WPRlRC54/SRl8 SUMMARY RECORD OF THE EIGHTH MEETING (WHO Conference Hall, Manila) Thursday, 11 September 2003 at 14:00 CHAIRPERSON: Dr Manuel DAYRIT (Philippines)
CONTENTS page I. 2. Severe acute respiratory syndrome (continued) ............................................................... . Expression of sympathy in connection with the recent SARS outbreak Regional strategy for improving access to essential medicines in the Western Pacific, 2004-2009 .................................................................................. . Framework Convention on Tobacco Control .................................................................... . 174 180
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SEVERE ACUTE RESPIRATORY SYNDROME: Item 14 of the Agenda (Document WPRlRC54/S) (continued) Dr WAQATAKIREWA (Fiji) praised the efforts made by Member States to control the
outbreak of severe acute respiratory syndrome (SARS), thanks to which the disease had not entered Fiji. Although three cases had been suspected, they had not been confirmed. None the less, in view of the staging of the South Pacific Games in Suva in July, his Government had introduced the requirement that all travellers from identified SARS-infected countries had to produce a certificate of good health. That episode had provided a good test of the integrity of Fiji's public health system; it had helped to uncover loopholes in current quarantine and public health legislation; had demonstrated the need to strengthen infection control procedures; and had raised awareness of the need to maintain disease surveillance in ports of entry even during periods oflow risk. The SARS outbreak had led to concentration at the highest political level and cooperation between many organizations. That had proved to be effective in containing the outbreak, and could be applied in other cases, such as the HfVI AIDS pandemic. Mr TRINH QUAN (Viet Nam) endorsed the actions proposed in the report under review and expressed his country's commitment to setting up robust systems to detect and respond to SARS should it reoccur. Viet Nam had been one of the first countries affected by the outbreak, and its response had been widely acknowledged as exemplary. In preparation for a potential resurgence, it was convening a symposium in Ha Noi in October to review containment experience, draw lessons for the future and share national preparedness plans. He invited ASEAN Members and other countries in the Region to participate. Dr FUKUDA (Japan) paid tribute to Dr Carlo Urbani and the many health workers who had
lost their lives in combating SARS. Member States had succeeded in controlling the outbreak through their intense efforts and with WHO's unfailing support. Japan had provided emergency funding for the purchase of equipment. An international laboratory network, which included the National Institute of Infectious
Diseases of Japan, had been set up during the outbreak, and had identified the pathogen. Nevertheless, the origin of the corona virus had not yet been identified, and no treatment yet existed. Countries, therefore, had to be prepared for a reoccurrence of the disease. Japan was giving priority to
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development of a rapid diagnostic test and the means to distinguish SARS from other respiratory infections. It had also learnt from the outbreak that its infection control legislation was not optimal; it was therefore revising its law on the prevention of infectious diseases. Dr ABIDIN (Brunei Darussalam) thanked WHO for the exceptional support given to his country during the SARS outbreak, but expressed his concern that, at the beginning of the influenza season, there were still no specific diagnostic kits and the symptoms of influenza and SARS were similar. Priority should be given to development of a testing kit and a more specific case definition. Guidance was also needed on regional and international travel. In that regard, the revision of the International Health Regulations, which would address some of the issues raised by the emergence of SARS, was very timely. Professor NYMADAWA (Mongolia) said that nine cases of SARS, all imported, had been reported in Mongolia, together with a large number of contacts, from which an infectivity index had been calculated of six cases per thousand contacts. Thanks to external support and national efforts, none of the patients had died, nor had health workers been infected. Mongolia's national control efforts had been guided mainly by WHO's website. However, the outbreak had highlighted the importance of timely provision of information to neighbouring countries. All Member States had a duty to others to provide timely information. The outbreak had also emphasized the vital need to strengthen laboratory services for future control of SARS or other emerging diseases. Without such services, cases could not be confirmed nor appropriate action taken. Development of diagnostic test kits would be a first step, and the
establishment of a regional network of reference laboratories was needed to prevent the resurgence. Dr MOHAMAD TAHA (Malaysia) said that five probable cases of SARS, all imported, had been reported in Malaysia. His country had issued improved SARS surveillance guidelines which incorporated all WHO's post-outbreak recommendations. The meeting of ministers of health of the Region in Kuala Lumpur at the height of the outbreak, and the subsequent conference of heads of government in Bangkok, Thailand, had highlighted the strong commitment at the highest political level to combat a common threat. That response to SARS had demonstrated the importance of cooperation through laboratory networking, standardization of prevention and control activities along common borders, and prompt notification of cases. However, uniform and common enforcement of international regulations was needed to prevent the spread of infectious diseases
