Memorandum by Novartis (PI 20)
1. As members of The Association of British
Pharmaceutical Industry (ABPI), Novartis fully endorses the Association's
submission made to the Health Select Committee. The following
submission should be read in conjunction with the ABPI's more
detailed submission, and is designed to give a fuller picture
of Novartis in terms of Novartis' ethos and principles, as well
as providing information on the UK's contribution to the efforts
of the global organisation.
2. We are proud that Novartis' products
reach patients in the NHS everyday, actively reducing morbidity
and mortality. All Novartis' staff are committed to our mission
to serve innovatively, responsibly and sustainably and to operate
at all times in an ethical and transparent way, whether that be
through playing a legitimate role in policy making or in communicating
about our products to healthcare professionals.
3. Novartis is a Swiss research-based company
created in 1996 from the merger of Ciba-Geigy and Sandoz whose
history dates back to 1758. Our core businesses are in pharmaceuticals,
consumer health, generics, eye care and animal health. As both
the fifth largest pharmaceutical company and also the world's
second largest producer of generic (non-branded) medicines, Novartis
occupies a unique position within the pharmaceutical industry.
4. Our name, derived from the Latin novae
artes, meaning "new skills", reflects our commitment
to focus on research and development to bring innovative new products
to the communities we serve, including those in the UK. To this
end, Novartis currently operates in over 140 countries worldwide
employing 78,500 people. In 2003 the company spent approximately
£2.06 billion on research and development.
5. Novartis aspires tirelessly to be a responsible
and conscientious global citizen with values based on trust, transparency
and accountability. This involves active societal engagement in
areas where we have the expertise and know-how to contribute,
proactively helping where it is needed most, and establishing
and implementing transparent ethical standards, policies and processes
across all of our activities. Novartis applies all of its ethical
standards globally and regularly exceeds the standards and legal
regulations required in many countries around the world including
the UK (eg Novartis' advertising standards).
6. Our primary and most important mission
is to discover, develop, sustainably produce and distribute high
quality medicines, addressing unmet medical needs. We want to
provide affordable, and thus accessible, well established treatment
options to the best of our abilities and as far as our resources
permit, for as many people as possible. By pursuing these goals,
to be "innovative, responsible and sustainable", we
can best provide value to our customers and, most importantly,
to society as a whole by helping patients live longer and live
Contribution to UK plc
7. In the UK Novartis employs around 3,000
people at 11 sites across the UK. Our sites are at Frimley (pharmaceuticals
and HQ), Horsham (R&D, consumer health and manufacturing),
Grimsby (manufacturing), London (research and a charitable foundation),
Dundee, Litlington and Braintree (animal health), Southampton
and Farnham (eye care), Bordon (generics) and Alfreton (manufacturing).
The pay and benefits provided to our UK employees was worth £117.9
million in 2003, with a further £8.5 million paid in tax.
Innovative Medicines for and From The UK
8. The pharmaceutical division in the UK
currently markets medicines in a range of disease areas, and much
research and trial work for these drugs was funded by Novartis
through hospitals and academic centres in the UK. In recent years
particular attention has been paid to our oncology unit, which
has developed the innovative drug Glivec (see case study below),
for patients with chronic myeloid leukaemia (CML) and gastro intestinal
stromal tumours (GIST). Much of the ongoing research work in the
use of Glivec is currently being carried out at the Hammersmith
Hospital. Femara, our treatment for breast cancer (beyond the
use of tamoxifen which is used for the first five years of treatment
post surgery), decreases mortality by 40% in patients for whom
no other medicine was previously available. Femara is also licensed
for treatment pre-surgery to shrink tumours and allow less invasive
surgery. The research work in this area was funded by Novartis,
and a significant amount took place in UK hospitals, with the
first use of Femara in patients taking place at the Royal Marsden
9. In the field of transplantation Novartis
pioneered the discovery of the immunosuppressant Neoral (cyclosporine),
which made possible the advances in transplant surgery of the
eighties and nineties. Much of the early research into the development
of cyclosporine was conducted with the Papworth Hospital where
many of the first patients received the drug, first in renal transplants,
and later in heart and lung transplants. Today Novartis is still
a world leader in the research and development of drugs in this
10. Visudyne is our innovative treatment
in the field of ophthalmology, for patients with AMD (age related
macular degeneration), the largest cause of blindness in the over
50s. No treatment was previously available for this condition.
In addition to these treatments we also provide medicines in the
areas of cardio vascular disease, Alzheimer's disease, treatment
resistant schizophrenia, asthma and pain relief.
