Chapter 1: Medical technologies: the fundamentals

A. Public health and medical technologies: the imperative for international cooperation

Health is a fundamental and universal human right. The attainment by all peoples of the highest possible level of health is the foundational objective of the WHO. The Preamble of the WHO Constitution emphasizes that international cooperation is essential for the promotion of health:

"The health of all peoples is fundamental to the attainment of peace and security and is dependent upon the fullest co-operation of individuals and States.

The achievement of any State in the promotion and protection of health is of value to all.

Unequal development in different countries in the promotion of health and control of disease, especially communicable disease, is a common danger."

This central objective of the WHO, the essential logic of international cooperation, and the responsibility to take practical action have compelling implications for the international community. Accordingly, public health outcomes are of importance to WIPO, which also focuses on the social and developmental dimensions of innovation and the transfer and dissemination of technology. WIPO policy discussions and technical cooperation activities, including a range of programmes conducted in partnership with the WHO and the WTO, have focused increasingly on public health matters.

(Doha Declaration)¹, members "recognize the gravity of the public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics", and articulate "the need for the WTO Agreement on Trade- Related Aspects of Intellectual Property Rights (TRIPS Agreement) to be part of wider national and international action to address these problems".

"... we will be exploring how best to harvest the potential of [the three organizations'] reserves of knowledge and information, to strengthen cooperation towards a goal all can surely share: put simply, that of getting needed medicines to the people who are in most need."²

   Pascal Lamy, Director-General, WTO

1. Policy coherence

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. The three organizations therefore share a responsibility to strengthen practical dialogue between themselves and other partners in order to fulfil their mandates  more  effectively, to ensure the efficient use of resources for technical cooperation and to avoid duplication of activities.

Coherence is vital in international action to address public health problems. Such coherence has never been more important for the technical cooperation work of the three organizations than it is at the present time. The WHO brings vast expertise in all areas of public health, including medicine and vaccine policies, medical devices, regulatory questions, pricing and procurement, in addition to other factors affecting access to medicines. WIPO is uniquely positioned to help organizations work towards 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 patents, including information on the patent status of key medicines and vaccines in  developing  countries, and to lend its expertise on patent law and its interplay with public policy. The WTO works on several aspects of trade policy that have direct relevance to public health, including IP rules and flexibilities within the international legal system, as they affect both the access and innovation dimensions.

The Doha Declaration has served as a catalyst for developing coherence at the international level. In conjunction with its role of making public health issues a central focus of work carried out by the WTO on IP and international trade, the Doha Declaration has been taken up in a series of World Health Assembly (WHA) resolutions on ensuring accessibility to essential medicines and public health, innovation and IP. Notably, the Doha Declaration was a point of reference in the negotiations on the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPA-PHI). The WIPO Development Agenda³ deals extensively with flexibilities in international IP law, including the health-related flexibilities specifically identified in the Doha Declaration.

These mandates and competencies  have been at the centre of policy  debates. For  example, the 2011 Political Declaration  of  the  High-level  Meeting  of  the  General Assembly on  the  Prevention  and  Control  of Non-communicableDiseases⁴ called for the WHO and other international organizations to work together in a coordinated manner to support national efforts to prevent and control non-communicable diseases (NCDs), and mitigate their impacts.

"Discussions [of access to medicines] almost inevitably turn to questions of prices, patents, intellectual property protection, and competition."⁵

Chan,Director-General, WHO

2. Scope of the study

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. While some of the lessons learned about access and innovation with respect to medicines may also be useful with respect to these other medical technologies, there are also significant differences regarding the role of IP and innovation and access. Other important determinants for public health, such as human resources, health financing and health systems, do not fall within the scope of this study.

3. The need for this study

Governments have choices to make regarding the appropriate implementation of policy instruments in their domestic systems and practices. Even though international standards apply to most of the main policy instruments – in particular IP – there is "policy space" within and around those standards. 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 aim of the technical cooperation activities of the WHO, WIPO and the WTO is to facilitate understanding of the full range of options and their operational context, rather than programmes that simply explain the legal framework. This study draws together the materials used in technical cooperation and it addresses emerging needs for information in an accessible, systematic format, in order to support ongoing collaborative efforts.

