Kostrzewakate.pdf
MEDICAL ETHICS AND THE
CONTRACEPTIVE USE REGIME IN BRAZIL
Kate Kostrzewa
Population Research Center
The University of Texas at Austin
Prepared for delivery at the 2001 meeting of the Latin American
Studies Association
Washington D.C., September 6-8, 2001
Do not cite without author's permission.
This paper examines the ethical obligations that arise in the doctor-patient
relationship. It focuses on doctors as providers of, and women as consumers of, contraceptive medical services. It is an effort to understand whether ethical processes work to limit and distort women's contraceptive options. This paper examines an area of law that imposes liability on doctors for their acts and omissions: professional liability for violations of law or of ethical rules of conduct.
If we examine contraceptive use regimes, using countries as the unit of
analysis, we find that in many countries there is a limited method mix with concentration of use on one or two methods, there is little or no use of other methods, and there is variation across countries in which methods are used (Potter 1999). There are also country-specific distortions in the way certain methods are distributed and employed meaning that methods are not always used in conformance with proper medical standards (id). The narrow method mix and non-optimal use of modern methods suggests that the reality of worldwide contraceptive use is problematic. It is problematic because there are limitations and distortions in the provision and use of contraceptive technologies and, it is problematic because these limitations and distortions compromise the health of individual contraceptive users.
Potter notes the surprising "persistence of a particular mix and the
tendency for the distribution of use to become more concentrated through time" (id at 707). Noting the sharp decline in the use of the intrauterine device ("IUD") in the United States and the increasing reliance in Brazil on just two methods1, Potter points out that there is no widely accepted explanation as to why the method mix does not become more diverse as more methods become available. He suggests that explanations for individual country patterns can be sought in country-specific peculiarities (id). This paper examines medical ethical rules as one of those country-specific peculiarities.
What, if any, impact does the imposition of professional liability for
violations of ethical rules of conduct have on contraceptive use by women in Brazil? What, if any, impact do opinion letters interpreting and applying the ethical rules have on contraceptive use by women in Brazil? Do these processes work to limit and distort women's contraceptive options? A limitation in women's contraceptive choice occurs when women are denied access to particular contraceptive methods. A distortion in women's contraceptive choice occurs
1 Contraceptive use in Brazil is dominated by the use of just two methods: the pill and female surgical sterilization.
when women use particular methods under non-optimal circumstances. I argue that the law, broadly defined, is an important country-specific macro structural factor that contributes to the limitations and distortions found in a country's contraceptive use regime. The law can work to broaden women's access to methods or to restrict it. The law also broadens or restricts access to information about methods. The law can help to assure that methods are used properly or it can promote non-optimal use of methods, sometimes under clandestine circumstances. In this paper, I examine just one area of law: medical ethics.
OVERVIEW
A doctor may be subject to professional, civil and/or criminal liability for
acts or omissions that occur while rendering medical services. This paper addresses only professional liability. In Brazil, women, as consumers of contraceptive medical services, are protected from the unethical practice of medicine by laws imposing disciplinary sanctions against doctors for violation of ethical rules of conduct. Doctors have a legal obligation to provide women with contraceptive technologies in conformance with the ethical rules. The failure to abide by the ethical rules can result in the initiation of a professional disciplinary proceeding against the doctor. These proceedings are brought before a Conselho Regional de Medicina2 ("CRM"). When a doctor is found liable, the CRM takes disciplinary action against the doctor that is, in theory, commensurate with the gravity of the offense. The available punishments range from a private verbal warning to revocation of the doctor's license to practice medicine.
Doctors provide contraceptives and advice about their use to their female
patients. Contraceptives that are safe and effective when used properly can cause harm when used under non-optimal conditions, i.e., when proper medical procedures and precautions are not followed. The ethical rules of conduct provide doctors with guidelines for the ethical practice of medicine. The risk of professional discipline is expected to serve as a deterrent to unethical conduct. In this paper, I argue that the above-described ethical processes, the manner in which they manifest in the Brazilian context and the extent to which they are successful in attaining their goals serve to limit and distort women's contraceptive options.
THE BRAZILIAN CONTRACEPTIVE USE REGIME
2 Regional Medical Council.
The Brazilian 1996 PNDS3 interviewed 12,612 women aged 15-49. Of
Brazilian women of reproductive age, sixty percent were women in union. Among women in union, 76.7% were current contraceptive users with 40.1% using female surgical sterilization and 20.7% using the pill. These two methods alone accounted for eighty percent of methods used by women in union and eighty-seven percent of modern method use; sterilization accounted for fifty-seven percent of modern method use. The data showed that the contraceptive use regime in Brazil is dominated by the use of just these two methods.
The 1996 data supports a finding of a causal relationship between the high
rates of female surgical sterilization and high rates of cesarean section births, but the direction of causality is unclear (Hopkins 1998; Potter 1999). Most sterilizations were performed at the time of birth (seventy-four percent of all sterilizations) and eighty percent of these were performed during a cesarean section birth. Statistics on the timing of sterilization reveal that between 1991 and 1996, for Brazil as a whole, 59.7% of sterilizations were performed during a cesarean section, 13.9% post-partum and 26.4% were interval operations (Potter 1999).
Brazilian demographer Elza Berquó has called attention to the existence of
a "culture" of cesarean section births and sterilization in Brazil (Berquó 1993). She cites data from São Paulo from 1992 showing that eighty percent of sterilizations are performed during a cesarean section birth, that fifty-two percent of sterilized women had mothers or sisters who were sterilized, that thirty-two percent of sterilized women stated that they had become pregnant in order to undergo a sterilization and that many sterilized women are satisfied with the procedure and would recommend it to other women (id). Berquó contends that the culture of sterilization in Brazil is perpetuated by complicity between women and health professionals (id). Women don't want more children and have problems taking the pill; their only other viable alternative is sterilization (id). Doctors perform the sterilization during cesarean section birth so that the public health care system covers part of the cost and the women make payment on the side (id).
