At the current rate of progress there are legitimate fears that Millennium Development Goal 5 to reduce maternal deaths by 75% will be missed. Research has shown that financial barriers to obstetric care are one of the major causes of the high rate of maternal and child deaths in Sub Saharan Africa. In 2005 Mali introduced fee exemptions for caesarean sections and a recent USAID evaluation of the policy found that it increased access to caesarean section and reduced maternal and neonatal deaths. These findings support the growing body of evidence that removing user fees for health services is an effective way of saving millions of vulnerable lives.
In Mali, maternal mortality is as high as 464 deaths per 100,000 live births. In addition less than 50% of women give birth in a healthcare facility. These trends are driven primarily by socio-economic factors, with poorer women having disproportionately less access to health care due to financial barriers created by user fees. In response, in 2005 the government of Mali initiated a universal policy on user fees exemption for caesarean section. Under the policy, the government pays for the direct cost of caesarean services for all women regardless of their socio-economic status. However, indirect cost associated with receiving these services such as transport costs to hospital are borne by households and in some cases community based solidarity funds.
But six years since the implementation of Mali’s free caesarean policy, what has been the impact of the policy on maternal health and what lessons can be learnt? A recent evaluation of the policy by USAID has found that between 2005 and 2009 caesarean rates in Mali has doubled from 0.9% to 2.3%, while facility deliveries also increased from 53% to 64 %. The policy also resulted in a decline in post caesarean and neonatal deaths.
The free caesarean policy was initiated by the Government of Mali and fully funded from internally generated funds. This, contrary to the much held view that poor countries are not financially capable of providing free healthcare, is an indication that given the right political commitment poor countries can mobilise the needed funds to provide free healthcare for their population.
Mali’s free caesarean policy still faces many challenges that need to be addressed. Firstly, the evidence from the USAID report suggests that the policy was less pro-poor than intended, with only 23% of women delivering by caesarean section in public facilities belonging to the lowest socio-economic group. The report finds that there are still barriers to access among women from the lowest socio-economic groups including a high cost of prescription drugs and indirect costs such as transport. These barriers need to be addressed if the policy is to have greater positive impact on the poor women. Christine Sow, who leads UNICEF’s Child Survival Section and is the Chair of Mali’s Health Sector Technical and Financial Partners Working Group noted at national conference on free health policy, these initiatives [ the caesarean policy] should not only increase access, but should ensure that the most vulnerable can and do benefit.”
Secondly, the report also shows that Mali’s free caesarean policy was limited by poor referral and the lack of emergency transport system. In addition, the policy is challenged by poor road conditions; poor supply of drugs and caesarean medical supplies; lack of awareness about the specific components of the policy; and socio-cultural barriers to maternal healthcare utilisation.
Indeed, the above highlights several important lessons in trying to improve access through the elimination of user fees. First, policies that deal with access to healthcare need to recognise that barriers to access are multi-faceted which requires coordination of the activities of different sectors of government and the involvement of diverse players in order to deal with healthcare access effectively. Second, it is important for policy makers to recognise that user fees removal creates a welcome increase in demand for healthcare, and thus, there is a need to expand healthcare resources and supply to meet this demand.
The free caesarean policy in Mali has shown that the elimination of user fees for healthcare is an effective approach for enhancing maternal and child health. It also demonstrates that domestically funded free healthcare policy is feasible in poor countries (albeit that this is limited to C-sections in Mali), and that by paying attention to other aspects of healthcare cost and access, the removal of user fees can serve as an effective measure for enhancing access to healthcare and improving health outcomes.
