1 / 25

Public Policies, Incentives and Partnerships for Development of Health Products

Public Policies, Incentives and Partnerships for Development of Health Products. Dr K. Satyanarayana Intellectual Property Rights Unit Indian Council of Medical Research Department of Health Research, New Delhi. The agenda. Public health priorities of poor countries

missy
Download Presentation

Public Policies, Incentives and Partnerships for Development of Health Products

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Public Policies, Incentives and Partnerships for Development of Health Products Dr K. Satyanarayana Intellectual Property Rights Unit Indian Council of Medical Research Department of Health Research, New Delhi

  2. The agenda • Public health priorities of poor countries • Epidemiological transition • Access to health products • Strategies to promote innovation • Push-Pull incentives • The way ahead International Conference on Equity and Access to Medicines: Role of innovations and Institutions, New Delhi May 12-13, 2011

  3. What is access to health products? • Available - in sufficient quantities everywhere • Acceptable – usability, appropriateness • Effective – of good quality and standard • Affordable - lowest possible cost International Conference on Equity and Access to Medicines: Role of innovations and Institutions, New Delhi May 12-13, 2011

  4. Concerns on access • About 50% global population lack access to essential medicines. • In India about 35% cannot afford even the essential medicines. • Increasing privatization of health care system • Market-driven research – IP rights • No new health products -10/90 gap • IPRs becoming a barrier? International Conference on Equity and Access to Medicines: Role of innovations and Institutions, New Delhi May 12-13, 2011

  5. Disease burden - India • Deaths - 10.3 million per year (2005) • 36% due to CDs, perinatal mortality etc. • 29% cardiovascular diseases • 11% Injuries • 7% Cancer • 7% chronic respiratory diseases • 2% diabetes • 7% other chronic diseases Reddy et al The Lancet October 5, 2005 International Conference on Equity and Access to Medicines: Role of innovations and Institutions, New Delhi May 12-13, 2011

  6. Disease prevention tools TUBERCULOSIS • BCG vaccine - 1930s • Streptomycin - 1944 • Isoniazid - 1952 • Pyrazinamide - 1952 • Rifampicin - 1970 MALARIA • Quinine two centuries old • Chloroquin - 1943 • Mefloquin - 1963 • Only artemicin in the horizon Emerging drug resistance HIV/AIDS – drugs/vaccine New emerging diseases H1N1 International Conference on Equity and Access to Medicines: Role of innovations and Institutions, New Delhi May 12-13, 2011

  7. Sum up challenges in CDs (infections) International Conference on Equity and Access to Medicines: Role of innovations and Institutions, New Delhi May 12-13, 2011

  8. Epidemiological transition in India International Conference on Equity and Access to Medicines: Role of innovations and Institutions, New Delhi May 12-13, 2011

  9. Proportion of disability adjusted life years (DALYs) lost by disease group (% total days) International Conference on Equity and Access to Medicines:Role of innovations and Institutions, New Delhi May 12-13, 2011

  10. Innovation gap

  11. Global R&D spend and 10/90 gap International Conference on Equity and Access to Medicines: Role of innovations and Institutions, New Delhi May 12-13, 2011

  12. R&D and Technological capability • Low and middle income countries account for just 21% of world GDP but less than 10% of world-wide R&D expenditure (9% BASIC) • OECD countries spent on R&D (US $ 553 billion) > than total national income of India (US $ 440 billion) • About 60% people live in countries with some technological capability (BASIC etc.) • About 25% people (Sub-Saharan Africa) live in climate of little or no technological capability. • Industrialized countries hold 97% of all patents, (MNCs - 90% of all IP in health) International Conference on Equity and Access to Medicines: Role of innovations and Institutions, New Delhi May 12-13, 2011

  13. PCT Patents International Conference on Equity and Access to Medicines: Role of innovations and Institutions, New Delhi May 12-13, 2011

  14. Tropical diseases: 13 Tuberculosis: 3 Few new health products developed for neglected diseases • Approx. 1-2% of global drug R&D targets neglected diseases • 10/90 gap in health research spending 1975-1999: 1,393 new chemical entities marketed 68·7% registered products presented little or no therapeutic gain 1% Source: DND International Conference on Equity and Access to Medicines: Role of innovations and Institutions, New Delhi May 12-13, 2011