PROFESSIONAL LIABILITY
This section examines laws and ethical rules of conduct that regulate the
practice of medicine in Brazil. The laws and ethical rules seek to ensure that
3 Pesquisa Nacional de Demografia e Saúde; National Demographic and Health Survey.
doctors practice medicine in conformance with ethical standards. In Brazil, the Conselho Federal de Medicina4 ("CFM") promulgates the Código de Ética Médica5 ("CEM"), the ethical rules that govern doctors' behavior. The CRMs enforce the ethical rules of conduct in Processos Éticos Profissionais6 ("PEP"). The CFM and the CRMs issue pareceres7 in response to inquiries from doctors, hospital administrators or anyone else needing an opinion as to the application of the ethical rules to a specific fact situation. In addition, the medical councils in Brazil engage in policy discussions of issues that affect the practice of medicine.
THE BRAZILIAN FEDERAL MEDICAL COUNCIL
In 1957, pursuant to Law 3.268/57, the Brazilian medical councils,
previously established by executive order, were transformed into "autarquias" (Law 3.268/57 Art. 1). Autarquias are:
Auxiliary autonomous entities, dissociated from public administration but subject to state oversight, with funding generated by their own resources and whose purpose is to carry out services of interest to the public (Novo Dicionário Aurélio da Língua Portuguesa 1986 (my translation)).
The CFM and the twenty-seven CRMs8 act as quasi-public entities supervising the ethics of the medical profession and judging and disciplining doctors for violation of the ethical rules of conduct (Law 3.268/57 Art. 2).
The CFM is headquartered in the nations capital9 (Law 3.268/57 Art. 3).
The CRMs have jurisdiction over doctors practicing medicine within their state; they are subordinate to the CFM (id). Delegates of the CRMs elect the twenty-member board that governs the CFM (Law 3.268/57 Art. 4). The CFM is charged with promulgating the CEM and hearing appeals of decisions by the CRMs in PEPs (Law 3.268/57 Art. 5). Primary funding for the operating budget of the CFM derives from the CRMs; the CRMs must pass one-third of the amount collected in annual dues to the CFM (Law 3.268/57 Art. 11).
4 Federal Medical Council. 5 Medical Ethics Code. 6 Professional Liability Proceeding. 7 Opinion letters. 8 There are twenty six state CRMs and one CRM that operates in the Distrito Federal (Brasília). 9 In 1957, the capital was Rio de Janeiro. The capital was moved to Brasília in the early 1960s.
The CFM establishes ethical norms for doctors' behavior by adopting and
enforcing the CEM and issuing opinion letters. The current version of the CEM, promulgated in 1988, significantly revised many of the articles found in the prior version of the CEM in an effort to coordinate the new code of ethics with the many changes in Brazilian law triggered by adoption of a new constitution in 1988. The CEM is a professional code of ethical conduct; doctors are mandated by law to abide by the CEM (Law 3.268/57). In response to inquiries, the CFM issues pareceres interpreting and applying the CEM to particular fact situations. Pareceres are the result of informal rule making by a quasi-public entity. The opinions are advisory only; they carry no official legal weight but they do set forth norms for ethical behavior in similar fact situations.
THE BRAZILIAN STATE MEDICAL COUNCILS
The CRMs are headquartered in the state capitals and in the Distrito
Federal (Brasília) (Law 3.268/57 Art. 12). Twenty-member boards elected by the doctors enrolled in the CRM govern the organizations (id). Once a person has completed their medical school education and passed qualifying exams, he or she is required to enroll with the CRM in the state in which that person intends to practice medicine (Law 3.268/57 Art. 17). Enrollment is required before a doctor can legally practice medicine in that state (id). Upon enrollment and payment of the annual dues, the doctor receives a professional license that entitles him or her to practice medicine anywhere in the country (Law 3.268/57 Art. 18). The CRMs are charged with enrolling doctors and providing them with their professional license, oversight of the practice of medicine within their jurisdiction, judging PEPs and imposing penalties on doctors found liable of ethical violations (Law 3.268/57 Art. 15).
The power to discipline and punish a doctor for ethical violations rests
exclusively with the CRM in which that doctor is enrolled at the time of the violation (Law 3.268/57 Art. 21). The punishments that the CRM can legally impose on doctors for ethical violations are set forth by law. There are five permissible punishments: a) a private warning issued in a meeting with the president of the CRM; b) a private condemnation issued in a meeting with the president of the CRM; c) a public condemnation published in the CRM journal; d) suspension of the doctor's license to practice medicine for a period of thirty days; and, e) revocation of the doctor's license to practice medicine (Law 3.268/57 Art. 22). Decisions by the CRM in PEPs can be appealed to the CFM within thirty days (Law 3.268/57 Art. 22, Sec. 4). Primary funding for the operating budget of state CRMs comes from the annual dues paid by doctors for the right to practice
medicine; the CRMs receive two-thirds of the annual dues and pass one-third on to the CFM (Law 3.268/57 Art. 16).
The jurisdiction of the CFM and CRMs is limited to ethical matters; they
have no criminal or civil enforcement capabilities (Conselho Regional de Medicina do Distrito Federal ("CRM-DF") 2000). The sanctions that are authorized by law and that can be imposed on doctors for violation of the ethical rules of conduct are intended as punishment
only for ethical violations (id). For example, punishment (d), suspension of license to practice is limited to a period of thirty days, a period equal to a doctor's annual vacation time, so that it does not constitute a financial penalty (CRM-DF 2000). Representatives of the CRMs with whom I spoke indicated that the enormous leap from a thirty-day suspension to a loss of one's license hampers the CRMs' ability to differentiate punishments based on more or less egregious conduct. CRM decisions revoking a doctor's license to practice are rare and are reserved for doctors who show themselves to be incompetent and not subject to rehabilitation, e.g., those who repeatedly commit serious ethical and/or legal violations, particularly where their conduct results in the death of a patient (Gomes & França 1999).
CONTRACEPTION AND THE CEM
Before the 1988 revision, the CEM explicitly condemned sterilization as
an unethical medical practice unless performed with medical indication acknowledged in writing by two doctors (former Art. 52). The 1988 revision of the CEM revoked Art. 5210 and enacted Arts. 43 and 67 governing sterilization and contraception. Art. 43 prohibits the doctor from failing to comply with specific legislation regarding sterilization. This article fails to take a position on sterilization, instead deferring to federal legislation. Until 1997, Brazil had no explicit federal legislation addressing sterilization. Between 1988 and 1997, the CFM and CRMs relied on Art. 43 (in conjunction with a finding that sterilization was a crime pursuant to Article 129 of the Penal Code) to condemn sterilization as an unethical medical practice except in cases of medical indication. This position was essentially the same as that taken explicitly by former Article 52. Art. 67 prohibits the doctor from disrespecting the right of the patient to decide freely about contraceptive methods and charges the doctor with a duty to make clear to the patient the use, efficiency, reversibility
and risks of each method. This article acknowledges the possibility of using either reversible methods or irreversible methods like sterilization.
