WPRJRC58/SRl6
SUMMARY RECORD OF THE SIXTH MEETING (Tamna Hall B, 5th floor, International Convention Center, Jeju, Republic of Korea Thursday, 13 September 2007 at 09:00)
CHAIRPERSON: Dr Victor YANO (Palau) CONTENTS
page 1.
Avian and pandemic influenza, International Health Regulations (2005), and the Asia Pacific Strategy for Emerging Diseases (continued) .............................................................................. . Consideration of draft resolutions ......................................................................... . 2.1
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2.
Progress towards achieving the Millennium Development Goals ........... .
3.
Public health, innovation and intellectual property ............................................... . People at the Centre of Care Initiative ................................................................... .
4.
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1.
AVIAN AND PANDEMIC INFLUENZA, lNTERNATIONAL Health Regulations (2005), and the Asia Pacific Strategy for Emerging Diseases: Item 12 of the Agenda (Document WPRlRC58/9) (continued) Dr BACIGALUPO (Nauru) said that her country appreciated the effort that had gone into the
fight against avian and pandemic influenza, and emerging diseases. She considered it critical for every country to have in place a national plan for pandemic preparedness; without preparedness and effective planning, small island countries would be most vulnerable. In Nauru, assessment of national capacity had been undertaken and a national plan for dealing with pandemics had been developed with inputs from various stakeholders, including Government, public health, medical services and civil society, and technical support from WHO. The op,erational plan still had to undergo testing, and some gaps, such as a zoonoses alert and response system, still needed to be fllied. Revision, updating and testing of the national plan would need to be dom: periodically, which would require technical support from WHO. The Government also needed fUrther support for laboratory and biosafety services. Clear channels of communications and operational links were critical components of early warning systems, as were the role of the national IHR focal point and the practicality of the operational plan for notification, information sharing, verification and determination of a public health emergency of international concern. Surveillance systems, such as the Pacific Public Health
Surveillance Network at the Secretariat of the Pacific Community (SPC), already existed and could serve as operational links for the Pacific. Dr PAUL (Marshall Islands) said that, although the Marshall Islands had not experienced an influenza A (H5Nl) outbreak, the country was taking the threat very seriously. A task force had been formed to coordinate activities in the event of an outbreak, and a national plan for pandemic preparedness had been developed and would be implemented shortly. Much effort had gone into that task and the Government was committed to seeing it to completion and implementation. Her country appreciated the technical support provided by WHO, SPC and the United States Centers for Disease Control and Prevention in evaluating the practicality of the plan. At the national level, it was
increasingly being recognized that the country could not expect to be spared in the event of an outbreak; at Iillievels, there was a need for more advocacy for the need for preparedness. Her Government had designated the Ministry of Health as the national IHR focal point, but further technical support would be needed for implementation of the IHR (2005). She reaffirmed the Government's commitment to cooperate in implementing the Region's overall strategy for the protection of the population of her country and the Region.
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Dr AKE (Tonga) reported on the status of development of Tonga's national plan for pandemic preparedness. As regards the llIR (2005), the Government was mindful of the need for national
legislation to support their implementation, particularly in relation to travel and trade regulations, and had joined a few other countries in requesting that their entry into force be delayed for one year, until 15 December 2008, to allow the legal basis for implementation of the regulations to be addressed. To that end, the Public Health Act had been reviewed and amendments would be introduced. He assured the meeting that the necessary amendments would be put before Parliament in the near future. It was expected that Tonga would meet its commitment, made to the Director-General, to the entry into force of the llIR (2005) on 15 December 2008. Ms GIDLOW (Samoa) highlighted the urgent need for internal operational mechanisms for implementation of the llIR (2005) and for establishment of isolation and treatment facilities. More work needed to be done at both the regional and national levels, even although great progress had already been made through the collaboration with WHO and SPC. The success of regional
approaches was dependent on strong national systems. The shortage of human resources in some countries, especially those dealing with communicable diseases, needed to be addressed as a national priority. Technical support from WHO and development partners would be important in capacitybuilding to ensure that commitments and obligations under the llIR(2005) were undertaken at national, regional and international levels. The threat of an influenza pandemic was very real to Samoa, with its history of an influenza outbreak in 1918, and the country was acutely aware of its geographical isolation and limited resources. To further highlight the urgency of the need for action, she reported that her Government had made the relatively large allocation of 2 million tala (US$ 741 200) for measures against avian influenza in the national budget for the financial year. The Cabinet had endorsed the Health Sector Medium-term Pandemic Preparedness Plan for 2006-2009, and the health sector was collaborating with the National Disaster Preparedness Council, the agriculture sector, civil society and other stakeholders to implement the plan. Dr GAFA (Niue) thanked WHO, SPC and the Government of New Zealand for their support in the development of Niue's national plan for pandemic preparedness, the draft of which had been submitted to the Cabinet. It had been a multi sectoral effort, with the National Disaster Council playing an important role. The operational plan would be tested in November 2007, and testing of similar national plans for cyclones and other disasters would be undertaken during the same month. ' She remarked on one area that needed to be addressed: the difficulties in obtaining cooperation from border control authorities, the business sector, power companies, food importers, local police and villagers. In Niue, villagers had contributed to plans for pandemic preparedness for their villages;
