International Regimes for Life-Taking and Life-Saving Products – Tobacco Control and Pharmaceuticals Trade

FIRST PART –PROGRESSIVELY ELIMINATING THE LIFE-TAKING PRODUCTS UNDER THE FRAMEWORK CONVENTION ON TOBACCO CONTROL

CHAPTER I – GENERAL ISSUES
1. Tobacco Products – Deadly products yet to be legally prohibited
2. Devastating consequences of tobacco consumption and “tobacco epidemic”
3. The Establishment and the Structure of UNFCTC
4. Guidelines and Protocol as Supplementary Mechanisms (Art. 33)
CHAPTER II – CERTAIN GENERAL PRINCIPLES
1. Objective of FCTC and its role in the operation and interpretation of the Convention
2. Guiding Principles
3. General Obligations (Art. 5)
CHAPTER III – DEMAND CONROL – TO REGULATE THE PRODUCTS
1. Price and Tax Measures (Art. 6)
2. Contents and Disclosure Regulations (Arts. 9 and 10)
3. Smokeless Tobacco and E-Cigarette Issues
CHAPTER IV – DEMAND CONTROL – TO REGULATE PROMOTIONAL PRACTICE
1. Packaging and Labelling (Art. 11)
2. Packaging Requirement (Art. 13)
CHAPTER V – DEMAND CONTROL – TO REGULATE TOBACCO COMPANIES’ BEHAVIORS
1. Protection of Policy from Vest Interests (Art. 5.3) 181
2. Liability Imposed on Tobacco Companies (Art. 19) 209
CHAPTER VI – DEMAND CONTROL – TO CHANGE SMOKERS’ BEHAVIORS AND TO PROTECT EVIRONMENT
1. Protection from Exposure to Tobacco Smoke (Passive smoking) (Art. 8) 211
2. Education, communication, training and public awareness (Art. 12) 225
3. Tobacco Dependence and Cessation (Art. 14) 249
4. Protection of Environment and Human Health (Art. 18) 265
CHAPTER VII – SUPPLY CONTROL – TO REGULATE ILLICIT TRADE
1. Spread of Tobacco Epidemic Caused by Illicit Trade and the Approaches Fighting It (Art. 15)
2. Tracking and Tracing Mechanism, Licensing, and Due Diligence Requirements and International Trade Rules
3. Spilled-over Benefits to Big Tobacco Companies and the Way of Easing the Situation
CHAPTER VIII – SUPPLY CONTROL – TO REGULATE INDIVIDUAL SELLERS AND TO HELP DISADVANTAGED PARTICIPANTS 337
1. Sales to and by Minors (Art. 16)
2. Helping Disadvantaged Participants – Economically Viable Alternative Activities
CHAPTER IX – RELATIONS WITH OHER INTERNATIONAL RULES
1. FCTC Rules Concerning Its Relations with Other Treaty Systems
2. WTO Rules Concerning Its Application to Tobacco Products – Freer trade and tobacco control
3. Regime Coherence between FCTC and WTO/BIT
CHAPTER X – RELATIONS WITH OHER INTERNATIONAL RULES
1. FCTC lacking Investment Rules - Closing the Loophole by Adopting FCTC Guidelines on the Control of Tobacco Investment
2. FCTC and Bilateral Investment Treaty
CHAPTER XI – INTERNATIONAL COOPERATION, INSTITUTIONAL ARRANGEMENT, DISPUTE SETTLEMENT, AND ENTRY INTO FORCE
1. Exchange of Information (Art. 20)
2. Cooperation in the scientific, technical, and legal fields (Art. 22)
3. Conference of the Parties (COP), Secretariat and Financial Resources (Arts. 23, 24 and 26)
4. Settlement of Dispute (Art. 27)
5. Adoption and Amendments (Arts. 29 & 28)
6. Entry into Force (Arts. 34-38)





