WTO ppt

International Institute of International Institute of Foreign Trade & ResearchForeign Trade & Research

Impact of WTO on Indian Pharmaceutical Impact of WTO on Indian Pharmaceutical IndustryIndustry

Presented Before: Presented Before: Presented By : Presented By : Prof. Nidhi Bajaj Richa Prof. Nidhi Bajaj Richa GuptaGupta

Samiksha AnandSamiksha Anand

IntroductionIntroduction The World Trade Organization was The World Trade Organization was

established in 1994 in Marrakech established in 1994 in Marrakech following the successful conclusion of the following the successful conclusion of the Uruguay Round of Trade Negotiations. Uruguay Round of Trade Negotiations. The predecessor to the WTO was the The predecessor to the WTO was the General Agreement on Tariffs and Trade General Agreement on Tariffs and Trade (GATT) . A key reform of the Uruguay (GATT) . A key reform of the Uruguay Round was the Agreement on Trade Round was the Agreement on Trade Related Aspects of Intellectual Property Related Aspects of Intellectual Property Rights.Rights.

Indian Pharmaceutical IndustryIndian Pharmaceutical Industry IPI is ranked 4th in volume terms and 11th in IPI is ranked 4th in volume terms and 11th in

value terms globally. value terms globally. Around 70% of the country's demand for Around 70% of the country's demand for

bulk drugs, drug intermediates, bulk drugs, drug intermediates, pharmaceutical formulations, chemicals, pharmaceutical formulations, chemicals, tablets, capsules, orals and vaccines is met tablets, capsules, orals and vaccines is met by IPI. by IPI.

The Pharmaceutical industry in India is The Pharmaceutical industry in India is fragmented with over 3,000 small/medium fragmented with over 3,000 small/medium sized generic pharmaceutical manufacturers.sized generic pharmaceutical manufacturers.

Role of Pharmaceutical Role of Pharmaceutical Industry in India’s GDPIndustry in India’s GDP

It ranks 4th in the world, pertaining to the It ranks 4th in the world, pertaining to the volume of salesvolume of sales

The estimated worth of the Indian The estimated worth of the Indian Pharmaceutical Industry is US$ 6 billionPharmaceutical Industry is US$ 6 billion

The growth rate of the industry is 13% per The growth rate of the industry is 13% per yearyear

The current revenues are estimated at The current revenues are estimated at US$5.5 billion and it is expected to grow at a US$5.5 billion and it is expected to grow at a compounded annual growth rate of 19% and compounded annual growth rate of 19% and touch US$25 billion in revenue by 2010.touch US$25 billion in revenue by 2010.

Major Requirements of TRIPS Major Requirements of TRIPS AgreementAgreement

WTO Member States must provide a level of WTO Member States must provide a level of rights equal to those provided in the major rights equal to those provided in the major global intellectual property treaties global intellectual property treaties administered by WIPO, including the Paris administered by WIPO, including the Paris Convention on Industrial Property. Convention on Industrial Property.

WTO member states may not discriminate WTO member states may not discriminate among technologies in providing patent among technologies in providing patent protection.protection.

WTO member states must provide patent WTO member states must provide patent protection for at least 20 years from the date of protection for at least 20 years from the date of filing a patent application filing a patent application

Major Requirements of TRIPS Major Requirements of TRIPS AgreementAgreement

WTO Member States must provide WTO Member States must provide effective judicial enforcement of effective judicial enforcement of intellectual property rights. intellectual property rights.

A TRIPS Council was created to coordinate A TRIPS Council was created to coordinate WTO policy in the area of intellectual WTO policy in the area of intellectual property rights and to manage the property rights and to manage the resolution of disputes among states on resolution of disputes among states on implementation of TRIPS obligations.implementation of TRIPS obligations.

Global Patent InstitutionsGlobal Patent Institutions

The World Intellectual Property The World Intellectual Property Organization Organization

It is the principal forum for negotiation of It is the principal forum for negotiation of new patent treaties and the leading provider new patent treaties and the leading provider of technical assistance to developing of technical assistance to developing countries in the field of intellectual property countries in the field of intellectual property rights. WIPO was created in 1967 as the rights. WIPO was created in 1967 as the successor organization to the International successor organization to the International Bureau for the Protection of Intellectual Bureau for the Protection of Intellectual Property, which had been in existence since Property, which had been in existence since the 19the 19thth Century. WIPO Currently has 179 Century. WIPO Currently has 179 member states. member states.