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however, cooperation from all sectors would be an important factor in disaster preparedness. Niue would need further technical support to strengthen communicable disease surveillance and for training related to the implementation of the IHR (2005). Dr OMAR (Malaysia) recognized the seriousness of the threat posed by influenza A (H5Nl) outbreaks in poultry, associated human cases and possible pandemics. His Government appreciated and strongly supported WHO's efforts. Implementation of the IHR (2005) would result in better sharing of information, risk assessment and communications in public health emergencies of international concern. Control of infectious diseases at an early stage depended on timely sharing of information. Health security was dependent on Member States' cooperation, based on guidelines and recommendations from best practice. Prompt and transparent reporting of infectious diseases in
humans would be critical for human safety in the era of globalization; rapid detection was most important. Proper functioning of surveillance and response systems required capacity and capability at all levels of the health care system. In Malaysia, measures recommended by a recent assessment of early warning and response (EWAR) functions were being implemented at every level. Evaluation of core capacity and
capability, especially at points of entry, had been undertaken, including surveillance and response capacity based on the requirements of IHR (2005) and APSED. Relevant strategies had been developed and activities had been implemented for the prevention and control of an influenza pandemic, and preparedness, response and mitigation measures had been tested in simulation trials. Dr BOREHAM (Tuvalu) said that, with the assistance of SPC and WHO, his country had endorsed a Pacific regional influenza pandemic prepare:dness project; however, that had yet to be implemented owing to an insufficient budget allocation. Human cases of avian influenza A (H5NI) had been detected in Indonesia and she feared that, should infection reach Tuvalu, the country would be unable to respond adequately owing to a lack of laboratory capabilities, insufficient stockpiled drugs and equipment, and few resources for mobilization. She thanked WHO for its initiative and assistance and the SPC for coordinating the preparednes~
project; her country hoped to receive further assistance to implement preparedness 1!lld
IHR-related activities. Mr SAMO (Federated States of Micronesia) said that, in July 2007, the IHR focal point in his country had notified WHO of an unusual illness. That illness had been identified as being caused by Zika virus, posing no international danger, but the exercise had provided a number of important lessons for dealing with future events. While notification protocols for WHO and the United States
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Centers for Disease Control and Prevention had worked well, there would be a significant time-lapse before technical support could be mobilized and personnel arrived on site, regardless of the best preplanning procedures. Critical collaboration and coordination with the relevant technical agencies worked best when augmented by local personnel. Laboratory capacity was crucial and his country had experienced difficulties in that area. There would also be delays caused by shipping specimen samples to reference laboratories, which would be counterproductive in the event of a pandemic. His Government supported the recommendations of the second meeting of the Asia Pacific Technical Advisory Group on Emerging Infectious Diseases and the meeting of programme managers for emerging infectious diseases and national IHR focal points in the Western Pacific Region. He reiterated his country's request for WHO technical support for the in-country workshop on the IHR (2005), implementation of which meant involving departments and agencies outside the health domain. At the invitation of the CHAIRPERSON, representatives of the Association of Southeast Asian Nations Secretariat and the Secretariat of the Pacific Community made statements to the Committee. The DIRECTOR, COMBATING COMMUNICABLE DISEASES, thanked representatives for their useful comments and said that, owing to time constraints, she would restrict herself to general comments. It was encouraging to note the high level of ownership by most Member States in the Asia Pacific Strategy for Emerging Diseases, and significant progress had been made since the strategy was endorsed by the Regional Committee at its fifty-seventh session. Many countries, including Cambodia, the Lao People's Democratic Republic, Mongolia, Papua New Guinea, the Philippines and Viet Nam, had completed country assessments using the APSED checklist, and the Lao People's Democratic Republic and the Philippines had developed national plans based on their assessments. It was rewarding to see that countries realized that core capacity-building using the APSED strategy increased preparedness for an avian influenza A (H5Nl) pandemic and capacities to comply with the IHR (2005). She thanked the representatives of Australia, China, New Zealand, Papua New Guinea and the Philippines, and many of the Pacific island countries, for highlighting that key elements to successful execution of pandemic preparedness plans and early warning responses included multisectoral collaboration, particularly when relying on local governments in an emergency situation; communication at and between all levels of society; and the need to mount a coordinated response. In that respect, the representative of Tonga had emphasized the need to adjust domestic legislation.
