by Camillo Giamundo and Joaquim Augusto Melo de Queiroz

1. Introduction

The interaction between physicians and the pharmaceutical and health products industry is an undeniable fact. This relationship is grounded in aspects that are intrinsic and indispensable to the development of new technologies. As is well known, for a researched molecule to evolve into an investigational drug and later achieve the status of a commercially viable medicine, a long path of laboratory studies and clinical trials must be followed. Physicians are an inseparable part of this process. They conduct, for example, clinical research with volunteer patients to evaluate new drugs. They are also responsible for a significant output of scientific articles, many of which are used in dossiers for granting health registrations. It is natural that this should be so — and even desirable. This is because this link can serve as an instrument for disseminating knowledge and as a vector for driving the development of new therapies. This relationship is not, however, spotless. Underlying it is a sensitive point: the financial support sometimes established and its influence on the professional’s independence in prescribing products.

This study aims to analyze this financial link and the regulatory mechanisms developed to reduce its harmful effects. More specifically, it will assess this link from the perspective of the physicians involved, focusing on those who perform public-sector activities. Based on these premises, it will examine the cases in which certain conduct may be characterized as potential acts of administrative improbity or even be subject to anti-corruption legislation.

 

2. The financial relationship

The logical premise inherent in the prescription of medicines and health products rests on the relationship of trust between physician and patient.

When choosing a particular physician, the patient trusts (i) the technical capacity and experience of the chosen professional; and (ii) their physician’s independence in prescribing the treatment best suited to their clinical condition[1].

Due to this particular situation of prescribing medicines and health products, embodied in the exclusive assignment of this task to physicians, there is a possibility that external elements may eventually influence the professional’s decision. And it is in this context that the financial relationship between the health industry and physicians arises.

The health industry’s implementation of financial practices with physicians is an undeniable fact. The resources used for this purpose are multiple and take heterogeneous approaches. However, this circumstance does not, in and of itself and automatically, constitute a conflict of interest[2].

Although the possibility that financial aspects arising from this relationship may eventually influence the professional’s practice is not ignored, establishing this corollary is not trivial and cannot be immediately presumed. And the reasons are varied.

To begin with, it must be borne in mind that the benefits granted by the industry encompass actions of the most varied kinds. Among the most common are (i) awards and bonuses; (ii) payment of travel, tickets, accommodation and meals; (iii) payment of expenses for attending congresses and similar events; (iv) giveaways, gifts and other goods; (v) payment of fees for consulting, presentation of scientific papers, lectures and the like; and (vi) engagement to work on scientific studies and research at any phase or stage.

Looking at the practices listed, it must be acknowledged that some of them correspond to activities usually linked to the development of new medicines and scientific production. Assuming that interactions of this nature would necessarily sway the physician’s autonomy would end up hindering scientific research, which often depends on private support for its funding.

Regarding practices that do not necessarily relate to scientific production and the dissemination of knowledge, some authors argue that such measures could covertly influence prescribing activity:

“We can then define conflict of interest as a set of conditions and circumstances that may unduly influence professional judgment regarding the primary interest (patient well-being and treatment, validity of research) in favor of a secondary interest (economic benefit, desire for notoriety, prestige, recognition and professional advancement), especially if we consider that gifts offered by laboratories to physicians, although not necessarily leading to a conflict of interest situation, may limit the neutrality required when making clinical decisions”.[3]

It is true that this bond may produce unconscious effects on the prescribing professional. However, measuring the correlation between the granting of benefits by the industry and its impact on the prescription of medicines is neither a simple nor a Cartesian task[4]. Gauging the exact extent to which a given benefit may have objectively driven a change in a particular physician’s prescribing activity requires analytical examination supported by an extensive data repository. And even that may not be enough. The exercise of translating the psyche into numbers may carry a high degree of subjectivity if consistent methodologies are not used.

Precisely because of these idiosyncrasies, an assessment of this nature requires the use of sophisticated statistical parameters and robust data analytics[5] procedures. This scenario brought to the fore mechanisms designed to bring greater transparency to the financial link between the health industry and physicians. In other words: with systematized data, there is a greater chance of reaching a well-founded conclusion on whether or not prescribing practice has been influenced, even if this assessment is not entirely immune to possible distortions.