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Another requirement was a classification system for control purposes. For example, did WHO classify the current case in Singapore as "probable" or "suspect"? What criteria were used to classify the case? Dr YU (China) endorsed the actions proposed in the report. China had recently undertaken a number of steps to enhance prevention and control and reduce the risk of a resurgence of SARS. Among other measures, it had: drawn up national guidelines which defined the technical and
management aspects of SARS prevention and control, together with guidelines on SARS surveillance and reporting; convened a number of expert consultations on detection, diagnosis and control in the case of a recurrence of SARS; revised principles and working procedures for detection of SARS and its differentiation from influenza; revised the reporting categories of infectious diseases that were prescribed by law; issued guidelines on response to public health emergencies in order to improve preparedness at different levels; and provided nationwide training on SARS, including the drafting of teaching materials on disease prevention, control and surveillance. China intended to focus on disease prevention and control, optimization of rapid response mechanisms, and improvement of information, monitoring and reporting systems, giving priority to rural health work. WHO should pay special attention to the development of rapid diagnostic tests, effective therapy, and legal aspects of infection control, as little progress had been made in those areas. Dr LOPEZ (Philippines) expressed his appreciation for the strong support received from WHO both during and after the outbreak. There were many lessons to be learnt from the experience, not only the need to strengthen epidemiological capabilities and maintain surveillance systems, but also to reaffirm infection control measures and personal hygiene practices. It had highlighted the importance of collaboration and networking at all levels and, above all, of political commitment at the highest level. Dr LAM (Hong Kong, China) affirmed that SARS was the biggest public health challenge that Hong Kong (China) had faced in recent years, and had cost the lives of some of its most dedicated health-care workers. prevent a resurgence. He fully endorsed WHO's updated surveillance framework for SARS. Hong Kong had greatly improved its surveillance of respiratory infections and was launching an influenza vaccination programme in order to reduce confusion between influenza and SARS during the coming influenza As one of the most affected places, it was taking all possible measures to
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season. It was massively expanding and upgrading hospital isolation facilities, providing training on infection conh·ol, and enforcing strict health measures at all entry points Hong Kong was utterly committed to collaborating with WHO and the international health community in combating SARS. It had joined a regional disease surveillance network that included parts of mainland China and Macao, China, and was allocating further human and financial resources to preparedness plans for a potential emerging infection. Dr GRANGEON (France) said that health checks had had to be rapidly set up at entry points into New Caledonia and French Polynesia, together with procedures for handling suspected cases. That had implied, at the height of the alert, checking tens of thousands of passengers arriving at Noumea international airport, which had required making available considerable human and financial resources. Fortunately, the three suspected cases had not been confirmed; otherwise it would have been necessary to quarantine the patients. In view of the regulatory problems that such action would have entailed, of the need to take account of ethical considerations and the legitimate expectation of patients to be treated in their home countries, of the lack of procedures to coordinate the interventions of insurance companies and airlines involved in a health evacuation, he requested WHO to give priority to establishing a common regulatory framework for adoption by Member States. Further, in the case of a crisis, WHO should, for strategic reasons, assume direction of the communication strategy on behalf of all involved, in order to provide sound and transparent information to both health professionals and the general public. Mr UNT ALAN (United States of America) asked whether WHO intended to amend its procedures for drafting and issuing travel advisories. hl particular, there should be adequate
consultation with the Member State involved before such advisories were issued. Another concern was the transport of biological specimens by commercial airlines, a common practice in the Region. Agreements should exist with all airlines to ensure that all appropriate
safeguards against infection were applied when transporting such specimens. Moreover, the bans on the sale for human consumption of animal species that were suspected reservoirs of the SARS virus and known reservoirs of coronaviruses should be maintained. He urged Member States to maintain and strengthen surveillance and to draw up preparedness plans in case of a resurgence of SARS. Further, Member States should share, not only tissue samples of SARS patients and possible animal reservoirs with the international network oflaboratories set up by WHO, but also the findings of SARS research conducted during and after the outbreak.