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The representatives of France, Nauru and several Pacific island countries had pointed out the importance of guidelines and protocols being translated into French to facilitate communication between countries and WHO focal points. WHO was cun-entlyat work on translations. She agreed with the representatives of New Zealand, Tokelau and Viet Nam, among others, that exercises were important to test preparedness plans and that those should be multisectoral and carried out regularly. In December 2006, WHO had organized workshops for those involved in planning and training for such exercises; a manual for exercise planners was in the fmal stages of development and would be published very soon. The representatives of Niue, Samoa, Tuvalu and Vanuatu had drawn attention to constraints to capacity-building for the lliR (2005), particularly in the smaller Pacific island countries, and had requested WHO support in that area. There had also been a request for WHO to increase the visibility of the lliR (2005), which was in progress: an epidemiologist had been based in the office of the WHO Representative in the South Pacific, in Suva, Fiji, to act liS a focal point for the Pacific island countries and areas, and there would be a fulltime staff member based in the Federated States of Micronesia. WHO also hoped to place an additional staff member in the Suva office. A meeting of national focal points for the Pacific island countries and areas would be organized to clarify roles and responsibilities. She urged all Member States to work on building capacity for APSED and pandemic influenza preparedness, which valuable work would also contribute to building core capacities to comply with the lliR (2005). The REGIONAL ADVISER, COMMUNICABLE DISEASE SURVEILLANCE AND RESPONSE observed that antiviral drugs were used for both prevention and early treatment. WHO therefore recommended their stockpiling in case of major epidemics. Fortunately, no pandemic had yet occurred, which meant that drugs were now approaching their expiry dates. WHO would not recommend the use of expired drugs that were no longer effective, and whose safety and quality could not be guaranteed. Tamiflu suspension had a shelf. life of two years. Stability tests showed that it shmlld not b~
used after that period. Tamiflu 75mg capsules had a shelf-life of five years whell stored
at a maximum of 25° Celsius, but much depended on the actual storage conditions. WHO could assist in providing data on the basis of sample testing, but any decision to extend and re-label had to be taken by governments, on the basis of the test results. On increased access to vaccine, in October 2006, WHO had announced a global pandemic influenza action plan to increase supply. That plan had three components: increased production
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capacity; more seasonal vaccine use; and research and development. With the support of Japan and the United States of America, six projects had been approved, including one in Viet Nam to establish in-country production capacity for influenza vaccine. WHO also surveyed current and expected demand and supply of seasonal influenza vaccine. More than 40 clinical trials of pandemic influenza vaccine in humans were under way. The scale of the work required good communications, so WHO Headquarters was taking the lead, but the Western Pacific Region was in close collaboration. Regarding the request from the representative of the Republic of Korea, the initiative would be explored at regional level if it proved effective. The REGIONAL DIRECTOR said that, although the sharing of samples had been discussed at many meetings in WHO and elsewhere, it remained contentious. Samples were needed for vaccine development and risk assessment. The representative of Singapore had asked why one particular country had not consistently and promptly shared samples. The country in question had said it was happy to share samples with WHO, on condition that it benefit from the sharing, along with other developing countries that could not produce vaccines. Meanwhile, producer countries pointed out that they had provided technology transfer, and invested in research, thereby increasing the volume of vaccine supply, and they regarded that as sufficient. At the most recent World Health Assembly, much time had been devoted to discussion of the issue. Three principles had been agreed: the terms of reference of the WHO collaborating centre had to be clarified; there should be standardized terms and conditions of sharing; and an oversight mechanism was needed. At the practical level, however, no consensus had been reached on what support would be provided by wealthier countries or how samples were to be shared. WHO had subsequently organized an interdisciplinary meeting, where similar views had been aired. Once again there had been agreement on the three principles, but not on the details. An intergovernmental meeting in November 2007 would continue the discussions, hopefully building on the previous two meetings. WHO would work to narrow the gap between developed and developing countries. The CHAIRPERSON requested the Rapporteurs to prepare an appropriate draft resolution for consideration later in the session. 2. 2.1 CONSIDERATION OF DRAFT RESOLUTIONS Progress towards achieving the Millennium Development Goals (Document WPRlRC58/Conf. Paper No.2). Ms ANDERSON (Australia) said that, as mentioned by the representative of Australia during the discussion of item 11, coordination of the efforts of all those working towards the attainment of
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the health-related MDGs was essential. She therefore proposed that a new operative paragraph 2(2) should be inserted to read as follows: "to continue to hannonize efforts with other United Nations agencies, regional organizations and other development partners at the global, regional and country level to achieve the MDGs". Ms ARTHUR (FRANCE) said that, as indicated during the discussion of item 11.3, strengthening of health systems was vital to accelerate progress towards the achievement of the MDGs and should be mentioned in the draft resolution. She therefore proposed the addition of a new operative paragraph 2(8) in which the Regional Committee fmnly requested the Global Fund to Fight AIDS, Tuberculosis and Malaria to take part in the funding of health systems, particularly in the least developed countries. The CHAIRPERSON suggested that the following text might reflect the proposal made by the representative of France: "to convey to the Global Fund to Fight AIDS, Tuberculosis and Malaria that the Regional Committee strongly requests the Global Fund to fInancially support health systems strengthening, especially in the least developed countries". Ms YUAN (United States of America) pointed out that the Regional Director did not have a mandate to convey messages to other organizations and suggested that the proposed wording should be amended to ensure that it did not appear as though the Regional Committee was dictating how the Global Fund should use its resources. The United States delegation was willing to work with that of France to revise the wording appropriately. It was so agreed. Dr PYAKALYIA (Papua New Guinea) proposed that operative paragraph 1(4) should be amended to read as follows: "to identify the highest-priority health problems and those populations with poor health outcomes resulting from these problems, and take concrete steps to focus their health systems on the problems identified and the affected populations". He further proposed the insertion in operative paragraph I (8) of the word "rural" after "highrisk" .
