How has Medical Technology changed over the years

how medical technology has changed our lives and how has medical technology changed in the last 50 years and how medical technology has advanced
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MarryCornor,Germany,Professional
Published Date:15-07-2017
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WHO – WIPO – WTO Promoting Access to Medical Technologies and Innovation Promoting Access to Medical Technologies and Innovation Intersections between public health, intellectual property and trade Medical technologies – medicines, vaccines and medical devices – are essential for public health. Access to essential medicines and the lack of research to address neglected diseases have been a major concern for many years. More recently, the focus of health policy debate has broadened to consider how to promote innovation and how to ensure equitable access to all vital medical technologies. Promoting Access to Medical Today’s health policy-makers need a clear understanding both of the innovation processes that lead to new technologies and of the ways in which these technologies are disseminated in health systems. This study seeks to reinforce the Technologies and Innovation understanding of the interplay between the distinct policy domains of health, trade and intellectual property, and of how they affect medical innovation and access to medical technologies. It captures a broad range of experience and data in dealing with the interplay between intellectual property, trade rules and the dynamics of access to, and innovation in, medical Intersections between public health, intellectual property and trade technologies. A collaborative effort by the World Health Organization, the World Intellectual Property Organization and the World Trade Organization draws together the three Secretariats’ respective areas of expertise. The study is intended to inform ongoing technical cooperation activities undertaken by the three organizations and to support policy discussions. Based on many years of field experience in technical cooperation, the study has been prepared to serve the needs of policy-makers who seek a comprehensive presentation of the full range of issues, as well as lawmakers, government officials, delegates to international organizations, non-governmental organizations and researchers. WTO ISBN 978-92-870-3839-5 WHO ISBN 978-92-415-0487-4 WIPO ISBN 978-92-805-2308-9 WIPO Publication No. 628E PAMTMI cover-Sept12.indd 1 25/01/2013 11:49FOReWORD By THe DIReCTORs-Gen eRAL Foreword by the Directors-General Public health has been a priority for global action for by the Declaration on the TRIPS Agreement and Public many years. The right of everyone to the enjoyment of the Health (Doha Declaration), adopted on 14 November highest attainable standard of physical and mental health 2001 at the Fourth Ministerial Conference of the WTO. is a universal human right, just as the burden of disease is That Declaration was followed by a number of significant shared by all humanity. developments: The constitution of the World Health Organization (WHO) ƒƒ The creation of new and innovative financing and underscores that achievements by any state in the procurement mechanisms, leading to significantly promotion and protection of health are of value to all. In increased funding for medicines procurement and the age of globalization, progress made in public health in vaccine development. one country has an impact on the international community ƒƒ An evolving and more diverse pharmaceutical industry, as a whole. Consequently, a compelling case can be made and increasing innovative capacity in some developing for effective international cooperation in public health, and countries. such cooperation is an essential foundation for sustainable ƒƒ Innovative approaches to medical research and development. development (R&D) and its financing – particularly for neglected diseases – with an emphasis on Public health and medical technologies are an important public–private initiatives to develop required medical focus of the international system, including in the system- technologies. wide work of the United Nations – most notably in the Millennium Development Goals (MDGs). The very founding ƒƒ Renewed attention to the cost-effectiveness of objective of the WHO is the attainment by all peoples of national health systems. the highest possible level of health. In addition, the World ƒƒ Growing global awareness of the impact of non- Intellectual Property Organization (WIPO) and the World communicable diseases (NCDs) on health and socio- Trade Organization (WTO) – in line with the mandates economic development, especially in developing given to them by governments and their respective areas countries. of expertise – have increasingly stepped up their efforts ƒƒ Increasing recognition of the need to move towards to support global endeavours to improve health outcomes. universal health coverage. ƒƒ Insights into the intersections between public International cooperation on public health takes many health, the IP system, trade and competition rules, forms. Recent years have seen an intensified focus on and measures to promote innovation and access to the role of medical technologies – both the innovation medical technologies. processes that lead to new technologies and the ways in which these technologies are disseminated in health ƒƒ Better, more comprehensive and more accessible data systems. Access to essential medicines as a dimension of on prices, access, patents and trade, enhancing the the right to health has been a major concern for several empirical base for informed priority setting and policy decades. Now, however, the focus has broadened to decisions. consider how to promote the requisite innovation, how ƒƒ Greater policy coherence and practical cooperation on to address neglected health needs, and how to ensure the intersection of health policy, trade and IP issues equitable access to all vital medical technologies, including within the broader perspectives established by the medicines, vaccines and medical devices. The evolving human rights dimension of health and the UN MDGs. state of the global disease burden creates a constant demand for new and adapted technologies, so innovation Today there is now a richer, more diverse and more inclusive and access are inevitably intertwined. body of empirical data and practical experience available to guide technical cooperation. The technical cooperation It is both a natural consequence of our mandated offered by the three organizations has been characterized responsibilities and increasingly a practical necessity for by active dialogue, coordination and partnership, leading the WHO, WIPO and WTO Secretariats to coordinate and to more effective and tailored capacity-building activities, cooperate ever more closely on issues such as patterns all based on a better informed factual background. One of innovation and access, legal and policy factors of the objectives of this cooperation has been to create affecting the production and dissemination of medical as much policy coherence as possible between the three technologies, and the interplay between public health, organizations. international trade rules and the intellectual property This study is an example of this strengthened trilateral (IP) system. These are long-standing issues. Their cooperation, capturing a broad range of experience in relevance to a broad policy community was confirmed 7 OO-FM-New.indd 7 04.09.13 15:39Promoting Access to m edic Al t echnologies And i nnov Ation dealing with the interplay between IP, trade rules and shared outlook defined by a common resolve to work the dynamics of access to, and innovation in, medical towards universal access to essential medical technologies technologies. It draws together the three Secretariats’ and to strengthen and diversify innovation systems. respective areas of expertise in relation to the overall framework concerning access to, and innovation in, The issues are complex and multifaceted, and call for the field of medical technologies, and it provides a diverse and tailored solutions: the following pages platform for sharing practical experience and data, will not yield simple answers to the difficult questions supporting and providing information to ongoing confronting policy-makers. Yet we do expect that this technical cooperation and policy discussions. The study study will provide a sound platform for future policy is guided by the approach to cooperation on public debate and analysis, and will serve those who seek health that has been catalysed by the Doha Declaration, answers to challenging questions. The publication of this by the WIPO Development Agenda, and by the WHO study also represents a milestone in the efforts of the Global Strategy and Plan of Action on Public Health, three agencies to deliver on their overlapping mandates Innovation and Intellectual Property. in a coherent and cooperative manner; and we pledge continuing commitment on the part of the three agencies We have been encouraged by the momentum, in recent to continue to work, together with other international years, towards a more informed, inclusive and nuanced partners, towards the shared objective of universal policy debate on public health issues, buttressed by the coverage and better health outcomes for all. Margaret Chan, Director-General, WHO Francis Gurry, Director General, WIPO Pascal Lamy, Director-General, WTO 8 OO-FM-New.indd 8 04.09.13 15:39exe CUTIve sU mmARy Executive Summary Why this study? s teps towards coherence Public health is inherently a global challenge and thus 2000 United Nations General Comment on the assumes high priority for international cooperation. The Right to Health World Health Organization (WHO) is the directing and 2001 WTO Doha Declaration on the TRIPS coordinating authority for health, but the interaction Agreement and Public Health between health issues and other policy domains – human rights, development policy, intellectual property (IP) 2002 