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Dr SELUKA (Tuvalu) said SARS had revealed the weaknesses in global and national health systems and had brought home the lesson that a regional surveillance network needed to be established to ensure rapid information exchange during disease outbreaks. Tuvalu appreciated the efforts of the WHO office in Suva and the Pacific Public Health Surveillance Network in keeping them informed of the daily development of the outbreak. He supported adoption of a resolution that would urge Member States to strengthen their national capacities for surveillance and outbreak response and establish effective infection control programmes. Dr McKINNON (Australia) acknowledged that the outbreak had stretched the resources of the Regional Office and countries in the Region. Australia had been pleased to have been able to contribute AUS$ 1.7 million to WHO for prevention and control of SARS outbreaks in the Western Pacific Region. Australia joined other Member States in emphasizing the importance of a regional surveillance and laboratory network. SARS had been declared a quarantinable disease in Australia under the Commonwealth Quarantine Act, making it a notifiable condition under the public health legislation at the State and Territory level. Through colleagues In
Hong Kong, samples of the SARS virus had been obtained by the
National High Security Quarantine Laboratory, which enabled it to develop and validate diagnostic tests for SARS. Although the Asia-Pacific region had contained SARS, the risk of another outbreak remained and Australia's health authorities, in close consultation with WHO and regional partners, remained vigilant and ready to increase protective health measures again if necessary. Australia broadly supported the actions proposed by WHO and acknowledged the challenges that the Region faced in preparing for serious infectious disease outbreaks. He would be interested to receive further information on the proposed regional stockpile of emergency supplies. The SARS epidemic had highlighted the importance of revising the International Health Regulations to make them relevant to the early detection and rapid response to epidemics. Australia was participating as a 'collaborating country' in that revisioll. Dr KUN (Macao, China) related that Macao had had only one imported case of SARS and no hospital or community outbreak, in spite of its proximity to Guangdong Province. That was largely
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due to the government's swift action to prevent and control SARS, which had included the setting up of a multi sectoral task force to oversee preventive and control activities. The Regional Director during his visit to Macao in August had emphasized the importance of early preparedness, strong political commitment, and good infection control facilities and practices, as welI as strict isolation and tracing procedures and a sensitive surveillance system. WHO's support had been sincerely appreciated. Macao strongly supported the strengthening of surveillance, response and coordination capabilities. Ms GO (Republic of Korea) thanked WHO for its efforts to control SARS. Thanks to Government action, there had been only three probable cases in her country, and no secondary transmission. The Republic of Korea was developing programmes to increase preparedness for any potential resurgence of SARS, including monitoring and control, capacity building of epidemiologists and various education activities. The REGIONAL DIRECTOR expressed his deep appreciation of the wholehearted and unprecedented support that WHO had received from Member States in the colIaborative efforts to contain SARS. In response to the query from Malaysia regarding the most recent SARS case in Singapore, he said that, in consultation with Singapore and colleagues in the Region, and based on the present, very good, level of surveillance in that country, no evidence could be found of human-to-human transmission. Although the case, who worked in a laboratory, had manifested only fever and not pneumonia, or other respiratory symptoms or abnormalities, he had tested positive by polymerase chain reaction (PCR) and serological testing. He believed that he had been infected through exposure to the virus in the laboratory. The Singapore authorities had already undertaken precautionary
measures and there was no cause for alarm. On the concerns that had been raised by the representatives of the United States of America and France regarding the need for a more consistent travel advisory policy, he infomled the meeting that, when WHO had had to issue a travel advisory against Hong Kong and Guangdong, it had been a very difficult decision to make because of the tremendous negative impact WHO knew it would have on their economies. The ongoing revision of the International Health Regulations would make the
process more objective and transparent in future. The REGIONAL ADVISER IN COMMUNICABLE DISEASE SURVEILLANCE AND RESPONSE informed the meeting that WHO had issued a new case definition of SARS on
