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Nursing in the United Kingdom – Wikipedia, the free encyclopedia

The Nursing and Midwifery Council

The core function of the NMC is to establish and improve standards of nursing and midwifery care in order to serve and protect the public. Its key tasks are to:

  • maintain a register listing all nurses and midwives;
  • set standards and guidelines for nursing and midwifery conduct, performance and ethics;

provide advice for registrants on professional standards;

  • quality assure nursing and midwifery education;
  • set standards and provide guidance for local supervising authorities for midwives;

consider allegations of misconduct, lack of competence or unfitness to practice due to ill health.

The powers of the NMC are set out in the The Nursing and Midwifery Order 2001.

The council consists of twelve registrant members, twelve alternate registrant members and eleven lay members. The registrant members consist of equal numbers of nurses, midwives and specialist community public health nurses. The lay members include people from education, employment and consumer groups (who are appointed by the Privy Council. The former president and vice-president were Sir Jonathon Asbridge and Mary Hanratty respectively.

The NMC held its first elections of registrants for its governing council, with all members. The new council came into being in July, 2006. The first elected President of the council is Sandra Arthur, with the vice-president position vacant.

[edit] Regulation

To practise lawfully as a registered nurse in the United Kingdom, the practitioner must hold a current and valid registration with the Nursing and Midwifery Council. The title “registered nurse” can only be granted to those holding such registration, this protected title is laid down in the Nurses, Midwives and Health Visitors Act 1997.

[edit] The register

As of August 2005, the NMC register split into three parts: nurses, midwives and specialist public health nurses. Previously, it only contained 15 “sub-parts”, a list of which can be viewed here

According to the NMC, there are 672,897 registered nurses on the register, as of 2005. Of these:

  • Over 10% of registrants are male.
  • Over 53% are on part 1 of the register (Adult).
  • Over 60% are under the age of 40.
  • There are only two male School nurses registered with the NMC.

[edit] Employment of nurses

The National Health Service is the provider of almost all healthcare in the United Kingdom, and employs the vast majority of UK nurses and midwives which number 386,000 according to the Department of Health.

The nursing staff is split into two main groups:

  • Non-registered staff
– e.g. auxiliary nurses and healthcare assistants.
  • Registered staff (split into four further groups)
– First level nurses.
– Second level nurses.
– Specialist nurses.
– Managers.

[edit] Non-registered staff

These staff can be found carrying out a number of roles, attracting various titles such as auxiliary nurse, healthcare assistant (HCA), clinical support worker, care assistant and nursing assistant. These titles all describe workers who work in direct patient care (often on wards), performing tasks such as personal care (washing and dressing), social care (feeding, communicating to patients and generally spending time with them) and more specialised tasks such as recording observations or vital signs (such as temperature, pulse, respirations TPR) or measuring blood pressure, urinalyisis, blood sugar monitoring, waterlow score, catheterisation, or canulisation).

Some unregistered staff can work in other roles, for example as phlebotomists (taking blood samples) and ECG technicians (recording electrocardiograms). Others can expand their ward-based role to include these tasks and others. Technically, there are few areas of nursing practice that cannot be legally performed by suitably trained non-registered staff, although they cannot fully replace them, as they legally must be supervised (either directly or indirectly) by a fully qualified registered nurse.

[edit] Registered staff

[edit] First level nurses

First level nurses make up the bulk of the registered nurses in the UK. They were previously known by titles such as RGN (registered general nurse), RSCN (registered sick children’s nurse), RMN (registered mental nurse), RNMH (registered nurse mentally handicapped N.B. Not to be confused with the more modern abbreviation for Mental Health Nurses i.e. Registered Nurse in Mental Health – see table to the right), RFN (registered fever nurse) and SRN (state registered nurse) etc.

Sub-part Level Branch Title Country
1 First General RGN UK-Wide
2 Second General EN(G) England and Wales
3 First Mental illness RMN UK-wide
4 Second Mental illness EN(M) England and Wales
5 First Learning disabilities RNLD UK-wide
6 Second Learning disabilities EN(LD) England and Wales
7 Second General SEN Scotland and NI
8 First Children RSCN UK-wide
9 First Fever (obsolete) RFN UK-wide
10 N/A Midwife RM UK-wide
11 N/A Health visitor HV UK-wide
12 First Adult RN/RNA UK-wide
13 First Mental health RN/RNMH UK-wide
14 First Learning disabilities RN/RNLD UK-wide
15 First Child RN/RNC UK-wide

The majority of first level nurses are employed as staff nurses with the minority in management and specialised roles.

[edit] Second level nurses

Second level (still referred to as EN’s) nurse training is no longer provided, however they are still legally able to practice in the United Kingdom as a nurse and also by law may refer to themselves as a registered nurse NMC. EN’s trained for a period of 24 months in England and Wales whilst training in Scotland was normally 18 months in duration. Many have now either retired or undertaken conversion courses to become first level nurses.

[edit] Specialist nurses

The NHS employs a huge variety of specialist nurses. These nurses have many years of experience in their field, in addition to extra education and training (see below).

They split into several major groups:

  • Nurse Practitioners – these nurses carry out care at an advanced practice level. They often perform roles similar to those of Doctors. They commonly work in primary care (e.g., GP surgeries) or A&E departments, although they are increasingly being seen in other areas of practice.
  • Specialist Community Public Health Nurses – traditionally known as District Nurses and Health Visitors, this group of practitioners now includes many School nurses and Occupational Health Nurses.
  • Clinical Nurse Specialists – undertaking these roles commonly provide clinical leadership and education for the Staff Nurses working in their department, and will also have special skills and knowledge which ward nurses can draw upon.
  • Nurse Consultants – these nurses are similar in many ways to the clinical nurse specialist, but at a higher level. These practitioners are responsible for clinical education and training of those in their department, and many also have active research and publication activities.
  • Lecturer-Practitioners – these nurses work both in the NHS, and in universities. They typically work for 2–3 days per week in each setting. In university, they may train pre-registration student nurses (see below), and often teach on specialist courses for post-registration nurses (e.g. a Lecturer-practitioner in critical care may teach on a Masters degree in critical care nursing). Lecturer-Practitioners are now more often referred to by the more common job title of Practice Education Facilitators (shortened by student nurses to PEFs).
  • Lecturers – these nurses are not employed by the NHS. Instead they work full time in universities, both teaching and performing research. Typically Lecturers in Nursing are qualified to a minimum of Masters Degree and some are also qualified to PhD level. Some senior lecturers also attain the title of Professor. This title is more often the School/Department Dean e.g. Dean/Vice Dean School of Health & Social Care.

[edit] Managers

Many nurses who have worked in clinical settings for a long time choose to leave clinical nursing and join the ranks of the NHS management. This used to be seen as a natural career progression for those who had reached ward management positions, however with the advent of specialist nursing roles (see above), this has become a less attractive option.

Nonetheless, many nurses fill positions in the senior management structure of NHS organisations, some even as board members. Others choose to stay a little closer to their clinical routes by becoming clinical nurse managers or Modern Matrons.

[edit] Nurse education

[edit] Non-registered staff

There is no mandatory training for most people undertaking these roles. The majority of NHS employers however, have created “in-house” training for these members of staff, both in the form of induction programmes and ongoing education to achieve a recognized qualification. Some work collaboratively with local further education colleges to provide theoretical input, and may award a recognised qualification. It is becoming more common for NHS employers to ask for some type of health or social care qualification for potential new members of staff for example, an SVQ/NVQ or HNC/HND with various qualification names including health care, social care and health & social care.

Many trusts and health boards create opportunities for these staff members to become qualified nurses, this is known as secondment (whereby the trust/health board continues to pay them for the duration of their training, and often guarantees employment as qualified nurses following the completion of their training).

[edit] Pre-registration

In order to become a registered nurse, and work as such in the NHS, one must complete a programme recognised by the Nursing and Midwifery Council. Currently, this involves completing a degree or diploma, available from a range of universities offering these courses, in the chosen branch speciality (see below), leading to both an academic award and professional registration as a 1st level registered nurse. Such a course is a 50/50 split of learning in university (i.e. through lectures, essays and examinations) and in practice (i.e., supervised patient care within a hospital or community setting).

These courses are three (occasionally four) years long and must be 4600 hours in length to meet the requirements of the NMC. The first year is known as the common foundation programme (CFP), and teaches the basic knowledge and skills required of all nurses. The remainder of the programme consists of training specific to the student’s chosen branch of nursing. These are:

  • Adult nursing.
  • Child nursing.
  • Mental health nursing.
  • Learning disabilities nursing.

Midwifery training is similar in length and structure, but is sufficiently different that it is not considered a branch of nursing. There are shortened (18 month) programmes to allow nurses already qualified in the adult branch to hold dual registration as a nurse and a midwife. Shortened courses lasting two years also exist for graduates of other disciplines to train as nurses. This is achieved by more intense study and a shortening of the common foundation programme.

Student nurses currently receive a bursary from the government to support them during their nurse training. Diploma students in England receive a non-means-tested bursary of around £6000 per year (with additional allowances for mature students or those with dependant children), whereas degree students have their bursary means tested (and so often receive less). Degree students are, however, eligible for a proportion of the government’s student loan, unlike diploma students. In Scotland and Wales, however, all student nurses regardless of which course they are undertaking, receive the same bursary in line with the English diploma course. All student nurses in Wales study, initially, for a degree, but may chose to remain at Level 2 for their third year, therefore achieving a diploma in place of a degree.

Before Project 2000, nurse education was the responsibility of hospitals and was not based in universities; hence many nurses who qualified prior to these reforms do not hold an academic award.

[edit] Post-registration

After the point of initial registration, there is an expectation that all qualified nurses will continue to update their skills and knowledge. The Nursing and Midwifery Council insists on a minimum of 35 hours of education every three years, as part of its post-registration education and practice (PREP) requirements.

There are also opportunities for many nurses to gain additional clinical skills after qualification. Cannulation, venepuncture, intravenous drug therapy and male catheterisation are the most common, although there are many others (such as advanced life support) which some nurses will undertake.

Many nurses who qualified with a diploma can choose to upgrade their qualification to a degree by studying part time. Many nurses prefer this option to gaining a degree initially, as there is often an opportunity to study in a specialist field as a part of this upgrading.[citation needed] Financially, in England, it is also much more lucrative, as diploma students get the full bursary during their initial training, and employers often pay for the degree course as well as the nurse’s salary.

In order to become specialist nurses (such as nurse consultants, nurse practitioners, etc.) or nurse educators, some nurses undertake further training above bachelors degree level. Masters degrees exist in various healthcare related topics, and some nurses choose to study for PhDs or other higher academic awards. District nurses and health visitors are also considered specialist nurses, and in order to become such they must undertake specialist training (often in the form of a top up degree (see above) or post graduate diploma).

All newly qualifying district nurses and health visitors are trained to prescribe from the Nurse Prescribers’ Formulary, a list of medications and dressings typically useful to those carrying out these roles. Many of these (and other) nurses will also undertake training in independent and supplementary prescribing, which allows them (as of May 1, 2006) to prescribe almost any drug in the British National Formulary. This has been the cause of a great deal of debate in both medical and nursing circles.[5]

[edit] Hierarchy and nursing roles

Traditionally, on completion of training, nurses would be employed on a hospital ward, and work as staff nurses. The ward hierarchy consists of:

  • Healthcare Assistants etc. (see above for other titles) – Unregistered staff responsible for providing direct patient care, under the supervision of qualified nurses (often staff nurses). Under clinical grading (see below), these staff usually attracted A or B grades, and are now employed in Bands 2-3 under Agenda for Change (see below) although some roles are continuing to be developed and warrant a position at band 4 perhaps with a different title and involves more experience and/or qualifications. These positions at band 4 can often be referred to as Associate Practitioners and provide a more complex support role to the Registered Practitioner and/or Physician.
  • Staff Nurses – the basic grade of qualified nursing staff. These nurses are responsible for a set group of patients (e.g. one bay of a ward) or tasks (e.g. administering medications). In clinical grading, these nurses were usually employed at D grade, under Agenda for Change they are most likely to attract a band 5 salary. Level two nurses often hold positions anywhere between C and E grades, but are now banded exactly the same as first level staff nurses.
  • Senior staff nurses – these nurses carry out many of the same tasks, but are more senior to the staff nurses. This difference is usually academic, although it is evident occasionally when a senior staff nurse is in charge of the ward or department area during a shift. Employed at E or F grade under clinical grading, and may be assigned band 5 or 6 under Agenda for Change.
  • Junior/Deputy Sister; Charge Nurse; Ward Manager – responsible for the day-to-day running of the ward, and may also carry specific responsibilities for the overall running of the ward (e.g., rostering) in accordance with the wishes of the ward manager. These nurses were usually employed at F grade under clinical grading, and now are most likely to be assigned band 6, although some have attracted a band 7 salary.
  • Sister/Charge Nurse; Ward Manager – this nurse is responsible for running a ward or unit, and usually has budgetary control. He/she will employ staff, and be responsible for all the local management (e.g., rostering, approving pay claims, purchasing equipment, delegation duties or tasks). These nurses were previously employed at G grade, and now usually attract a band 7 salary (occasionally band 6, e.g. in the case of a small ward/ department, or if responsibility is shared).
  • Senior Sister; Charge Nurse; Senior Ward Manager – if there is a need to employ several nurses at a ward manager level (e.g. in A&E), then one of them often acts as the senior ward manager. These nurses were previously graded G or H, and now attract a banding anywhere between 6 and 8c.

