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2016 Advocacy Mission MEETINGS WITH CONGRESS BUSBC Staff Lead: João Barroso Aloysio Nunes, Senator, US-Brazil Agenda Aloysio Nunes is currently the Government’s Leader on Senate and one of the main leaderships in the PSDB party. An attorney with Master Degree in Political Science. He is president of the Foreign Affairs and National Defense Committee for the 2015- 2016 biennium. In 2014, he ran in the presidential elections as Vice-President with Senator Aécio Neves for President. His main political issues and expertise in Congress are business environment and tax, legal and political reforms. Mário Heringer, Deputy, US-Brazil Agenda Mário Heringer is on his 4th mandate as deputy and is a physician. He is state president for his party PDT/MG (Democratic Worker’s Party, Minas Gerais). One of his main political agenda is healthcare. CONGRESS

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Page 1: MEETINGS WITH CONGRESS

2016 Advocacy Mission

MEETINGS WITH CONGRESS BUSBC Staff Lead: João Barroso Aloysio Nunes, Senator, US-Brazil Agenda

Aloysio Nunes is currently the Government’s Leader on Senate and one of the main leaderships in the PSDB party. An attorney with Master Degree in Political Science. He is president of the Foreign Affairs and National Defense Committee for the 2015-2016 biennium. In 2014, he ran in the presidential elections as Vice-President with Senator Aécio Neves for President. His main political issues and expertise in Congress are business environment and tax, legal and political reforms.

Mário Heringer, Deputy, US-Brazil Agenda

Mário Heringer is on his 4th mandate as deputy and is a physician. He is state president for his party PDT/MG (Democratic Worker’s Party, Minas Gerais). One of his main political agenda is healthcare.

CONGRESS

Trade Agreement Regulatory Coherence Trade Facilitation: WTO Agreement, Single Window Project Expedited Shipments Express Delivery

Page 2: MEETINGS WITH CONGRESS

2016 Advocacy Mission

Darcísio Perondi, Deputy, Health Agenda

Darcísio Perondi is in his 6th mandate as Federal Deputy and is Vice-Leader of the Government at the Chamber of Deputies. Reputed policy maker on Healthcare, he is also relevant for his work on government management. He was the rapporteur for the Public Spending Cap Bill at the Chamber. He is a doctor, being a key player in the Social Security and Family Commission.

Julio Lopes, Deputy, Health and Bilateral Agenda

Julio Lopes was reelected for his 4th mandate as Federal Deputy in 2014. He is a member of the Special Commissions that discuss the Political Reform and the proposals for changes in Bidding Legislation. He was twice president of the Urban Development Commission. Between 2007 and 2014 he was State Secretary of Transportation in Rio de Janeiro. The deputy is increasing his engagement with the Healthcare agenda in the Chamber of Deputies

Orlando Silva, Deputy, Innovation Agenda

Orlando Silva is a Federal Deputy and was Minister of Sports during Lula’s administration and part of Roussef’s. He is State President of his party PCdoB (Communist Party of Brazil) in So Paulo. His main political agenda is focused on culture and sports. He is currently the rapporteur for the Data Privacy Bill.

Page 3: MEETINGS WITH CONGRESS

2016 Advocacy Mission

Bruna Furlan, Deputy, Innovation Agenda

Deputy Bruna Furlan is in her second mandate and is the Coordinator of the Parliamentary Front in Defense of Human Mobility. Currently, she is the President of the Special Committee on Data Privacy and has been working jointly with deputy Orlando Silva to advance the bill on data protection.

Luiz Carlos Hauly, Deputy, US-Brazil Agenda

Luis Carlos Hauly is in his 7th mandate as Federal Deputy. He is a member of the Foreign Affairs and National Defense Commission and rapporteur in the Special Commission of Tax Reform. Hauly has a leadership role in the Brazil-U.S. Parliamentary Group.

US-Brazil Agenda

Top priorities for U.S. companies

Legislative one pager Innovation Agenda

Innovation one pager

POLICY AGENDA

Trade Agreement Regulatory Coherence Trade Facilitation: WTO Agreement, Single Window Project Expedited Shipments Express Delivery

Page 4: MEETINGS WITH CONGRESS

2016 Advocacy Mission

Comments to Special Committee on Data Privacy

Health Agenda

Health study – phase one and two

Healthcare one pager

Presentation by companies – diabetes, CVDs, vector control, colorectal cancer

Proposal for an industry dialogue on Healthcare

Page 5: MEETINGS WITH CONGRESS

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Tax Reform as a Path to GrowthReduction of the complexity and cumulative nature of the federal/state tax system to help reduce the costs of enterprises and improve legal certainty.

Labor Reform and Job CreationCreation of clear, stable and �exible rules, especially with respect to outsourcingor specialized service contracts. Support outsourcing viability in Brazil soentrepreneurs may choose which activities to outsource based on their businessmodels and protection of outsourced employees’ rights under the law.