Research and Development in the UKa Global
11. Innovation is at the core of what we
do at Novartis globally and the UK plays an important role in
this regard. Novartis spends £50 million each year on R&D
alone in the UK. In addition, the company opened a £42 million
research centre, one of the largest respiratory research centres
in the world, alongside our existing facilities in Horsham The
new facility is capable of accommodating 200 scientists and is
part of the company's investment in respiratory disease research
in the UK. The work currently being undertaken focuses on chronic
asthma and COPD (chronic obstructive pulmonary disease). Horsham
is now the global HQ for Novartis' research and development in
Research and DevelopmentInvestment in UK
People and Science
12. The Horsham site not only provides employment
for 500 people in the UK (250 each in research and development).
The £1 million invested each week enables Novartis to attract
significant numbers of early and late phase clinical trials to
the UK, and initiate clinical research collaborations and consultative
agreements with NHS and non-industry research partners. This work
does not include the large number of projects at NHS hospitals,
which we fund each year through grants. The wider benefits to
the UK are harder to quantify, such as the career opportunities
we provide to scientists and the research scientists of the future
through our programmes for school leavers, undergraduate degree
placements and post graduate employment as well as a host of initiatives
to promote science in schools. An integral part of this commitment
to science education is the "Visions of Science" photography
awards, exhibitions and lecture series which are held across the
UK, in coordination with the Daily Telegraph and NESTA (National
Endowment for Science Technology and the Arts).
Innovation in the UKunseen costs
13. Novartis' commitment to innovation is
reflected in the excellent pipeline of new medicines which the
company enjoys. In October 2003 the city analysts, Lehman Brothers,
reported Novartis as having the top rated pipeline in the industry.
As a consequence of this successful pipeline, Novartis has participated
in thirteen NICE appraisals of its products to date. The volume
of work arising from NICE technology appraisals has led Novartis
to make a considerable investment in a dedicated team of health
economists and pharmacists, as well as enrolling the assistance
of outside academic centres, to ensure that we can provide NICE
with the detailed information which they require. With appraisals
taking anywhere from nine months to over two years, this represents
a significant investment of time and resources by Novartis UK.
14. There are other additional costs to
working in the UK which are not incurred elsewhere, such as the
security measures required to protect our staff from animal rights
extremists. Novartis UK has spent an extra £1 million on
security measures at its sites in the last two years alone. There
are also extensive costs associated with running trials or research
projects in NHS hospitals. In addition to funding for the laboratory
time and the researchers themselves, most hospitals make a charge
for "overheads". In most cases these extra costs are
reasonable and amount to between 30-40% extra. However, some NHS
hospitals arbitrarily charge in excess of 100% extra. These costs
and the other additional costs of operating in the UK are often
cited when Novartis UK is competing at a global level to win investment
in R&D, clinical trials or other projects.
15. As part of our commitment to Corporate
Citizenship, Novartis is committed to trying to help on a case
by case basis where there is immediate need with products, funds
and other supportive measures. This encompasses free or subsidised
treatment programmes in developing and industrialised countries,
discounts and access to health programmes for patients without
adequate medical insurance or other similar measures in industrialised
countries. In addition, the company also makes ad hoc donations
aimed at addressing special needs such as leprosy, tuberculosis
and disaster relief in various parts of the world. Novartis is
also proud that it was the first pharmaceutical company to sign
the United Nations Global Compact, which now forms the basis of
our Corporate Citizenship Guidelines and which include a commitment
to fair working conditions, business ethics, human rights and
third party management. Each of these policies is integrated into
audit programmes across the UK Company and the Company's employees
are required to adhere to them.
Global Action from the UKMalaria, TB, and
166 One major commitment by Novartis is
the work we are currently doing in partnership with the World
Health Organisation (WHO). In a unique private-public partnership
with the WHO, Novartis' drug for treatment resistant malaria,
Coartem, is currently being made available in developing countries
at cost whilst the company is currently working with the not-for-profit
health organisation, Malaria Venture, to develop a paediatric
formulation of the drug. These projects have already treated 650,000
patients since launch. Part of the development of Coartem took
place in the UK at the Novartis Horsham site whilst other work
was carried out, and continues, with the Tropical Disease Unit
at Oxford University.
17. In December 2003 Novartis also signed
a five year agreement with the WHO to provide half a million tuberculosis
treatments free of charge as part of the work of the Global Fund
to Fight AIDS, Tuberculosis and Malaria. Novartis is also committed
to eradicating leprosy and as such we are working with the WHO
by providing free MDT treatment. So far 2,500,000 patients have
been reached600,000 in 2003 alone.