Positive Impact of TRIPSPositive Impact of TRIPS TRIPS has challenged developing countries TRIPS has challenged developing countries

in issues like public health.in issues like public health. It has allowed the developing countries It has allowed the developing countries

greater international trade of patented greater international trade of patented medicines.medicines.

Members may choose to implement laws Members may choose to implement laws which provide more extensive protection which provide more extensive protection than is required in the agreement, so long as than is required in the agreement, so long as the additional protection does not the additional protection does not contravene the provisions of the agreement. contravene the provisions of the agreement.

Negative Impact of TRIPSNegative Impact of TRIPS It has failed to resist the patenting of genetic It has failed to resist the patenting of genetic

resources.resources. It has failed to create effective rules for benefit It has failed to create effective rules for benefit

sharing.sharing. The new legislative measures to meet India’s The new legislative measures to meet India’s

TRIPS obligations are currently in the process of TRIPS obligations are currently in the process of being finalized. The Patents (Second being finalized. The Patents (Second Amendment) Bill 1999, which introduces Amendment) Bill 1999, which introduces product patents for pharmaceuticals and product patents for pharmaceuticals and agrochemicals in India’s patent law, is yet to be agrochemicals in India’s patent law, is yet to be enacted.enacted.

Important Declarations MadeImportant Declarations MadeS.No. Year INSTRUMENTS ADOPTED ON

TRIPS AND PUBLIC HEALTH1 2001 Declaration on TRIPS adopted on

14 Nov 2001 by the 4th WTO Ministerial Conference, Doha, Qatar.

2 27th June 2002

Decision on the extension of the transition period under Article 66.1 of the TRIPS Agreement for Least Developed Country Members for certain obligations with respect to Pharmaceutical Products.

3 8th July 2002

Decision on Least Developed Country MembersObligations under Article 70.9of the TRIPS Agreement with respect to Pharmaceutical Products.

Important Declarations MadeImportant Declarations Made

S.No. Year INSTRUMENTS ADOPTED ON TRIPS AND PUBLIC HEALTH

4 30th August 2003

Decision on the implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health.

5 6th December 2005

Decision on the Amendment of the TRIPS Agreement.

6 2005 Hong Kong Ministerial Declaration Paragraph 40 on TRIPS and Public Health.

7 2008 Decision to extend deadline for accepting TRIPS Agreement Amendment.

Future of Indian pharma industry Future of Indian pharma industry The key to survival would be the exponential The key to survival would be the exponential

growth of R&D expenditure. Indian companies growth of R&D expenditure. Indian companies need product patent protection to encourage need product patent protection to encourage research in developing inexpensive drugs that suit research in developing inexpensive drugs that suit the Indian disease profile.the Indian disease profile.

The obligations imposed on India are going to have The obligations imposed on India are going to have a significant impact on India’s successful bulk and a significant impact on India’s successful bulk and formulation-oriented pharmaceutical industry. formulation-oriented pharmaceutical industry. Indian companies could focus on producing Indian companies could focus on producing patented drugs under license from foreign patented drugs under license from foreign companies or generating revenues from producing companies or generating revenues from producing generic drugs.generic drugs.

ConclusionConclusion Ranbaxy Laboratories Ltd., India’s largest Ranbaxy Laboratories Ltd., India’s largest

pharmaceutical company topped the list of the pharmaceutical company topped the list of the companies from third world to file patents in companies from third world to file patents in the area of drug applications. It has filed the area of drug applications. It has filed patent for 240patent for 240products.products. According to the PCT , the Indian According to the PCT , the Indian drug companies have filed almost 4200 patent drug companies have filed almost 4200 patent applications. Dr Reddy Laboratories and applications. Dr Reddy Laboratories and Mumbai based Sun Pharmaceuticals have filed Mumbai based Sun Pharmaceuticals have filed patent application for around 100 products patent application for around 100 products and Cipla has filed for 50 patents.and Cipla has filed for 50 patents.