EFFECTIVENESS CRITERIA FOR A COMPLIANCE PROGRAM IN THE PHARMACEUTICAL INDUSTRY

GUILHERME CAMARGO COSTA

TATIANA KASCHER

Conclusion paper for the “Healthcare Compliance Certification” course written by Guilherme Costa and Tatiana Kascher on the elements that must be addressed by a pharmaceutical industry for their Compliance Program to be considered effective, as required by law. Updated in January 2020 by Guilherme Costa with correlation analysis of the Brazilian law with the American and British anticorruption laws.

S?o Paulo / Brazil 2017 Published / 2020 Updated

1. Introduction

Integrity has become a key issue for all organisations as a result of several changes not only in Brazil, but around the world. The lack of accounting controls and corruption and fraud scandals are examples of factors that led to the creation of some of the most important laws when it comes to integrity.

The US Foreign Corrupt Practices Act (“FCPA”), the UK Bribery Act, Sarbanes-Oxley, the Spanish Penal Code (as amended in 2010), the Sapin II Act in France, and Brazil's Act No. 12,846 of August 2013 (“Brazilian Clean Company Act”), among others, are legal instruments that contributed to the convergence of various sectors of society in the construction of a more ethical environment for doing business, especially in cases of interaction with government agencies and civil servants. These normative instruments established the responsibility of individuals and legal entities that violate the prescribed integrity precepts, but also sought to guide organisations to establish mechanisms that contribute to the prevention of unethical practices and the consolidation of a sound business environment, the so-called integrity program or compliance program.

The purpose of this paper is to discuss the elements required for a compliance program of a pharmaceutical industry to be considered effective under three of the main anti-corruption laws for an industry operating in Brazil: the FCPA, the UK Bribery Act and the Brazilian Clean Company Act (the first two applicable to most pharmaceutical industries due to their transnational character). This is an importance issue as a pre-existing robust and effective program serves as a relevant factor in mitigating the application of sanctions that can be quite severe.

We know that it is not possible to design an effective generic program applicable to all pharmaceutical industries and we are not proposing that. It would be impossible for the same program to effectively serve a multinational manufacturer with a varied drug portfolio and a small manufacturer focused on manufacturing a narrow range of medicines. The challenges faced by these companies can differ in many ways, so each compliance program must be tailored to the reality of each company.

However, healthcare industries and related companies have certain recurring risks that should be addressed with particular attention, especially in higher-risk regions, as noted by Transparency International reports such as Latin America, Africa and Asia. Therefore, in this paper we will (i) consider the benefits of an effective compliance program, (ii) consider the five pillars for creating an effective compliance program, as recommended by the Brazilian Comptroller General of the Union (“CGU”); (iii) indicate how the CGU recommendations align with the US and UK guidelines; and (iv) discuss some relationships that present potential risks to drug manufacturing companies due to the conflicts of interest inherent in these relationships.

2. Advantages of an effective integrity program

Establishing an effective integrity program is an evident goal for an organisation willing to invest resources to make up the necessary policies and procedures, but it is also a fundamental legal requirement for an organisation to benefit from mitigating assessments of their responsibilities in case of violation of anti-corruption laws.

Taking as an example three of the most relevant regulatory instruments for organisations operating in Brazil, the Brazilian Clean Company Act, the FCPA and the UK Bribery Act, the three encourage the adoption of integrity programs so that the organisation can benefit from mitigating if prosecuted for acts of corruption.

The Brazilian Clean Company Act, for example, states that the effective application of a code of conduct within the legal entity should be considered as a mitigating criterion in the application of sanctions. Decree No. 8,420 / 2015, which regulated the Brazilian Clean Company Act (“Decree”) further details the possibility that between one percent (1%) and four percent (4%) of gross revenues will be deducted from the amount of the fine to be paid, if it is established that the legal entity had and applied an integrity program. Brazilian law, however, requires that the integrity program be effective in complying with the parameters set forth in said Decree.