There are also positions which exist above the ward level:

  • Clinical Nurse Manager/ Nurse Lead – A nurse who is responsible for an entire directorate/department (i.e. Surgical, Medical Diagnostic & Imaging etc.) or at least more than one ward, is often referred to as a clinical nurse manager. Depending on both the inclination of the NHS trust and themselves, they may be more or less involved in actual clinical nursing or management on a clinical level. Often employed at H grade, these nurses now attract band 8a (or occasionally 8b/8c) under Agenda for Change.
  • Modern Matrons – brought in in response to patients’ perceived detachment of nursing from its vocational history, the modern matron is responsible for overseeing all nursing within a department or directorate. Modern matrons used to be employed at H or I grades, and are now most commonly employed on bands 8a-c, occasionally on band 7. See Matron for more details of this role and its historical roots. Modern matrons were poorly received by the majority of nursing staff and their imposition was not called for by any professional group within the health service leading to many seeing the role as a waste of money and a professional step backwards especially as there is no clear role for them across the health service.[citation needed]

The status in the hierarchy of specialist nurses is variable, as each specialist nurse has a slightly different role within their respective NHS organisation. They are generally experienced nurses, however, and are employed at least on band 6 (previously F grade).

[edit] Pay scales

Until recently October 2004, all nurses in the NHS were employed on a scale known as clinical grading (see below). Agenda for Change was developed by the NHS in response to criticisms that the old scale reflected length of service more than knowledge, responsibility and skills.

Whilst developed by the NHS for its own use, both of these systems are in widespread use throughout the private sector.

[edit] Clinical grading

Also known as the Whitley system. This placed nurses (and some other hospital staff) on “grades” between A and I (with A being the most junior, and I the most senior).

Unregistered staff were employed on grades A and B (and occasionally C). Second level nurses were employed on various grades (usually between C and E), with first level nurses taking up grades D-I.

This system is still very popular amongst nurses, who will often refer to themselves by their old clinical grade than their Agenda for Change band (see below).[citation needed]

[edit] Agenda for Change

This system puts nurses (and most other non-medical/dental staff) on “bands” between 2 and 9. Unregistered staff take up bands 2-4, with qualified staff taking bands 5-8. Band 9 posts are for the most senior members of NHS management, currently there are no such positions in existence for nurses, although there will probably be such a position in future nursing in the UK.

The idea of this system is “equal pay for work of equal value”. There was a perceived discrepancy, under clinical grading, between ones grade (and therefore pay) and the work which one actually did, which Agenda for Change aimed to fix. Most NHS staff are now on the AfC system which took quite a long time to implement across the UK. A small percentage of staff are still going through an appeal procedure as they disagree with the band that they have been placed on.

Agenda for Change pay bands starting 1 April 2010, for the period of 2010/11. Pay for nurses on each of the bands is as follows:

  • Band 2: £13,653 – £16,753
  • Band 3: £15,610 – £18,577
  • Band 4: £18,152 – £21,798
  • Band 5: £21,173 – £27,534
  • Band 6: £25,472 – £34,189
  • Band 7: £30,460 – £40,157
  • Band 8a: £38,851 – £46,621
  • Band 8b: £45,254 – £55,945
  • Band 8c: £54,454 – £67,134
  • Band 8d: £65,270 – £80,810
  • Band 9: £77,079 – £97,478 [6]

Most nurses in England and Wales are now employed under Agenda for Change terms, however there are some still employed on clinical grades, especially in Scotland where only 9%[7] of the workforce has been assimilated. The government has set numerous targets for the transition to be complete (all now passed), but a full transition is yet to take effect.

There have recently been complaints of Agenda for Change being a sexist system, as nurses, who are mostly female, claim that, as a profession, they are under-valued using this system.

 

WHO: Observations on Vaccine Production Technologies and Factors Potentially Influencing Pandemic Influenza Vaccine Choices in Developing Countries, 2009 – WikiLeaks

  Observations on Vaccine Production
  Technologies and Factors Potentially
Influencing Pandemic Influenza Vaccine
    Choices in Developing Countries
                A discussion paper




                             World Health
                             Organization
            SoulMiitAtiaR*      WestwnhcMc~
�                                                        SEA-TRH-006
                                                 Distribution: Limited




  Observations on Vaccine Production
  Technologies and Factors Potentially
Influencing Pandemic Influenza vaccine
    Choices in Developing Countries
              A discussion paper




                       World Health
                       Organization
           Regional Office for South-East Asia
�@ World Health Organization 2009

This document is not issued to the general public, and all rights are reserved by the
World Health Organization (WHO). The document may not be reviewed,
abstracted, quoted, reproduced or translated, in part or in whole, without the prior
written permission of WHO. No part of this document may be stored in a retrieval
system or transmitted in any form or by any means - electronic, mechanical or
other - without the prior written permission of WHO.

The views expressed in documents by named authors are solely the responsibility
of those authors.

                                  Printed in India
�                                                          Contents

                                                                                                                                        Page


Acknowledgments .................................................................................................. v

Acronyms ..............................................................................................................vii

Introduction...........................................................................................................
                                                                                                                    1

        Background ...................................................................................................
                                                                                                                  2

        Overview of influenza vaccine production technologies ................................4
        Classic influenza vaccine produced in eggs .....................................................................                     4
        Live attenuated influenza vaccine ................................................................................... 5
        Influenza vaccines from cell culture ................................................................................                7
        Second generation biotech vaccines ............................................................................... 9
        Candidate seed strains and antigens..............................................................................                  10

        Issues and challenges...................................................................................11
        The question of adjuvants............................................................................................. 11
        Conditions imposed on commercial use of reverse genetics ........................................... 14
        Biotechnology and public perception ........................................................................... 15
        Export controls .............................................................................................................      17

        Options .......................................................................................................
                                                                                                                    19
        Timing and technology choices.....................................................................................                  19
        Fill/finish projects and importation of bulk antigen ........................................................
                                                                                                                    21
        The option of animal vaccine plant conversion.............................................................. 22

      Concluding discussion ...................................................................................24



                                                              Annexes

1.      Overview table of influenza vaccine technologies ........................................
                                                                                               27

2.      Relevant reports available online .................................................................
                                                                                                         31



                                                                                                                                        Page iii
�                        Acknowledgments
This paper has been written by Edward Hammond for the WHO Regional
Office for South-East Asia. It is intended as a contribution to the debate on
the sharing of influenza viruses and access to vaccines and other benefits
arising from their commercial exploitation, and to efforts to move forward
the issues raised by resolution WHA 60.28.




                                                                        Page v
�                        Acronyms

CBW     chemical and biological weapons

DNA     deoxyribonucleic acid

GAP     global action plan

GISN    global influenza surveillance network

IGM     intergovernmental meeting

IIV     inactivated influenza vaccine

LAIV    live attenuated influenza vaccine

MTA     material transfer agreement

PIP     pandemic influenza preparedness

RNA     ribonucleic acid

TRIPS   (Agreement on) Trade-Related Aspects of Intellectual
        Property Rights

VLP     virus-like particle

WHO     World Health Organization




                                                               Page vIi
�         Introduction
         As a result of concerns raised over the sharing of influenza viruses and the
         lack of affordable vaccines and medicines, the Pandemic Influenza
         Preparedness (PIP) Intergovernmental Meeting (IGM) is discussing the
         possible establishment of a new system for sharing of potentially pandemic
         influenza viruses, a well as sharing of the benefits resulting from research
                             s
         utilizing them.

              Among the possible benefits being discussed is expanded transfer of
         vaccine-related technology to developing countries, and a sustainable
         financing mechanism for developing country pandemic preparedness.
         WHO Member States hope that this financing and technology transfer
         would help close the gap between pandemic vaccine supply and demand.

              But what specific technological approaches are best suited for
         developing countries? Influenza vaccine technologies need to be
         categorized and assessed for their costlbenefit implications and respective
         tradeoffs and risks. Not all technologies are freely available or equally easy
         to use, so this codbenefit assessment needs to be made in the light of the
         constraints imposed by intellectual property claims as well as "hard"
         technology and know-how requirements.

               Other important considerations, including export controls and
         regulation of biotechnology, remain underexplored, but may influence
         decisions by developing countries with respect to a possible PIP IGM
         benefit sharing system.

               This paper discusses these issues in five sections. Section I provides a
         short background. Section II describes briefly the main technologies that are
         currently available or that are under development, as well as their
         comparative advantages and potential challenges1. Section Ill discusses a
         number of cross-cutting issues of practical significance (adjuvants,
         conditions related to seed strains, public perception of some of the
         technologies, and export controls) that lie outside the production-related
         questions, but that nevertheless need to be addressed. Section IV considers
         various options. Finally, Section V contains some concluding remarks.

' A table summarizing key features of the various technologies is attached as Annex 1.
�A discussion paper



          Background
          Ensuring adequate availability of pandemic influenza vaccines is not an easy
          task in any country of the world, and no single solution will be universally
          appropriate. Limited global production capacity for human influenza
          vaccines is the result of limited demand for seasonal influenza vaccines and
          technical challenges to influenza vaccine production. Adding to the
          difficulty is a recent sharp increase in patents and patent applications
          related to influenza vaccines, which may impede access to vaccine
          production technologies.

                Pandemic preparedness efforts cannot be considered in isolation from
          other public health concerns and must be weighed in the context of
          programmes to address other priorities, complementing them when
          possible. For example, the infrastructure to produce some types of
          influenza vaccine is useful for making other kinds of vaccines, yet
          paradoxically, the flu vaccine technologies that are most adaptable may be
          the most expensive and technologically-challengingto utilize, as well as the
          most impacted by intellectual property claims.

                Some have proposed to expand seasonal influenza vaccination in
          order to expand pandemic production capacity. This strategy is a key part
          of the WHO Global Action Plan (GAP), whose overarching goal is to
          increase pandemic influenza vaccine supply by stimulating demand for
          seasonal influenza vaccines. Greater seasonal demand, it is reasoned, will
          stimulate the private sector and others to construct additional influenza
          vaccine production capacity that can then be used in a pandemic.

                But in many countries, and especially developing countries, there is
          low demand for seasonal flu vaccines and limited prospects of expanding it,
          particularly among citizens in lower economic strata with competing health-
          care priorities. The cost of implementing the GAP, even with optimistic
          economic and antigen assumptions, is estimated to rise to US$ 3.5 billion
          to US$ 5 billion annually by 2012, with an emphasis on spending in
          developed countries to stimulate demand there, and the questionable
          assumption that excess pandemic vaccine will quickly be used to vaccinate
          those in other countries.'


* WHO IVR. The Global Action Plan (CAP) to Increase Supply of Pandemic Influenza Vaccines, First
  Meeting of the Advisory Croup, WHO/IVB/08.10, 19 October 2007, Geneva.


Page 2
�                         Observat ions on Vaccine Production technologies and Factors Potentially Influencing
                                                Pandemic Influenza Vaccine Choices in Develooine Countries



             It is unwise not to squarely recognize the limitations on seasonal
       influenza vaccine demand and the great challenges facing the GAP. Even in
       developed countries where demand and income are higher, and despite
       hefty economic stimuli, manufacturers currently are hesitant to expand
       production capacity. This is in large part due to limited seasonal vaccine
       demand. For instance, a large European manufacturer recently backed out
       of an agreement to build an influenza vaccine facility in the United States
       because it said that a US$ 298 million government subsidy was in~ufficient.~

             Others have proposed emergency conversion of animal vaccine plants
       if a pandemic strikes, particularly of poultry vaccine facilities with egg-based
       production systems that probably can be adapted to produce human
       influenza vaccine. With global human influenza vaccine production
       capacity at least 70% short of providing vaccination for the global
       population within six months of a pandemicI4 this suggestion makes
       obvious sense. Where such capacity exists, this could expand pandemic
       vaccine supply, but there are significant technical and safety hurdles.

              Another strategy that has been proposed is to concentrate vaccine
        antigen production in a small number of developed countries, on the theory
        that making vaccine antigen is best done in a few expert facilities and that, if
        these facilities are collectively made large enough, their surplus production
        can be exported to developing countries in the event of a pandemic. Yet this
        strategy, encouraged by the WHO GAP, leaves developing countries in a
        state of dependency and at the end of the queue to receive vaccine.

             All of the above factors, together with mounting pressure on health
        budgets as a result of the global economic downturn, make ensuring
        availability of influenza vaccines particularly difficult for most developing
        countries.