 

3. Regulation of the physician/pharmaceutical industry relationship

The correlation between transfers of value from the health industry to physicians and their possible impact on product prescribing activity drove the emergence of laws and regulations to govern this practice.

Several countries have specific legislation on the disclosure of transfers of value under the premises discussed here. The Physician Payments Sunshine Act (Section 6002 of Public Law 111-148, of March 23, 2010), the U.S. law on the subject, has become a global benchmark for regulation in this area — to the point of inspiring and being emulated in legislative initiatives in several other countries.

It is a law with a twofold objective: on the one hand, to bring greater transparency to the expenses incurred by the industry and the payments received by physicians; on the other, to restrict the receipt of these benefits by health professionals in order to promote greater economic rationality in the health system. The ratio essendi is that there would be a cause-and-effect relationship between the benefits granted to physicians and the increase in the number of prescriptions of certain medicines to the detriment of others. This would lead to higher prices for the prescribed products, as a result of the demand induced by the financial relationship between the industry and the physician.

To control this scenario, the Physician Payments Sunshine Act (“PPSA”) established, in general terms, an annual obligation for manufacturers to submit information on payments and transfers of value to physicians and to teaching hospitals (the equivalent of Brazilian university hospitals). This information includes, in summary, (i) the name of the recipient; (ii) the recipient’s business address and the physician’s identification number; (iii) the amount of the payment or value transferred; (iv) the dates of the payment or transfer of value; (v) a description of the form of payment or transfer of value (cash, in-kind items or services, stock, stock options, other types of return on investment, etc.); (vi) a description of the nature of the payment or transfer of value (consulting fees, compensation for services other than consulting, gifts, meals, education, travel, etc.); and (vii) specific information on payments and transfers of value related to drugs, medical devices and medical treatments covered by the government.

The PPSA’s intention is to provide greater transparency in the financial interaction between the industry and physicians, so as to allow patients to verify the professional’s actual independence when prescribing[6].

As Alex Pereira Leutério explains in a monograph addressing this subject, the PPSA does not intend to interfere directly with physicians’ autonomy in prescribing medicines:

“In this regard, we point out that international regulation on conflicts of interest, especially the Sunshine Act, significantly requires and guides the raising of integrity levels in the operational routine of pharmaceutical companies, through compliance program parameters and codes of good medical practice, by means of mandatory and maximum transparency in the financial aspects of the physician–pharmaceutical industry relationship, without, however, interfering with the autonomy of health professionals when prescribing medicines”.[7]

Some authors argue that disclosing information on payments and transfers of value could eventually change physicians’ behavior. The aim would be to avoid financial relationships with the industry and thus guard against possible distrust from patients, as well as disapproval from their peers, or even becoming the target of media exposure or government investigation[8].

Following the publication of the PPSA, the effects of the new regulation became the subject of extensive studies devoted to this issue[9]. Some of these studies point to effects of the new law in relation to the regulations previously in place in U.S. states. The first is the shift of payments and transfers of value to other professionals authorized to prescribe but not covered by the PPSA (namely, physician assistants and nursing professionals). The second is the possibility that greater disclosure of payments and transfers of value could harm legitimate financial relationships that are indispensable for innovation research and the development of new technologies. The third is a novelty of the PPSA compared to U.S. state rules: the need to disclose payments relating to studies, including clinical research. Until then, disclosure of payments of this nature was not mandatory in most U.S. states[10]. The PPSA, in turn, established a system of delayed disclosure of these payments, to take place four years after the completion of the clinical study.

Be that as it may, perhaps the most visible effect of the PPSA is the proliferation of laws inspired by it in other countries. The new legislation echoed in countries with diverse profiles, such as (i) France (2011); (ii) Portugal (2013), Denmark (2014), Greece (2014), Belgium (2016), Canada (2017), Colombia (2018) and Italy (2022), among others.