Improving Brazilian InfrastructureRevision of rules regarding infrastructure public bidding according to bestpractices and dissemination of new rules to gain investors interest.Important issues are:• Project bidding process prioritization;• Transparent bidding process promotion;• Environmental licensing process simpli�cation;• Local content requirement �exibility; and• Innovative project �nancing models consideration.

Short and Mid-Term Priorities

Long Term Strategic Priorities (with next steps)

• U.S.-Brazil Trade AgreementInitiation of a "scoping exercise" between the U.S. and Brazil governments with input from private sectors for a potential agreement.• Bilateral Tax TreatyReopening of formal negotiations addressing divergence issues.• Visa Waiver ProgramInclusion of Brazil in the U.S. Global Entry and Visa Waiver programs with reciprocal Brazilian government action to facilitate entry to both countries for U.S. and Brazilian citizens.

The Brazil-U.S. Business Council, U.S. Section, recommends the following priorities to drive investment and economic growth in Brazil, while advancing the U.S-Brazil relationship.

TOP POLICY PRIORITIES FOR U.S. COMPANIES IN BRAZIL

Page 6: MEETINGS WITH CONGRESS

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Framework and Bilateral Agreements to Grow Economic Opportunity• Brazil’s full insertion into world trade by advancing its membership to the:

- Organization for Economic Cooperation and Development;- WTO Trade in Services Agreement;- WTO Information Technology Agreement, and- WTO Government Procurement Agreement.

• Reinvigoration of standing bilateral dialogues and MOUs, such as the:- U.S.-Brazil MOU on Health Care and Medical Sciences;- U.S.-Brazil Consultative Committee on Agriculture (CCA);- U.S.-Brazil Commercial Dialogue;- Bilateral Commission on the Agreement on Trade and Economic Cooperation;- Defense Cooperation Dialogue; and- Economic and Finance Dialogue, among others.

• Trade in Services• Information Technology; and• Government Procurement Agreements

Industry Local Content Requirements to Facilitate InvestmentPromotion of more flexible local content and Basic Productive Process (referred to as PPBs) requirements to accommodate rapid innovation and local supply gaps, prevalent in high-tech, IT and oil & gas industries, where the requirements do not align with the fast-paced reality of advanced manufacturing.

Trade Facilitation to Improve Trade Flows• Full implementation of the WTO Trade Facilitation Agreement and innovativeprograms such as Single Window and the Authorized Economic Operator (AEO).Work towards achieving a U.S.-Brazil mutual recognition agreement of AEO andthe U.S. Customs Trade Partnership against Terrorism (C-TPAT).• Streamlining Brazil’s bureaucratic procedures while at the same time assuring astable and predictable legal and regulatory framework for Brazilian and foreigninvestors, with the enactment of a law to harmonize the rule-making process.

SINGLE WINDOW

TOP POLICY PRIORITIES FOR U.S. COMPANIES IN BRAZIL

Page 7: MEETINGS WITH CONGRESS

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The Brazil Council commends the Brazil-U.S. Parliamentary Group of the Brazilian Congress and encourages cooperation with the Brazil Caucus of the U.S. House of Representatives. We support a legislative agenda of priorities in Brazil that would enhance legal certainty, boost industry competitiveness and make it more attractive to foreign investment, while simultaneously strengthening the Brazil-U.S. trade and investment relationship. The proposed agenda is outlined below:

• Harmonize Rule-Making ProcessApprove bills establishing a comprehensive framework for rule-making process reform toward a more transparent and harmonized system applicable to all regulatory agencies and ministries. Support PRO-REG and CAMEX activities on regulatory coherence.

• Revise Brazil’s Main Public Bidding LawApprove bills creating a consolidated framework on public bidding placing less emphasis on price criteria for bid selection and more on technology offered by bidder.

• Legalize Outsourcing Activities and Specialized Services Contracts Support bills that make outsourcing viable in Brazil so entrepreneurs may choose which activities to outsource based on their business models and protect outsourced employees’ rights under the law.

• Promote Robust Anti-Corruption Legal FrameworkApprove bill that encourages prevention of corruption through transparency, due process and protection of information sources; creates a special process for public employees; reformulates the penalty structure establishing felony status for corruption crimes of high amounts; and provides for specific liability for political parties and the criminalization of slush funds.

• Approve Legal Framework for Environmental LicensesApprove streamlining licensing process, creating a wide legal framework, including general requirements, impact studies, public consultations and clear rules on agencies' work coordination, among other topics.

• Protect Data Privacy without Disrupting Information FlowPromote internet regulations that accommodate trans-border information flows and its decentralized nature; allowing consumers to benefit from secure data use and privacy.

• Ease Petrobras’ Monopoly over Pre-Salt AreasSupport PL 4567/2016, providing Petrobras with right of first refusal to act as operator and hold a minimum of 30% interest of the consortia formed for the oil exploration blocks auctioned in the production-sharing regime.

• Authorize Gambling ActivitiesApprove bills authorizing gambling in Brazil with provisions encouraging the gaming industry to make the public aware of responsible gaming resources, while simultaneously incorporating responsible gaming into business operations.

