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                               Life is our life’s
         The National Institute for Clinical Excellence
The National Institute for Clinical Excellence (NICE) was established as a special health
authority for England and Wales on 1st April 1999 on a statutory basis. Its purpose is to
promote the clinical excellence and the effective use of resources within the NHS. It aims
to provide patients, carers, health professionals and NHS managers with authoritative and
reliable guidance. This is based on evidence of clinical and cost effectiveness, to inform
their decisions about treatment and healthcare.
NICE’s guidance covers individual health technologies, including medicines, the clinical
management of specific conditions, and clinical audit methods.
One of the institute’s objectives is the promotion of faster patient access to innovative
technologies that provide improved health outcomes for patients, while eliminating
ineffective or outmoded treatments. While Pfizer fully supports the objective of faster
patient access to innovative, new technologies across England and Wales, the company is
opposed to any intention for NICE to be used as a method for cost-containment.
Pfizer is concerned that the issue of affordability influences the work of NICE at the
expense of the impact on patients and cost effectiveness, which should be the important
criteria. If affordability is viewed as being the main influence on NICE guidance this will
undermine the credibility of the institute, its processes and its guidance. Decisions on
affordability of medicines should be transparent and be decided by health ministers after
NICE has completed its work independently of the Department of Health.
Ongoing dialogue should take place between companies, the Department of Health and
NICE throughout the product development period to improve understanding of a new
medicine, its potential impact on the condition and its potential value to the NHS. Pfizer
recognises and supports the NHS’s need for early information on new products but
fundamentally disagrees with any intention to provide specific guidance on the use of all
new products at launch.
The Government needs to consider the significant time and financial investment that is
made by pharmaceutical companies engaged in the research and development of a new
medicine when it introduces new requirements for approval in the UK. Pharmaceutical
R&D programmes are designed and implemented over a period of up to ten years and
unexpected changes in the requirements for product approval can undermine the
commercial viability of a new product. Any changes for product assessment should
therefore be phased in to enable appropriate changes to ongoing R&D programmes
without jeopardising long-term investment in the UK.
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 Pfizer Limited                                                      
 Walton Oaks Dorking Road                                         
                                 2000       2001          2003
 Walton-on-the-Hill                                                           Tel: 01737 330478
                                  AWARDED TO PFIZER LIMITED
 Surrey. KT20 7NS                                                             Fax: 01737 332526

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