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The Impact of Intellectual Property Rights on the Healthy Lifestyle Regulations: A Case of Tobacco Control in South Asia

Sanath Sameera Wijesinghe Lecturer in Law

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Road map

Introduction & objectives Methodology The burden of tobacco on public health Results and discussion

Implementation of healthy lifestyle regulations on tobacco products World Health Organization Framework Convention on Tobacco Products (WHO FCTC) Tobacco control in South Asia

The game of cat and mouse between tobacco control and tobacco industry IPR claims on international trade and investment agreements IPR claims on constitutional provisions and national IP law

A way forward Conclusion

2

Introduction & objectives (research focus) Healthy lifestyle regulations – laws relating to prevent health risks

and promote general health and well-being of the people Healthy lifestyle regulations on tobacco products - laws relating to

regulate the production, packaging and labelling, advertising, sale and disposing tobacco products (smoking forms and smokeless forms)

Graphic health warning measures – health warnings which contain the risk of tobacco consumption –

Graphic health warnings communicate both to tobacco users and non-users the harms of tobacco use, including to youth… with zero cost with greater emphasize of the harm of tobacco

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Globalization of trade – tobacco – tobacco epidemic has come to a central stage of discussion

Graphic health warning measures itself create a conflict between the economic and IP rights of the tobacco companies and public health rights

How and to what extent Graphic health warning measures can be justified?

What policy options can be made to harmonize the conflict?

South Asian Region

Research objectives; to explore how healthy lifestyle regulations of tobacco

(graphic health warnings) impact on the utilization of intellectual property rights of tobacco companies

To examine the extent to which these regulations can be justified in light of the public health rights in the South Asian region

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Methodology Qualitative approach

Doctrinal method (analyse the implementation, rational and effectiveness) Primary sources – international legal instruments, national legislations, case law Secondary sources – books, journal articles, reports and monographs

Comparative legal research method (analyse the effectiveness, challenges and make suggestions) Compare and contrast the South Asian experience with international standards and

selected jurisdictions

Analysis of secondary data relating to the effectiveness of graphic health warnings (analyse the effectiveness, and make suggestions) Evaluation of the effectiveness of graphic health warnings on health evidence – WHO

reports, health reports in selected jurisdictions

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The burden of tobacco on public health Tobacco smoke exposes a lethal mixture of more than 7,000

toxic chemicals (Tobacco Atlas, 2018)

Each year 5.1 million people die from smoking (Fiona, 2015)

Second-hand tobacco smoke which causes more than 890,000 premature deaths per year! (WHO Key Facts of Tobacco, 2018)

Largest group of male smokers numbering 675 million (68% of total male smokers) live in the middle income countries! (WHO Report on Global Tobacco Epidemic, 2017)

Cost of tobacco (health and economic) causes a heavy burden on developing countries

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Burden of Tobacco in the South Asian Region

Sri Lanka, India, Bangladesh, Maldives, Pakistan, Nepal, Bhutan & Afghanistan

South Asia is housed to 1/4 of the total global population (Population of Southern Asia, 2018)

The single largest area on the globe for production and consumption of tobacco products (Tobacco in South Asia, 2012)

170 million (30% of males and 4% of female smokers out of total population)- adult smokers (age 15 or above) in the South Asian region (South Asia, 2016)

India, Pakistan and Bangladesh are listed included in the top 13 countries list which claims nearly 2/3 of the world smokers (Economics of Tobacco, 2013)

1.2 million people die every year from tobacco use in the South Asian Region

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Results and discussion

Implementation of healthy lifestyle regulations on tobacco products

The game of cat and mouse between tobacco control and tobacco industry

A way forward

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Implementation of healthy lifestyle regulations on tobacco products

World Health Organization Framework Convention on Tobacco Control (WHO FCTC -2003)

Most widely and rapidly embraced treaties in the UN history (Gostin, 2015)

‘States parties have an obligation to protect public health by recognizing the global nature of tobacco epidemic’ – Preamble of WHO FCTC

“Tobacco is everybody’s business” – Gro Harlem Brundtland

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Implementation cont…Tobacco measures relating to reduction of

demand and supply of tobacco Laws & regulations (implemented and suggested by MPOWER Package -2008)

Price and tax Taxes comprise at least 75% of retail price of tobacco brands

preventing the exposure to tobacco smoke Laws relating to smoke-free environments (public places, schools etc.)

content and disclosure of tobacco products Laws relating to the content of tobacco products

Tobacco products packaging and labelling Health warnings, graphic health warnings and plain packaging of tobacco products

Education, communication, training and public awareness

Regulations relating to training, awareness and communication of health risk of tobacco (media)

Tobacco advertising, promotion and sponsorship

Laws relating to banning of direct and indirect tobacco related advertising (television, radio, local magazines, newspapers, billboards, promotional discounts and sponsored events etc.)