              Several studies have recently discussed options for expanding
        prepandemic and pandemic influenza vaccine production capacity. A
        number of these reports are listed in the annex to this report. While these
        are valuable and discuss some technical aspects of influenza vaccines in
        greater detail, there are key issues related to pandemic vaccination
        strategies that remain under-contextualized for policy-makers. This paper
        seeks to fill that gap.

McKenna M. Plant cancellation shows problems in flu vaccine business in CIDRAP News, 3 Ocl. 2008
WHO. Business Plan for the Global Pandemic Influenza Action Plan to Increase Vaccine Supply,
February 2008.


                                                                                                      Page 3
�A discussion oaoer



                 This paper assumes that developing countries will largely not be
          satisfied with reliance on pandemic vaccines and/or bulk antigen exported
          from Europe, North America, or Japan, particularly because such supplies
          currently cannot be made available in a timely fashion. Therefore is difficult
          to argue that such reliance is an adequate pandemic vaccine supply plan.
          Rather, here it is presumed that developing countries will continue to seek
          the development of national or regional 'vaccine production capacity
          through technology transfer and sharing of benefits of influenza research.


2.        Overview of influenza vaccine production
          technologies
          There are a variety of technologies that are used or have been proposed for
          production of human influenza vaccines. Often, significant parts of the
          production process are similar. This is especially true in the later stages of
          manufacture, such as packaging. The technologies may be categorized in
          several ways. Below, they have been divided into four basic technological
          approaches.


          Classic influenza vaccine produced in eggs

          With few exceptions, currently available seasonal and prepandemic
          influenza vaccines are manufactured through egg-based production
          methods. The system is cumbersome and inefficient in comparison to the
          theoretical possibilities of newer cell-based production (see below), leading
          some to characterize egg-based production as antiquated. Such
          comparisons, however, are invariably made against technologies that have
          yet to be fully commercially deployed and proven. Moreover, although it
          may not be new, this decades-old technology is relatively cheap, very well
          proven, and largely unencumbered by intellectual property claims.

                Egg-based production is employed throughout the world for animal
          and human vaccines. Apart from influenza, however, the only human
          vaccines for which the egg-based system is utilized are yellow fever and
          Japanese encephalitis vaccine. This means that apart from making flu
          vaccine, egg-based production lines have limited broader utility for human
          public health.'


  Egg-based lines arc important for animal heakh, however, as discussed below.


Page 4
�              Observations on Vaccine Production Technologies and Factors Potentially Influencing
                                    Pandemic Influenza Vaccine Choices in Developing Countries



      Egg-based production requires a supply of fertile chicken eggs
produced under relatively stringent conditions (in comparison to eggs
produced for food consumption). This is to ensure that they do not carry
pathogens that might taint the vaccine. The eggs are infected with a vaccine
strain and the fluid harvested from them yields vaccine after separation and
further production steps.

      The reluctance of H5 viruses to grow to high titer in eggs (because the
virus strains are too efficient at killing chicken embryos) is a problem that
has bedeviled H5 vaccine development. While this remains a significant
technical challenge, the problems with growing H5 viruses in eggs are being
overcome, mainly by attenuating the hemagglutinin (HA) gene of the
vaccine strain, typically through reverse genetics (see below). It may be
noted that some of these techniques are proprietary however.

      Major requirements of the egg-based production system include the
process of "candling" the eggs (inspection under bright light); equipment to
inoculate the eggs with virus; incubators in which to keep the eggs while
the virus is reproducing; and equipment to harvest, separate, and purify the
vaccine virus after incubation.

     Some of the technology required to produce the vaccine strain is
specialized; however, none of it is reported to be particularly expensive,
complicated or difficult to operate. In the newest facilities the entire
process is automated, while in others some steps in production (for
example, candling and harvesting) are conducted by human technicians.

     Later steps of egg-based vaccine production, including formulation
and packaging, may be similar or identical to the process used with other
technologies.


Live attenuated influenza vaccine

Live attenuated influenza vaccine, abbreviated "LAIV", is an influenza
vaccine production technology in limited commercial use in the Russian
Federation and in the United States. LAIV offers the possibility of producing
significantly more vaccine than classic egg-based production using same
production line; however there are significant additional scientific and
intellectual property hurdles that may reduce LAIVis attraction for
developing countries.

                                                                                          Page 5
�A discussion oaner


                  The production process for LAIV vaccines is similar to that of classic
            egg-based vaccines, with some notable exceptions. LAIVs are administered
            live. This means that when the vaccine strain-containing fluid is harvested
            from eggs, it is not exposed to a detergent. Thus, if adventitious pathogens
            are present in the eggs, these may survive the formulation process and
            eventually infect human vaccine recipients. Therefore, eggs used in LAIV
            production may require even higher production standards than those used
            to produce classic killed vaccine. This increased danger of contamination
            means biosafety practices in production need to be more stringent than
            those used for classic killed vaccine.

                  While there are a number of well-characterized backbone strains6
            available for classic vaccines, the "cold-adapted"' backbones used in LAIVs
            are proprietary, such as the "Ann Arbor" strain used in the United States
            and the "Leningrad" strain used in the Russian Federation. LAIVs thus
            require a proprietary backbone strain6 and cannot be produced using the
            vaccine seeds strains currently distributed by WHO global influenza
            surveillance network (which do not have "cold-adapted" backbones).

                  Harvesting is simpler for LAIVs (no detergent wash is needed), but the
            final product is more delicate because the live vaccine must be kept viable
            "alive") until it is used. This means LAIVs require cold storage.

                  The fact that LAIVs are not killed potentially offers a major advantage
            over classic vaccine, but at a cost. LAIVs reproduce in the body of
            immunized persons; thus, they effectively act as their own adjuvants, which
            means they should require a lower dose of antigen than killed vaccine. This
            means the same production line may yield considerably more LAIV than
            classic killed vaccine, although estimates of the increased yield vary widely.'


    Influenza vaccines typically are comprised of a(n) HA gene(s) taken from a viral isolate that is inserted
     into another, laboratory-adaptedstrain by reassortment or recombinant (reverse genetics) means.
     While the immunogenic HA gene is the most important part of the vaccine, the labadapted strain into
     which it is placed has typically been selected for useful characteristics for lab and industrial use (high
     growth rate, tolerance for lab conditions and temperature ranges, etc). This labadapted strain is called
     the "backbone" strain.
'   "Cold adapted" influenza strains are laboratory-adapted types that are suitable for use in live vaccines,
     which must be kept cold until use in order to maintain the vaccine's viability.
' Discussions to license the Russian "Leningrad" LAIV strains for H5 vaccine production .ire taking place,
   however, no detailed information concerning the terms and restrictions of any possible license is
   available, and no final agreement has been reported to have been reached.
' The WHO CAP estimate is 4.5 times, whereas others have estimated a yield as high as 10 limes that of
 '
   the c:lassic trivalent killed vaccine process.


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�               Observations on Vaccine Production Technologies and Factors Potentially Influencing
                                     Pandemic Influenza Vaccine Choices in iheloping Countries



      One price of this antigen efficiency is that LAIVs are administered as
an intranasal aerosol (i.e. sprayed into the nose), rather than being injected.
They thus require a special closer instead of standard syringes. Sufficient
supplies of this doser are required in order to use LAlVs.

      Another limitation of LAIVs is that they are unsuitable for
prepandemic vaccines because of the possibility that the live prepandemic
vaccine strain could mutate or recombine with circulating strains,
potentially causing or contributing to a new epidemic or even pandemic flu
strain. While this concern is not applicable to seasonal vaccines (because of
the antigens used), it does seriously limit the ability to test LAIV procedures
and formulations prior to an actual pandemic.

      Of note, in the future it may become practical for LAIVs to be
produced in cell culture (see below), although at present they are produced
in eggs.


Influenza vaccines from cell culture

Influenza vaccines produced by cell culture are currently under
development in several places but so far are not produced commercially on
a large scale. In the cell culture process, animal or other cells are infected
with a vaccine virus, which is then harvested and formulated into vaccine.
The process takes place in vessels called bioreactors (or fermenters), in basic
design not dissimilar from those used in brewing.

      Cell culture typically starts by growing cells in a nutrient-rich fluid in
small containers, scaling up to larger ones as the cells reproduce. When the
desired cell density and scale is reached (hundreds or thousands of litres for
commercial production), the cells are infected with vaccine strain virus.
After the virus reproduces, the cells are harvested and virus processed into
vaccine.

      In some cell culture systems, gently agitated cells grow freely in a sort
of "soup" mixed with nutrients and (eventually) with vaccine virus. In other
cell culture systems, the cells grow affixed to a substrate such as tiny gold-
coated beads. They are then released by agitation.



                                                                                              --

                                                                                           Page 7
�A discussion oamr


                For large-scale commercial production, the process requires large
          bioreactors, from hundreds to thousands of litres in size. Production of cell
          culture vaccines also requires equipment t o build and maintain a "cell
          bank" to provide a new supply of fresh identical cells after batches of virus-
          infected cells are harvested.

                 Cell culture systems are likely to be more flexible than egg-based
          systems for production of other human vaccines, potentially increasing a
          facility's utility. For H5 influenza viruses in particular, there are claims of cell
          culture systems that grow the virus to a higher titer than is possible in eggs.

                 Although cell culture vaccines are a major focus of research and
          development (R&D), as yet they remain in limited commercial use.
          Scientific limitations for their use in flu vaccines include the inability to be
          certain ahead of time that a particular cell line will be appropriate to grow
          the pandemic strain, and the need for substantial bioreactor capacity, of
          which there is little to no global surplus. Although investment may be
          recouped through a multi-use facility, cell culture has considerably higher
          facility construction costs at an industrial scale.

                In addition to potential patent claims over the influenza genes (which
          also impact egg-based vaccines) and backbones used in vaccine strains,
          there are additional intellectual property issues related to cell culture
          influenza vaccines. The cell lines that are used are themselves often
          patented, and the information necessary for their use and for regulatory
          approval is proprietary.

  Table 1 Examples of proprietary cells lines used in cell culture vaccine production
         :


 Avian embryonic stem cells         Vivalis (France)         Licensed to Novartis,
                                                             GlaxoSmithKline, and others


                                                             Vero cells per se are not
 cells (Vero)                                                proprietary, but Baxter's
                                                             process of using them is.

                To date, few cell culture-produced vaccines have been approved for
          human use, and they are likely to prompt more intense regulatory scrutiny
          than egg-produced vaccines. Cell culture vaccines require approval for the
          vaccine as well as characterization and safety demonstration of the cells used.

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�                              Olwervations on Vaccine Production technologies and factors Potentially Influencing
                                                    Pandemic Influenza Vaccine Choices in Uwelooinc Count rics



            Second generation biotech vaccines

            If cell culture vaccines, because of their sophisticated biological
            manufacturing process, may be considered the first generation of
            biotechnological flu vaccines, then a basket of different technologies currently
            under development could constitute the second. While supporters of these
            technologies believe they may be useful for pandemic influenza vaccines,
            several of them are at early stages of development and none are proven and
            ready for commercial use. Therefore, although it is difficult to generalize
            about these new technologies, they are unlikely to be selected in the short
            term for pandemic vaccine production in developed or developing countries.
            These technologies depend on the WHO global influenza surveillance
            network (GISN) for antigens and WHO selections of the best antigens for use
            in vaccines, but do not utilize WHO candidate seed strain.

                  Taking a longer a view, however, it is possible that some of these
            technologies, for example virus-like particles (VLPs), may become viable for
            large-scale use. The fact that they are new and mainly privately developed,
            however, means that in general they are heavily covered by intellectual
            property claims and may require very new kinds of know-how. For most
            countries it is too early to tell, however, if national patents will be issued, so
            the extent of intellectual property impediments for any particular
            developing country remains unclear.