Despite the profusion of countries with specific national legislation on this matter, in a significant share of the countries of the European Union the self-regulation system, based on the European Disclosure Code, still prevails. This is a set of rules drawn up by the companies associated with the European Federation of Pharmaceutical Industries and Associations (EFPIA)[11].

 

4. The State of Minas Gerais Sunshine Act (State Law No. 22,440/2016)

In Brazil, the influence of the PPSA was expressed through the enactment of State Law No. 22,440/2016 by the State of Minas Gerais, which came to be known as the “Minas Gerais Sunshine Act”. It is the first law in the country to regulate this matter.

This law was admittedly structured on the basis of the U.S. legislation and is regulated by State Decree No. 47,334/2017. In general terms, its aim was:

“(…) to make relationships in the pharmaceutical industry more transparent, in the sense that companies involved in the production, manufacturing, processing, distribution and even sale of medicines, orthoses, prostheses, equipment and implants must report to the Minas Gerais State Department of Health (SES) any type of benefit or donation, such as gifts, tickets, event registrations, accommodation, funding of research stages, consulting and lectures, offered to health professionals registered with a professional council, as well as to their family members, companions and guests, including through a publicly accessible system allowing individual searches by physician, enabling society to verify the benefits received by each health professional and thereby minimizing possible conflict of interest situations in the health sector”[12].

This pioneering state law introduced provisions aimed at ensuring even greater transparency than the PPSA. Indeed, the Minas Gerais Sunshine Act establishes the duty to disclose information without restricting its scope to companies providing services or supplying products to the Unified Health System (SUS). On this point, it differs from the PPSA, since the U.S. legislation assigns this duty only to companies supplying products and services to the U.S. public system. It also differs from the PPSA by covering broader categories of health professionals, such as nurses, pharmacists, nutritionists, etc., and not only physicians.

The State of Minas Gerais went even further. It enacted State Law No. 22,921/2018, setting rules on the obligation of companies producing health products and products of interest to health to inform the competent state body of sponsorship for scientific events.

However, despite their pioneering nature, the Minas Gerais state laws did not lead to a movement to spread these regulatory principles to other states of the federation. Nor has a federal law on this matter been enacted, although bills are under discussion in Congress.

 

5. Pending legislative proposals

Although a regulatory framework on the subject is still awaited, several federal legislative proposals emerged after the enactment of the Minas Gerais Sunshine Act.

Four main bills are currently pending in the Chamber of Deputies. The first, Bill No. 7,990/2017, provides for transparency and disclosure of financial relationships between the health industry and physicians. This bill imposes an obligation on suppliers of health products to disclose, on their websites and other social media, all benefits granted to health professionals[13]. It also requires the federal entities responsible for health protection and health surveillance to publish this information on their websites. Finally, it provides for the possibility of investigating potential conflicts of interest in relationships between physicians and suppliers of health products[14].

The second bill (PL 11,050/2018)[15] contains provisions practically identical to PL 7,990/2017, to which it is attached. Bill No. 11,177/2018, in turn, broadens the scope of regulation on the matter by also establishing guidelines for disclosing the costs incurred in sponsoring scientific events (possibly inspired by Minas Gerais State Law No. 22,921/2018). It also provides further details on the information system[16] and the sanctions that may be imposed. Finally, Bill No. 204/2019, also attached to PL 7,990/2017, does not introduce significant changes compared to the other legislative proposals, essentially replicating the provisions of the other bills.

Rumors about the issuance of a Provisional Measure to address this matter circulated in mid-2022[17]. However, to date, no legal text has been formally presented.

 

6. Subjects of the conduct

Having established the contours of the practice of granting benefits to health professionals, it is necessary to examine the specific case of these benefits being granted to a professional performing a public function, as well as the consequences of such conduct.

This exercise first involves assessing whether the professional qualifies as a public official, an essential premise for the subsequent steps. Although this characterization may seem simple, it involves conditions that may add complexity.

First, it is necessary to determine whether the state agent has a private law or public law relationship with the entity to which they are affiliated. If the relationship is governed by private law, it must then be determined whether or not there is an employment relationship.

