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Our mission at Novartis

Bioethics and commercial R&D in the life sciences WIPO LIFE SCIENCES SYMPOSIUM ON INTELLECTUAL PROPERTY (IP) AND BIOETHICS SEPTEMBER 4, 2007. Our mission at Novartis.

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Our mission at Novartis

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  1. Bioethics and commercial R&D in the life sciences WIPO LIFE SCIENCES SYMPOSIUM ON INTELLECTUAL PROPERTY (IP) AND BIOETHICSSEPTEMBER 4, 2007

  2. Our mission at Novartis We want to discover, develop and successfully market innovative products to prevent and cure diseases, to ease suffering, and to enhance quality of life. We also want to provide a shareholder return that reflects outstanding performance and to adequately reward those who invest ideas and work in our company. Daniel VasellaChairman & CEO

  3. Unique portfolio to meet changing healthcare needs: Leading innovative pharmaceuticals High-quality, low-cost generics Preventive vaccines Consumer health products World’s third largest pharmaceutical company by sales One of 20 largest companies by market capitalization Ranked among most respected companies worldwide Novartis at a glance

  4. Our strategy: How we address the trends Innovative medicines Prevention Self care Reducing economic burden Access • Answering unmet needs • Better efficacy and side-effect profiles • Diagnosis, vaccination, patient compliance • Quality, safety, availability • Generics – freeing up funds for innovation • Helping to reduce global burden of disease

  5. Bioethics, IP and Commercial R&D (Bio)Ethics IP R&D

  6. Bioethics & Commercial R&D • Bioethical issues are inherent in almost all life-science R&D • Many of them relate to very fundamental ethical questions (e.g. use of animals in biomedical R&D, healthy volunteers) • Large, multinational corporations represent a “melting-pot” of diverse intra- and international values and norms • Proper understanding of key ethical issues is essential to gain and sustain trust and credibility internally and externally • For many of these issues an external ethical review is mandatory (e.g. ethics committees for clinical trials) • However, often neither societies at large nor legal systems provide clear guidance (e.g. somatic nuclear transfer technologies)

  7. Novartis R&D is Global R&D  example Pharma/NIBR/Corp. Research: R&D-Sites Vienna Horsham Basel Tsukuba Cambridge East Hanover Emeryville San Diego Singapore

  8. Highly diverse norms Global R&D requires common grounds – an immense challenge for applied ethics Huge conceptualdifferences

  9. In a global environment…. Which “Ethics” is the right one?

  10. IP and Commercial R&D • IP is central to all Novartis R&D activities • Our unique position in the market (strong Rx, Gx and Vaccines business) enables us to better analyze and understand many controversial issues • However, very rarely intellectual property per se can be considered as a leading cause for (bio)ethical problems • In the majority of publicly debated cases the ethical problems arise either prior to initiation of the IP process (e.g. “production” of transgenic organisms) or by the way successful inventions are commercialized (e.g. appropriate benefit sharing or adequate access to medicines) Proposition: Like the famous knife the IP system itself is morally neutral. It is rather the means chosen to achieve innovation and the ways in which successful innovations are being commercialized which require ethical justification.

  11. “IP” seems not to be “IP” Human genes from Early Onset Alzheimer’s Disease Patients DNA Injection into mice eggs Transgenic Mouse + human genes from Early Onset Alzheimer’s Disease Patients Example: APP mutations (e.g. Swedish Mutation the APP 23 mouse model)

  12. Bioethics, IP and Commercial R&D • Although different disciplines, cultural values, moral and ethics are essentially different throughout the globe – and often even within a given nation/society • Commercial entities have to operate in an ethically sound way – however, they are not (and shall not) act as norm-setting entities • If critical assessment of existing norms and their applicability to real-life business/R&D activities reveals a gap of interculturally acceptable guidance ethical support/facilitation is most appropriate • Novartis is seeking external ethical advise on different levels  example: Novartis Ethics Advisory Board

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