The American law also has such a requirement. As described in The Resource Guide to the U.S. Foreign Corrupt Practices Act, handbook published by the Department of Justice and the US Securities and Exchange Commission:

"DOJ and SEC also consider the adequacy of a company’s compliance program when deciding what, if any, action to take. (…) SEC’s Seaboard Report focuses, among other things, on a company’s self-policing (…), including whether it had established effective compliance procedures. Likewise, three of the nine factors set forth in DOJ’s Principles of Federal Prosecution of Business Organizations relate, either directly or indirectly, to a compliance program’s design and implementation, including (…) the existence and effectiveness of the company’s pre-existing compliance program.”

In the same vein, the UK Bribery Act guidelines recognise: “(...) the commercial organisation will have a full defence if it can show that despite a particular case of bribery it nevertheless had adequate procedures in place to prevent persons associated with it from bribing”.

3. Essential legal requirements for designing an effective integrity program

In Brazil, the Decree defined in its art. 41 that an integrity program should include, among others, a set of internal integrity and audit mechanisms and procedures. In addition, the guidelines for a private company integrity program published by the CGU teach that an effective integrity program must be based on five pillars, (i) senior management commitment, (ii) responsible body definition, (iii) risk analysis (iv) rules and instruments, and (v) continuous monitoring.

(i) Senior Management Commitment

According to the Association of Certified Fraud Examiners (US), top management support would be critical since the tone given by the organisation's leadership would set other members’ behaviour. Therefore, an ethical atmosphere in the workplace would depend on top management tone and examples. It is no coincidence that senior management's commitment to the compliance program is the first element listed by the regulator in Art. 42 of the Decree when listing the elements required for a compliance program to be considered effective.

When critical situations related to fraud and corruption in organisations involve decisions from higher levels, the employees' interpretation of these situations would be that committing fraud is acceptable to increase the organisation's profits. Leadership actions help shape the company's culture by setting a standard to follow.

Engaging in energetic corrective action in the event of deviations and proactive preventive actions are some examples that can help senior management build an ethical culture within the company. In an industry so closely linked to people's quality of life, the example of senior management is crucial not only for safeguarding the integrity of the company, but also for the integrity of patients.

This requirement is in line with the expectations of the US and UK authorities as follows respectively:

“Within a business organization, compliance begins with the board of directors and senior executives setting the proper tone for the rest of the company. Managers and employees take their cues from these corporate leaders. Thus, DOJ and SEC consider the commitment of corpo- rate leaders to a 'culture of compliance' and look to see if this high-level commitment is also reinforced and implemented by middle managers and employees at all levels of a business” (A Resource Guide to the U.S. Foreign Corrupt Practices Act).

“Those at the top of an organisation are in the best position to foster a culture of integrity where bribery is unacceptable. The purpose of this principle is to encourage the involvement of top-level management in the determination of bribery prevention procedures. It is also to encourage top-level involvement in any key decision making relating to bribery risk where that is appropriate for the organisation’s management structure” (The UK Bribery Act 2010 - Guidance).

(ii) Responsible Body Definition

According to the CGU guidelines, whichever instance is responsible for the integrity program within the organisation, it must be endowed with autonomy and independence, including through material, human and financial resources, for its full functioning. The possibility of direct access, when necessary, to the highest decision-making body of the company is a guarantee of this autonomy and independence.

The US guidelines on effectiveness indicate that individuals responsible for the company's integrity program must have appropriate levels of authority within the organisation and sufficient resources to effectively implement the program. Appropriate levels of autonomy should generally include direct access to company authority bodies such as directors and the board of directors.

Similarly, UK effectiveness requirements refer to “Appropriate resourcing” which should reflect the size of each organisation's business and the need to identify and prioritise all relevant risks.

(iii) Risk Analysis

For the integrity program to be effective, it must be tailored to the specific risks of the organisation to be covered. Such customisation is only possible after the identification and mapping of risks to which the company is exposed. Risk analysis helps initially determine which relationships expose the company to risks of corruption by allowing policies and procedures to be tailored to reduce or eliminate them.

Therefore, risk analysis is a demand from various legal systems to ascertain the effectiveness of an integrity program and should serve as a starting point for planning an appropriate and effective integrity program. In the case of Brazilian law, risk analysis is expressly required by the Decree in its art. 42, item V.

