Select Committee on Innovation, Universities, Science and Skills Written Evidence

Memorandum 31

Submission from the British Embassy, Berne, Switzerland



  In comparison with neighbouring countries and despite her small size, Switzerland has a dense network of accredited high-level category (CAT) III and category IV biosecurity labs. This is due to Switzerland's substantial industry and research base in biotechnology, pharmaceuticals and biomedicine. It may also be due, at least in part, to Switzerland's historical problem with repeated incidence of mad cow disease, BSE, as in the UK.

  In the above context, the Swiss tend to talk about biosafety rather than biosecurity. This report uses both words interchangeably and in the same context.

  The Swiss Ordinance on Contained Use of Organisms (ESV, see 4. below) stipulates that laboratory research at Swiss CAT I and II biosecurity labs (with nil to minimal security risk) is subject to notification/registration and that laboratory research at Swiss CAT III and IV (moderate to high security risk) is subject to issue of a specific licence.

  At the highest danger level, the government maintains two CAT IV and one CAT III national reference laboratories:

    —  The Central Virological Lab (LCV), CAT IV, since February 2007, within the Central Bacteriological Lab at the University Hospital of Geneva, for dangerous human pathogenic material (, English pages also). A new dedicated website is under construction. This falls under the Swiss Federal Office of Public Health (FOPH/BAG).

    —  The Institute for Animal Viral Disease and Immuneprophylaxis (IVI), CAT IV, since 1992, for diagnosis, monitoring and control of highly contagious animal pests at the Mittelhäusern animal facility near Berne ( This falls under the Swiss Federal Office for Veterinary Affairs, BVET, and, in turn, under the Swiss Federal Office for the Environment (FOEN/BAFU).

    —  The National Reference Lab for Anthrax (NANT), CAT III, at the Institute for Veterinary Bacteriology at the University of Berne (

New Spiez High Containment Laboratory (CATs IV, III)

  In November 2007 construction started on a second human CAT IV pathogenic reference laboratory at the existing Spiez nuclear biological chemical (NBC) lab facility near Berne. This for an approved price tag of 28 million Swiss Francs (UK £12.5 million) and after 10 years of deliberation and planning. Covering four floors over an area of 2,300m2, the new facility is slated for commissioning in 2010 ( A six page technical briefing brochure in English can be downloaded at

  Biosecurity at Swiss laboratories falls under the jurisdiction of several Swiss Federal Agencies or Offices, as well as local cantonal authorities. The governing Federal Offices are:

    —  Federal Office for Public Health, FOPH/BAG—dedicated Section on Biological Security

    —  Federal Office for the Environment, FOEN/BAFU—dedicated Section on Biotechnology and flows of matter

    —  Swiss Expert Committee on Biosafety, SECB/EFBS


1.   By what mechanisms are micro-organisms classified wrt their potential danger and their need to be contained?

  By European norms. Please see EU Council Directive 2000/54/EC under

  The Swiss govt also has separate general classification schemes (see Containment Ordinance under 6.) and specific ones for parasites (2003, 40p), bacteria (2003, 176p), fungi (2004, 115p, English) viruses (2004, English, 32p) and cell lines (2007, English). All can be accessed electronically under

  Unless explicitly stated above, documents are available only in German, French and Italian.

2.   What are the categories of biological containment in use?

  Categories I-IV.

  By European norms. Please see EU Council Directive 2000/54/EC under

  Specifically, Swiss bio labs are subdivided into biosecurity categories 1, 1D, 2, 2D, 3, 3D and 4D. The three CAT IV biosecurity labs have been listed above.

  At the CAT III level, there are more than 40 accredited public and private sector labs. Accreditation is issued on the basis of individual disease/pathogen indications, so the number of dedicated individual labs breaks down to 32.