WHO–WTO joint study WTO Agreements and international trade – creates a strong rationale for and Public Health cooperation and coordination between the WHO and other 2003/5 WTO creates new TRIPS flexibility for international organizations such as the World Intellectual access to medicines in countries lacking Property Organization (WIPO) and the World Trade manufacturing capacity Organization (WTO). This study has emerged from an ongoing programme of trilateral cooperation between these 2006 WHO Commission report on Public health, agencies. It responds to an increasing demand, particularly innovation and intellectual property rights in developing countries, for strengthened capacity for 2007 WIPO Development Agenda informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation 2008 WHO Global Strategy and Plan of Action of medicines and other medical technologies. The need for on Public Health, Innovation and Intellectual cooperation and coherence at the international level has Property intensified over the past decade, as successive multilateral 2009 WHO–WIPO–WTO trilateral cooperation decisions have confirmed (see box). commences The study is set in an evolving health policy context: notably, from an initial focus, a decade ago, on access to medicines for infectious epidemics, debate has mean a declining capacity to meet an evolving global broadened to consider innovation policy and a wider disease burden; and innovators need to consider how new range of diseases and medical technologies. Policy- technologies can reach those most in need. makers increasingly need to understand the complex interplay between different disciplines, at a time when ƒƒ Chapter I presents the general background to health stronger analytical tools and improved data open up policy relating to medical technologies, sets out the new possibilities for this work. An integrated approach distinct roles and mandates of the three cooperating can reinforce a dynamic, positive interplay between the agencies, and outlines the global disease burden measures that promote innovation and those that ensure that defines the essential challenge for health access to vital medical technologies. While addressing policy. In view of the significant contribution to the broader issue of innovation and access to the whole health policy of a range of diverse actors, Annex I range of medical technologies, the study focuses mainly describes a selection of entities active in current on the area of medicines for which most practical policy processes. experience and data are available. ƒƒ Chapter II outlines the essential elements of the international framework – health policy, IP and trade policy – laying an integrated basis for the following Navigating the study more detailed analysis of the innovation and access dimensions. It outlines the key insights of economics The study has been prepared as a capacity-building for medical technology innovation and access, in view resource for policy-makers. The study is structured so of the growing use of economic concepts to inform as to enable users to grasp the policy essentials, and health policy discussions. A final section reviews then to look more deeply into areas of particular interest. the policy issues associated with traditional medical It therefore lays out a general panorama of the policy knowledge, in view of its significance for national landscape (see Chapter II), so that all interrelated elements health systems and as an input to medical research. can be seen in context. It then provides more detailed ƒƒ Chapter III provides a more detailed overview of accounts of issues specifically connected with innovation policy issues concerning the innovation dimension of (see Chapter III) and access (see Chapter IV). The contents medical technologies. The historical pattern of medical mirror the evolution of multilateral policy debate over the research and development (R&D) provides a backdrop past decade, recognizing that innovation and access are for analysing current trends in the R&D landscape. The inevitably intertwined – access without innovation would 9 OO-FM-New.indd 9 04.09.13 15:39Promoting Access to m edic Al t echnologies And i nnov Ation chapter looks at the innovation challenge presented respectively for the innovation process and for access to by neglected diseases and related alternative and medical technologies. Regarding trade policy, Chapter II complementary instruments to promote research sets out the main elements and Chapter IV considers the and development. It outlines the role of IP rights impact of trade and trade policy settings on access to in the innovation cycle. A final section looks at medicines and other medical technologies. influenza vaccines as a distinct example of innovation management and product development to address a specific global health need. ƒƒ Chapter IV deals with key aspects of the access The global disease burden is a moving dimension, describing the context for access to target, requiring dynamic responses … medical technologies and the current access framework for essential medicines. It then sets out Currently, most people in high-income countries live the key determinants of access related to health beyond the age of 70 and die of chronic diseases; systems, IP and trade. It reviews in particular pricing these are also leading causes of death in middle-income policies, taxes and mark-ups, and procurement countries, along with tuberculosis, HIV/AIDS and road mechanisms, as well as regulatory aspects and traffic accidents; but in low-income countries, people initiatives to transfer technology and boost local predominantly die of infectious diseases and more than production, patent quality and review procedures, a third of all deaths are among persons aged under 15. compulsory and voluntary licences, trade agreements, Large declines in mortality from principal communicable, tariffs and competition policy. maternal, perinatal and nutritional causes are projected for 2030. But ageing of populations in low- and middle- income countries (LMICs) will result in more deaths due to non-communicable diseases leading to a double burden As access and innovation issues are increasingly of disease. While preventive measures with respect to considered across a broader perspective, a more lifestyle, physical inactivity, tobacco use and harmful use diverse set of stakeholders, values, experience, of alcohol, nutrition and environmental factors are key, the expertise and empirical data now shapes and informs innovation system has to adjust to these changes in the policy debates, through: global disease burden. The focus on access to medicines – •ƒgreater diversity of policy voices, creating which in the past has been on communicable diseases opportunities for cross-fertilization between such as HIV/AIDS and malaria – has broadened. Access traditionally distinct policy domains (see Annex I) to treatments for non-communicable disease, including •ƒ enhanced possibilities for harvesting the practical expensive cancer treatments in middle-income countries, lessons of a far wider range of innovation and will be the challenge of the future and the focus of the access initiatives access debate (see Chapter I, Section C). •ƒimproved global inclusiveness, quality and availability of empirical data on a range of interconnected factors, including the global Access to medicines and health burden, access and pricing of medicines, the right to health regulatory and trade policy settings, and national IP systems. Access to essential medicines and health services is an element of the fulfillment of the right of everyone to the enjoyment of the highest attainable standard of The cross-cutting character of these policy domains health. Furthering access to medicines is also part of the means that some themes are introduced in Chapter Millennium Development Goals (see Chapter II, Section II, in the course of sketching out the general policy A.1-3). The WHO framework for access to medicines framework, and are later elaborated in either Chapter recognizes that lack of access to medical technologies III and/or Chapter IV which look in more detail at how is rarely due to a single isolated factor and thus includes these elements have bearing on innovation and access rational selection and use of medicines; affordable prices; respectively. For example, the general elements and sustainable financing; and reliable health and supply principles of IP policy are set out in Chapter II, while systems with quality as an underpinning element (see Chapter III elaborates aspects of IP policy, law and Chapter IV, Section A.1). Rational selection of the needed practice that bear particularly on innovation of medical medication requires a country to identify which medicines technologies, and Chapter IV considers how specific are most important to address the national burden of aspects of IP impact on access to technologies. disease. This selection can be guided by the WHO Model Similarly, the broad rationale for regulation of medical Lists of Essential Medicines. Political commitment to technologies is set out in Chapter II, and Chapters III adequate and sustainable funding is a basic condition for effective and sustainable access (see Chapter IV, and IV deal with the implications of product regulation 10 OO-FM-New.indd 10 04.09.13 15:39exe CUTIve sU mmARy Section A.1). Affordable prices are a critical determinant of leveraging technology transfer, which raises issues of access to medicines, especially in countries where public access to medicines, economic and commercial factors, health sector is weak and where those with most limited and industrial policy (see Chapter IV, Section B.6). means are often required to secure medicines at market prices. Generic competition is a key factor in driving prices With regard to access to patented products, countries down; yet even low priced generic medicines are often also make use of the flexibilities available under the WTO still unaffordable for large parts of the population in many Agreement on Trade-Related