Title: Rationing hepatitis C treatment in the context of
austerity policies in France and Cameroon: a transnational
perspective on the pharmaceuticalization of healthcare
systems
Authors 1, 2, 3*
*Alphabetical order
1. Chabrol, Fanny;
a- Sciences Economiques et Sociales de la Santé et Traitement de l'Information Médicale,
SESSTIM, UMR912 Inserm, IRD, Aix-Marseille Université, 27 bd Jean Moulin, 13385 Marseille
b- Centre de recherche, médecine, sciences, santé, santé mentale, société, CERMES 3, UMR988
Inserm, CNRS, EHESS, Université Paris 5 Descartes, 7, rue Guy Môquet, 94801 Villejuif,
fannychabrol@gmail.com
2. David, Pierre-Marie;
Université Paris Diderot, SPHERE, piemdavid@gmail.com
3. Krikorian Gaëlle;
IRIS, Paris, gaelle.krikorian@gmail.com
Corresponding author: Fanny Chabrol, SESSTIM, Marseille and CERMES3,
fannychabrol@gmail.com
Acknowledgements:
Authors are very grateful to the people who allowed them to be part of discussions and decisions
about hepatitis C treatment access in France and Cameroun. Authors also wish to thank the
anonymous reviewers for their insightful comments and valuable suggestions on earlier draft of
the article. We are grateful to Erin Martineau for English revisions. Finally authors are grateful to
FRQSC, ANRS and Sidaction for financial support.
New powerful drugs against hepatitis C can cure the disease, but they are not widely distributed because their exorbitant prices are destabilizing healthcare systems in both African and European countries. This article takes access to hepatitis C treatments since 2013 in France and in Cameroon as a lens to analyze the rationing of pharmaceutical treatments in relation to recent transformations of health systems. Access to these treatments is analyzed thanks to ethnographic observation and interviews lead in Paris and Yaoundé, with patients, associations, health professionals and public health experts. In Cameroon, rationing takes place through various layers of socio-economic restrictions, and no patient organization advocates for hepatitis treatment. In France, access to hepatitis C treatments has become politicized, and collective mobilizations have denounced rationing as a threat to the promise of universal social security. In this study, we examine Africa’s long experience with rationing in the context of structural adjustment, and we bring together experiences in France and Cameroon. This article analyses the phenomenon of the pharmaceuticalization of healthcare systems, that is to say the growing use of pharmaceuticals in healthcare systems, by documenting the social and political construction of scarcity. Indeed, whereas pharmaceuticalization is a concept that has often been used in situations of drugs abundance, a parallel analysis of rationing highlights a political economy of pharmaceuticals that shapes public health debates and policies according to an economy of scarcity, especially in times of austerity.
Keywords:
hepatitis C; rationing; pharmaceuticalization; DAA; France; Cameroon; anthropology; austerity
Research highlights
- Explores rationing as a key concept to understand access to hepatitis C treatments.
- Compares the cases of France and Cameroon in a transnational perspective. - Examines the politicization of rationing in France and in Cameroon.
- Analyzes pharmaceuticalization of healthcare systems through DAAs rationing.
- Argues that the rhetoric of "access" might contribute to an economy of scarcity.
Background
Access to medicines is coming back under the spotlight of global health with the arrival of new treatments that can cure the hepatitis C infection. These direct-acting antivirals (DAAs), in combinations of two or three molecules taken in 12-week regimens, cure more than 90% of patients. They are much more efficient than the old regimens of pegylated interferon and ribavirine that cause many strong side effects. Despite a certain disparity between markets, their prices are extremely high, ranging from € 23500 to € 78000 in high-income countries (Andrieux-Meyer et al., 2015). In low-income countries, they can still reach € 18800. Generic versions can cost a few hundred dollars, but, due to patent protection, they are illegal in most countries. As a consequence the prescription and use of DAAs are severely limited, and in many countries, such as Cameroon, pegylated interferon and ribavirine remain the only available treatment, and only at a very high price.
Hepatitis C in France and in Cameroon
Infection with the hepatitis C virus is a global epidemic that affects 130–170 million people (2%–3% of the world’s population) who are chronically infected (WHO, 2016). This infection is associated with significant morbidity and mortality: more than 350,000 deaths are attributed to hepatitis C infection each year. The epidemic is a serious public health issue in Europe as well as in Africa, although with specific epidemiological patterns. In France around 230,000 people are infected with hepatitis C. More than half of them are unaware of their status, and the prevalence is around 44% among people who use drugs (Weil-Barillet et al., 2016). In Africa, Cameroon stands as the worst hit country after Egypt, with a prevalence of 4.9% in the adult population (Riou et al., 2016). Similarly to Egypt, hepatitis C prevalence is an iatrogenic epidemic inherited from colonial medicine and the mass medical campaigns of the 1950-1960s, which explains why it is mostly found amongst people over 50 years old. Prevalence can reach 50% in these age groups in certain regions (Nerrienet et al., 2005). While there is no transmission pattern related to injection drug use in Cameroon, residual risk of transmission through blood transfusion or needle exposure remains high in the context of hospitals (Noah Noah et al., 2011). Although it is a severe public health issue in Cameroon, until now hepatitis C was neither a priority for the government nor for donors. This situation is slowly evolving due to greater international efforts in the global hepatitis epidemic and to offers from pharmaceutical companies to the government of Cameroon. In France, although the practice of charging exorbitant prices is not new, the level of DAA prices has provoked unprecedented criticism. While the costs of medicines for deadly diseases such as hepatitis C are fully covered by the national health
insurance system, patient groups worry that these prices could jeopardize the principle of universal access. Despite strong differences between France and Cameroon the issue of rationing allows us to explore asymmetries and similarities between these countries and to analyze what the high prices of drugs produce in various contexts of austerity.
Austerity and structural adjustment
Like many countries in sub-Saharan Africa, Cameroon was hard hit by the economic crisis of the early 1980s. The government signed an agreement with the International Monetary Fund in 1988 to implement the first structural adjustment plan (1989–1992), which led to a public health budget reduction of nearly 20% between 1988 and 1992 (Kamdoum, 1994). Austerity measures were drastic and had detrimental effects on health, particularly in relation to: i) the deterioration of public health management and services, ii) the inaccessibility of services for segments of the population, and iii) the proliferation of street pharmacies and the informal market (Kamdoum, 1994). User fees were generalized and the cost of care was transferred to citizens, in accordance with the 1987 Bamako Initiative that advocated for a policy of user fees in the health sector in Africa. Two other structural adjustment plans, one of which officially ended in 2004, have not managed to reverse the continuing degradation of access to healthcare.
