Global Strategy and Plan of Action on Public Health
Introduction, Background and Aims
The Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPOA) established by the World Health Organisation (WHO) in 2008 suggested that the WHO should take a central role when it comes to managing the relationship between innovation, intellectual property and the provision of health services across the globe. As noted in the background understanding of the strategy set out by the WHO, 4.8 billion people are living in what is considered to be a developing country, with 2.
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7 billion of those living on a budget of less than two US dollars a day. Linking this to the provision of healthcare services and the recognition that communicable diseases are often central to the mortality rate in these countries, the WHO recommended looking at how new products could legally be managed so that they are made available to fight diseases within the developing countries, thus providing the necessary foundation for the pharmaceutical industry, so that there would be no gap in treatment between the developed and developing regions.
The purpose of this report is to consider how effective the strategy has been in terms of dealing with the issues of neglected diseases and ensuring that individuals have access to medicines, based on their needs and not determined by where they live or their financial resources.
This paper will first look at the perceived problems that were to be addressed by the strategy in terms of the innovation gap and why the developing regions seem to be lagging behind where access to medicine is concerned. It will also explore the link that has been established between accessibility and the ability to protect intellectual property, and encourage innovation. The key elements of the strategy, including how these are to be prioritised will then be looked at, to ascertain which are likely to encourage such innovation and the legal provisions that are likely to be formative in achieving this. Consideration will then be given to regional platforms and ways in which this strategy has been applied in localised developing regions, as well as identifying any ongoing issues that have emerged in more recent years; finally, recommendations will be made for the future, in order to deal with any weaknesses in the original agenda of the strategy.
The Problem – Innovation Gap
Before looking at whether or not the strategy and subsequent legal approach has been successful in addressing neglected diseases and improving general levels of access to medicine, it is first necessary to consider the stated problems which the strategy aims to deal with and the way in which it viewed the issue of innovation, at the outset, when setting out the appropriate strategy to deal with this gap.
The need to deal with the issue of access to basic medical care is increasingly important according to the international agenda for global health. Much of this has been encouraged by the HIV pandemic taking place in the developing countries at a much more serious rate than that the experience of the more developed locales. With this in mind and in the context of the introduction of the World Trade Organisation Agreement on trade related aspects of intellectual property rights by offering patent protection to pharmaceutical products, there is increasing attention being placed on issues relating to the availability and pricing of the essential medicines.
The issue of dealing with the innovation gap and the resulting gap in the availability of medicines between the developing and developed regions is something that emerged during the 2008 strategy and is also central to the research undertaken by the Commission on Health Research and Development, back in the 1990s, where commitments were made as part of the millennium development goals to ensure that activities would be undertaken to benefit some of the poorest countries in the world; for example, encouraging donations from both public and private sectors, in order to ensure that these countries were able to undertake their own research and development, thus reducing any disparity that existed within global health. Despite this commitment, the innovation gap remains, and this has led to the establishment of the 2008 strategy.
Since the establishment of the 1995 World Trade Organisation protection of intellectual property rights relating to pharmaceutical products, there has been an ongoing tension between the ability of commercial organisations to achieve financial success as a result of patenting pharmaceutical products and the need to ensure consistent global health services. This tension was such that, in 2003, it was decided by the World Health Organisation that it was necessary to obtain the advice of an independent expert commission. As a result, the Commission on Intellectual Property Rights, Innovation and Public Health established that there are key policy measures that need to be created, in order to fill in the gaps which have emerged in this area and to deal with the ever increasing disparity in health care services. In particular, the commission focused on the gap that existed in the innovation cycle. The commission saw the crucial step of breaking down the innovation cycle as a means of looking at the various stages of bringing medicines to the market and, critically, identifying any weaknesses within the developing regions that emerge as part of the innovation cycle. When looking at countries that have made essential innovative improvements, it is possible to identify more accurately how the developing countries could potentially improve in the future, so as to ensure that appropriate medicines becomes available on a needs’ basis, rather than on an economic basis. Recommendations were made on policy improvement in the area and as such the Working Group on Public Health, Innovation and Intellectual Property was established.
