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Month: July 2022

Success Story: Reducing the burden of compulsory licensing on Brazilian consumers

The Issue:

In 2021, the Senate introduced a bill (Projeto de Lei n° 12, de 2021) to suspend the obligations of the Federative Republic of Brazil to implement or apply the TRIPS Agreement in relation to the prevention, containment or treatment of COVID-19 while the public health emergency remained in force. In other words, a law that would introduce compulsory licensing for all COVID-19 vaccines and technologies – something that was not only unprecedented but would also go against the TRIPS agreement, to which Brazil is a signatory.

The bill was passed in Congress in both houses and went to the approval of President Jair Bolsonaro. However, the President vetoed three key paragraphs:

8, “The holder of the patent or patent application subject to a compulsory license must provide the necessary and sufficient information for the effective reproduction of the object protected by the patent.”

9, “If there is biological material essential for the practical realisation of the object protected by the patent or by the patent application, the holder must provide such material to the licensee”, and 

10, Imposed penalties if the holder of the patent or patent application refuses to provide the information or biological material

The redacted bill went back to Congress to further discussion and final voting that could have overridden the veto and reinstated the removed paragraphs.

The entire bill n° 12 of 2021, but particularly paragraphs 8, 9 and 10, would have had terrible consequences for consumers and patients in Brazil, depriving them of future vaccines and medical innovations. The Consumer Choice Center promptly intervened to protect consumers.

CCC Response:

We understood that the vetoed provisions were simply unprecedented and inconsistent with the Agreement on Trade-Related Aspects of Intellectual Property Rights and denied innovators the certainty and predictability needed to confidently invest and accelerate the launch of new medicines in Brazil. Consequently, the bill would have deprived consumers and patients of life-saving drugs and vaccines because of government-created legal uncertainty. 

The moment the bill hit the Congressional floor, we began working with members of Congress and the Caucus to inform them about the risks of such legislation and the unnecessary burden to consumers and to persuade the policymakers to keep the vetoes. We sent letters presenting our arguments to both the Presidents of the House and the Senate.

Furthermore, we put the discussion to public debate, reacting, commenting and giving our expert opinion to news outlets. We were featured in a handful of influential media outlets, including Metropolis’s website, the most important about Brazil politics.

We argued that Intellectual Property was never a barrier to accessing the COVID-19 vaccines. In fact, it facilitated the collaborations among manufacturers and suppliers necessary to promote investment and access. An example of such collaboration includes the Pfizer Inc./BioNTech SE agreement with Brazilian biopharmaceutical company Eurofarma Laboratórios SA to manufacture COVID-19 mRNA vaccines for distribution within Latin America.

Pursuing flawed compulsory licensing initiatives coupled with mandatory technology transfers would have hindered Brazil’s desire to foster innovation and facilitate access to medicines. Indeed, it called into question how seriously Brazil took its international commitments and obligations.

The Outcome:

On July 5th, 2022, the bill was passed, maintaining the vetoes and thus reducing the impact and burden to consumers of the compulsory licensing. 

Even though the bill was enacted into law, we were able to keep the veto of the more egregious elements of PL nº 12/2021 including (1) provisions related to mandatory technology transfer (including trade secrets, technical information, and know-how) and the sharing of biological material related to an issued compulsory license; and (2) a provision that would have applied compulsory licensing mechanisms to COVID-19 related products, including treatments and vaccines.

Consumers in Brazil may now enjoy, for a bit longer, the marvellous and proven benefits and innovations that strong IP laws provide. We’ll be watching closely if new developments in this area arise.

The Counterfactual: What role do ENDS play in smoking cessation?

Republished from Clivebates.com with the consent of the author

To date, evidence on the use of ENDS as a cessation aid is inconclusive. In part due to the diversity of ENDS products and the low certainty surrounding many studies, the potential for ENDS to play a role as a population-level tobacco cessation intervention is unclear.

The evidence actually supports significant effects on smoking cessation. The evidence is only unclear if you insist on looking away from it or imposing a far higher standard of certainty than on any other tobacco control measure. All evidence is unclear to some degree, but evidence from multiple sources triangulates to strongly suggest that vaping assists with smoking cessation and that e-cigarettes function as economic substitutes for cigarettes. This is exactly what we should expect.

