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Brussels 21-22 September 2008

EICC – IMC Roundtable on Pharmaceutical Industry. Indian Pharmaceutical Industry Innovation, IPRs & Counterfeits. by D G Shah Secretary General Indian Pharmaceutical Alliance. Brussels 21-22 September 2008. Outline of Presentation. Indian Pharmaceutical Industry

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Brussels 21-22 September 2008

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  1. EICC – IMC Roundtable on Pharmaceutical Industry Indian Pharmaceutical Industry Innovation, IPRs & Counterfeits by D G Shah Secretary General Indian Pharmaceutical Alliance Brussels 21-22 September 2008

  2. Outline of Presentation • Indian Pharmaceutical Industry • The Patents Act – Restoring “Balance” • TRIPS Article 39.3 • IPRs & Innovation • IPRs & Public Health • Anti-Counterfeit Drive IPA:09/08

  3. Indian Pharmaceutical Industry Investment in Capacity Creation Source: CMIE, Study Report: 1996-2004 IPA: 09/08

  4. Indian Pharmaceutical Industry Globalization of Business: 2005-06 Source: Pharmexcil IPA: 09/08

  5. Indian Pharmaceutical Industry Global Sales of Pharmaceuticals: 1990-2010P 1990 2005 2010P Pharmacy of the World IPA: 09/08

  6. Indian Pharmaceutical Industry R & D Spend: How Top Sectors Fare Source: Capitaline Plus Pharma Spends More Than All Industries Put Together IPA: 09/08

  7. Indian Pharmaceutical Industry R & D Spend @ Constant $ (1 = INR 45) Source: IPA Balancing Short-Term Profitability with Sustainable Long-Term Growth IPA: 09/08

  8. 2006 2000 5% 30% NCE Chiral 35% 30% Analogue NDDS 35% 65% Process Development Indian Pharmaceutical Industry Moving Up the Value Chain of R & D IPA: 09/08

  9. The Patents Act Embodies TRIPS Agreement • Article 7 (OBJECTIVE): The Enforcement of Intellectual Property Rights should be “…… in a manner conducive to social and economic welfare, and to a balance of rights and obligations”. • Article 8 (PRINCIPLES): WTO Members are Allowed to “…… adopt measures necessary to protect public health and nutrition, and to promote the public interest”. IPA:09/08

  10. The Patents Act Implements Flexibilities • Criteria for Patentability - S.3 (d) & (e) • Use of Transitional Period - S.11A(7) • Pre-Grant Opposition - S.25 • Compulsory Licence - S.84 • Government Use Licence - S.92 & 92A • Exception For Early Working - S.107(a) • Parallel Imports – S.107A(b) Focus on Quality of Patents & Public Health IPA:09/08

  11. The Patents Act Encourages Innovation “We need to ensure that the global IP systems evolve so that they may contribute to the development of developing countries, by stimulating innovation and technology transfer relevant to them, while also making available the products of technology at the most competitive prices possible .” • Integrating Intellectual Property Rights and Development Policy-CIPR • - Prof John Barton - George E. Osborne Prof of Law, Stanford University • Mr Daniel Alexander – Barrister, London, UK • Prof Carlos Correa – Director, Masters Programme on Science and Technology Policy and • Management, University of Buenos Aires, Argentina • - Dr Ramesh Mashelkar FRS – Director General, Indian Council of Scientific and • Industrial Research, New Delhi, India • Dr Gill Samules CBE – Senior Director of Science Policy and Scientific Affairs (Europe) • at Pfizer Ltd, Sandwich, UK • - Dr Sandy Thomas – Director of Nuffield Council on Bioethics, London, UK IPA:09/08

  12. The Patents Act Restoring “Balance” Should India Emulate or Evolve? • Pressure to Emulate the US System: United States spends over 14% of GDP on Healthcare and yet 1/3 of its people do not have access to medicines • India Trying to Evolve Own System: India needs a system that encourages real innovation while ensuring access to medicines FDA Granted Priority Status to Less than 25% of 1,284 Drug Patents IPA:09/08

  13. The Patents Act Restoring “Balance”Healthcare Spend as % of GDP - 2005 Source : WHO Should India Emulate or Evolve? IPA:09/08

  14. TRIPS Article 39.3 Protection of Undisclosed Test Data Member States’ obligation is to protect “undisclosed test or other data” submitted to Regulatory Authority against “unfair commercial use” It does not mean “Market Exclusivity”; and Use of originator’s data for regulatory approval is “not unfair commercial use.” Canadian Federal Court Judgement IPA:09/08

  15. TRIPS Article 39.3 Demand of Big Pharma • 10-Year “Data Exclusivity” • From Date of Marketing Authorization in the Country • Irrespective of Patent Status • For Any ‘New Product’ IPA:09/08