The guidelines for private companies integrity programs published by the Comptroller General of the Union state that: “(…) an integrity program should be developed taking into consideration the size and specificity of the company, based on information such as: (i) market sectors in which it operates in Brazil and abroad; (ii) organisational structure (internal hierarchy, decision making and key competencies of boards, committees and internal departments); (iii) number of employees; (iv) level of interaction with the public administration, especially considering the relevance of processes for obtaining government authorisations, licenses and permits in its activities, the quantity and values of contracts entered into with public entities and agencies, the frequency and relevance of using third parties in interactions with the public sector; and (v) equity interests involving the legal entity as parent, subsidiary, affiliate or joint-ventures".

Still according to CGU guidelines, other important considerations in risk analysis should take into account the market elements in which the company operates, such as local culture, state regulation level and history of corruption. This information matters to determine the likelihood of fraud and corruption, including in connection with bids and contracts. Similarly, for Antitrust Law purposes, the Compliance Program Guide published by the Administrative Council for Economic Defense (“CADE”) also presents risk analysis regarding the sector, the capillarity of its activities and the level of education of employees as an elemental point for a compliance program to be considered robust.

Precisely identifying the public officials with whom the company relates as well as other risk relationships is critical to reducing the company's exposure to the risk of violation of applicable anti-corruption laws. Some examples of relationships that expose drug manufacturers to risks of corruption are those with: (i) doctors when public hospital employees and therefore public officials, even if the relationship is not within the public environment; (ii) drug distributors, especially those authorised to participate in tenders, (iii) customs brokers, because they are usually hired to perform customs clearance of medicines and pharmaceutical supplies, interacting daily with customs authorities; (iv) third parties hired to assist with obtaining Business Operating Authorities, state and municipal health licenses and registrations of new drugs; (v) patient associations; among others.

Finally, determining what the risks are and their relevance is the purpose of risk analysis, and establishing a risk matrix helps determine the points of attention that must necessarily be addressed and mitigated in order for the organisation's integrity program to be considered effective. Based on the identified risks, the organisation should develop rules, policies and procedures to prevent, detect and remedy the occurrence of unwanted acts. The greater the risk, the greater must be the controls to address them and thus protect both the organisation itself and the community in which it operates.

It is also important that the risk analysis process is repeated periodically to identify changes in the initial risk matrix, whether due to new laws and regulations or internal changes within the company itself.

Regarding risk analysis, the US guidelines on the FCPA are equally high:

“Assessment of risk is fundamental to developing a strong compliance program, and is another factor DOJ and SEC evaluate when assessing a company’s compliance program. One-size-fits-all compliance programs are generally ill-conceived and ineffective because resources inevitably are spread too thin, with too much focus on low- risk markets and transactions to the detriment of high-risk areas”.

The UK Bribery Act guidance issued by the UK Government confirms the need for a risk analysis:

“As the principles make clear commercial organisations should adopt a risk-based approach to managing bribery risks. Procedures should be proportionate to the risks faced by an organisation. No policies or procedures are capable of detecting and preventing all bribery. A risk-based approach will, however, serve to focus the effort where it is needed and will have most impact. A risk-based approach recognises that the bribery threat to organisations varies across jurisdictions, business sectors, business partners and transactions”.

(iv) Rules and Instruments

After conducting risk analysis to identify relationships that expose the company to risks of corruption, the company should develop and distribute compliance policies that will establish the procedures and practices that will guide the company and set the expected standards of conduct for its employees.

Policies and procedures should be provided to all Company employees and to third parties who may expose the Company to risks of corruption. Some examples of third parties that generally relate to pharmaceutical industries that should receive such documents are: (i) dispatchers and technical consultants, as they are hired to interact with government officials on behalf of the company, (ii) distributors, as they may potentially offer bribes to complete sales to government and other health organisations, (iii) hospitals and clinics (clients) that are visited by sales representatives, so they know how to report acts of corruption practiced by sales representatives, among others. In this sense, the Decree establishes in its art. 42, items II and III, that standards of conduct, codes of ethics and integrity policies and procedures must be followed by both employees and third parties.