Selon le niveau de progression actuel, il existe des raisons légitimes de penser que le 5ème objectif du millénaire pour le développement visant la réduction de la mortalité maternelle de 75 %, ne sera pas atteint. Des études ont démontré que les contraintes financières pour l’amélioration des soins obstétriques constituent les principales causes du taux élevé de la mortalité infantile et maternelle en Afrique sub-saharienne. En 2005, le Mali a mis en place un système d’exemption de paiement pour les césariennes, et une évaluation récente de cette mesure, conduite par l’USAID, a montré qu’entre 2005 et 2009 le taux de césariennes a doublé allant de 0,9% à 2,3%, tandis que le taux de fréquentation des services de maternité a augmenté de 53% à 64%. La politique a également eu pour conséquence une baisse de la mortalité post-césarienne et néonatale. Ces résultats viennent renforcer les preuves de plus en plus nombreuses indiquant que l’abolition du paiement direct au niveau des services de santé est un moyen efficace qui permet de sauver des millions de vie vulnérables.
Au Mali, la mortalité maternelle a atteint 464 décès pour 100000 naissances. En outre, moins de 50% des femmes accouchent dans un centre de maternité. Ces tendances résultent principalement de facteurs socio-économiques : de manière disproportionnée, les femmes les plus démunies ont un accès limité aux soins de santé à cause de la barrière financière que représente le paiement direct par l’usager. En guise de réponse, le gouvernement malien a initié en 2005 une politique universelle d’exemption de paiement pour les accouchements par césarienne. Afin de mener une telle politique, le gouvernement subventionne le coût de la césarienne pour chaque femme quel que soit son statut socio-économique. Cependant, les coûts indirects associés à un tel service, comme le transport vers l’hôpital restent à la charge des ménages et parfois ils sont supportés par un fonds de solidarité communautaire.
Six ans près la mise en place de la politique malienne de gratuité de la césarienne, quel en a été l’impact sur la santé maternelle et quelles sont les leçons à retenir ? Selon une évaluation récente de cette politique par l’USAID, entre 2005 et 2009 les taux de césarienne au Mali ont doublé de 0,9% à 2,3%, tandis que le taux de fréquentation des centres de santé a également progressé de 53% à 64%. Cette politique a donc eu pour conséquence la baisse de la mortalité post-césarienne et néonatale.
Cette politique de gratuité de la césarienne a été initiée par le gouvernement malien et entièrement financée par des ressources domestiques. Ce qui, contrairement à l’argument récurrent selon lequel les pays pauvres sont dans l’incapacité financière de fournir des soins de santé gratuits, démontre que lorsque l’engagement politique est réel les pays pauvres sont en en mesure de mobiliser les fonds nécessaires pour délivrer des soins de santé gratuits à leur population.
La politique malienne de gratuité de la césarienne est néanmoins toujours confrontée à des défis qui doivent être résolus. En premier lieu, la preuve émanant du rapport de l’USAID suggère que cette politique a moins bénéficié aux démunies que prévu. En effet, seuls 23% des femmes accouchant par césarienne dans des services de santé publics sont issues de la catégorie socio-économique la plus basse. Selon ce rapport, il existe toujours des barrières à l’accès pour les femmes appartenant aux groupes socio économiques les plus défavorisés : le coût élevé des ordonnances et des coûts indirects liés au transport. Ces barrières à l’accès doivent être prises en considération pour permettre à cette politique d’avoir un impact positif plus significatif sur les femmes démunies. Christine Sow, qui dirige la division de l’Unicef pour la survie de l’enfant et la Chaire malienne du groupe de travail des partenaires techniques et financiers en santé a indiqué lors d’une conférence sur les politiques de gratuite en santé que « ces initiatives [la gratuité de la césarienne] ne doivent pas seulement augmenter la capacité d’accès aux soins, mais aussi garantir que les couches les plus vulnérables peuvent concrètement en bénéficier ».
En second lieu, ce rapport montre également que la politique malienne de gratuité de la césarienne a été freinée par un système médical de référence ? Défaillant ainsi qu’un manque de système de transport d’urgence. En outre, cette politique est mise en difficulté par le caractère vétuste du réseau routier, une fourniture faible en médicaments et en matériel médical pour la césarienne ; le manque d’information sur les composantes spécifiques de cette politique ; les barrières socioculturelles liées à l’utilisation des soins de santé maternelle.