10 Article 52 now addresses an unrelated matter.
A culture of cesarean section births and sterilization exists in Brazil
(Berquó 1993). A third cesarean section birth constitutes medical indication for a surgical sterilization. The three cesarean section birth exception to the ethical ban on contraceptive sterilizations served as a stimulus to the use of cesarean section births both as a way to "hide" sterilization procedures performed and as a way of providing the required "medical necessity" for a sterilization intervention (Hopkins 1998). Rather than dissuading doctors and women from employing sterilization for contraceptive purposes, the ethical rules may have contributed to the development of a perverse relationship between cesarean section births and sterilizations. Demand for female surgical sterilization is thought to be an important underlying cause of the extremely high rate of cesarean section births in Brazil (id).
PEP: PROCESSO ÉTICO PROFISSIONAL
An important function of the medical councils in Brazil is enforcement of
the CEM. The CRMs receive complaints about doctors charging them with violations of the ethical rules of conduct. Complaints are most often made by doctors or hospital administrators. The President of the CRM assigns each complaint to one of the twenty board members for review. The member investigates the facts and makes a recommendation.
A committee made up of five board members makes the final decision as
to whether a PEP is opened or the case is closed; the committee generally follows their colleague's recommendation. A PEP is a formal process in which both sides have an opportunity to be heard and the doctor has a right to present a defense. The President of the CRM assigns a board member (other than the one who was originally assigned to review the complaint) to draft a parecer containing a ruling and the reasoning supporting the ruling, including an explanation as to whether and why the doctor's behavior violated the ethical rules and a recommendation for punishment. The recommendation to absolve or punish the doctor is presented to the entire twenty-member board and a vote is taken to accept or reject the recommendation.
During fieldwork in Brazil, I visited three CRMS: CREMERJ11, CRM-
DF12 and CREMESP13. I also visited the headquarters of the CFM in Brasília.
11 Conselho Regional de Medicina do Estado de Rio de Janeiro; Regional Medical Council for the State of Rio de Janeiro.
There are approximately 226,000 doctors enrolled with the CRMs; of these about 190,000 are actively engaged in the practice of medicine (Gomes & França 1999). CREMESP operates in Brazil's most developed and populous state, São Paulo. I was told in interviews that approximately 80,000 doctors, thirty-five percent of all doctors enrolled in Brazil, are enrolled in CREMESP. The CRM-DF operates in the Distrito Federal (Brasília). I was told that approximately 5,000 doctors (or just over two percent) are enrolled in the CRM-DF.
Despite three formal written requests over a two-year period and help
from several contacts inside the organization, I was unable to obtain an interview with a member of CREMERJ's board or to obtain statistical data on disciplinary proceedings from CREMERJ14. For this reason, the only PEP in Rio de Janeiro involving contraceptive methods of which I have knowledge is the case of Sonia Beltrão from the mid-1980s (Congresso Federal 1993). Ms Beltrão, a middle-class architect, gave birth at the Praça Quinze Hospital, a public hospital in Rio de Janeiro. After the birth, she overheard a nurse commenting to another nurse that a tubal ligation had been performed at the time of the birth. Ms Beltrão had not authorized the tubal ligation procedure and did not want a sterilization15. She filed a complaint with CREMERJ against the doctors involved. According to her deposition testimony given during the federal CPMI16, the doctors engaged in collusion and lied at the CREMERJ proceedings stating that a medical emergency arose during the birth that called for an emergency tubal ligation. The case against the doctors was dismissed.
Ms Beltrão's case received media attention at the time of the event in the
mid-1980s and again in the early 1990s when she testified in front of the CPMI.
12 Conselho Regional de Medicina do Distrito Federal; Regional Medical Council for the Federal District. 13 Conselho Regional de Medicina do Estado de São Paulo; Regional Medical Council for the State of São Paulo. 14 It was suggested to me in private conversations that CREMERJ may have been hesitant to provide me with statistical data on PEPs because complaints rarely result in any action against doctors. Without data, I cannot confirm or deny this charge. 15 It was suggested to me in private conversations that what in fact happened was that the woman in the bed next to Ms Beltrão requested a sterilization and that the procedure was mistakenly performed on Ms Beltrão. This is not the only case in which it was suggested to me that women in the bed next to the woman requesting the sterilization were mistakenly operated on. 16 Commissão Parlamentar Mista de Inquérito; Mixed Parliamentary Commission of Inquiry. A congressional investigatory commission set up jointly by the Brazilian Senado and the Câmara dos Deputados. Ms Beltrão was deposed as part of the 1992 CPMI charged with investigating the "mass sterilization of Brazilian women".
Her charges that the doctors lied in order to protect each other are an example of a common perception that there is a high level of corporativismo17 within the medical profession and that this makes it difficult to prove wrongdoing or negligence. Charges of corporativismo surfaced repeatedly during my conversations with health care professionals, including doctors. I asked about this in interviews with representatives of the medical councils. The President of CRM-DF and a board member of CREMESP both dismissed the charges indicating that this was a problem in the past but that by the 1990s the situation had improved.
I interviewed the President of CRM-DF and he provided me with an
explanation of how the medical council handles PEPs. He also gave me a CRM-DF publication on PEPs. The CRM-DF statistics department performed a search and provided me with general information on PEPs. Their search did not turn up any PEPs involving contraceptive methods other than female surgical sterilization.
The general data on PEPs indicated that from 1988 to 1999, the CRM-DF
opened 262 disciplinary proceedings and issued decisions in 180 cases18. In those cases, charges were dismissed against 188 doctors while a total of 134 doctors were found to have violated the CEM19. Few doctors are brought before the CRM-DF on disciplinary charges and fewer still are punished for violating the ethical rules; during the twelve-year period for which I have data, just three percent of the total number of doctors enrolled with the CRM-DF were found liable in professional disciplinary proceedings and received punishment. The doctors found liable received the following punishments: thirty-two (24%) were given private warnings; thirty (23%) were given private condemnations; fifty (37%) were given public condemnations published in the CRM-DF journal; nineteen (14%) were suspended from practice for thirty days and three (2%) lost their license to practice medicine. The data on PEPs showed that from 1988 to 1999, the CRM-DF initiated fifteen PEPs (or about six percent of the total number of cases) related to the provision of female surgical sterilization procedures. I was able to obtain details for five of the fifteen cases. This information is presented in Table One.