Aspects of Intellectual LMICs and availability of essential medicines in the public Property Rights (TRIPS Agreement). sector is still insufficient (see Chapter IV, Section A). The overarching condition for providing access to needed medical technologies and health services is a functioning Regulation of technologies is vital national healthcare system (See Chapter II, Section A.5, in itself, but can impact innovation and Chapter IV, Section B). and access Access for HIV/AIDS treatments has been a major focus Regulation of medical technologies addresses essential for policy-makers in recent years. Low prices for generic health policy objectives: products must be safe, efficacious antiretroviral treatments have helped governments and and of adequate quality. Yet, regulation also shapes donor programmes progress towards the goal of having the landscape for access and innovation: higher safety 15 million people on treatment by 2015 (see Chapter standards require the generation of more data and thus IV, Section A.2). Other critical areas are access to and increases the cost of innovation. Unjustified regulatory innovation of paediatric formulations and medical devices barriers and lengthy marketing authorization processes (see Chapter IV, Sections A.2 and A.3). The changing delay access to needed medical technologies (see burden of disease also leads to a greater focus on Chapter II, Section A.6). Most clinical trials are carried out access and IP issues in relation to non-communicable by or on behalf of the companies developing the tested diseases (see Chapter IV, Section A.2). National products. The registration of these trials is a scientific immunization programmes are a highly effective public and ethical responsibility and therefore WHO runs the health tool for the prevention of illness and the spread International Clinical Trials Registry Platform. From the of infectious diseases. Distinct market conditions and perspective of public health policy, clinical trial results know-how requirements create a different landscape should be publicly available, so that researchers and other for the development and dissemination of vaccines (see interested groups themselves can assess the efficacy Chapter III, Section B.4, and Chapter IV, Section A.2, and potential side effects of new products (see Chapter see also Chapter III, Section E). III, Section B.5). The emergence of biological medicines has raised challenges for established regulatory systems, Governments explore further notably how to regulate “biosimilar” follow-on products (see Chapter II, Section B.6) while still sufficiently measures to contain costs and incentivising originator companies. increase access Another challenge for regulatory systems is the steady Governments employ many different means to cut prices increase of substandard and spurious/falsely-labelled/ for medical technologies, including direct price controls, falsified/counterfeit (SFFC) medical products that are reference pricing, and reimbursement limits; and they posing serious public health problems globally, and increasingly use health technology assessments to control especially in regions where the regulatory and enforcement costs (see Chapter IV, Section B.1). On top of import systems are weak. To effectively combat substandard and tariffs (see Chapter IV, Section D), various taxes (see SFFC medicines a mix of measures is required. Enforcement Chapter IV, Section B.3) and mark-ups along the supply of good manufacturing practice standards is required chain (see Chapter IV, Section B.4) also boost consumer to eliminate substandard products while to fight SFFC prices and constrain access. Removing tariffs and taxes products additional measures are needed, including border and regulating supply chain distribution mark-ups can controls and criminal law along with collaboration between lower prices, where passed on to consumers. Yet, price legislative bodies, enforcement agencies and courts at the regulation equally needs to ensure sustainable margins for national and international levels (see Chapter II, Section B.1, commercial suppliers. and Chapter IV, Section B.7). Differential pricing applied by companies can be a complementary tool to increase access, by linking prices Overall, regulators face the challenge to balance to the differing capacity to pay according to income levels the benefit of the early release of new products with within distinct markets (see Chapter IV, Section B.2). safety concerns and to define an acceptable level of Another strategy for enhanced access to medicines risk. The need to simplify regulation while maintaining stresses developing local production capacity and its stringency and cost-effectiveness requires more 11 OO-FM-New.indd 11 04.09.13 15:39Promoting Access to m edic Al t echnologies And i nnov Ation coordination through regional and international medical research and product development; the exposure regulatory mechanisms, so as to enable suppliers to to stricter product regulation and greater liability risks; new service regional markets without undue regulatory technologies enabling targeted treatment; and the greater complexity or cost (see Chapter II, Section A.6). Full share of global demand from emerging markets. The international harmonization of regulatory standards historic industry model of vertically integrated in-house remains an elusive goal. The WHO Prequalification R&D and exclusive marketing is opening up to more diverse Programme has greatly facilitated the access to quality and collaborative structures, with major industry players medical products in developing countries (see Chapter IV, developing products by integrating technologies sourced section B.7). elsewhere, either licensed in or acquired through mergers and integration of smaller firms. Research-based firms have also invested in generic production capacity. The role of public research and academic institutions, increasingly Innovation in medical technologies in developing countries, has also come under the spotlight operates in a complex, fast evolving as they seek to reconcile public interest responsibilities policy framework … with the need for private sector partnerships to deliver new medical products (See Chapter III, Sections A and B, and Innovation in medical technologies requires a complex Chapter II, Section C). mix of private and public sector inputs; it differs from innovation in general due to the ethical dimension of medical research, a rigorous regulatory framework, liability questions, and the high cost and high risk Neglected diseases: a policy of failure. Economic, commercial, technological and challenge but a growing focus of regulatory factors have precipitated rapid change in practical initiatives the current landscape for R&D, involving more diverse innovation models and a wider range of active players. Market-based innovation models fail to address the Providing specific incentives to absorb the high cost disease burden specific to developing countries, the and associated risks and liabilities is a central policy so-called neglected diseases. Since this research gap has challenge; this has been the historic role of the patent been identified, the landscape of health research for these system in particular as applied to pharmaceuticals. While diseases has evolved. Product development partnerships estimates vary of the actual cost of medical research (PDPs) have been a significant development over the past and product development, innovation is undoubtedly decade, drawing together not-for-profit entities and industry costly and time consuming. The risk and uncertainty of players, with major philanthropic funding, significantly innovation increases R&D costs in this sector, as the cost increasing the number of products in development for of products that fail to clear regulatory hurdles to become neglected diseases, and identifying pathways regarding commercialized products has to be added (see Chapter existing research gaps (see Chapter III, Section C.4). III, Section B.3). Rising expenditure for medical research Pharmaceutical research based companies also engage has not been matched by a proportionate increase in increasingly in philanthropic research. Several companies new products entering the market, sparking a debate have established dedicated research institutes to research about research productivity and a quest for new models on diseases disproportionately affecting developing of innovation and for financing R&D. Many initiatives countries or participated in cooperative projects to share are exploring new strategies for product development, assets and knowledge, such as WIPO Re:Search, which has thus informing a rich debate about how to improve been developed to make better use of IP protected assets and diversify innovation structures to address unmet and improve access (See Chapter III, Sections C.5-6). health needs. Current policy discussions have reviewed However, much more needs to be done by the international possibilities for open innovation structures, and a range community in this area. The WHO Consultative Expert of push and pull incentives, including schemes such as Working Group has recommended that negotiations begin prize funds that would delink the price of products from on a globally binding treaty on R&D for neglected diseases. the cost of R&D (see Chapter III, Section C.2). The recommendations of the Group were discussed by WHO member states in an intergovernmental meeting in November 2012 (see Chapter III, Section C.3). … sparking new thinking on industry’s role and structure, and on the public/ The IP system at the centre of debate private divide on innovation and access … This evolving innovation landscape is driving change in the pharmaceutical industry; driving factors include tighter Several elements of the IP system touch both on government health budgets; non-profit entities engaged in innovation and on access (see Chapter II, Section B.1). 