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INTELLECTUAL PROPERTY: WHO-WIPO-WTO BOOK

Chapter 1: Medical technologies: the fundamentals

 

D. Factors shaping public health policy

Key points

 

  • Achieving sustainable and more equitable public health outcomes depends on the dynamic interplay of national public health policy, including effective health systems and adequate financing of health systems, a sound regulatory environment, trade and competition settings, procurement policies, innovation strategies and the intellectual property (IP) system.
  • The policy processes of the past decade have led to a better understanding of how these distinct policy components can and should work together to produce public health outcomes by seeking positive synergies between human rights, health, access, innovation and commercial dimensions.
  • Innovation cannot take place in isolation from concerns about access, and access has to be seen in the broader context of the need for innovation and effective regulation. 
  • The greater availability and breadth of data in each of these policy domains offers a rich empirical basis for decision-making. 
  • An increasing number of national, regional and international policy processes, including the framing of trade agreements, involving a multiplicity of agencies, are tackling issues that impact on access to, and future innovations in, medical technologies. 

 

1. Seeking effective outcomes within a complex policy environment

Building a sustainable global response to the demand both for innovations in medical technology and for effective and equitable access to needed technologies is a complex and constantly evolving challenge. While it is often expressed in abstract or political terms, the effort fundamentally concerns how to deliver improved health outcomes. Creating new medical technologies, assessing these technologies, providing for their effective distribution and ensuring that they are used rationally are, ultimately, practical processes. These processes range from the work of laboratory research scientists to the care provided by nurses in a field clinic.

The policy, economic and legal environment influences and can determine the actions, choices, priorities and allocation of resources that are applied at a practical level. This policy environment is complex: it comprises laws, regulations and policy instruments, at national, regional and international levels, that address diverse fields, including public health, international trade and the IP system. Effective progress and sustained impact on public health cannot be attained by working within the confines of one discrete set of policy measures or legal instruments. Lack of coherence, or the prospect of conflict, between law and policy in different fields can thwart progress and impede practical benefits. It follows that understanding the intersections between these different policy measures is key to ensuring that they work harmoniously for overall public health benefit.

2. Transforming policy intersections: from boundaries to synergies

The emphasis on "intersections" – understanding the linkages and interplay between distinct areas of law and policy (see Figure 1.3) – is a consistent theme in recent debate on public health policy. This study identifies two levels of intersection:

  • Points of interaction between the legal and policy principles in different domains, so that law and policy instruments can be interpreted and applied in practice to promote public health.
  • The integration of sets of data drawn from diverse fields, so that policy-makers can work from an improved, integral base of information, combining data on public health, determinants of access to medical technologies, coverage of relevant IP rights, and trade settings.

The idea of synergy can illuminate how these intersections can be transformed from formal boundaries between different policy domains, to points of reinforcement and mutual benefit. Synergy refers to diverse elements working together to achieve results that could not be obtained by individual actions. Access to medicines is a compelling example of synergy in action. Indeed, the synergistic relationship between health, trade and IP is, perhaps, the core practical lesson to be learned from the decade-long debate about IP and access to medicines.

Trade and commercial perspectives are sometimes regarded as being essentially at odds with promoting public health. Yet the commercial environment, promotion of competition and of private sector innovation, and the regulation of trade, are crucial determinants for access to medicines. International trade is vital for access to medical technologies, and no country can aim to be entirely self-sufficient, even though some aim at boosting local production. To the extent that access depends on affordability, economies of scale for industry and a more competitive marketplace yield opportunities for improved health outcomes. Openness to international trade generally promotes competition, and offers improved affordability and access. By enabling a wider range of suppliers to serve the population, it can also enhance security of supply. Trade policy settings, such as tariffs, quotas and other regulations, have a direct effect on prices and availability. Many governments have taken national legal and policy measures to enable or promote generic competition in the supply of medicines so as to help reduce prices. WTO rules have been interpreted in dispute settlement to provide for public health objectives, such as enhanced entry of generic medicines; and the Declaration on the TRIPS Agreement and Public Health (Doha Declaration) has affirmed that the Agreement can be interpreted from a public health perspective.

Trade policy and the economics of global production systems are also key factors in strategic plans to build domestic production capacity that aim for better access to medical products. Procurement policies favouring open and competitive tendering, coupled with the rational use of medicines, become all the more important in ensuring continued access in a fiscal climate where national budgets are under pressure and philanthropic programmes face funding constraints. Programmes for access to medicines also stand to benefit from better, more integrated use of data, including on current and projected disease burdens, on efficacy of medicines, on price and IP coverage of medicines, and on trade and regulatory measures.

Over the past decade, access to medicines has moved to the centre of a cross-cutting debate between different policy dimensions. Policy-makers have progressively developed the policy framework for access, including through the Doha Declaration, through World Health Assembly (WHA) resolutions, and through human rights instruments. More recently, policy discussions have turned also to the innovation dimension. Indeed, the intersection between innovation and access is fundamental, and forms the fulcrum of the present study.