While it is impossible to list here all the issues that should be addressed in policies and procedures, as they should be designed based on each company's risk analysis, as discussed above, it is worth mentioning some points that must necessarily be included in any compliance program of a pharmaceutical industry.

a. clearly and precisely who are the people affected by the policies, who is the person designated to enforce them, and what consequences apply in the case of infringements;

b. a list of values, behaviours and conducts expected from every employee, regardless of hierarchical level;

c. a criterion for assessing misconduct and the applicable penalties. The gradation of the risk should vary from mild to very serious, and serious infractions should be penalised with dismissal;

d. third parties involved or suspected of engaging in corruption practices should be investigated and the company has the right to terminate the contracts. Therefore, policies need to provide that contracts with third parties must contain anti-corruption clauses and the possibility of early termination in cases of suspected corruption;

e. establish how employees and third parties should report suspected corruption. Whenever possible, companies should hire an outside telephone service.

In addition, policies and procedures should provide for investigative procedures that should be adopted to investigate reported complaints.

Among the guidelines of the US authorities for FCPA compliance, we can find the following regarding rules and instruments:

“A company’s code of conduct is often the foundation upon which an effective compliance program is built. As DOJ has repeatedly noted in its charging documents, the most effective codes are clear, concise, and accessible to all employees and to those conducting business on the company’s behalf. Indeed, it would be difficult to effectively implement a compliance program if it was not available in the local language so that employees in foreign subsidiaries can access and understand it. (...) Whether a company has policies and procedures that outline responsibilities for compliance within the company, detail proper internal controls, auditing practices, and documentation policies, and set forth disciplinary procedures will also be considered by DOJ and SEC”.

In the same vein, the UK guidelines state that companies should include policies and processes to prevent the payment of fees by associated persons. Such policies should be clear, practical, accessible and effectively enforced.

Important Policies for Pharmaceutical Industries

To make it easier for you to see our rules and instruments considerations, here are some of the policies and procedures that typically make up the compliance program of drug or medical device industry:

• Conflicts of interest;
• Travel, gifts, hospitality and entertainment;
• Donations and sponsorships;
• Whistleblowing channels and investigations;
• Use of insider trading;
• Harassment and discrimination;
• Antitrust policies;
• Management and retention of accounting records and controls;
• Promotional practices;
• Interaction with health professionals;
• Trade compliance (trade sanctions);
• Health Safety and environment;
• Patient data privacy;
• Ethics in clinical research.

Depending on the need of the industry these issues may be addressed directly in the Code of Conduct or in specific policies.

Specific procedures of the pharmaceutical industry are usually those of approval and registration for expenses with healthcare professionals, hospitals and patient associations, whether due to contributions, support for scientific research, contracting for consultancy services, invitation to educational events, among others. It is important to record and document that such interactions occurred transparently and at market value, without the intention of creating undue favoritisms. In the US, “Sunshine Laws” have required the industry to publicize payments made to healthcare professionals, and in Brazil the legislative trend should follow, with the state of Minas Gerais being the first to have issued laws in this regard.

(v) Continuous Monitoring

By art. 45, item XV, of the Decree, Brazilian law requires companies to draw up a monitoring plan to identify failures of the integrity program that may lead to corrections and improvements. According to Alexandre Serpa, Allegan Compliance Officer for Latin America and Canada, “to monitor is to verify if the implementation of the compliance program is having the planned effects, and if the pillars are operating. It also identifies whether the identified risks have changed or new risks have arisen”(2016, p. 75).

Without continuous monitoring, it would be impossible for a company to adjust its integrity program to respond in a timely manner to new risks that arise during its operation. Therefore, continuously updating company policies to cover new needs, including consideration of information obtained through the reporting channel, updating the risk matrix, conducting audits, updating employees on policies through training, are, among others, important actions to ensure the compliance program is updated through continuous monitoring.

Finally, one last element that deserves attention among the monitoring actions would be the updating of the third party audit. Due to the objective liability attributed by the Brazilian Clean Company Act to companies for the actions of third parties acting on their behalf, including distributors, even if they have not requested or authorised an unlawful act by a service provider, the industry may also have to respond for such act, as if she had practiced it herself. Thus, knowing the third parties to be hired through a prior audit is essential, including for the integrity program to be considered effective, as required by the Decree. In the Resource Guide to the US Foreign Corrupt Practices Act, the US government also makes its attention clear to third party auditing for FCPA-subject industries: “Risk-based due diligence is particularly important with third parties and will also be considered by DOJ and SEC in assessing the effects of the company's compliance program”(USA, p. 60. Year).