Professor Kenneth Warner of the University of Michigan summarises the state of the evidence as follows

To truly help tobacco users quit and to strengthen global tobacco control, governments need to scale up policies and interventions that we know work. Tried and tested interventions, such as brief advice from health professionals, national toll-free quit lines and cessation interventions delivered via mobile text messaging are recommended. Where economically feasible, governments should also consider promoting nicotine replacement therapies and non-nicotine pharmacotherapies for cessation.

Smoking cessation and harm reduction are compatible, not opposing strategies. There is nothing wrong with some of these smoking cessation measures, but there is much less evidence than WHO implies that they work at scale in real-world settings or reach the smokers who are at the greatest risk (those who don’t want to quit). But they are not alternatives to harm reduction approaches and they work in a different way. E-cigarettes are not primarily a smoking cessation treatment (though they can be that as well) but work as a much safer consumer alternative to cigarettes for people who want to use nicotine.

WHO overstates its own role in addressing smoking. Nor are they the same as the measures promoted by WHO at last year’s World No Tobacco Day – Commit to Quit – when WHO launched a year-long campaign to help 100 million people quit tobacco. A year on we have heard little of this and no progress report. A year later, these claims look like empty hubris. 

Written by Clive Bates

The Counterfactual: What are the policy options for regulating ENDS?

Republished from Clivebates.com with the consent of the author

WHO leads with outright prohibition as its preferred policy, though it has never bothered to justify this with reference to intended and unintended consequences or the rights of smokers to access lower risk products. Almost everything else it proposes functions as a de facto protection of the cigarette trade.

How a country approaches ENDS will depend on factors particular to its situation. ENDS are currently banned in over 30 countries worldwide. In others they are regulated as consumer products, as pharmaceutical products, as tobacco products, other categories or totally unregulated.

Where they are not banned, WHO recommends that ENDS be regulated.

WHO starts with an anchoring bias: that the normal policy response should be the prohibition of ENDS. There is no scientific or ethical basis for this policy. Why would it make sense to ban the much safer nicotine product, deliberately deny law-abiding smokers better options, protect the cigarette trade from competition, stimulate unregulated black markets in vaping products, and draw young people into the illicit supply chain, and therefore into criminal networks? 

WHO has never assessed the costs and risks of ENDS prohibition, but relentlessly promotes it all the same. I have written about WHO’s strong support of vaping prohibition here: Prohibitionists at work: how the WHO damages public health through hostility to tobacco harm reduction

The arguments against prohibition are well put in this document by the consumers’ organisation INNCO: 10 reasons why blanket bans of e-cigarettes and HTPs in low- and middle-income countries (LMICs) are not fit for purpose.

International Network of Nicotine Consumer Organisations (INNCO), 
10 reasons why blanket bans of e-cigarettes and HTPs in low- and middle-income countries (LMICs) are not fit for purpose, March 20

Regulatory objectives include:

Preventing initiation of ENDS use by non-smokers and children, such as by preventing or restricting advertising, promotion and sponsorship, and restricting flavours that appeal to children 

Minimizing as far as possible potential health and/or risks to ENDS users, such as by regulating product characteristics

Protecting non-users from exposure to their emissions, such as by prohibiting ENDS use in indoor spaces where smoking is not permitted

Preventing unproven health claims

Protecting public health policies from commercial and other vested interests

WHO fails to grasp trade-offs and unintended consequences in policymaking. There is nothing in this regulatory package that shows that WHO has grasped the basics of policymaking in this area. The critical policy insight is that excessive regulation of vaping products functions as a barrier to entry and protection of the more dangerous cigarette products. The Royal College of Physicians (London) expressed this well in its 2016 report, Nicotine with smoke: tobacco harm reduction:

Tobacco Working Group. Royal College of Physicians (London) 
Nicotine without smoke: tobacco harm reduction 28 April 2016

There are other trade-offs: the protection of young people from relatively minor risks (e.g. experimental vaping) could have the effect of imposing major risks on adults (continued smoking or relapse from vaping to smoking). A further complication is that for some adolescents, vaping will function as a diversion from smoking. For these young people, the teenagers most at risk, vaping creates a significant health benefit.

Written by Clive Bates

THE COUNTERFACTUAL: Are ENDS addictive?

