Intellectual Property Rights, Investment and Transfer of Technology in the Pharmaceutical Sector Patrizia Carlevaro Head of the International Aid Unit Syria, Damascus April 25 and 26, 2005

2 Innovation for Better Health The discovery of new drugs is the only way to address the challenges of current and emerging diseases It becomes more and more costly to discover and develop new drugs (average 1 Billion USD) and, for the inventor, to recoup its costs

3 IP rights encourage discovery, recognize innovation as being essential for the industry development and bring improvement to public health More than 95% of the WHO Essential Drugs ED List is off patent Innovation for Better Health

4 Before the creation of the IPRs System, the knowledge was not widely disseminated and societies could not benefit from this disclosed information The IPRs allow science to progress and people to benefit from new discoveries 10,000 products have to be tested to eventually come up to the discovery of one

5 Innovation for Better Health Within the same therapeutical class a considerable competition exists in terms of quality, efficacy and price Thanks to IPRs, the generic industry can have full access to data related to invention and discovery Most of the drugs used worldwide are developed and marketed by the private industry

6 Affordable Prices Access to healthcare services is not exclusively a drug price issue Although a large number of generic drugs are available at very competitive prices, they are not present in certain markets and when they are, they have not been able to change or improve the populations health profile

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8 A Good IP System Adequate standards of protection System for applying the standards Limited exceptions A brief and effective transition period The TRIPS agreement is the result of delicate and careful negotiations, humanity needs it in order to continue to progress

9 A Good Data Exclusivity System Is a key starting point for creating a core competency in life sciences, pharmaceuticals, biotechnology Aims to encourage development of all data (Phase I, II, III) necessary to establish that a drug is both safe and efficacious for human consumption, and to fully compensate the originator for its efforts Provides incentives outside of traditional forms of IPR for companies to invest in research and clinical development of drugs, drug combinations and uses Spurs the development and testing of new active ingredients – particularly when patents are not available

10 Time Costs Reference: DiMasi, J.R., New Drug Development In the USA ( ), Clinical Pharmacology & Therapeutics May, 69(s). Time to Bring an Innovative Drug to Market has Increased Significantly

11 Development Costs Companies are challenged to reduce costs and increase productivity and efficiencies Without IPR, a company is unlikely to invest in product launch,, Physician education programs,, Clinical research efforts,, Public awareness efforts,, Corporate Philanthropy

12 Potential Partnerships with the Pharmaceutical Industry As much with the Public sector and as the Private sector Important to better serve the local markets and create a long-term goal Contribute with the Transfer of Technology and its competencies Contribute to the economical and social development Bring additional resources to populations most in need

13 Factors Pharmaceutical Companies Consider Prior to Investing Country politically and economically stable Barriers to entry (e.g. currency restrictions, slow regulatory approvals) Size of local pharmaceutical market and growths potential Intellectual property protection and enforcement measures,, Patents for pharmaceutical (compound protection),, Trademark and copyright laws,, Data for registration protected from disclosure

14 WTO Member or in process of joining Current Good Manufacturing Practices (cGMPs) available Multinational companies treated same as local companies Potential to export from country (free trade agreements) Transparent regulatory/pricing and tender processes Tax - other incentives to invest Factors Pharmaceutical Companies Consider Prior to Investing

15 Investment Types / Cooperation Develop research projects with local institutions both public & private Build manufacturing facilities alone or with local partner Use local manufacturers as 3 rd parties Use local manufacturers to toll manufacturing products (package) y yMulti-national or local company market or both (co-marketing) Sell bulk products to local manufacturers allow them to market y yWith or without manufacturing know how Sell or license trademarks, patents or other rights to local companies

16 Some Changes Required in Syrian Law for TRIPS Compliance Provide protection for Pharmaceutical compounds (product protection) Patent term of 20 years from filing date Data package exclusivity – period during which another company cannot rely on innovators safety and efficacy data

17 Success in Jordan Provides a Good Example for Syria s, No IPR protection for pharmaceuticals 1999, Jordan joined the WTO TRIPS compliant January 1, 2000 Innovative Life Sciences Sector Created New drug approvals take 120 days (previously it was minimum 2 – 3 years) Established 5 years of Data Exclusivity protection Pharmaceutical exports increased by more than 30% from 1999 – 2002 Jordanian CROs & Medical Tourism created Jordan Becomes Springboard for Investment & Development in Middle East – –Increased FDI by 500% since 1999 – –US exports increased by 300% Syria PopulationGDP GrowthGDP/PPP* 18 million0.9 %US$ 3,300 Jordan PopulationGDP GrowthGDP/PPP* 5.6 million3.1%US$ 4,300 * CIA World Fact Book, This entry shows GDP on a purchasing power parity basis divided by population as of 1 July for the same year (2003)