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Ms YUAN (United States of America) said that, on the basis of informal consultations with the delegation of New Zealand, she wished to propose that the third preambular paragraph should be amended to read as follows: ''Noting with concern that lack of access to quality care could result in health inequity, especially among poor and marginalized sections of the population, which may hamper efforts to achieve the health-related goals". She further proposed that in operative paragraph 1(5) the words "inter alia" should be inserted after "mortality", and that in operative paragraph 2(4) the word "services" should be replaced by "prevention and treatment". The CHAIRPERSON suggested that the Rapporteurs be requested to revise the draft resolution taking into account the proposed amendments and to submit the revised text for consideration by the Regional Committee. It was so decided. 3. PUBLIC HEALTH, INNOVATION AND INTELLECTUAL PROPERTY (Documents WPRJRC58110 and WPRJRC581INF.DOC. 2) Introducing Agenda item l3, the DIRECTOR, HEALTH SECTOR DEVELOPMENT noted that so-called diseases of poverty were contributing to over 50% of the burden of disease in lowincome developing countries. Reducing the very high incidence of communicable diseases was
therefore an overriding priority. At the same time, however, it was important to ensure that the increasing problem of noncommunicable diseases in developing countries was being addressed. Given the current awareness of the fundamental inequities inherent in the disproportionate burden on deVeloping countries, the world needed to fmd ways to tackle the health needs of the poor and vulnerable, particularly women and children, more effectively. Concerned about that, the Fifty-sixth World Health Assembly, in 2003, had requested the Director-General to establish "an appropriate time-limited body" to produce an analysis of intellectual property rights, innovation and public health, including the question of appropriate funding and incentive mechanisms for the creation of new medicines and other products for diseases disproportionately affecting developing countries. Thus, a broad-based Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) had been created. The CIPIH had submitted its report in April 2006. The report addressed a wide range of issues, from basic research to the
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delivery of medicines to the end-user, and contained a total of 60 recommendations targeting various stakeholders. Subsequently, the Fifty-ninth World Health Assembly, in May 2006, had adopted resolution WHA59.24, establishing an intergovernmental working group (IGWG) open to all interested Member States to draw up a global strategy and plan of action to provide a medium-term framework based on the recommendations of the CIPIH. The IGWG had held its fIrst meeting from 4 to 8 December 2006 in Geneva. The meeting had been attended by delegates from almost 100 countries. From the
Western PacifIc Region, delegates from Australia, China, the Lao People's Democratic Republic, Malaysia, the Republic of Korea, Japan, New Zealand, Samoa, Singapore and Viet Nam had participated in the meeting. The meeting had been chaired by Canada and fIve Vice-Chairpersons had been elected from WHO Regional Offices. From the Western PacifIc Region, Singapore had been elected as Vice-Chairperson. The outcome of that fIrst IGWG meeting was the draft document "Elements of a Global Strategy and Plan of Action". The proposed global strategy was designed to promote innovation, build capacity, and improve access to medicines. It would establish a research and development agenda to cover the health needs of developing countries, and implementation mechanisms. The Secretariat had built on inputs received from Member States during the fIrst IGWG meeting, as well as the submissions received following the fIrst session, to develop a revised working document. The draft Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (Document AlPHIlIGWG/2/2) had been dispatched to all Member States, and would be the basis for negotiation during IGWG-2. Resolution WHA60.30 had requested WHO to provide support for regional consultative meetings to set regional priorities that would inform the work of the IGWG. In the Western PacifIc Region, two intercountry consultative meetings had been organized. The fIrst one, for Pacific island countries, was held in Tonga from 7 to 9 August 2007, and the second for Asian countries, was held in Manila from 5 to 7 September 2007. The next IGWG meeting would be held from 5 to 10 November 2007. Its aim was to
negotiate and fInalize the draft Global Strategy and Plan of Action. The plan would then be submitted to the Sixty-first World Health Assembly through the Executive Board. Member States were strongly encouraged to participate in negotiations during the second rGWG meeting. Relevant officials should be appointed to best represent national interests in the meeting. Member States might wish to undertake national consultations involving relevant ministries
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to discuss related issues concerning public health, innovation and intellectual property. WHO was committed to supporting Member States in that process. Dr METAl (Kiribati) observed that, while innovation could help solve health problems, new technologies and drugs all had costs, and access to them required negotiation with the owners. Innovation implied new ways of tackling problems, with new technologies and supplies that belonged to companies or individuals. Individual countries, apart from the large ones, were perhaps unable to negotiate effectively, so it would be better if the producers were approached by WHO, representing countries' interests. Dr LIU (China) commended the efforts of the Western Pacific Regional Office to promote the strategy, which China would support. Protection of intellectual property was in the interests of individual countries and all humankind. Also, the long-term interests of human development entailed full respect for public health needs, ensuring that countries had access to medicines and technologies. Through collective efforts, he hoped a good balance could be achieved between public health needs and protection of intellectual property. He supported the strategy and plan of action and hoped that WHO could defend the public health interests of countries in the Region. The Regional Office could strengthen research to identify priorities in public health and set up a long-term fmancing mechanism for public health innovation in developing countries, to improve innovation capacity. Ms IMAl (Japan), with regard to the development of new medicines, exhorted WHO to continue to play a leading role in ensuring access to such medicines for diseases which affected developing countries more than developed. Japan recognized the importance of the matter, contributing to the Special Programme for Training and Research in Tropical Diseases (TDR) and other WHO activities, and the Global Fund to Fight AIDS, Tuberculosis and Malaria, besides providing technical cooperation through the public and private sectors in the form of training courses and dispatch of experts on medicines, vaccines and intellectual property. Japan would take an active part in the intergovernmental working group. Turning to document WPRJRC58/1O, she proposed the deletion from paragraph 3 on page 6 of the phrase "and any additional early implementation activities endorsed by Member States", since further discussion was needed on areas for early implementation. Furthermore, in annex 2, the fourth paragraph on page 11 of the document stated that "these provisions must be incorporated in national legislation". Japan understood that that was for each country to decide. Finally, with regard to the last paragraph on page 11, she questioned whether the Bolar provision allowed regulatory approval of generic versions of a drug before expiry of its patent. The concept corresponding to the Bolar provision in Japan permitted testing with a view to applying for regulatory approval of generics, but not the actual approval of generics at that stage.