17 Collusion. 18 The 180 cases do not necessarily correspond to the 262 PEPs as some of the 180 cases decided between 1988 and 1999 were initiated prior to 1988. 19 The total number of doctors either exonerated or found to have violated the CEM exceeds the total number of cases because most cases involve charges against more than one doctor.
The data in Table One reveals that the PEPs addressed alleged violations
of several different articles of the CEM including: Article 9 (trading medical services for side payment); Article 32 (denying he/she performed a procedure); Article 33 (falsely claiming he/she performed a procedure); Article 42 (doing something prohibited by law); and, Article 43 (not abiding by sterilization legislation). In the case involving ten cesarean section births and sterilizations performed at the time of birth and the case involving side payment for the sterilization procedure, the license of the doctor involved was suspended for thirty days. In another case where the doctors registered a procedure other than a sterilization on the prontuário, two of the doctors received a private condemnation from the President of the CRM-DF. In the other two cases, one alleging that the doctor registered a procedure other than a sterilization on the prontuário and another in which the sterilization was ineffective, the doctors were not punished.
The President of CREMESP was not available for an interview but
another board member agreed to meet with me. He, too, provided me with an explanation of how the medical council handles PEPs. He asked the research department to search for and copy all of the pareceres issued since the mid-1980s related to sterilization. In addition, the CREMESP statistics department provided me with general information on PEPs.
The general data on PEPs indicated that from 1990 to 1999, CREMESP
received a total of 14,745 complaints against doctors. For most years during this time period, the number of complaints received each year exceeded the number received in the prior year. The number of complaints received per year almost doubled during the decade, rising from 1044 in 1990 to 2005 in 1999. During the same time frame, C7REMESP initiated 1,776 PEPs and rendered decisions in 900 cases20. The 900 cases that were decided resulted in punishments administered to a total of 661 doctors. During the ten-year period, less than one percent of the doctors enrolled in CREMESP were found liable in professional disciplinary proceedings and received disciplinary action. Of the 661 doctors, 129 (20%) received a private warning; 181 (27%) received a private condemnation; 197 (30%) received a public condemnation; 119 (18%) received a thirty-day suspension; and, 35 (5%) had their license to practice revoked.
20 The 900 cases do not necessarily correspond to the 1,776 PEPs as some of the 900 cases decided between 1990 and 1999 were initiated prior to 1990 .
TABLE ONE
CRM-DF RULINGS IN PEPS INVOLVING
SURGICAL STERILIZATION
1988 - 1999
DATE CEM §§
VIOLATION
DECISION
32: Denying he/she
Sterilization performed in Doctor absolved of
performed a procedure;
public hospital; Doctor
professional liability.
42: Doing something
registered a different
Case closed.
prohibited by law;
medical procedure on the
43: Not abiding by
sterilization legislation.
9: Trading medical
Sterilization not effective.
Case closed as time for
services for side pymt;
Woman later became
filing complaint had
42: Doing something
pregnant.
prohibited by law.
9: Trading medical
Ten of eleven patients
Suspend License for 30
services for side pymt;
had cesarean section
42: Doing something
births; sterilizations
prohibited by law;
performed at the same
43: Not abiding by
sterilization legislation.
32: Denying he/she
Sterilization performed.
Doctors 1 & 2:
performed a procedure;
Doctor registered a
absolved.
33: Falsely claiming
different medical
Doctors 3 & 4: Private
he/she performed a
procedure on the
procedure.
9: Trading medical
Sterilization in exchange
Suspend License for 30
services for side pymt.
for money.
Sources: Dr. Eduardo Pinheiro Guerra, President CRM-DF; CRM-DF Statistics
Department; Conselho Regional de Medicina do Distrito Federal. (2000). Votos Selecionados:
Como os Conselheiros Julgam os Processos Éticos. Brasília-DF: Athalaia Gráfica.
21 Form attesting to medical procedures performed. 22 The result of the appeal of this case is found on line 5 of TABLE TWO: CRM RULINGS IN PEPS INVOLVING SURGICAL STERILIZATION APPEALED TO THE CFM/1990 – 1999.
The CREMESP statistics department was unable to determine with
accuracy which PEPs involved contraception, including surgical sterilization. Instead, they separated out the PEPs that involved violation of either Article 43 or Article 6723. From 1990 to 1999, CREMESP instituted twenty-five PEPs alleging violation of Article 43. Of these, eleven cases were decided, seven were closed and in seven no decision had been issued. In the eleven cases that were decided, fifteen doctors were disciplined: one (7%) received a private warning, three (20%) received private condemnations, 2 (13%) received public condemnations, five (33%) had their license to practice suspended for thirty days and four (27%) had their license to practice revoked. During the same time period, CREMESP initiated three PEPs alleging violation of Article 67. None of the three cases resulted in disciplinary action against any doctors.
CREMESP also provided me with data showing that obstetrics and
gynecology ("ObGyn") is the medical specialty that receives the highest number of complaints. Data for the ten most commonly complained about medical specialties showed that from January 1996 to April 2000, one in four complaints involved ObGyn24. Pediatrics, with the second highest number of complaints, received just over fourteen percent. A breakdown of ObGyn complaints by classification of procedure for the period from October 1993 to November 1999 found just under one-percent (0.90%), or only about eight, of the ObGyn complaints received involved surgical sterilization. It is impossible to know the exact number of doctors involved in these cases but assuming ten doctors per complaint25, just eighty out of 80,000 doctors or .1% of doctors enrolled in CREMESP had complaints involving sterilization filed against them during a four-year period26.
