A Case Study From Brazil

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How Action by Civil Society Can Help Improve Access to Cancer Medications: A
Case Study From Brazil
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How Action by Civil Society Can Help Improve Access to Cancer Medications: A Case Study From Brazil
May 26, 2016
By Gilberto de Lima Lopes, Jr., MD, MBA, FAMS
Article Highlights
In 2013, Brazil’s Congress passed legislation requiring that all private health insurance companies provide access to oral
antineoplastic treatment.
Elements of this successful advocacy case included investment in strategic communication, specialized knowledge of
regulatory policy, and the ability to act through democratic channels of political representation.
This case builds evidence for the role of civil society in advocating access to cancer treatment within a middle-income country
and provides an example that can be followed by other low- and middle- income nations and health care systems.

2. Click to Expand.
Civil society is often defined as a community or aggregate of individuals connected by a common interest and by collective activity.
Civil society organizations (CSOs), a term often used interchangeably with nongovernmental organizations (NGOs), have become
important actors in the social services and international development stage.
In health care, we can easily cite examples of civil society evoking change. Such examples include the efforts led by Jane Addams
and the Hull House in Chicago in the 19th century, aiming to improve public health in American cities, and the myriad international
groups that lobbied governments and companies in the high-income world in the 1990s, which eventually improved access to HIV
medications in low- and middle-income countries. In Brazil, a recent drive to increase coverage for oral chemotherapy and targeted
agents is illustrative of how civil society can help us increase access to cancer treatments in low- and middle-income countries.
Access to Oral Chemotherapy
When a new parenterally administered anticancer drug is approved by ANVISA, the Brazilian regulatory agency for medicines, it is
automatically covered in the private health care system after an interministerial commission sets the price for the new drug. Oral
chemotherapy and targeted agents are promising interventions for cancer treatment, but they are usually unavailable in low- and
middle-income countries because of cost. Brazil was no exception to this rule until recently.
With more than 200 million people, Brazil has one of the largest public health systems in the world. Known as SUS after its initials
in Portuguese, which stand for unified health care system, Brazil’s public health system covers both citizens and foreigners who are
physically in the country (including illegal aliens). Even so, mainly because of wait times and the lack of widespread availability of
newer technologies, approximately 25% of the population is also enrolled in private health insurance (known locally as the
supplemental health sector and regulated by a specific and separate agency, the National Regulatory Agency for Private Health
Insurance and Plans [ANS]). Because the 1998 Private Health Insurance Act (Law 9656) only mandated the coverage of medicines
used during periods of hospitalization or ambulatory visits, patients historically have had to pay out of pocket for oral cancer
medications.
Civil Society’s Call to Action
In 2013, after strong lobbying from civil society, Brazil’s Congress passed legislation requiring that all private health insurance
companies provide access to oral antineoplastic treatment. The decision to scale up the provision of oral chemotherapy was a
watershed event in the regulation of private health insurance in Brazil. Until then, private insurers had been exempt from the
provision of pharmaceutical drugs for home care treatments. In a recent Journal of Global Oncology article, my colleagues and I
explored the political process involved in proposing and approving this new Act.1 Elements of this successful advocacy case
included investment in strategic communication, specialized knowledge of regulatory policy, and the ability to act through
democratic channels of political representation.
Click to Expand.

3. Every 2 years, ANS revises its minimal list of procedures with obligatory coverage by private health insurance companies, and this
process is open to different segments of society through public consultation. In May 2011, with the promotion of Public
Consultation No. 40, Instituto Oncoguia, an NGO representing the interests of individuals living with cancer, saw an opportunity for
action. This CSO—which received training on strategic political advocacy and technical assistance from the American Cancer
Society, and which is sponsored by pharmaceutical entities and other private-sector companies, such as Google Grants, ASICS, and
others—launched a large mass media campaign called the “Campaign for Inclusion of Oral Chemotherapy in Healthcare Plans.”
The effort was coordinated with a number of other entities representing patients with other diseases (such as HIV and hepatitis
infection) and professional organizations. The social media campaign elicited more than 900 mentions in the press, and a petition
with 18,000 signatures was submitted to ANS. ANS rejected the request of mandating coverage for oral cancer medicines, arguing
that legislation did not allow for this addition.
In parallel, the campaign managed to convince Senator Ana Amélia Lemos (Rio Grande do Sul) to propose a bill to Congress
mandating coverage. In December 2011, a public hearing was held in the Brazilian Parliament to discuss the different positions
around this bill. With strong opposition from Abramge, the representative association for private health insurance providers, the bill
nonetheless made it through the relevant congressional committee (Commission on Constitution, Justice, and Citizenship), was
approved in the Senate, and was finally signed into law by President Dilma Rousseff in December 2013. Concomitantly, and
realizing the inevitability of the new legislation being enacted, ANS published a new resolution including coverage for 37 oral
cancer drugs. Insurance claims data from 2015 and information obtained from IMS Health suggest that access to the oral drugs
included has increased substantially in Brazil.
Civil Society’s Regulatory Impact
This Brazilian case study suggests that civil society played a crucial role in the regulatory process. As mentioned, but worth
repeating, the main elements leading to this successful intervention were (1) the investment in strategic communication, (2) the
possession of specialized knowledge of regulatory policy, and (3) the ability to act through democratic channels of political
representation, such as public consultations. In turn, the receptiveness of government branches opened a window of opportunity for
the change desired by these groups. The impact of civil society was less a result of the material resources of the CSOs involved but
rather related to their capacity to persuade the public and decision makers, despite the strong and resourceful lobbying of the private
health insurance sector.
It is particularly important to highlight that this case builds evidence for the role of civil society in advocating access to cancer
treatment within a middle-income country and provides an example that can be followed by low-income nations and health care
systems. Prospects for expanded access to such medicines in the public health system are bleak in the short term, however, because
of the ongoing political and economic crisis, and further action is sorely needed in this arena. Universal coverage for the treatment
of HIV infection and more recently for hepatitis C shows that governments can be stirred toward action, and we hope that essential
cancer medicines will eventually be covered in the public health systems throughout the globe.
“Of all the forms of inequality, injustice in health care is the most shocking and inhumane,” Martin Luther King, Jr., reportedly said
at the Second National Convention of the Medical Committee for Human Rights in Chicago in 1966. Fifty years later, in Brazil, the
United States, and around the world, we still have unfinished work to do in our fight for what has been called the forgotten civil
right: health care.
Disclosure: Dr. Lopes is on Instituto Oncoguia’s medical board.
Reference:
1. Massard da Fonseca E, et al. JGO. JGO001917; published online on January 20, 2016.
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