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14 August. Referring to the new case in Singapore, he said the case did not meet clinical definitions of SARS but did meet the laboratory case definition. Emergency supplies had already been sent to countries using funds from the Japanese Government and he urged countries to maintain stockpiles of supplies to deal with future disease outbreaks. There were also stockpiles in the Regional Office. Recommendations on border controls were being reviewed and recommendations would be made in terms of emerging diseases. The CHAIRPERSON requested the rapporteurs to draft an appropriate resolution. 2. EXPRESSION OF SYMPATHY IN CONNECTION WITH THE RECENT OUTBREAK. OF SEVERE ACUTE RESPIRATORY SYNDROME (SARS) At the proposal of the Chairperson, the Regional Committee observed a minute of silence in tribute to WHO staff member Dr Carlo Urbani and other health workers who had lost their lives during the SARS outbreak. 3. REGIONAL STRATEGY FOR IMPROVING ACCESS TO ESSENTIAL MEDICINES IN THE WESTERN PACIFIC, 2004-2009: Item 15 of the Agenda (Document WPRlRC54/9) The REGIONAL DIRECTOR said access to good quality essential medicines could make a vital contribution to improving health and reducing mortality and morbidity. However, essential medicines would save lives and improve health only if they were available, affordable and properly used. During the past 25 years, WHO had worked with Member Sates to implement the concept of essential medicines. Many countries in the Western Pacific Region now had national essential
medicine lists, which to some extent served as a basis for procurement in the public sector. However, despite national essential medicines lists, treatment guidelines and medicine formularies, many people in the Region did not yet have regular access to the medicines they needed. This had a major impact on health, since most common illnesses in developing countries could be treated or alleviated with simple essential medicines. In contrast, unnecessary and nonessential medicines were often widely available, draining limited resources. Trade globalization and the implementation of the Agreement on Trade Related Aspects of the Intellectual Property Rights (TRIPS) had made the issue of access to essential medicines, and especially to patented medicines such as antiretroviral agents, more acute than ever. This had been
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recognized by the Fifty-sixth World Health Assembly in May 2003 and by the Regional Committee at its last meeting in Kyoto. In response, the Regional Office had worked closely with international experts and Member States to draft the regional strategy for improving access to essential medicines in the Western Pacific Region, 2004-2009, attached to document WPRlRC54/9 as Annex 2. The overall objective of the regional strategy was to provide operational and practical guidance to Member States and WHO on improving access to essential medicines. A dramatic improvement in access to essential medicines, particularly among the poorer populations in the Region, would be seen if the strategies and actions recommended in the regional strategy were carried out by both Member States and WHO. He hoped that the Regional Committee would welcome the regional strategy and discuss how to implement the recommended strategies and actions. The Committee's ultimate goal should be to make medicines available and affordable to every person in the Region in need of them. That goal was still a long way off, but he was looking forward to hearing from Member States on how the regional strategy could be used to bring it a little closer. Mr YOSHIDA (Japan) supported the aims of the strategy in general, but said that the overall text needed further review. He addressed two issues arising from the strategy. The first was dissemination of best practice. It was often difficult to apply best practice that had been identified in one country in another because of differences in systems. Criteria or standards based on biological findings, such as treatment
guidelines and drug safety guidelines, were more likely to be standardized, as were materials for public education and advocacy. These could be standardized across the Region. However, the effects of policy interventions, where financial incentives played a key role, would be directly influenced by the system in a particular country. Drug pricing policy, for example, might depend on the role of pharmacists or the reimbursement system for physicians. It was, therefore, necessary to be careful about implementing best practices across the Region. Each country should be able to come up with the option best suited to its local context The second issue related to consistency ll1
the regional strategy regarding "issues and
challenges", "strategies" and "actions". He believed that strategies and actions should correspond with issues and challenges. Regarding the language used in the text in the area of "quality" he requested clarification on the scope of this term, and asked whether it covered counterfeit or substandard medicines.