[T]here is a vast area of practical cooperation, which isvery important in the achievement of the balance betweenon theone hand, and diffusion of the social benefitcreation, on the other hand."⁶

Francis Gurry, Director General, WIPO

• Non-communicable Diseases called for the WHO and other international organizations to work together in a coordinated manner to support national efforts to prevent and control non-communicable diseases (NCDs), and mitigate their impacts.

the most rational way.

"Public health now finds itself caught in a cross-current of rising expectations and ambitions, set against rising demands and costs, at a time when funds are stagnant or shrinking. In such a situation, introducing greater efficiency is a far better option than cutting budgets and services."⁷

Margaret Chan, Director-General, WHO

health-care costs have led to increased national public health budgets and higher public expectations for healthcare. In difficult economic times, there is even more reasontoevaluate the efficiency and fairness of their health services, including expenditure on medicine and medical technology. Effective delivery of health care also means adapting technologies to diverse local needs and priorities.Developingcountries are facing an increased diseaseburden of NCDs. The increased availability of patents for medicines has implications which pose a further challengein a wider range of countries, notably in key low-cost exporting countries that have traditionally specialized in generic medicine production. The evolving disease burden, the lack of medicines required for treating neglecteddiseases, and the challenges of drug resistance all require the development of new medicines, vaccines and effective dosage forms, as well as effective delivery mechanisms. Innovation needs to be encouraged – both in terms of inventing new medicines and also in terms of providing effective systems to bring new products through verycomplex product development stages, and to market and deliver them  to patients.  Policy-makers haverecognized the need to look beyond conventional approachesto R&D in order to address the innovation gap –particularly in the area of neglected diseases.

"... [T]here is indeed great potential, still mostly untapped, for the use of empirical data to inform policy debate on health innovation and access to medicines. ... [A]ll of us who care deeply about health innovation and access to medicines would benefit from improved accessibility of these raw data, but also from the careful putting together of all the pieces of the empirical puzzle."⁸

Pascal Lamy, Director-General, WTO

4. The timing of the study

medicines arising from paragraph 6 of the Doha Declaration, with the conscious goal of creating additional flexibilityfor countries with the least resources. Recent years have seen a proliferation of new initiatives – public, private  and  philanthropic  –  for  innovation  and  product developmentto address unmet health needs, together with new and adapted approaches to procurement. Today, much better data is available globally on areas such as pricing, scope of access to medicines and patent coverage.

and Public Health: A Joint Study by the WHO and the WTO Secretariat. This earlier study examined the linkages between trade and health policies in general to enable trade officials and health officials to better understandand monitor the effects of their work on each other's areas of responsibility. This new study updates the material on IP and other trade aspects as they relate to innovation of, and access to, medical technologies, the areas which have seen most change in the decade since then. The 2002 study remains a useful resource on many issues, such as health services, infectious disease control, food safety and tobacco.

"Health, trade and innovation are indispensable issues when tackling the problems that we are increasingly facing in a globalized world."⁹

 

Francis Gurry, Director General, WIPO

5. Who should read this study

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. It is also designed to serve as a resource for the three organizations' technical cooperation activities. 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 of the full range of issues, including institutions and legal concepts with which they are unfamiliar.

The study represents the first joint publication by the WHO, WIPO and the WTO, with the aim of providing a solid factual foundation for ongoing policy debates. Nothing in the study should be taken as a formal position or the interpretation of rights and obligations by any of the three organizations, or by any of their respective member states. Actual policy choices and interpretations of member states' rights and obligations remain exclusively a matter for governments.

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WTO document WT/MIN(01)/DEC/2. back to text

Opening remarks, "Access to Medicines: Pricing and Procurement Practices", A Joint Technical Symposium by WHO, WIPO and WTO, Geneva, 16 July 2010.back to text

WIPO, The 45 Adopted Recommendations under the WIPO back to text

UN document A/RES/66/2. back to text

Opening remarks, "Access to Medicines: Pricing and Procurement Practices", A Joint Technical Symposium by      WHO, WIPO and WTO, Geneva, 16 July 2010. back to text

Ibid. back to text

Opening remarks, "Access to Medicines: Patent Information and Freedom to Operate", A Joint Technical Symposium by WHO, WIPO and WTO, Geneva, 18 February 2011. back to text

Ibid. back to text

Ibid. back to text