At the same time, a state agent with a non-political, civil (and therefore non-military) public law relationship may work as a civil servant or non-civil servant. If they are not a civil servant, their work may fall under various legal regimes, reflected in Laws 8,666/1993, 8,987/1995, 9,637/1998, 9,790/1999 and 11,079/2004. If they are a civil servant, the public official will be either statutory or temporary[18].

From a private law perspective, there are also the legal entities of the pharmaceutical industry and, possibly, their legal representatives, who must also observe the legal rules and premises in their relationship with the public official or the public medical/pharmaceutical establishment, specifically regarding the promise or granting of benefits and advantages.

 

7. Classification of the conduct under the legal types

Once it has been established that the physician effectively performs public duties, and that the legal entities of the pharmaceutical industry maintain a relationship with the Government, it is necessary to assess the consequences of that professional receiving any benefits.

As an initial matter, it is worth determining the scope of Law 12,813/2013 and its implementing decree. Although both statutes contain rules on the receipt of gifts and hospitality by holders of positions and jobs in the federal Executive Branch, art. 2 of Law 12,813/2013[19] excludes these rules from the case analyzed here (physicians performing public activities).

With these rules ruled out as regards the subject of this essay, it is necessary to examine which regulatory treatment would actually be appropriate for this conduct where the person concerned is a physician performing a public function, given the absence of a specific law on the subject (Sunshine Act). More specifically, to determine whether the laws making up the microsystem for combating administrative corruption[20] would provide the most appropriate regulatory framework for this situation.

It is well known that Law 8,429/1992 (the “Administrative Improbity Law”) provides for the sanctions applicable for acts of administrative improbity. However, the classification under Law 8,429/1992 of the conduct of a public-sector physician who receives benefits from a private party, as well as the conduct of private legal entities (pharmaceutical companies) that maintain professional relationships with them, is not automatic.

First, it is important to analyze the persons listed by the law for the purpose of classifying acts of administrative improbity. According to art. 2 of the Administrative Improbity Law, “a public official is considered to be a political agent, a civil servant and anyone who holds, even temporarily or without remuneration, by election, appointment, designation, hiring or any other form of investiture or relationship, a mandate, position, job or function in the entities referred to in art. 1 of this Law”. Next, the sole paragraph of art. 2 provides that the sanctions set forth in the law apply to “the private party, individual or legal entity, that enters into an agreement, transfer contract, management contract, partnership agreement, cooperation agreement or equivalent administrative arrangement with the public administration”, as well as to anyone “who, even if not a public official, intentionally induces or contributes to the commission of the act of improbity”,

Based on the wording of these provisions, it is possible to consider that a physician who receives advantages and benefits from a private party may commit an act of administrative improbity, with the private party contributing to the allegedly unlawful conduct and therefore being subject to the same penalties. However, for this practice to actually be classified as such, it is essential to examine the subjective element underlying it, which requires an analytical examination of the factors surrounding this conduct.

Indeed, § 3 of art. 1 of the Administrative Improbity Law provides that “the mere exercise of a function or performance of public duties, without proof of an intentional act with an unlawful purpose, rules out liability for an act of administrative improbity”. This is an innovation introduced by Law 14,230/2021, which made explicit the combination of two factors for liability for an act of improbity: (i) proof of an intentional act; and (ii) the unlawful purpose of the conduct.

In addition to the inherent difficulty of proving a physician’s intent when prescribing a given product, linking it to any benefit or advantage received, the very open-ended nature of the acts that may be classified makes this analysis even more difficult.

Indeed, the classification of a given act as administrative improbity takes multiple forms, precisely because it involves indeterminate legal concepts, according to the teaching of Emerson Garcia[21]:

“Acts of administrative improbity are described in the three sections that make up Chapter II of Law 8,429/1992, grouped into three distinct categories, depending on whether the act results in unlawful enrichment (art. 9), causes damage to the public treasury (art. 10) or merely violates the principles of public administration (art. 11).