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He asked that a small working group be set up to further review the draft text with the participation of interested countries. Dr SHAO (China) said that the accessibility of medicines had significantly improved since the adoption of the essential medicines list by many countries in the Region. However, with an
increasing occurrence of HIV/AIDS, drug-resistant malaria and tuberculosis in the Region, coupled with the SARS outbreak earlier in the year, access to essential medicine had become even more challenging and important. Ensuring that essential medicines were accessible to China's 1.2 billion population was not an easy task, so the Govemment was carrying out a national essential medicines policy. China, as a developing country, had faced the problems and challenges mentioned in the regional strategy. China's list of essential medicines had not always been used as the basis of medicine procurement, reimbursement and prescription. Irrational or unnecessary use of medicine including counterfeit
medicines, still existed. Joint efforts by every sector would be needed to develop and implement the policies. The draft regional strategy could serve as a guide in the next five years to strengthen and promote China's national medicine policies. Dr HARE PAKA (Niue) pledged his country's support for the proposed regional strategy.
Procurement and transportation of essential medicines to and within small island countries, such as his own, represented a considerable challenge. Cost was also a major constraint. Support in those areas was vital to ensure equitable access to affordable medicines. He suggested that WHO should evaluate the outcome of earlier training workshops in the area of essential medicines prior to the next workshop, to be held in Fiji in November 2003. Dr MANN (Papua New Guinea) commended the draft regional strategy, which he supported. Papua New Guinea had approved its national drug policy and the Medicines and Cosmetics Act in 1998. The country currently imported all medicines, including sterile water. He endorsed the WHO List of Essential Medicines in principle, but suggested that, for each country, selection of medicines should be based on the morbidity pattems and types of intervention being employed, and that use should be in accordance with standard treatment manuals, as was the case in Papua New Guinea. Such procedures would facilitate the procurement and quality control of essential medicines, and their rational use. In addition to the development of treatment guidelines, activities to evaluate the impact of interventions on prescribing patterns, drug resistance and commercial interests should also be considered. WHO would need to provide technical support for capacity-building in those areas.
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Although the price of medicines had decreased significantly, many were still too expensive for developing countries, and further measures were needed to improve affordability. Governments should ensure commitment to the sustainable financing of essential medicines, especially for use in primary health care activities and priority programmes for the poorest people in the community. The recent economic decline in Papua New Guinea had reduced its capacity to supply rural health facilities with essential medicines, although the Australian Government had provided support for procurement and distribution. A survey was being conducted on expenditure on drugs and other medical supplies, disaggregating urban and rural data, with a view to improving efficiency and costeffectiveness. WHO should disseminate best practices in the Region and make further efforts to establish a multi-country mechanism for bulk procurement at competitive prices. WHO should facilitate appropriate training in the management of supply systems and encourage further research on rational selection and use of drugs, quality control, financing mechanisms and supply system management. The establishment of a regional collaborating centre on quality control, linked to bulk purchasing mechanisms, would greatly assist Member States. He expressed appreciation for the generous support provided by WHO, UNICEF, Australia, China and Japan in the area of essential medicines. Dr GRANGEON (France) commended the Regional Office on the approach taken in developing the proposed regional strategy, in particular as regards financing mechanisms. While he endorsed the strategy in principle, further work was needed to define the methods and tools to be used and to set out a timetable for implementation. He welcomed the current list of essential medicines as well as the publication of the reasons for inclusion on or exclusion from the list and the establishment of an electronic database providing information on rational use. Clearly, exclusion of a medicine from the list should not prohibit the use of that medicine. The inclusion of antiretroviral drugs for the treatment of
nIV
infections and not only for the prevention of mother-to-child transmission of the
infection was a welcome development. Price was a determining factor and a policy in favour of generic drugs, as suggested in the proposed strategy, should be adopted. New Caledonia had formed a working group on rational use of drugs in accordance with the government health expenditure programme, which included a component of compulsory continuing training for health professionals. Most of the population had access to drugs thanks to a provincial medical aid system.