  Most are specialist University or hospital labs and cantonal labs. All can be referenced and called up by multiparameter searches (eg region, year of registration etc) on the public register database of the Swiss Federal Office for the Environment FOEN/BAFU at

  None of Switzerland's large biopharma corporations eg Novartis, Roche maintain CAT III or CAT IV labs in Switzerland, but do so abroad. This may relate to the strictness of legislation pertaining to such labs in Switzerland. Some other private sector CAT III labs in Switzerland are:

    —  Nestle Research Labs at Vers-chez-les-Blanc/Lausanne (though currently operating only at CAT II level)

    —  Crucell-Berna Biotech AG, Berne

    —  Institut Viollier AG at Allschwil/Basel—a Swiss network of commercial analytical labs

    —  Prionics AG, in Zurich—Swiss SME focused on animal diagnostics, esp BSE

    —  Alicon AG, in Zürich—Swiss SME founded in 2004, focused on food diagnostics and CJD

    —  Institute for Res in Biomedicine, IRB, in Bellinzona, canton of Ticino

  At the national level, the Swiss national conference of health directors commissioned the establishment of a network of regional high security government reference laboratories in 2006. This involved subdivision of Switzerland into six regions to more effectively manage potential crises brought about by human or animal epidemics or pandemics. The advantages of this network of high security government biolabs are cited as being flexibility, geographic coverage and a healthy measure of redundancy between respective laboratories. These regional government CAT III reference labs are listed in Appendix 1.

3.   How are licenses to use dangerous pathogens in research awarded?

  Licenses are awarded by Swiss Federal Office for the Environment, FOEN/BAFU on the basis of:

    —  guidance—see

    —  formal electronic application procedures—see

    —  implementation guides—see

  At FOEN, the entry and exit point for all notifications and licence applications under the Swiss Containment Ordinance (see 4 below) is the Federal Coordination Centre for Biotechnology. See

4.   What is the inspection regime for laboratories licensed to use dangerous pathogens?

  Switzerland has ratified the Cartagena Protocol on Biosafety. Please refer

  The Federal Government has devolved inspections to the regions that are known locally as cantons (see article 20 of Swiss Ordinance on Contained Use of Organisms, ESV; section 6.) There are 26 cantons and every canton has its own laboratory. However, only a few cantons have CAT III or CAT IV laboratories.

  Please refer in particular to Cantonal inspections: practical aspects, p 51-53 in Biosafety Officer Manual 2006

Cantonal authorities also determine the frequency of inspections. However, inspections can also be ordered immediately or ad hoc on consensus between federal and cantonal authorities in instances where non-compliance with Swiss Ordinance on Contained Use of Organisms, ESV, is suspected. Training and further education of cantonal inspectors is handled by the cantonal authorities and by means of periodic courses that are convened by Federal agencies.

  Insofar as possible, inspections are standardised at the national level and according to international norms. For example, a normed checklist is used,


  In general an inspection is made after a licence has been granted by the appropriate authority (FOEN or FOPH), ie while an activity is carried out. During the construction of a new lab inspections are carried out during the commissioning process.

Example: Institute for Animal Viral Infections, IVI, near Berne (FOEN/BAFU)

  IVI's security measures are audited by independent experts. This includes assessment of risk management measures.

  The maximum-security area of IVI is situated in a separate building about 100 metres away from the office and administration building. It has an electronically secured and monitored fence and gate. The main entrance door to the building opens only with a valid badge. If the gate or the door are not closed again within a certain time, or if someone climbs the fence, the monitoring system automatically alerts both an internal 24-hour-stand-by for emergency duties and the police. This serves to prevent unauthorised access and theft of animal pathogens. Such an incident has thus far not happened.

  Inside the maximum-security area several security measures must be followed to gain access to the laboratory. First, there is a single person decontamination area which is accessible only by badge, after that there is an outer change room, where everyone has to get completely undressed (including jewellery, etc.) before entering an air-tight shower. After this shower there is an inner personnel clothing room where special clothing is provided by the laboratory. In this area there is already a negative pressure to ensure that airborne pathogens cannot escape. The next door leads to the sanctum which—considering the time-consuming procedure to get here—looks quite normal and does give the impression of being a category 4 maximum security lab. Staff do not wear protective clothing but the same green and white clothes as the visitors. The security category 4 applies only with respect to the outside world. Inside the lab no special precaution is necessary because the pathogens that are analysed usually are nonhazardous for human beings. Only when work is done with rabies- or bird-flu H5N1-viruses additional security measures are applied.

