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GATT, WTO and International
Agreement in Pharmaceutical Sector
Prepared By: Guided By:
Chandani Tripathi Dr. Gayatri Patel
17MPHRA010 Associate Professor
1
Table of Content
 What is GATT?
 Background
 Objectives
 Fall of GATT
 WTO
 Formation of WTO
 Functions of WTO
 Organization of WTO
 TRIPS
 TRIMS
 Difference between GATT and WTO.
 DOHA Declaration
 Compulsory Licensing
 Parallel Importation
 Case Study
 Summary
 References
2
3
GATT (GENERAL AGREEMENT ON TARIFFS AND
TRADE)
 A Treaty, Not An Organization
“An International Agreement to reduce trade barriers among Member Countries.”
4
WHAT IS GATT?
 Set of multilateral trade agreements
 To provide an international forum - expansion of world trade that encouraged
free trade between member states
 By regulating and reducing tariffs on traded goods
 Providing a common mechanism for resolving trade disputes eliminating
discrimination.
5
WTO T, History P. The WTO and GATT: A Principled History. 1947; 10–21.
BACKGROUND
 1930 Depression in international trade.
 In 1950 as an outcome of the failure of negotiating governments to create
the International Trade Organization (ITO)
 Part of economic recovery after World War II, Bretton Woods Conference
suggested an organization to regulate trade
 Parallel to the Governments negotiating the ITO, 15 negotiating states began
negotiating for the GATT as away to attain early tariff reductions
 GATT agreement was introduced On 1 January, 1948 along with 23 countries
including India.
 An independent multifunctional treaty between the member countries------
designed to boost the economy by international trade for globalization.
 IPR Handbook for Pharma Students and Researchers, Parikshit Bansal, Pg. 141-162. 6
YEAR COUNTRIES NEGOTIATION TIME PURPOSE
1947 Geneva, Switzerland 7 months The objective was tariffs, and to establish tax
concessions affecting in trade.
1949 Annecy, France 5 months Tariffs were discussed again more tax concessions
were exchanged between countries.
1951 Torquay, England 8 months Nearly 9,000 tariff concessions were agreed
upon reducing many tax levels by up to 25%.
1956 Geneva, Switzerland 5 months This round was for a $2.5 billion reduction in tariffs
across the globe.
1960-1961 Dillon Round, Geneva,
Switzerland
11 months To elimination of an additional $4.9 billion in global
tariffs.
1964-1967 Kennedy Round, Geneva,
Switzerland
37 months Approximately $40 billion of tariff concessions along
with discussions on the curbing of predatory pricing
policies known as dumping.
1973-1979 Tokyo, Japan 74 months Around 102 countries achieved $300 billion in global
tariff reductions.
1986-1993 Uruguay, South America 87 months Many more subjects like including intellectual
property, agriculture and dispute settlement.
7
IPR Handbook for Pharma Students and Researchers, Parikshit Bansal, Pg. 121-132.
OBJECTIVES OF GATT
To provide equal opportunities to all countries in terms of trade in
international market
Increase effective demand for real income growth goods
Minimize tariffs and other restrictions on trade
Ensure better living standard
To strengthen and clarify rules for agricultural trade
Provide amicable solutions to dispute related to international trade
8
Bown CP. Self-enforcing trade: developing countries and WTO dispute settlement. Brookings Institution Press; 2010 Feb 1.
Fall of GATT
Trade In Merchandise Goods Only
Negligence Of Some Sectors Such like
Agriculture, textile Clothing
No Institutional Foundation
Slow Dispute Settlement System
Provisional Basis and Temporary
Agreement
9
IPR Handbook for Pharma Students and Researchers, Parikshit Bansal, Pg. 141-162.
WTO (WORLD TRADE
ORGANIZATION)
GATT has got Successor……
10
11
FORMATION OF WTO
 On 1st January, 1995, under an agreement ------at the 8th GATT round of
discussions held at Uruguay, 15th Dec. 1993 and the “Marrakesh
Declaration”, Morocco, 15th April, 1994,
 The WTO has around 150 members, accounting over 97% of world trade. India
in considered as a profounding member of WTO.
With an aim….
 To strengthen world economy
 To increase trade and investment
 To promote employment and income growth globally
12
IPR Handbook for Pharma Students and Researchers, Parikshit Bansal, Pg. 141-162.
Functions of WTO
 Administering WTO trade agreements
 Forum for trade negotiations
 Handling trade disputes
 Monitoring National Trade policies
 Technical assistance and training for developing countries
 Cooperation with other international organizations.
13
TRIPS and Pharmaceutical Industry, Impact on Developing Countries, Manish Ashiya, Pg. 26-33.