France has also been affected by the financial and economic crisis that started in 2008, with the following consequences: increased unemployment, lower purchasing power, greater poverty, and an increase in public debt (OECD, 2008; Oxfam International, 2013). At first, the government’s strategy to address the crisis was not to drastically cut public spending but rather to raise taxes. However, following
European Union austerity policies, since 2010 several rounds of measures have been put in place that combine tax increases and public spending cuts (Oxfam International, 2013). At a minimum, such policies have had the effect of counteracting a set of health-related laws that had been enacted since 2004 to reduce health inequalities. In addition, the trend over the past decades has been to increase both the share of the cost of pharmaceuticals borne by patients and the share of medical coverage provided by private insurance (Lancry and Sandier, 1999). In spite of almost universal membership in the national health insurance system, and despite the fact that health insurance coverage remains broad and redistributive in comparison with other OECD countries, equity with regard to access to care is declining and there is a serious risk of social fragmentation of the system (Nay et al., 2016).
The violent impact of adjustment policies on healthcare delivery in sub-Saharan Africa have been well documented (Pfeiffer and Chapman, 2010), but rarely have transnational perspectives been offered in which experiences in Africa shed light (methodologically and theoretically) on situations in Western countries. At the origin of this study is our belief that “theory from the South”—taking the South as a source of theory and explanation for world historical events (Comaroff and Comaroff, 2012) — can help describe and explain rationing practices, the specific forms they take in different contexts, and what they generate or reflect politically. Current hepatitis C treatment policies in these two countries offer an opportunity to examine how forms of rationing are developed, managed, and criticized.
Access to hepatitis C treatment framed as rationing of healthcare
Rationing is generally defined as the controlled distribution of scarce resources, which produces an artificial restriction of demand. It is often considered as a historical feature inherent to biomedicine and health policies that inevitably have to deal with a demand that outstrips supply (Lachenal, Lefève and Nguyen, 2014). The purpose of any rationing system is to match demand to the available supply and it is therefore presented as a technical matter. Analysts have distinguished between explicit rationing and implicit rationing: “explicit rationing refers to decisions made by an administrative authority as to amounts and types of resources to be made available, eligible populations, and specific rules for allocation. (…) Implicit rationing, in contrast, refers to discretionary decisions made by managers, professionals, and other health personnel functioning within a fixed budgetary allowance” (Mechanic, 1997: 84).
Rationing is mostly understood as an economic fact, the product of an economic rationality, applied to the realm of healthcare. We follow Light and Hughes (2001), who call for empirical case studies of rationing practices, in order to generate sociological insight into the “black box of rationing” and reveal the “micro-politics of rationing.” Despite the authors’ prescience, scholars have not expended much attention on sociological approaches to understanding rationing since the 2000s. Meanwhile, the rationing of healthcare, as an unquestioned and naturalized policy, seems to have increased in various settings around the world.
The concept of pharmaceuticalization, popular in the sociology of health and medical anthropology, points to the social process turning problems into ones that can be fixed with pharmaceuticals, leading to an overwhelming presence of
pharmaceuticals in public health and analyses the growing role that the pharmaceutical industry plays in the framing of health policies and regulations in various societies (Abraham, 2010; Bell and Figert, 2012, 2015; Desclaux and Egrot, 2015; Collin and David, 2016). In this article, we show that rationing is also an intrinsic part of pharmaceuticalization.
Material and methods
Study designThe case studies discussed are qualitative studies using an ethnographic approach. Qualitative ethnographic methods include interviews and non-participant and participant observation, such as observing medical consultations or interactions between professionals and activists. Observation is a powerful research tool to generate insights into care practices, including the prescription and availability of drugs.
In Cameroon, the study used an ethnographic approach to hospital care, or “hospital ethnography” (Van der Geest and Finkler, 2004; Fassin, 2008), and conducted forty-two (42) in-depth interviews of patients, healthcare workers, non-governmental organization (NGO) staff, public health officers, and international experts. Fieldwork was undertaken during several months in 2013 and in 2014 mainly in Yaoundé, Cameroon’s capital city. In France, the study relied on ethnographic observations, conducted mostly in Paris, of social change organizations and their interactions with authorities about the price of DAAs and access to these treatments between 2014
and 2016. Between 2013 and 2016 Krikorian engaged with members of patient groups and NGO staff to follow the process of collective action they have developed. Data collection methods
In Cameroon, a qualitative sociological study of the management of viral hepatitis B and C and hepatitis-HIV co-infection was conducted in Yaoundé. Chabrol conducted observations in hospital wards and during medical consultations (52 consultations in HIV services and 74 consultations in the gastroenterology ward). Chabrol also recruited patients, healthcare providers, public health officers, and members of NGOs who were interviewed through semi-structured interviews within the framework of the EVOLCAM study, an evaluation of the national program battling co-infection of tuberculosis and viral hepatitis in two regions (Littoral and Centre). The Ethics Review Board of the Ministry of Health in Cameroon granted ethical approval for this study. Patients and health professionals gave informed consent prior to interviews and observations. Audio recordings of interviews were transcribed and analyzed.
The qualitative research in France was based on documentary analysis and observation of events. Media reports covering the introduction of DAAs in France and the issue of their price; public releases and reports from associations, NGOs, and public institutions; and gray documentation (administrative reports, internal notes, and legal texts) were collected and analyzed. Observations (of 28 events in total) were conducted mostly in Paris during collaborations with patient groups and NGOs (work sessions, meetings, and conference calls); during public meetings, events, and conferences (including at the Ministry of Health, the congress of the French society against HIV/AIDS, the national Parliament, the Francophone conference against
HIV/AIDS and hepatitis, and the National Research Agency on HIV/AIDS and hepatitis C); and during exchanges on digital mailing lists that involved health professionals, associations, and social workers both in France and Africa. Ethical approval was granted for this research by the INSERM institutional review board.