• Support Expansion of e-Commerce and e-Books TradeSupport PL 4534/2012, extending fiscal benefits granted to printed books to include digital, magnetic, optic and Braille versions; fostering social inclusion for millions, and widening their access to low-cost e-books.

• Soften Local Content RequirementsUrge adoption of flexible approach to local content requirements, accommodating rapid innovation and local supply gaps, prevalent in high-tech and IT industries, where basic production process (PPB) requirements do not align with the fast-paced reality of advanced manufacturing.

• Brazil’s full insertion into world trade withmembership in:

In alignment with the “Bridge to the Future” (BTF) document to drive investment and economic growth in Brazil, the U.S. Section of the Brazil

Council proposes:

Framework and Bilateral Agreements

• A U.S. government "scoping exercise," with privatesector contributions, for potential U.S.-Brazil Trade Agreement and reopening of formal bilateral tax treaty negotiations.

&

• Full implementation of the WTO Trade Facilitation Agreement and innovative programs such as:

'Ease of Doing Business' Initiatives

• Streamlining Brazil’s bureaucratic processes toward a predictable legal framework for investors; enactment of law to simplify rule-making process. • Conclusion of international cooperation agreements on:

& SINGLE WINDOW

IP Rights

Trademark

• Promotion of policy agenda designed for foreign investors, including U.S. as strategic partner under the U.S.-Brazil Memorandum of Cooperation for infrastructure development.• Launching of Investment Partnerships Program to strengthen cooperation between state and private sectors through public infrastructure projects and privatizations.

Infrastructure Reforms

• Trade in Services• Information Technology; and• Government Procurement

Agreements

Licensee

2016-2017 LEGISLATIVE POLICY AGENDA

and optimization of patent and trademark processes. Intensification of preventive measures and enforcement of IP violations.

Patent

Page 8: MEETINGS WITH CONGRESS

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Contact us: [email protected]

INNOVATION POLICY AGENDA

The Brazil Council Innovation Task Force recognizes that as participation in international investment and technology transfer becomes more competitive around the world, it is critical that both industry and government collaborate to ensure Brazil becomes a global technology leader. To that end, the Council proposes the following agenda:

• Brazil’s full insertion into world trade withmembership in:

In alignment with the “Bridge to the Future” (BTF) document to drive investment and economic growth in Brazil, the U.S. Section of the Brazil

Council proposes:

Framework and Bilateral Agreements

• A U.S. government "scoping exercise," with privatesector contributions, for potential U.S.-Brazil Trade Agreement and reopening of formal bilateral tax treaty negotiations.

• Trade in Services• Information Technology; and• Government Procurement

&

• Full implementation of the WTO Trade Facilitation Agreement and innovative programs such as:

'Ease of Doing Business' Initiatives

• Streamlining Brazil’s bureaucratic processes toward a predictable legal framework for investors; enactment of law to simplify rule-making process. • Conclusion of international cooperation agreements on:

and optimization of patent and trademark processes. Intensification of preventive measures and enforcement of IP violations.

& SINGLE WINDOW

IP Rights

Trademark

• Promotion of policy agenda designed for foreign investors, including U.S. as strategic partner under the U.S.-Brazil Memorandum of Cooperation for infrastructure development.• Launching of Investment Partnerships Program to strengthen cooperation between state and private sectors through public infrastructure projects and privatizations.

Infrastructure Reforms

Licensee

Agreements

• Encouraging adoption of regulations furthering data privacywhile promoting trade and growth, and striking a balancebetween public and private interests.

• Supporting data protection interoperability initiatives, as well as privacy regimes and frameworks that are technology neutral; ensure accountable cross-border flows of information; protect consumers; reflect today’s global business models; and allow benefits of e-commerce and cloud computing.

• Promoting internet regulations that accommodate trans-border information flows and its decentralized nature; allowing consumers to benefit from secure data use and privacy.

• Supporting increased measures to ensure adequate and effective enforcement of all forms of IP rights. Advocating adherence to the Madrid Protocol for the International Registration of Marks to expedite trademark applications and approvals.

• Encouraging implementation of the Inter-American Telecommunication Commission’s (CITEL) Mutual Recognition Agreement (MRA) with regard to theU.S.; providing mutual recognition of conformity assessment bodies and acceptance of testing results and certification procedures for telecommunications equipment.

• Urging the withdrawal of local content requirements to accommodate rapid innovation prevalent in high-tech and IT industries, with special attention to instances where basic production process requirements and CERTICS do not align with the fast-paced reality of advanced manufacturing, software, and other advanced technology industries.

• Supporting PL 4534/2012, which considers e-books and e-readersto be similar to printed books; approval of such bill would widenaccess to affordable e-books and foster social inclusion for millionsof Brazilians.

• Promoting initiatives that reduce regulatory burdens,facilitate business and increase accessibility byreducing internet and mobile broadband costs;especially considering the importance of the newapplication industry in creating jobs, supporting smallbusiness and generating wealth.