Organization Chart
14
http://www.simplynotes.in/wp-content/uploads/2016/03/organisational_structure_001.jpg Date of Access: 18.2.2018
Trade Related aspects of Intellectual Property Rights
(TRIPS)
 Developed countries do not prefer to trade with developing countries in
order to protect their goods and products from getting copied.
 Huge amount of loss in sales in sectors like chemicals, pharmaceutical,
movies and computer software
 TRIPS ----------allow protection of products in food, pharmaceutical,
agricultural and chemical sectors and biological materials.
15WTO T, History P. The WTO and GATT: A Principled History. 1947; 10–21.
Trade Related Investment Measures (TRIMS)
 Some countries often try to imply conditions on foreign investors ------ to
encourage the investment according to certain national priorities.
 Under GATT, countries have to use the measure consistent with GATT rule of
National Treatment and rules which prohibit the application of qualitative
restriction to imported goods.
 TRIMS agreement applies to trade in goods only.
16
TRIPS and Pharmaceutical Industry, Impact on Developing Countries, Manish Ashiya, Pg. 26-33.
Difference between GATT & WTO
Parameter GATT WTO
Institutional Does not have any institutional foundation
rather it is a set of rules and agreements by a
group of countries.
It is a full-fledged body with the permanent
institutional foundation along with rules and
agreement.
Only a small associated secretariat
established under the concept of
International Trade Organization (ITO).
A permanent and well-established secretariat
at Geneva.
Permanency It is still treated as provisional and the
commitments are also susceptible to change
and revision.
It is considered as permanent commitments
there is no liability of any changes once it is
committed.
Objectives Applies only to trade in merchandise goods. Applies to trade in goods along with trade in
Services and Intellectual Property.
Scope Selective in execution of agreement
between member countries.
It is multilateral and applicable to all
members.
Dispute
settlement
Dispute settlements were slower with
certain backlogs and resistance.
Dispute settlements were faster, automatic
and less prone to interference with more
power and strengths.
17
WTO T, History P. The WTO and GATT: A Principled History. 1947; 10–21.
DOHA DECLARATION
 Defined as a legally binding agreement on all member countries which signed
the TRIPS agreement, under which individual member countries have been
given the flexibility to deal with the problems relating to public health
which may arise as a result of enforcement of TRIPS.”
 On 14th November, 2001 WTO Ministerial Conference at Doha adopted DOHA
Declaration on TRIPS agreement and Public Health which consist of seven
paragraphs.
18
Lalitha N. Doha Declaration and Public Health Issues. 2008; 13(September):401–13.
DOHA Declaration introduced because…
 HIV crisis in sub-Saharan African countries.
 Attempts by the pharmaceutical industry, backed by some governments to
block the implementation of TRIPS- compatible measures by the South African
Government.
 Compliant brought by the USA against Brazil in relation to the compulsory
licenses.
 Practical difficulties faced by authorities in developing countries in making
use of ‘flexibilities’ provided in TRIPS agreement on issues pertaining to
health.
19
Lalitha N. Doha Declaration and Public Health Issues. 2008; 13(September):401–13.
Compulsory license
Is a permission granted by the government in public interest, to a non-
patentee to make a patented product”.
For example:
if there is any patented new drug and the non-patentee wants to manufacture
that drug , then the non-patentee has to undergo a compulsory licensing
procedure as generic drug for the manufacture of the patented drug.
20
TRIPS and Pharmaceutical Industry, Impact on Developing Countries, Manish Ashiya, Pg. 26-33.
Parallel importation :
 (Article 6) allows countries to import a patented product marketed in
another country at a lower price.
 As per the declaration Paragraph 5 (d) explicitly reaffirms members, that the
person has freedom to determine its own regimes for exhaustion of
intellectual property
21TRIPS and Pharmaceutical Industry, Impact on Developing Countries, Manish Ashiya, Pg. 26-33.
Disadvantages for India
 TRIPs agreement went against the Indian Patents Act (1970)
 Introduction of product patents in India lead to hike in drug prices by the
MNCs. Hence the poor were left with no generic option
 Extension of intellectual property right to agriculture has negative effects on
India and Indian research institutions
 Application of TRIMs agreement undermines any plan or strategy of self
reliant growth based on local technology.
 Service sectors in India are backward compared to the service sectors in
developed countries. Hence inclusion of trade in services is detrimental to the
interest of India.
 The MFN clause proved to be detrimental to India’s interest & provided
grounds for Chinese invasion in Indian market through dumping.
22
TRIPS and Pharmaceutical Industry, Impact on Developing Countries, Manish Ashiya, Pg. 26-33.