Measures concerning tobacco dependency and cessation

Rules relating to national toll-free quit line, free cessation programmes and free nicotine replacement treatments

Illicit trade on tobacco products laws relating to prevent illicit trade of tobacco products

Minimum age relating to selling and buying tobacco

laws relating to increasing the age of buying of tobacco

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Implementation cont…Tobacco control measures

Non-tax measures

Health warnings

Advertising and sponsorship ban

Tobacco-free places

Cessation and quit lines

Tax measures

Tobacco taxes

Global prevalence 24.73% - 2005

22.18% - 2015

Health warnings (word only warnings, word + graphic warnings, plain packaging)

Health warnings work on smokers desires and non-smokers desires as well

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Graphic health warnings as a non-tax measure

Article 11 & guidelines “Given the evidence that the

effectiveness of health warnings and messages increases with their size, Parties should consider using health warnings and messages that cover more than 50% of the principal display areas and aim to cover as much of the principle display area as possible’

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1. Highly cost effective means of health communication

2. Graphic health warnings reach every consumer everyday

3. Warnings are seen not only by consumers but also those around by consumers such as family, friends and co-workers

4. Effective means of nudging –(which proposes positive reinforcement and indirect suggestions as ways to influence the behavior and decision making of individuals)

Implementation of graphic health warnings in the South Asian Region (2018) 14

Country Year of ratification of WHO FCTC

Whether graphic health warnings are mandatory?

Size of the graphic health warnings (average of package front and back)

International ranking in terms of the health warning size as an average of the front and back

Afghanistan 2010 Yes - From February 2016 0% 160

Bangladesh 2004 Yes - From March 2015 50% 70

Bhutan 2004 No - 166India 2004 Yes - From May 2009 85% 05

Maldives 2004 Yes - From October 2004(no graphic warning)

30% 128

Nepal 2006 Yes - From November 2011 90% 02

Pakistan 2004 Yes - From June 2016 60% 57Sri Lanka 2003 Yes - From August 2012 80% 09

Graphic health warnings in the South Asian Region cont…

Bangladesh Sri Lanka India Nepal

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Impact of intellectual property rights (IPR) on graphic health warnings (international level)

Tobacco industry has chosen their IPRs as a weapon to challenge the implementation of tobacco control measures viz. graphic health warnings

Challenges are based on Trademark rights of products and packaging

Copyright works displayed on products and packaging

Trade dress and get-up Registered and unregistered designs Patents relating to packaging and ingredients

Unfair competition

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IPR challenges

Inte

rnat

iona

l leve

l •Claims on international trade agreements

•Claims on international investment agreements •TRIPS Agreement 1994

•TBT Agreement 1994

•GATT Agreement 1994

Dom

estic

leve

l •Constitutional property rights claims

•National level IP rights

WTO Flexibilities and Healthy lifestyle regulations 18

General Agreement on Tariffs and Trade 1994 (GATT Agreement

Agreement on Technical Barriers to Trade- 1994 (TBT Agreement)

Agreement on Trade-Related Aspects of Intellectual Property - 1994 (TRIPS Agreement)

Article xx ‘necessary to protect human health’

Article 2.1 + 6th

recital of the preamble

Article 2.2

‘necessary to protect…human health

Article 7 ‘the protection and enforcement of intellectual property rights…..in a manner conducive to social and economic welfare, and to balance of rights and obligations’

Article 8.1 ‘Members may in formulating and amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance for their socio-economic and technological development, provided that such measures are consistent with the provisions of this Agreement.’

Doha Declaration on TRIPS and Public Health – 2001

The TRIPS Agreement should not and does not prevent Members from taking measures to protect public health…the Agreement can and should be interpreted in a manner to supportive of WTO members’ right to protect public health…’

IPR Challenges cont…

Tobacco Plain Packaging - Australia case Permanent Court of Arbitration, PCA Case No. 2012-12

• Ukraine, Honduras, Dominican Republic, Cuba and Indonesia (industry lobbying)

• Honduras and Ukraine are party to the WHO FCTC

• Supported by many others • public health concerns prevail over

trademark rights of tobacco company as long as the limitations paused by tobacco control regulations do not create unnecessary encumbrances on trademarks

Philip Morris International v. Oriental Republic of Uruguay ICSID Case No. ABR/10/7

• based on the Switzerland-Uruguay BIT, the complaint was against not on the State’s right to promote and protect public health but on the nature of indirect expropriation without making any compensation

• 80 per cent health warning coverage violated their right to use the trademarks and deprive them from generating profits from their investments

• Uruguay laws were in accordance with the WHO FCTC treaty was evidence-based, so measures consistent with WHO FCTC provisions could also be considered as being evidence-based

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IPR (trademarks) v. TRIPS Flexibilities on public health 20TRIPS Provision Special remarks Analysis of WTO panel

2.1 + 6 of the Paris Convention ‘every trademark duly registered in the country of origin not be discriminated by other countries’

Protection only conferred as a result of registration rather than how that trademark is to be protected

TPP measures only restrict the use of certain trademarks on tobacco retail packaging and products…not reject the registration. No violation