Patent

Page 9: MEETINGS WITH CONGRESS

COMMENTS ON THE REGULATION OF THETREATMENT OF PERSONAL DATA

The U.S. Section of the Brazil-U.S. Business Council supports the goal of pursuing a personal data protection framework that protects the rights and freedoms of individuals, while at the same time enabling the free flow of the information for the creation of new businesses and the continued growth of the digital economy in Brazil and abroad. To that end, the Council respectfully proposes the following recommendations to the Brazilian government regarding Brazil’s data privacy bills currently in Congress:

Implied or informed consumer consent for data use and transfer, rather than express or affirmative consent, is an appropriate default option. Implied and Informed consent preserve the protection of personal data while allowing innovation.

Types of Data • Personal Data: The Council supports a definition of personal data as the data that enables the identification of a natural person and opposes any type of ambiguous definition which may harm innovation and the development of the economy based in data.

• De-Anonymized or Anonymized Data: The Council recommends that the future law includes language that de-anonymized or anonymized data is outside the scope of the law. This type of data is an important tool for businesses, research, since identifiable elements of personal data are removed to make it safer to use in privacy terms, while still retaining its commercial, scientific and public value.

• Sensitive Data: The definition of sensitive data should be clearer with objective standards. Sensitive data may be defined as “personal data revealing racial or ethnic origins, religion, political opinions, union, affiliation to political/union entities or religious/philosophical/political organizations, health conditions and sexual orientation; and genetic data expressly linked to an individual or medical record.”

• Publicly Available Data: There is a clear public interest in accessing and processing public records. Public interest or common good uses include employment, identity or credit verification services, prevention or investigation of fraud, law enforcement purposes and even the use of real estate data. The privacy law should consider language that is on par with Brazilian access to information law, where government agencies may provide personal data to private individuals or companies without obtaining the data subjects’ consent if the agencies determine it serves the common good, and that such recipients use the data in accordance with the law.

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• Legitimate Interest: The law should provide for certain waivers to consent, such as legitimate interest, to allow important economic functions (e.g. the execution of legal procedures, including debt collection through out-of-court procedures; misuse of services; and prevention of money laundering). The data protection authority should determine whether the interest is legitimate and determine how companies demonstrate compliance; while ensuring transparency in the process.

Data Transfer: Liability and International Data Transfer Responsible entities should be allowed by the law to contractually allocate their liability, reflecting their respective roles and direct or indirect relationships with data subjects.

• Brazil’s full insertion into world trade withmembership in:

In alignment with the “Bridge to the Future” (BTF) document to drive investment and economic growth in Brazil, the U.S. Section of the Brazil

Council proposes:

Framework and Bilateral Agreements

• A U.S. government "scoping exercise," with private sector contributions, for potential U.S.-Brazil Trade Agreement and reopening of formal bilateral tax treaty negotiations.

• Trade in Services• Information Technology; and• Government Procurement Agreements

&

• Full implementation of the WTO Trade Facilitation Agreement and innovative programs such as:

'Ease of Doing Business' Initiatives

• Streamlining Brazil’s bureaucratic processes toward a predictable legal framework for investors; enactment of law to simplify rule-making process. • Conclusion of international cooperation agreements on:

and optimization of patent and trademark processes. Intensification of preventive measures and enforcement of IP rights violations.

& SINGLE WINDOW

IP Rights

Trademark Licensee

• Promotion of policy agenda designed for foreign investors, including U.S. as strategic partner under the U.S.-Brazil Memorandum of Cooperation for infrastructure development.• Launching of Investment Partnerships Program to strengthen cooperation between state and private sectors through public infrastructure projects and privatizations.

Infrastructure Reforms

Patent

Page 10: MEETINGS WITH CONGRESS

COMMENTS ON THE REGULATION OF THETREATMENT OF PERSONAL DATA

Creation of a Specific Regulatory AgencyIn order to meet data protection challenges, any competent agency should be fully funded, staffed, and independent. Future agency requirements should be developed in conjunction with meaningful stakeholder engagement and feature an appropriate phase in period. It is also important that the law not take effect without the creation of such regulatory agency.

Penalties and Compliance Programs The Council supports the notion of allowing for a flexible scale of penalties to be applied according to the extent and duration of the infraction. The law should avoid enumerating specific percentages or value amounts for fines. Any type of sanction aimed at suspending data processing should affect only the data specifically related to the infraction and not the entire data collected and stored at a data base.

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• Joint Liability: It is inappropriate to expect a small company to be held to the same potential damages as a large multinational company. The joint liability should only apply to joint responsible entities where they have not determined their responsibilities and liabilities in a written arrangement.

• International Data Transfer: It is estimated that restrictions on cross-border data transfers in Brazil would result in a GDP loss of 0.8 percent and an investment decrease of 4.2 percent. Mandating consent for international transfer of data significantly affects the growth of the Internet of Things (IoT) and the digital economy as a whole; and it is not adequate in the context of a global economy where international data transfers are needed and an integral part of companies’ daily life.

Page 11: MEETINGS WITH CONGRESS

The Brazil Council Healthcare Task Force encourages policies and programs that drive smart investments in health, economic growth, job creation, wellness, increased productivity in Brazil, and strengthening of the commercial ties between Brazil and the U.S.