Aussi, ces éléments mettent en exergue plusieurs leçons importantes à retenir dans le processus d’amélioration de l’accès aux services de santé par l’élimination du paiement direct par les usagers. Tout d’abord, les politiques en faveur de l’accès aux soins de santé doivent prendre en compte la complexité des barrières à l’accès aux soins et la nécessité d’une coordination des activités des différents secteurs du gouvernement de même que l’implication de divers acteurs afin de pouvoir gérer efficacement l’accès aux soins. Ensuite, il est primordial que les décideurs acceptent que l’élimination du paiement direct génère une augmentation souhaitable de la demande en soins de santé, ce faisant, il est nécessaire d’accroître les ressources en soins et fournitures de santé afin de répondre à une telle demande.
La politique malienne de gratuité de la césarienne a démontré que la suppression du paiement direct par les usagers constitue une démarche efficace pour l’amélioration de la santé maternelle et infantile. Elle a également prouvé que le financement des politiques de gratuité des soins de santé par des ressources nationales est réalisable dans les pays pauvres (même si cela se limite à une politique de gratuité ciblée au Mali). Aussi, en considérant les autres aspects liés à l’accès et au coût des soins de santé, la suppression du paiement direct est une mesure efficace pour renforcer l’accès aux soins de santé et améliorer le niveau de santé.
In an open letter to the citizens of Europe, the Chairperson of South Africa’s world famous Treatment Action Campaign appeals for collective action to stop European leaders pursuing harmful intellectual property provisions in the EU-India free trade agreement. India supplies 80% of the HIV medicines used in developing countries – the free trade agreement threatens this live saving supply.
An Open Letter to the Citizens of Europe
from Nonkosi Khumalo, Chairperson, Treatment Action Campaign, South Africa
Dear Citizens of Europe:
We are writing to you as people living with HIV/AIDS, who rely on access to affordable medicines to stay alive. We are writing to you because your governments are pushing to limit our access to medicines through a Free Trade Agreement the EU is negotiating with India, which is the world’s largest producer of affordable generic medicines. This week, as the EU and India meet for a summit in Delhi, our lives hang in the balance as the two sides make trade-offs to come to an agreement. Don’t let your governments trade away our lives.
The Treatment Action Campaign (TAC) was launched in South Africa in 1998 at a time when people across Africa were dying from AIDS because they couldn’t afford the high price of life-saving antiretroviral medicines. Over the past decade, TAC has campaigned with our international partners for affordable access to these medicines – seeing a nearly 99% drop in the price of a standard triple drug combination, from roughly 9,000 EUR per patient per year in 2000 to below 115 EUR per patient per year today. These prices came down primarily because of market competition among generic drug producers in India. Yet the battle for medicines access is not over, and many medicines, including cancer drugs and newer HIV medicines that people need after time, remain inaccessible to people in the developing world because of their high price.
We implore you, as citizens of the European Union, to stand with us against policies that are being pursued by your governments through the EU-India Free Trade Agreement (FTA) that will block our access to affordable medicines – putting our health and lives at risk. The agreement is being negotiated in secret, without opportunity for input by the citizens of EU member states and India. The EU has threatened to back out of the negotiations if the FTA is not signed by February – an attempt to force India to accept many of the harmful provisions the EU demands.
Ensuring that access to HIV medicines is protected is crucial to save lives and also reduce transmission of the virus. Last year, a landmark clinical trial showed that HIV treatment reduces by 96% the risk that the virus will be passed on. It is imperative that medicines remain available and affordable so that we can begin to turn the epidemic around.
India is often called the ‘pharmacy of the developing world.’ A study found that between 2003 and 2008, India supplied more than 80% of the HIV medicines used for the treatment of people living with HIV in developing countries. Beyond HIV, India is a vital supplier of affordable generic medicines to treat many other diseases.
But all this could change if the EU continues to pressure India to agree to more stringent intellectual property protection than that required by international trade rules. The United Nations, the World Health Organisation, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and UNITAID have all warned against the adoption of these stringent measures that exceed India’s obligations. The adverse impact these excessive intellectual property provisions have on access to medicines is well documented.