Republished from Clivebates.com with the consent of the author

The claim of addiction depends on what you mean by addiction and how the nicotine is delivered. WHO does not bother with such subtleties. There are two issues. 

First, what is meant by the word “addiction”? This term is often used very loosely and often with the intention of stigmatising “the addict”, However, it has a specific meaning that does not apply to all forms of nicotine use. 

E-cigarette use does not meet this definition for most users because nicotine itself isn’t that harmful and vaping just isn’t that harmful either. 

Second, it depends on the way it is delivered. The dependence-forming characteristics of nicotine vary according to how it is delivered to the body – how much and how fast it reaches the brain, and also whether there are other agents that add to the effect. It is quite likely that many smokers who have taken up vaping “transfer” their nicotine dependence to the new products while benefitting from the greatly reduced risk.

This issue was discussed in the paper in the American Journal of Public Health by fifteen past presidents of the Society for Research on Nicotine and Tobacco. 

Balfour, D. J. K., Benowitz, N. L., Colby, et al. (2021). Balancing Consideration of the Risks and Benefits of E-Cigarettes. American Journal of Public Health111(9), 1661–1672.

Written by Clive Bates

CCC joins coalition urging republicans to reject Klobuchar antitrust bill

Dear Senate Republican Leader Mitch McConnell and House Republican Leader Kevin McCarthy,

We write in opposition to S. 2992, the “American Innovation and Choice Online Act,” legislation that would massively expand the size and scope of the federal government.

Despite what some politicians may claim, Sen. Amy Klobuchar’s antitrust bill gives the Biden Administration vast new regulatory authority over American businesses, fails to address conservative censorship concerns and would make inflation worse for American families.

Conservatives have legitimate concerns over Big Tech’s targeting of conservative speech and the creeping influence of non-economic issues in the business decisions of America’s largest companies. In reaction to this problem, a few Republicans have co-sponsored the Klobuchar bill with the hope that it will help reduce discrimination against conservative voices online.

In reality, the bill would worsen these issues by forcing targeted companies into a “mother-may-I” relationship with the federal government. The institutional Left is in universal agreement about the effects the bill will have. The Center for American Progress endorsed the bill on the grounds that it will spur “much needed improvements in content moderation and technologies.”

Whatever so-called “improvements” that the left has in mind for content moderation will certainly not work out in favor of conservatives’ free speech. If conservatives are unhappy with the status quo, just imagine Big Tech targeting conservative speech on behalf of Biden bureaucrats.

S. 2992 outlaws a slew of routine business activity for companies with over $550 billion in market cap and 50 million monthly users. If a business runs afoul of these new government mandates, the government can levy a fine of up to 10 percent of the business’ revenue.

Supporters promise the bill will only apply to four or five American companies…for now. This bill opens the door for future government regulation based on the size of a company, a government cap on innovation and a permanent dial that
Democrats can use to trap more companies under the heavy hand of government control.

While supporters claim this is the first serious antitrust bill in nearly a century, S. 2992 hardly resembles antitrust law as traditionally understood. For almost 50 years, the consumer welfare standard has anchored American antitrust law. Antitrust enforcers generally do not act unless consumers are being harmed via tangible effects like higher prices, reduced innovation, or lower quality.

S. 2992 would push the U.S. towards a European-style approach, where the government picks economic winners and losers and targets politically disfavored companies with frivolous lawsuits. Bureaucrats win, consumers lose.

For policy and political reasons alike, it seems foolish for Republicans to help Democrats ram through such a sweeping regulatory bill as the midterms approach. Pocketbook issues like generation-high inflation and skyrocketing gas prices are top of mind for American families.

A recent Gallup poll shows 52 percent of Americans name inflation as their top issue – antitrust does not even rank. The last thing families and consumers need is a law that would restrict access to the generic products that they reach for in order to make ends meet.

Even some Democrats admit that S. 2992 will increase inflationary pressure on American families. One Democrat
aide blasted the bill as Sen. Klobuchar’s “pet project” with little political payoff, saying “We should be focused on items that will help consumers deal with rising costs…[and] nobody can figure

out why it would be a priority.” Another aide was quoted asking, “Does the Klobuchar bill reduce rising costs in the short term for consumers? No. So why would it be a focus between now and the election?”