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In French overseas departments and territories, there was a free-market as well as a hospital-
based drug supply and management system. In New Caledonia the free-market system was competitive and provided flexibility in supply options. Quality control was carried out by the health authorities in metropolitan France, as there were no local facilities. He welcomed the recent WTO agreement concerning compulsory licensing for countries with no local drug mannfacturing facilities, with particular reference to drugs used for the treatment of HIV infection, which had been achieved thanks to pressure from WHO and certain States, including France. It was vital for all countries to have operational access to essential medicines. The effective provision of essential medicines demanded adequate financing, and he welcomed the additional sums being made available by the Global Fund to Fight AIDS, Tuberculosis and Malaria. Mr BHAT (United States of America), recognizing the need for improved access to essential medicines in the Region and across the world, welcomed the recent agreement reached at WTO concerning paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, which would facilitate access to generic and patented drugs. While he supported promotion of availability of generic drugs - indeed the United States had a robust generics industry - such agents were not always the best or least costly option. For example, the research-based pharmaceutical industry had recently agreed prices lower than those of comparable generic drugs for sales of certain patented drugs in some African and Asian countries, and governments and industry had undertaken a variety of collaborative activities in Africa that might serve as a model for the Western Pacific Region. It was a matter of regret that the draft regional strategy made no reference to the research-based pharmaceutical industry, since providers of both patented and generic drugs would be necessary for its implementation. All countries and citizens should pay due attention to the need for rational use of essential medicines, and transparent and ethical national policies to ensure adequate financing, quality control, effective procurement and supply, and distribution management systems would be essential elements of the regional strategy. Ministries of health should collaborate with other government sectors and interested parties to develop and implement strategies to ensure strict adherence to appropriate laws and regulatiuns and to target and penalize manufacturers and distributors of ineffective and counterfeit drugs. Comprehensive monitoring and evaluation programmes, with the authority to act on findings, would be needed.
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He said that there were factual inaccuracies in the draft strategy conceming the roles of WHO and WTO in relation to the TRIPS Agreement and that there was a bias towards generic drugs. In his opinion, the text required revision, in particular to reflect the recent WTO agreement and the comments made by Regional Committee representatives. He therefore supported the proposal made by the representative of Japan. Dr LO Veasna Kiry (Cambodia) commended the draft regional strategy and requested further
information on the actions proposed for supporting Member States in ensuring quality control and tackling the problem of counterfeit drugs. Ms WARD (Australia) commended the timely discussion of a regional strategy on essential medicines. The relation between international trade and equitable access to drugs had recently dominated discussions, although there were many other important factors to be taken into account, including national policies, drug supply systems and availability of appropriate human resources. Nevertheless, the recent historic WTO agreement would enable poorer countries that lacked pharmaceutical manufacturing capacity to make use of compulsory licensing agreements. The draft regional strategy under consideration proposed various actions that would be relevant to different countries in different circumstances, some of which had not yet been costed. She therefore supported the proposal made by the representative of Japan that a working group should be established to revise and refine the strategy. Australia stood ready to participate in the group, in which all relevant interests should be represented. Dr BENJAMIN (Federated States of Micronesia) expressed support for the completion of the
draft regional strategy, which would provide useful guidance to Member States, especially those with limited resources, in improving access to essential medicines in the face of increasing commercial pressures. His country was currently finalizing a five-year national drug policy that took the regional strategy into account. He thanked WHO for the provision of technical support for that activity. Dr LOPEZ (Philippines) said that equitable access to affordable essential medicines, which was vital to improve health, required strong partnership between the public and private sectors and between developed and developing countries. He supported the draft regional strategy and commended the extensive consultation process followed by WHO during its preparation. Dr SULEIMAN (Malaysia) supported the draft regional strategy, elements of which had been
incorporated into Malaysia'S national medicines policy, which was currently being finalized. A national essential drugs list had been drawn up in 2000 and, to promote rational use, the Ministry of Health was collaborating with relevant professional bodies to produce consensus statements to serve