(…) From reading these legal provisions, the coexistence of two legislative techniques can be inferred: according to the first, seen in the caput of the provisions defining improbity, indeterminate legal concepts are used, serving as an appropriate instrument for classifying the endless number of unlawful acts that may be committed, which are the inevitable fruit of human creativity and improvisation; the second, in turn, was used in drafting the various items of arts. 9, 10 and 11, consisting of specific provisions, or provisions capable of integration, describing the situations that commonly constitute improbity, which, in addition to facilitating the understanding of the indeterminate concepts in the caput, are merely illustrative in nature, as follows from the very use of the adverb ‘notably’”.

It would seem that assessing these elements in the situation addressed in this essay presents even greater obstacles. This is due to the asymmetry of the information needed to link the granting of a given benefit to an actual increase in the number of prescriptions of a health product[22]. In this regard, note Emerson Garcia’s remarks on the efforts involved in this assessment exercise:[23]

“The use of indeterminate legal concepts will require the interpreter to assess the circumstances surrounding the case, which will allow their content to be given substance and the rule to be applied accordingly. Unlike a mere subsumption operation, in which the rule contains all the characteristics essential to its application, here an evaluative operation mediating between the legal provision and the fact will be essential.

This operation, by its very nature, will require a responsible attitude on the part of the interpreter, which will make it possible to achieve fully acceptable results. This will be possible by identifying the characteristic elements of the typical figures, those that are essential for the legal classification to apply, and whether the degree and intensity with which they appear in the specific case correspond to the pattern of conduct sought to be repelled by the prohibitive rules implicit in arts. 9, 10 and 11 of the Improbity Law. Fitting the conduct into the legal type presupposes not only the presence of the characteristic elements, but also that any distinguishing features are unable to override them, requiring a broad identification of the values accepted in the legal and social spheres”.

In addition, three groups of conduct punished by the Administrative Improbity Law can be highlighted: (i) those resulting in unlawful enrichment (art. 9); (ii) those causing damage to the public treasury; and (iii) those that violate the principles of Public Administration.

Starting from a hypothetical scenario in which a physician is granted or promised a benefit by a health company, this benefit could, in theory, constitute any of the three types of conduct prohibited by the Administrative Improbity Law, provided, of course, that the other requirements imposed by the law are met (proof of an intentional act and the unlawful purpose of the conduct).

Regarding the first group of conduct, the act could fall under art. 9, item I, of the Administrative Improbity Law[24]. The same act could potentially fall under art. 10, item II[25], if it were to guide, for example, the drafting of the Clinical Protocol and Therapeutic Guidelines (PCDT) of a given public hospital, favoring the purchase of a specific medicine over others. The conduct could also fall under art. 11, item V, if it were to give rise to a waiver of tender for the purchase of a specific medicine produced by the company that benefited the health professional or their institution.

From this perspective, a concerted standardization by the management of a given public hospital, in exchange for benefits granted by a specific company, could even trigger the application of Law 12,846/2013 (the “Anti-Corruption Law”). In this case, the application of art. 5, item I of the Anti-Corruption Law[26], for example, could be understandable.

In any event, access to a systematized information repository, made possible, for example, by legislation similar to the PPSA, is part of the essential core for this assessment to be carried out accurately and with a minimum of reliability. It is an indispensable tool for this task, especially in a context in which this assessment is inherently subjective.

 

8. Conclusion

It has therefore been seen that the interaction between physicians and the pharmaceutical and health products industry, far from being a situation that raises doubts about the integrity of medical practice and potential conflicts of interest, represents an important stage in the development of new technologies, insofar as it supports research into experimental solutions and their viability for future commercialization.

However, such interaction requires the observance of certain premises, so as to prevent the practice from becoming commonplace, as well as to avoid discrediting physicians when they prescribe medicines.

Thus, specific measures and legislation are considered salutary, such as the Physician Payments Sunshine Act (Section 6002 of Public Law 111-148, of March 23, 2010), created in the United States and, more specifically in Brazil, State Law No. 22,440/2016, enacted by the State of Minas Gerais, which came to be known as the “Minas Gerais Sunshine Act”, and which inspired bills pending in the Chamber of Deputies[27].

They are salutary because regulation and the definition of premises are important not only to make the physician-patient relationship transparent and to favor ethics within it, but also in professionals’ work in the management, administration and running of hospitals, especially public ones, whose function is subject to the rules inherent to public management, in particular the Administrative Improbity Law and the Anti-Corruption Law.