To that end, the Council proposes the following agenda:

• Furthering discussion of the economic impact caused by certaindiseases in Brazil, with regard to:- Public healthcare costs;- Worker productivity decline;- Preventable mortality and morbidity;- Economic output; and- Family budgets for managing NCDs.

• Supporting initiatives that foster innovation and technology aimed atenhancing:- Life expectancy;- Quality of life;- Diagnostic and treatment options; and- Efficiency and cost effectiveness of the healthcare system.

• Promoting cooperation between the U.S. and Brazilian governmentsand encouraging contributions from the private sector, with respectto:- The and dialogue;- Brazil-U.S. Commercial Dialogue; and- The Memorandum of Understanding between the U.S. and Brazil on

Health and Medical Sciences.

• Urging to allocate more auditors and staff dedicated to border inspections for a more expeditious release of imported medical devices.

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HEALTHCARE POLICY AGENDA

• Brazil’s full insertion into world trade withmembership in:

In alignment with the “Bridge to the Future” (BTF) document to drive investment and economic growth in Brazil, the U.S. Section of the Brazil

Council proposes:

Framework and Bilateral Agreements

• A U.S. government "scoping exercise," with privatesector contributions, for potential U.S.-Brazil Trade Agreement and reopening of formal bilateral tax treaty negotiations.

&

• Full implementation of the WTO Trade Facilitation Agreement and innovative programs such as:

'Ease of Doing Business' Initiatives

• Streamlining Brazil’s bureaucratic processes toward a predictable legal framework for investors; enactment of law to simplify rule-making process. • Conclusion of international cooperation agreements on:

& SINGLE WINDOW

• Promotion of policy agenda designed for foreign investors, including U.S. as strategic partner under the U.S.-Brazil Memorandum of Cooperation for infrastructure development.• Launching of Investment Partnerships Program to strengthen cooperation between state and private sectors through public infrastructure projects and privatizations.

Infrastructure Reforms

Licensee

• Trade in Services• Information Technology; and• Government Procurement

Agreements

IP Rights

Trademark Patentand optimization of patent and trademark processes. Intensification of preventive measures and enforcement of IP violations.

Page 12: MEETINGS WITH CONGRESS

Follow us at:

Contact us: +1.202.463.5729 [email protected] brazilcouncil.org

Recognizing that the U.S. and Brazilian governments intend to enhance and expand cooperative efforts in healthcare and medical science and the important role of the private sectors in collaborating and supporting government actions, the U.S. section of the Brazil-U.S. Business Council proposes the creation of an industry dialogue as a formal mechanism of discussion between industry, government, and research institutes. The Brazil Council offers to be a convener to facilitate dialogue and information sharing regarding the following issues:

PROPOSAL FOR A PRIVATE SECTOR DIALOGUE RELATED TO THE BRAZIL-U.S. MOU ON HEALTHCARE AND MEDICAL SCIENCES

In alignment with the “Bridge to the Future” (BTF) document to drive investment and economic growth in Brazil, the U.S. Section of the Brazil

Council proposes:

• Brazil’s full insertion into world trade withmembership in:

Framework and Bilateral Agreements

• A U.S. government "scoping exercise," with private sector contributions, for potential U.S.-Brazil Trade Agreement and reopening of formal bilateral tax treaty negotiations.

• Trade in Services• Information Technology; and• Government Procurement Agreements

&

• Full implementation of the WTO Trade Facilitation Agreement and innovative programs such as:

'Ease of Doing Business' Initiatives

• Streamlining Brazil’s bureaucratic processes toward a predictable legal framework for investors; enactment of law to simplify rule-making process. • Conclusion of international cooperation agreements on:

and optimization of patent and trademark processes. Intensification of preventive measures and enforcement of IP rights violations.

& SINGLE WINDOW

IP Rights

Trademark Licensee

• Promotion of policy agenda designed for foreign investors, including U.S. as strategic partner under the U.S.-Brazil Memorandum of Cooperation for infrastructure development.• Launching of Investment Partnerships Program to strengthen cooperation between state and private sectors through public infrastructure projects and privatizations.

Infrastructure Reforms

Patent

• Exchange best practices between regulatory agencies on a variety of themes (e.g. clinical trials, private healthcare systems; approvals; post-market surveillance).

• The inclusion of new, frontier regulatory themes in the ANVISA & FDA dialogue.

Bilateral Regulatory Cooperation

• Innovative solutions: Initiate dialogue regarding how best to match innovative solutions and technology advances with public healthcare needs (e.g. telemedicine, mobile technology, innovative vector control).

• Admin. Procedures: Encourage dialogue to improve administrative procedures and practices aiming at reducing costs and increasing transparency.

• Value-based healthcare: Promote a dialogue about integrated systems that consider and treat patients holistically. Discuss the approaches of services based on volume (such as fee-for-service) or value (the cost of the full cycle of care compared with patient outcomes).

• Healthcare force: Promote education to advance building a strong healthcare workforce.