Although I was unable to schedule an interview with the President of the
CFM, I went to CFM headquarters in Brasília to obtain information. I was able to speak with a staff member in the statistics section who searched for CRM PEPs involving contraception (including surgical sterilization) that were appealed to that body. For the period 1990 to 1999, the search did not turn up any PEPs 23 It is impossible to tell if these proceedings actually involved either sterilization or contraception given that the language of these CEM articles is not limited to these matters. For example, Article 43 proscribes failure to abide by legislation governing organ or tissue transplants, assisted reproduction or abortion in addition to sterilization and Article 67 proscribes disrespect for the patient's free choice of both contraception and conception services. 24 ObGyn received 871 of a total of 3,465 complaints, or twenty-five percent. 25 Based on the data I obtained, this is a high estimate. 26 I assume none of the complaints were received after the August 1997 legalization of surgical sterilization.
involving contraceptive methods other than female surgical sterilization. The data showed that eight PEPs involving sterilization were appealed. These cases are outlined in Table Two.
The data in Table Two reveals that the PEPs addressed alleged violations
of several different articles of the CEM including: Article 9 (trading medical services for side payment); Article 29 (practicing unnecessary medical acts); Article 42 (doing something prohibited by law); Article 43 (not abiding by sterilization legislation), Article 65 (taking advantage of the doctor-patient relationship for political gain) and Article 67 (disrespecting the patient's right to make a free and informed choice of contraceptive method). The eight PEPs include an example of sterilization performed in exchange for vote, sterilizations performed in exchange for side payments, sterilizations performed at the time of cesarean section births and sterilization performed without consent.
Published data shows that from December 1989 to April 1996, of the
ninety-eight PEPs appealed to the CFM, the decision of the CRM was overruled and the punishment altered in forty-three percent (43%) of the cases while the decisions were upheld in fifty-seven percent (57%) of the cases (Gomes & França 1999). By comparison, in the eight PEPs involving sterilization detailed in Table Two, fourteen doctors were disciplined by the CRMs. On appeal, the CFM overruled the CRM and altered the punishment in seven (50%) of the cases and upheld the CRM decision in seven (50%) of the cases. In the seven instances in which the CFM overturned the CRM rulings, three resulted in thirty day suspensions rather than revocation of the doctor's license to practice medicine, in one case the charges were dismissed based on a lack of evidence and in three cases the decision to close the case was reversed and the case was reopened.
For many years, the main activity of the CRMs was the registration of
doctors practicing in that state. The CRMs appear to have been notoriously weak in their role as enforcers and arbiters of the ethical rules of conduct. Although the formal procedures for processing ethical violations were in place, there was little reporting of violations and, even where proceedings were instituted, few doctors received punishment. The councils were criticized in the press for failing to rigorously enforce the ethical rules and for handing down punishments that were disproportionate to the seriousness of the violation (Gomes & França 1999).
TABLE TWO
CRM RULINGS IN PEPS INVOLVING SURGICAL STERILIZATION
APPEALED TO THE CFM BETWEEN 1990 – 1999
DATE27 STATE
VIOLATION
CRM DECISION
1 01/03/94
Espírito Santo
42: Doing something
Sterilization in
prohibited by law;
exchange for
43: Not abiding by
in CRM Journal
sterilization legislation;
65: Taking advantage of
doctor-patient relation-
ship for political gain.
2 03/09/94
Pernambuco
42: Doing something
Sterilization w/o
Revoke License
prohibited by law.
medical need in
to Practice
exchange for
Medicine
ZMMS Revoke License
to Practice
Medicine
Suspend License
for 30 Days
3 09/29/94
42: Doing something
prohibited by law;
43: Not abiding by
sterilization legislation.
Private Warning
4 09/29/94
29: Practicing unnecessary Sterilization
medical acts.
Condemnation in
CRM Journal
27 Date of CFM decision.
Condemnation in
CRM Journal
Distrito
9: Trading medical
Ten of eleven
Suspend License
services for side pymt;
patients had
for 30 Days
42: Doing something
cesarean section
prohibited by law;
43: Not abiding by
sterilization legislation.
performed at the
time of birth
6 07/10/97
Minas Gérais
42: Doing something
Sterilization w/o
prohibited by law;
medical need for
Condemnation in
43: Not abiding by
personal gain
CRM Journal
sterilization legislation.
7 11/14/97
Rio de Janeiro 9: Trading medical
Revoke License
services for side pymt;
to Practice
43: Not abiding by
Medicine
sterilization legislation.
8 12/17/98
São Paulo
29: Practicing unnecessary Sterilization w/o
Complaint
medical acts;
Archived
42: Doing something
prohibited by law;
67: Disrespecting the
patient's right to make a
free and informed choice
of contraceptive method.
Complaint
Archived
Complaint
Archived
Source: CFM Statistics Department Computer Database.
According to information received in interviews, as the military period
came to a close, the CRMs in São Paulo and Brasília began to adopt a more organized approach to both their enforcement and rule making roles. Each year, about 300 million consultations with doctors take place in Brazil and about 20 million surgical procedures are performed (Gomes & França 1999). Although the council members interviewed suggested increased enforcement since the mid-1980s, the small number of cases involving female surgical sterilization compared to the huge number of procedures performed in Brazil during the same time frame tells us that only an unlucky few got caught. This suggests an atmosphere of permissibility for performing tubal ligations within the medical profession despite formal expressions condemning these procedures as illegal and unethical by the governing entities.
PARECERES
Another important function of the CFM and the state level CRMs is the
issuance of pareceres. Pareceres express the opinions of medical councils about ethical dilemmas posed in letters of inquiry. The inquiries come from doctors, hospital administrators, government employees in the public health sector and researchers (See Table Three and Table Four). They generally present a particular fact situation and ask the medical council to issue an opinion as to the application of the ethical rules of conduct to the facts presented. The pareceres provide guidance for those concerned about how to handle certain situations and serve to supplement and expand upon the CEM. The pareceres establish norms for ethical behavior in specific settings. The pareceres are advisory only but their issuance presumably has an effect on how, at least some, doctors behave. The research and writing process that produces pareceres is an informal rule making procedure by a quasi-public agency; the rule making process is exempt from public scrutiny.
My sources at CREMESP furnished me with a complete list of CREMESP
pareceres addressing surgical sterilization. There are seventeen pareceres listed in Table Three: five of the requests came from individual doctors, another seven from doctors working in the public health sector, three from medical school professors and one from a judge. The eight pareceres issued between 1985 and 1994 address, either directly or indirectly, the issue of the legality of sterilization or the propriety of performing sterilizations with or without medical need. Of these eight, seven support the contention that sterilization is illegal under Penal Code Art. 129 except in cases of medical indication. One of the pareceres, however, after a lengthy and detailed discussion of the legal arguments and debate
surrounding sterilization, takes the opposite approach. This parecer, issued in 1994, states that the procedure is neither illegal nor unethical. The approach of this particular parecer may reflect the fact that by 1994 sterilization was the topic of a national debate, a hot political topic and the subject of several legislative proposals.