12 OO-FM-New.indd 12 04.09.13 15:39exe CUTIve sU mmARy The focus has been on the patent system and test data protection of test data, but does not specify the exact form protection, but other relevant aspects of IP include it should take, and national authorities have taken diverse the relationship between trademarks and international approaches (see Chapter II, Section B.1). nonproprietary names (INN) and copyright questions regarding the package insert of medicines (see Chapter II, Section B.1). The patent system has been How patents are licensed can widely used for medical technologies especially by determine their impact on public the pharmaceutical sector. Indeed, the pharmaceutical health … sector stands out in terms of its dependence on patents to capture returns to R&D, but its role in innovation Appropriate licensing of patents can help build and how to enhance its effectiveness are matters of partnerships and enable innovation through cooperation continuing debate (see Chapter III, Section B). Patents, to bring new medical technologies to fruition. Private in principle, promote innovation by providing incentive to sector licensing strategies typically aim at commercial invest in R&D, a particular consideration for the private objectives, but public sector entities can use patents sector. Patents function to structure, define and build expressly to leverage public health outcomes. New innovation partnerships. The impact of patents on access models of socially responsible licensing protect IP while is complex and an area of particular focus: policy options ensuring that new medical technologies are available mean that the mere existence of a patent need not be and affordable for underserved communities. Public– an absolute barrier to access, but equally the absence of private partnerships have resulted in creative licensing an enforceable patent right does not guarantee effective agreements that forgo profit maximization in favour of access (see Chapter IV, Section C). providing essential technologies to poorer countries at affordable prices. Voluntary licences also form part of The TRIPS Agreement sets minimum standards for IP corporate social responsibility programmes, especially protection and enforcement. For example, patents must for HIV/AIDS treatments. The Medicines Patent Pool be available for any innovations in all fields of technology, has reinforced the trend towards voluntary licensing provided they are new, involve an inventive step (or are programmes that increase access to medicines by non-obvious) and are capable of industrial application (or enabling new formulations and enhancing provision of are useful). The role of intellectual property rights in the cheaper generic medicines for developing countries (see innovation cycle is addressed in Chapter III, Section D. Chapter IV, Section C.2). Strict patentability criteria and strict patent examination supported by patenting examination guidelines contribute to prevent strategies employed to delay the … as do policy options and entry of generic competition, such as “evergreening” IP flexibilities (see Chapter III, Section D.3, and Chapter IV, Section C.1). Integral to the patent system is the A wide range of policy options and flexibilities are built requirement to make accessible such innovation through into the international IP regime that can be used to public disclosure, thus creating an extensive knowledge pursue public health objectives. These options are not base. The resultant patent information serves as a tool self-actuating at the international level, though, and for charting freedom to operate, potential technology attention and action are needed at the domestic level as partnerships, and procurement options, as well as giving to how best to implement such flexibilities, so that the policy-makers insights into patterns of innovation (see national IP regime responds to each country’s individual Chapter IV, Section B.5). Patent information is more needs and policy objectives. Key options include accessible in general, but coverage of data concerning transition periods for LDCs (see Chapter II, Section B.1), many developing countries remains a challenge. Recent differing IP exhaustion regimes, refining the criteria for trends show a growth in patent applications on medical grant of a patent, pre-grant and post-grant opposition technologies from a more diverse range of public and procedures, as well as exceptions and limitations to private entities, and from key emerging economies (see patent rights once granted, including regulatory review Chapter II, Section B.1). exception (“Bolar” exception) to facilitate market entry of generics, compulsory licences and government use. The protection of clinical trial data also illustrates Countries have used these instruments to improve the complex relationship between the IP system and access to medicines for both communicable and non- innovation and access. Protecting these data against communicable diseases (see Chapter IV, Sections unfair commercial use is important given the considerable C.1-3). WTO members have agreed to amend the efforts made to generate these data and thus bring new TRIPS Agreement to permit a wider use of compulsory medicines to the market. On the other hand, certain licensing for access to medicines, clearing a potential forms of test data protection potentially delay the entry legal barrier for countries that need to import medicines of generic medicines. The TRIPS Agreement requires produced abroad under a compulsory licence, through 13 OO-FM-New.indd 13 04.09.13 15:39Promoting Access to m edic Al t echnologies And i nnov Ation the grant of special compulsory licences for export Competition policy promotes effective under what is termed the “Paragraph 6 System” (see innovation and helps shape the Chapter IV, Section C.2, and Annex II). While the legal conditions for access scope for flexibilities is now clearer, thanks also to the Doha Declaration on Public Health, and some flexibilities Competition policy is relevant to all stages in the process are widely implemented (such as “Bolar” exceptions), of supplying medical technology to patients, from their policy debate continues on the use of measures such as development to their sale and delivery. The creation of compulsory licensing. sound competitive market structures through competition law and enforcement has thus an important role to play in enhancing both access to medical technology and International trade is an essential fostering innovation in the pharmaceutical sector. It can avenue to access, but does not serve as a corrective tool if IP rights hinder competition and thus constitute a potential barrier to innovation and eliminate economic disparities access. Competition authorities in several jurisdictions International trade is vital for access to medicines and have taken action to address anticompetitive practices other medical technologies, markedly so for smaller and in the pharmaceutical sector, including some patent less resourced countries. Trade stimulates competition, settlements, certain licensing practices and pricing which in turn reduces prices and offers a wider range of policies. Competition policy also has an important role to suppliers, improving security and predictability of supply. play in preventing collusion among suppliers of medical Trade policy settings, such as tariffs on medicines, technology participating in procurement processes (see pharmaceutical ingredients and medical technologies, Chapter II, Section C.2, and Chapter IV, Section D.2). therefore directly affect their accessibility (see Chapter II, Sections B.3-5, and Chapter IV, Section D). Trade policy and the economics of global production Access to medical technologies systems, are also key factors in strategic plans to build through more effective government domestic production capacity in medical products. Non- discriminatory domestic regulations founded on sound procurement health policy principles are also important for a stable supply of quality health products. Access to foreign trade Access to medical technologies in many countries opportunities can create economies of scale to support largely results from government procurement, with the costs and uncertainties of medical research and pharmaceuticals made available through public funds or product development processes. subsidies. Procurement systems aim to obtain medicines and other medical products of good quality, at the right Developed countries have dominated trade in health- time, in the required quantities, and at favourable costs. related products but India and China have emerged as These principles are particularly important in the health leading global exporters of pharmaceutical and chemical sector given the large expenditures, health impact of value inputs, and some other developing countries have shown for money and quality issues, with some programmes strong recent export growth. Countries’ imports of health reportedly paying considerably more than necessary for related products differ dramatically according to level of medicines (see Chapter IV, Section B.5). Procurement development, illustrating substantial and widening gaps in policies favouring open and competitive tendering become access: over recent years, LDC imports have grown least, increasingly important in a fiscal climate when national starting from a low base. budgets are under pressure, and philanthropic programmes confront funding constraints. Good governance in Import tariffs on health-related products can affect access: procurement is consistent with increasing access to medical since they increase cost early in the value chain, their technologies through lower prices and uninterrupted impact on price may be magnified. Developed countries supply. The WTO’s plurilateral Government Procurement have largely eliminated such tariffs, in line with a WTO deal Agreement provides an international framework of rules on pharmaceutical trade. Other countries have reduced to promote efficiency and good governance in public tariffs significantly, but the picture is still mixed: some procurement, with particular application to procurement developing countries structure tariffs to promote local of medicines, promoting transparency, fair competition production, while LDCs apply lower tariffs (see Chapter IV, and improved value for public expenditure (see Chapter II, Section D.1). Section B.4). 