CASE STUDY
 This issue relates to the geographical indication (GI) protection of Darjeeling tea
due to the unauthorized use and registration of ‘Darjeeling and Darjeeling logo’
by International Tea KK, a Japanese company, already registered in Japan by the
Tea Board of India.
 The words ‘Darjeeling and Darjeeling logo’ by some other countries like France,
Russia, United States, Germany, Israel, Norway and Sri Lanka.
SOLUTION PROPOSED BY INDIA:
 In order to deal with the situations described ahead, India, along with several other
member countries of the WTO, wants to extend the proposed register for GI to
include products or goods, other than wines and spirits.
23
Bown CP. Self-enforcing trade: developing countries and WTO dispute settlement. Brookings Institution Press; 2010 Feb 1.
RESULT:
 The Doha Ministerial Declaration under paragraphs 12 and 18 also
provides a mandate for the issue of providing a higher level of
protection to GIs to products other than ‘wines and spirits’ to be
addressed by the TRIPS Council.
 During the last four years the Tea Board of India has spent
approximately US$200, 000 for legal and registration expenses,
costs of hiring a international watch agency and fighting
infringements in overseas jurisdictions.
24
Summary
 The General Agreement on Tariffs and Trade and the World Trade Organization
identifies a number of important issues related to pharmaceutical sectors.
 reciprocal balance of trade obligations across countries is what has allowed
them to keep the trade barriers low toward one another, for the most part,
over the next 60 years.
 WTO members use the dispute settlement process to self-enforce the
agreement and maintain this reciprocal balance in the face of relatively
challenging political and economic circumstances.
25
References
 IPR Handbook for Pharma Students and Researchers, Parikshit Bansal, Pg. 141-
162.
 TRIPS and Pharmaceutical Industry, Impact on Developing Countries, Manish
Ashiya, Pg. 26-33.
 WTO T, History P. The WTO and GATT: A Principled History. 1947; 10–21.
 Lalitha N. Doha Declaration and Public Health Issues. 2008;
13(September):401–13.
 Bown CP. Self-enforcing trade: developing countries and WTO dispute
settlement. Brookings Institution Press; 2010 Feb 1.
 Jackson JH. The world trading system: law and policy of international
economic relations. MIT press; 1997.
 Murthy D. The future of compulsory licensing: deciphering the Doha
Declaration on the TRIPS Agreement and public health. Am. U. Int'l L. Rev..
2001;17: 1299.
26
27

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Gatt

  • 1. GATT, WTO and International Agreement in Pharmaceutical Sector Prepared By: Guided By: Chandani Tripathi Dr. Gayatri Patel 17MPHRA010 Associate Professor 1
  • 2. Table of Content  What is GATT?  Background  Objectives  Fall of GATT  WTO  Formation of WTO  Functions of WTO  Organization of WTO  TRIPS  TRIMS  Difference between GATT and WTO.  DOHA Declaration  Compulsory Licensing  Parallel Importation  Case Study  Summary  References 2
  • 3. 3
  • 4. GATT (GENERAL AGREEMENT ON TARIFFS AND TRADE)  A Treaty, Not An Organization “An International Agreement to reduce trade barriers among Member Countries.” 4
  • 5. WHAT IS GATT?  Set of multilateral trade agreements  To provide an international forum - expansion of world trade that encouraged free trade between member states  By regulating and reducing tariffs on traded goods  Providing a common mechanism for resolving trade disputes eliminating discrimination. 5 WTO T, History P. The WTO and GATT: A Principled History. 1947; 10–21.
  • 6. BACKGROUND  1930 Depression in international trade.  In 1950 as an outcome of the failure of negotiating governments to create the International Trade Organization (ITO)  Part of economic recovery after World War II, Bretton Woods Conference suggested an organization to regulate trade  Parallel to the Governments negotiating the ITO, 15 negotiating states began negotiating for the GATT as away to attain early tariff reductions  GATT agreement was introduced On 1 January, 1948 along with 23 countries including India.  An independent multifunctional treaty between the member countries------ designed to boost the economy by international trade for globalization.  IPR Handbook for Pharma Students and Researchers, Parikshit Bansal, Pg. 141-162. 6
  • 7. YEAR COUNTRIES NEGOTIATION TIME PURPOSE 1947 Geneva, Switzerland 7 months The objective was tariffs, and to establish tax concessions affecting in trade. 1949 Annecy, France 5 months Tariffs were discussed again more tax concessions were exchanged between countries. 1951 Torquay, England 8 months Nearly 9,000 tariff concessions were agreed upon reducing many tax levels by up to 25%. 1956 Geneva, Switzerland 5 months This round was for a $2.5 billion reduction in tariffs across the globe. 1960-1961 Dillon Round, Geneva, Switzerland 11 months To elimination of an additional $4.9 billion in global tariffs. 1964-1967 Kennedy Round, Geneva, Switzerland 37 months Approximately $40 billion of tariff concessions along with discussions on the curbing of predatory pricing policies known as dumping. 1973-1979 Tokyo, Japan 74 months Around 102 countries achieved $300 billion in global tariff reductions. 1986-1993 Uruguay, South America 87 months Many more subjects like including intellectual property, agriculture and dispute settlement. 7 IPR Handbook for Pharma Students and Researchers, Parikshit Bansal, Pg. 121-132.
