Chapter 1: Medical technologies: the fundamentals

B. The cooperating agencies: the WHO, WIPO and the WTO

This section provides a brief overview of the specific roles, mandates and functions of the WHO, WIPO and the WTO, which cooperate within the general international framework on issues related to the interface between public health, intellectual property (IP) and trade concerning innovation in, and access to, medical technologies. Additional information on the work of a range of other international organizations, NGOs, industry bodies and other stakeholders can be found in Annex I.

1. World Health Organization

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.

Monitoring the impact of trade and intellectual property rights (IPRs) on public health is one of the strategic areas of the work of the WHO. Following the adoption of the WTO Agreement on Trade-Related Aspects of Intellectual 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 public health and IP.¹ In subsequent years, often following long negotiations, many more resolutions were adopted, continually broadening and reinforcing the WHO mandate to work on issues related to public health, trade and IP.

In May 2003, WHO member states decided to establish the Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH), which was chaired by former Swiss Federal Councillor Ruth Dreifuss, to produce an analysis of the interface between IPRs, innovation and public health.² In April 2006, the CIPIH published its report (WHO, 2006b), which contained 60 recommendations aimed at fostering innovation and improving access to medicines. It concluded that:

"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 there are profitable markets. However, the fact that a patent can be obtained may contribute nothing or little to innovation if the market is too small or scientific and technological capability inadequate. Where most consumers of health products are poor, as are the great majority in developing countries, the monopoly costs associated with patents can limit the affordability of patented health-care products required by poor people in the absence of other measures to reduce prices or increase funding."

Following CIPIH recommendations, WHO member states subsequently developed a global strategy and plan of action on public health, innovation and IP.³

Its adoption was the result of a debate that continued for many years and can be considered a major step forward in the process of achieving global consensus on practical action on public health, innovation and IP. For the WHO, the GSPA-PHI is a milestone, as it reaffirms and extends the mandate of the WHO to work at the interface of public health and IP. It also demonstrates that it is feasible to find a common ground, based on dialogue.

IP issues have also been addressed during other negotiation processes at the WHO, such as:

• the establishment of the Pandemic Influenza Preparedness (PIP) Framework for the Sharing of Influenza Viruses and Access to Vaccines and other Benefits
• the creation of an international mechanism to combat substandard and spurious/falsely-labelled/falsified/ counterfeit medical products
• the WHO Global Health Sector Strategy on HIV/AIDS, 2011-2015
• the prevention and control of NCDs.

The WHO has produced a large body of material to provide evidence-based guidance to its member states in order to support them during the process of shaping their policies on public health and IP. The WHO has also jointly hosted with other relevant organizations numerous training and capacity-building activities in all WHO regions, and it continues to do so in close collaboration with WIPO and the WTO. Member states have also requested on a regular basis technical assistance on issues related to public health and IP.

2. World Intellectual Property Organization

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 activities of WIPO include:

• administering multilateral treaties and supporting the evolution of the international legal IP frameworks
• providing global IP services to facilitate easier and more cost-effective international protection, and also to facilitate arbitration, mediation and other alternative dispute resolution services
• assisting in establishing national IP and innovation strategies, developing appropriate regulatory frameworks and building the infrastructure and human capacity needed to harness the potential of IP for economic development
• developing technical platforms to facilitate cooperation among IP offices
• developing free databases of patents, trademarks and industrial designs to facilitate access to knowledge
• building awareness, understanding and respect for IP
• working in partnership with the United Nations and other organizations to identify IP-based contributions to climate change, food security, public health and other global challenges.

The 2007 WIPO General Assembly established the WIPO Development Agenda⁴ to ensure that development considerations form an integral part of the work of WIPO. Development is considered a cross-cutting issue which impacts on sectors of the organization. The 45 Development Agenda recommendations guide the work of WIPO.

In addition to the promotion of technological innovation and technology dissemination as general objectives of the patent system, several areas of the work carried out by WIPO have particular relevance for public health.

In 2009, WIPO established the Global Challenges Program to address innovation and IP as they relate to global and interconnected issues, such as climate change, public health and food security. Innovation and access to the results of innovation are central issues in the area of IP. The challenge for public health policy-makers is to provide an environment for health innovation and to promote access to new medical technologies. The WIPO Global Challenges Program seeks to raise awareness and understanding of the interplay between innovation, technology transfer and the 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 IP and expertise to promote the development of medicines to treat neglected diseases (see Chapter III, Section C.6).

WIPO seeks to ensure that the development of international patent law keeps pace with the rapidly evolving technological, economic and social environment. The continuing growth in the number of patent applications worldwide and the constant development of technologies present a challenge for the effective and efficient handling of patent applications, for the achievement of high quality in patents which are granted internationally, and for the role of patents in contributing to innovation and the dissemination of technology. WIPO not only advises its member states how to implement the requisite legal framework but also how to assess options and to develop coherent policy strategies. WIPO member states have been engaged in discussions with the Standing Committee on the Law of Patents (SCP) on issues related to patents and health since 2011.