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Dr OMAR (Malaysia) said that the global strategy and plan of action to be drawn up by the Intergovernmental Working Group on Public Health and Intellectual Property (IGWG) in response to World Health Assembly resolution WHA59.24 would be of significance in the search for research and development mechanisms relevant to the diseases that disproportionately affected developing countries. Management of intellectual property rights was one of the areas to be examined; the current system should be re-evaluated, with emphasis on ensuring that public health needs were not adversely affected in terms of the accessibility and affordability of pharmaceuticals. The report of the WHO Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) had indicated that there was no evidence that the increased level of intellectual property rights protection would result in increased research and development of pharmaceuticals for type II and type ill diseases. That was especially true in countries where the market was considered too small to be profitable. The draft global strategy and plan of action should take account of the need to provide an alternative to the implementation of strong intellectual property rights protection as a reward for pharmaceutical innovation, since a system relying purely on economic mechanisms could not solve the problem of access to medicines. Ms GIDLOW (Samoa) affirmed that Samoa continued to endorse resolution WHA56.27 and the direction being taken by the Secretariat. Samoa had participated in the first meeting of the IGWG in 2006 and had also benefited from two consultant visits from WHO Headquarters. However, the implications of intellectual property rights for public health were complex, and further support from WHO was requested, in the form of regional or subregional technical meetings, to facilitate Samoa's further understanding of the topic. Samoa had established links between the Ministry of Health and the Ministries of Trade and Commerce to consider the matter, but would welcome further guidance. The draft plan of action should take into account the specific needs of countries in relation to research and development, which should be country-based wherever possible. Professor NGUYEN THI KIM TIEN (Viet Nam) said that work on the public health implications of intellectual property rights could not be left to the World Trade Or~anization
(WTO)
and the World International Property Organization (WIPO) alone, since they did not have the necessary public health expertise; WHO must also be involved. WHO should help Me1llber States to understand and assess those implications. It should also identify the needs and priorities in relation to research and development that would have the greatest impact on public health, taking into account the need to harmonize the interests of developed and developing countries and to seek technical and financial support from the former. Specific support to developing countries should include help in regulating the prices of patented and generic medicines.