Policy measures aimed at promoting access or innovation need to recognize that these two concepts are intrinsically intertwined. Merely to leverage enhanced access to the stock of existing, proven medicines is insufficient. The current pharmacopeia needs constant expansion to keep pace with the evolving disease burden. The disease burden continues to evolve, with policy-makers recently turning their attention, for instance, to the growing burden of non­communicable diseases (NCDs) in the developing world. New strains of viruses and the problem of resistance of bacteria against current medicines challenge the efficacy of existing treatments. And medical innovation has historically failed to address major diseases that are endemic in the developing world.

Shifting patterns of needs and requirements – due not least to the constant evolution of the disease burden – create an ever-changing set of demands both for new and adapted technologies. Accordingly, the interplay between access and innovation can be seen in an integrated way, as a positive feedback loop between the health burden and the innovative response: linking the identification of health needs; innovation in, and adaptation of, technologies to meet the needs identified; and the implementation, dissemination and distribution of safe and effective technologies of proven quality. Innovation may aim specifically at enhancing access: for example, where use of diagnostic technologies requires skilled clinical support or infrastructure – and this is simply not available for many patients – then leveraging access for communities in resource-poor settings may entail creating new versions of the technology that can be operated without such support or infrastructure.

3. Building stronger links between local, national and global levels

Promoting medical innovation policy is a particular challenge, as it operates at the intersection of several policy domains. The essential challenge for innovation in the area of medical technologies can be expressed in simple terms:

  • first, to secure the requisite resources (including know-how, research and product development capacity, clinical trial expertise, regulatory infrastructure, background and platform technologies and research tools, and the investment of public and private capital)
  • second, to apply these innovation resources most effectively towards addressing unmet public health needs.

Yet, meeting this challenge entails working on complex intersections between different policy areas, applying a mix of incentives and market interventions, funding and other support for R&D, infrastructure development, and building a public research base and a skilled research workforce. Equally, promoting innovation can entail better utilization of existing resources, leveraging access to existing technologies, drawing on drug development skills and R&D infrastructure, and drawing more effectively on indigenous research and innovation capacity, so as to expand the medical technology development pipeline. A host of international, regional and national legal and policy instruments influences innovative activity.

International legal instruments need to be understood through the prism of national experience with their implementation. Thus, a systematic understanding of the intersections between these different layers of policy and practice requires a more sophisticated understanding of how they interact and influence one another (see the central column in Figure 1.4) – so as to assess how international, national and institutional policies determine actual innovation outcomes, and how, in turn, practical experience influences the policy framework.

4. The empirical challenge: an accessible base for policy

Policy-makers dealing with the challenges of medical technology access and innovation are more numerous and more diverse than at any time previously, and contend with a host of policy, legal and administrative structures at national, regional and international levels. For example, national regulatory authorities who seek to safeguard the public against unsafe or ineffective medicines deal with clinical trial data that may be protected by IP laws, and work within a legal and policy framework shaped by multiple international and regional instruments. Patent offices, which face unprecedented workloads, must use the best possible sources of technological data when searching and examining prior art1 to decide on whether or not to grant patents on claimed inventions. Procurement programmes have to contend with a host of rapidly evolving factors, while assessing evolving disease burdens, clinical needs, the selection of essential medical technologies, efficacy, prices and availability, and regulatory and IP aspects. Common to all these diverse challenges is the requirement for a stronger empirical base so that policy choices are more likely to address practical needs. Fortunately, the past decade has seen significant improvements in the quality and inclusiveness of data, as well as access to the necessary information technology tools required to convert raw data into accessible knowledge services for stakeholders.

Technology is unquestionably an essential component of public health (see Box 1.2): medicines, ranging from antibiotics to antiretrovirals (ARVs), have been central in ensuring dramatically improved public health outcomes; vaccines have all but eliminated the threat of certain diseases; and other technologies, such as medical imaging, have led to transformations in diagnosis and treatment. Such technologies cannot be taken for granted – they are the product of extensive R&D activities. Development of these technologies has been a complex, often risky and uncertain process, drawing on diverse inputs, originating from both public and private sectors, and often requiring scrupulous testing and regulatory oversight. Innovation in medicines is among the most uncertain and expensive forms of technology development, creating the need for distinct innovation structures, close regulatory and ethical attention, appropriately high standards of safety and efficacy, and specific or targeted incentives.

Box 1.2. Health and medical technologies: fundamental concepts 

 

While the terms health technologies and medical technologies sometimes are used interchangeably, health technologies is the broader term, encompassing medical technologies. There are no watertight definitions of either term. The WHO defines health technology as application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve a health problem and improve quality of lives.2

 

Health technologies include, for example, assistive technologies, such as a white stick which may be used by a person who is blind, or a treadmill and exercise equipment which may be used as a health-promoting device. Medical technologies are associated with the concept of medical intervention. These interventions can be preventive (e.g. vaccine), diagnostic (e.g. in vitro diagnostic kit, stethoscope or thermometer), therapeutic (e.g. medicine, surgical instrument, surgical procedure and implant), rehabilitative (e.g. physiotherapy equipment, assistive device such as a crutch). Medical devices are a subgroup of medical technologies, including any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article that does not achieve its primary intended action in or on the human body solely by pharmacological, immunological or metabolic means. Examples include syringes, defibrillators, in vitro tests or hip prostheses.