The Klobuchar bill would grow the size and scope of government, worsen conservative censorship, and increase inflationary pressure on American families. Instead of addressing pocketbook issues, Sen. Klobuchar’s top priority is empowering Biden bureaucrats before Democrats lose control of Congress. Republicans should not throw Sen. Klobuchar a lifeline.

Sincerely,

Grover Norquist
President, Americans for Tax Reform

Robert H. Bork, Jr.

Dr. Arthur B. Laffer

Richard Rahn

Stephen Moore 
Economist

Marty Connors
Chair, Alabama Center-Right Coalition

Dick Patten
President, American Business Defense Council

Phil Kerpen
President, American Commitment

Steve Pociask
President/CEO, American Consumer Institute

Richard Manning
President, Americans for Limited Government

Brent Wm. Gardner
Chief Government Affairs Officer, Americans for Prosperity

Kevin Waterman
Chair, Annapolis Center Right Coalition Meeting

James L. Martin
Founder/Chairman, 60 Plus Association

Saulius “Saul” Anuzis 
President, 60 Plus Association

Hannah Cox
Co-founder, BASEDPolitics

Ralph Benko
Chairman, The Capitalist League

Daniel J. Mitchell
Chairman, Center for Freedom and Prosperity

Andrew F. Quinlan
President, Center for Freedom and Prosperity

Jeff Mazzella
President, Center for Individual Freedom

Ashley Baker
Director of Policy, Committee for Justice

Curt Levey
President, Committee for Justice

James Edwards
Executive Director, Conservatives for Property Rights

Yaël Ossowski
Deputy Director, Consumer Choice Center

Christopher Butler
Interim Director, Digital Liberty

John Tamny
Vice President, FreedomWorks

George Landrith
President, Frontiers of Freedom

Mario H. Lopez
President, Hispanic Leadership Fund

Heather R. Higgins
CEO, Independent Women’s Voice

Tom Giovanetti
President, Institute for Policy Innovation

Sal Nuzzo
Vice President of Policy, James Madison Institute

Caden Rosenbaum
Tech & Innovation Policy Analyst, Libertas Institute

Charles Sauer
President, Market Institute

Rodolfo E. Milani 
Miami Freedom Forum

Stephen Stepanek
Chairman, New Hampshire Republican Party
President, Pine Tree Public Policy Institute
Co-chairman, New Hampshire Center Right Coalition Meeting

William O’Brien
Former Speaker, NH House of Representatives
Chairman, Pine Tree Public Policy Institute
Co-chairman, New Hampshire Center Right Coalition Meeting

Eric Peterson
Director, Pelican Center for Technology and Innovation

Lorenzo Montanari
Executive Director, Property Rights Alliance

Doug Kellogg
Executive Director, Ohioans for Tax Reform

Jonathan Small
President, Oklahoma Council of Public Affairs

Tom Hebert
Executive Director, Open Competition Center

Bryan Bashur
Executive Director, Shareholder Advocacy Forum

Karen Kerrigan
President, Small Business & Entrepreneurship Council

Maureen Blum
President, Strategic Coalitions & Initiatives LLC

Patrick Hedger
Executive Director, Taxpayers Protection Alliance

Rusty Cannon
President, Utah Taxpayers Association

Casey Given
Executive Director, Young Voices

Cc: House Republican Conference 
Senate Republican Conference

Time to get modern on this topic; and community policing

Hollywood Casino in Kansas City, Kan. is just a stone’s throw away from Platte County and a very short drive for those of us who live along the I-435 corridor. Hollywood Casino is about to become more popular with a lot of folks who live in Platte County. That’s a Between the Lines prediction for you.

And that prediction is based on the fact that sports betting has been legalized in Kansas. You can bet Hollywood Casino is gearing up to offer legalized sports betting about the time the football season opens this fall. Hollywood Casino plans to be ready to take your sports wagers when the NFL regular season opens around Sept. 11. The Kansas Speedway, coincidentally, will host the Hollywood Casino 400 NASCAR race that same weekend. And that’s another sports wagering opportunity.

Kansas officially legalized sports betting effective July 1. By now you probably know where I’m headed with this. Sports betting is not legal in Missouri. Look to your legislators at the statehouse for the reasons why. Our legislators can be an interesting group on certain topics, sometimes slow to come around to modern times on some issues. This is one of those issues.

