CALL FOR A REVIEW OF THE UK VACCINE POLICY MAKING PROCESS
(Under review: December 2009)

The UK Vaccine Industry Group (UVIG) fully supports the national immunisation programme in the UK - coverage is high, resulting in good public health outcomes.  Given the focus on continuing to improve the quality of health provision in the UK, the time is right for a review and update of the process for the recommendation of vaccines and vaccination programmes, if UK vaccination policy is to keep pace with the anticipated developments in vaccine technology (see Annex 1).   UVIG does not question the quality of the decisions made by the JCVI, yet there can be long delays between the licensing of a vaccine and a JCVI recommendation for the use of that vaccine (see Annex 2).  UVIG is pleased that the NHS Constitution for England will enshrine a right to vaccines, and endorses the Chief Medical Officer’s call for continued commitment in this area, to maximise the public health opportunities and value that new vaccines can bring.

Review of the policy making process should consider four key areas:

1.    Understanding the Government’s vaccine priorities and strategy:
•    Regular publication of the Government’s public health strategy
UVIG welcomes the priority accorded to vaccines in the CMO’s 2007 Annual Report, which describes vaccines as “probably the most successful public health measure of all time.”   However, manufacturers plan up to fifteen years in advance to ensure that vaccines are thoroughly researched and are available in the quantities required.  UVIG calls for the regular publication of the Government’s infectious disease strategy, setting out its disease priorities and timeframes for consideration.
•    A formal horizon scanning process
A more formal horizon scanning process would provide an opportunity for researchers, academics and industry to inform the JCVI and others of the details and timings of pipeline developments.  This information would help the JCVI and Health Departments to plan the consideration and review of new and existing policies, and limit delays in vaccine access.   

2.    Greater stakeholder interaction, including:
•    Formal consultation with all relevant stakeholders
Consultation should never undermine the deliberations of experts, but it can facilitate greater communication and better sharing of information between the decision making bodies and other stakeholders.    
•    Opportunity to present evidence to subgroups and the main JCVI
Manufacturers have the expertise and experience pertaining to their vaccines, research programmes, manufacture and distribution.  Formalising the way in which manufacturers and others can submit and present information to the JCVI, as well as respond to incorrect assumptions at agreed points in the process, would allow a more informed and accurate basis on which to make decisions.   UVIG is disappointed that in February 2009 the JCVI overturned its earlier decision to allow manufacturers to present evidence to the sub groups^1,2.   ,   
3.    Greater clarity around the economic evidence base:
•    Clarity around JCVI economic models and inclusion of societal data
UVIG fully understands, and accepts, that vaccines must demonstrate their cost effectiveness.  Transparency of the economic modelling, including the use of societal data, is fundamental to any fair decision on cost effectiveness. Therefore, UVIG calls for greater clarity around the economic modelling to be reviewed by the JCVI, to demonstrate the real value of vaccination.  

4.    Expanded publication of JCVI material and deliberations, including:
•    Formal timelines and processes for JCVI review and decision
UVIG calls for the publication of formal timelines, including information about the processes to be used, for the JCVI review of specific vaccines.  This should ideally be done in parallel with the licensing process, as proposed for other pharmaceutical interventions, together with information as to when the decision and rationale for the JCVI recommendation will be published.  This is common practice in other organisations when producing guidance and guidelines, and a more streamlined process would enable industry to plan its long term manufacturing and R&D programmes more effectively.  It would also aid planning and resource allocation for the DH and the JCVI, and enable early communication with healthcare professionals and the public.
•    Timely publication of JCVI minutes and agendas
UVIG welcomes the more timely publication of the minutes and the agenda for recent JCVI meetings, and hopes that this will continue.  Early access to JCVI deliberations, including those of sub-groups, enables manufacturers and others to plan more effectively for the introduction of a new vaccine or respond to changes in policy or strategy.
•    Publication of the rationale for vaccine recommendations
The publication of the rationale for the introduction of Hib and Men C boosters and HPV vaccination is welcome, and should be continued.  Greater understanding of the rationale behind JCVI decisions enables manufacturers and others to be more responsive as they work to support UK priorities.  

Conclusion
Vaccine research and manufacture is a global business, with the UK competing against other markets to ensure that its requirements are prioritised.  If manufacturers, and others, are better informed and better understand the UK’s priorities and processes, there is likely to be greater alignment between vaccine development and the Government’s plans, with clear public health benefits.