It is therefore hoped that there will be a movement to spread these regulatory principles to other states of the federation besides Minas Gerais, or even the enactment of a federal law on the matter, recognizing that this is an important subject of high relevance to the public interest.

 

9. References

GARCIA, Emerson. Improbidade administrativa. 8th ed. São Paulo: Saraiva, 2014.

GORLACH, I., and PHAM-KANTER, G. Brightening Up: The Effect of the Physician Payment Sunshine Act on Existing Regulation of Pharmaceutical Marketing in Journal of Law, Medicine & Ethics, (2013). Available at https://www.med.upenn.edu/kanterresearch/assets/user-content/documents/gorlach%20phamkanter%20brightening%20JLME%202013.pdf. Accessed on 10.15.2022

JUSTEN FILHO, Marçal. Curso de direito administrativo. 9th ed. São Paulo: Editora Revista dos Tribunais

LEUTÉRIO, Alex Pereira. Criminal compliance em indústrias farmacêuticas: mecanismos de prevenção à criminalidade corporativa e à violação de princípios bioéticos, São Paulo: 2019

MASSUD FILHO, João. Medicina farmacêutica: conceitos e aplicações. Porto Alegre: Artmed, 2016.

ROSENTHAL, Meredith B., and MELLO, Michelle M. Sunlight as Disinfectant — New Rules on Disclosure of Industry Payments to Physicians. In New England Journal of Medicine 368 (2013). Available at: doi:10.1056/nejmp1305090. Accessed on October 31, 2022.

[1] “The physician’s main objective is to promote health and treat disease. Since ancient times, there has been a search for substances that could positively affect a patient’s illness. On the other hand, until then there were no known technological resources or therapeutic arsenal capable of addressing all pathologies. (…) With the evolution of knowledge, physicians gained access to many technological resources and a highly effective therapeutic arsenal. While on the one hand there were few resources, on the other there was strong interaction between the powerful figure of the physician and their patients. Thus, a physician-patient relationship was established that was very important for the treatment and eventual cure of certain diseases. Today, there is an abundance of technology and therapeutics, and a lack of a physician-patient relationship more focused on the human being and their anxieties. (…) Almost all physicians use medicines in their daily practice, which they routinely learn about through pharmaceutical industry representatives”. MASSUD FILHO, João. Medicina farmacêutica: conceitos e aplicações. Porto Alegre: Artmed, 2016, p. 323.

[2] The Justification of Bill No. 7,990/2017 highlights the dual nature of the benefits that may be obtained: “Various types of interactions involving financial benefits, or benefits that can be measured monetarily by analyzing the costs involved, may be established between the health industry and the professionals who recommend its products. Obviously, some of these interactions may be linked to the development of innovations, product improvement and scientific innovation. But there are other interactions that may be covertly aimed at influencing preferences and thus generating conflicting interests between those who prescribe and supply the recommended material and the patient”.

https://www.camara.leg.br/proposicoesWeb/prop_mostrarintegra?codteor=1574876&filename=PL+7990/2017, Accessed on October 31, 2022.

[3] LEUTÉRIO, Alex Pereira. Criminal compliance em indústrias farmacêuticas: mecanismos de prevenção à criminalidade corporativa e à violação de princípios bioéticos, São Paulo: 2019, p. 204.

[4] “Thus, it can be said that the concept of conflict of interest is not synonymous with a judgment about a person’s honesty, but expresses a latent interference that is often difficult or impossible to detect as a harmful influence”, LEUTÉRIO, Alex Pereira. Criminal compliance em indústrias farmacêuticas: mecanismos de prevenção à criminalidade corporativa e à violação de princípios bioéticos, São Paulo: 2019, p. 206.

[5] In this regard, see the study prepared on this subject (GRENNAN et al, 2018). https://faculty.wharton.upenn.edu/wp-content/uploads/2018.