14 OO-FM-New.indd 14 04.09.13 15:39l e v e D y r e v o c s i D exe CUTIve sU mmARy trade agreements are designed to incentivize innovation, Free trade agreements beyond the but also have the potential to affect access to medicines multilateral sphere have increasing by delaying the market entry of generic products (see relevance for access issues Chapter IV, Section C.5). These agreements also set standards in other policy areas with implications for access, notably standards established on government procurement The international policy and legal framework has been and competition policy, as well as preferential tariffs on made more complex by the recent growth of trade and pharmaceuticals, inputs, and other health products (see IP agreements, outside the established multilateral forums. Chapter II, Section B.5, and Chapter IV, Section C.5). The Policy debate has focused on intellectual property and overall impact of this trend for the international system pharmaceutical regulation measures in these agreements, is yet to be systematically analysed, in particular the full and their impact on access to medicines. For example, implications of the entire range of such agreements for patent term extensions, data exclusivity and other access to medical technologies. measures such as patent linkage contained in certain free mapping the policy intersections: key areas of law and policy for innovation and access priority medical technologies human procurement rights policies dimension affordability, competition pricing policy & Public Health policy financing universal health coverage regulation for tariffs and Innovation quality, safety non-tariff and efficacy & measures access Intellectual Trade Property economic & commercial policy international innovation systems & innovation trade technology diffusion policy agreements trade marks licensing and and freedom nonproprietary to operate names test data patent protection system 15 OO-FM-New.indd 15 04.09.13 15:39 y r e v i l e D t n e m p oI. Medical technologies: the fundamentals Against the background of the global burden of disease and global health risks, this chapter outlines the fundamental imperative for collaboration between various stakeholders interested in medical technologies. It also demonstrates the need for a coordinated approach, taking into account health, intellectual property and trade variables, in order to ensure coherent decision-making in the area of public health at the international, regional and domestic levels. 16 01-CH01-new.indd 16 04.09.13 15:27A. Pic h Ath Ad m Al I – Med Ial techc ognol Ies: th e funad Ment sal tech u bl e iognol se l n edic Contents A. Public health and medical technologies: the imperative for international cooperation 18 B. The cooperating agencies: the WHO, WIPO and the WTO 21 C. The global burden of disease and global health risks 25 D. Factors shaping public health policy 30 17 01-CH01-new.indd 17 04.09.13 15:27Promoting Access to m edic Al t echnologies And i nnov Ation A. Public health and medical technologies: the imperative for international cooperation Key points •• The WHO, WIPO and the WTO each have distinct, but complementary, mandates to work on issues relating to public health, innovation and intellectual property (IP), and trade. •• Although the main international developments mostly relate to medicines, this study also covers to a certain extent other medical technologies, such as vaccines and medical devices, including diagnostics, due to their importance for achieving public health outcomes. •• Public health and IP policy-makers are faced with the challenging task of identifying the right mix of policy options to best advance their national objectives. Governments are therefore seeking more coherent, comprehensive and accessible information for policy debate. •• The tenth anniversary of the adoption of the Doha Declaration provided a timely opportunity to harvest the experience gained in improving access to, and promoting, medical innovation. •• This study is designed to serve as a background reference for policy-makers in the widest sense – lawmakers, government officials, delegates to international organizations, non-governmental organizations (NGOs) and researchers. Health is a fundamental and universal human right. The the public health problems afflicting many developing and attainment by all peoples of the highest possible level of health least-developed countries, especially those resulting from is the foundational objective of the WHO. The Preamble of the HIV/AIDS, tuberculosis, malaria and other epidemics”, and WHO Constitution emphasizes that international cooperation articulate “the need for the WTO Agreement on Trade- is essential for the promotion of health: Related Aspects of Intellectual Property Rights (TRIPS Agreement) to be part of wider national and international “The health of all peoples is fundamental to the action to address these problems”. attainment of peace and security and is dependent upon the fullest co-operation of individuals and States. “... we will be exploring how best to harvest the potential The achievement of any State in the promotion and of the three organizations’ reserves of knowledge and protection of health is of value to all. information, to strengthen cooperation towards a goal all can surely share: put simply, that of getting needed medicines to Unequal development in different countries in the 2 the people who are in most need.” promotion of health and control of disease, especially communicable disease, is a common danger.” Pascal Lamy, Director-General, WTO This central objective of the WHO, the essential logic of international cooperation, and the responsibility to take practical action have compelling implications for 1. Policy coherence the international community. Accordingly, public health outcomes are of importance to WIPO, which also focuses The WHO, WIPO and the WTO each have distinct, but on the social and developmental dimensions of innovation complementary, mandates to work on issues relating to and the transfer and dissemination of technology. WIPO public health, innovation and intellectual property (IP), policy discussions and technical cooperation activities, and trade. The three organizations therefore share a including a range of programmes conducted in partnership responsibility to strengthen practical dialogue between with the WHO and the WTO, have focused increasingly on themselves and other partners in order to fulfil their public health matters. mandates more effectively, to ensure the efficient use of resources for technical cooperation and to avoid WTO members have stressed the need for a positive link duplication of activities. between public health and the global trading system. In the Declaration on the TRIPS Agreement and Public Health Coherence is vital in international action to address 1 (Doha Declaration), members “recognize the gravity of public health problems. Such coherence has never been 18 01-CH01-new.indd 18 04.09.13 15:27A. Pic h Ath Ad m Al I – Med Ial techc ognol Ies: th e funad Ment sal tech more important for the technical cooperation work of the lessons learned about access and innovation with respect u lb e three organizations than it is at the present time. The to medicines may also be useful with respect to these other goinol es WHO brings vast expertise in all areas of public health, medical technologies, there are also significant differences including medicine and vaccine policies, medical devices, regarding the role of IP and innovation and access. Other l regulatory questions, pricing and procurement, in addition important determinants for public health, such as human to other factors affecting access to medicines. WIPO is resources, health financing and health systems, do not fall n dice uniquely positioned to help organizations work towards within the scope of this study. creating a truly global view and understanding of the IP system, including the flexibilities to implement the patent system at the national level, to provide information on 3. The need for this study patents, including information on the patent status of key medicines and vaccines in developing countries, Governments have choices to make regarding the and to lend its expertise on patent law and its interplay appropriate implementation of policy instruments in their with public policy. The WTO works on several aspects of domestic systems and practices. Even though international trade policy that have direct relevance to public health, standards apply to most of the main policy instruments – including IP rules and flexibilities within the international in particular IP – there is “policy space” within and around legal system, as they affect both the access and those standards. Public health and IP policy-makers are innovation dimensions. faced with the challenging task of identifying the right mix of policy options to best advance their national objectives. The Doha Declaration has served as a catalyst for Governments are therefore seeking more coherent, developing coherence at the international level. In comprehensive and accessible information for policy conjunction with its role of making public health issues a debate. The aim of the technical cooperation activities of central focus of work carried out by the WTO on IP and the WHO, WIPO and the WTO is to facilitate understanding international trade, the Doha Declaration has been taken of the full range of options and their operational context, up in a series of World Health Assembly (WHA) resolutions rather than programmes that simply explain the legal on ensuring accessibility to essential medicines and public framework. This study draws together the materials used health, innovation and IP. Notably, the Doha Declaration in technical cooperation