The time is right for change.  A number of companies are moving into the vaccine field, and the vaccine pipeline is considerable and exciting.  The CMO has called for a “streamlined process” to expedite the benefits of vaccination for the population.  Other experts have echoed these sentiments, and called for greater transparency within the JCVI, as well as increased public involvement in decisions about future vaccinations in the UK³.  Change now will help to deliver timely access to vaccines for the UK population, and will ensure that the UK maintains its position as a global leader in public health, and will further strengthen the reputation of the DH, JCVI and others, and build public confidence in vaccines and the UK vaccine programme.   UVIG and its member companies are keen to work with the Department of Health, the JCVI and others to be part of the debate on how to move forward and bring about a transparent and more consultative process.  

1  http://www.advisorybodies.doh.gov.uk/jcvi/mins17Oct07.htm
2  JCVI minutes, February 2009 http://www.advisorybodies.doh.gov.uk/jcvi/Draft_Minutes_18_Feb_2009.pdf
3  ‘Not immune: UK vaccination policy in a changing world’, Mark Weston. A 2020 Health Discussion Paper, February 2009

ANNEX 1: GLOBAL R&D PIPELINE

ANNEX 2: POLICY PROCESS CASE STUDIES

Pneumococcal conjugate vaccine   
•    Licensed in the UK February 2001
•    No formal sub group was set up for Pneumococcal until 2007, a year after the national immunisation programme was implemented. 
•    Pneumococcal vaccination was included in the UK national immunisation programme from September 2006    
•    In December 2007 the Department of Health announced that 300 cases of pneumonia, septicaemia and meningitis were avoided in the first year.  It is estimated that 17 of these cases would have died and 30 would have been left with permanent disability.  
•    Had the vaccine been introduced as part of a national universal programme in 2001, an estimated 1,500 cases may have been avoided, preventing associated mortality and morbidity.
•    In the US the vaccine was licensed in February 2000 with a policy decision in January 2001.
•    Six European markets implemented vaccination programmes ahead of the UK including France, Germany and the Netherlands.

HPV   
•    First vaccine licensed in September 2006, with a second vaccine a year later. 
•    JCVI began to review the need for HPV vaccination in May 2006
•    Decision made to implement a national UK immunisation programme made in October 2007, and the programme began in September 2008
•    There are an estimated 38,000 cases of cervical cancer and high grade precancerous lesions caused by HPV 16 and 18 reported each year.
•    9 European countries made recommendations for the use of HPV vaccine ahead of the UK
o    Austria, December 2006
o    Italy and Luxembourg, February 2007
o    France and Germany March 2007
o    Belgium, May 2007
o    Norway, April 2007
o    Switzerland, June 2007
o    Denmark, October 2007

Rotavirus   
•    Licensed vaccines available since 2006   
•    The JCVI committed to establish a Rotavirus sub group in May 2006.  However, the first sub group meeting was not held until March 2008
•    In March 2008 the sub group recommended to the JCVI that, based on its own assumptions, rotavirus vaccination would not be cost effective in the UK and so could not be recommended.  The decision was ratified by the main JCVI in June 2008.          
•    7 European countries have rotavirus vaccines as part of infant immunisation programmes.  These include:
o    Belgium, Luxembourg, Austria, and Finland.

Varicella / Zoster   
•    Varicella vaccines have been licensed since the 1990s. A zoster vaccine has been licensed since 2006
•    The JCVI recommended establishing a subgroup in November 2001
•    The first sub group meeting was held in December 2007, with the stated aim of making a recommendation to the main JCVI in 2009; its remit is to consider both Varicella and Zoster vaccination 
•    The second sub group meeting took place in April 2008
•    A third sub group meeting was proposed but no date is available
o    Consideration is being given to various strategies of varicella vaccination to prevent chickenpox (universal for toddlers, targeted for adolescents and/or post-partum women) and zoster vaccination to prevent shingles and post-herpetic neuralgia in older adults. 

Flu   
•    A number of vaccines are licensed and routinely used in the national flu vaccination programme each winter
•    Lowering the age for routine vaccination from 65 to 50 years
o    The sub group began to review the evidence for change in April 2005.  No reference to this work was made in the sub group or main JCVI minutes until December 2008, when the group agreed to consider the cost effectiveness of vaccinating 60 – 64 year olds. A decision is awaited.
•    Childhood programme
o    The sub group began to review the need for a childhood programme in November 2003
o    Minutes of the September 2006 sub group noted that there would be no plans to implement a programme at this time. This was reaffirmed at the December 2008 meeting.
•    Pregnancy
o    In April 2005, the JCVI flu sub group recommended vaccination for pregnant women.  In December 2008 the sub group recommended a review of the cost effectiveness of this proposal.  A final decision is outstanding.
•    Multiple Sclerosis
o    In September 2005 the flu sub group recommended vaccination for people with MS, which was approved by the main JCVI in September 2006.  However, the timing of the decision did not allow for effective implementation of the change in policy until the 2007 season.


 June 2009  (Under review: December 2009)