Optimizing Healthcare Technology and Innovation

• Health and Active Living: Develop cooperation that promotes the benefits of health and active living to reduce the healthcare burden and to improve prevention and management of non-communicable diseases.

• Technology and NCDs: Develop corporation agreements that promote the advancement of evidence-based use of technology to reduce the burden of non-communicable diseases.

Prevention and Treatment of Non-Communicable Diseases (NCDs)

Page 13: MEETINGS WITH CONGRESS

Examples of Brazil-U.S. Business Council member companies’

The Brazil-U.S. Business CouncilThe Brazil-U.S. Business Council

strengthening the economic and

the two countries. The Council exists within the structure of the U.S. Chamber of Commerce and is based in Washington, D.C. Formore than four decades, the House and the Council have promoted a close dialogue between the Brazilian government and U.S. companies that invest and produce in Brazil, establishingstrong commercial and

has more than 100 member companies to date and is always growing.

Healthcare Task ForceThe Council’s Healthcare Task Force encourages polices that drive investments in the health care sector of Brazil while helping to grow the economy, create jobs and foster social stability and workforce

Chair: Johnson & Johnson

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which allows anyone with a computer or mobile device to contribute to the research process.

tapped into more than 400,000 points of sale across Brazil to distribute official public health

of the mosquito and the disease throughout the country.

manual processing.

Oxitec Ltd., a wholly-owned subsidiary of Intrexon Corp., has pioneered the use of bioengineering

dengue, chikungunya and yellow fever. Oxitec’s OX513A mosquito was developed in 2002 and has

these successful trials were in Brazil, where OX513A was approved by CTNBio in 2014. Since April 2015, Oxitec has protected the neighborhoods of Piracicaba, and it is now expanding the control

(RET, Registro Especial Temporário) to Oxitec.

COMBATING THE ZIKA EPIDEMIC:COLLABORATIVE EFFORTS OF THE U.S. PRIVATE SECTOR

Page 14: MEETINGS WITH CONGRESS

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To help health care professionals, medical researchers and the public understand the outgoing outbreak of the Zika virus, Elsevier, the publishing arm of RELX Group, has created the Zika Virus Resource Center. With content in English, Portuguese and Spanish, the resource center compiles

and the effects of the outbreak and how best to respond. Decisions affecting the public’s health should be supported by the best available data, so the center will be constantly updated with the latest research from top medical journals, such as The Lancet.

For more information, visit: https://www.elsevier.com/connect/zika-virus-resource-center

developing public health worker training programs focused on improving care for pregnant women, babies with microcephaly and their

Campina Grande (PB) with the goal of training 1,650 health professionals.

Examples of Brazil-U.S. Business Council member companies’

For more than 60 years, SC Johnson has manufactured pest control brands, such as Raid® and OFF!®, which protect families from mosquitoes and the diseases they may carry. Since the beginning stages of the Zika outbreak, SC Johnson has mobilized all possible resources to assist Brazilians in protecting themselves against mosquitoes that may transmit the disease, as well dengue and chikungunya. In addition, SC Johnson launched an educational campaign, which has reached more than 20 million views, about mosquitoes and proper repellent use on all of its social media platforms, including tips for pregnant women, myths and truths and more. And as part of a large donation of OFF!® and Autan® products across Latin American markets, SC Johnson donated close to 300 thousand units to a number of Brazilian-based NGOs, including Instituto Fazer Acontecer, Instituto de Desenvolvimento Educação e Cultura da Amazônia (Idesca), Instituto Esporte Educação, Instituto de Ações Projetos e Pesquisas Sociais (INAPPES), Bola Pra Frente and Associação Saúde Criança, expanding SC Johnson’s local community engagement that help support Brazilian families in need. As a family company, SC Jonhson takes the well-being of those who use our products very seriously, and Brazil is one of our top priorities. For more information, please go to www.scjohnson.com/mosquitoes.

COMBATING THE ZIKA EPIDEMIC:COLLABORATIVE EFFORTS OF THE U.S. PRIVATE SECTOR

Page 15: MEETINGS WITH CONGRESS

PROVIDING A MORE COMPREHENSIVE TREATMENT FOR COLORECTAL CANCER IN BRAZIL

Epidemiology

Colorectal cancer estimated incidence in Brazil: 2016 and 20351

Incidence and Mortality - Brazil

Diagnosis and Staging of Colorectal Cancer

Corresponds to 10% of the worldwide new cancer cases1 with highest mortality rates in developing countries.1 The incidence is

increasing with the aging population.2

In Brazil, colorectal is the third and the second most incident cancer in men and

women, respectively3

w w w. b r a z i l c o u n c i l . o r g

17,600deathsnew cases

29,600potentially surgical cases

The main factor associated with the cure is the early stage at diagnosis and treatment4.

STAGE 5 YEAR SURVIVAL4 UNITED KINGDOM 20024 SÃO PAULO 20145

STAGE I / DUKES A 95-100% 16.8% / 25.2% 2% / 15%

STAGE II / DUKES B 80-90% 26% 29%

STAGE III / DUKES C 65% 25.2% 29%

STAGE IV / DUKES D 5-10% 1.5% 25%

Despite the 244.774 colonoscopies performed in 20156, 72,9% of doctors consider the waiting time for a colonoscopy prolonged or too prolonged7.

