JACS codes beginning:
— J4—Polymers and Textiles.
— J5—Materials Technology not
otherwise specified.
— J7—Industrial Biotechnology.
— J9—Others in Technology.
1. Subjects included for Taught Masters as
well as Doctorate and Masters degrees by research (but not MEng,
MPharm, MSci):
— F3—Physics (including Nuclear
Physics).
— H3—Mechanical Engineering.
— H4—Aerospace Engineering.
— J5—Materials Technology not
otherwise specified.
CONCLUSION
Universities take their responsibilities for
biosecurity very seriously. As has been outlined in this note
there are a number of legal and regulatory requirements covering
the condition and maintenance, and security of university labs.
There are also wider requirements on the exchange of knowledge
and technologies, processes to vet students, and conditions and
requirements outlined by funders of research.
Universities UK believe that the current framework
of regulation, which has developed over time, provides a high
level of reassurance. Any further regulation or requirements could
have the potential to duplicate what is already there, damage
legitimate scientific activity, or create significant burden for
universities. Further requirements, must also; of course be proportionate
to the risk. Any further proposals in this area must therefore
be considered very carefully. We are mindful that processes can
always be improved and have indicated some areas where we feel
this could be the case eg more widespread biosafety training.
January 2008
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