                 Briefly, second-generation biotech vaccines include, among other
            approaches:

                   >     production of recombinant HA protein in other, easily grown,
                         organisms (e.g. transgenic bacteria);

                   >     "naked" and plasmid DNA vaccines in which "codon
                         ~ p t i m i z e d ' " flu genes are used directly as vaccine, and
                                               ~
                   >-    genetically engineered systems to co-express HA, NA,           M2
                         genes from flu, manufacturing a "virus like particle" (VLP) that is
                         purified from culture and used as vaccine.


lo   "Codon opiiniized" genes have nucleic acids that have been altered-typically changed from RNA to
     DNA-so 1h.11ihe gcnr can be he~terexpressed in a biotechnological application (e.g. . v,iccinc').
                                                                                          I



                                                                                                          Page 9
�A discussion paper



             Summary of the basic technological approaches to influenza vaccine
             production
             1. Egg-based "classic" influenza vaccine: Vaccine virus is injected into fertilized
             eggs. The eggs are placed in incubators and the virus reproduces in the eggs. Fluid
             is then harvested from the eggs and washed with detergent The resulting killed
             virus material is separated and used for vaccine formulation. This type of vaccine is
             one kind of inactivated (i.e. killed) influenza vaccine, or "11V".
             2. Live attenuated influenza vaccine ("LAIV"): Vaccine virus is grown in eggs (or
             in the future, potentially in cell culture) in a process similar to classic flu vaccine.
             The live virus uses a special type of genetic backbone (currently of limited
             availability since they are proprietary). Harvesting and formulation is simpler than
             with killed vaccines. The final product is more delicate and requires a cold chain,
             but the process potentially is considerably more efficient, producing more flu shots
             with the same number of eggs.
             3. Cell culture influenza vaccines: Mammalian, avian, or other cells are cultured in
             growth media. This culture is scaled up to the desired density of cells in large
             bioreactors (fermented up to thousands of litres in capacity. The culture is infected
             with vaccine strain, which multiplies in the cells, producing large quantities of vaccine
             virus. Harvesting, purification and packagingare essentially the same as with egg-
             based vaccines. This is another type of IIV, produced by a different method.
             4. "Second generation" biotechnologicalvaccines: Many techniques are under
             study, including: producing recombinant HA protein in other, easily grown,
             organisms (e.g. transgenic bacteria); "naked* and plasmid DNAvaccines in which
             "codon optimized" genes are used as vaccine; and genetically engineered systems
             to co-expressflu genes, making a virus-like particle (VLP) that is used a vaccine.
                                                                                        s


            Candidate seed strains and antigens

            The W H O system develops and distributes candidate H5 vaccine seed
            strains. he& seed strain; are suitable for producing vaccine in eggs and
            incorporate antigens that have been selected by WHO. In the event of a
            pandemic, the W H O system may develop and make available LAIV-
            suitable seed strains; however, W H O does not presently have rights to the
            proprietary LAIV backbones.

                Although at a technical level, current W H O candidate seed strains can
            be used to produce H5 vaccine, there are legal restrictions imposed on
            them in a required Material Transfer Agreement (MTA).ll This is because


l1    For example, the Material Transfer Agreement for the WHO candidate seed strain NIBRG-23, made
     from an HSN1 strain isolated in Turkey, can be viewed here:
     h~p://www.11ibsc.ac.uk~flu_site/Docs/spotlighl/H5N1MTA-NIBRG-23.doc


Page 10
�                     Observations on Vaccine Production Technologies and Factors Potentially Influencing
                                           Pandemic Influeni'a Vaccine Choices in Developing Countries



     they are created using proprietary reverse genetics technology. (See also the
     discussion on conditions imposed on commercial use of reverse genetics in
     section Ill below.)

           The advantage that the WHO seed strains theoretically offer is that the
     strain is a known quantity that may be quickly used, reducing the amount
     of work and time needed for new strains to go into production.

           Vaccine makers and other companies, however, may choose not to
     use WHO candidate seed strains for any of several reasons. These may
     include a desire to avoid the intellectual property restrictions imposed by
     the WHO MTA, or they may wish to use a technology type for which the
     WHO strain is not suitable (e.g. LAIVs), or they may wish to make other
     alterations particular to their production system (for example, to introduce a
     mutation intended to make the virus grow to higher titer).

            If a vaccine maker does not use the WHO candidate vaccine seed strain
     in actual production, however, it is still highly likely to use the antigens selected
     by the WHO system        C
                              SImost immunogenic. In this case, the maker would
     obtain the HA (andlor NA) gene(s) from the WHO system or synthesize them
     from sequence data. The maker then incorporates the WHO-selected
     antigenk) into its own vaccine strain. Thus, particularly in the future, of
     arguably even greater importance than the WHO candidate vaccine seed
     strain are the genes that the WHO system determines to be most suitable for
     use in vaccines, because these will be used by manufacturers whether or not
     the manufacturer utilizes the WHO candidate seed strain.


3.   Issues and challenges
     The question of adjuvants
     Adjuvants are substances that are added to a vaccine in order to enhance
     its immunological effect. Most adjuvants act on the human immune system
     and are not linked to a particular vaccine strain or even a particular disease.
     Thus a particular adjuvant may be used not only for influenza vaccine; but
     also in vaccines against other diseases.

          Adjuvants can both reduce the amount of antigen needed per vaccine
     dose (potentially of great importance in a pandemic) and increase the
     "take" of vaccines-lhat is, the rate of successful vaccination.


                                                                                                Page 1 7
�A discussion paper



                 Many adjuvants that may be used in influenza vaccines today are
            inorganic chemicals. These are sometimes aluminum-related compounds,
            such as aluminum hydroxide (or gibbsite, (Al(OH)J), which is more familiar
            in medicine for its use as an oral antacid. One adjuvant that has long been
            used, alum, is patent-free and easily obtained, but it is not generally
            considered promising for H5 vaccines.                 ,




                  Major influenza vaccine manufacturers are increasingly using newer
            adjuvants of a type called oil-in-water emulsions. Companies claim these
            offer substantial improvements over other adjuvants. The proprietary oil-in-
            water adjuvants used by Novartis and Gla~oSmithKline'~ based on
                                                                         are
            squalene, an organic compound produced in small quantities by many
            animals and some plants, and are subject to patents and trade secrets.

                 A large number of biotechnological adjuvants, such as short pieces of
            DNA that are active in the body and are designed to make vaccines more
            immunogenic through specific gene or protein-level effects on the immune
            system, are undergoing research. These, however, remain experimental.13

                   Not all vaccines contain an adjuvant. LAIVs do not need to be
            adjuvanted because they are alive and reproduce in the upper respiratory
            tract. One H5 vaccine, produced in cell culture by Baxter International, is
            a killed virus vaccine that is unadjuvanted.14

                  One problem with assessing the potential use of adjuvants for
            pandemic vaccine production in developing countries is that they are often
            highly proprietary. For instance, detailed information on production of
            vaccines with oil-in-water emulsion adjuvants is limited, as the adjuvants
            are often patented and their use is covered by trade secrets.

                   Table 2 provides an overview of a number of adjuvants.


  Sanofi's
'¥          proprietary formulation is reportedly similar, but its exact composition does not appear to
     have been made public.
" Because these     adjuvants are varied in nature and generally in earlier development stages, this paper
     focuses on adjuvants in current use or advanced development
l4    The Baxter vaccine has an unusual composition and production method. It uses unaltered H5N1 virus
     isolates that have not been placed on a labadapted backbone or had genetic alterations to reduce
     pathogenicity. Because the live vaccine virus is virulent for birds and, potentially, humans and other
     animals, it must be grown under very careful biosafety procedures in P-3 (BSL-3) containment. This
     method of production requires a cell culture system, with the added challenge of stringent BSL-3
     practices and facilities.


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�                                 Observations on Vaccine Production Technologies and Factors Potentially Influencing
                                                       Pandemic Influenza Vaccine Choices in DevelopingCountries



          Table 2: Adjuvants that may be used in pandemic influenza vaccines



What is it?           An inorganic     Chemicals         An oil-in-      An oil-in-       An oil-in-       Biological
                      chemical,        related to        water           water            water            materials
                      potassium        alum,             emulsion,       emulsion,        emulsion,        designed to
                      aluminum         including         consisting of   consisting of    whose            boost
                      sulfa~e.         aluminum          squalene,       squalene,        formulation      immune
                                       hydroxide         polysor'Jate    plysorbate       does not         syst-
                                       and               80 (Tween       80, and DL-      appear to        response.
                                       aluminum          801, and        a-               have been
                                       phosphate.        sorbitane       tocopherol.      published.
                                                         trioleate
                                                         (Span 85).
                                                                         Yes             1 yes            1 Yes. Includes
                                                                                                           JVRS-100
                                                                                          Avenlis)         fluventus),

                                                                                                           (Intercell) etc.
Use                   Has long         Clinical trials   Used in         Used in          Does not         Experimental:
                      been used in     are underway      vaccines        vaccines         currently        some have
                      various          of pandemic       licensed in     licensed in      appear to be     advanced to
                      vaccines.        flu vaccines      some            some             licensed.        human trials.
                                       utilizing         countries.      countries.                        Regulatory
                                       these. Also                                                         hurdles likely
                                       used in other                                                       to be quite
                                       vaccines.                                                           substantial.
Efficacy issues       Used in trials   Potentially       Deemed          Deemed           AF03 is           Unproven.
                      and in one       more              effective and   effective and    thought to
                      US-licensed      effective than    licensed for    licensed for     be similar to
                      prepandemic      alum, but less    use in non-     use in non-      MF59 and
                      vaccine; but     so than           influenza       influenza        ,4503.
                      often            proprietary       vaccines.
                      regarded as      adjuvants.
                      inadequate       Mixed results
                      for use with     in research to
                  '   H5 vaccines.     date.

                 Based on their reported composition, adjuvants such a MF59 do not
                                                                      s
           appear to utilize unusual or expensive ingredients; however, it cannot be
           assumed that effectively incorporating them into vaccines is as
           straightforward as their reported chemical composition because details of
           their use are proprietary.

                 In some countries, vaccination has been associated with social
           controversies due to perceived risks. Some vaccine critics have claimed that
           certain adjuvants are unsafe, including aluminum hydroxide (alleged to be


                                                                                                                  Page 13
�A discussion caper


          linked to Alzheimer disease) and MF59 (which has received scrutiny for its
          use in a controversial US anthrax vaccine). While the scientific merit of
          these criticisms is debated-the compounds have passed regulatory review
          in many countries-where concern exists it would be inappropriate to ignore
          the potential disruption to vaccination campaigns due to widespread worry
          over adjuvant safety.

                It is clear that in the event of a pandemic, the presently limited global
          vaccine virus production capacity means that the supply of pandemic
          vaccine antigen (in any form) will be far outstripped by demand, especially
          in the early stages. With the exception of unadjuvanted LAIVs, in the
          dominant planning scenario, widespread use of the most effective adjuvants
          is highly desirable because it will enable more people to be vaccinated with
          the limited amount of antigen available, especially at earlier stages of the
          pandemic. Failure to use the most effective adjuvants would "waste"
          antigen because each suboptimally adjuvanted dose would "rob" antigen
          from the global supply.


          Conditions imposed on commercial use of reverse genetics
          Reverse genetics is a relatively new proprietary technology that is being
          applied to the development of influenza vaccines as well as other products. At
          present the technology is used in the creation of WHO GISN H5 vaccine seed
          strains, although it is not strictly technically obligatory to use it when making
          pandemic vaccine strains. Because of the advantages it offers, however, the
          technology will likely be increasingly used in future vaccine strains.

                Primarily developed by American and British universities, and covered
          by a large number of patents, reverse genetics intellectual property has
          been accumulated by Medimmune, a US-based subsidiary of the United
          Kingdom's Astra Zeneca, a large flu vaccine maker. Meclimmune has thus
          far allowed use of its reverse genetics intellectual property in pandemic
          vaccine R&D, however, it has indicated that it will not permit commercial
          use of the technology without a license.

                Material transfer agreements for WHO candidate seed strains of H5
          vaccines thus include protections for Medimmune's intellectual property and
          thereby impose restrictions on those that receive seed strains (through contract
          law), even in countries where Medimmune's patents have not been issued.

               Reverse genetics technology involves creation of loops of DNA called
          plasmids whose key parts encode for influenza genes. When the plasmids


Page 14
�               Observations on Vaccine Production Technologies and Factors Potentially Influencing
                                     Pandemic Influenza Vaccine Choices in Developing Countries



are introduced into cells, the DNA is transcribed into RNA and influenza
virus is produced. The technology enables scientists to "edit" the influenza
viral genes by making alterations to the DNA plasmid, for example, deleting
bases from the HA gene to make the virus avirulent.

      In addition to allowing manipulation of individual genes, reverse
genetics allows scientists to relatively easily mix and match genes from
different influenza strains, particularly when inserting new genes onto
'backbone" strains for which plasmid systems are already constructed. This
is useful for research purposes and for creation of vaccine strains, because it
can be more straightforward and reliable than the traditional reassortment
method, whereby cells are coinfected with different strains and the resulting
hybrid viruses identified and selected by scientists.

      Reverse genetics is potentially a very useful technology for egg-based,
cell culture, and other types of flu vaccines. It is, however, controlled by
Medimmune and because it is used in current WHO candidate seed
strains, recipients of those strains are already obligated to negotiate with
Medimmune should they choose to commercially produce vaccine from
those strains. This point has perhaps not received the attention it warrants.


Biotechnology and public perception

An important policy and health consideration underappreciated to date is
the potential for problems with social and regulatory acceptance of
recombinant pandemic influenza vaccines-that is, those that are the
product of biotechnology. Some countries may have additional regulatory
requirements for such vaccines. This may influence the decisions that
governments take in vaccine supplies. Decisions may be complicated by
the fact that influenza vaccines make use of biotechnologies that might or
might not be popularly and legally understood as "genetic engineering".