and it addresses emerging needs was a point of reference in the negotiations on the WHO for information in an accessible, systematic format, in order Global Strategy and Plan of Action on Public Health, to support ongoing collaborative efforts. Innovation and Intellectual Property (GSPA-PHI). The WIPO 3 Development Agenda deals extensively with flexibilities in “... There is a vast area of practical cooperation, which is international IP law, including the health-related flexibilities very important in the achievement of the balance between specifically identified in the Doha Declaration. creation, on the one hand, and diffusion of the social benefit 6 of creation, on the other hand.” These mandates and competencies have been at the centre of policy debates. For example, the 2011 Francis Gurry, Director General, WIPO Political Declaration of the High-level Meeting of the General Assembly on the Prevention and Control of 4 Non-communicable Diseases called for the WHO and The Doha Declaration recognized that “intellectual other international organizations to work together in a property protection is important for the development of coordinated manner to support national efforts to prevent new medicines”. However, it also recognized the concerns and control non-communicable diseases (NCDs), and about IP effects on prices. The challenge for governments mitigate their impacts. is to use the policy instruments at their disposal to address both aspects in a mutually reinforcing manner. Since the early 2000s, policy-makers have sought effective ways “Discussions of access to medicines almost inevitably to strengthen the positive linkages between, on the one turn to questions of prices, patents, intellectual property hand, the private sector’s capacity to finance research and 5 protection, and competition.” development (R&D) and, on the other hand, the public policy goals of selecting, supplying and using medicines in Margaret Chan, Director-General, WHO the most rational way. “Public health now finds itself caught in a cross-current 2. Scope of the study of rising expectations and ambitions, set against rising demands and costs, at a time when funds are stagnant or Although the main international developments mostly relate shrinking. In such a situation, introducing greater efficiency to medicines, this study also covers to a certain extent 7 is a far better option than cutting budgets and services.” other medical technologies, such as vaccines and medical devices, including diagnostics, due to their importance Margaret Chan, Director-General, WHO for achieving public health outcomes. While some of the 19 01-CH01-new.indd 19 04.09.13 15:27Promoting Access to m edic Al t echnologies And i nnov Ation Rising health-care costs have led to increased national development to address unmet health needs, together with public health budgets and higher public expectations for new and adapted approaches to procurement. Today, much health care. In difficult economic times, there is even more better data is available globally on areas such as pricing, reason to evaluate the efficiency and fairness of their scope of access to medicines and patent coverage. health services, including expenditure on medicine and medical technology. Effective delivery of health care also This study follows on from the 2002 study entitled WTO means adapting technologies to diverse local needs and Agreements and Public Health: A Joint Study by the WHO priorities. Developing countries are facing an increased and the WTO Secretariat. This earlier study examined the disease burden of NCDs. The increased availability of linkages between trade and health policies in general patents for medicines has implications which pose a to enable trade officials and health officials to better further challenge in a wider range of countries, notably understand and monitor the effects of their work on each in key low-cost exporting countries that have traditionally other’s areas of responsibility. This new study updates the specialized in generic medicine production. The evolving material on IP and other trade aspects as they relate to disease burden, the lack of medicines required for treating innovation of, and access to, medical technologies, the neglected diseases, and the challenges of drug resistance areas which have seen most change in the decade since all require the development of new medicines, vaccines then. The 2002 study remains a useful resource on many and effective dosage forms, as well as effective delivery issues, such as health services, infectious disease control, mechanisms. Innovation needs to be encouraged – both food safety and tobacco. in terms of inventing new medicines and also in terms of providing effective systems to bring new products “Health, trade and innovation are indispensable issues when through very complex product development stages, and tackling the problems that we are increasingly facing in a to market and deliver them to patients. Policy-makers 9 globalized world.” have recognized the need to look beyond conventional approaches to R&D in order to address the innovation gap – Francis Gurry, Director General, WIPO particularly in the area of neglected diseases. “... There is indeed great potential, still mostly untapped, 5. Who should read this study? for the use of empirical data to inform policy debate on health innovation and access to medicines. ... All of us who This study is designed to serve as a background care deeply about health innovation and access to medicines reference for policy-makers in the widest sense – would benefit from improved accessibility of these raw data, lawmakers, government officials, delegates to international but also from the careful putting together of all the pieces of organizations, non-governmental organizations (NGOs) 8 the empirical puzzle.” and researchers. It is also designed to serve as a resource for the three organizations’ technical cooperation activities. Pascal Lamy, Director-General, WTO It has been prepared to serve the needs of policy-makers who may already have a strong background in either trade or IP or the health aspects of improved access and medical innovation, and who seek a comprehensive presentation 4. The timing of the study of the full range of issues, including institutions and legal The tenth anniversary of the adoption of the Doha concepts with which they are unfamiliar. Declaration provided a timely opportunity to harvest the experience gained in improving access to, and promoting, The study represents the first joint publication by the medical innovation. Today there is a greater understanding WHO, WIPO and the WTO, with the aim of providing a solid of legal and policy options, which has led to richer dialogue. factual foundation for ongoing policy debates. Nothing There has been a change in the WTO rules on patents in the study should be taken as a formal position or the for medicines arising from paragraph 6 of the Doha interpretation of rights and obligations by any of the three Declaration, with the conscious goal of creating additional organizations, or by any of their respective member states. flexibility for countries with the least resources. Recent Actual policy choices and interpretations of member states’ rights and obligations remain exclusively a matter years have seen a proliferation of new initiatives – public, for governments. private and philanthropic – for innovation and product 20 01-CH01-new.indd 20 04.09.13 15:27B. The coopera Ting ag encies: The Who , Wipo and The WT o I – Med Ial techc ognol Ies: th e funad Ment sal B. The cooperating agencies: the WHO, WIPO and the WTO Key points •• The WHO is the directing and coordinating authority for health within the UN system. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends. •• WIPO is the specialized agency of the United Nations dedicated to developing a balanced and accessible IP system which rewards creativity, stimulates innovation and contributes to economic development in the public interest. •• The core mission of the WTO is to open trade as well as to maintain and further develop the rules-based international trading system. •• Given that partnership is crucial for an effective international response to the ever-evolving challenges facing public health, the WHO, WIPO and WTO Secretariats have intensified interagency collaboration on matters related to public health, intellectual property and trade. This section provides a brief overview of the specific roles, Innovation and Public Health (CIPIH), which was chaired mandates and functions of the WHO, WIPO and the WTO, by former Swiss Federal Councillor Ruth Dreifuss, to which cooperate within the general international framework produce an analysis of the interface between IPRs, 11 on issues related to the interface between public health, innovation and public health. In April 2006, the CIPIH intellectual property (IP) and trade concerning innovation in, published its report (WHO, 2006b), which contained 60 and access to, medical technologies. Additional information recommendations aimed at fostering innovation and on the work of a range of other international organizations, improving access to medicines. It concluded that: NGOs, industry bodies and other stakeholders can be found in Annex I. “Intellectual property rights have an important role to play in stimulating innovation in health-care products in countries where financial and technological capacities exist, and in relation to products for which 1. World Health Organization there are profitable markets. However, the fact that a patent can be obtained may contribute nothing The WHO is the directing and coordinating authority or little to innovation if the market is too small or for health within the UN system. It is responsible for scientific and technological capability inadequate. providing leadership on global health matters, shaping Where most consumers of health products are poor, the health research agenda, setting norms and standards, as are the great majority in developing countries, the articulating