Analysis
Both contexts are characterized by limited access to very expensive therapies, pegylated interferon and new treatments in Cameroon and sofosbuvir and other DAAs in France. Our research questioned how access to life-saving medicines is socially and politically apprehended by various actors in these contexts. How are hepatitis C treatments distributed? How is access controlled and managed? Do actors problematize restrictions to hepatitis C treatment in terms of rationing? We used the coding of our respective transcripts to generate themes (Denzin and Lincoln, 2011) that were then collectively discussed. Bringing together fieldwork data from France and Cameroon allowed us to identify common issues: i) rationing practices, ii) social mobilizations, and iii) the place of medications in the definition of public health policies. The analysis was informed by the authors’ previous work on experiences of HIV-treatment access in Central and Southern Africa (Chabrol, 2014, 2016; David, 2014, 2017).
Our analytical strategy is twofold. First, we assume that African countries’ experiences of health system crises can offer key insights to apprehend current situations in Western countries, including France’s approach to hepatitis C treatments. Second, we believe that the dynamics of pharmaceuticalization can be best captured through tracing a pattern of rationing that is common in the South as well as the North (Bell and Figert, 2012).
Results
Rationing through an access program in Cameroon
Anastasia is a 51-year-old schoolteacher who works far from her home village where her two daughters live. She is HIV positive and has been on antiretroviral therapy for seven years. She was diagnosed with hepatitis C in the course of her HIV follow up and she has no hope of treatment for hepatitis, as she is unable to pay even for the pre-therapeutic tests that the gastroenterologist in one public hospital of Yaoundé asked her to perform.
I presented these results [hepatitis C +] to the doctor and then he
ordered other tests that were very expensive, far too expensive. I am a
schoolteacher and a widow with two children to look after, and now it’s
time to prepare for school expenses for them. (…) Today I am here with
fees amounting to 80,000, 85,000, 60,000 [CFA]. It’s a little too hard, a
little too hard. (Interview with Anastasia, Yaoundé, June 2014)
While she is enumerating the costs for a Fibrotest (€ 122), genotyping (€ 129), and viral load test (€ 91), Anastasia is struggling to make sense of this new diagnosis. She cannot imagine being able to gather an amount of money that equates to several months of salary. In a generalized HIV epidemic, Anastasia’s experience shows how the hepatitis B and C epidemics have an additional impact, and are very hard felt in healthcare structures and by many patients in Cameroon and elsewhere in Africa (Lemoine, Nayagam, and Thursz, 2013). These epidemics have not been addressed despite local initiatives by physicians who have tried to alert public health authorities. International mobilizations, donors, and national stakeholders prioritized
the response to HIV/AIDS during the 2000s, but there is currently no broad governmental initiative to tackle the hepatitis epidemic except for a vaccination against hepatitis B, administered six weeks after birth as part of the national immunization program. In the context of a very constrained, donor-driven health governance, the hepatitis C epidemic poses severe political challenges in Cameroon in relation to the high cost of interferon-based treatments, not to mention DAA therapies that, at the time of the study, were not even in the scope of health policy makers and clinicians’ projects.
In 2012, the Hoffman-La Roche laboratory offered an “Access” program to the government of Cameroon, which reduced the price of interferon-based hepatitis C treatments. The memorandum of agreement signed in August 2012 between the Ministry of Health and Hoffman-La Roche stipulates that Hoffman-La Roche will provide pegylated interferon injections at a 33% discount. The price per injection of CFA 159,000 (€ 242) was lowered to CFA 102,000 (€ 155). The cost of a full 48-week course of treatment then amounted to CFA 4,896,000 (€ 7500) or CFA 7,344,000 (€ 11,200) for 72 weeks. Because genotypes 1 and 4, present in Cameroon, have lower virological responses, treatment is sometimes extended up to 72 or 96 weeks. In 2014, another 50% discount was granted, which brought the cost of one ampoule of pegylated interferon to CFA 57,000 (€ 86). The company also helped health authorities to organize testing campaigns and provided laboratory some follow-up tests for free for patients within the program. Through this Access program, medication is provided to a limited number of patients selected by an eligibility committee, resembling many of those put in place at the very beginning of the pilot antiretroviral (ARV) program throughout Africa (Desclaux et al., 2002). Increasingly, eligibility committees have been adopted for treatment programs all over Africa.
Restrictions to access through eligibility
There are several layers of restrictions to the Access program. The most important, even more than the price of the medicine, is the other expensive fees at the hospital. Anastasia’s case shows that to pursue hepatitis C treatment in Cameroon, a patient has to pay for a costly pre-therapeutic evaluation, a situation deplored by many physicians. As one gastroenterologist put it, “Our patients, those who get treated, I would say that it depends on their pocket [money]” (Interview, Yaoundé, June 2014). Most physicians denounce the consequences of this highly unequal healthcare system that makes it difficult to follow up after diagnosing the infection. The same gastroenterologist lamented, “At the hospital, when the patient comes it is usually too late” (Interview, Yaoundé, April 2014). Having to pay for the complicated and costly pre-therapeutic laboratory work-up that amounts to more than CFA 275,000 (€ 420) is a major restriction to access these therapies.
The eligibility committee is a medical committee composed of physicians – mainly hepato-gastroenterologists – and sometimes pharmacists, who meet once a month in Yaoundé and in Douala. A staff person at the Ministry of Health described the committee:
The committee has been put in place with the pharmaceutical
company, the Cameroonian society of gastroenterologists, and the
Ministry of Health; one of its activities is to evaluate this program,
especially the statistics on patients treated. It’s important for the
company, they want these statistics about who enters the program.
(Interview, Yaoundé, October 2013)
Hepato-gastroenterologists from Yaounde’s main public and private hospitals meet and present their patients. Their medical profiles are evaluated (such as fibrosis, viral load and co-morbidities), as well as their social and family environment. There are no national medical guidelines that can determine whether a patient gets or is denied access. Observing the meetings of the eligibility committee in Yaoundé, through which discounted treatments and access to facilities are granted, we noted several layers of triage in the presentation of patients’ files and the deliberation of medical, behavioral, and socioeconomic aspects. First and foremost, the committee would only evaluate patients who had already completed the entire costly pre-therapeutic evaluation, and who had the capacity to pay for one interferon injection per week for anywhere from 48 weeks up to 72 or 96 weeks.