In 1998, WIPO established the Traditional Knowledge Program. One of the objectives of this programme is to achieve the more effective use of IP principles and systems for the legal protection of traditional knowledge, including traditional medicine.

In line with its goal of fostering international policy dialogue on IP and public health, WIPO also engages substantively with other relevant stakeholders – UN and intergovernmental organizations, governments of member states, civil society and NGOs, as well as the private sector and academia.

3. World Trade Organization

The core mission of the WTO is to open trade as well as to maintain and further develop the rules-based international trading system. International trade and trade rules intersect with public health objectives in various areas and in many different ways. Most directly, integration into the world economy can enhance access to the most basic requirements for good health, such as the safe supply of food or access to health-related products and services. Indirectly, trade offers the opportunity for economies to grow and thus contributes to the alleviation of poverty and ill health.

The importance of public health has been recognized in the rules of the multilateral trading system since 1947. The General Agreement on Tariffs and Trade (GATT), adopted in 1947 and subsequently incorporated in the GATT 1994, contains an exception in Article XX(b) which explicitly recognizes the right of governments to enact trade-restricting measures whenever these are necessary to protect human life and health. The right to take measures for the protection of health is also included in other relevant WTO agreements, including the TRIPS Agreement.⁵

The implementation of the rights and obligations established under the WTO agreements, including those related to public health, is overseen by the competent WTO 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 WTO have dealt with measures related to human health protection. In these particular cases, what was challenged was not the right to protect health, but the appropriateness of the measures chosen to achieve the objective of health protection.⁶ The WTO Dispute Settlement Body has consistently maintained that it is within the authority of each WTO member to set the public health objectives it seeks to achieve. Governments have thus retained the right to use available exceptions and flexibilities necessary to achieve their targeted levels of health protection.⁷

The search for a balance between the need to protect IPRs to provide incentives for R&D on the one hand and, on the other hand, to address concerns about the potential impact of such protection on the health sector – in particular its effect on prices – has been an important consideration in the WTO's work. A number of provisions in the TRIPS Agreement are directly relevant to public health. WTO members have the flexibility to interpret and implement these provisions in a manner supportive of their right to protect public health. The importance of creating a positive, mutually reinforcing link between the IP system and access to medicines was explicitly recognized in the Doha Declaration. Two years later, the Doha Declaration led to the adoption of a mechanism often referred to as the "Paragraph 6 System". This additional flexibility – in the form of a special compulsory licence for export established under the 2003 waiver decision⁸ and the 2005 Protocol Amending the TRIPS Agreement⁹ – was designed to deal with the difficulties of WTO members lacking sufficient manufacturing capacities to make effective use of compulsory licensing.

These and other developments demonstrate that the WTO can serve as a useful and effective forum for discussions regarding the interface between IPRs and public health. Thus, the TRIPS Council's discussions have led to the adoption of the two important instruments referenced above. The Paragraph 6 System is also the first ever proposed amendment to the WTO Agreement in the form of the 2005 Protocol Amending the TRIPS Agreement. This provides evidence of the importance that WTO members attach to these questions.

Another core function of the WTO is the Dispute Settlement Mechanism, which has resulted in some important clarifications of the relevant rules under the TRIPS Agreement, including how they relate to public health.¹⁰ Furthermore, the WTO Secretariat aims to enhance the participation and informed decision-making of its members and observer governments through awareness-raising, capacity-building, and the provision of factual and technical information. To achieve this objective, the WTO regularly engages in technical assistance activities, which comprehensively cover the relationship between IPRs and public health.¹¹

4. Trilateral cooperation

The adoption of the Doha Declaration was a landmark occasion for issues that intersect public health, IP and trade. Since 2001, the principles enshrined in the Doha Declaration have shaped the framework for multilateral cooperation in this area, which included the provision of technical and policy support requested by members, joint publications and mutual participation in training programmes. Based on the adoption of the Development Agenda by the WIPO General Assembly in 2007 – specifically Recommendation 40 – WIPO was requested to intensify its cooperation on IP-related issues with relevant international organizations, and in particular with the WHO and the WTO, in order to strengthen the coordination required to achieve maximum efficiency when undertaking development programmes.¹² The move towards reinforced coordination and dialogue was further supported by the process leading to, and the adoption of, the GSPA-PHI by the WHA in 2008. It explicitly requested the WHO Director-General "to coordinate with other relevant international intergovernmental organizations, including WIPO, WTO and UNCTAD, to effectively implement the global strategy and plan of action".¹³ In addition, in the case of more than 20 activities detailed in the plan of action¹⁴, the three organizations along with other international organizations are listed as the stakeholders responsible for the implementation of these activities.