evidence-based policy options, providing monopoly costs associated with patents can limit technical support to countries, and monitoring and the affordability of patented health-care products assessing health trends. required by poor people in the absence of other measures to reduce prices or increase funding.” Monitoring the impact of trade and intellectual property rights (IPRs) on public health is one of the strategic areas Following CIPIH recommendations, WHO member states of the work of the WHO. Following the adoption of the subsequently developed a global strategy and plan of WTO Agreement on Trade-Related Aspects of Intellectual 12 action on public health, innovation and IP. Property Rights (TRIPS Agreement), the Forty-ninth World Health Assembly (WHA), in May 1996, adopted the first mandate of the WHO, to work on the interface between Its adoption was the result of a debate that continued for 10 public health and IP. In subsequent years, often following many years and can be considered a major step forward long negotiations, many more resolutions were adopted, in the process of achieving global consensus on practical continually broadening and reinforcing the WHO mandate action on public health, innovation and IP. For the WHO, to work on issues related to public health, trade and IP. the GSPA-PHI is a milestone, as it reaffirms and extends the mandate of the WHO to work at the interface of public In May 2003, WHO member states decided to health and IP. It also demonstrates that it is feasible to find establish the Commission on Intellectual Property Rights, a common ground, based on dialogue. 21 01-CH01-new.indd 21 04.09.13 15:27Promoting Access to m edic Al t echnologies And i nnov Ation IP issues have also been addressed during other negotiation The 2007 WIPO General Assembly established the 13 processes at the WHO, such as: WIPO Development Agenda to ensure that development considerations form an integral part of the work of ƒƒ the establishment of the Pandemic Influenza WIPO. Development is considered a cross-cutting issue Preparedness (PIP) Framework for the Sharing of which impacts on sectors of the organization. The 45 Influenza Viruses and Access to Vaccines and other Development Agenda recommendations guide the work Benefits of WIPO. ƒƒ the creation of an international mechanism to combat In addition to the promotion of technological innovation substandard and spurious/falsely-labelled/falsified/ and technology dissemination as general objectives of the counterfeit medical products patent system, several areas of the work carried out by ƒƒ the WHO Global Health Sector Strategy on HIV/AIDS, WIPO have particular relevance for public health. 2011-2015 ƒƒ the prevention and control of NCDs. In 2009, WIPO established the Global Challenges Program to address innovation and IP as they relate to global and The WHO has produced a large body of material to provide interconnected issues, such as climate change, public evidence-based guidance to its member states in order to health and food security. Innovation and access to the support them during the process of shaping their policies on results of innovation are central issues in the area of IP. The public health and IP. The WHO has also jointly hosted with challenge for public health policy-makers is to provide an other relevant organizations numerous training and capacity- environment for health innovation and to promote access building activities in all WHO regions, and it continues to do to new medical technologies. The WIPO Global Challenges so in close collaboration with WIPO and the WTO. Member Program seeks to raise awareness and understanding of the states have also requested on a regular basis technical interplay between innovation, technology transfer and the assistance on issues related to public health and IP. dissemination of technology, among others, as they relate to health innovation and access to medicines. WIPO works also with both private and public sector and has launched a new consortium, WIPO Re:Search, to enable the sharing of 2. World Intellectual Property IP and expertise to promote the development of medicines Organization to treat neglected diseases (see Chapter III, Section C.6). WIPO is the specialized agency of the United Nations WIPO seeks to ensure that the development of dedicated to developing a balanced and accessible IP international patent law keeps pace with the rapidly system which rewards creativity, stimulates innovation evolving technological, economic and social environment. and contributes to economic development in the public The continuing growth in the number of patent applications interest. worldwide and the constant development of technologies present a challenge for the effective and efficient handling The core activities of WIPO include: of patent applications, for the achievement of high quality in patents which are granted internationally, and ƒƒ administering multilateral treaties and supporting the for the role of patents in contributing to innovation and evolution of the international legal IP frameworks the dissemination of technology. WIPO not only advises ƒƒ providing global IP services to facilitate easier and its member states how to implement the requisite legal more cost-effective international protection, and also framework but also how to assess options and to develop to facilitate arbitration, mediation and other alternative coherent policy strategies. WIPO member states have been dispute resolution services engaged in discussions with the Standing Committee on ƒƒ assisting in establishing national IP and innovation the Law of Patents (SCP) on issues related to patents and strategies, developing appropriate regulatory frameworks health since 2011. and building the infrastructure and human capacity needed to harness the potential of IP for economic In 1998, WIPO established the Traditional Knowledge development Program. One of the objectives of this programme is to achieve the more effective use of IP principles and ƒƒ developing technical platforms to facilitate cooperation systems for the legal protection of traditional knowledge, among IP offices including traditional medicine. ƒƒ developing free databases of patents, trademarks and industrial designs to facilitate access to knowledge In line with its goal of fostering international policy ƒƒ building awareness, understanding and respect for IP dialogue on IP and public health, WIPO also engages ƒƒ working in partnership with the United Nations and substantively with other relevant stakeholders – UN and other organizations to identify IP-based contributions intergovernmental organizations, governments of member to climate change, food security, public health and states, civil society and NGOs, as well as the private sector other global challenges. and academia. 22 01-CH01-new.indd 22 04.09.13 15:27B. The coopera Ting ag encies: The Who , Wipo and The WT o I – Med Ial techc ognol Ies: th e funad Ment sal 17 established under the 2003 waiver decision and the 3. World Trade Organization 18 2005 Protocol Amending the TRIPS Agreement – was designed to deal with the difficulties of WTO members The core mission of the WTO is to open trade as well as to lacking sufficient manufacturing capacities to make maintain and further develop the rules-based international effective use of compulsory licensing. trading system. International trade and trade rules intersect with public health objectives in various areas and These and other developments demonstrate that the WTO in many different ways. Most directly, integration into the can serve as a useful and effective forum for discussions world economy can enhance access to the most basic regarding the interface between IPRs and public health. requirements for good health, such as the safe supply of Thus, the TRIPS Council’s discussions have led to the food or access to health-related products and services. adoption of the two important instruments referenced Indirectly, trade offers the opportunity for economies to above. The Paragraph 6 System is also the first ever grow and thus contributes to the alleviation of poverty and proposed amendment to the WTO Agreement in the form ill health. of the 2005 Protocol Amending the TRIPS Agreement. This provides evidence of the importance that WTO The importance of public health has been recognized members attach to these questions. in the rules of the multilateral trading system since 1947. The General Agreement on Tariffs and Trade (GATT), Another core function of the WTO is the Dispute Settlement adopted in 1947 and subsequently incorporated in the Mechanism, which has resulted in some important GATT 1994, contains an exception in Article XX(b) which clarifications of the relevant rules under the TRIPS explicitly recognizes the right of governments to enact 19 Agreement, including how they relate to public health. trade-restricting measures whenever these are necessary Furthermore, the WTO Secretariat aims to enhance to protect human life and health. The right to take measures the participation and informed decision-making of its for the protection of health is also included in other relevant 14 members and observer governments through awareness- WTO agreements, including the TRIPS Agreement. raising, capacity-building, and the provision of factual and technical information. To achieve this objective, the WTO The implementation of the rights and obligations regularly engages in technical assistance activities, which established under the WTO agreements, including those comprehensively cover the relationship between IPRs and related to public health, is overseen by the competent WTO 20 public health. bodies. While most issues related to the implementation and compliance with those obligations are resolved through bilateral consultations, or within the competent WTO bodies, only very few disputes brought to the 4. Trilateral cooperation WTO have dealt with measures related to human health protection. In these particular cases, what was challenged The adoption of the Doha Declaration was a