UK Bribery Act UK compliance guidelines are clear about expectations for companies to properly monitor not only their internal risks but also third parties who provide services on behalf of the company to authorities, customers and, in the case of industries pharmaceutical companies, of course the medical community:

"Due diligence is firmly established as an element of corporate good governance and it is envisaged that due diligence related to bribery prevention will often form part of 12 a wider due diligence framework. Due diligence procedures are both a form of bribery risk assessment and a means of mitigating a risk. By way of illustration, a commercial organisation may identify risks that as a general proposition attach to doing business in reliance upon local third party intermediaries. Due diligence of specific prospective third party intermediaries could significantly mitigate these risks. The significance of the role of due diligence in bribery risk mitigation justifies its inclusion here as a Principle in its own right”.

Given the importance of third party auditing within an integrity program and considering that a third contract may be approved in the audit at the time of engagement, but during the course of the contract, this third party may commit acts that would be detrimental to the contracting industry, it is critical that updating these audits as part of ongoing monitoring.

4. Relevant risks of the relationship with other stakeholders

In this chapter we examine some examples of common interactions in the daily life of pharmaceutical industries that are susceptible to improper bribery and corruption practices, with a view to extracting from these examples some clever elements for the composition of an effective integrity program.

The following examples do not serve as a typology of acts of corruption within the aforementioned laws, but depending on the rationality and artifice used for such practices, they may lead the company to gain an improper advantage for its private interests. In the case of public officials, when filing an administrative proceeding or lawsuit based on the Brazilian Clean Company Act, the lawful authority to file the lawsuit (i.e. prosecutor, public attorney, CGU) will seek to prove that the accused company offered / granted an improper advantage (which may be commercial or non-commercial) for a civil servant to act in its best interests.

Since they may be punished whenever there is a causal link between the wrongful act committed for their benefit or interest and the harm to the public administration, pharmaceutical industries should closely monitor the interactions described below and other risky interactions outlined in risk analysis.

(i) Interactions with the Medical Community

Since many hospitals are public and therefore their physicians and general staff are considered public officials, identifying such stakeholders in the industry's relationship with the medical community is critical to taking steps to ensure that relationships cannot influence such professionals to favor the industry.

In dealing with physicians who are public servants, in addition to complying with all applicable laws, and the codes of conduct of trade associations and the medical profession, pharmaceutical industries also need to pay attention to the provisions of the applicable codes to public officials in question. Although these documents address public officials, in listing benefits that cannot be accepted by such servers, such documents strongly indicate that the provision of such benefits may be construed as offering improper advantage.

(ii) Sales Representatives

A common sales promotion practice is to send sales representatives to hospitals and doctors' offices to promote company products. The practice itself is not a problem, but representatives often cross the line that would be considered a fair and transparent business relationship, for example, offering gifts and meals in an attempt to influence purchasing decisions, or offering prescription compensation.

For the compliance program to be considered effective, companies must have robust controls over these interactions.

(iii)Medical Education

While pharmaceutical company-sponsored medical education is part of its strategies to foster scientific content, these relationships expose the company to a number of risks as invitations to doctors to lecture or attend congresses or other educational events may be construed as a improper attempt to influence guests to prescribe industry products.

The selection of these professionals should not have a business purpose to influence them to prescribe products from the sponsoring industry. In other words, the invitation of doctors to congress cannot be a bargaining chip for prescriptions. Therefore, an effective compliance program should establish rules such as criteria for defining who should be invited, providing that payments will be made directly to service providers (e.g. travel agencies), event should be appropriate by filling most of the guests day etc. The program must also prohibit the offering of gifts of significant value.

Many pharmaceutical industry trade associations currently prohibit through their codes of conduct that the industry sponsors the participation of healthcare professionals in third party events such as ABMED in Brazil, AdvaMed in the United States, MedTech in Europe and AMID in Mexico, among others.

However, the legislation allows pharmaceutical companies to hire doctors to give lectures at educational events, as long as the speaker makes clear that he has been hired by a particular company and that he has complete freedom in his speech. The freedom of speech aims to prevent doctors from providing partial opinions due to the monetary consideration received for performing the service.

Thus, an effective compliance program should determine a fair market value for the compensation of amounts to be paid to physicians and other healthcare professionals.