The harmful measures pushed by the EU include: so-called ‘data exclusivity’ that will delay the registration of generic medicines; investment rules that will allow multinational companies to sue the Indian government for implementing pro-health policies, and intellectual property enforcement measures that will, for example, block legitimate medicines from leaving India on their way to patients in other developing countries. The EU’s own experiment in increasing the enforcement of intellectual property has already had harmful consequences on access to medicines, with generic HIV medicines made in India being detained by European Customs officials on their way to Africa on allegations of intellectual property violation. The very real consequence of these seizures is stock-outs of medicines in clinics in poor countries and the interruption of life-saving treatment. The EU is now trying to legitimize these measures through trade agreements.
The European Parliament itself has recognised the role of India in supplying medicines to the developing world and understands the policies the European Commission (EC) is pushing through the FTA will have “a detrimental impact … on the availability of generic medicines.” Since the FTA negotiations started in 2007, health and public interest groups have repeatedly written to the European Commission asking them to remove these harmful demands. Across Latin America, Asia, Africa and Europe, people living with HIV have taken to the streets demanding that the EC withdraw its demands. Yet the EC persists.
As people living in developing countries, we are deeply dismayed that EU governments are pushing policies that prioritize profits of the already extremely profitable pharmaceutical industry at the expense of our lives.
For the first time in the history of the epidemic, we can now talk about reversing HIV/AIDS. We now know that HIV treatment itself—which TAC and countless other groups across the developing world have fought for over the past decade—holds the key to stopping infections. As citizens of the EU, we ask you to stand with us in solidarity by calling on your leaders not to pursue harmful intellectual property provisions in the FTA that will take this treatment out of our hands.
We ask you to stand up for our lives.
Nonkosi Khumalo, Chairperson, Treatment Action Campaign, South Africa
India is known as the pharmacy of the world but 65% of Indians have no access to essential medicines. Watch this video to see how the State of Rajasthan in India is tackling the problem by promoting generic medicines and providing these free of charge in the public sector.
This week negotiations continue on the EU-India Free Trade Agreement. Worldwide there are serious concerns that the deal will include stricter intellectual property rules than necessary and result in a deadly escalation in medicine prices for developing countries. Such a deal would also threaten innovative and progressive schemes like this one in India itself.
This week, Indian and European Union (EU) trade negotiators in New Delhi will most likely announce that they have reached a preliminary agreement on a trade pact that will forge a new commercial relationship between the two economies. The EU wants the pact to include new intellectual property (IP) rules that go beyond current requirements under international law. These new IP rules would serve the interests of multinational pharmaceutical companies in Europe, while drastically increasing medicines prices for millions of poor people in India and other developing countries.
If India accepts the new rules, the impact on public health would be severe, especially for the poorest people in India who buy medicines out of pocket. The Government has found that 80% of all out of pocket expenses for health care are medicines, meaning people are highly sensitive to any rise in medicine prices. If the Indian Government caves in to EU demands, it may force Indian households to forego life-saving treatment in the future, or to make difficult choices between medicines and other basic necessities. Some States in India have recognized the negative impact of people paying out of pocket for medicines and provide free medicines instead. Such a scheme is working particularly well in Rajisthan for example. However, such progressive programs could be put at risk if medicine costs rise as a result of this trade agreement.
Compounding these concerns is India’s role as the ‘pharmacy of the developing world’. India produces over two-thirds of all of the generic medicines (identical copies of originator medicines) used in low and middle income countries, including over 80% of all medicines used to treat HIV and AIDS. Competition in the Indian marketplace is fierce, and producers continuously innovate new ways to reduce the cost of making quality medicines, both simple and complex. Competition from Indian generics has reduced the cost of providing treatment for a range of illnesses through multilateral and government programs, in addition to making quality medicines more accessible for patients who must buy them out of pocket. The price of medicines to treat HIV and AIDS fell drastically, from 10,000 USD per patient per year, to less than 80 USD, thanks in large part to robust generic competition amongst manufacturers in India.
