Memorandum submitted by the National Institute
for Clinical Excellence (PI 32)
HEALTH POLICY,
RESEARCH, PRESCRIBING
PRACTICE AND
PATIENT USE
1. Introduction
1.1 The National Institute for Clinical
Excellence (NICE) involves a wide range of stakeholders in the
development of its guidance including NHS staff, healthcare professionals,
patients and carers, the academic world and the pharmaceutical
and medical devices industries. The pharmaceutical industry has
the same rights and responsibilities as any other stakeholder.
1.2 We take a structured approach to our
engagement with the pharmaceutical industry that enables companies
to make an appropriate contribution to the development of guidance
and encourages them to work transparently, alongside other stakeholders.
1.3 The purpose of this memorandum is to
describe the role of the Institute, to outline the way we work
with our stakeholders, and to set the contribution made by the
pharmaceutical industry within this context.
2. The Institute
2.1 NICE was established as a special health
authority in 1999. Our role is to provide advice to the NHS in
England and Wales on the clinical and cost effectiveness of drugs
and other treatments. Our advice is for people who rely on the
NHS for their care and for health professionals. Further information
about the work of the Institute can be found at www.nice.org.uk.
2.2 A summary of the four main types of
NICE guidance is set out below.
2.2.1 Technology appraisals: recommendations
on the use of new and existing medicines and other treatments
(devices, surgical and other procedures, diagnostic techniques
and health promotion methods).
2.2.2 Clinical guidelines: recommendations
on the appropriate treatment and care of patients with specific
diseases and conditions, such as diabetes and schizophrenia.
2.2.3 Cancer service guidance: recommendations
on arrangements for the organisation and delivery of services
for people with cancer.
2.2.4 Interventional procedures: guidance
about whether interventional procedures used for diagnosis and
treatment are safe enough and work well enough for routine use.
An interventional procedure is one used for diagnosis or treatment
that involves making a cut or hole in the body, entry into a body
cavity or using electromagnetic radiation (including X-rays or
lasers) and ultrasound.
2.3 We publish around 25 technology appraisals,
12 clinical guidelines and 60 pieces of interventional procedures
guidance each year.
2.4 NICE guidance is a key component of
the national standards to which the NHS is now expected to work.
Technology appraisals and interventional procedures guidance are
"core" standards, which require immediate implementation,
and clinical guidelines are regarded as "developmental"
standards, the implementation of which will take place over a
longer period.
2.5 The Institute is based in offices in
central London. It has a budget of nearly £20 million, which
is largely provided by the Department of Health but also includes
a contribution from the Welsh Assembly Government, to which the
Institute is jointly accountable. The Institute directly employs
around 100 people.
3. Working with stakeholders
3.1 Since its inception, the Institute has
taken the approach that those whom its decisions affect are entitled
to express their views on how we go about our work and on the
development of individual pieces of guidance. We define these
groups as including, but not necessarily limited to:
3.1.1 patients, carers and the public, and
those who speak for them;
3.1.2 healthcare professionals;
3.1.3 NHS management;
3.1.4 healthcare industries;
3.1.5 the Government.
We recognise these constituencies as key stakeholders
in our work alongside a much larger group including, for example,
other NHS agencies with related functions, research organisations
and trade unions.
3.2 We make sure that our stakeholders (sometimes
called consultees) have clear and reasonable opportunities to
engage with us when we are developing guidance on a particular
topic. The arrangements we have put in place have evolved as our
experience of working with a diverse community of interested parties
has grown. The main elements of these arrangements are summarised
below.
3.2.1 Our processes and methods are developed
in consultation with our stakeholders and with the independent
experts who sit on our advisory committees. Drafts of our process
and methods documents are exposed to public consultation and the
comments received, together with the final versions of the documents,
are approved by the Board in public session.
3.2.2 We consult with stakeholders on our
interpretation (the "scope") of the topics referred
to NICE by the Department of Health and Welsh Assembly Government.
These scopes form the basis of each guidance development project.
3.2.3 All draft guidance is subject to consultation
with stakeholders and the wider public through the Institute's
website.
3.2.4 All documentation associated with
the development of guidance, other than where we have agreed to
restrictions for reasons of commercial or academic confidence
(see Section 4.5), is released into the public domain.
3.2.5 Comments submitted to the Institute
by stakeholders are made publicly available along with the Institute's
response.
3.3 We take the view that those who rely
on our guidance should be able to understand how it has been developed;
in effect, they should be able to see an "audit trail"
from the evidence to the recommendations. It should be clear why
our advisory committees reached their conclusions, where any changesfrom
the draft to the final conclusionshave been made and why.
To this end each of our programmes displays a common set of characteristics,
which are summarised below.
3.3.1 Use of the best available evidence:
each programme secures a comprehensive evidence base, by contracting
the work to an independent body or by undertaking the work in-house,
and stakeholders are invited to check that all relevant evidence
has been considered.
3.3.2 Involvement of clinical and patient
experts: ensuring that our advisory bodies have access to
clinical expertise and patient and carer perspectives as they
interpret the evidence is crucial both to the relevance of the
recommendations and to their credibility.
3.3.3 Independent advisory bodies: the
guidance that NICE publishes is prepared by independent standing
committees (for technology appraisals and interventional procedures)
and individual development groups (for clinical guidelines). All
our advisory bodies include healthcare professionals working in
the NHS and people who are familiar with the issues affecting
patients and carers. The standing advisory committees also include
people who have current experience working in the healthcare industries.