Eligibility is mainly determined through socio-economic status, which is closely tied up with being a part of the state’s elites. For instance, amongst the 15 files examined during one eligibility committee session, 12 were men, the average age was 57 years old, and almost all were either civil servants or retired civil servants (5), or family members (4) who were serving or had served in public administration, government ministries, or the military. The remaining 3 men were wealthy businessmen or bank managers.
We observed the same mechanism when ARVs were introduced in various African countries where control over access to discounts was crucial and did often benefit local economic and political elites (Whyte et al., 2006). One’s position within and proximity to the state (benefitting from national insurance schemes) and to power and wealth (having one’s own fortune) decide whether you have a chance to gain access to the therapies. In addition, Hoffman-La Roche organizes testing campaigns in the ministries and in large national companies. They are hence targeting
personnel who, if tested positive can then benefit from other subsidized mechanisms in accordance to their professional status, like insurance schemes, that help finance the expensive pre-therapeutic evaluation. The Access program comes after existing resources available to certain categories of the population for whom proximity to the state is characteristic: government elites, civil servants, military and judicial officials, and close relatives of all of these groups. In Cameroon, access to care does not depend on following medical guidelines, even if medical criteria are important. The socio-economic triage is prominent, a consequence of an extremely unequal healthcare system.
One pharmaceutical access program standing as the national policy
Even if Hoffman-La Roche strongly insisted on describing his company as being only a partner of the government (interview with company representative, Yaoundé, June 2014), it is worth noting that the program is considered by most health officers as the embryonic policy for a future national program. This is typical of healthcare politics after structural adjustment in Africa, in which the agenda is set by external initiatives including those of pharmaceutical companies and rarely includes a comprehensive framework for prevention and care. The mobilizations of professional societies in Cameroon were nonetheless noticeable, especially the Cameroonian Society of Gastroenterology whose members often combine clinical experience in hospitals, political work in ministries, and international collaborations mainly with other French-speaking African countries and French clinicians through a pan-African network.
Whereas Cameroonian NGOs were amongst the leading African groups fighting for ARV access in the beginning of the 2000s, there are currently no NGO or patient
groups mobilized to gain access to hepatitis treatment in the country. This absence of politicization regarding access for hepatitis C treatment can be explained by the fact that HIV activist groups are dealing already with numerous urgent matters, such as closely monitoring stock outs of ARVs and laboratory tests, maintaining social support, and so on. Fighting for access to treatment for hepatitis C seems a far-off horizon with so many immediate crises to confront and no specific funding for such new activities. Also the population who is most affected is older than 50 years old and less likely to organize themselves within a patient community. Although there are many HIV activists pleading for access to treatment worldwide (Ford et al., 2012), it is unclear at this stage if the transnational connections that helped activists in the North and in the South to combine their efforts to challenge ARV prices and claim access for all in the case of HIV/AIDS at the end of the 1990s and during the 2000s could be reactivated in the years to come for hepatitis C medicines. It also remains to be seen if and how actors in Cameroon, and in particular activists or medical professionals, will connect with these mobilizations.
Another access program benefitting wealthy patients?
In order to facilitate access to DAAs such as sofosbuvir, the Cameroonian government may also purchase generic medicines under certain circumstances (Njoya et al., 2015). In 2015 Gilead granted voluntary licenses to several Indian generic producers and Cameroon is one of the 91 countries that can benefit from this action (Gilead, 2015). In January 2016, the government announced agreements with Gilead and the generic producer Mylan in order to get sofosbuvir and ribavirine for € 230 per month for genotype 2 or a combination of sofosbuvir, ribavirine and pegylated interferon for € 530 a month, all of which for three months duration of treatment minimum (Tietcheu Galani, Njouom and Moundipa, 2016) but sometimes
up to 24 weeks given difficulties in treating certain genotypes. Despite these agreements, there is no evidence as of the end of 2016 that these drugs are available for prescription. Moreover, patients still have to be able to afford the pre-therapeutic evaluation.
Mobilizations against "rationing" in France
On May 23, 2016, Magalie’s testimony appeared on the website of SOS Hepatites, an association supporting people with hepatitis C. It read:
I have had hepatitis C since 1992, I found out during a blood donation. I was divorced with a kid, and I had to fight (1 medical protocol in 1994 and 1 treatment with Interferon and Ribavirin in 2001) without being able to stop working, always trying to hide my fatigue from my colleagues, my relationships. (...) But the hardest, when you are a brave little soldier “relapser,” who acts as if everything is okay, and tries to live, it is when your hepatologist tells you, “Yes, there is a treatment that can cure you, much shorter, without the side effects of the interferon, with 95% chance of healing but the hospital will not pay € 46,000 to cure you, you have moderate fibrosis, come back in 12 months, we will know a little more.“ (translated by the authors)
Magalie denounced an injustice she suffers on top of carrying hepatitis C: her inability to access a treatment that would most probably cure her, one that her doctor won’t prescribe until her health deteriorates. Two days later, the French Minister of Health and Social Affairs Marisol Touraine announced: “Today I decide universal access to treatment against hepatitis C.” The wording is peculiar, as we will discuss later, but in any event, this declaration ended two years of intense mobilization of patients’ groups and NGOs in France against what they framed as a
“rationing” of the new hepatitis C treatments. A medical triage
It all started in 2013 when the pharmaceutical company Gilead requested a marketing authorization for Sovaldi, the first new DAA against hepatitis C that was ready to be commercialized. In July of the same year the National Agency for Medicines (Agence Nationale de Sécurité du Médicament, ANSM) granted 96 temporary authorizations for use (ATU nominative) for individuals waiting for liver transplants while the marketing authorization was still under review. In August 2013, activists started to complain about the limited access to the medicine. In 2014, the media took up the issue of the price: € 56,000 per patient for a 12-week course of Sovaldi, a cost that “shakes up the social security system,” as pointed out by the conservative newspaper Le Figaro (2014).