SECOND PART - TRADE IN THE LIFE-SAVING PRODUCTS – ENHANCING EQUITABLE AVAILABILITY OF PHARMACEUTICALS UNDER THE WTO

INTRODUCTION – ESSENCE AND COMPLEXITY OF THE ISSUES
CHAPTER 1. MEANING AND SCOPE OF PHARMACEUTICAL PRODUCTS
1.1 Terms used
1.2 Meaning of pharmaceutical products
1.3 Distinction of drugs from other products
1.4 Different categories of drugs
CHAPTER 2. HUMAN RIGHT ISSUES CONCERNING PHARMACEUTICAL PRODUCTS – THE SCOPE OF RIGHT TO MEDICINE
2.1 Meaning and functions of human rights
2.2 Human right in relation to human health – the right to health
2.3 Right to health in relation to medicines
2.4 Internal and external obligations under right to health
2.5 Right to health in relation to trade in pharmaceutical product inequality
CHAPTER 3. GATT RULES FOR PHARMACEUTICAL PRODUCTS AND IMPLICATIONS FOR RIGHT TO HEALTH
3.1 WTO’s failure to recognize the status of human right or right to health
3.2 Pharmaceutical products as an industrial product under GATT
3.3 Trade liberalization and the implications for right to health
3.4 Non-discrimination based on the origin of the pharmaceutical products or other criteria – MFN and national treatments
3.5 Trade Liberalization and non-discrimination’s implication for the right to health
3.6 Exceptions and the implications for right to health
CHAPTER 4. CERTAIN TECHNICAL RULES RELATED TO TRADE IN PHARMACEUTICAL PRODUCTS
4.1 Safety, quality and efficacy regulations and their implications for right to heath
4.2 Trade rules governing safety, quality and efficacy regulations and standards
4.3 Government policies for pharmaceutical sector and the right to health implication
CHAPTER 5. SPECIFIC TRADE ISSUES IN LIKE PRODUCT, COUNTERFEITS/SMUGGLINGS, AND GOODS IN TRANSIT CONCERNING PHARMACEUTICAL PRODUCTS
5.1 Determination of “like product” and “directly competitive product”
5.2 The application of “like products” and “competitive products” to pharmaceutical products
5.3 Counterfeit medicine and smuggling issues under trade rules
5.4 Transit of pharmaceutical products
CHAPTER 6. TRADE-RELATED ISSUES IN BIOTECHNOLOGY AND BIOPHARMACEUTICAL PRODUCTS
6.1 Reasons to identify trade issues in biotechnology and biopharmaceutical products
6.2 The concepts of biotechnology and biopharmaceutical products and the ethical rules for biotechnology
6.3 WTO rules concerning public morals, public order and human life or health
6.4 Linkage of biotechnology with trade
CHAPTER 7. TRADITIONAL CHINESE MEDICINES AND TBT/SPS ISSUES
7.1 The concepts of traditional medicines and reasons to identify their trade issues
7.2 WTO rules on TBT/SPS and their dichotomy
7.3 Government regulations applying to traditional Chinese medicinal materials
7.4 Nature of regulations imposed on Chinese medicinal materials
CHAPTER 8. GOVERNMENT PROCUREMENT, PRICE REGULATIONS, AND GATS RELATED ISSUES CONCERNING PHARMACEUTICAL PRODUCTS
8.1 Government procurement of pharmaceutical products
8.2 Price control of pharmaceutical products and trade issues
8.3 Service trade rules concerning pharmaceutical products and internet sale of pharmaceutical products
CHAPTER 9. TRADE RELATED IP PROTECTION FOR DRUGS – PATENTABILITY AND THE EXCEPTION FOR NORMAL EXPLOITATION
9.1 TRIPS as part of WTO agreements
9.2 Patent protection and drug development
9.3 Normal exploitation or fair use – Bolar exception
CHAPTER 10. TRADE RELATED IP PROTECTION FOR DRUGS – MAKING COMPULSORY LICENSING FRIENDLIER TO DEVELOPING COUNTRIES
10.1 Licensing contract and compulsory licensing
10.2 Meaning of compulsory licensing and its effect for public health
10.3 TRIPS requirements for compulsory licensing
10.4 Practices after the waivers and implication for access to medicine
CHAPTER 11. TRADE RELATED IP PROTECTION FOR DRUGS – DATA PROTECTION OR DATA EXCLUSIVITY AND GENERIC PRODUCTION
11.1 The undisclosed information and pharmaceutical data under TRIPS
11.2 The kind of protection for pharmaceutical data under TRIPS
11.3 Data protection and generic drugs
CHAPTER 12. TRADE RELATED IP PROTECTION FOR DRUGS – ADDRESSING PARALLEL IMPORTATION UNDER TRIPS AND GATT TO ENHANCE ACCESS TO MEDICINE
12.1 Relevance of parallel importation with drugs
12.2 Meaning and types of parallel importation of drugs and views on the merits
12.3 Relevant Provisions under TRIPS
12.4 Relevant provisions under the GATT
CHAPTER 13. TRADE RELATED IP PROTECTION FOR DRUGS – COPYRIGHT PROTECTION IN RELATION TO MEDICINE AND AVAILABILITY OF GENERIC DRUGS
13.1 Copyright protection under TRIPS
13.2 Exceptions to the exclusive rights
13.3 Test data and copyright protection
13.4 Package insert as copyright protectable work
CHAPTER 14. TRADE RELATED IP PROTECTION FOR DRUGS – ANTI-COMPETITIVE PRACTICES UNDER TRIPS
14.1 Anti-competitive practices being trade and IP related
14.2 Pharmaceutical companies engaging in anti-competitive practices
14.3 TRIPS approach