18. In addition to these projects the Novartis
Foundation for Sustainable Development has, for last 25 years,
been funded by the company. The Foundation is independent of the
economic interests of the Novartis group of companies and seeks
to support innovative, performance-related development projects.
In some projects the Foundation seeks to provide assistance through
drug provisionnot just where we manufacture the treatment
(eg in malaria and TB) but also for diseases where we don't (eg
AIDS). The Foundation also collaborates in several non-drug projects
as part of a commitment to improve access to healthcare in developing
countries. For example, in Tanzania we work with partners Terre
des Hommes to provide psychosocial support for AIDS orphans, including
regular sessions to help them cope with their bereavement, training
of teachers and social workers in basic psychology skills and,
with a sustainable focus, the development and implementation of
income-generating activities, supported by the orphans organisation
and youth bank. The Foundation is currently planning to extend
the project to Eastern and Southern Africa.
Developing DrugsThe Not For Profit Future
19. In the past the pharmaceutical industry
has been criticised for concentrating on those diseases more prevalent
among industrialised nations. In contrast to this perception,
in July 2004 Novartis officially opened the Novartis Institute
for Tropical Diseases (NITD) in Singapore. The purpose of the
Institute is to discover novel treatments and prevention methods
for major tropical diseases and to make them available without
profit. Novartis believes that this is an innovative, responsible
and, crucially, sustainable commitment to fighting tropical diseases.
Whilst the set-up costs are being committed now (£108.4 million
in partnership with the economic development board in Singapore),
the real value of this project will be the availability and access
to effective treatments across the developing world in the years
Responsible MarketingGlobally and in the
20. Novartis is fully committed to the ABPI
code of practice which regulates our pharmaceutical promotional
practice in the UK. In addition, the Novartis' pharmaceutical
division has also proactively implemented a Marketing Code to
ensure consistently high standards in our promotional activity.
In order to secure adherence to the code, sales and marketing
management personnel are trained in workshops, while a compliance
organisation within the division conducts various audits. Violations
of the code have resulted in dismissals.
Working with Patient Groups in the UK
21. Patient groups, who effectively represent
the interests of those patients, will always take a keen interest
in the development of new medicines which may benefit their members.
The Novartis pipeline of innovative treatments has attracted considerable
interest in regards to availability of places on clinical trials,
dates for the licensing of particular products, availability on
the NHS and, of course, issues such as clinical safety and efficacy.
Within the bounds of commercial sensitivity Novartis works to
ensure that accurate information is provided transparently. Within
this context, we are also committed to publishing the results
of all our clinical trials and were one of the first companies
to sign up to the ABPI register of clinical trials.
22. In respect of sponsorship or funding,
Novartis seeks to be an ethical partner in our collaborations
with patient groups, with the nature of the partnership set out
explicitly at the outset. Our experience of UK patients groups
is that they are keen to set out the parameters of the relationship
and what is appropriate. This reflects a desire amongst patient
groups to protect their independence which Novartis fully supports.
Invariably such groups also have independent links with senior
clinicians, who they will consult to ensure that the information
we provide is accurate. Not only would it be ethically inappropriate
but the sophistication and scrupulousness of UK patient groups
and the veracity of the British press represents checks and balances
to prevent this kind of unhealthy relationship developing.
23. Novartis does not provide funds for
all the patient groups with whom we workwe are also happy
to share information which is important to patients. In many circumstances,
particularly where innovative or novel drugs are concerned, we
are clearly best placed to provide the information about the medicines
we have developed and, where appropriate and where our strict
guidelines allow, we provide this information to patient groups.
Novartis has often provided sales data to the Department of Health
directly in order to help the Government carry out audits of services
and to ensure that treatments are reaching patients appropriately.
However, whether a relationship involves sponsorship or just the
exchange of information and ideas, Novartis places the highest
value on being a transparent and legitimate partner.
Sustaining the Environment and Growth in the UK
24. Sustainable growth is a cornerstone
of the Novartis approach to business. This reflects a commitment
to growth in the UK as well as a commitment to sustainable environmental
policies at our R&D and manufacturing sites. As part of this
commitment we are committed to reporting our CO2 submissions in
absolute terms and we continue a programme of remediation at our
older sites in the UK. The new Respiratory Centre in Horsham for
example, was designed to reduce the amount of chemicals used at
25. However, for Novartis UK, sustainability
also means attracting and retaining investment in the UK from
our global company. When making the business case for such investment,
there are a number of key elements such as the state of the UK
market as a place to do business (including the PPRS, reimbursement,
NICE etc), the availability of the relevant skills and education
and the threats posed by animal rights extremists.