15.4‘the nature of the goods or services shall in no case from an obstacle to registration of the trademark’

a country can restrict or prohibit the use of trademark in its territory unless such country does not refuse the registration based on the nature of the product

TPP measures only put restrictions on the use of certain trademarks….would not impact the protection available for duly registered tobacco related trademarks No violation

16.1 ‘registered trademark owner shall have exclusive rights to prevent others from similar and identical signs

The owners are not deprived from their rights to refrain others from using similar and identical signs Trademark rights are negative rights

TPP measures do not erode a trademark owners rights to prevent users of similar signs that create a likelihood of confusionNo violation

20‘the use of a trademark in the course of trade shall not be unjustifiably encumbered

Tobacco control measures can be justifiable on the ground of health objectives

TPP measures are justifiable whereas those are adopted on an appropriate policy intervention to address its public health concerns in relation to tobacco products No violation

2.1 + 10 bis of the Paris Convention Unfair competition

Tobacco control measures do not interfere with the interested parties to prevent misleading or false representations through legal avenues

TPP measures do not create a confusion or mislead consumers. It only aims to reduce tobacco consumption No violation

National level IPR challenges based on Constitutional property clauses and national IP

laws (world & Asia)

JT International v. Commonwealth of Australia (2012) 250 CLR 1

Plain packaging regulations are not in compliance with the Australia’s IP obligations under TRIPS

Plain packaging amounts to an acquisition of property without just term is a violation of Art. 51(xxxi) of the Constitution (acquisition of property)

‘the restrictions paused by the Plain Packaging Act is no more than a restriction on a commercial activity which is reasonably necessary to prevent or reduce the harm of tobacco on public health.’

British American Tobacco v. The Queen (2016) EWHC 1169

Standardised Packaging of Tobacco Products Regulation 2015 was contrary to the ‘fundamental right to property’

TRIPS Agreement and WHO FCTC should be seen as compatible with public interest

‘IP rights are not absolute and must be balanced against other competing public interests’

‘Usage of intellectual property rights may be subjected to limitations on grounds of public health’

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National level IPR cont…

Health for Millions Trust v. Union of India and Others CC No. 22186-22187/2012.

‘health concerns take precedent over the rights of tobacco related trademark owners’

’85% of graphic health warning requirements does not violate the right to practice any profession under Article 19 (1) (g) of the Indian Constitution

Ceylon Tobacco Company Ltd., et al. v. Hon. NimalSiripala de Silva, et al., S.C.(SD) App. Nos.1 to 6/2006.

Ceylon Tobacco Company (CTC) challenged the constitutionality of the National Authority on Tobacco and Alcohol Bill, No. 27 of 2006 (NATA Act)

Article 12(1) - equal treatment of the law

Article 14(1) (g) - freedom to engage in a lawful profession

IP rights

‘[I]t is indeed the bounden duty of the State to take such measures an envisaged in the bill in the face of the proven risk to public health resulting from the use or the consumption of tobacco and alcohol products’

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National level IPR cont…

Ceylon Tobacco PLC v. Minister of Health CA 336/2012 (Writ)

CTC challenged the regulation for mandatory graphic health warnings covering 80 per cent of the packs, arguing that the regulation violates the company’s intellectual property (IP) rights, in particular, its trademark rights.

Court of Appeal endorsed that a registered trademark conferred both negative and positive rights on its trademark owners under IP Act No.36 of 2003

‘80% of graphic health warnings would occur an unjustifiable encumbrance on CTC’s trademarks’

‘the size of the warnings should be reduced to cover 50% to 60% of the cigarette pack to give tobacco companies more space for displaying their trademarks on tobacco packaging’

the matter of Article 122(1)(b) of the Constitution (S.C. (SD) No.2/2015).

‘80% of graphic health warnings on tobacco packages does not encroach upon the IP rights of the CTC

‘the new regulation aims a greater social benefit based on public health concerns of tobacco consumption’

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What lessons for the South Asian Region? implementation of the laws relating to the Elimination of Illicit Trade of Tobacco

Products (ratification of international Convention and enacting enabling legislations)

implementation of bilateral, multilateral and regional IP agreements would provide better vigil for tobacco control measures (consideration of being parties to the Trans Pacific Partnership/TPP)

developing regional health and human rights framework (Asian Human Right Declaration/AHRD in the ASEAN Community)

implementation of ‘National Tobacco Control Policies’ strengthening existing laws relating to public health measures and expanding

administrative mechanisms to advanced tobacco control giving particular reference to the ‘defenses against IPR claims’ in designing and

implementing national level healthy lifestyle regulations on tobacco control

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Defenses against the IPR claims of tobacco industry

Impact of tobacco control in a particular country or domestic population (medical cost + social cost)

Actual and expected impact on health outcome of a tobacco control measure

Evidence about existing tobacco control measures and impact of such measures

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“to achieve the social and communal benefits protecting health, the State retain the power to restrict personal interest, autonomy and economic interests as well”

Lawrence O. Gostin

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Thank you

sanathwijesinghe@gmail.com

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