  To minimise risk, there is a significant difference to a normal lab: What comes in, stays in or gets out only after it has been sterilised and decontaminated.

  Exhaust air is piped through two aerosol filters that retain even the smallest particles including viruses and bacteria. All sewage from the lab, shower, toilet and from the maximum-security animal wing is heat-treated to kill pathogens before leaving the site. Every apparatus or device that has to leave the lab (eg for repair) is disinfected with formaldehyde or ethylene oxide. Animals that were infected with pathogens for testing purposes are slaughtered in a separate room, dissected and heated-treated an autoclave. Although the facility was built 15 years ago it has been continuously upgraded and remains state-of-the-art.

  Security measures are maintained at a consistently high level and are described as above-average. Other laboratories raise or lower their security levels at different times—depending on the danger level of work being carried out. Or other labs define different areas with different security levels. At IVI, the maximum risk rules are applied at any time and anywhere without exception. So the green and white clothing stays within the maximum security area and is washed and dried there. It is forbidden to take notes or print-outs to the administration building, everything has to be sent by e-mail or fax. Finally the employees have to take a shower (and to use the shower gel twice) that lasts at least three and a half minutes every time they leave the lab. For reasons of time-efficiency, the lunch break is held within the cat 4 facility—a cook in a fully equipped kitchen within the cat 4 area prepares meals for the 30 to 35 persons working inside.

  Every employee is placed on a three-day quarantine after having left the lab. Contact with "epidemic susceptible animals", ie cattle, pigs, goats, sheep and other cloven-hoofed animals is strictly forbidden. In particular, visits to zoos, farms and circuses are forbidden.

5.   What training is mandatory/recommended for staff working in containment facilities?

  Currently, there is no mandatory training scheme.

  The Swiss Federal Office of Public Health FOPH/BAG, the Swiss Federal Office for the Environment FOEN/BAFU and the Swiss Expert Committee for Biosafety EFBS all run one basic one day course for Biosafety Officers once a year. This is recommended for all biosafety officers (BSOs). See

  Beyond this, half day thematic seminars are offered.

  Staff training is offered by a Swiss virtual Institute based in Berne. It is called the Biosafety Institute, b-safe GmbH ( ). B-safe was founded in 2003 with the role of providing specialist training and knowledge transfer. It is a non-profit organisation.

  Swiss Federal Offices are preparing a formal curriculum for training of Biosafety Officers for CAT I—CAT III labs. The curriculum is made up of 39 thematic areas for BSOs and this training will take three to seven full days spread over several months, depending on the lab safety level addressed. Once approved, this training will become mandatory and will include a formal examination. These courses are slated for launch from or after 2009.

  The two cat 4 labs train/coach their staff themselves according to their needs. Inspections by the Cantons and of federal offices (FOEN, FOPH, Swiss National Accident Insurance Agency—SUVA) as well as international reviews ensure that the training is up-to-date.

6.   What are the regulations regarding the storage & transportation of dangerous pathogens?


  Governed by Swiss Ordinances on Contained Use of Organisms (ESV), and European Agreement on International Carriage of Dangerous Goods by Road (ADR).

  Swiss Ordinance on Contained Use of Organisms, CO of 26 August 1999 (36 sides). SR 814.912. Non-binding English translation available under

Transportation (subject to detailed regulations)

  Transport is a very complicated issue. Fact sheet memoranda are in preparation by Swiss Expert Committee for Biosafety, EFBS. Will be available in public domain once completed.

  Governed by international ordinances from IATA (International Air Transport Association) and IMO (International Maritime Organisation).

  See also

  Transport regulations in Biosafety Officer (BSO) manual 2006, Nov 2006, p 36-50, at

  Link J. (23 Nov 2006). Transport of infectious substances and GMO. Swiss Expert Committee for Biosafety. English slide presentation, 21 slides, pdf. Avail at

  Transport of infectious biological reagents and organisms, Aug 2006, Berne/Zurich, 36 sides, valid until 30 June 2007. Authors Küng & AWEL.