The group worked with the notion that the development of innovation is a complex process and requires a wide range of policy areas to be considered including the actual scientific and medical fields, but also taking into account social, economic and historic factors, all of which are likely to be relevant when it comes to the underlying success of policy initiatives. Despite this, the focus remains on the concept of pharmaceutical innovation, which looks at the process of discovering, developing, producing and delivering medical products, as and when people require them. Each of these four steps is potentially relevant when considering why certain groups in certain countries do not achieve an acceptable level of health care. Any blockage at any of these stages will have a detrimental impact on the ability of individuals to be treated on a needs’ basis.
By using health innovation as an ongoing cycle, several critical practical realities need to be considered. Firstly, it is noted that any form of health innovation will continuously lead in to further health innovation and therefore it will be necessary for experts to have access to previously gained knowledge, before they can then develop this into new knowledge. Secondly, it is also noted that the development of new drugs in isolation is insufficient, as a health infrastructure is required in order to ensure that the correct people have access to the medical care that is produced. This is often perceived to be an underlying problem of intellectual property, in itself, as it may be possible for an individual within an industry to develop a new product or new process, but it is ensuring that this new product or process enters the market which ultimately makes it commercially viable. The health innovation market is no different and, whilst it may be possible for key individuals to develop new innovations, if there is no structure available to ensure that everyone gains access to these medicines, the cycle is broken and the underlying goal of the WHO is not achieved.
Therefore, in the developing regions, there is the difficulty, not only of lacking potential technical expertise to develop the drugs, but also of being unable to develop, produce and distribute any medical advancement, which will ultimately block the ability of key individuals to receive the treatment they require based on need.
Core Elements of the GSPA
Eight core elements are identified as relevant as part of this policy for legal and research reform. Each of these is considered briefly, in order to identify the impact that they have had on the overall development of the ability of developing countries to utilise health innovation in such a way that will benefit the necessary groups of individuals.
Prioritising research and development needs: starting at the outset of the health cycle, the WHO ensured that a better understanding of the health needs of developing countries was required, so that any research and development is focused on these key areas. This crucial stage is vital when identifying neglected diseases as, without identifying the diseases to be targeted, it is difficult to ensure that appropriate innovation takes place.
Promoting research and development: although there are multiple different ways of determining the innovative capacity of a particular region, the WHO feels that those responsible for ensuring that neglected diseases in the developing countries are managed more effectively should receive enhanced support to bring their research and development more in line with the developed regions.
Building and improving innovative capacity: effective policies and regulations that will promote any abilities and capabilities that are emerging within the developing countries for health innovation; for example, allowing developing countries to undertake their own clinical trials and improving intellectual property protection, as well as the local production of pharmaceuticals.
Technology transfer: a large amount of the focus here is placed on ensuring that capacity is noted in the developing regions for policies which also recognise that technology transfer and development is a key way in which the developing countries can gain at least some benefit from existing technologies in other regions. For example, the TRIPS Agreement offered specific incentives for developed countries to work alongside developing regions; therefore, these incentives need to be reviewed, in order to ensure that they are sufficiently strong to encourage and develop countries to transfer technology wherever possible.
Application and management of intellectual property: there needs to be recognition that there is a requirement to strengthen capacity to allow intellectual property to be developed within developing regions. It has been proposed by the WHO that there needs to be a review of the application of intellectual property rights within health innovation, to offer incentives to promote the use of intellectual property in the developing countries, even where it may not be immediately perceived to be commercially beneficial.
Improving delivery and access: as noted at the outset, establishing health innovation is merely one step in the innovation cycle and there needs to be a strong infrastructure in place to ensure that mechanisms are available to ensure that quality medicines are made available directly to those people who require them, at the correct time, with this being inherently linked to pricing and taxation.
Ensuring sustainable financing mechanism: this core element looks more towards the long-term impact on the provision of healthcare services within the developing countries. Whilst there are often substantial financial injections into the developing countries, this needs to be made on a more sustainable footing in order to ensure that there are no substantial gaps in the financing of research and that the development cycle is continuous.
Establishing a monitoring and reporting system: the final stage of the focus is to ensure that ongoing monitoring takes place and any potential gaps identified at the earliest opportunity, so that other aspects of the policy can be tweaked in order to encourage appropriate behaviour from both the developing countries themselves and also commercial organisations elsewhere which regularly interact with the developing regions, particularly when it comes to the provision of intellectual property and health innovation.