  15. Challenges - HIV/AIDS and access • Total present infected over 40 million. • Over 5 million being added every year. • 25 million died since 1981 - 2 million in 2008; 20% < 5yr • No therapeutic available. • Available ARVs out of reach for many due to cost • Even at - US$ 10,000 to US$ 87 ppp (generics). • Universal access (MDG-6, 2010) still remains a dream. • Of 9.5 million needing drugs only 4.5 million have access. • 95% children and 75% pregnant women. • Second generation ARVs? International Conference on Equity and Access to Medicines: Role of innovations and Institutions, New Delhi May 12-13, 2011

  16. Prices of drugs for Cancers International Conference on Equity and Access to Medicines: Role of innovations and Institutions, New Delhi May 12-13, 2011

  17. Incentives for Pharma R&D • Govt of India introduced several incentives to promote pharma industry • Recognition by Department of Scientific & Industrial Research (DSIR) • In-house R&D units recognised by DSIR only are only eligible for these fiscal incentives/grants/loans from government departments viz., DST, DBT, CSIR, ICMR, ICAR, TDB etc. • This is the only scheme in the entire government system for benchmarking the industrial R&D. International Conference on Equity and Access to Medicines: Role of innovations and Institutions, New Delhi May 12-13, 2011

  18. Fiscal incentives- Direct taxes • 100% write off of revenue expenditure on R&D; • 100% write off of capital expenditure on R&D in the year the expenditure is incurred • Weighted tax deduction @175% (to the sponsor) for payments made to approved national laboratories etc. for R&D • Weighted tax deduction @200% on expenditure (other than land & buildings) incurred on approved in-house R&D* • Accelerated depreciation allowance for investment on plant and machinery, made on the basis of indigenous technology • *Includes bio-technology, clinical trials, obtaining approvals from any regulatory authority and filing an application for a patents International Conference on Equity and Access to Medicines: Role of innovations and Institutions, New Delhi May 12-13, 2011

  19. Fiscal incentives- Indirect taxes • Customs duty exemption for capital equipment and consumables needed for R&D • Central excise duty exemption for capital equipment and consumables needed for R&D. • Central excise duty waiver for 3 years on goods designed and developed by a wholly owned Indian company and patented in any two countries out of: India, USA, Japan and any one country of European Union • Exemption from customs duty on imports made for R&D projects funded by Government in industry. • Duty free import of goods specified in List-28 (comprising of analytical and specialty equipment) for use in pharmaceutical and biotechnology sector International Conference on Equity and Access to Medicines: Role of innovations and Institutions, New Delhi May 12-13, 2011

  20. Push-Pull incentives to promote drug development • Push incentives - funding policies that aim to incentivize industry via reducing industry’s costs during the research and development stages • Pull incentives - mechanisms create incentives for private sector engagement by creating viable market demand • Push mechanisms essentially pay for “effort” on the part of researchers, by underwriting the cost of that effort, while pull mechanisms pay for “results” International Conference on Equity and Access to Medicines: Role of innovations and Institutions, New Delhi May 12-13, 2011

  21. Push Incentives for drug development • Direct public spending • R&D tax credits • R&D grants to private sector • Public-private partnerships (PPPs) • public support (such as direct public spending, R&D grants, tax credits etc.) Very strong support in India

  22. Pull incentives for drug development • Transferable market exclusivity • Advance purchase commitments • Tax credit on sales • Patent buyouts • Prizes/other rewards • Prize Fund • Health Impact Fund • Fast track regulatory approvals

  23. Some major schemes for drug development in India - Push • Technology Development Board (DST) • The New Millennium Indian Technology Leadership Initiative (CSIR) • Drugs and Pharmaceuticals Research Program - DST • Technology Development and Innovation Program – DSIR • Technology-mission programs - DBT • Small Business Innovation Research Initiative - DBT • Biotechnology Industry Research & Development Assistance Programme BIRAP – (DBT) • Open Drug Discovery Initiative (CSIR) • Extramural support from all R&D agencies International Conference on Equity and Access to Medicines: Role of innovations and Institutions, New Delhi May 12-13, 2011

  24. The way ahead • Diseases of the poor still a concern • Epidemiological transition: Dual disease burden • No new health products • Privatization of health care, costs going up, especially price of medicines • Access to health products still a concern – more focus on ‘affordable’ • Efficacy of Push and Pull mechanisms for R&D for drugs of ongoing schemes • Indigenous efforts – South-led (BASIC) • South-South collaboration: India-China HIF? International Conference on Equity and Access to Medicines: Role of innovations and Institutions, New Delhi May 12-13, 2011

  25. Thank you

More Related