In January 2013, the minister of health asked the National Research Agency on HIV and Hepatitis (ANRS) to prepare a report on the social, medical, and ethical aspects of hepatitis B and C, including therapeutic guidelines. Professor Daniel Dhumeaux, chief of the hepato-gastroenterology department at Henri-Mondor Hospital, was given the task to lead this work under the auspices of the ANRS and the French association for the study of the liver (AFEF) that gathers medical doctors and research specialists in hepatology. Meanwhile the issue of the price was getting traction in the media and within the political sphere. On November 25, 2013, the minister of health addressed the National Assembly to reassure the members of Parliament: the new financing law would “allow the treatment of new patients” under a temporary authorizations for use and the imminent marketing authorization. Six months later, Professor Dhumeaux published his report. It proposed guidelines
for the care of people based on the different stages of the evolution of hepatitis C virus disease—describing the degree of fibrosis from 1 to 4—with stage 4 corresponding to cirrhosis, which can progress to end-stage liver disease and/or liver cancer. The report prescribed access to DAAs for all people at stage 2 or above, and for some specific population categories regardless of individual stages (those co-infected with HIV, injecting drug users, inmates, people waiting for liver transplants, woman wanting to have children, etc.). However, a few weeks later, in June 2014, the High Authority for Health (Haute Autorité de Santé, HAS), in charge of providing guidelines to the minister of health and medical professionals, issued different guidelines: only stages 3 and 4 were prescribed access, and no specific categories of patients were declared eligible except patients with HIV or cryoglobulinemia, a blood disease. In a context of intense pressure due to the price of the medicines, the HAS was limiting the number of patients eligible by setting more restrictive criteria.
The concerns of patient groups and NGOs grew. An informal collective formed in May 2014, gathering together SOS Hepatites, AIDS organizations and platforms (AIDES, TRT-5), an NGO working on health inequalities (Médecins du Monde), and an association defending the health of migrants (COMEDE). When the Dhumeaux report was presented at the National Assembly on May 27, 2014, the collective demanded “treatment for each patient” and called for a “fair price.” They then increased their public interventions and held meetings with the authorities, including members from the health ministry and representatives of the Economic Committee of Health Products (Comité économique des produits de santé, CEPS), which is in charge of negotiating prices with pharmaceutical companies. They quickly problematized the situation as an issue of rationing, confronting the authorities and insisting that “rationing [was] not the solution” (hearing set by the CEPS with NGOs on July 3,
2014). The use of the term “rationing” triggered reactions from officials (including members of the health minister’s cabinet, the head of the CEPS, for instance) who strongly rejected the term to describe the policy implemented. Despite the mobilization, the HAS recommendations were implemented.
Slowing down the patient flow and the number of treatments bought?
At the end of 2014, health authorities instituted a system to regulate the prescription of DAAs, through an eligibility review by a pluridisciplinary group (Réunion de concertation pluridisciplinaire, RCP). A doctor willing to prescribe DAAs to a patient should file a request to this collective of professionals that includes a hepatologist, a caregiver in therapeutic education, a virologist, a pharmacist, a social worker, and a clinical research associate. Eligibility for DAAs was to be decided on a case-by-case basis by the RCP, and medical care with DAAs could only take place at hospitals.
National institutions argued that this system was aiming at “an optimal level of organization for the follow-up of treated patients, in order to maximize the benefit expected from these new treatments and to ensure equality in their availability throughout the national territory” (Ministry of Health, 2015) (translated by the authors). Patients’ interpretation of this policy was, however, somewhat different. As the process mechanically slows down the prescription of DAAs to new people, patients viewed it as a way to keep control over and limit the number of treatments purchased.
In October 2014, the minister of health presented a new budget tool dedicated to containing spending on medicines. A ceiling on sales was set by law: pharmaceutical companies would have to return a percentage of their revenues to social security
coffers after earnings of € 450 million in 2014 and € 700 million in 2015. However, as it takes place ex ante, this mechanism does not take the budgetary pressure off hospitals or medical doctors – the price of the medicines stays extremely high and has to be paid when the drugs are purchased. As a consequence it continues to influence prescribing and, for instance, doctors who may be tempted to carry out social triage by giving up on requesting treatments for some categories of patients (those who seem to have more risk of being re-infected, foreigners, people with precarious administrative situations, etc.).
The issue of prices was not only raised by civil society organizations. The HAS concluded its report with a clear alert: “The College of the HAS is highly concerned about the impact that such prices could have. (…) The objective of safeguarding a fair and equitable health system requires the utmost vigilance and a firmly critical approach towards the argumentation to justify prices” (HAS, 2014: 16) (translation by the authors). NGOs and patient groups, for their part, did not only question the price and the way prices were negotiated. They raised the matter of the monopoly established by the patent, should the patents have been granted (MDM, 2015), and called on the government to lift this protection so that generic versions of the medicines—which could be more than one hundred times cheaper—could be bought, and hence rationing removed.
Limited universality and the paradox of patient groups’ positions
For two years, the demand for greater access to the new medicines came together with a critique of certain features of the economy of pharmaceuticals responsible for high prices. But the absence of universal access eventually led most of them (AIDES, TRT5, SOS Hepatites, COMEDE) to reshape their demands, at least temporarily, and
put the issue of treatment availability at the center while releasing the pressure on the issue of patent and price. During the first quarter of 2016, representatives of the medical community (AFEF, ANRS, etc.) and most activists aligned their positions to advocate for universal access to DAAs; criticizing high prices and patent monopolies was considered counterproductive by prominent representatives of the medical profession.
Meanwhile, Gilead started to point out that the budget of € 700 million to buy treatment in 2015 had not been fully spent. Representatives from Gilead insisted that “access for all” was their objective too. In something presented as a philanthropic gesture at several meetings (including an event at the Carnegie Endowment for International Peace in Washington, DC, on April 14, 2015), they even mentioned that they could extend credit to allow states to pay for the three-month cure over a longer period. With pharmaceuticals at the heart of the politics of hepatitis C and with this chorus of voices for universal access, it became difficult not only for patient groups but also for the state to distinguished their agendas from that of the industry: all focused on access while the issue of the economic conditions set by the industry was pushed into the background.