[6] “Under the Sunshine Act, manufacturers of drugs, medical devices, biologics and medical supplies covered by three federal health programs (Medicare, Medicaid and the State Children’s Health Insurance Program (SCHIP)) must collect, publish and maintain traceability of their financial relationships with physicians and teaching hospitals, reporting them to the Centers for Medicare and Medicaid Services (CMS). It should be noted that the purpose of the law is to increase the transparency of financial relationships between health care providers and manufacturers of pharmaceutical products, in order to curb possible conflicts of interest. Therefore, the pursuit of greater transparency is justified because, in addition to mitigating possible misconduct, it will help improve the financial sustainability of the health system by promoting better use of resources and conveying confidence and security to patients, insofar as it helps avoid treatments based on unnecessary and excessive indications”. LEUTÉRIO, Alex Pereira. Criminal compliance em indústrias farmacêuticas: mecanismos de prevenção à criminalidade corporativa e à violação de princípios bioéticos, São Paulo: 2019, p. 133.

[7] LEUTÉRIO, Alex Pereira. Criminal compliance em indústrias farmacêuticas: mecanismos de prevenção à criminalidade corporativa e à violação de princípios bioéticos, São Paulo: 2019, p. 226.

[8] ROSENTHAL, Meredith B., and MELLO, Michelle M. Sunlight as Disinfectant — New Rules on Disclosure of Industry Payments to Physicians. In New England Journal of Medicine 368 (2013). Available at: doi:10.1056/nejmp1305090. Accessed on October 31, 2022.

[9] GORLACH, I., and PHAM-KANTER, G. Brightening Up: The Effect of the Physician Payment Sunshine Act on Existing Regulation of Pharmaceutical Marketing in Journal of Law, Medicine & Ethics, (2013). Available at https://www.med.upenn.edu/kanterresearch/assets/user-content/documents/gorlach%20phamkanter%20brightening%20JLME%202013.pdf. Accessed on 10.15.2022.

[10] The legislation of the State of Vermont contained a similar provision: “Payments for clinical trials have traditionally been exempt from state disclosure laws, and Vermont only recently required reporting for clinical trials, where payments for these trials must be reported four years after the trial has completed or at the time of product approval, whichever comes first. PPSA follows a similar model of allowing for delayed reporting of payments for research”.

[11] Mental Health Europe, Sunshine & Transparency Laws, Regulations and Codes Across Europe. Available at https://mhe-sme.org/wp-content/uploads/2017/09/Mapping-of-Sunshine-Laws-in-Europe.pdf. Accessed on October 31, 2022.

[12] LEUTÉRIO, Alex Pereira. Criminal compliance em indústrias farmacêuticas: mecanismos de prevenção à criminalidade corporativa e à violação de princípios bioéticos, São Paulo: 2019, p. 113.

[13] “Art. 4 Suppliers of health products, such as pharmaceutical and pharmochemical laboratories, suppliers and producers of orthoses, prostheses and medical equipment, and complementary testing laboratories, including importers of these products, are required to provide full transparency, by publishing on their websites and other social media, all benefits, direct or indirect, monetary or in the form of goods, utilities and facilities, distributed to health professionals, whether individuals or legal entities, and to health institutions and teaching hospitals.

Sole paragraph. The data disclosed as required by this article must be sent to the Ministry of Health and the National Health Surveillance Agency annually, within ninety days after the end of the fiscal year in which the benefit was granted.

[14] “Art. 6 The possible existence of conflicts of interest in the financial relationships covered by this law shall be investigated by the Government, in accordance with the powers of each entity established in current legislation.

Sole paragraph. Any public authority that becomes aware of a conflict of interest in relationships between physicians, suppliers of health products and patients shall notify the health authorities, health surveillance authorities and other entities competent to investigate and hold accountable unlawful acts harmful to individuals arising from medical practice influenced by the receipt of the benefits covered by this law”.

[15] Available at https://www.camara.leg.br/proposicoesWeb/fichadetramitacao?idProposicao=2187330. Accessed on October 31, 2022.