Under the Institute's policy on declaration of interests, the
members of our independent advisory bodies, who are mainly unpaid
advisors, are required to register their interests and declare
any interests they may have in the specific topic under discussion
at the start of each meeting. If a conflict of interest is identified,
the individuals are required to stand down and do not take part
in the relevant decision-making process for that project.
3.3.4 Genuine consultation: all NICE
guidance undergoes widespread consultation with stakeholders and
the public. "Genuine" means that our advisory bodies
will respond to reasoned argument that can stand up to independent
scrutiny and, if necessary, change their original thinking.
3.3.5 Regular review: technology
appraisal guidance and clinical guidelines are reviewed at regular
intervals to ensure that they remain current. Review dates are
set on the basis of the advisory body's understanding of the anticipated
pace of change in the evidence base.
4. Engaging with the pharmaceutical industry
4.1 We regard the pharmaceutical industry
as a stakeholder in our work. As such, they have the same rights
and responsibilities as any other stakeholder. Organisations developing
health technologies on which patients rely have knowledge about
disease areas and the therapeutic value of their own technology.
They also have access to important clinical data that the advisory
bodies need to access. The pharmaceutical industry employs staff
who are skilled in the interpretation of clinical trial data and
the outputs of economic analysis and they make a valuable contribution
to the development of high quality guidance.
4.2 However, the Institute is conscious
of the conflict of interest that manufacturers of health technologies
have when engaging with usthat their desire, ultimately,
is to ensure a market for their products and a return for their
shareholders. Our structured arrangements for engaging with companies
ensure that this conflict does not inappropriately influence the
development of guidance.
4.3 The pharmaceutical industry mainly engages
with the Institute in the development of the technology appraisals
guidance and clinical guidelines, and it is on this basis that
the following details are provided. Our structured approach to
engaging with the pharmaceutical industry in these programmes
(as with all our other stakeholders) is summarised below.
4.3.1 NICE drafts a written consultation
on the scope for a technology appraisal or a clinical guideline.
4.3.2 NICE invites relevant members of the
pharmaceutical industry, alongside the other stakeholders, to
a meeting at the start of the development of a piece of guidance
to discuss the scope, the approach to assembling the evidence
base, and the key issues that will be addressed during the development
of the guidance.
4.3.3 NICE consults on the evidence to be
used by the advisory body and all stakeholders are given the opportunity
to supplement the evidence base. Ultimately, the evidence that
is taken account of is a matter for the advisory body, which sets
out the rationale for the use or otherwise of the evidence submitted
by all stakeholders.
4.3.4 The advisory body prepares a written
consultation on the draft recommendations, on two occasions during
the development of a clinical guideline (where there is no appeal
stage), and on one occasion during the development of technology
appraisal guidance (where there is an appeal stage). Comments
received from the pharmaceutical industry on draft documents,
in common with responses from other stakeholders, are posted on
the Institute's website.
4.3.5 In the technology appraisal programme
the relevant pharmaceutical company, alongside other stakeholders,
has the opportunity to submit an appeal on the grounds that the
Institute has exceeded its powers or has failed to follow its
process, or that the guidance is perverse.
4.4 One aspect of the way in which we engage
with the healthcare industries which does differ from other stakeholders
is that manufacturers do not attend meetings of the technology
appraisals advisory committee, whereas patient and carer groups
and healthcare professionals do attend these meetings. In our
view this an important part of minimising the risks associated
with the potential conflict of interest referred to in Section
4.2.
4.5 Guidelines on the release of company
data into the public domain during a technology appraisal were
agreed between NICE and the Association of the British Pharmaceutical
Industry (ABPI) in May 2004. This agreement acknowledges the importance
of putting relevant information into the public domain to ensure
the credibility of NICE guidance. These guidelines are helpful
in achieving consistency of approach by the pharmaceutical industry,
and they are a step towards our long-term goal of achieving unrestricted
access to and publication of all relevant data for the development
of our guidance (see attachment).
4.6 The pharmaceutical industry has an interest
in monitoring the implementation of the Institute's guidance.
Where individual companies or trade bodies have monitored the
uptake of medicines or medical devices and have agreed to make
this information publicly available, the Institute has published
this information on its website alongside studies commissioned
by the Institute itself and those provided by patient organisations.
4.7 We believe that this structured and
transparent approach to our engagement with pharmaceutical companies
enables us to take advantage of the knowledge and expertise of
these companies and access to their data while shielding those
who are formulating recommendations on behalf of the Institute
from the potential distorting effect of an over-enthusiastic presentation
of the benefit of a product.
5. Supplemental evidence
5.1 A copy of the agreement made between
NICE and the ABPI on the release of company data into the public
domain and referred to in 4.5 is attached at Appendix A for information.
5.2 Members of the Health Select Committee
are also invited to review the detail of our arrangements for
engaging with the pharmaceutical industry and other stakeholders
in the process documents for the technology appraisals and clinical
guidelines programmes, which are enclosed as Appendix B and C
for information.
6. Conclusion
6.1 The pharmaceutical industry, alongside
other stakeholders, contributes to the development of high quality,
credible guidance that supports healthcare professionals and patients
and their carers in making decisions about treatment and care.
6.2 The Institute takes a structured approach
to the involvement of the pharmaceutical industry in the development
of its guidance in order to manage appropriately the conflict
of interest that the industry may have when dealing with NICE.
6.3 The Institute works with the pharmaceutical
industry to encourage a consistent approach to placing relevant
data in the public domain in order to support the transparency
and credibility of guidance recommendations and enhance public
knowledge.
National Institute for Clinical Excellence
August 2004
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