Select Committee on Health Written Evidence


APPENDIX 9

Memorandum by Novartis (PI 20)

INTRODUCTION

  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.

NOVARTIS GLOBAL—INNOVATIVE, RESPONSIBLE, SUSTAINABLE

  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 healthier.

NOVARTIS IN THE UK

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

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 Hospital.

  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 field.

  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 UK—a Global HQ

  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 respiratory disease.

Research and Development—Investment 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 UK—unseen 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.

RESPONSIBLE

Global Responsibility

  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 UK—Malaria, TB, and Leprosy

  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 reached—600,000 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 provision—not 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 Drugs—The 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 to come.

Responsible Marketing—Globally and in the UK

  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 work—we 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.

SUSTAINABLE

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 the site.

  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.

CONCLUSION

  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 STUDY—GLIVEC (IMATINIB)

WHAT IS CML?

  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.

TREATMENTS FOR CML

  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 (IMATINIB)

  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.

GIST

  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.





 
previous page contents next page

House of Commons home page Parliament home page House of Lords home page search page enquiries index

© Parliamentary copyright 2005
Prepared 26 April 2005