 

As technology evolves, more combination products materialize – mainly in the area of medicines in medical devices delivery sets. There are also more and more examples of combined medical technologies. The respiratory inhaler for the treatment of asthma is one example of a medicine delivered through a dosed aerosol device. 

 

Table 1.2 presents examples of health and medical technologies from the perspective of their purpose and material nature. Providing access to essential medical technology – the key focus of this study – is an essential ingredient for an effective response, but it is far from being sufficient. At the national level, political commitment of governments is required in order to allocate the requisite financial resources to the health sector to develop strong health systems. Prevention is another key aspect. For example, major proportion of the burden of NCDs can be prevented by reducing the exposure of populations to tobacco use, unhealthy diets, physical inactivity and harmful use of alcohol. To this end, effective health prevention and promotion programmes are required to address the main risk factors. An improved medicine is potentially injurious if it is incorrectly prescribed or improperly administered. Advanced medical imagery technology is useless unless it is accompanied by skilled diagnosticians and the requisite infrastructure. Thus, effective access to medical technologies can be dependent on access to appropriate clinical infrastructure and medical services, whether clinical or technical.

Table 1.2. Medical technologies: semantics, purpose and material nature

Health technologies: purpose or application (examples)

Prevention: Vaccines, contraceptive devices, immunization, hospital infection control programme, fluoridated water supply, iodized salt.

Screening: Pap smear, tuberculin test, mammography, serum cholesterol testing.

Diagnosis: Stethoscope, in vitro diagnosis, electrocardiogram, serological test for typhoid, x-ray.

Treatment: Antiviral therapy, haemodialysis, coronary artery bypass surgery, psychotherapy, medicines for pain, antibiotics.

Rehabilitation: Exercise programme for post-stroke patients, assistive device for severe speech impairment, incontinence aid, hearing aid.

Health/medical technologies: material nature

Medicines: Chemically synthesized substances intended for use in the medical diagnosis, treatment, or prevention of disease. Examples: acetylsalicylic acid, beta-blockers, antibiotics, antidepressants.

Biologics: Therapeutic substances derived from the human body or animals, and products of biotechnology. Examples: vaccines, blood products, cellular and gene therapies.

Medical devices: A medical device is any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article that does not achieve its primary intended action in or on the human body solely by pharmacological, immunological or metabolic means.3 Examples: syringes, defibrillators, HIV in vitro tests, surgical instruments, hip prostheses, linear accelerators.

Medical and surgical procedures: Psychotherapy, nutrition counselling, coronary angiography, gall bladder removal.

 

Support systems: Electronic patient record systems, telemedicine systems, medicine formularies, blood banks, clinical laboratories.

 

Organizational and managerial systems: Prospective payment using diagnosis-related groups, alternative health care delivery configurations, clinical pathways, total quality management programmes.

Source: National Information Center on Health Services Research and Health Care Technology (NICHSR), HTA101: II. Fundamental Concepts, available at www.nlm.nih.gov/nichsr/hta101/ta10104.html.

As the disease burden shifts and evolves, there is a continuing need for new, adapted and more effective medicines. Access to necessary medical technologies is not, therefore, a static equation – an integral feature of appropriate access strategies must be a recognition of the value of targeted and appropriate innovation, both for major new breakthroughs and for adaptations to, and improvements in, existing technologies.

Innovation does not take place in isolation from concerns about equitable access to medicines and other medical technologies. Obviously, the social value of medical innovation must be measured in part by the extent to which it is effectively and sustainably available to the people who need it. The widespread and equitable health impact of new technologies cannot be achieved without ensuring appropriate means of access to finished products. Thus, an overall policy on medical innovation needs to consider the access dimension as well – how, in practice, a new technology will be made available to those who need it, so that it does not remain an abstract theory and is not reserved for a narrow segment of society only. Building access considerations into innovation policy has numerous dimensions, ranging from the core aim of research and product development activities, to work on "appropriate" or adaptive forms of existing technologies suitable for resource-poor clinical environments, to consideration of freedom to operate strategies and mechanisms for integrating technologies in a finished product, so that it can be distributed widely and in the most effective form.

Access also has to be understood in a wider context. For example, regulation of medical products is an integral part of the access equation. "Access" is not simply the capacity to purchase – or to be supplied with – a basic commodity or consumer product. The availability of a technology generally must be backed by sound regulation that is both monitored and enforced, so as to provide reasonable guarantees that the technology is safe and effective. Equally, many medicines and technologies require a certain degree of clinical support and backup, including diagnosis, prescription and dispensation, and appropriate follow-up.


For more information on prior art, see Chapter II, Endnote 67. back to text

WHA, Resolution: WHA60.29: Health technologies back to text

Based on definition adopted by the Global Harmonization Task Force (GHTF). See GHTF (2005) and this chapter, Section A.6. back to text