Read the full text here

Consumer Group Says Legalizing MO Sports Betting Key to Stopping Illegal Bets

The only way to stop a bad guy from taking unregulated bets is with a good guy taking legal bets, more or less the message from Consumer Choice Center manager David Clement, who targets his attention on North American sports betting affairs, an active topic these days.

In a recent statement, Clement had this to say regarding Missouri’s stalled legal sports betting market:

The key to stamping out the illegal sports betting market is legalizing sports betting and having an open and competitive market where legal sports books compete for consumers. Not only does this help grow the legal market, it actively discourages consumers from placing bets in the illegal market which is ripe for fraud and abuse.

The Consumer Choice Center is a “consumer advocacy group supporting lifestyle freedom, innovation, privacy, science, and consumer choice,” and what manager Clement is suggesting is nothing new to Missouri lawmakers who are struggling to pick a betting bill and go with it.

It’s a battle between state House and Senate ideas of what a Missouri sports betting market should look like, something Consumer Choice Center manager Clement seems qualified to weigh in on.

Read the full text here

Pentingnya Meningkatkan Penelitian Produk-Produk Tembakau Alternatif di Dalam Negeri

Vape atau rokok elektrik saat ini merupakan produk yang kerap menimbulkan pro dan kontra dari berbagai kalangan. Bagi sebagian kalangan, vape atau rokok elektrik merupakan produk yang sangat berbahaya bagi kesehatan, sehingga harus dilarang secara penuh, atau setidaknya diregulasi secara sangat ketat.

Sementara itu, bagi kalangan lain, vape atau rokok elektrik dianggap sebagai produk yang sangat penting, khususnya untuk membantu para perokok untuk berhenti merokok. Untuk itu, bila pemerintah melarang atau meregulasi produk-produk vape secara sangat ketat, maka kebijakan tersebut merupakan sesuatu yang tidak tepat, kerena hal tersebut akan membatasi kesempatan para perokok untuk mendapatkan produk alternatf lain yang dapat membantu menghilangkan kebiasaan merokoknya.

Terlepas dari pro dan kontra tersebut, tidak bisa dipungkiri bahwa, fenomena penggunaan produk-produk rokok elektrik merupakan hal yang kian meningkat dari waktu ke waktu, khususnya bagi mereka yang tinggal di masyarakat urban. Pada tahun 2017, diperkirakan ada sekitar 900 ribu pengguna vape di Indonesia. Dalam jangka waktu 3 tahun, tepatnya tahun 2020, angka tersebut meningkat pesat menjadi 2,2 juta pengguna vape di negara kita (medcom.id, 22/01/2021).

Fenomena semakin meningkatnya pengguna vape ini juga bukan merupakan hal tarjadi di Indonesia saja, tetapi juga di dunia secara keseluruhan. Berdasarkan laporan dari Global Harm Reduction 2021 misalnya, secara total diperkirakan ada 82 juta pengguna vape di seluruh dunia. Angka ini meningkat dari sebelumnya sekitar 68 juta pengguna vape aktif di dunia pada tahun 2020 (tribunnews.com, 22/06/2022).

Untuk itu, tentunya kerangka kebijakan yang tepat dalam menghadapi fenomena ini merupakan sesuatu yang sangat penting yang harus dilakukan oleh para pembuat kebijakan. Tanpa adanya kebijakan yang tepat, tentunya konsumen menjadi salah satu pihak yang paling dirugikan, selain tentunya para pekerja yang mendapatkan penghasilannya dari industri tersebut.

Untuk mampu merancang kebijakan yang tepat, salah satu langkah utama yang sanga penting untuk dilakukan tentunya adalah dengan melakukan riset dan penelitian terlebih dahulu terkait dengan produk-produk rokok elektrik, dan juga produk-produk tembakau alternatif lainnya secara lebih luas. Tanpa adanya penelitian yang memadai, tentunya akan sangat sulit bagi kita untuk bisa menemukan kebijakan yang tepat dalam merespon fenomena semakin tingginya pengguna vape di Indonesia.

Di berbagai negara lain, penelitian terahdap produk-produk rokok elektrik atau vape merupakan sesuatu yang sudah sangat banyak dilakukan, salah satunya adalah Britania Raya. Pada tahun 2015, lembaga kesehatan publik asal Inggris, Public Health England (PHE), mengeluarkan laporan yang menunjukkan bahwa, vape atau rokok elektrik 95% jauh lebih tidak berbahaya bila dibandingkan dengan rokok konvensional yang dibakar (www.gov.uk, 19/08/2015).