  Bureau for waste,water,energy and atmosphere, AWEL

  Department for waste and operations

  Biosafety Section

  Construction Directorate of the Canton of Zurich

  NB This document is available only in German.

  World Health Organisation home page

    —  WHO: Transport of infectious substances

    —  WHO: Transport of samples containing avian influenza

  Other regulations/laws/ordinances for environment, employees, food, animal protection, etc.

  Please see

  Potential relevance (text available in German, French, Italian only)

    —  Federal law on epidemics (1974, 14p).

    —  Federal law on epizooties (1967, 22p).

7.   What measures are in place to be implemented when pathogenic material cannot be accounted for?

  Measures are governed by the Swiss Ordinance on Major Accidents, OMA (German: Störfallverordnung, StFV) of April 1991, Swiss Law document SR 814.012.

  The document can be downloaded as 30p pdf file in German, French, Italian only, from

  Regional, ie Cantonal authorities are responsible for executing inspections. As a rule, every lab operator is charged with putting in place an emergency plan. The lab operator is also fully responsible for this emergency plan.

8.   Who is responsible for overseeing security clearance for research students working with dangerous pathogens—what is the role of universities in this process?

  According to the Containment Ordinance the applicant (project leader, head of lab etc) and/or the BSO are responsible for observing the general and the supplemental safety rules. See also FOEN guideline "Biosafety Officers (BSO). Status, duties and responsibilities. 2005".

  The Ordinance on occupational safety in biotechnology (SAMV) states that the employer is responsible for safety. Particularly inexperienced employees have to be trained and invigilated with the utmost care.

  Universities themselves play no particular role.

9.   Further information on Switzerland Swiss Expert Committee for Biosafety

Elected for 4 year terms of office

Current President Prof med Pascal Meylan,

Clinical Virologist, Inst for Microbiology, University of Lausanne
Biological Safety Section

Swiss Federal Office for Public Health, FOPH
Swiss Federal Coordination Centre for Biotechnology

Within Swiss Federal Office for the Environment, FOEN, Berne

www.erfa-bio.chSwiss intercantonal knowledge exchange portal for expert groups in biotechnology and genetics (German only)
www.bats.chPortal of Swiss Centre for Biosafety and Sustainability, Zurich and Basel

Chapters on Biosafety, Medicine, Agriculture

Concerned with assessment of new technologies in biosafety area

www.ecogen.chPortal of Swiss Federal Coordination Centre for Biotechnology for notifications and licence applications for authorisation under the Ordinance on the Contained Use of Organisms (SR 814.912—see 6.1)
University Risk Institutes concerned with Biosafety issues
Crisis and Risk Network, CRN, at Swiss Federal Institute of Technology at Zurich, ETHZ
www.risiko.unibe.chExpert Centre on Risk Management, University of Berne (website in German only)

  We can furnish names and contact details of experts at Swiss CAT IV (and CAT III) biosecurity labs on request.

10.   Useful literature

  FOPH/BAG Bulletin (14 Aug 2006). Bulletin 33, p 668-672.

  Diagnostics in the domain of biological agents—state of the art and perspectives on the regional network of (high security) laboratories in Switzerland. (hard copies in German, French, Italian only).

  Biosafety Officer (BSO) manual (23 Nov 2006). 65 p. English. Available as pdf file at

  Gschwind, M. (23 Nov 2006), Swiss Accident Insurance Agency SUVA.

English presentation Biosafety Regulations in Switzerland, 117 slides, pdf. Available at


RegionLocation Name/Institutewww
NorthBasel-StadtCantonal Laboratory of the City of Basel

(English pages available)

SouthBellinzonaCantonal Institute for Microbiology


EastZurichInstitute for Medical Microbiology lab, IMM

Inst for Medical Virology lab,


also National Centre for Retro-viruses, Univ of Zurich




Central Laboratories for Virology and Bacteriology, University Hospitals of Geneva;

Institute for Microbiology, University Hospital of Vaud


Central-EastLucerne Institute for Medical Microbiology, Cantonal Hospital of Lucerne


Central-WestSpiez near Berne Spiez NBC (German, English pages available)
January 2008

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