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as treatment guidelines. Negotiations with patent holders had been conducted, using the avenues available under the TRIPS Agreement, and patent laws had been amended. He endorsed the use of compulsory licensing by countries lacking phannaceutical manufacturing capacity. The REGIONAL DIRECTOR, thanking representatives for their comments, said that, although the complex factors affecting access to essential medicines had been discussed many times at the Executive Board and Health Assembly, the subject had not been considered by the Regional Committee in recent years, and there had been no regional strategy or action plans in that area. Yet Member Stales had frequently requested him to ensure that WHO played a more proactive role in improving the accessibility and afford ability of essential medicines. Moreover, the declaration adopted at the 200 I United Nations General Assembly special session on HIV I AIDS had called for the development of regional alliances to combat that disease. He had therefore requested his staff to develop a draft strategy for improving access to essential medicines as a starting point for discussions in the Region. A consultation to which a wide range of experts from inside and outside the Region had been invited had been planned for March 2003. Owing to the SARS outbreak, however, the consultation had been postponed until July 2003 and there had been little time since then to draft the strategy, which he agreed needed refining. The representative of Japan had made some useful proposals, in particular as regards definition of terms, the need for consistency between challenges and proposed activitics, and the potential problems associated with user fees. He suggested that a working group should be convened in the coming months to revise the draft strategy in the light of the comments made, and requested Member States to indicate their interest in participating in that exercise. The REGIONAL ADVISER IN PHARMACEUTICALS responded to commments from several countries on best practices. Whether the subject was promotion of certain practices, or supply or delivery of essential medicines, WHO sought to explain in detail why certain practices did work and others did not. This took into account the relevant environmental factors. In this way countries could decide whether a given practice was applicable in their context. WHO would update the
regional strategy in the light of the recent agreement by the Council of the World Trade Organization on the use of compulsory licensing for countries without manufacturing capacity, and would seek to assist countries in making best use of the Agreement on Trade-Related Aspects of Intellectual Property (TRIPS). The matter of counterfeit drugs had been raised by Cambodia and the United States of America; this was a growing problem that WHO had been fighting for many years by developing guidelines, training, strengthening of inspections, as well as registration and regulation of drugs.
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However, the approach had to be adjusted, with more emphasis on law enforcement. In response to the question from the United States of America, he said that monitoring and evaluation of pharmaceutical sectors was proceeding in Malaysia, the Philippines and other Member States, where the availability, quality and affordability of essential medicines were being assessed. The information gathered could then be used as baseline data, to measure progress. A meeting on the situation in Pacific island countries and other small countries would be held in Fiji in November. The CHAIRPERSON suggested that, as proposed by the representative of Japan and supported by several other representatives and the Regional Director, a working group be formed, and that a revision of the draft strategy should be submitted to the Regional Committee for consideration at a subsequent session. 4. FRAMEWORK CONVENTION ON TOBACCO CONTROL: Item 16 of the Agenda (Document WPRlRC54110) The REGIONAL DIRECTOR said that the epidemic of tobacco use was one of the greatest threats to global health today. In response, for the first time in its 55-year history, the World Health Organization had led negotiations that eventually produced an international treaty to regulate tobacco and protect the public from the hazards of smoking. In May 2003, 192 governments from around the world had adopted the WHO Framework Convention on Tobacco Control (the Convention) at the Fifty-sixth World Health Assembly. The resolution adopting the Convention, which had the text annexed to it, was attached to document WPRlRC54/10. The first challenge for this Region was to add to the six countries that had already signed the Convention. While congratulating the representatives of Marshall Islands, Mongolia, New Zealand, Palau, the Republic of Korea and Viet Nam for the fact that their countries had already signed the Convention, he urged representatives of the remaining countries to use their persuasive powers to the utmost to convince the rest of their government colleagues of the many health benefits that would accrue from signing the Convention. He understood that five other countries - Malaysia, Samoa, the Solomon Islands, Tonga and Singapore - would be signing within the month. The next stage was for all the signatories to ratify the Convention and to ensure that its provisions were reflected, or even exceeded, in domestic legislation. The Convention had set the minimum basic standards for tobacco control, and countries were encouraged to exceed the provisions of the treaty. But this could not happen until a critical mass of countries ratified it and made their domestic laws conform to it. Hence, the challenge ahead was to ratify the Convention and to muster the political will to implement it.