In May 2016, the French state staged its allegiance to the principle of universal access. But it did so in a somewhat ambiguous way. When Minister of Health Marisol Touraine said, “Today I decide universal access to treatment against hepatitis C” (Aujourd'hui, je décide l'accès universel aux traitements de l'hépatite C) (Touraine, 2016), many people heard that universal access was declared. However, Touraine said, “today I decide”; she did not say that today universal access now exists. As a matter of fact, on the day of this declaration the HAS only gave a green light to extending the eligibility criteria to stage 2 patients and certain populations
considered particularly vulnerable. Thus, if for the French authorities it was not possible to publicly justify rationing, it was also impossible to allow all the patients who could benefit from the treatment to access it at the price requested by the company. For the patients, at this point, the demand for access trumped the issue of price and the economics of pharmaceuticals.
Discussion
Rationing as indicative of the politicization of access
A close look at the specific organization and history of "rationing" enables us to discern asymmetries as well as similarities between France and Cameroon. In France, restrictive medical criteria in official recommendations were used to limit eligibility while the setting up of a funnel in the process of treatment initiation slowed down the number of patients beginning treatment. The setting looks similar to the rationing based on biomedical criteria of ARVs against HIV described in developing countries (Bennett and Chanfreau, 2005). Medical rationing appears when a eligibility threshold is set lower than in medical guidelines established by recognized experts in the field, and is used to limit the number of patients accessing a medical treatment or product. In France, treatment decisions could lead to forms of triage depending on social criteria associated with a better treatment efficacy, thereby excluding people living in precarious situations, for instance. In Cameroon, the eligibility committee decides medical criteria, but social and economic criteria such as a patient’s connection to elites remain the key to gain access to drugs. These settings contribute to make rationing a social and relatively unnoticed practice, behind the affirmation of strict medical criteria.
In France the political stakes were raised by the use of the word “rationing.” Because “the majority of the French population is in favor of public financing and is opposed to rationing medical care services” (Lancry and Sandier, 1999: 36) policy makers anticipated that raising the idea of rationing would “provoke the public” (Light and Hughes, 2001: 562) and “create negative reactions and (…) lead to political opposition” (Lancry and Sandier, 1999: 38). Therefore they strongly rejected its use in describing the policy of access to DAAs. In this context, for patient groups and NGOs, using the term could precisely help raise public awareness about this new social and economic problem, foregrounding the principle of universal access dear to French society. Framing the issue as “rationing” was a way to organize interactions and power relations related to access to DAAs. According to French activists, instead of building labyrinthine systems for access to medicines, the government should question both the price and the rationale behind it.
Linking the issue of access to the issue of price was new for activists in France and indicative of the politicization of the economy of pharmaceuticals. Until then, patient groups and NGOs never talked about the price of HIV drugs or of the previous generation of hepatitis C treatments (which, although less expensive, were already more than € 10,000 euros per patient per year). The goal for them was to make sure patients were 100% covered by the National Health Insurance (NHI, or Assurance-maladie) and its national sickness fund, and that patients were not made to pay for the treatment. Between 2013 and 2016, in contrast, because universal access was not implemented, they sought to make the government eschew rationing by questioning the way prices were set and a monopoly situation established by the patents. They denounced rationing for it penalized patients while leaving untouched the economic system that produces it.
As Bennett and Chanfreau (2005) detected in their review on the rationing of ARVs in Africa, the more implicit the rationing is, the more difficult it is to identify, denounce, and politicize. In Cameroon and in several Africa countries, rationing has not really and durably been denounced in the past decades, but instead remains hidden behind the rhetoric of “access,” leaving inequities in access to healthcare unnoticed and depoliticized. This is a consequence of structural adjustment policies and user fee policies in public health facilities. In this sense relying on the capacity to pay within sporadic vertical programs to access innovative drugs has led to a naturalized form of rationing. Based on this comparison of Cameroon and France, we argue that the rhetoric of “access” (well known in post-structural-adjustment Africa, and growing in France) might be a way to hide—and make acceptable—rationing policies in an austerity context.
Cameroonian health officials acknowledge that the government has started to take action against hepatitis C. Hoffman-La Roche is considered as the first partner of the government and the Access program is seen as a pilot program from which lessons learned will help build a strong national hepatitis program. This institutional process is inherited from the model developed for ARV provision in the 2000s in which small pilot programs with a few hundred or thousand patients, with the participation of pharmaceutical companies, were used to design future policy. These programs provided policy makers with proof of patients’ adherence and recommendations regarding the organization of care. While mentioned in the discourse of pharmaceutical companies, “universal access” is rarely their objective, leaving the state with the hard task of integrating these programs and offering decentralized and nation-wide access to drugs, with limited infrastructure and resources.
In Cameroon, although still theoretical at this point, DAAs are supposed to be made accessible through voluntary licenses granted by the company Gilead. In France, in response to critiques about the limiting of access, the company proposed some price reductions (from € 56,000 to € 41,000) and introduced the idea of payment through credit. In both contexts, these initiatives reinforce the control of the pharmaceutical industry over the economy of medicines and public health policies.
The production of scarcity in a time of austerity
In their review of recent trends in studies of pharmaceuticalization, Bell and Figert (2012: 781) argue that “recalibrating the balance of research sites towards the global South will enrich our understandings of the global flow of pharmaceuticals.” Indeed, trying to understand the social process supporting the phenomenon of pharmaceuticalization of healthcare systems, scholars analyze how specific drug access programs in the South produce, through industry foundations, philanthropic foundations, and public/private partnerships, a kind of “abundance” of medications and associated services (therapeutic education, food supplementation, cash for income-generating activities, etc.) (Biehl, 2007). This abundance is commonly described in terms of “extension” (like the WHO’s “3 by 5” initiative, which called for the treatment of 3 million HIV-positive people in 2005) or “scaling up” (Kenworthy and Parker, 2014). The massive flow of money and drugs for HIV have made obvious the contrasts between pockets of abundance and states of abandonment, requiring an analysis in terms of an “economy of scarcity” (Kalofonos, 2010; Sullivan, 2011). As a concept that defines social processes that transform problems into ones which can be solved with pharmaceuticals, pharmaceuticalization points to situations of scarcity and more so to the production
of scarcity, especially in contexts of budgetary constraints, beyond North–South distinctions.