Pareceres issued in 1995 and 1996, rather than stating definitively that
Penal Code Art. 129 applies, acknowledge a lacuna in the law and are couched in terms supporting federal government regulation of the procedure (Pareceres 10 and 12). Parecer 12 addresses a 1995 São Paulo municipal ordinance authorizing the provision of free sterilizations in that city's public hospitals. The parecer does not condemn the São Paulo law or suggest that federal law controls; the parecer simply states that CREMESP is awaiting federal legislation regulating family planning and sterilization procedures. At the time this opinion was issued, Law 9.263/96 except for Article 10 (legalizing and regulating surgical sterilization) had been enacted. Article 10 was adopted in 1997.
Pareceres 14, 15 and 17 address the most controversial language in Article
10 of Law 9.263/96, the restriction on time of birth sterilizations. Parecer 14 finds that women with serious medical conditions indicating a need for sterilization are exempt from the time of birth restriction. Pareceres 15 and 17 take opposing positions on the time of birth issue. Parecer 15 finds that so long as the requirements of Law 9.263/96, including the sixty-day waiting period, are observed sterilization can legally be performed immediately after the birth. However, Parecer 17, issued just a few months later, finds that the law is restrictive with regard to time of birth sterilizations and that absent medical need, sterilizations should take place at least forty-two days after birth. The conflict in the two opinions likely derives from the language of Portaria 48 containing regulations issued by the Ministério da Saúde on February 11, 1999. Art. 4, Sec. IV, parágrafo único of the Portaria clearly establishes the forty-two day rule.
I put together a list of twelve CFM pareceres (Table Four) relating to
sterilization and contraception obtained from CREMESP and from the CFM library in Brasília. Only one of the pareceres was requested by an individual doctor, three were requested by CRMs, five came from public agencies including the Ministério da Saúde and its subsidiary agency, DIMED28, two from private
28 Divisão Nacional de Medicamentos; National Medication Division. The division of the Ministério da Saúde responsible for registering drugs and medical devices.
TABLE FOUR
CFM PARECERES ADDRESSING
SURGICAL STERILIZATION
1985 TO 1999
REQUESTED BY
ISSUES RAISED
CFM OPINION
04/13/85
CRM/MG41
CEM Art. 12 (now 43):
Find sterilization is illegal under Penal Code
Not abiding by sterilization
Art. 129 even if performed with consent of
patient. Ethical only if based on medical
What legislation applies to
02/20/86
Request opinion regarding the
Condemn study: Find numerous
Norplant clinical trials.
irregularities including: study initiated
without authorization; failure to follow
procedures required by law; failure to use
proper consent forms; unauthorized
increases in number of clinics and women
involved.
07/12/86
SMS/Manaus
Request opinion regarding family
Condemn program. Conclude it is a
CRM/AM43
planning program in Manaus funded
population control program not a family
by Pathfinder.
planning, program.
11/08/86
BEMFAM44
BEMFAM report explaining how they Refuse to alter CFM position condemning
have revised their approach to the
BEMFAM activities. Find that BEMFAM
work they do. Request re-evaluation
continues to promote population control
of their activities.
including the use of sterilization.
10/10/87
Associação de
Seek authorization to perform tubal
Refuse to grant authorization. Sterilization is
41 Conselho Regional de Medicina/Minas Gerais; Regional Medical Council/Minas Gerais. 42 Divisão Nacional de Vigilância Sanitária de Medicamentos; National Division of Sanitary Oversight for Medications. 43 Secretaria Municipal de Saúde/Manaus; Municipal Secretary of Health/Manaus; Conselho Regional de Medicina/Amazonas; Regional Medical Council/Amazonas.
44 Sociedade de Bem-Estar Familiar; Society for Family Well-Being.
Orientação aos
ligations on illiterate women who
illegal under Penal Code Art. 129 even if
request the procedure based on their
performed with consent. Ethical only if
inability to use other methods.
based on medical need.
01/12/90
Request opinion regarding Projeto de
Oppose proposed law. Problems include:
Lei47 2.538/89 authorizing
denies adolescents access to family planning
contraceptive services.
information and methods; promotes the use
of voluntary sterilization which is illegal;
promotes self-medication
08/31/92
Clínica Ginecológia Request opinion regarding whether
Find ethical to prescribe hormonal methods
Infância e
ethical to prescribe hormonal
to adolescents. Doctor should first determine
contraceptives to minors.
the maturity level of the minor and provide
appropriate information about human
sexuality and contraceptive methods.
09/02/96
CEPARH49
Request opinion regarding whether
Find toll telephone service unethical;
ethical to operate toll telephone
violation of CEM §§ 62 and 134; Find pre-
service offering family planning
recorded answers to questions insufficient;
advice and information.
subject to errors in interpretation; personal
evaluation by, and advice from, doctor
required.
11/11/96
Ministério da
Request opinion regarding whether
Find no ethical violation. Also note that the
ethical to offer family planning, STD
Doctor is not permitted to discuss treatment
and HIV information and medical
or other details with parents or legal
services to unaccompanied minors.
guardian without minor's permission or in
cases where the minor is in danger.
06/18/98
CRM/MGS50
Seek clarification of some aspects of
Find that, except in emergencies, sterilization
Ministry of Health regulation of Law
always requires consent of both spouses; that
45 Association of Orientation Services for the Disabled. 46 Conselho Nacional dos Direitos da Mulher; National Council for Women's Rights. 47 Proposed law. 48 Infant and Adolescent Gynecology Clinic. 49 Centro de Pesquisa em Reprodução Humana; Research Center on Human Reproduction. 50 Conselho Regional de Medicina/Mato Grosso do Sul; Regional Medical Council/Mato Grosso do Sul.
9.263/96, the "Family Planning Law".
all legal requirements of law must be met
before sterilization can be performed; that
number of prior cesarean section births
should be expressly stated; that it is up to the
clinic director to determine which health care
professionals make up "multi-disciplinary
team"; that Ministry of Health Portaria51
No. 148 regulates the law.