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, IP and trade.¹⁵ Within their respective mandates and budgets, common activities are planned and carried out jointly to ensure that data, experiences and other information are exchanged, and also to ensure that the best use is made of the available resources. The three Secretariats' collaboration has primarily focused on supporting the implementation of the GSPA-PHI, but it is not limited to it. Other areas of cooperation have included addressing the IP-related issues raised during the preparatory work which led to the establishment of the WHO PIP Framework.

Of course, this collaboration does not exclude close cooperation with other international organizations, and the WHO, WIPO and the WTO have broadened the base of their collaborative and consultative networks dealing with public health issues. The WHO, for example, has stepped up its programme activities with other partners such as the United Nations Conference on Trade and Development (UNCTAD), in line with the GSPA-PHI.

At the Conference on Intellectual Property and Public Policy Issues, organized by WIPO in July 2009, the three Directors-General addressed the topic of strengthening multilateral cooperation on public health IP and trade.¹⁶ In 2010, the WHO, WIPO and the WTO held a technical symposium on access to medicines, pricing and procurement practices.¹⁷ It was followed by a second symposium in 2011¹⁸ on access to medicines, patent information and freedom to operate, highlighting the prospects for using patent information to assist more informed choices on access to medicines. This series of symposia is designed to improve the flow of practical information to guide and support technical cooperation in the future. Similarly, this trilateral study is a further milestone on the road towards stronger cooperation.

5. Other international key stakeholders

The period since 2001 has seen dramatic growth in the number and diversity of participants in international policy debates concerning innovation in, and access to medical technologies. Consideration of these issues necessarily entails a multidisciplinary and pluralistic approach. A distinctive feature of the debates has been the range of perspectives during discussions, coupled with the depth of expertise and practical experience that has been drawn from international and intergovernmental organizations, procurement and product development initiatives, and NGOs such as public health advocates and industry associations.

Annex I provides more detailed accounts of an illustrative – yet not fully representative – selection of some of these policy stakeholders provided by the organizations themselves. The study recognizes and values the work of many others, and no suggestion is made about the relative importance of any organization, whether mentioned or not.

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WHA, Resolution: WHA49.14: Revised drug strategy. back to text

WHA, Resolution: WHA56.27: Intellectual property rights, innovation and public health. back to text

WHA, Resolution: WHA61.21: Global strategy and plan of action on public health, innovation and intellectual property; Resolution: WHA62.16: Global strategy and plan of action on public health, innovation and intellectual property. back to text

See: www.wipo.int/ip-development/en/agenda/. back to text

See also: Articles 8, 27.2 and 27.3(a) of the TRIPS Agreement; the Doha Declaration on the TRIPS Agreement and Public Health; Article 2.1 of the Agreement on the Application of Sanitary and Phytosanitary Measures; Article 2.2 of the Agreement on Technical Barriers to Trade; and Article XIV(b) of the General Agreement on Trade in Services. back to text

The following WTO disputes have addressed, among others, health-related measures: European Communities – Measures Concerning Meat and Meat Products (Hormones) (DS26 and DS48); European Communities – Measures Affecting Asbestos and Asbestos-Containing Products (DS135); European Communities – Measures Affecting the Approval and Marketing  of  Biotech  Products  (DS291,  DS292  and  DS293); Brazil – Measures Affecting Imports of Retreaded Tyres (DS332); United States – Continued Suspension of Obligations in the EC – Hormones Dispute (DS320); and Canada – Continued Suspension of Obligations in the EC – Hormones Dispute (DS321). back to text

A pro-public health interpretation of permissible exceptions to patent rights may be found in the panel report on Canada – Patent Protection of Pharmaceutical Products (DS114). back to text

WTO documents WT/L/540 and WT/L/540/Corr.1. back to text

WTO document WT/L/641.  back to text

See the panel report on Canada – Patent Protection of Pharmaceutical Products (DS114). back to text

For more information on the WTO activities, see WTO document IP/C/W/577. back to text

See www.wipo.int/ip-development/en/agenda/recommendations.html. back to text

WHA, Resolution: WHA61.21: Global strategy and plan of action on public health, innovation and intellectual property, para. 4(5). back to text

WHA, Resolution: WHA61.21: Global strategy and plan of action on public health, innovation and intellectual property; Resolution: WHA62.16: Global strategy and plan of action on public health, innovation and intellectual property. back to text

See: www.who.int/phi/implementation/trilateral_cooperation/en/index.html; www.wipo.int/globalchallenges/en/health/trilateral_cooperation.html; and www.wto.org/english/tratop_e/trips_e/who_wipo_wto_e.htm. back to text

WIPO, "WIPO Conference on Intellectual Property and Public Policies Wraps Up", PR/2009/594, 14 July 2009. back to text

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

"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