  • 8. OBJECTIVES OF GATT To provide equal opportunities to all countries in terms of trade in international market Increase effective demand for real income growth goods Minimize tariffs and other restrictions on trade Ensure better living standard To strengthen and clarify rules for agricultural trade Provide amicable solutions to dispute related to international trade 8 Bown CP. Self-enforcing trade: developing countries and WTO dispute settlement. Brookings Institution Press; 2010 Feb 1.
  • 9. Fall of GATT Trade In Merchandise Goods Only Negligence Of Some Sectors Such like Agriculture, textile Clothing No Institutional Foundation Slow Dispute Settlement System Provisional Basis and Temporary Agreement 9 IPR Handbook for Pharma Students and Researchers, Parikshit Bansal, Pg. 141-162.
  • 10. WTO (WORLD TRADE ORGANIZATION) GATT has got Successor…… 10
  • 11. 11
  • 12. FORMATION OF WTO  On 1st January, 1995, under an agreement ------at the 8th GATT round of discussions held at Uruguay, 15th Dec. 1993 and the “Marrakesh Declaration”, Morocco, 15th April, 1994,  The WTO has around 150 members, accounting over 97% of world trade. India in considered as a profounding member of WTO. With an aim….  To strengthen world economy  To increase trade and investment  To promote employment and income growth globally 12 IPR Handbook for Pharma Students and Researchers, Parikshit Bansal, Pg. 141-162.
  • 13. Functions of WTO  Administering WTO trade agreements  Forum for trade negotiations  Handling trade disputes  Monitoring National Trade policies  Technical assistance and training for developing countries  Cooperation with other international organizations. 13 TRIPS and Pharmaceutical Industry, Impact on Developing Countries, Manish Ashiya, Pg. 26-33.
  • 15. Trade Related aspects of Intellectual Property Rights (TRIPS)  Developed countries do not prefer to trade with developing countries in order to protect their goods and products from getting copied.  Huge amount of loss in sales in sectors like chemicals, pharmaceutical, movies and computer software  TRIPS ----------allow protection of products in food, pharmaceutical, agricultural and chemical sectors and biological materials. 15WTO T, History P. The WTO and GATT: A Principled History. 1947; 10–21.
  • 16. Trade Related Investment Measures (TRIMS)  Some countries often try to imply conditions on foreign investors ------ to encourage the investment according to certain national priorities.  Under GATT, countries have to use the measure consistent with GATT rule of National Treatment and rules which prohibit the application of qualitative restriction to imported goods.  TRIMS agreement applies to trade in goods only. 16 TRIPS and Pharmaceutical Industry, Impact on Developing Countries, Manish Ashiya, Pg. 26-33.
  • 17. Difference between GATT & WTO Parameter GATT WTO Institutional Does not have any institutional foundation rather it is a set of rules and agreements by a group of countries. It is a full-fledged body with the permanent institutional foundation along with rules and agreement. Only a small associated secretariat established under the concept of International Trade Organization (ITO). A permanent and well-established secretariat at Geneva. Permanency It is still treated as provisional and the commitments are also susceptible to change and revision. It is considered as permanent commitments there is no liability of any changes once it is committed. Objectives Applies only to trade in merchandise goods. Applies to trade in goods along with trade in Services and Intellectual Property. Scope Selective in execution of agreement between member countries. It is multilateral and applicable to all members. Dispute settlement Dispute settlements were slower with certain backlogs and resistance. Dispute settlements were faster, automatic and less prone to interference with more power and strengths. 17 WTO T, History P. The WTO and GATT: A Principled History. 1947; 10–21.
  • 18. DOHA DECLARATION  Defined as a legally binding agreement on all member countries which signed the TRIPS agreement, under which individual member countries have been given the flexibility to deal with the problems relating to public health which may arise as a result of enforcement of TRIPS.”  On 14th November, 2001 WTO Ministerial Conference at Doha adopted DOHA Declaration on TRIPS agreement and Public Health which consist of seven paragraphs. 18 Lalitha N. Doha Declaration and Public Health Issues. 2008; 13(September):401–13.