11/18/98
Request opinion regarding the
No. The legislation clearly prohibits time of
prohibition on time of birth
birth sterilizations. Time of birth
sterilizations. If all the legal
sterilizations are allowed only in cases of
requirements are met including the 60 proven medical necessity including prior
day waiting period, can sterilization
successive cesarean section births.
be performed shortly after a vaginal
or cesarean section birth?
03/30/99
CRM/DF52
Request evaluation of a proposed
Find the proposed resolution is in line with
CRM/DF resolution setting forth
law. Note: The resolution requires
ethical standards for sterilization
"reproductive risk" before a sterilization can
procedures.
be performed. Reproductive risk includes:
pregnancy presents health risk to the woman;
5 or more prior pregnancies; 5 or more prior
abortions; 35 years of age or older; or, risk to
life of the mother.
Source: CFM Library; Dr. Cristião Rosas of CREMESP.
51 Administrative document containing pronouncements that are within the jurisdiction of the issuing agency. 52 Conselho Regional de Medicina/Distrito Federal (Brasília); Regional Medical Council/Federal District (Brasilia).
clinics and one from BEMFAM53. The pareceres address a wide variety of issues related to sterilization and contraception. What I found most interesting in reading the pareceres was that they were not limited to a legalistic type of analysis applying the CEM to the facts presented; many of them include strong public policy statements based on philosophical and political considerations.
The earliest opinion listed on Table Four (Parecer 1) dating from 1985,
establishes the CFM's general rule that, based on Penal Code Art. 129, sterilization is illegal and therefore unethical unless medically indicated. Parecer 2 condemns Norplant clinical trials undertaken in Brazil in 1984. Pareceres 3 and 4 contain a lot of language condemning population control efforts in Brazil funded by international agencies. Parecer 4 is an effort by BEMFAM to convince the CFM that the organization has reformed itself and seeks "approval" of its activities by the CFM; the CFM refused to change its position condemning what it considered the "population control" agenda of BEMFAM. In Parecer 6, a government agency requests CFM's opinion on proposed legislation; the CFM reiterates its opinion that sterilization is illegal and should not be included in a program providing contraceptive services. Pareceres 7 and 9 take a liberal view toward the provision of contraceptive information and methods to minors and protect the minor's right to privacy.
CEPARH requested Parecer 8; the director of CEPARH is Dr. Elsimar
Coutinho from Bahía. Dr. Coutinho has been active in the population control, family planning, reproductive health arena for many years. He is vilified by feminists and many who work with women's reproductive health issues, but to others he is a champion of progress in modern contraceptive methods and women's reproductive health. He has published numerous books and articles. One of his more recent publications contends that menstruation is unnecessary for any woman not intending to become pregnant. He recommends everything from taking hormonal contraceptive pills for the full twenty-eight days of the cycle rather than the usual twenty-one day dose to hysterectomy to eliminate this unnecessary bodily function (Coutinho 1996).
The CFM issued Pareceres 10, 11 and 12 after adoption of Art. 10 of Law
9.263/96 legalizing and regulating surgical sterilization for contraceptive purposes. Parecer 10 provides a general overview of the requirements of the law emphasizing that consent must be obtained from both spouses, that all legal
53 Sociedade Civil de Bem-Estar Familiar; Civil Society for Family Well-Being. The Brazilian branch of the International Planned Parenthood Federation, established in 1965.
requirements must be met before a sterilization can be performed and that the number of prior cesarean section births should be expressly stated. In Parecer 11, the CFM pronounces their position on the controversial "time of birth" prohibition finding that sterilizations cannot be performed shortly after a vaginal or cesarean section birth even where all the legal requirements have been met. This parecer, issued in November 1998, directly contradicts the CREMESP parecer (Table Three, Parecer 14) issued in October 1997. The later CREMESP parecer (Table Three, Parecer 17) issued in March 1999 coincides with the CFM opinion by taking the position that sterilizations should not be performed at the time of birth absent medical need. The last CFM parecer on the list (Parecer 12) addresses the issue as to whether a CRM can set ethical standards that are more restrictive than those found in Law 9.263/96. The CFM finds this acceptable. Thus, a CRM-DF resolution requiring "reproductive risk" before a sterilization can be performed is deemed acceptable under the law. Reproductive risk is defined as 1) pregnancy presents a health risk to the woman; 2) five or more prior pregnancies; 3) five or more abortions; 4) age thirty-five or older; or, 5) risk to the life of the mother. The CFM parecer is consistent with verbal opinions given by CREMESP board members that a hospital's restriction on sterilizations to women aged thirty and over is acceptable under the law54.
ANALYSIS: LIMITATIONS AND DISTORTIONS
This paper examines professional liability of medical doctors in Brazil in
an effort to understand how ethical processes have contributed to limitations and distortions found in the Brazilian contraceptive use regime. The ethical rules govern doctors as providers of, and women as consumers of, contraceptive medical services.
A 1957 federal law established the current system of self-regulation of the
medical profession in Brazil by quasi-public entities. Each state has a CRM that is responsible for licensing doctors to practice medicine, for holding PEPs, for sanctioning doctors found to have violated the CEM and for issuing pareceres addressing particular fact situations. The CFM promulgates the CEM, hears appeals of disciplinary proceedings and issues pareceres.
All of the activities of the CFM and the CRMs are exempt from public
scrutiny. A twenty-member board elected by delegates of the CRMs governs the CFM and has the power to amend the CEM. The CEM reflects the philosophical
54 Information provided by Dr. Aníbal Faudes, email correspondence dated May 2, 2001.
and political views of these elite members of the medical profession. It establishes norms for the ethical practice of medicine in Brazil. The legal right to promulgate the ethical rules of conduct grants law-making power to the CFM.
The CEM defers to federal civil and criminal legislation governing
medical practices. In the opinions issued in PEPs and in pareceres, CRMs and the CFM often interpret and apply federal law. These two types of opinions also establish ethical norms that apply in cases in which the federal law is unclear, ambiguous or non-existent. The power to interpret federal law and establish ethical norms that apply to situations not directly governed by federal law or court decision grants rule making power to the CRMs and the CFM. An excellent example is the finding by medical councils that sterilization was illegal under Penal Code Article 129. I found no evidence of criminal prosecutions of doctors under the penal code for performing sterilizations. I did find a debate in the legal literature; some scholars, applying the same reasoning as the medical councils, found sterilization to be illegal; other scholars suggested that the penal code section did not apply to voluntary sterilizations making them both legal and ethical. Despite the conflict in scholarly opinion, the medical councils "ruled" on application of the penal code section to the sterilization context adopting a legal position on an issue that the legislature and the courts had never directly addressed.