Ongoing Monitoring on Impact
Having set out the various different policy approaches, it is proposed here that, if these were to be effectively applied, the developing countries would be in a much stronger position to ensure that health innovations are developed securely in relation to neglected diseases and are more readily available to those in need. However, the strength of these policies really lies in their implementation and whether or not implementation has been successfully achieved, on a practical level. For this reason, the latter stage of this analysis looks at monitoring and evaluating the impact of these policies.
By looking in more detail at the area of the policy that is focused on establishing a robust monitoring and reporting systems, the WHO suggests that four areas need to be monitored, specifically. These include, the gap that exists in terms of health products and medical devices; the impact that intellectual property has on all aspects of the policies under scrutiny; the impact of any incentive mechanisms for transferring technology between the developed and developing regions; and finally, the level of investment in research and development, particularly in the developing regions.
The key difficulty when it comes to monitoring the impact of the strategy has been that it requires interactions among a variety of different entities, not all of whom are within the health sector. For example, it is necessary to look at the various political and economic issues, as well as goals, in order to gain an understanding of how effective the strategy is proving, from a practical perspective.
To a large extent, it is suggested here that the best approach for strategy implementation is to utilise regional platforms. By recognising that such a wide variety of landscapes exist among the various different countries, it is necessary to start at a regional level to develop platforms that will enable these regions to promote the underlying strategy, rather than focussing on one consistent approach. The same is true for the development of intellectual property, where having one overall global policy is simply impractical. Here, again, there is a need for intellectual property protection to take into account the demands from developing regions and for incentives to be provided to ensure that those producing medical developments are offered sufficient incentives to provide this information to the developing regions, despite reduced economic capabilities in these regions.
When looking at this from a legal perspective and in particular the TRIPS Agreement, it can be seen that there are elements of incentives offered to ensure that developing countries are able t to attract at least some element of intellectual property development; however, these need to be looked at in more detail, to encourage greater practical application, if the WHO strategy is to be successful and the gap between developing and developed countries is not to increase to an unsustainable level. Fundamentally, therefore, mechanisms need to be put in place in order to ensure that the commercial agents developing these medicines are encouraged to focus on those areas of greatest need, rather than on those areas with the greatest financial resources are able to pay for medicines that have been developed.
It is concluded here, that there is always likely to be a disparity between commercial demands, as a result of intellectual property protection and health requirements weakening the position of the poorer regions. It is therefore down to international bodies such as the WHO to ensure that there is an incentive mechanisms are in place, in order to redress this imbalance as simple economic tools of supply and demand will not achieve this alone.
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Borrell, J.-R. (2007) ‘Pricing and Patents of HIV/AIDS Drugs in Developing Countries’.Applied Economics 39(4): 505–18
Branstetter, L., R. Fisman and C.F. Foley (2006) ‘Do Stronger Intellectual Property Rights Increase International Technology TransferEmpirical Evidence from US Firm-level Panel Data’. Quarterly Journal of Economics 121(1): 321–49
Chaudhuri S. (2010), “R&D for development of new drugs for neglected diseases in India”, Int. J. Technology and Globalisation, Vol. 5, Nos. ?, pp. 61-75
Giaccotto, C., R.E. Santerre and J.A. Vernon (2005) ‘Drug Prices and Research and Development Investment Behavior in the Pharmaceutical Industry’. Journal of Law and Economics 48(1): 195–214.
Ito, B. and R. Wakasugi (2007) ‘What Factors Determine the Mode of Overseas R&D by MultinationalsEmpirical Evidence’. Research Policy 36(8): 1275–87.
Kremer, M. and R. Glennerster (2004) Strong Medicine: Creating Incentives for
Pharmaceutical Research on Neglected Diseases. Princeton, NJ: Princeton University
MSF (2001)., Drugs for Neglected Diseases Working Group and the Campaign for Access to Essential Medicines, Fatal Imbalance: The Crisis in Research and Development for Drugs for Neglected Diseases, MSF, Geneva.
