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Action plan to ease disease burden of developing world

By Arti Malik

Despite the staggeringly disproportionate impact of disease on the developing world, pharmaceuticals develop drugs that have a potentially profitable market rather than drugs that are urgently required in poorer countries. Will this change with the World Health Assembly’s recent adoption of a global strategy to fill gaps in existing R&D and work towards drugs needed for diseases that affect developing countries?

With the floods in Bihar and Orissa comes the looming threat of disease that is often associated with natural catastrophes. In the event of limited medical resources and drug supplies, this again brings one’s attention to the public health situation in developing countries. For long, governments of developing and least developed countries, health activists and health experts worldwide have raised serious concerns about the dismal state of public health in the world. The developments in science and technology, over the past two decades, do not seem to have made a dent in improving the health of a majority of the world’s population. People in developing countries continue to die of diseases that are either curable, treatable or preventable. For two main reasons -- either there are no effective medicines available or, if there are medicines, they are not easily accessible because of their high cost.

This scenario has highlighted one of the core areas that directly affects public health -- innovations in medicine and intellectual property rights. Due to the high costs involved in the research and development (R&D) of new drugs, much of the pharmaceutical industry’s focus has been on developing drugs that have a potentially profitable market, rather than drugs that are urgently required. Even the protection offered by intellectual property rights, in the form of patents for pharmaceutical products, has not been incentive enough to engage in needs-driven research and development.

With most developing countries disproportionately burdened with disease, there is an urgent need to address the issues of innovation and intellectual property rights that have a far reaching impact on the health of the world’s poor. In this regard, the World Health Organisation (WHO) has been leading deliberations on the impact of intellectual property rights on innovation and public health for several years and has finally come to a consensus on the way forward.

World Health Assembly adopts global strategy

At this year’s meeting of the World Health Assembly (WHA), the highest governing body of the WHO consisting of health ministers from member states, the WHA passed a resolution on May 24 adopting a global strategy aimed at filling gaps in the existing R&D model to ensure innovation of drugs needed for diseases that affect developing countries. The global strategy on innovation, intellectual property rights and public health is the result of two years of hard negotiations by an inter-governmental working group set up by the WHO, and was hailed as a “breakthrough in public health” by the WHO’s director general Margaret Chan.

The strategy not only provides ways to promote needs-driven research with a special focus on diseases in developing countries, it also encourages countries and organisations to explore ways to de-link the cost of innovation with the price of the product so as to make these products affordable and more accessible. One such example is the recent announcement by UNITAID (an international drug purchasing facility) to establish a ‘patent pool’ for HIV/AIDS drugs in order to increase access to more appropriate and cheaper medicines in low- and middle-income countries. The announcement came soon after the adoption of a global strategy that encourages the establishment of ‘patent pools’.

These two developments are a step towards addressing the thorny issues of intellectual property and making access to medicines widely available in developing countries.

Developing countries carry heavy burden of disease

The developing world, which makes up more than 80% of the world’s population, is disproportionately burdened with disease. Almost 50% of the so-called poverty diseases (communicable, maternal, perinatal and nutrition-related) in the world are found in low-income countries -- that’s approximately 10 times more than the burden in developed countries. Over 6 million people die every year from diseases such as malaria, tuberculosis, HIV/AIDS, sleeping sickness and kala-azar; an estimated 97% of the deaths occur in developing countries.

Moreover, according to WHO projections, the proportion of non-communicable diseases such as diabetes, cancer and heart disease is rising in developing countries. And so developing countries suffer the “double burden” of not only having to deal with diseases that are synonymous with poverty but also coping with the rising number of non-communicable diseases. 

Among the numerous initiatives required for improving the health status of people living in developing countries, development of new medical products such as drugs, diagnostics and vaccines, and access to these products, lies at the centre of the fight against disease. Despite the staggering statistics that show the disproportionate impact of disease on the developing world, there has not yet been a significant effort in the innovation of new medicines for diseases that are typically found in developing countries. 

For instance, diseases like sleeping sickness (which is found only in sub-Saharan Africa) and chagas disease (which is found in central and South America) have limited treatment options despite the fact that they affect millions of people. For other diseases such as malaria, tuberculosis and HIV/AIDS -- which largely affect the developing world -- accessibility to treatment is hindered by the sheer cost involved.  There is an urgent need to develop new medicines to treat diseases prevalent in developing countries, and to make these and other medicines affordable and easily accessible. 

Medical R&D, intellectual property rights and access to medicines

Intellectual property rights play a vital role in the innovation of new medicines and access to these medicines. By ensuring protection for new innovations in the form of patent monopolies for a given period, intellectual property rights are supposed to provide much-needed incentive to the pharmaceutical industry to invest in the research and development of new medicines. They also, however, have the potential of hampering access to these medicines due to their unaffordable prices, which are a direct result of patent monopolies.