  16. TRIPS Article 39.3 Data Exclusivity in EC “different salts, esters, ethers, isomers, mixture of isomers, complexes or derivatives of an active substance shall be considered to be same substance unless they differ significantly in properties with regard to safety and/or efficacy” European Parliament Directive 2001/83/EC, as amended by Directive 2002/98/EC, as amended by 2004/24/EC, as amended by 2004/27/EC, Art. 10(1) (2004) Derivative, if Significantly Different, is also Eligible for 10-Year Exclusivity IPA:09/08

  17. TRIPS Article 39.3 Implications of Exceeding TRIPS Obligations • Longer than 20-Year Market Monopoly • Delays Entry of Generics • Protection to Weak Patents • Tool for “Evergreening” • Offers Market Exclusivity to Pre-1995 Molecules IPA:09/08

  18. TRIPS Article 39.3 What India is Doing • No Obligation to Go Beyond TRIPS Agreement; • Taking Calibrated Approach; • Avoiding Data Exclusivity; • Making Appropriate Provision for Protection of “Undisclosed Test Data”; • Protecting Flexibility Conferred by the TRIPS Agreement for Defining Patentability; • Monitoring Impact of the TRIPS Agreement on Access to Medicines and the Local Industry IPA:09/08

  19. IPRs & Innovation Protection v/s Competition IP Laws are Designed to Provide Exclusive Rights as Incentives for Investment in R & D But In Many Sectors Competition (Absence of Exclusivity) Drives Technological Development There is Inherent Tension between IPRs & Competition IPA:09/08

  20. IPRs & Innovation Protection v/s Competition IPRs are Designed to Foster Innovation and Sustain Economic Growth But Kill Competition and thereby Restrict Innovation Need for Balancing IPRs & Competition IPA:09/08

  21. IPRs & Innovation Protection (P) vs. Innovation (I) Maximal Innovation Level Optimal Protection Level Minimal Protection Level Source: Swiss Federal Institute of Intellectual Property, October 2006 Beyond a Point, IPRs are Counterproductive IPA:09/08

  22. IPRs & Public Health Key Elements of India’s IPR Policy • Exclusive Rights should Not Prevent Pro-competitive Environment. Both are Needed for Innovation • There is No “One-Size-Fits-All” Model for Striking the Balance between IPR and Innovation • Stronger IPR = More Innovations? Not So Simple • Access to Medicine – Public Health Need for Flexibility in the IPR System IPA:09/08

  23. IPRs & Public Health World Audited Market - 2005 +Source: IMS Health: MIDAS, MAT March 2005 * Source: EarthTrends DataTables 18% of the World Population Contributes 89% of Sales IPA:09/08

  24. Anti–Counterfeit Drive Scope & Definition • “Medicines which are deliberately and fraudulently mislabeled with respect to identity or source.Counterfeiting occurs both with branded and generic products and counterfeit medicines may include products with the correct ingredients but fake packaging, with wrong ingredients, without active ingredients or with insufficient active ingredients” Source : WHO IPA:09/08

  25. Anti–Counterfeit Drive Report of the EC Taxation and Customs Unit - 2007 • “China, responsible for almost 60% of all counterfeit goods seized, continues to be the main source. However, in some categories, such as articles for personal care, other countries such as Georgia and Turkey are the main sources whilst Switzerland, India and United Arab Emirates top the list for medicines” Source : Community customs activities on counterfeit and piracy - Results at the European border - 2007 IPA:09/08

  26. Anti–Counterfeit Drive Other Initiatives – Diffusing the Focus • IMPACT by WHO • SECURE by World Customs Organization • ACTA by G–8 / USTR • EU Council Regulation No. 1383/2003 Expanded IP Protection & Enforcement of Patents and Data Exclusivity Diffuse Anti-Counterfeiting Focus IPA:09/08

  27. Anti–Counterfeit Drive EU Directive 2004/48/EC: Article 3.2 • “The measures, procedures and remedies shall be applied in such a manner as to avoid the creation of barriers to legitimate trade and to provide for safeguards against their abuse” Yet, Anti-Counterfeiting Campaigns Go Beyond Counterfeits IPA:09/08

  28. Anti–Counterfeit Drive Adopt One Uniform Definition • Counterfeits:Medicines which are deliberately and fraudulently mislabeled with respect to identity or source • What is not Counterfeit • Products infringing Patent Rights • Parallel importation of original products from a third country where they have been sold by the appropriate right-holder • Diversion of supplies of authorized items • Import of medicines for personal use, not duly registered in the country • Substandard need not be counterfeit and should be defined asAny medicine with incorrect ingredients IPA:09/08

  29. THANK YOU dgshah@vision-india.com IPA:09/08

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