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Public health, particularly tropical and emerging diseases, were of great concern to Viet Nam. With the support of WHO and international donors, the Government had undertaken research and development in the areas of vaccines, drugs, traditional medicine and technology transfer. Although funding for research and development, as well as for local production of drugs and vaccines, had been increased, further resources were needed. In that regard, she acknowledged the contribution of Japan, the United States of America and others to the development of an influenza A (HSN1) vaccine. She hoped that resources would be forthcoming from international donors for the upgrading of vaccine production technology, to increase local production, for example, of rabies vaccine. Viet Nam was taking steps to join WTO and had complied with WTO agreements. Access to essential medicines, especially for poor segments of the population, was relatively good, but there were difficulties in the supply of some specialist drugs because of high and fluctuating market prices, which had implications for public health. She requested support in that area. With the support of WHO, Viet Nam was convening an intracountry consultation in October 2007 to prepare for the second meeting of the IGWG in November 2007. Mrs BLACKWOOD (United States of America) expressed support for efforts to frod ways of strengthening biomedical research to address diseases and conditions that were disproportionately affecting developing countries. The United States had participated actively in the first meeting of the IGWG and looked forward to the second meeting. The report of the CIPIH provided a solid basis for a way forward and she endorsed many of its recommendations. However, progress had been slow, and efforts must be accelerated to fmalize the draft global strategy and plan of action, as requested by the Fifty-ninth World Health Assembly. The United States of America had contributed some ideas for the working document for the second meeting of the IGWG, which was available as document WPRlRCS8/INF.DOC.2, and she urged Member States to review that document carefully. It was important to recognize the critical role played by innovation in the development of products relevant to public health, particularly in relation to conditions prevalent in developing countries. The IGWG should not propose any action that could jeopardize the critical incentives that spurred innovation. Dr LEE (Republic of Korea) pointed out that, owing to the high research and development
costs of developing a new drug, there were increasing calls for stronger protection of intellectual property rights. The Republic of Korea currently provided six years of protection for new drugs to motivate innovation. That policy was in line with Article 39 of the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS). The Government also prohibited the manufacture of pharmaceutical products that had been ruled as infringing patents. Those conditions were clearly set out in bilateral free- trade agreements. However, the Government acknowledged the significance of
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the Doha Declaration of the TRIPS Agreement, wbjch stated that intellectual property rights protection should not prevent developing countries from taking measures to protect public health, and was therefore trying to maintain a balance between protection of intellectual property rights and public health in bilateral agreements. Within the Republic of Korea, efforts were under way to strike an appropriate balance between generic and patented drugs. The demand for protection of intellectual property rights for pharmaceuticals would continue to brrow, and Member States would need to pay increasing attention to provision of government support for domestic production while continuing to value innovation and equitable access to health care. The Republic of Korea looked forward to participating in further discussions on the issue. Dr MAOATE (Cook Islands) welcomed the progress made since the adoption of resolution WHA56.27. The IGWG had recognized that small island states and poor countries had a limited ability to develop intellectual property rights, enforce compulsory licensing and produce pharmaceutical products. However, there were indirect pathways to achieving strategic objectives in those areas and the Secretariat should help Member States to understand the options available to them. For example, small Member States could collaborate Wllth more developed partners, as had happened with China and the Republic of Korea, to use compulsory licensing in respect of exports of medicines to countries lacking domestic production capacity. Current agreements gave priority to pharmaceuticals and medical products. Other relevant areas, such as traditional medicine, health practices and health research outcomes, should also be taken into consideration. WHO should provide tools to enable Member States to take effective control of ownership of their intellectual property in such areas. The draft global strategy and plan of action should be closely aligned with WHO's health research strategy. Mr WHITE (Australia) said that the draft global strategy and plan of action would provide a good foundation for negotiations at the second meeting of the IGWG in November 2007. Australia looked forward to constructive discussions leading to outcomes that were practical in nature; would strengthen Member States' health systems; and would be consistent with the international intellectual property framework. The protection of intellectual property rights would be important for investment in research and development, globally. That said, balance would be an essential objective of the intellectual property system. Accordingly, it was also necessary to find ways for countries to have access to affordable medicines and to vaccines. That would be particularly crucial for developing countries. Creative thinking would therefore be required, especially in the case of diseases such as HIV/AIDS and avian influenza. In that context, adherence to the framework of the TRIPS Agreement would be essential.
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Mr SOALAOI (Solomon Islands) said that research and development, with a focus on small and developing countries, was the first essential aspect of health development for those countries. The second such aspect was the promotion of research or research sustainability, which was unachievable without appropriate national human resources and facilities. He noted the key issues already flagged by the Regional Office concerning accessibility to essential medicines and public health technologies, which were among the many reasons for reluctance to share samples. In that context, domestic laws played a role in the restriction of the sharing or movement of raw materials and finished or processed medical products. It was a matter of who benefited most from the sharing and who owned the product. He was optimistic, however, that the draft strategy and plan of action were aimed at developing and providing solutions to such issues of concern. Dr WONG (Singapore) said that Singapore's robust national intellectual property regime had