The issue here is whether the system of intellectual property rights, that seems to encourage future innovation of pharmaceutical products, is actually working for the purpose of developing new drugs to treat diseases that disproportionately affect people in developing countries. As has been stated above, there are diseases, particularly in the developing world, that still cannot be effectively treated. In the past two decades, the rate of innovation of new drugs for tropical diseases typically affecting developing countries has been approximately 1%. 

The WHO, in a report on intellectual property rights, innovation and public health submitted to the WHA in 2003, stated that while the need for innovation in medical products to improve public health has increased substantially, developing countries have not been able to reap the benefits of advancements in medical technology and innovations that are taking place in the developed world. One of the main reasons for this is the high price of medicines.

As a significant proportion of people in developing countries access healthcare privately, the high cost of medicines makes this access almost impossible for a vast majority of people, many of whom live on less than US$ 2 a day. For instance, Africa and India together account for more than half the world’s population that goes without access to essential medicines. On the other hand, the United States, Europe and Japan account for almost 86% of global pharmaceutical sales. In the search for profitable markets for medical products, the need to research and develop drugs that may not necessarily recover the high costs involved has had little success in the pharmaceutical industry. 

Intellectual property rights have not been able to provide enough incentive to the private pharmaceutical industry to develop drugs for a non-profitable market, namely the developing world. On the contrary, in an attempt to universalise the patent protection system, intellectual property rights have served as a barrier in accessing treatment and medicine. The Agreement on Trade-Related Intellectual Property Rights (TRIPS), which is administered by the World Trade Organisation (WTO), obliges member states to adhere to minimal standards of intellectual property rights. In the case of patents, TRIPS mandates product patents for pharmaceuticals for a period of 20 years, thus preventing generic competition for that period and resulting in monopolies and higher prices.

A market-driven system of innovation does not necessarily work for the purpose of improving public health. What is needed is an alternative mechanism for creating incentives to promote needs-based drug innovations that do not result in an increased burden on patients. And a global commitment towards using existing mechanisms to ensure access to medicines for all. There has been growing support globally for a system of research and development that ensures sustainable funding and global coordination for medical innovation on diseases affecting the developing world. 

Commission on Intellectual Property, Innovation and Public Health (CIPIH)

In the wake of increasing concerns about failing innovation and rising drug prices, the Commission on Intellectual Property, Innovation and Public Health (CIPIH) was set up in 2003 as a result of a WHA resolution. While passing the resolution, members of the WHA recognised concerns about the impact of intellectual property rights on public health, especially regarding their effect on access to medicines, the disproportionate burden of death and disease on developing countries, and insufficient research and development on diseases that predominantly affect the world’s poor.

To address these issues, the commission was tasked with assessing the impact of intellectual property rights on public health and access to medicines; and to make recommendations on funding for research and new incentive mechanisms for the development of products to fight diseases that disproportionately affect developing countries. After three years of consultations and deliberations with governments, public health experts, the pharmaceuticals industry and health advocacy groups, the commission submitted its report in 2006.

The report has been welcomed as a significant step towards addressing public health concerns, especially those associated with developing countries. Despite the presence of members from diverse backgrounds and interests in the commission, the report stood the challenge of coming to a consensus and not only recognised the adverse impact of intellectual property rights on innovation and access to medicines, but also made important recommendations in this regard that have formed the basis for future efforts.

In a detailed analysis of the health situation of the world’s population, the report recognised the growing burden of disease in poor and developing countries and the lack of adequate treatment and affordable medicines to treat these diseases. One of the key conclusions of the report was the inability of the system of patent protection to stimulate innovation where profitable markets are not available. And that if intellectual property rights are unable to create enough incentive for the development of medicines for diseases found in the developing world, then there is a need to create other mechanisms to foster such incentives.

The report came out with a series of recommendations to facilitate early research into developing drugs that are most urgently needed. As a lot of early research into pharmaceuticals happens at public institutions, the report calls on governments of both developed and developing nations to set priorities for needs-based research and provide appropriate financing for it. The report emphasised the role of developed countries, where most of the R&D in pharmaceuticals is conducted, in ensuring that access to R&D is not denied to developing countries. It also made several recommendations with regard to policies related to intellectual property rights that could impact future R&D. One important recommendation is the creation of a ‘patent pool’ to promote innovation that is especially relevant to developing countries.

A patent pool is collective management of intellectual property rights, where patents can be licensed to one another or third parties. Patent pools can be used to solve both research and development and access problems.