2016

37.116 new colorectal cancer cases

2035

67.912 new colorectal cancer cases

37,000 67,900

2016

2035

Page 16: MEETINGS WITH CONGRESS

Demand and Offer: Surgical Treatment

Promote the use of laparoscopy and enhanced

protocols to decrease complications rates, LOS and leverage efficiency to the

healthcare system.

Implant a clinical outpatients protocol to treat patients in medium complexity hospitals to improve access of non-treated

patients to high complexity hospitals

Unify medical information systems in all healthcare services

for appropriate follow-up, referral

and to ensure a more comprehensive care

for patients

Create a Screening Program

via fecal occult blood test

(FOBT) in Brazil for early stage

diagnosis.

Create conditions for a rapid diagnosis - colonoscopy and biopsy to patients with positive FOBT

tests.

Social and Economic Burden of Colorectal Cancer

25.500 new cases are expected in this segment

in 20163,8

8.500 new cases are expected in this segment

in 20163,8

According to ANS, 8.684 colorectal surgeries were

performed in the last 12 months.

Is estimated that 4.466 colorectal surgeries were

performed in 20158

Potentially, 39,5% of surgical coverage in SUS11

Potentially, 100% of surgical coverage in the Brazilian Private

Healthcare11

w w w. b r a z i l c o u n c i l . o r g

Policy Recommendations

(1) GLOBOCAN (2) American Cancer Society. Colorectal cancer facts and figures 2011-2013. (3) INCA. Cancer Incidence 2016. (4) http://www.cancerresearchuk.org/about-cancer/type/bowel-cancer/treatment/statistics-and-outlook-for-bowel-cancer(5) FOSP. RHC 2016. (6) DATASUS – SIA(7) TCU - RELATÓRIO DE AUDITORIA OPERACIONAL. Política Nacional de Atenção Oncológica 2011.(8) ANS – TABNET - Beneficiários por UFs, Regiões Metropolitanas (RM) e Capitais(9) DATASUS – SIH (10) ORIZON(11) Sullivan, Richard et al. Global cancer surgery: delivering safe, affordable, and timely cancer surgery. The Lancet Oncology 2015, Volume 16, Issue 11, 1193–1224(12) NICE. The diagnosis and management of colorectal cancer. 2011(13) Lansdorp-Vogelaar, I et al. Effect of rising chemotherapy costs on the cost savings of colorectal cancer screening. J Natl Cancer Inst (2009) 101: 1412–22.

2015 TOTAL ANNUAL EXPENDITURE WITH COLORECTAL CANCER IN SUS6,9

SUS 2015 Outpatient Inpatient

Chemotherapy114.624

R$ 234.067.264,50

Radiotherapy*885.527

R$ 28.974.082,05

Surgery8.049

R$ 50.838.249,32

Hospitalisation59.749

R$ 119.101.993,99

60,75% R$ 263.041.346,55

The main cost driver in Brazil is the outpatient-

related costs, mainly due to the advanced stage during the diagnosis.

39,25% R$ 169.940.243,31

R$ 432.981.589,86 * RHC FOSP. According to RHC-FOSP, 9% of patients whose did radiotherapy were diagnosed with colorectal cancer in 2014

ANNUAL COSTS OF INITIAL PHASE OF CARE FOR COLORECTAL CANCER PER STAGE13

Early treatment is more effective, with much higher patient survival rates

Early treatment has significantly lower costs, estimated to be 66% lower per patient13

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One of the Most Dangerous Animals in Brazil

The Economic Burden Caused by Aedes in Brazil

Select Policy Recommendations for Improving the Control of the Aedes aegypti Population

Promote an integrated pest

management program that includes the use of new

vector control technologies that are more effective in suppressing

the population of mosquitoes.

Ministry of Health spent

BRL

1.2 Billionto fight the

mosquitoes in 2015.*

Expedite the regulatory approval

process of technologies that have proven to be environmentally friendly and to have no persistence in the

environment.

The total budget for health surveillance

wasBRL

1.5 Billionin 2015.**

Closely monitor existing

trials involving vector control technologies

and co-sponsor larger projects.

The total social cost of dengue alone in Brazil

was estimated to have been

BRL

2.7 Billionin 2013.***

Involve private

players in working groups to plan the best

possible combined efforts to fight the

mosquitoes.

Each dengue patient costs the public

healthcare system in Brazil approximately

BRL

650in treatment. ***

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Aedes aegypti mosquitoes are capable of transmitting various arboviruses including dengue, chikungunya, Zika and yellow fever. These can lead to damaging health disorders

putting enormous burdens on healthcare systems.