been instrumental in developing its biotechnological, pharmaceutical and health-care research centres, thereby indicating the important role of intellectual property rights in the promotion of innovation. Singapore nevertheless also agreed with the views expressed concerning a balance between the needs of developing countries without the resources to obtain pharmaceuticals and the need for a strong patent framework that promoted the continuing innovation, deVelopment and creation of new lifesaving drugs. It further believed that the intellectual property and public health system could be tailored to benefit countries that lacked the capacity to respond effectively to public health emergencies. It also urged the continuing encouragement of innovation that was beneficial to developing countries. Dr DANGA (Philippines) said that she fully supported the work of the IGWG. Amendments to the Philippines intellectual property code had already been proposed to provide for the exclusion of new users from patentability; adoption of the international exhaustion doctrine; early working provisions; and the expansion of government-use situations. A second priority measure was to strengthen the Philippines Bureau of Food and Drugs to enable it to cope with an increase in parallel drug importation activities. The national legislature was also expected to pass a law on cheaper medicines in the near future, taking into account the flexibility offered by the TRIPS Agreement and the desire to improve access to low-cost, quality drugs and medicines, particularly at the grassroots level. The DIRECTOR, HEALTH SECTOR DEVELOPMENT, thanked representatives for their rich co=ents and continued engagement in the subject matter. A clear emphasis of the discussion had been the importance of striking a balance between the accessibility of drugs and vaccines and the incentive that intellectual property rights provided for the development of new medicines and vaccines. The challenges facing small countries, including research and development, had also
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emerged as another issue of concern and WHO would continue to lend its support in the areas concerned. Indeed, a meeting to discuss the challenges specific to the Pacific region would be held in October 2007. WHO was also strengthening its capacity to provide the additional support needed in the very complex area of technology. He looked forward to an ongoing communication and exchange of ideas on such issues from all concerned parties in the interest of achieving more progress. The EXECUTNE SECRETARY, SECRETARIAT ON PUBLIC HEALTH, INNOVATION AND INTELLECTUAL PROPERTY, WHO HEADQUARTERS also welcomed the positive and engaging contributions of representatives to the debate. Given the difficult task involved in incorporating all inputs into the draft global strategy and plan of action, he was pleased that both were viewed as a good basis for the work of the second IGWG meeting in November 2007. The comments made had been noted and the opportunity to build further on the draft would be provided at that meeting, where it was also hoped that it would be finalized. He emphasized the importance of the proposed national consultations to the negotiation process, particularly with regard to the identification of practical outcomes and solutions. He therefore looked forward to the active participation of Member States in that process. The REGIONAL ADVISER, PHARMACEUTICALS, added that, in response to the request of Member States, a feasibility study had been initiated in the Pacific island countries on the subject of the "collective approach" to pricing, the fmdings of which would be reported in due course. On another note, to best utilize provisions relating to public health safeguards, he encouraged Member States to incorporate such provisions into their national legislation so that needs could be anticipated in the event of an emergency. 4. PEOPLE AT THE CENTRE OF CARE INITIATNE: Item 14 of the Agenda (Document WPR/RC58111) The REGIONAL DIRECTOR reminded the Regional Committee that, in resolution WPR/RC55.RI, the Committee had requested the WHO Regional Office for the Western Pacific to produce, in collaboration with Member States and the WHO Regional Office for South-East Asia, a draft policy framework that would emphasize the need for a more holistic approach, including psychosocial factors affecting health outcomes, and to present it to the Regional Committee at the appropriate time. In response to that mandate, WHO would present for the Regional Committee's consideration
the draft People-centred Health Care: A Policy Framework, a product of the Regional Office for the Western Pacific's collaborative efforts with the Regional Office for South-East Asia.
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The DIRECTOR, BUILDING HEALTHY COMMUNITIES AND POPULATIONS, said that she would deviate from the usual introduction of agenda items by starting with some quotations. In his keynote address to the Fifty-ninth World Health Assembly in May 2006, His Royal Highness, The Prince of Wales, had stated that, "Centuries ago, Plato said, 'The cure of the part should not be attempted without treatment of the whole'. Centuries later, WHO recognized this
principle in its 1948 Constitution when it defmed health as a 'complete state of physical, mental and social well-being'. Today, therefore, is our chance to redefine our health systems so that they provide the balance and connectedness that the 21st century so desperately needs." In her opening address at the International Conference on Health and Development, held in Buenos Aires in August 2007, the Director-General had said, "In matters of health, I believe our world is out of balance, possibly as never before in history. We have never had such a sophisticated arsenal of technologies for treating disease and prolonging life. Yet the gaps in health outcomes keep getting wider". Dr Bernard Lown, Professor Emeritus of Cardiology, Harvard School of Public Health, had said, "Never before has medicine had the capacity to do so much good, yet never have people been so disenchanted with their doctors. The problem is that doctors have lost the art of healing, which involves much more than diagnostic skills and the ability to mobilize technology. At its core is the doctor-patient relationship. There is a new paradigm: medicine with a human face, in which the art of healing is as important as the mastery of medical techniques". A former Secretary of Health had said, "We do not realize that in the traditional way we relate to our patients - a superior to be strictly obeyed, by a subordinate to unquestionably comply-we are perpetuating an imbalance that makes for poor management of health and economics. Generalist or specialist, community or hospital based, we can restore a sense of balance by giving our patients and those around them the appropriate and correct information about their body physiology, with words and images that they can understand, and insist that they be co-responsible for their own health." SOlll~
four years ago, the Regional Director, Dr Omi himself, had also said, "I believe the
time has come to look at the quality of medical practice. Treating and caring for a sick person is not just a matter of curing his or her disease. A patient has other needs as well. Being unwell can be a disorienting experience. Living with fear or anxiety is not easy. For some, just being in hospital is stressful, particularly if it means separation from loved ones. In the past, doctors have failed to address these problems because they have been preoccupied with disease. Therefore, we will be aiming for a more holistic approach to health care, where the whole person is treated, rather than just