      It is logical that in the event of a severe pandemic the vast majority of
people would opt for vaccination even if concerned about the safety of a
recombinant vaccine, for the simple reason that fear of severe illness or
death from the disease is greater than concern about the vaccine. It is also
true, however, that genetically engineered products used in humans remain
controversial in many parts of the world and some citizens may be reluctant
to be vaccinated, particularly in scenarios such as a slow-spreading
pandemic or widespread use of a recombinant (pre)pandemic vaccine.


                                                                                          Page 7 5
�A discussion paper



                 Although not strictly tied to biotechnology, recent cases of problems
           in polio vaccination campaigns and the rejection of childhood vaccination
           among some religious communities are evidence of the importance of
           safety perceptions and belief. In the case of pandemic influenza vaccines,
           the degree to which the vaccine could be termed "genetically engineered"
           varies by the technology used. Perceptions may be further influenced by
           other factors, such as use of animal products in cell culture, and whether
           the vaccine is live or killed, with killed vaccines presumably engendering
           less resistance.

                A brief breakdown of some pertinent influenza vaccine technologies
           and how they might be consideredis given in Table 3.

                 Table 3: Brief overview of key influenza vaccine technologies
      lechmtogy        -                    What is it?-                          Islt-geneticc~ng?
Reverse genetics              Assenlbly of influenza viruses through      Viruses produced by reverse genetics are
                              the creation of DNA plasmids bearing        recombinant products and are, as it is
                              influenza genes that are transcribed into   generally understood (and regulated),
                              virus in infected cells. Although not       genetically engineered. If the virus genes
                              strictly necessary for most influenza       have not been significantly changed,
                              vaccines, it may offer time savings and     however, then the resulting vaccine virus
                              other R&D advantages.                       may not substantially differ from
                                                                          reassortant viruses or natural virus isolates.
HA gene deletions             To facilitate safe handling of H5N1         The manipulation of the HA gene creates
                              research viruses and vaccine production.    a recombinant product. The modified HA
                              part of the HA gene is deleted to make      gene is not transgenic, however, because
                              it nonpathogenic. This altered gene is      it does not incorporate foreign genetic
                              then used in the vacane strain.             material.
Virus-like particles (VLPs)   Insertion of nucleic acids coding for       The VLP vaccine itself is non-living;
                              influenza virus genes into other cells,     however, i t is the product of an organism
                              triggering the production of non-living     that is genetically engineered to express
                              particles that mimic key parts of           non-native genes.
                              influenza viruses, and can trigger an
                              immune reaction.
Recombinant LAIV              While it is possible to create LAIVs        A live genetically engineered vaccine is
                              without use of recombinant DNA, lor         the type most likely to encounter stricter
                              technical reasons i t is likely that a      regulatory requirements and safety
                              pandemic LAIV would be produced             questions.
                              with reverse genetics and possibly
                              incorporate additional genetic
                              modifications.
                              For many of the same reasons as LAIVs,      These vaccines will contain a genetically
                              (pre)pandemickilled flu vaccines,           engineered product Regulatory and social
                              produced in eggs or cell culture, may be    concerns may be fewer, however,
                              recombinant products.                       because the vaccine virus is killed before
                                                                          administration.



Page 16
�                           Observations on Vaccine Production Technologies and factors Pofentially Influencing
                                                 Pandemic Influenza Vaccine Choices in Revelopinc Countries




         Export controls

        Export controls are imposed by national laws. They are designed to regulate
        and sometimes prevent the transfer of technologies (hat may be used to
        create nuclear, chemical, or biological weapons as well as certain other
        items, such as missile-related technology. They are discussed in particular
        here because they have generally not been discussed with respect to
        pandemic vaccine production to date.

              Export controls are necessary to consider because research on highly
         pathogenic influenza viruses and production of vaccines require facilities,
         know-how and equipment that could be abused in biological weapons
         programmes. As a result, some of the same technologies that can be used to
         protect public health by producing vaccines can be difficult to acquire
         because they may fall under export control laws.

               Biological export control laws are controversial and have been a
         matter of intense debate at the Biological and Toxin Weapons Convention.
         The countries that impose the most rigorous export controls (mainly
         developed countries) argue that they are necessary for national security and
         anti-proliferation reasons. On the other hand, the countries that are most
         often denied technology (mainly developing countries) counter that export
         controls are arbitrary and unfair, and that they are often motivated by
         political or economic considerations not related to weapons proliferation.

              Export controls are not governed by any international agreement.
         Some countries that have biological (and chemical) export control systems
         attempt to coordinate them through the Australia Croup, a collection of
         countries whose stated aim is "to minimise the risk of assisting chemical and
         biological weapon (CBW) proliferation".

               The majority of the members of the Australia Croup are OECD
         Member States. The Croup calls itself an "informal arrangement" that
         "meets annually to discuss ways of increasing the effectiveness of
         participating countries' national export licensing measures to prevent
         would-be proliferators from obtaining materials for CBW programme^".^^



'" See hltp://www.ai~straliagroup.net.

                                                                                                      Page 7 7
�A discussion paper



                 For influenza vaccines, export control laws may limit the transfer of a
            wide variety of research and vaccine production-related technology, and
            even shipments of vaccines themselves.16

                  Export controls are applied to equipment, organisms, and ideas. The
            different types of items that can fall under export controls,include:

                     >   Physical items used in research and vaccine production such as
                         bioreactors (fermenters), lyophilizers (freeze dryers), separation
                         and packaging (filling) equipment.
                     >   Know-how such a blueprints, design and engineering services
                                             s
                         for high-containment laboratories and biological production
                         facilities, as well as certain kinds of scientific procedures and
                         knowledge.
                     >   Biological materials-for example, highly virulent disease strains
                         or, in some cases, vaccines.

                  Export controls apply in different degrees to different countries and
            technologies. Items considered by export-controlling countries to be of
            highest risk1' may be more difficult to export than items that are considered
            lower risk (for example, vaccines). Generally, when an export license for a
            controlled item (or technology) is sought, the item is classified for its
            intrinsic risk and then cross-referenced against a list of countries that
            themselves have been categorized according to the degree of weapons
            proliferation threat they are alleged to impose.

                 An additional pertinent consideration may be the entity in the
            importing country that seeks access to the technology. For example, a well-
            known international pharmaceutical company may be less likely to be
            denied an export controlled item than a government research institute in
            the same country, if the exporting county is suspicious of the aims of the
            importing country's government research programme.

                Finally, when export licenses are issued, typically they are contingent
            upon the recipient of the controlled items agreeing to no further transfers of

"' A particularly severe export conlrol has recently been highlighted in news articles pointing out that
     export controls in the United States would apply to H5N1 vaccine exports to several countries. See,
     for example, URL: http://www.exportlawblog.com/archives/406(accessed 25 November 2008).
l7   For example, a large, high-quality fermentcr, which might be used to produce biological weapons
     agents instead of vaccine.


Page 7 8
�                               Observations on Vaccine Production Technologies and Factors Potentially Influencing
                                                     Pandemic Influenza Vaccine Choices in Developing Countries



            the technology. While as practical matter this type of re-export restriction is
            difficult to enforce, entities that transfer export-controlled technologies
            place at great risk their future ability to obtain export-controlled
            techn~logies.'~

                  While the Non-Aligned Movement and others have been critical of
            the Australia Group's biological export control system,'' there are no signs
            that export controls are being relaxed even with the prospect of an
            influenza pandemic. Countries must therefore take into consideration the
            issue of export controls when making pandemic preparedness decisions.
            Many developing countries are subject to Australia Group's export control
            restrictions, which could impede their access to influenza vaccine
            production technology.

                  The impact of export control regimes will vary by country and
            technology. While export controls will not be a major issue for all countries,
            particular technologies, such as cell culture systems, may be more prone to
            export control problems than others. Countries that wish to develop a
            domestic production capacity that utilizes imported technologies will need
            to address these issues.


4.           Options
             Timing and technology choices
             It is difficult to reconcile the severity of fears of an imminent pandemic with
             the slow pace of expansion of global influenza vaccination and vaccine
             production capacity. Years of meetings and rhetoric have passed since the
             H5 pandemic scare began, yet most countries in the world-including many
             wealthy countries-have thus far not ensured pandemic vaccine supplies for
             their own populations.


18   Countries that impose export controls maintain lists of commercial, governmental and other entities
     that have received (or sought to receive) export-controlled items for transfer to others without the
     approval of the original exporting country.
l9   See, for example, the statement of Cuba (on behalf of NAM) and other statements at the 2007
     Meeting of States Parties of the Biological and Toxin Weapons Convention, URL:
     http://www.opbw.org/newprocess/msp2007/msp2007_s>a~emcn~.htm
�A discussion oamr



                If the pandemic threat is so dire, why is the practical response so
          muted? Limited resources are certainly a factor; but clearly, not everyone
          shares the same views with respect to the imminence and likely severity of an
          outbreak.

                Those who warn that a pandemic may envelop the world within
          months from its onset, and there are many experts that do, suggest a health
          emergency that arguably would require strong government action such as
          nationalization of pertinent production facilities and invoking of TRIPS
          flexibilities to allow for greater availability of affordable treatments. A
          pandemic could circle the globe so quickly that initiating such steps after the
          appearance of a pandemic strain might be pointless.

                Despite the dire predictions, steps like compulsory licensing of antivirals
          have yet to be taken, suggesting that governments may be dubious of the
          claims made by some scientists of the imminence of a severe H5 human
          pandemic. Is this foolish, or an efficient use of overstretched resources?It will
          only become clearer in retrospect

                Nobody argues against improved pandemic preparedness now and in
          the future, for everyone seems to accept that a new pandemic will occur,
          sooner or later. Yet, at the same time, it is clearly not possible today to
          abandon other public health efforts because the argument that a highly lethal
          pandemic strain is nearly upon us may turn out to be correct

                For those seeking to get ready for a pandemic now, proven technology-
          mainly egg-based production of classic flu vaccine-offers degrees of certainty
          that emerging biotechnologies cannot. Methods to grow H5 viruses in eggs
          are improving, and egg-based production is already available and does not
          require any potentially expensive and unreliable "bleeding edge" technology.
          And in theory, the same production facility can also be used for production
          of pandemic LAIVs.

                  Although egg-based production is sometimes maligned as "antique", it
          is telling that major vaccine makers investing in biotechnology remain heavily
          reliant on egg-based systems for their own flu vaccine production. The major
          problem, of course, is what-if anything-to do with the production capacity
          when it is not required for (pre)pandemic vaccines, in view of the fact that
          there is limited other use for egg-based facilities and, for many developing
          countries, seasonal flu vaccination is a losing economic proposition.
          Maintaining an unused production base is expensive. WHO estimates that
          maintaining an idle capacity to produce 200 million seasonal vaccine doses
          would cost US $100 million per year.


Page 20
�               Observations on Vaccine Production Technologies and factors Potentially Influencing
                                     Pandemic Influenza Vaccine Choices in Developing Countries



     Viewed in a longer timeframe, technology selection may become
more complicated. The flexibilities and potential efficiencies of cell culture
are attractive because they may offer a faster pandemic response and,
especially, a facility with potentially broader public health uses-if the
technology is available and markets exist for the other types of human
vaccines that may be produced in cell culture.

     However, the relatively unproven status and considerably greater cost
of hardware for cell culture technologies (estimated at ten or more times
the cost of egg-based facilities), both in terms of equipment and intellectual
property, at present make them a daunting proposition for most developing
countries.


Fill/finish projects and importation of bulk antigen

Indonesian and Mexican vaccine manufacturers, with W H O support, are
developing filllfinish capacity for local vaccine sales. In the filllfinish
approach, developing country manufacturers import bulk vaccine antigen
produced by an overseas company and use it in a locally branded, finished
product. In the current WHO-supported projects, the antigen
manufacturers are Biken (to Indonesia) and Sanofi-Aventis (to Mexico).

      The imported bulk antigen, suitable for a classic killed vaccine, is
processed in-country into a finished product. The national manufacturer
creates filling and packaging facilities, and some associated technology
transfer takes place.

     Importation of bulk antigen and fillinglfinishing in developing
countries favours the argument, advanced by some, that it is rational for
global influenza antigen production to be concentrated in a few locations
with well-developed capacity and expertise.

      Local manufacturers importing bulk antigen remain dependent,
however, on product supplied from abroad, which is unlikely to be
available in the event of a pandemic (particularly in its early stages), so long
as global production capacity remains well below that which is necessary.




                                                                                          Page 21
�A discussion oaoer



            The option of animal vaccine plant conversion

            Current global capacity for human influenza vaccine production falls well
            short of that needed for pandemic response, even with optimistic
            assumptions about demandlyield of pandemic antigen. Often unmentioned
            is the substantial additional manufacturing base that uses egg-based
            production systems to make animal vaccines. These facilities could lessen
            the gap between pandemic vaccine supply and demand. They use a very
            similar production process as that used for human influenza vaccines.
            Estimates of the global size of the egg-based animal vaccine industry,
            however, vary wildly.