In addition, as a trusted member of the medical community, industry must ensure that the scientific and medical information provided by the R&D, Medical Affairs or Clinical Affairs departments on research, clinical studies and products are: (i) medically and scientifically accurate; (ii) objective, precise, impartial and duly validated; (iii) provided with the fair balance, complete and without omissions of material information; (iv) scientific in tone and free of promotional messages; (v) provided by scientifically trained personnel working in research, clinical and medical positions; and (vi) label compatible when proactively, and informatively provided for new indications not yet approved only if in response to a spontaneous request or as appropriate during a peer-to-peer scientific exchange on industry research programs.

(iv)Donations to Public Entities

Pharmaceutical companies may have the strategy of donating drugs, medical equipment or even currency to public and private health organisations, as well as conducting disease awareness campaigns. But even if lawful, these gifts can be interpreted as offering improper advantage for business, depending on the situations surrounding such gifts.

To mitigate risks and ensure program effectiveness, policies should provide, among other things, for documentation to be maintained for any and all payments or donations to government agencies and / or public officials, including contracts signed by all parties with clear purpose of the allocation of the resources offered.

(v) Relations with Patient Associations

Relations with patient associations are also susceptible to corruption and are being heavily investigated by the Brazilian federal police. For example, employees of Mantecorp, Wyeth and Merck-Serono are being criminally prosecuted for corruption-related crimes. In short, according to the accusations, these companies would fund patient associations so that they would co-opt patients, obtain false medical reports, and file lawsuits (instructed with false reports) to seek court decisions mandating the Unified Health System (SUS) to provide medicines registered by the accused companies. The scheme would be funded by companies through fraudulent sponsorship and donation contracts. Evidence supporting the allegations was obtained by telephone interceptions and documents collected from companies and patient associations.

Undoubtedly, an effective compliance program should make it clear that the company repudiates any and all situations that may give rise to situations such as the one above. Among other issues, policies on relationships with patient associations (i) should prohibit financial donations to patient associations subject to the encouragement or support of prosecution against ensurers, primarily linked to the payment of doctors and lawyers; (ii) establish that assistance programs should be conducted by a third party, (iii) prohibit company representatives from discussing patient cases with patient association members.

5. Conclusion

An effective compliance program is extremely important to ensure the good operation of a pharmaceutical industry and a fundamental requirement for the organisation to benefit from mitigating assessments of its responsibilities in case of violation of anti-corruption laws. Brazilian, US and UK laws require the integrity program to be effective in meeting certain parameters.

In Brazil, as guided by the CGU, to be effective, an integrity program must be based on five pillars: (i) senior management commitment, (ii) responsible body definition, (iii) risk analysis, (iv) rules and instruments; and (v) continuous monitoring, enforced by full senior management commitment, vigorous corrective actions in case of deviations and proactive actions to prevent corruption.

Furthermore, there is no point in having a compliance program, even if it is based on the five pillars if it is not designed taking into account the risks faced by the company in question. It is not possible to design a generic program applicable to all pharmaceutical industries that is effective, but as we pointed out above, some relationships are quite recurring and companies must make sure they are properly included in their integrity programs.

6. Bibliography

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b. AYRES, CARLOS HENRIQUE DA SILVA. Healthcare Compliance Risks in Latin America. Acessado em 2017. Disponível em https://fcpamericas.com/english/anti-corruption-compliance/ healthcarecompliance-risks-latin-america/

c. A Resource Guide to the U.S. Foreign Corrupt Practices Act. Disponível em : https:// www.justice.gov/criminal-fraud/fcpa-guidance

d. The UK Bribery Act 2010 - Guidance - https://www.justice.gov.uk/downloads/ legislation/bribery-act-2010-guidance.pdf

e. Programa de Integridade – Diretrizes para Empresas Privadas (CGU) - https:// www.cgu.gov.br/Publicacoes/etica-e-integridade/arquivos/programa-de-integridade-diretrizes-paraempresas-privadas.pdf

f. Guia de Programas de Compliance publicado pelo Conselho Administrativo de Defesa Econ?mica – CADE - https://www.cade.gov.br/acesso-a-informacao/publicacoes-institucionais/ guias_do_Cade/guia-compliance-versao-oficial.pdf

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