The underlying goal of the CEM, its enforcement through PEPs and the
issuance of pareceres is to set the standards for the ethical practice of medicine and to encourage compliance by doctors of those standards. In examining the ethical standards and the impact of PEPs and pareceres on doctors' behavior as it relates to the provision of contraceptive services, I find evidence to support a finding that the system has worked in ways that result in limitations and distortions in women's contraceptive use in Brazil.
The CEM and pareceres issued prior to 1997 by the Brazilian medical
councils took a firm stand against contraceptive sterilization declaring the procedure illegal under the penal code and therefore unethical under the CEM. Despite the strong language condemning the procedure unless performed with medical indication, national level surveys show extremely high usage of sterilization for contraceptive purposes. The evidence on ethical disciplinary proceedings presented in this paper shows that very few doctors were subjected to PEPs for performing "unethical" sterilization procedures. This is likely due to several factors. Scholarly works and information received in interviews with
representatives of CRMs suggest that, at least until recently, vigorous enforcement of the CEM was not a priority for CRMs. Even now, CRMs pursue disciplinary action against doctors only when complaints are received. Most complaints are filed by doctors or hospital administrators, not by patients. I was told in interviews that these complaints are most often motivated by personality conflicts or work place politics not concern for the ethical rules or the patient's rights. The lack of enforcement permitted a permissive attitude by doctors as there was little accountability for violation of the CEM.
Furthermore, there was little reason to expect women to file complaints.
Women lacked access to contraceptive methods other than the pill and many experienced difficulties taking the pill55 making sterilization the only viable contraceptive alternative. Women had to overcome legal, ethical and institutional barriers to obtain the procedure and most women were satisfied with it. For those women with reason to complain about the medical services they received, the "illegal" status of the procedure served as a disincentive.
The data obtained from CRM-DF and CREMESP reveals that, over the
course of the 1990s, doctors were subject to little risk of being reported for ethical violations, that if they were reported there was about a fifty-fifty chance of being held liable and that if held liable there was little chance of severe punishment. The CRM-DF punished just three percent of enrolled doctors over a twelve year period while CREMESP punished just one percent over a ten year period. In São Paulo from 1993 to 1997, just .1% of doctors had complaints filed against them involving the provision of surgical sterilization procedures. Of the CRM decisions appealed to the CFM, the CFM overturned sanctions revoking the license of the doctor in all three cases involving sterilization by downgrading the sanction to suspension of license for thirty days.
The data presented shows that few doctors were punished by CREMESP
or CRM-DF for performing surgical sterilizations. It is reasonable to assume that there was greater enforcement, and hence greater accountability of doctors, in these two jurisdictions than in the many of the less developed Brazilian states.
The CFM and CREMESP (orally) issued opinions that permit CRMs and
hospitals to establish criteria for qualifying for a sterilization procedure that are more restrictive than the criteria established by federal law. The more restrictive
55 The difficulties experienced by Brazilian women with the birth control pill were exacerbated by the fact that most women obtain birth control pills directly from the pharmacy without the benefit of a doctor's advice.
criteria often involve age limitations. For example, a hospital might decide to offer sterilizations only to women aged thirty years or older. Law 9.263/96 permits sterilizations at age twenty-five or at age eighteen (the age of civil majority) if the woman has two children. By permitting individual institutions to establish their own criteria, the medical councils undermine one of the goals of the law – the democratization of access to contraception and female surgical sterilization. By giving institutions the right to establish their own criteria, the medical councils authorize institutions to disregard the legislative intent and to establish barriers to access that place limitations on Brazilian women's contraceptive options. Both the Brazilian Constitution and Law 9.263/96 guarantee individuals the right to choice of contraceptive method and access to family planning services. Whether, by permitting more restrictive rules to apply to access to sterilization, the medical councils violate the Constitution or Law 9.263/96 is an open question that has not been (and is not likely to be) addressed by the courts. The ability of the medical councils to set ethical rules that undermine constitutional and legislative rights reveals the awesome power that these institutions wield.
An additional reason we find few PEPs involving sterilization is the use of
cesarean sections births to provide the medical indication that makes the procedure ethical. Women who underwent a series of cesarean section births could "qualify" for a time of birth sterilization at the time of the birth of their third child. Statistical data from 1996 confirms that almost sixty percent of all sterilizations in Brazil are performed at the time of birth and that as many as eighty percent of these were performed at the time of a cesarean section birth. The medical councils, via strong statements condemning sterilization, promoted the use of unnecessary cesarean section births as a means of qualifying for the procedure creating a serious distortion in use of this contraceptive method.
The culture of sterilization and cesarean section birth that developed in
Brazil led to calls for legislation to legalize and regulate the procedure. Article 10 of Law 9.263/96 was a response to the problematic nature of contraceptive use in Brazil. The law seeks to promote reversible methods of birth control and to dissociate sterilization from cesarean section births. The law does so by placing restrictions on access to sterilization including a sixty day waiting period during which education regarding reversible methods must be provided and by restricting time of birth sterilizations to cases of medical need.
The Brazilian medical councils have issued pareceres interpreting and
applying provisions of the law. The time of birth restriction is the most
controversial aspect of the new law. The time of birth is a medically opportune time to perform a tubal ligation. By delaying procedures for a forty-two day period after the time of birth, the law makes access difficult for women, especially poor women, who may not have the resources required to return to the hospital at a later date. The restriction also puts pressure on public hospitals in Brazil where there is a chronic shortage of hospital beds. By separating the birth and the sterilization procedure, the demand for hospital beds is increased. Additionally, requiring women to enter the hospital on two occasions results in less efficient use of public monies. In order to overcome these barriers to access, doctors and women in Brazil are likely to continue to use the three cesarean section exception to the time of birth restriction. If this is the case, rather than dissociating sterilizations from the time of birth, the law will continue to promote a serious distortion in the use of this method.
The information presented here provides a preliminary look at the CRMs
and the CFM and the role they may have played in Brazil with respect to the use of female surgical sterilization and other contraceptives. A more detailed study of these entities is warranted.
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