Hasil dari penelitian tersebut tentunya memiliki dampak yang sangat signifikan terhadap para pembuat kebijakan di Britania Raya untuk menyusun kebijakan terkait vape dan produk tembakau alternatif lainnya secara tepat. Britania Raya sendiri akhirnya menjadi salah satu negara pelopor yang menjadikan produk tersebut sebagai produk alternatif untuk membantu para perokok untuk berhentu merokok (insidesources.com, 03/05/2021).

Negara kita tentu bisa belajar dari langkah yang dilakukan oleh Pemerintah Inggris. Riset dan penelitian mengenai vape dan produk tembakau alternatif lainnya masih cukup kurang di negara kita, yang membuat masih banyaknya berbagai kabar misinformasi terkait dengan produk-produk tersebut, seperti vape atau rokok elektrik memiliki kandungan yang sama bahayanya atau bahkan lebih berbahaya dari rokok konvensional yang dibakar.

Hal ini juga diakui oleh beberapa pihak terkait di Indonesia, salah satuya adalah Asosiasi Vapers Indonesia (AVI). AVI menyatakan bahwa, industri vape dan produk-produk tembakau alternatif lainnya merupakan industri yang saat ini sedang mengalami perkembangan di Indonesia, dan untuk itu dibutuhkan penelitian yang lebih besar terkait dengan produk-produk tersebut (tribunnews.com, 22/06/2022).

Melalui penelitian yang memadai, tentu hal tersebut dapat membantu para pengambil kebijakan untuk mengeluarkan kbeijakan terkait vape dan produk tembakau alternatif lainnya yang tepat, agar tidak merugikan para konsumen dan juga para pekerja. Jangan sampai, regulasi dan juga auran yang diberlakukan etrsebut justru menjadi kontraproduktif, dan justru merugikan para konsumen karena membuat mereka lebih sulit untuk mendapatkan produk alternatif tembakau yang memiliki resiko jauh lebih rendah.

Sebagai penutup, adanya penelitian yang memadai terhadap rokok elektrik, dan juga produk-produk tembakau alternatif lainnya, merupakan hal yang sangat penting, agar para pembuat kebijakan bisa menyusun kerangka kebijakan yang tepat terkait dengan produk-produk tersebut. Dengan demikian, diharapkan para pembuat kebijakan dapat menyusun kebijakan yang tepat, yang dapat membantu jutaan para perokok di Indonesia untuk menghentikan kebiasaan merokoknya yang sangat berbahaya bagi kesehatan.

Originally published here

Consumer group encourages Missouri to enable sports betting

After another legislative session came and went without sports betting passed in Missouri, a global advocacy group is among those urging the state to go all-in next year.

David Clement, the North American affairs manager for Consumer Choice Center and co-author of a new study diving into sports betting policies from state to state as well as the revenue they pull in, encouraged the Show-Me State to enact its own version in the near future to cut down on illegal gaming and reap the financial benefits of a new market.

“The key to stamping out the illegal sports betting market is legalizing sports betting, and having an open and competitive market where legal sports books compete for consumers,” Clement said in a statement. “Not only does this help grow the legal market, it actively discourages consumers from placing bets in the illegal market which is ripe for fraud and abuse.”

He added, “Missouri should immediately legalize sports betting, and do so in a way that opens the market and encourages competition.”

Read the full text here

Utah Dead Last In US Sports Betting Index

A new report published by the Consumer Choice Center evaluates all 50 states on how consumer friendly their sports betting markets are. Unfortunately, with sports betting still illegal in Utah, Utah ranks dead last in the index. Utah, and the 14 other states who have maintained their ban on sports betting are in large part why the illegal betting market in the US is still thriving. It is estimated that the illegal sports betting market generated $50-$200 billion in revenue in 2020.

The Consumer Choice Center’s North American Affairs Manager, and co-author of the report, David Clement explained stating, “The key to stamping out the illegal sports betting market is legalizing sports betting, and having an open and competitive market where legal sportsbooks compete for consumers. Not only does this help grow the legal market, it actively discourages consumers from placing bets in the illegal market which is ripe for fraud and abuse”

Read the full text here

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