[16] “Art. 10 – The Federal Government shall, regardless of any request, disclose the information referred to, within the scope of its competence. § 1 – To comply with the caput, the Federal Government shall use official websites, in addition to other means and instruments available to it. § 2 – The websites referred to in § 1 shall, as set forth in regulations, meet, among others, the following requirements: I – contain a content search tool allowing access to information objectively, transparently and in easy-to-understand language; II – allow reports to be saved in various electronic formats, including open and non-proprietary formats, such as spreadsheets and text, so as to facilitate analysis of the information; III – allow automated access by external systems in open, structured and machine-readable formats; IV – disclose in detail the formats used to structure the information; V – guarantee the authenticity and integrity of the information available for access; VI – keep the information available for access up to date; VII – indicate a location and instructions enabling interested parties to communicate, electronically or by telephone, with the body or entity that owns the website; VIII – allow the submission of complaints of non-compliance or attempted concealment of a fact giving rise to the duty to report provided for in this law; IX – adopt the measures necessary to ensure content accessibility for persons with disabilities, under art. 17 of Federal Law No. 10,098, of December 19, 2000, and art. 9 of the Convention on the Rights of Persons with Disabilities, approved by Legislative Decree No. 186, of July 9, 2008”.

[17] Available at https://oglobo.globo.com/saude/medicina/noticia/2022/06/medicos-e-laboratorios-farmaceuticos-entenda-o-que-devera-mudar-em-breve-nessa-relacao-conflituosa.ghtml. Accessed on October 31, 2022.

[18] JUSTEN FILHO, Marçal. Curso de direito administrativo. 9th ed. São Paulo: Editora Revista dos Tribunais, p. 871.

[19] Art. 2 The holders of the following positions and jobs are subject to the regime of this Law:

I – Minister of State;

II – special-nature positions or equivalent;

III – president, vice president and director, or equivalent, of autonomous agencies, public foundations, public companies or mixed-capital companies; and

IV – Senior Management and Advisory Group (DAS), levels 6 and 5 or equivalent.

Sole paragraph. In addition to the public officials mentioned in items I to IV, holders of positions or jobs whose exercise provides access to privileged information capable of bringing economic or financial advantage to the public official or to a third party, as defined in regulations, are subject to the provisions of this Law.

[20] Law 8,429/1992 and Law 12,846/2013.

[21] GARCIA, Emerson. Improbidade administrativa. 8th ed. São Paulo: Saraiva, 2014, p. 379.

[22] A presumption based on the absence of a nationwide data repository on the benefits and advantages obtained by health professionals.

[23] GARCIA, Emerson. Improbidade administrativa. 8th ed. São Paulo: Saraiva, 2014, p. 380.

[24] “Art. 9 An act of administrative improbity resulting in unlawful enrichment consists of obtaining, through an intentional act, any type of undue financial advantage by virtue of the exercise of a position, mandate, function, job or activity in the entities referred to in art. 1 of this Law, and notably:

I – receiving, for oneself or for another, money, movable or immovable property, or any other economic advantage, direct or indirect, as a commission, percentage, bonus or gift from anyone with a direct or indirect interest that may be affected or protected by an action or omission arising from the public official’s duties”.

[25] Art. 10. An act of administrative improbity causing damage to the public treasury consists of any intentional action or omission that effectively and demonstrably results in the loss, diversion, misappropriation, squandering or dissipation of the assets or funds of the entities referred to in art. 1 of this Law, and notably:

(…) II – allowing or contributing to a private individual or legal entity using assets, revenues, funds or amounts forming part of the assets of the entities mentioned in art. 1 of this law, without observing the legal or regulatory formalities applicable to the case;

^[26] Art. 5 For the purposes of this Law, acts harmful to the national or foreign public administration are all those committed by the legal entities mentioned in the sole paragraph of art. 1 that are against national or foreign public assets, the principles of public administration or the international commitments undertaken by Brazil, defined as follows:

I – promising, offering or giving, directly or indirectly, an undue advantage to a public official, or to a third party related to them;

^[27] Bill No. 7,990/2017, Bill No. 11,050/2018, Bill No. 11,177/2018 and Bill No. 204/2019.

 

 

Article originally published by the Brazilian Journal of Development (BJD) (in Portuguese), Vol. 9, n.1., on 01.02.2023.