The report, in discussing product development, highlighted the importance of increased and sustainable funding to develop these products and bring them to the market. Traditionally, the rewards of spending on R&D for large pharmaceutical companies are returns from product earnings. This, however, cannot be the case for expenditure on R&D that targets diseases in developing countries where the market may be very small. The report therefore recommended devising different mechanisms to create a sustainable environment for this kind of research and development. One of the mechanisms examined by members of the committee was the feasibility of public-private partnerships to address existing research gaps and to develop medicines on a needs basis. The report found public-private partnerships to be a new, effective and important means of addressing the health needs of developing countries. It recommended that efforts be made to enhance the sustainability of such partnerships.

The report also examined the proposal for a global biomedical R&D treaty that would commit governments to spending a certain proportion of their national income on medical R&D, and recommended that further work be undertaken to develop this idea. 

Another significant point that the report makes is the dual importance of more innovation in medicines and better access to these medicines as critical to achieving the goals of public health. As intellectual property rights pose a significant barrier in accessing medicines, the report urged governments to utilise existing mechanisms in the intellectual property regime to reduce the price of medicines in developing countries.

For instance, the report reiterated the importance of the Doha Declaration on the TRIPS Agreement and Public Health that affirmed that the TRIPS Agreement did not restrict member states from taking measures to protect public health; it stated that every member state had the freedom to determine the grounds for granting compulsory licences on patented medicines. The TRIPS Agreement allows the use of compulsory licences, enabling the government to license the use of a patented innovation by a third party without the consent of the patent-holder.

In recent years, several governments have granted compulsory licences on patented drugs as a tool to making them more easily accessible to people; this practice has aroused a lot of opposition and controversy. The report’s recommendation therefore, to use compulsory licences as a means to make medicines more accessible to patients, is a positive step. Other important recommendations were for governments to ensure that the pricing of medicines was consistent with public health policies, and to avoid provisions in bilateral trade agreements that restrict access to medicines in developing countries.

The recommendations made by the commission in its report encompassed diverse and complex issues and a large number of stakeholders. The most important outcome of the report was its recommendation to the WHO to develop a global plan of action that would provide a framework for global cooperation to address public health problems.

Inter-Governmental Working Group on intellectual property, innovation and public health (IGWG)

The IGWG was set up as a result of a WHA resolution following the release of the CIPIH report in May 2006. The working group consisted of governments and a number of people invited as observers, experts or stakeholders. As recommended by the commission, the primary task of the IGWG was to draw up a global strategy and plan of action to provide a framework based on the recommendations of the CIPIH report, which aimed at securing a sustainable basis for needs-driven health R&D relevant to diseases that disproportionately affect developing countries.

After a series of consultations and gruelling negotiations over a period of two years, the IGWG submitted a draft strategy and plan of action. A number of issues remained unresolved; they were taken up and finalised at the following WHA session. The WHA finally passed a resolution adopting the Global Strategy and Plan of Action on May 24, 2008.

The global strategy aims at promoting new thinking in innovation and access to medicines not entirely based on the intellectual property rights regime, that is, it encourages needs-based research rather than market-driven research to target diseases affecting the majority of people in developing countries. An important aspect of the global strategy, that has been widely welcomed, is the proposal that the WHO will play a strategic and central role in the relationship between public health, innovation and related intellectual property issues, and take action in implementing the global strategy and certain specific aspects of the plan of action.

The global strategy contains a number of elements on the lines of the CIPIH report.  These include prioritising research and development needs; promoting research and development; building and improving innovative capacity; transfer of technology; application and management of intellectual property to contribute to innovation and promote public health; improving delivery and access; promoting sustainable financing mechanisms; and establishing monitoring and reporting mechanisms. Some of the key features of the strategy are the agreement to encourage future discussions on the biomedical R&D treaty; to explore other R&D initiatives such as prize funds that do not rely on patent monopolies; to create patent pools that share technology and provide a common platform for future innovations; and to adopt and implement legislation that prevents and penalises anti-competitive practices.   

Conclusion

The WHA resolution adopting the global strategy has marked a new beginning in terms of how we think about innovation and access in public health. With the Global Strategy and Plan of Action set to be implemented by the WHO, governments of member states and various other organisations and stakeholders, in the coming years, there is the real possibility of changing the perception that intellectual property is the only way to ensure innovation. UNITAID, with its announcement of establishing patent pools, is already showing the way. Civil society organisations and health advocacy groups have applauded this decision as an important step in addressing the problems of access to second-generation drugs that are not available at affordable prices due to existing patents and lack of generic competition, and perhaps also for future innovations of new drugs.

InfoChange News & Features, September 2008