In the South as well as in the North the patent protections on medicines increased in number and duration in recent decades (Krikorian, 2010a ; 2010b). These monopoly rights are considered essential to the research and development of new pharmaceutical products, but they also have a strong impact on the circulation of knowledge and the price of products. In the absence of competition, prices can become extremely high, as witnessed in the case of DAAs. Such prices render medicines, while cheap to produce (Hill et al., 2014), out of reach for patients, not only in the low- and middle-income countries, where this has been the reality for many years, but now also in countries with social welfare and national health insurance where access to new medical innovations has emerged as a new social problem. This trend, generated by patent and intellectual property law, is reinforced by the financialization of the pharmaceutical sector since the 1980s and 1990s, which, in connection with structural adjustment policies, has produced "speculative markets" (Peterson, 2014), multi-billion dollar corporate mergers, and the acquisition of start-up companies and patents, as exemplified by Gilead and sofosbuvir (Prescrire, 2014). The current economics of pharmaceuticals rests on a monopoly system, dominated by a handful of multinationals, that organizes an economy of scarcity. Although being in theory relatively cheap to manufacture and sell, medicines are made inaccessible to many across the globe through the regulation of monopolies. Hence, we argue that the phenomenon of pharmaceuticalization of healthcare systems is not only related to pharmaceutical abundance or pharmaceutical spread through marketing and communication techniques, as it is often described. It is also about the controlled distribution of pharmaceuticals as
products of scarcity. Rationing, generated by the economics of pharmaceuticals, exacerbates, in return, a context of austerity.
Conclusion
Rationing is a key field of research to understand current developments in public health systems especially in times of austerity, and lessons can be drawn from the African continent where rationing healthcare and drugs has become the norm since the structural adjustment policies adopted in the 1980s. African countries rely heavily on user fees and pharmaceutical companies’ initiatives such as the "Access" program for hepatitis C in Cameroon. Eligibility for the drugs is determined by social, economic, and political factors within a very unequal healthcare system. A closer look at rationing practices helps us understand both the functioning of African healthcare systems where scarcity has become the norm, and the growing concern about access in countries where social welfare systems are hit by economic crisis and austerity policies. In France, the term “rationing” was used politically to denounce the prices of medications, the patent system, and the economy of scarcity. But social mobilizations struggled to distance themselves from the agenda of pharmaceutical companies, and eventually the rhetoric of "access" eclipsed their critiques of the economy of pharmaceuticals, and more generally of the economy of scarcity that goes with it. In the end, the political economy of pharmaceuticals shapes public health policies and favors rationing practices that in turn spread a rationality of austerity. The study of social processes connected to austerity might benefit from further transnational studies exploring in greater length the micro-politics of rationing.
References
Abraham, J. (2010). Pharmaceuticalization of society in context: theoretical, empirical and health dimensions. Sociology 44 (4), 603-22.
Andrieux-Meyer, I., Cohn, J. Affonso de Araújo, S., Saeed, S. H. (2015). Disparity in market prices for hepatitis C virus direct-acting drugs. Lancet Glob. Health. 3(11), e676-77.
Bell, S. E., & Figert, A. E. (Eds.). (2015). Reimagining (bio) medicalization,
pharmaceuticals and genetics: old critiques and new engagements.
Routledge.
Bell, S., E., & Figert, A. E. (2012). Medicalization and pharmaceuticalization at the intersections: Looking backward, sideways and forward. Social Science &
Medicine 75(5), 775–783.
Bennett, S., Chanfreau, C. (2005). Approaches to rationing antiretroviral treatment: ethical and equity implications. Bull. World Health Organ. 83(7), 541–547. Biehl, J., (2007). Pharmaceuticalization: AIDS treatment and global health politics.
Anthropol. Q. 80, 1083–1126.
Chabrol F. (2014). Biomedicine, Public Health, and Citizenship in the Advent of Antiretrovirals in Botswana. Developing World Bioethics. août 2014;(2):75-82. Chabrol F. (2016). Les paradoxes de la pharmaceuticalisation de la santé publique en
Afrique. Les hépatites virales au Cameroun dans le sillon du VIH/sida. In: Collin J, David P-M, éditeurs. Vers une pharmaceuticalisation de la société? Le
médicament comme objet social. Montreal: Presses Universitaires du Québec; 2016. p. 77-98.
Collin J. and David P-M. (2016). Vers une pharmaceuticalisation de la société? Le
medicament comme objet social. Presses de l'Université du Québec, Québec.
Comaroff, J. & Comaroff, J. (2012). Theory from the South, Or, How Euro-America Is
Evolving Toward Africa. Boulder: Paradigm Publishers.
David, P. M. (2014). Towards the embodiment of biosocial resistance? How to account for the unexpected effects of antiretroviral scale-up in the Central African Republic. Glob. public health, 9(1-2), 144-159.
David, P. M. (2017). Measurement,“scriptural economies,” and social justice: governing HIV/AIDS treatments by numbers in a fragile state, the Central African Republic (CAR). Developing world bioethics. 17(1), 32-39.
Denzin, N., & Lincoln, Y. (2011). The SAGE Handbook of Qualitative Research. SAGE. Desclaux, A., Egrot M. (2015). Anthropologie du médicament au Sud. La
pharmaceuticalisation à ses marges. Paris: L'Harmattan.
Desclaux, A., Lanièce, I., Ndoye, I., Taverne, B. (2002). The Senegalese Antiretroviral Drug Access Initiative: an economic, social, behavioural and biomedical
analysis. Sciences sociales et sida. Paris: ANRS.
Fassin, D. (2008). The elementary forms of care: An empirical approach to ethics in a South African Hospital. Social Science & Medicine 67(2): 262–270.
Ford, N., K. Singh, S., Cooke, G., Mills, E., von Schoen-Angerer, T., Kamarulzaman, A., du Cros, P. (2012). Expanding access to treatment for hepatitis c in resource-limited settings: Lessons from HIV/AIDS. Clin. Infect. Dis. 54(10), 1465–1472. Gilead. (2015). Chronic hepatitis C treatment expansion generic manufacturing for
developing countries. August,
https://www.gilead.com/~/media/files/pdfs/other/hcv%20generic
HAS. (2014). Recommandations du collège. Prise en charge de l'hépatite C par les médicaments anti-viraux à action directe (AAD). June.
Hill, A., Khoo, S., Fortunak, J., Simmons, B., Ford, N. (2014). Minimum costs for producing hepatitis c direct-acting antivirals for use in large-scale treatment access programs in developing countries. Clin. Infect. Dis., janvier, ciu012. Kalofonos, I. (2010). “All I eat is ARVs!” The Paradox of AIDS treatment interventions
in Mozambique. Med. Anthropol. Q. 24(3): 363–380.