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the clinical condition. This means dealing with people in the context of their human dignity, their rights, their families, their culture, and their society". Indeed, promoting and protecting health in its fullest sense clearly called for the reorientation of health systems to provide an environment that supported people-centred health care. Beyond the basics of access and coverage, addressing the multidimensional needs, legitimate demands and expectations of patients significantly impacted health. continued commitment. The draft People-centred Health Care: A Policy Framework provided a variety of policy options to meet the challenge of safe, holistic and people··centred health care. She anticipated that the Policy Framework would be used as a guide for national policy and plans of action, for regional and subregional collaboration, and for advocacy and resource mobilization, adding that it was intended to complement work on the strengthening of health systems. The draft Policy Framework was the product of a series of consultations: first, with experts representing governments, academic institutions, professional organizations and other health care institutions; and second, with representatives of health. stakeholder groups and constituencies in selected countries in the Asia Pacific region, namely the Republic of Korea, Malaysia, Bhutan and Thailand. It was intended to be a well-balanced and evidence-based framework to guide efforts at both the national and regional levels. The Policy Framework identified four core areas or domains where reforms could be undertaken to translate the principles behind the people-centred approach into concrete, appropriate and setting-specific interventions that produced the desired results: (1) informed and empowered individuals, families and communities; (2) competent and responsive health practitioners; (3) effective health care organizations; and (4) supportive health systems. Member States would be able to use the recommended responses for each of those four areas in developing and strengthening their own health policies and interventions, as well as in establishing mechanisms to monitor progress. She stressed. however, that the actions identified in those core areas were neither exhaustive nor prescriptive. She invited discussion and consideration of the proposed People-centred Health Care: A Policy Framework. Dr OMAR (Malaysia) said that his country sought to attain the goal of a healthy nation
That issue deserved urgent attention and
through the development of a consumer-friendly, quality health care system, to which patient-centred
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197
services were integral. The Malaysian system aimed to include many elements of such services, to which great importance was attached, with emphasis on patient empowerment and personal responsibility for health. To that end, the timely provision of knowledge and information to patients was deemed essential to their informed decision-making and self-care skills. The people-centred care initiative, which had been in place in Malaysian hospitals for over a decade, encompassed a variety of features, including patient redeployment, decentralization of services, cross-training of care-givers and the implementation of care protocols. Malaysia endorsed the draft policy framework for people-centred health care and would continue its work with WHO to ensure that health services, both at home and within the Region, remained people-centred, with a view to enhancing customer satisfaction. Dr SHINOZAKI (Japan) said that the people-centred approach should encompass the entire spectrum of health care and should not be limited mainly to the patient-clinician encounter. The phrase "patient-centred", which referred to the clinical encounter, should be understood to be part of the broader concept of people-centred health care. The WHO definition of health implied that all people-individuals, families and communities-were part of the health care system, even when they were not ill. The optimal state, according to WHO, went beyond the absence of disease or infirmity: health began with the prevention of disease and the protection or promotion of well-being. The people-centred approach should include consideration of how a focus on people's needs and desires could be translated into their involvement, not only at the clinical level, but throughout the health system, up to the level at which policies and decisions were made. It should acknowledge that health care professionals were also people and that health care organizations and systems themselves were made up of people. Due attention should therefore be given to equipping and empowering people within the health care system to change that system for the better. He recalled that when he had been Director-General of the Health Policy Bureau in his country, a policy paper entitled Vision of Medical Service System Reform Toward the 21st Century had been issued. As chief editor of that paper, he had emphasized that the reform should be based on pat(~nt-ceIltred
Uledical
~are,
and that pltilosophy had been backed up by amendments to the relevant
laws. During the same period, the "Healthy Japan 21" movement had been launched to promote healthy lives for disease prevention. He was therefore pleased to support the draft policy framework, which was in line with that which he had envisaged several years previously. He informed the Committee that an international symposium entitled "People at the Centre: Reorienting Health Care in the 21 st Century" would be held in Tokyo in November 2007.
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Dr NGUYEN HOANG LONG (Viet Nam), expressing support for the draft framework, said that it covered many factors that affected people's health care, both directly and indirectly. Nevertheless, it focused too heavily on the health sector, while his delegation considered that it should place greater emphasis on the roles of government authorities, policy-makers, national and subnational leaders and other social organizations. Health policies should be analysed and designed from the point of view of people, who should participat(: fully in their formulation. Health financing policy should also be addressed from the people's perspective, taking into account non-medical and other expenses, which could considerably reduce access of the poor to basic health care services. People and patients should be empowered by proper infOlmation and education to participate in health decision-making, with other appropriate mechanisms to reduce the hegemony of the provider. Ms GIDLOW (Samoa) endorsed the policy paper under discussion. She commented that the framework for the initiative was in line with the Alma-Ata Declaration on primary health care and the Ottawa Charter for Health Promotion, so that the priorities advocated were not new. Her delegation considered that the countries of the Region would have no difficulty in implementing the proposed policy, as it could easily be linked to other regional initiatives such as "New horizons in health" and "Healthy islands". She was pleased that health professionals were being called upon to make a paradigm shift from the traditional medical model to a more holistic one. The health system and health practices in Samoa had been reoriented over the past decade to focus on people, as reflected in legislative reforms that recognized the roles of allied health workers and alternative health practitioners in the health system. Recognition of the :Importance of families and communities in hospital care reflected recognition of the psychosocial and cultural contexts. Dr TANGI (Tonga) said that he supported the concept of patient-centred care. It was not new, as it was at the heart of the culture of most countries of the Region. He recalled that, when he had become Minister of Health in his country, he had decided that his mission would be to be responsive to the health-care needs of the people of Tonga. The meeting rose at 11 :53.