                  On the high end, according to one source20the annual global egg-
            based animal influenza vaccine capacity, as of 2006, was approximately 41
            billion avian doses (at 100 doses per egg), or about 410 million eggs. In
            terms of human vaccines, this implies a capacity of approximately 410
            million doses of human trivalent seasonal vaccine. Using this capacity
            estimate, output of a monovalent pandemic LAIV could be between 1.8
            billion (WHO conversion factor) and up to 4 billion or more vaccinations
            per year (other conversion fa~tor),~'
                                                depending on antigen assumptions. In
            either case, this would allow vaccination of a substantial proportion of the
            world's population.

                     But WHO CAP consultants, also citing industry sources, come up with
             very different numbers for the potential contribution of animal vaccine
             facilities. They report that the animal vaccine industry can handle only
             about 78 million eggs annually. This implies an annual pandemic LAIV
             output of approximately 340 to 750 million human vaccine courses per
             year, a much lower but still substantial figure.

                 It is thus difficult to be precise about (pre)pandemic capacity of
             animal vaccine facilities because of conflicting and limited data and the

2fl   Hcldens, J G M. Production capacity for human and veterinary influenza, June 2006,at URL: http://
     www.dut&bio.org/'meetings/list/dutch_vaccines_group/files/influenza_dag/
     DVC%2Ojacco%20Heldens,%2026.06.06.pdf           (Heldens represented Akzo Nobel, which owned
     Inletvet, a major animal vaccine maker, until it was sold to Schering Plough in 2007.)
21    See: Fedson DS, Dunnill P. New approaches to confronting an imminent influenza pandemic. Perm J
      2007;11:639,   URL: http://xnet.kp.orp/permancnteiournal/SUM07/influeriza-oandemic.h~rnl and
      Fedson DS, Dunnill P.From Scarcity to Abundance: Pandemic Vaccines and Other Agents for "Have
      Not"Countries in journal of Public Health Policy (2007) 28,322-340.
      doi: 10.1057/palgrave.jphp.3200147


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�              Observations on Vaccine Production Jechnohgies and Factors Potentially Influencing
                                    Pandemic Influenza Vaccine Choices in Developing Countries



variety of assumptions that could be made about antigen production and
vaccine type. But even a low-end estimate would represent a large addition
to human production capacity. Notably, a large proportion of global animal
vaccine production capacity is located in Asia, and additional capacity
exists in Latin America.

     Converting an animal influenza vaccine facility to human vaccine
production is not, however, as simple as switching vaccine seed strains.
There can be significant hurdles, the severity of which will vary with the
specific equipment and process used at each manufacturing plant.

       Major issues to be addressed in such a conversion are regulatory
certification of the manufacturing process to human vaccine standards,
ensuring appropriate biosafety practices, adequate egg supply, improved
virus purification processes, and adoption of adjuvants approved for human
use.

      Regulatory hurdles will be country-specific. In some places, animal
vaccine plants are already held to manufacturing standards near or equal to
those for human vaccines; however, this is not always the case. A related
issue is biosafety practices which, in some animal vaccine plants, would
need improvement-both in operating procedures and, potentially, to
equipment.

      Conversion of animal facilities to human vaccine production may also
strain egg supplies, especially in countries or regions where H5 vaccination
of poultry currently occurs, because eggs laid by hens vaccinated against H5
cannot be used to produce vaccine.

        Human flu vaccines produced in eggs go through an extensive
filtration process to remove egg proteins and other contaminants that can
cause an adverse reaction. Animal vaccines are generally not subjected to
the same level of filtration, and improvement of filtration in converted
animal vaccine plants would be necessary.

     The adjuvants used in animal vaccines are not typically approved for
use in humans, and animal vaccine plants would have to switch to
appropriate adjuvants, unless they are producing a human pandemic LAIV
(which is unadjuvanted).



                                                                                        Page 23
�A discussion oaoer


                 Human vaccine producers and pharmaceutical companies own a
          significant proportion of global animal vaccine production capacity. For
          example, Merial, the world's largest animal vaccine maker, is a joint venture
          of Sanofi Aventis and Merck. Ft. Dodge, another large animal vaccine
          company, is a division of Wyeth. Intervet, a third large animal vaccine maker,
          is owned by Schering Plough. Other drug companies, such as Pfizer and
          Novartis, also have animcil vaccine businesses. Thus, human and animal
          vaccine makers should not be thought of as wholly separate industries.


5.        Concluding discussion
          Which technologies should developing countries seek multilaterally to
          improve pandemic preparedness? The answer, of course, depends on many
          factors.

                 Reliance on a s m d number of developed country sources for
          pandemic vaccine and/or antigen is unlikely to remain an acceptable
          solution for most developing countries, particularly in view of the fact that
          the developed country industry is not currently in a position to offer
          sufficient quantities of antigen in a timely manner after the appearance of a
          pandemic strain.

                Practically, the present situation of dependency, which is effectively
          unaltered by the WHO Pandemic Action Plan, means that the vast majority
          of developing countries will only receive significant quantities of vaccine
          after the needs of developed countries are met, which will likely be many
          months after the onset of a pandemic-months during which pandemic
          mortality may be severe.

               As a result of the inequity, in the event of a pandemic, developing
          countries will suffer a disproportionate burden of serious disease and death,
          a problem that could be ameliorated by increased and equitably distributed
          global vaccine supplies, particularly in the developing world. These vaccine
          supply problems may be further exacerbated by non-health factors, in the
          form of export controls that may inhibit the ability of some countries to
          prepare for a pandemic because some kinds of technology transfer are
          unavailable to them.

                Developing country leaders are likely to face question from their
          citizens if they remain vulnerable while the citizens of wealthy countries are
          vaccinated; this situation could become especially tense if a pandemic is
          severe enough to cause serious socioeconomic disruption.

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�              Observations on Vaccine Production Technologies and factors Potentially Influencing
                                    Pandemic Influenza Vaccine Choices in Developing Countries



     Vaccination for the population at the earliest point possible following
the onset of a pandemic isn't the entirety of pandemic preparedness; but it
is a high priority. But at present, there is little consensus among experts
about how best to achieve that.

      It is also clear that no single technological approach will be
appropriate for all countries or regions and that greater funding and
improved access to proprietary technologies will be necessary for
developing countries to improve protection of their citizens from pandemic
flu. Regional cooperation in production and technology to take advantage
of economies of scale will likely be far more fruitful than trying to go it
alone for most countries.

      Several options for financing and technology transfer have been
mentioned in the context of the Pandemic Influenza Preparedness
Intergovernmental Meeting (IGM). These include increasing vaccine
production in developing countries, possibly supported by royalty-free
licensing of vaccine production technology. Contributions to a global fund,
and contributions of vaccines to a WHO stockpile by entities that use
pandemic preparedness biological materials in research and development
of vaccines and other biomedical items have also been proposed.

      While a WHO stockpile may be useful to help stamp out or slow down
the emergence of a pandemic influenza strain, it is not designed-nor will it
serve-to ensure any country's vaccine supply. A WHO vaccine stockpile is
also mandated by WHO Member States outside the WHO PIP IGM
discussions, and is thus not a central objective of the benefit-sharing
discussion.

      Because increasing national or regional vaccine production capacity in
developing countries requires flexibility in technological approaches, no
single technology transfer and cooperative arrangement is likely to be
effective. There is strong evidence that proprietary and emerging
technologies, such as reverse genetics, adjuvants, and in the future cell
culture, could serve to greatly increase the efficiency of preparedness
efforts. Specific technology selections, however, must be made in the
regional and national contexts.

     In principle, developing countries may seek to formalize a system of
equitable reciprocity wherein those developed country companies and
other entities that utilize Global Influenza Surveillance Network (GISN)


                                                                                         Page 25
�A discussion oaoer


          materials to develop vaccines commit to transfer their vaccine technologies
          so that they may be used by developing countries.

               Therefore, in the PIP ICM negotiations, developing countries have
          explored the possibility of creating a mechanism for transfer of influenza
          vaccine technology, through mandatory royalty-free licensing and other low
          or no-cost means, including for both formal patents and related know-how
          and trade secrets. The technologies prioritized by any such pandemic
          preparedness technology transfer program should be those that are used by
          industry to manufacture products that include WHO GISN materials (e.g.
          H5 vaccines) or are developed utilizing WHO GISN materials.
                Reducing proprietary barriers to the technology needed to produce
          pandemic vaccines would represent a significant step forward; however,
          making technology available does not guarantee that it will be effectively
          used. Ways to optimize the use of technologies include, for example, the
          creation of a financing mechanism by which the real-world transfer of these
          technologies can be effected (for instance, to pay for the necessary
          equipment and training to utilize them). A pandemic preparedness
          cooperation fund could also be established, with contributions from
          manufacturers that utilize WHO GISN materials in commercial products (to
          be defined in a WHO material transfer agreement), and possibly
          contributions from governments. A cooperation fund could also help enable
          the use of nonproprietary technologies, such as egg-based production lines
          and fill/finish capacity, which will be important elements of any national or
          regional effort to increase vaccine production capacity.
                Pandemic preparedness is a problem of daunting complexity, and
          solutions will only come with time and contributions from many quarters.
          The PIP IGM is an important process but not one that by itself can solve all
          problems. Developing countries may wish to focus on important specific
          benefits that will enhance their preparedness.

               With the timing of a pandemic uncertain, but the time needed to
          construct and validate vaccine facilities typically measured in years, it is
          urgent that progress be made now to expand developing country vaccine
          production capacity. Developing countries will have to work together to
          identify the best technologies for their circumstances. The PIP ICM's
          decisions may help to make key technologies affordably available to
          developing countries, and through a cooperation fund, provide means
          through which to effect their transfer and use.




Page 26
�                          Observations on Vaccine Produaion Technologies and Factors PotentiallyInfluencing
                                                Pandemic Influenza vaccine Choices in evel lop& ~ountries




                                              Annex 1

        Overview table of influenza vaccine technologies
                                      .- -            -

                                       Cell culture
                                     produced vacdnes
                                                      -
-
    -
    .                                                                                 -
                                                                                        vaccines, =-.
                                                                                       --     - -
                                                                                                  etc)   F
                                                                                                         -
                                                                                                          Z  --

Description    Inject vaccine        Animal, insect, or     A vaccine seed          Many techniques are
               virus into            other cells are        strain using a          under study, including:
               fertilized eggs,      cultured in growth     special type of
               allow virus to        media, scaling up      backbone (from a        - Producing
               grow. Harvest         the quantity to the    lab-adapted flu           recombinant HA in
               fluid from eggs,      desired density of     strain) is grown in       other, more easily
               wash with             cells in industrial    eggs (or potentially      grown organisms
               detergent to kill     bioreactors            cell culture). The        (e.g. transgenic
               cells, separate out   [fermenters) of        live virus is             bacteria).
               virus material for    hundreds to            harvested, purified     - "Naked"   and
               vaccine               thousands of litres    and formulated for        plasmid DNA
               formulation.          capacity. The          use. Harvesting and       vaccines in which
               Generally, the        culture is infected    formulation is            "codon optimized"
               vaccine strain        with vaccine strain,   simpler than with         flu genes are used
               consists of the H A   producing large        killed vaccines, but      directly as vaccine.
               and NA genes of a     quantities of          the live final
               "wild type" of        vaccine virus.         product is more         - Genetically
               influenza fused       Harvesting,            delicate.                 engineered systems
               onto a lab-           purification and                                 to co-express HA,
               adapted               packaging is                                     NA, and other flu
               "backbone" strain     essentially the                                  genes, making a
               with the other        same as with egg-                                "virus-like particle"
               viral genes.          based methods.                                   (VLP)which is used
                                                                                      as vaccine.
                                                                  -


"Hard"         Large BSL-2           Large BSL-2                        +
                                                            Large BSL-2 . May       Will vary with specific
technology     space, incubators,    bioreactors for cell   be grown in eggs or     technology; however,
requirements   inoculation and       culture, equipment     bioreactors (see        all are likely to require
               harvesting            to maintain cell       respective              BSL-2 CMP space and
               equipment.            bank and scale-up.     requirements at         microbial fermentation
               Centrifuges           In some cases          left), but currently    /coil culture capacity.
               (separationand        growth substrates.     the process is done
               purification) and     After harvestingof     in eggs. Purification
               packaging             virus, purification    and formulation
               equipment.            and formulation        differs from that for
                                     requirementsare        killed egg and cell
                                     the same as for        culture vaccines.
                                     eggs.
�A discussion paper




-                    Egg-based W&sicn'
                         flu vaccine           I
                                                                 -
                                                     0 1 1 culture
                                                   producedvaccines       -
                                                                              Liveatenuated
                                                                                 ("lAIVw)
                                                                                                -'