Kamdoum, A. (1994). Planification sanitaire et ajustement structurel au Cameroun. Paris, les dossiers du CEPED, n°29, décembre.
Kenworthy, N., & Parker, R. (2014). HIV scale-up and the politics of global health.
Glob. Public Health 9(1-2), 1–6.
Krikorian G. (2010a). Free Trade Agreements and Neoliberalism: how to derail the political logics imposing strong IP protection? in Krikorian G. & Kapczynski, A. Eds (2010). Access to Knowledge in the Age of Intellectual Property, Zone Books Eds., New York, 293-328.
Krikorian G. (2010b). « Dispositions ADPIC-plus introduites dans le cadre des négociations internationales ». In G. Velasquez & C. M. Correa (éd.),
Innovation pharmaceutique et santé publique, L’Harmattan, Paris, 131-143.
Lachenal, G., Lefève C. & V.-K. Nguyen (2013). La médecine du tri. Paris: PUF. Lancry, P.-J. & Sandier, S. (1999). Rationing health care in France. Health Policy.
50(1), 23–38.
Le Figaro. 2014. Hépatite C : le médicament qui bouleverse la Sécu. September 27. Available at:
Lemoine, M., Nayagam, S. & M. Thursz. (2013). Viral hepatitis in resource-limited countries and access to antiviral therapies: current and future challenges.
Future Virol. 8(4), 371–380.
Light, D. & D. Hughes. (2001). Introduction: A sociological perspective on rationing: power, rhetoric and situated practices. Sociol. Health Illn. 23(5), 551–569. Madhava, V., Burgess C., Drucker, E. (2002). Epidemiology of chronic hepatitis C
virus infection in sub-Saharan Africa. Lancet Infect Dis. 2(5), 293-302. Mechanic, D. (1997). Muddling through elegantly: finding the proper balance in
rationing. Health Aff. 16(5), 83.
Médecins du Monde. (2015). Médecins du Monde s’oppose au brevet sur le sofosbuvir. Hépatite C: fléau, remède et scandale. 10 February. Ministry of Health. (2015).
http://social-sante.gouv.fr/soins-et-maladies/maladies/maladies-infectieuses/article/l-hepatite-c, consulted on September 26, 2016.
Nerrienet, E., R. Pouillot, G. Lachenal, R. Njouom, J. Mfoupouendoun, C. Bilong, P. Mauclere, C. Pasquier & A. Ayouba. (2005). Hepatitis C virus infection in Cameroon: A cohort-effect. J. Med. Virol. 76(2), 208–214.
Nguyen, V-K. (2009). Government-by-exception: Enrolment and experimentality in mass HIV treatment programs in Africa. Soc. Theory Health. 7(3), 196–217. Njoya, O., Essi, M.-J., Ngono Mballa R., Miambe, S. (2016). Propriété intellectuelle et
traitement des Hépatites Virales B et C au Cameroun: une etude des enjeux.
Health Sci. Dis. 16(3), 1-5.
Noah Noah, D., Njouom R., Bonny A., Pirsou, Meli, J., Biwole Sida, M. (2011). HBs antigene prevalence in blood donors and the risk of transfusion of hepatitis B at the central hospital of Yaounde, Cameroon. O. J. Gas. 1, 23-27.
OECD. 2008. OECD Economic Outlook, No. 84, November.
Oxfam International. 2013. The true cost of austerity and inequality.
https://www.oxfam.org/sites/www.oxfam.org/files/file_attachments/cs-true-cost-austerity-inequality-france-120913-en_0.pdf, accessed 10 January 2017. Peterson, K. 2014. Speculative Markets: Drug Circuits and Derivative Life in Nigeria.
Durham, NC: Duke University Press.
Pfeiffer, J., Chapman, R. (2010). Anthropological perspectives on structural adjustment and public health. Ann. Rev. Anthropol. 39(1), 149-65.
Riou, J., Aït Ahmed, M., Blake, A., Vozlinsky, S., Brichler, S., Eholié, S., Boëlle, P.-Y., Fontanet, A., the HCV epidemiology in Africa group. (2016). Hepatitis C virus seroprevalence in adults in Africa: a systematic review and meta-analysis. J
Viral Hepat. 23, 244–255.
Prescrire. (2014). Oser refuser un prix exorbitant pour Solvadi! October, 34 (372): 765.
Sullivan, N. (2011). Mediating abundance and scarcity: Implementing an HIV/AIDS-targeted project within a government hospital in Tanzania. Med. Anthropol. 30, 2, 202–221.
Tietcheu Galani BR, Njouom R, Moundipa PF. (2016). Hepatitis C in Cameroon: What is the progress from 2001 to 2016? J Transl Int Med. 4, 4, 162-9.
Touraine, M. (2016). Discours de Marisol Touraine: Journée de lutte contre les hépatites virales, 25 May.
http://social- sante.gouv.fr/actualites/presse/discours/article/discours-de-marisol-touraine-journee-de-lutte-contre-les-hepatites-virales
Van der Geest, S. & Finkler, K. (2004). Hospital ethnography: introduction. Social
Weill-Barillet, L., Pillonel, J., Semaille, C., Léon, L., Le Strat, Y., Pascal, X., ... Jauffret-Roustide, M. (2016). Hepatitis C virus and HIV seroprevalences,
sociodemographic characteristics, behaviors and access to syringes among drug users, a comparison of geographical areas in France, ANRS-Coquelicot 2011 survey. Revue Epidemiol. Sante Publique. 64(4), 301-312.
World Health Organization. 2016. Global Report on Access to Hepatitis C Treatment.
Focus on Overcoming Barriers. October,
http://apps.who.int/iris/bitstream/10665/250625/1/WHO-HIV-2016.20-eng.pdf, accessed 10 January 2017.
Whyte, S., Whyte, M., Meinert, L., & Kyaddondo, B. (2006). Treating AIDS: Dilemmas of unequal access in Uganda. In Petryna, A., Lakoff, A. & Kleinman, A. (Eds).
Global Pharmaceuticals. Ethics, Markets, Practices. Duke University Press,