Lacetera N. and Orsenigo L. (2001), “Political regimes. technological regimes and innovation in the evolution of the pharmaceutical industry in the USA and in Europe”, paper prepared for the Conference on Evolutionary Economics, John Hopkins University, Baltimore, 30-31 March 2001
Ostergard, R.L. (2000) ‘The Measurement of Intellectual Property Rights Protection’.
Journal of International Business Studies 31(2): 349–60.
Resolution WHA61.21, “Global strategy and plan of action on public health, innovation and intellectual property”, i Sixty-First World Health Assembly, Geneva, 19–24 May 2008, Volume 1. Resolutions and decisions. Geneva, World Health Organization
Sampath P. (2010), “Global health innovation, big pharma and emerging trends”, in Reconfiguring Global Health Innovation: Creating Capacity for Disease of the Poor, Routledge Publishing, September 2010.
Santa Cruz M. and Roffe P., “A review of recent developments at the multilateral level with respect to intellectual property and the pharmaceutical industry”, Journal of Generic Medicines 6, 323-331
World Health Organization (2006), Public Health, Innovation and Intellectual Property Rights, Report of the Commission on Intellectual Property Rights, Innovation and Public Health, WHO, Geneva, , p. 174.
Yamin A. (2003), “Not Just a Tragedy: Access to Medications as a Right Under International Law”, Boston University Law Journal, vol. 21:325-372
 Resolution WHA61.21, “Global strategy and plan of action on public health, innovation and intellectual property”, i Sixty-First World Health Assembly, Geneva, 19–24 May 2008, Volume 1. Resolutions and decisions. Geneva, World Health Organization
 World Health Organization (2006), Public Health, Innovation and Intellectual Property Rights, Report of the Commission on Intellectual Property Rights, Innovation and Public Health, WHO, Geneva, , p. 174
 Ito, B. and R. Wakasugi (2007) ‘What Factors Determine the Mode of Overseas R&D by MultinationalsEmpirical Evidence’. Research Policy 36(8): 1275–87.
 Borrell, J.-R. (2007) ‘Pricing and Patents of HIV/AIDS Drugs in Developing Countries’.Applied Economics 39(4): 505–18
 Santa Cruz M. and Roffe P., “A review of recent developments at the multilateral level with respect to intellectual property and the pharmaceutical industry”, Journal of Generic Medicines 6, 323-331
 Abbott, F.M. (2005) ‘The WTO Medicines Decision: World Pharmaceutical Trade and the Protection of Public Health’. American Journal of International Law 99(2): 317–58.
 Sampath P. (2010), “Global health innovation, big pharma and emerging trends”, in Reconfiguring Global Health Innovation: Creating Capacity for Disease of the Poor, Routledge Publishing, September 2010.
 Ostergard, R.L. (2000) ‘The Measurement of Intellectual Property Rights Protection’. Journal of International Business Studies 31(2): 349–60.
 Yamin A. (2003), “Not Just a Tragedy: Access to Medications as a Right Under International Law”, Boston University Law Journal, vol. 21:325-372
 Branstetter, L., R. Fisman and C.F. Foley (2006) ‘Do Stronger Intellectual Property Rights Increase International Technology TransferEmpirical Evidence from US Firm-level Panel Data’. Quarterly Journal of Economics 121(1): 321–49
 Kremer, M. and R. Glennerster (2004) Strong Medicine: Creating Incentives for
Pharmaceutical Research on Neglected Diseases. Princeton, NJ: Princeton University
 Chaudhuri S. (2010), “R&D for development of new drugs for neglected diseases in India”, Int. J. Technology and Globalisation, Vol. 5, Nos. ?, pp. 61-75
 MSF (2001)., Drugs for Neglected Diseases Working Group and the Campaign for Access to Essential Medicines, Fatal Imbalance: The Crisis in Research and Development for Drugs for Neglected Diseases, MSF, Geneva.
 Lacetera N. and Orsenigo L. (2001), “Political regimes. technological regimes and innovation in the evolution of the pharmaceutical industry in the USA and in Europe”, paper prepared for the Conference on Evolutionary Economics, John Hopkins University, Baltimore, 30-31 March 2001
 Giaccotto, C., R.E. Santerre and J.A. Vernon (2005) ‘Drug Prices and Research and Development Investment Behavior in the Pharmaceutical Industry’. Journal of Law and Economics 48(1): 195–214