landmark was not the right to protect health, but the appropriateness occasion for issues that intersect public health, IP and of the measures chosen to achieve the objective of health trade. Since 2001, the principles enshrined in the Doha 15 protection. The WTO Dispute Settlement Body has Declaration have shaped the framework for multilateral consistently maintained that it is within the authority of cooperation in this area, which included the provision each WTO member to set the public health objectives it of technical and policy support requested by members, seeks to achieve. Governments have thus retained the joint publications and mutual participation in training right to use available exceptions and flexibilities necessary programmes. Based on the adoption of the Development 16 to achieve their targeted levels of health protection. Agenda by the WIPO General Assembly in 2007 – specifically Recommendation 40 – WIPO was requested to The search for a balance between the need to protect intensify its cooperation on IP-related issues with relevant IPRs to provide incentives for R&D on the one hand international organizations, and in particular with the WHO and, on the other hand, to address concerns about the and the WTO, in order to strengthen the coordination potential impact of such protection on the health sector – required to achieve maximum efficiency when undertaking 21 in particular its effect on prices – has been an important development programmes. The move towards reinforced consideration in the WTO’s work. A number of provisions coordination and dialogue was further supported by the in the TRIPS Agreement are directly relevant to public process leading to, and the adoption of, the GSPA-PHI health. WTO members have the flexibility to interpret and by the WHA in 2008. It explicitly requested the WHO implement these provisions in a manner supportive of their Director-General “to coordinate with other relevant right to protect public health. The importance of creating international intergovernmental organizations, including a positive, mutually reinforcing link between the IP system WIPO, WTO and UNCTAD, to effectively implement the 22 and access to medicines was explicitly recognized in the global strategy and plan of action”. In addition, in the case 23 Doha Declaration. Two years later, the Doha Declaration of more than 20 activities detailed in the plan of action, led to the adoption of a mechanism often referred to as the three organizations along with other international the “Paragraph 6 System”. This additional flexibility – organizations are listed as the stakeholders responsible in the form of a special compulsory licence for export for the implementation of these activities. 23 01-CH01-new.indd 23 04.09.13 15:27Promoting Access to m edic Al t echnologies And i nnov Ation 27 Given that partnership is crucial for an effective international symposium in 2011 on access to medicines, patent response to the ever-evolving challenges facing public information and freedom to operate, highlighting the health, the WHO, WIPO and WTO Secretariats have prospects for using patent information to assist more intensified interagency collaboration on matters related informed choices on access to medicines. This series 24 to public health, IP and trade. Within their respective of symposia is designed to improve the flow of practical mandates and budgets, common activities are planned information to guide and support technical cooperation and carried out jointly to ensure that data, experiences in the future. Similarly, this trilateral study is a further and other information are exchanged, and also to ensure milestone on the road towards stronger cooperation. that the best use is made of the available resources. The three Secretariats’ collaboration has primarily focused 5. Other international key on supporting the implementation of the GSPA-PHI, but it is not limited to it. Other areas of cooperation have stakeholders included addressing the IP-related issues raised during the preparatory work which led to the establishment of the The period since 2001 has seen dramatic growth in the WHO PIP Framework. number and diversity of participants in international policy debates concerning innovation in, and access to medical Of course, this collaboration does not exclude close technologies. Consideration of these issues necessarily cooperation with other international organizations, and the entails a multidisciplinary and pluralistic approach. A WHO, WIPO and the WTO have broadened the base of distinctive feature of the debates has been the range of their collaborative and consultative networks dealing with perspectives during discussions, coupled with the depth public health issues. The WHO, for example, has stepped of expertise and practical experience that has been drawn up its programme activities with other partners such as the from international and intergovernmental organizations, United Nations Conference on Trade and Development procurement and product development initiatives, and (UNCTAD), in line with the GSPA-PHI. NGOs such as public health advocates and industry associations. At the Conference on Intellectual Property and Public Policy Issues, organized by WIPO in July 2009, the three Annex I provides more detailed accounts of an illustrative – Directors-General addressed the topic of strengthening yet not fully representative – selection of some of these policy 25 multilateral cooperation on public health IP and trade. stakeholders provided by the organizations themselves. The In 2010, the WHO, WIPO and the WTO held a technical study recognizes and values the work of many others, and symposium on access to medicines, pricing and no suggestion is made about the relative importance of any 26 procurement practices. It was followed by a second organization, whether mentioned or not. 24 01-CH01-new.indd 24 04.09.13 15:27c . The glo Bal Burden of di sease and glo Bal heal Th ris s I – Med Ial techc ognol Ies: th e funad Ment sal C. The global burden of disease and global health risks Key points k •• Understanding the evolution of the global burden of disease (GBD) and the role of major health risks is important in order to develop effective strategies to improve global health and also in order to identify the range of medical technologies that are needed. •• Large declines in mortality between 2004 and 2030 are projected for all of the principal communicable, maternal, perinatal and nutritional causes of death, including HIV/AIDS, tuberculosis (TB) and malaria. •• The ageing of populations in low- and middle-income countries (LMICs) will result in a significant increase in total deaths due to non-communicable diseases (NCDs) over the next 25 years. Globally, NCDs are projected to account for over three quarters of all deaths by 2030. •• The leading global risks for mortality in the world are high blood pressure, tobacco use, high blood glucose, physical inactivity, and overweight and obesity. The leading global risks for burden of disease are underweight and unsafe sex, followed by alcohol use and unsafe water, sanitation and hygiene. •• A greater diversity of medical technologies will be needed in order to meet the challenges presented by the evolving GBD within a wider context of preventive measures focusing on lifestyle, nutrition and environmental factors. The development of effective strategies to improve (b) Current data on global average global health and react to changes in the global burden of disease burden of disease (GBD) requires an understanding of the GBD and of GBD-related trends, coupled with The average GBD across all regions in 2004 was 237 an understanding of major health risks. These are DALYs per 1,000 population, of which about 60 per cent introduced in this section. were due to premature death and 40 per cent were due to nonfatal health outcomes (WHO, 2008). The contribution of premature death varied dramatically across regions, with years of life lost (YLL) rates seven times higher in 1. Defining the need Africa than in high-income countries. In contrast, the International efforts to address public health issues years lost due to disability (YLD) rates were less varied, need to be grounded in a clear empirical understanding with Africa having 80 per cent higher rates than high- of the GBD, and future efforts should be guided, as far income countries. South-East Asia and Africa together as possible, by best estimates on the evolving disease bore 54 per cent of the total GBD in 2004, although these landscape. regions account for only about 40 per cent of the world’s population. The high levels of burden of disease for the WHO regions (a) Measuring the global burden of disease of Africa, South-East Asia and the Eastern Mediterranean, compared with other regions, are predominantly due to The WHO studies on the GBD aim to summarize overall Group I conditions (communicable diseases, and maternal, loss of health associated with diseases and injuries. perinatal and nutritional conditions). Injury DALY rates are GBD measurement methods were developed in order also higher than they are in other regions. to generate comprehensive and internally consistent estimates of mortality and morbidity by age, sex and region. The key feature of this concept is a summary Almost half of the disease burden in LMICs is currently measure called the disability-adjusted life year (DALY). caused by NCDs. Ischaemic heart disease and stroke are The DALY concept was introduced as a single measure the largest sources of this burden, especially in European to quantify the burden of disease, injuries and risk factors LMICs, where cardiovascular diseases account for more (Murray and Lopez, 1996). The DALY is based on years than one quarter of the total disease burden. Injuries of life lost due to premature death, and years of life lived accounted for 17 per cent of the disease burden in adults in less than full health (see Box 1.1). aged 15-59 years in 2004. 25 01-CH01-new.indd 25 04.09.13 15:27

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