Dengue: 1.4 million reported cases in 2016.*

Chikungunya: Transmission of chikungunya has

occurred throughout Brazil. Pernambuco

registered 473 cases of chikungunya per 100,000 inhabitants

in 2016.*

Zika: Over 200,000 reported cases of Zika

in 2016* (note Zika is 80% asymptomatic

which may lead to underreporting);

2,063 microcephaly cases confirmed

to date.*

Severe Dengue: Antibody-Dependent Enhancement (ADE) increases the risk of severe dengue, and in 2015 there were 833 deaths due to dengue in

Brazil. Recent studies note potential of ADE between

dengue and Zika.**

*Source: PAHO and Brazilian Ministry of Health.***Source: (1) Specificity, cross-reactivity, and function of antibodies elicited by Zika virus infection Stettler K., et al. (2016) Science. 353(6301):823-6. (2) Dengue virus sero-cross-reactivity drives antibody-dependent enhancement of infection with zika virus Dejnirattisai W., et al. (2016) Nature Immunology. 17:1102–8.

*Source: Brazilian Ministry of Health. **Source: FGV DAPP. ***Source: Tropical Health Institute at University of Goias.

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Porque é tão importante para a população brasileira reduzir os altos níveis de LDL-Colesterol ou “Colesterol ruim”

O Colesterol ruim (LDL-Colesterol) e as doenças cardiovasculares

Os custos

R$ 30,8 bilhões

é o custo mínimo anual associado às DCVs.9

Hipercolesterolemia Familiar (HF) é uma doença genética

que resulta em níveis bastante elevados de LDL-colesterol e um

risco de DCV prematura 20 x maior que o esperado.3

Mais de

940 milhospitalizações / ano relacionadas à doença cardiovascular ocorrem no sistema público de saúde.6,7

O LDL- colesterol é o principal fator

de risco modificável para DCV.1

R$ 40,9milé estimado como o custo médio de hospitalização no sistema de saúde

suplementar, em 15,2 dias por hospitalização por evento CV.8

No mundo, as DCV representam aproximadamente um terço de todas as mortes, sendo mais que o dobro de mortes de todos os canceres

somados.2

Os números da DCV no Brasil

A DCV é a causa número um de mortes

no Brasil1

A cada 2 minutos um brasileiro

morre devido a DCV.1,4

31,3% de todas as mortes

que ocorrem no Brasil são atribuídas às

DCVs.1

45% dos brasileiros com alto risco cardiovascular não atingem níveis de LDL-C < 100 mg/dL

utilizando as terapias atuais.4,5

RecomendaçõesCriação de uma rede de

assistência específica através de centros de referência em

dislipidemia para pacientes de alto risco CV.

Atenção específica para pacientes

com HF.

Ampliação do acesso à medicações inovadoras, permitindo uma melhor qualidade de vida aos

pacientes em tratamento.

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5 a 10 % dos eventos

cardiovasculares (CVs) são

causados pela HF.6

Referências:1. World Health Organization, Cardiovascular Diseases2. X World Health Organization, Cardiovascular Diseases3. Institute for Health Metrics and Evaluation. Global Burden of Disease Study Brazil. Acessado em http://www.healthdata.org/sites/default/files/files/country_profiles/GBD/ihme_gbd_

country_report_brazil.pdf on November 24, 2014. Study date 2010.4. Hopkins P. Clin Lipidol. 2010;5(3):339-3545. Waters D, Brotons C, Chiang C, et al. Lipid treatment assessment project 2: a multinational survey to evaluate the proportion of patients achieving low-density lipoprotein cholesterol

goals. Circulation. Jul 7 2009;120(1):28-346. Santos et al. Arq Bras Cardiol. Aug 2012;99(2 Suppl 2):1-287. Ribeiro AL, Duncan BB, Brant LC, Lotufo PA, Mill JG, Barreto SM. Cardiovascular Health in Brazil: Trends and Perspectives. Circulation. Jan 26 2016;133(4):422-4338. Teich et al, Acute Coronary Syndrome Treatment Costs from the Perspective of the Supplementary Health System9. Azambuja MI, Foppa M, Maranhao MF, Achutti AC. Economic burden of severe cardiovascular diseases in Brazil: an estimate based on secondary data. Arq Bras Cardiol. Sep

2008;91(3):148-155, 163-171.

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Improving Type 2 Diabetes (T2D) Therapy Compliance in Brazil

What is T2D?

The Cost

Avoidable costs from complications:

R$ 4.2 Billiona year

Annual cost of

R$ 66 Billiona year to treat illness

Estimated to increase to

R$ 108 Billiona year by 2040

The Rise of T2D in Brazil

6.9%of population in 2016– increased

from 5.5% in 2006

13MPatients with Diabetes – 90% Type 2

77%sub-optimal levels of compliance and

persistence

43%of patients with

diabetes abandon treatment in first

two years

Recommendations

Promote the use of electronic medical records and keep

track of compliance and persistence.

Provide education on T2D management,

including compliance and persistence.

Leverage technology and digital offerings to maintain Patient with Diabetes Activation.

Add compliance and persistence discussions as a

priority theme for education within both

national and local initiatives.

It is a chronic disease characterized by insulin resistance. People with T2D suffer from elevated levels of blood glucose,

which can result in long-term health complications.

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