-
- - --
Major                The technology is         Theoretically higher       Live vaccine is likely     Dependent upon
advantages           well known and has        antigen output than        to be effective in         specific'


                     been successfully         eggs, theoretically        much lower doses           technology. Nearly
                     utilized for decades.     more scalable. May         than killed vaccines.      all purport to be
                     Essentially the same      grow some U    S           Assuming                   able to provide
                     technology is used        vaccines viruses to        production capacity        more vaa5ne
                     for some poultry          higher liter. Cell         can be harnessed,          faster, but these
                     vaccines, making          culture vaccine            more LAIV vaccine          claims are as yet
                     conversion of animal      plants likely to prove     may be made                unproven.
                     vaccine plants and        more flexible for          available in a             May offer more
                     personnel a               producing other            shorter time period
                                                                                                     dependable
                     possibility in an         kinds of human             than with other
                                                                                                     vaccine yield per
                     emergency.                vaccines than egg          '"T'es.                    production run.
                                               based plants.
Major                Not as efficient as       Cell culture vaccines      Not suitable for           Dependent upon
limitations          cell culture              are a major focus of       prepandemic                specific
                     theoretically is.         R&D; but as yet they       vaccines due to            technology.
                     Requires many eggs,       are in limited             recombination risks.
                     the availability of       commercial use.            Difficult to test with
                     which may be              Inability to be certain    prepandemic
                     limited in a              that a particular cell     strains. Requires
                     pandemic (eggs may        line will be               more stringent
                     be available from the     appropriate to grow        conditions on egg
                     broiler industry). Egg-   11iepandemic strain.       supplies than killed
                     based plants are          Requires substantial       vaccine production.
                     unlikely to be used       bioreactor capacity        Higher biosafety
                     for other human           of which there is little   requirements for
                     vaccines (except for      to no global surplus.      production. More
                     Japaneseencephalitis      Much higher cost           difficult to store
                     vaccine).                 facility at industrial     vaccine. Intranasal
                                               scale.                     administration
                                                                          requires special
                                                                          delivery device.
Regulatory1          Fewer impediments         Few cell-culture           Seasonal LAIVs             These products, if
safety               as these vaccines will    produced vaccines          have limited use in        successful, will be
approvals            he produced in the        hwe been approved          the U ("FluMist")
                                                                                S                    new to regulatory
                     same manner and           for human use and          and in Russia;             systems and are
                     with the same             they are likely to         however, most              highly likely to
                     facilities as seasonal    prompt more intense        regulatory                 require substantial
                     vaccines, although        regulatory scrutiny.       authorities would          safety review.
                     converted animal          Require approval for       be encounteringa
                     vaccine plants likely     the vaccine as well as     live (and likely
                     will not already          characteriition and        genetically
                     possess approvals to      safety demonstration       engineered)
                     produce human             of the cells used.         influenza vaccine
                     vaccine.                                             for the first time.



Page 28
�                           Observations on Vaccine Production Technologies and factors Potentially Influencing
                                                 Pandemic Influenza Vaccine Choices in Developing Countries




Administration   Syringe                 Syringe                  Intranasal (requires    Method of
                                                                  appropriate delivery    administration
                                                                  device)                 (injected, oral,
                                                                                          intranasal, etc.)
                                                                                          will depend on the
                                                                                          specific product
Recombinant      Probably. Seed strain   Same as egg-based        Probably, with the      Vaccine will be
(genetically-    may be produced         production. Other        notable difference      genetically
engineered?)     with reverse genetics   genetic modifications    that the vaccine is     engineered or be
                 and, for example,       of the vaccine strain    administered live.      the product of a
                 may contain a           may occur to                                     genetically-
                 modified HA gene        optimize growth in                               engineered
                 (deletions) to make     cell cullure.                                    organism.
                 the virus less
                 pathogenic. Virus is
                 killed before use.
Adjuvanled       Almost certainly, to    Same as egg-based.       Probably not. The       Depends on
(pandemic        make more efficient     One exception is         vaccine virus           specific
vaccine?)        use of bulk antigen     unadjuvanted killed      replicates in the       technology.
                 and potentially to      ''wild-type" virus       upper respiratory
                 reduce the number       (being tested by         tract, stimulating
                 and size of required    Baxter); however,        immune response.
                 doses.                  producingsuch a          Nevertheless, some
                                         vaccine is a biosafety   research has
                                         challenge, requiring     focused on
                                         cell culture in large    increasing immune
                                         scale BSL-3              response to LAIVs
                                         containment.             with adjuvants.
Intellectual     Few IPR problems        Many IP  R               Only a small            Impedimentswill
property         for egg-based           impediments. These       number of               depend on
                 process, except for     include patents on       backbone strains        specific
                 adjuvants where IPR     cell lines and           are suitable for use.   technology;
                 and supply problems     production systems,      Intellectual property   however, it may
                 may exist.              as well as trade         impediments exist       be anticipated that
                 Potential additional    secrets on safety        on the use of           these technologies
                 problem if seed         profile of cells. Cell   strains; patents and    will have robust
                 strain is produced      characterizationis       trade secrets cover     IPR coverage as
                 using reverse           only reportedly          the formulations.       they are mainly
                 genetics.               publicly available for   Seed may need           being developed
                                         Vero (monkey) cells.     reverse genetics.       by biotech
                                                                                          companies and/or
                                                                                          universities
                                                                                          seeking to sell this
                                                                                          technology.

                                                                  -
                                                                                                      Page 29
�A discussionpaper




Other issues        Some (generally       Requires supply of      Safe production       The vast majority
                    minor) side effects   growth media and        will require more     of R&D in these .
                    from egg proteins     other relatively        stringent biosafety   lines of research
                    and other possible    exotic supplies. In     procedures than       appears to be
                    impurities.           addition to technical   killed vaccines to    conducted by
                                          challenges, cell        prevent               companies in a
                                          culture production      contamination of      handful of
                                          may be especially       live final product.   developed
                                          prone to export         Societal resistance   countries.
                                          control issues for a    may be significant,
                                          number of countries.    particularly for
                                                                  seasonal use.




 Page 30
�                              Observations on Vaccine Production Technologies and factors Potentially Influencing
                                                    Pandemic Influenza Vaccine Choices in Developing Countries




                                                 Annex 2

                        Relevant reports available online

    Friede M, Serdobova I, Palkonyay L, Kieny MP. Technology transfer hub for pandemic influenza
    vaccine. Vaccine. 2008 Nov 18. (ht@://dx.doi.ore/lO. 1016/i.vaccine.2008.10.080 - accessed 9
    January2009).

    Lozano B. The veterinary hiological industry and the production of human pandemic influenza vaccines
    in Mexico. Geneva: WHO FA0 OIE Consultation Seminar. 2006.
    (http://www.who.int/entitv/csr/disease/influenza/Bernardo Lozano A v i m e x d f
    - accessed 9 January2009).
    National Academy of Engineering. V-36-3 engineering and vaccine production for an influenza
    pandemic. The Bridge. Fall 2006; 36(3). h~~://w.nae.edu/nae/brideecom.nsf/wel~links/MKEZ-
                                                                       -

    6SZRM2?OpenDocument- accessed 9 January 2009).

    Oliver Wyman Consultants. Influenza vaccine strategies for broad global access: key Findings and
    project methodology. Scatlle: Path, 2007. (htl~://www.~ath.or~/files/VAC publ rpt 1 0 - 0 7 . d -
                                                                              infl
    accessed 9 January 2009)

    World Health Organization. Business plan for the global pandemic influenza action plan to increase
    vaccine supply. Geneva, WHO, 2008.
    htt~://www.who.int/entitv/vaccine research/documents~Re~ort%2520McKinsev%2520Business%2520
    Plan%2520Flu3.pdf - accessed 9 January2009).

    World Health Organization. Mapping of intellectual property related to the production ofpandemic
    Influenza Vaccines. Geneva: WHO, 2007.
    (httD://www.who.int/vaccine research/diseases/influenza/Ma~~inp   Intellectual Propem Pandemic I
    nfluenza Vaccinemdf - accessed 9 January 2009).

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�      This paper presents an overview of technologies currently available for the
      production of influenza vaccine, as well as others that are under
      development. It draws attention to pertinent issues and challenges that
      policy-makers in developing countries may need to consider when
      reviewing their options for accessing influenza vaccine production
      technologies. It is intended as a contribution to the debate on the sharing
      of influenza viruses and access to vaccines and other benefits arising from
      their commercial exploitation.




            World Health
            Organization
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World Health House
Indraprastha Estate,
Mahatma Gandhi Marg,
New Delhi-110002, India

9 luglio – Silenzio stampa

HOW TO BEAT THE HEAT FOR A SAFE SUMMER, 2010

C_17_opuscoliPoster_59_ulterioriallegati_ulterioreallegato_0_alleg.pdf Oggetto application/pdf.

A Nursing Manifesto

Introduction:

As nurses, we reach for meaningful expressions of our values, too often finding overwhelming constraint and resistance, sometimes within ourselves and sometimes imposed from without. We are calling for a movement to awaken those precious and powerful ideals that are rooted in nursing’s worldwide historical traditions. We call forth the written and spoken voice of nursing to be claimed and reclaimed. We seek to inspire the fullest expression of the heart of nursing through individual and collective acts. We believe there are profound possibilities in claiming our individual and professional sovereignty.

We believe that it is possible to find connection in the midst of alienation, to find inspiration in the midst of cynicism, to find nourishment and meaning in the midst of spiritual impoverishment, to find hope in the midst of despair, to find wholeness in the midst of fragmentation, to find peace in the midst of violence, to find enrichment in the midst of economic idolatry, and to find sovereignty in the midst of constraints. Our communities, our patients, share this hope.

The situation we find ourselves in has been created from an array of forces. While economic issues have helped create a situation in which nurses cannot practice nursing, we, as nurses, have participated by remaining silent. Our professional sovereignty is threatened. The health of global humankind is at risk. It is now time to ask ourselves, who benefits from the situation as it now exists? As long as we know that the current situation inhibits the fullest expression of nursing’s highest values, and that people who need our care are not receiving the best we can offer, we know that we, and those we serve, are not benefiting. If nurses are to significantly contribute to a mission of caring for people and communities, we must find our voice, acting now to create situations in which our values come to the center and from which we can realize our best intentions.

Now, seeking meaningful avenues for action, we choose to identify ourselves with the heritage and future of nurses. From nursing history we have learned the fullness of our own potential as nurses, the strength of nurses, the effect of nurses in communities and to individuals. We have seen our own common self interest, and common oppression. Having found these authentic bonds as nurses, we realize we can rely on each other as we seek conscience-based action to shape a new future for nursing and for health care.

We do not seek to define what is “radical,” “revolutionary,” “moral,” or “reform” — we seek to call forth what is good for nurses and nursing, and what is good for the health of people worldwide. We are not questioning, challenging, or critiquing existing organizations. nor are we calling for the creation of a new organization. Rather, we are calling for nurses to join together with other nurses, in whatever way they can, to act consciously and with conscience.

We call forth in all nurses the possibilities inherent in discovering one’s own truth and living fully as a person and nurse from this truth. We call forth a willingness to reach for making a critical difference toward betterment of humankind. We call forth the power to act forcefully out of conscience to shape a future that is consistent with our values. We call forth the reawakening of our personal and professional sovereignty to determine our own destinies and to act individually and collectively to transcend the forces that would constrain us.

We call forth the passion of practicing nursing from this state of sovereignty and rightfully claim governance of our discipline. We call forth a repudiation of patterns that we create, or that are imposed upon us, that inhibit the full expression of our beings as nurses and persons. We call forth the opening of our hearts to reveal the prospects for action that carry us beyond the negative forces of passivity, contempt, frustration, cynicism, and despair; forces that keep us from living our wholeness and creating a world of peace and healing.

Ideals and Principles

We offer the following ideals and principles upon which this call to action is based.