  • 19. DOHA Declaration introduced because…  HIV crisis in sub-Saharan African countries.  Attempts by the pharmaceutical industry, backed by some governments to block the implementation of TRIPS- compatible measures by the South African Government.  Compliant brought by the USA against Brazil in relation to the compulsory licenses.  Practical difficulties faced by authorities in developing countries in making use of ‘flexibilities’ provided in TRIPS agreement on issues pertaining to health. 19 Lalitha N. Doha Declaration and Public Health Issues. 2008; 13(September):401–13.
  • 20. Compulsory license Is a permission granted by the government in public interest, to a non- patentee to make a patented product”. For example: if there is any patented new drug and the non-patentee wants to manufacture that drug , then the non-patentee has to undergo a compulsory licensing procedure as generic drug for the manufacture of the patented drug. 20 TRIPS and Pharmaceutical Industry, Impact on Developing Countries, Manish Ashiya, Pg. 26-33.
  • 21. Parallel importation :  (Article 6) allows countries to import a patented product marketed in another country at a lower price.  As per the declaration Paragraph 5 (d) explicitly reaffirms members, that the person has freedom to determine its own regimes for exhaustion of intellectual property 21TRIPS and Pharmaceutical Industry, Impact on Developing Countries, Manish Ashiya, Pg. 26-33.
  • 22. Disadvantages for India  TRIPs agreement went against the Indian Patents Act (1970)  Introduction of product patents in India lead to hike in drug prices by the MNCs. Hence the poor were left with no generic option  Extension of intellectual property right to agriculture has negative effects on India and Indian research institutions  Application of TRIMs agreement undermines any plan or strategy of self reliant growth based on local technology.  Service sectors in India are backward compared to the service sectors in developed countries. Hence inclusion of trade in services is detrimental to the interest of India.  The MFN clause proved to be detrimental to India’s interest & provided grounds for Chinese invasion in Indian market through dumping. 22 TRIPS and Pharmaceutical Industry, Impact on Developing Countries, Manish Ashiya, Pg. 26-33.
  • 23. CASE STUDY  This issue relates to the geographical indication (GI) protection of Darjeeling tea due to the unauthorized use and registration of ‘Darjeeling and Darjeeling logo’ by International Tea KK, a Japanese company, already registered in Japan by the Tea Board of India.  The words ‘Darjeeling and Darjeeling logo’ by some other countries like France, Russia, United States, Germany, Israel, Norway and Sri Lanka. SOLUTION PROPOSED BY INDIA:  In order to deal with the situations described ahead, India, along with several other member countries of the WTO, wants to extend the proposed register for GI to include products or goods, other than wines and spirits. 23 Bown CP. Self-enforcing trade: developing countries and WTO dispute settlement. Brookings Institution Press; 2010 Feb 1.
  • 24. RESULT:  The Doha Ministerial Declaration under paragraphs 12 and 18 also provides a mandate for the issue of providing a higher level of protection to GIs to products other than ‘wines and spirits’ to be addressed by the TRIPS Council.  During the last four years the Tea Board of India has spent approximately US$200, 000 for legal and registration expenses, costs of hiring a international watch agency and fighting infringements in overseas jurisdictions. 24
  • 25. Summary  The General Agreement on Tariffs and Trade and the World Trade Organization identifies a number of important issues related to pharmaceutical sectors.  reciprocal balance of trade obligations across countries is what has allowed them to keep the trade barriers low toward one another, for the most part, over the next 60 years.  WTO members use the dispute settlement process to self-enforce the agreement and maintain this reciprocal balance in the face of relatively challenging political and economic circumstances. 25
  • 26. References  IPR Handbook for Pharma Students and Researchers, Parikshit Bansal, Pg. 141- 162.  TRIPS and Pharmaceutical Industry, Impact on Developing Countries, Manish Ashiya, Pg. 26-33.  WTO T, History P. The WTO and GATT: A Principled History. 1947; 10–21.  Lalitha N. Doha Declaration and Public Health Issues. 2008; 13(September):401–13.  Bown CP. Self-enforcing trade: developing countries and WTO dispute settlement. Brookings Institution Press; 2010 Feb 1.  Jackson JH. The world trading system: law and policy of international economic relations. MIT press; 1997.  Murthy D. The future of compulsory licensing: deciphering the Doha Declaration on the TRIPS Agreement and public health. Am. U. Int'l L. Rev.. 2001;17: 1299. 26
  • 27. 27