Yet India’s role as pharmacy of the developing world is already eroding. Today, India is a member of the World Trade Organization (WTO) and therefore already plays by certain trade rules, including in relation to intellectual property. For instance, it must provide patents, which confer a time-limited monopoly, to innovative companies to reward them for developing new products including medicines. Indian companies must wait for a patent to expire before they can produce identical, quality copies of innovator medicines for use in India and for export to poor patients around the world. From 2005, India started granting patents for medicines, meaning delays to provide generics are increasing.
It hasn’t been all bad news until now. An important feature of these global trade rules is they do not prevent countries from addressing public health concerns, including high medicine prices. Countries have recourse to a set of policy tools that can be used to keep medicine prices from rising, and to ensure that competition can be stimulated to bring down prices. The right of countries to use these tools was affirmed in 2001, when WTO members unanimously agreed to the Doha Declaration on TRIPS and Public Health, which stated that the rules must be applied in a way that promotes public health and, in particular, access to medicines for all.
Having entered trade negotiations with the EU, the Indian Government is under immense pressure from EU trade negotiators to accept stricter IP rules that contradict the Doha Declaration and to give up these tools and provisions that can safeguard the health of millions of people in India and other developing countries. Such strict new rules can be extremely damaging when implemented in low and middle-income countries.
Oxfam has observed over time a measurable, negative impact on access to medicines in those countries that have implemented stricter IP rules along the lines of those proposed by the EU. For instance, a 2007 Oxfam study in Jordan found that medicines prices rose by 20% following implementation of a 2001 trade agreement with the United States, with the cost of medicines to treat heart disease and cancer, the two leading causes of death in Jordan, rising markedly. A second study published in Health Affairs in 2009 found a similar impact in Guatemala following implementation of its 2005 trade deal with the United States.
Why do costs keep going up as IP rules get stricter? When armed with patent monopolies on new medicines, innovator pharmaceutical companies charge the highest price a market will bear, even if this means the product is unaffordable for government health programs and poor people. Competition from generics producers brings down prices for medicines that have gone off-patent – but new treatments remain unaffordable during the monopoly patent period. The innovator companies argue they are changing their pricing policies for new products which are under monopoly protection, and, indeed, some companies appear to be trying to find ways to improve access for patients in poorer countries. Oxfam has applauded some of these changes. Overall, however, our assessment is that this is an industry that is still failing to put access to medicines at the heart of its business model. Indeed, the cost of new medicines under patent, even when companies say they have tried their best, remains too high.
The dangers of high medicine prices are relevant for communicable diseases, such as HIV/AIDS, and also for non-communicable diseases like cancer and diabetes. The World Health Organization estimates that over 80 percent of all deaths from non-communicable diseases now occur in low-income countries. Less than six months ago, the United Nations issued a landmark political declaration on Non-Communicable Diseases, calling attention to the enormous challenges faced by rich and poor countries alike in addressing NCDs in the coming decades. Like HIV/AIDS, treatment for cancer, heart disease, and diabetes often requires extended treatment, making the cost of medicines a crucial factor as to whether patients can receive health care.
Today, in an era of economic crisis and austerity, ensuring that foreign assistance is effective means the global community must find every way possible to save money, including keeping down the price of medicines. The European Union has done much to provide effective aid in the health sector. It has harmonized its aid through budget support, and it has invested in effective multi-lateral institutions such as the Global Fund. However, these efforts are countered by an EU trade agenda that would harm public health in poor countries.
Civil society groups and public health experts around the world will hold their collective breath next week as the final deal is announced and finalized. As in any negotiation, both sides must make trade-offs in order to reach a final agreement. One hopes that India will recognize that public health, both of millions of Indians and millions of people in other developing countries, should not be traded off.
Rohit Malpani is a campaigns advisor at Oxfam and leads the organization’s access to medicines campaign