  • Our concern covers the world and we seek to embrace a global perspective. We can no longer consider our values and actions out of the context of all beings.
  • Historically, although organizations serve useful purposes to society and to disciplines, fundamental societal change does not occur through organizations. Organizations serve to mobilize resources and people and codify actions aimed at disciplinary concerns. However, they rarely create the daily experiential responses that are necessary to change the world.
  • Organizations are not changing because people in organizations are not changing. We seek to inspire and excite the desire for claiming personal and professional sovereignty. We are seeking no less than fundamental change in a movement that awakens us to the possibilities for transformation of individual and collective consciousness and to that which restrains us. This is the meaning of realizing sovereignty.
  • We are opposed to colonization; that is, we do not wish to impose our views onto others. Rather, we are calling for nurses who share our concerns to join in collective consciousness-raising and action based on chosen values.
  • We are opposed to all forms of oppression, including that based on gender, race, ethnicity, nationality, sexual identity, physical abilities, economic status, or any other attribute seen as “difference”.
  • We welcome all who are attracted to this process and yearn for change that will come from engagement with others. We do not wish to distinguish those who join in this journey by educational or social background, chosen work role, or specialization.
  • We believe that nurses are particularly attuned to the needs for social justice throughout the world, given their connection to humans in times of personal change and challenge. It is because we cannot practice the art of nursing that we act. While we may have grown silent, our patients believe in us. We must listen. We must speak.
  • The concept of wholeness is something we fully embrace. Our notion of wholeness involves a commitment to the inherent oneness of all beings. We seek to recognize, appreciate, celebrate, and exploit this individual and universal wholeness in order to create health.
  • It is our firm conviction that there is a body of knowledge that is specific, if not unique, to nursing’s concerns and interests. We think that this knowledge is grounded in appreciation of wholeness, concern for human well being, and ways in which we accommodate healing through the art and science of nursing. We value theoretical and practical plurality with the centrality of nursing knowledge at the forefront of practice and knowledge development.
  • We advocate for a critical formulation of the educational enterprise of nursing that places a greater emphasis on personal and professional sovereignty and that nurtures the development of action generated from reflection, contemplation, and recognition of values. We believe that it is time to attend to inherent wholeness and natural healing tendencies that are often educated out of nurses as students.
  • Nursing practice is guided by conscience, competence, connection with individuals and communities, and a belief in all beings’ essential worth. We own our power to transform.
  • Our goals are no less than revolutionary changes, which will improve the lives of patients and families, communities and organizations, nurses and administrators, students and faculty. We believe in approaches to such changes that involve an awakening to potential power and an enactment of that power infused in our daily lives. We understand that a movement of this magnitude requires a shift in many traditional power relationships and the creation of new ways of relating to one another.
  • We believe that our journeys to enact this manifesto will certainly require a reuniting of the inner and outer life, accepting our wholeness and owning our freedom – a wholeness and freedom that will strengthen our outer capacity to love and serve. “If we understand our common work as fundamentally unifying the inner life of mind and spirit and the outer life of service, we must inhabit and do our work with a deeper vision that focuses our attention on the world that is nearest to us, the world within our own hearts. Within the world of being, we discover, again and again, that our common work is to support each other in the deepest, most sacred part of our own selves. This work of being leads us repeatedly into the world of action and service, where our energies can contribute to those cultural trends that are renewing the relationship between the interior and exterior dimensions of life” (Rob Lehman, The Institute Report, Fetzer Institute, 1998). We believe in the possibilities for fundamental change and nourishing a “community of consciousness” that enlivens all the work of nursing.

Inspirations

We are inspired by the many events, people, and expressions of nursing that surround us. We hear nursing students yearning to heal; we hear nurses despair in the midst of too many patients and too little time; we hear patients remembering the meaning of nursing.

We are inspired by widespread public dismay and despair about the conditions that prevent nurses from practicing fully and about the fragmentation and dehumanization of health care. The public is demanding accountability for quality and respect in health care; we are inspired to act.

Nurses are telling stories about their frustrations in not being able to practice nursing consistent with the values that they hold most precious. There is acknowledgment of and discontent with the social inequities that are foundational to our most persistent health problems. We are inspired to shift these realities to overcome these frustrations.

There are indications that nurses seek ways to practice their ideal vision and values, seeking autonomy and control, in spite of restraints imposed by systems of health care and perceived economic contingencies. There is a clear rediscovery of natural ways of healing and a movement toward innovation in holistic healing modalities. We are inspired to make these values more real.

Concerns

The historical evidence is overwhelming that movements grow out of dissatisfactions with injustices and inequities. Likewise, we are inspired to act, and feel an urgency to act, based on a long list of concerns that we have detailed below. We have phrased our concerns in such a way that we hope suggests and inspires what could be, rather than simply what is. We caution everyone, ourselves included, that to focus on these concerns would drag us back into a mire of despair and frustration. Therefore, we ask that as we consider these concerns, we do so holding to a beacon of hope and conviction that, through our transformative expressions of personal and professional sovereignty, we can move toward new realities.

These are the concerns that cause us to pause, reflect, and call for change:

  • The clinicalization of human experience that is instrumental in denying important facets of human life, and not fully accounting for the essence and wholeness of human experience
  • Overemphasis on clinical specialization while sacrificing our attention on the healing potentials within wholeness.
  • Client interventions shaped by economics rather than need that arise from a society consumed with economic and material idolatry.
  • Distorted priorities in our educational and health care systems that place nursing’s attention on outcomes and economics at the expense of human needs, experiences, and quality of life.
  • General subjugation of spiritual consciousness to the economics of health care.
  • Persistent racism, sexism, classism, heterosexism, and hosts of other “isms” that prevail in nursing and health care, undermining our sensitivities to the fundamental humanness and value of all people everywhere.
  • Over-reliance on physical/material conceptions of human health and illness, rather than a perspective accounting for the whole of experience.
  • The idol of the current health care system symbolized by achieving measurable outcomes in an economically feasible manner in the shortest amount of time, at the expense and depletion of even more valuable resources such as caring, understanding, real human connections, and spiritual and physical renewal.
  • Depletion, rather than integration, of the sacredness of nursing practices and rituals within the technology and artistry of nursing care and nursing research.
  • The long-standing ideology (acquired consciousness) of nurses being subservient to other interests, and not encouraged to be deeply committed to their own healing work.
  • Loss of soul in nursing care and in nursing science.
  • Educating for compliance rather than creativity.
  • Practicing in ways whereby we lose touch with the real needs of our patients and communities.
  • Putting a heavier emphasis on testing and evaluation, rather than on teaching and development, that often results in the worship of grades, standardized test scores, and merit scores, outside the context of other features of nursing care.
  • Disrespecting nursing practice and nurses who practice.
  • Dogmas associated with what forms of knowledge are most relevant to nursing and what warrants financial support for expanding the discipline’s knowledge.
  • The tendency to treat one another with cynicism, suspicion, and contempt because of differences in educational preparation, roles, views, theoretical orientations, political ideologies, and specializations, rather than bringing to our interactions a generosity of spirit that honors the dignity and worth of all.
  • The creation of environments for learning and healing which are not based on what we know is best for learning and healing, but rather on what is most practical and cost-effective for the institution.
  • The gradual divorce of nursing from nature and its potentials for enhancing the quality of lives and promotion of healing.
  • The parallel shifts in nursing and medicine that have enabled nurses to abandon nursing to practice medicine, and have enabled physicians to practice nursing while maintaining their medical practice.
  • An overemphasis on diagnosis and treatment of disease and a lessening of attention on experiential features of health and illness.
  • Denigration of nursing theory and all forms of what we know as nursing that provides distinction to a discipline.
  • Limited definitions and manifestations of what constitutes “legitimate nursing.”
  • Disembodied physiology in which nurses perceive human physiology as a mechanistic process that is distinct from the rest of human experience.
  • Denial of the relevance of the uniqueness, essence, and wholeness of human experience.
  • Unconscious use and abuse of data to serve one’s own ends and self-interests.
  • Limited and constricting ways in which performance is judged for students, educators, and practitioners, not accounting for the richness and variety of human expressions of nursing
  • Lack of a full and clear voice for nurses in the systems and arenas that influence health care.

Vision

We believe in a world in which:

  • Nurses practice healing with transformative results.
  • Nurses support, mentor, and nurture one another through participation in learning, researching, and practicing.
  • Nurses act from our most fundamental values.
  • Nurses control our own work lives.
  • Nurses are strong and creative in the face of adversity.
  • Nurses are powerful as healers and as participants in caring and healing processes.

Ours is a call to conscience and action that grows from the awareness of this conscience. We prefer not to prescribe what is necessary for such a movement. We offer suggestions for individual and collective ways to encourage sharing, changing, reflection and action. We are willing to provide resources and to tell the stories associated with this movement if you heed our call. Most importantly, we provide a place from which to begin to tell our stories and listen to other nurses.

Suggestions for Action

Peace and Power Processes

The actions are not prescriptions, but rather suggestions for individuals and groups to consider as they begin to develop habits of cooperation, nurturance, respect, and wholeness.

Participatory Research

Participatory, cooperative, feminist, activist, and appreciative methods are ways in which to do research that returns to “subjects” the legitimacy of their own knowing and the capability to produce and use their particular ways of knowing as a guide in their own action. These emancipatory research methods are founded on the beliefs that humans long for wholeness; wholeness requires connection; connection demands participation; participation leads to empathy; empathy implies responsibility; and humans cannot experience wholeness or freedom without responsibility. Participatory research provokes, envisions and values differences. These are research projects that are founded on critical assumptions that re-orient the research enterprise toward participation and action. Research must be meaningful to those it is intended to serve, and the best way to create this meaning is through involving participants as co-researchers. Research, to be of social relevance, needs to be oriented toward action in practice. Participatory and activist research is expressed through mutual engagement among individuals throughout the research process from the identification of issues, concerns, and problems to plans for action and researching that action to implementation to evaluation of the research endeavor.

Patient and Nurse Collaboration

Hearing the stories of patients and acting WITH them to change the structural and personal obstacles to health is a way to begin to practice nursing as we envision it. The act of listening to and being in presence with patients can provide a strong foundation for change. Listening individually, asking how we can partner with patients, is an act of courage. Growing our awareness to a community of patients, holding living room and coffee shop conversations about together changing health care, is a revolution. It will provide a vision of what can be in practice and in partnership.

Community Meetings, Town Meetings, and Citizen Salons

Community and town meetings would provide an opportunity to invite members to come and discuss the issues and concerns and reflect on possibilities for action. The community could be defined as any group of individuals you think might have similar concerns and interests. These would be open meetings structured according to the intentions of the participants and conveners. Citizen salons are smaller forums for discussion and dialogue held in individual’s homes. These are usually invitational and involve a specifically defined topic for the focus of the group. With any of the meetings, the goals would be conscious raising and exploration of possible strategies for action consistent with conscious intentions. A good resource for citizen salon information is the book, The Healing of America by Marianne Williamson.

Sovereignty Circles

These are experiential group encounters designed by participants to nurture personal and professional sovereignty. The experience is very thoughtfully designed and planned to draw everyone’s focus and attention on that which can shift our abilities to act powerfully in the world. One such design can be focused on acknowledging the barriers that exist to nurses claiming and acting from a place of personal and professional sovereignty. The meeting room can be designed to provide barrier and resistance “stations.” Each participant visits each station and declares what they wish to seek. For instance, one might say, “I wish to practice nursing spending more time with patients and less time with paper work.” The station attendants make declarative statements about why this is impossible saying aloud all the reasons for not accepting the desired possibility. “You are crazy. We have to document all our actions. There is not enough time.” The participant keeps stating their desire only to hear reasons to abandon their desire. Once the participant feels brave enough to claim his or her personal and professional sovereignty, he or she enters the center of the room and declares loudly, “I claim my personal and professional sovereignty to practice nursing as I see fit with my patients.” The act of claiming one’s sovereignty is celebrated with verbal acknowledgments and rituals. Participants are free to design these group encounters in ways that support and nurture this public proclamation of sovereignty.

Finding Your Heart Space and Living From That Space

Nurses find ways to get in touch with what matters most to them. This can be done by solitude, meditation, reflection, making crafts, playing music and spending time in nature or any method that allows for delving into the inner world that is often abandoned due to external constraints. Another way to think about this is to find that which is most sacred to you, that which is your truth and passion. The next step is to contemplate ways to express yourself more fully from this sacred space. For instance, you may journal about your reflections and allow yourself to discover new ways of acting in your work and personal life, nurturing the spirit within. The goal is to manifest love in our lives.

Practice Rituals That Nurture the Spirit

This is totally individual. It might be creating a garden for meditation or building an altar with things that represent your values and commitments. It might involve journaling or relaxation exercises and practices. It may include walks and experiences in nature. It may be individual or include others. You define what “inspirits” you and create rituals that manifest this “inspiritedness.”

Make Change

Making personal and social change fuels the soul. What in your community or personal life is calling for you to speak and act? Anything, from turning off the TV for a month or learning photography to starting a tutoring program for at-risk kids or speaking out at your local school board meeting, constitutes change. The power of making change is profound. The process of change provides opportunities to question our values, define and refine our priorities, act consciously, and feel our personal and/or collective power. It is that power from which we act that can be translated into resonating change.

Deliberate Hope Projects

These are task-oriented projects that people come together to accomplish, bringing their shared values as a foundation for both the processes and the products that they envision. Such groups can use some of the suggestions in Peace and Power to identify and define what they plan to accomplish, as well as how they are going to accomplish it. Such projects bring into focus the difficulties involved in working together in a different way, in the context of a group that has mutually made a commitment to learn the new ways. This kind of group can also nurture the vision of what is possible in the world.

Storytelling

Seek to tell your story about your experiences of nursing with other nurses. Seek to hear their stories. You could do this through face-to-face encounters or through cyperspace Share stories of nursing, struggles and challenges, but also of courage and accomplishment. Also re-tell and re-story the lines of the story to create the desired future you would like to have. We invite you to share your stories through this website. We appeal to you to seek out the stories of two other nurses and share them on the website if they agree. This is an act done to make visible what is invisible to others and to raise consciousness for change.

New domains added

Here we come with 2 new domains:
http://www.nursemod.org
http://www.digitalheathcare.info

As soon as possible we will create our Manifesto
Tnx
CGT