26. Novartis UK is proud that we have won
the development of a new manufacturing site as part of our chemical
operations in Grimsby. The existing site has a hard won reputation
for cost effectiveness, reliability and efficiency of production
and supply. Part of the success of the plant has been the excellent
links with local universities and schools to sustain the expertise
required. The new building to be opened in 2005 is a £160
million investment, which should help to sustain and secure Novartis'
operation in Grimsby, and the manufacturing jobs which it provides
in the medium to long term.
27. Novartis is committed to bringing innovative,
affordable and accessible products to the communities that we
serve in the UK in a responsible and sustainable way. With our
3,000 UK-based staff, operating in a complex regulatory framework,
it is vital that the UK has a supportive innovation environment
and that there is recognition of the operating environment of
R&D in the UK, including those difficulties imposed by animal
rights activists and the problems that still exist with implementation
of NICE guidance.
CASE STUDYGLIVEC (IMATINIB)
Chronic Myeloid Leukaemia (CML) is a debilitating
cancer occurring predominantly in older patients. Although relatively
rare, it is one of the four most common types of leukaemia. There
are approximately 500-800 new cases diagnosed in the UK every
year and about 4,000 patients in total. CML accounts for about
500 deaths a year in England and Wales.
Symptoms include feeling very tired and breathless.
Patients are often anaemic, due to a shortage of red blood cells.
The disease progresses through three distinct phases: the chronic
phase (typically lasting from three to four years), the accelerated
phase (typically lasting from three to nine months), and blast
crisis (typically lasting from three to six months). As a patient
moves through these stages, the disease usually becomes increasingly
refractory to therapy and, therefore, more difficult to treat.
The greatest chance of altering the normal progression of the
disease is in the chronic phase.
Glivec (imatinib) is used as a first line therapy
in the treatment of CML and is considered the gold standard in
treating the disease. Prior to the introduction of Glivec, treatment
was limited to chemotherapy with hydroxyurea and busulfan, but
mainly interferon-alfa. Associated 100-day mortality rates ranged
from 30-60%. Where a suitable donor can be found, bone marrow
transplant is still the only known cure. However, only 20% of
the CML population are eligible for this complicated procedure.
Glivec is an innovative treatment that has produced
startling life-prolonging results in some patients previously
with little hope. It is part of a new class of drugs called signal
transduction inhibitors and works by stopping the enzyme that
causes the leukaemia cells to grow. Glivec is well tolerated by
patients and is a simple oral therapy (tablets). It is the first
cancer treatment to target cancer cells specifically whilst leaving
the healthy ones alone thus leading to fewer unpleasant side effects
than conventional cancer treatments. In addition, Glivec has been
shown to have a significant survival advantage over interferon
alpha. Studies have shown that at 24 months 79.2% of patients
at chronic phase on Glivec experienced a complete cytogenic remission
as compared to 18.5% on interferon plus chemotherapy. Gilvec patients
were also able to maintain their quality of life (QoL) whereas
those in the interferon group experienced a decline in QoL that
was evident within the first month of treatment.
Glivec was given regulatory approval in record
time in both Europe and the United States because of its impressive
results. It has also been awarded orphan drug status in the US,
EU and Japan demonstrating the importance of Glivec to the medical
community and patients.
Prior to it receiving health authority funding,
Glivec was made available to over 500 patients in the UK alone
via a compassionate programme, under which the drug was provided
free of charge until it became commercially available.
In addition to CML, Glivec is also licensed
for patients with gastrointestinal stromal tumours (GIST). Prior
to Glivec, if surgery was not curative or an option, other methods
for treating GIST were limited and offered little hope of recovery.
Now treatment with Glivec has been demonstrated to result in a
reduction in tumour size (over 50%) in more than half of patients
with advanced inoperable (unresctable) or metastatic (that has
spread to other parts of the body) GIST. Nearly 83% of patients
had a response in their tumour and a study has shown that after
34 months of treatment with Glivec, 50% of patients are still
alive, This compares with a historical median survival of 12 months
for patients not treated with Glivec.
There are currently studies under way looking
at optimal use of Glivec in GIST and how it might be used in association
with both pre-operative and post-operative surgery.