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Dr RAHIM (Malaysia) congratulated WHO on the Convention. Unlike the rapid response to SARS, the tobacco epidemic had raged for decades before an international response had emerged. Malaysia had taken part in the work over the past three years, and was pleased with the outcome. The Convention would allow the global community to move towards a tobacco-free future. A World Bank report had shown that increases in taxation led to sharp reductions in consumption in certain groups, especially children, without affecting government revenue. Malaysia welcomed the proposal to boost tobacco taxes under article 6 of the Convention, and was studying a system for using tax revenue from tobacco and alcohol to run tobacco control and other health-promotion activities. The Government of Malaysia held that human health should prevail over the profits of a few corporations. Malaysia would be signing the Convention that month, and it hoped to ratify the instrument as soon as possible. Dr TANGI (Tonga) had travelled to Geneva to sign the Convention, but delays in preparing the document for signature had meant that he was unable to do so. However, his Prime Minister would soon be travelling to New York, and would therefore sign on behalf of Tonga. He asked what arrangements had been made for countries that had trouble travelling to Geneva or New York. Dr FUKUDA (Japan) said that his country had agreed on the Convention because it recognized its importance, and that it would enable each party to take steps to control tobacco in accordance with national law. Japan was in the process of signing and ratifying. It would subscribe to action plans as long as they accorded with the Convention, which had taken a long time to accommodate the differences of opinion between Member States. Care must be taken not to misinterpret clauses, especially those on taxation, labelling and liability. Referring to document WPRlRC54/1O, Japan supported proposed action (I), but parliamentary approval was not swift in countries such as Japan, so WHO should not carelessly urge ratification of the Convention. Proposed action (2) seemed to suggest negotiation of protocols before the
Convention came into effect, contrary to the understanding that this would not happen before the rules of procedure of the Conference of the Parties had been written. He therefore requested that the expression "while awaiting the entry into force of the Convention on Tobacco Control" be removed. He supported action 3. Action 5 seemed to encourage each country to establish a health foundation with revenues from tobacco taxes. Such a specific matter should be left to individual countries. Japan therefore requested amendments to that recommendation. Dr AFFENDY (Brunei Darussalam) said that strengthening tobacco control was a priority in his country. The Sultan had recently reiterated the need to further strengthen tobacco control and agreed to ratify the Convention.
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He hoped WHO would continue to provide advice and support for such areas as legislation, strengthening of national tobacco control policy, provision of clinical cessation services, and other activities. He suggested that the Convention should remain on the Regional Committee's annual agenda for several years, examining various aspects of the Convention, so Member States could benefit from each other's experiences. Dr JOO (Republic of Korea) reported that his country had signed the Convention in July, and was preparing to raise cigarette prices by 60%; implement a comprehensive ban on advertising,
promotion and sponsorship; put wamings on at least 30% of the surface of packaging; prevent the use of misleading descriptions of tobacco products; ban sales methods that afford direct access to children and adolescents; and forbid the sale of cigarette-shaped toys or sweets. The relevant laws, including the National Health Promotion Act and the Tobacco Industry Act would be amended, coming into effect upon ratification of the Convention. Dr KIENENE (Kiribati) said that his country had not signed the Convention because of changes of govemment. The former govemment had been very supportive of the Convention; had it remained in power until the World Health Assembly, and had the papers been ready for signing then, the Convention might have been signed already. Nevertheless, he hoped his country would be ready to sign in New y'ork soon. Dr REN (China) expressed his country's appreciation of WHO's long-term efforts to control tobacco globally, and its strong support for that action. China was the world's largest tobacco
producer and consumer, but the govemment had taken steps to reduce the resultant harm. Lawson protecting the rights of children and adolescents, tobacco sales and prevention of juvenile delinquency, all contained clauses on tobacco control. Many provinces and cities had passed laws to ban smoking in public places. The country was now working with WHO on implementation of several tobacco control programmes. The legal procedures for ratification of the Convention were under way and China was preparing to implement its provisions. In China, health education was used to protect children and young people from smoking. Since 2000, an activity called "refuse the first cigarette in your life" had been under way in primary and secondary schools. So far over 3 million students had taken part. The Government had introduced strict control of tobacco production and intensified its efforts to reform the tobacco industry. Over 50 tobacco factories had been closed, and about 100000 workers had been re-assigned to other employment. The tobacco industry had been encouraged to engage in
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other areas of production. No new tobacco factories were allowed to open, nor were tobacco joint ventures permitted. The impact of tobacco production on the economy had been studied at a workshop. Events had been organized such as tobacco-free sports, television programmes, films and fashion shows. Mrs BLACKWOOD (United States of America) said her country had been glad to join the adoption of the Convention by consensus and that its goal had been the achievement of a strong, effective instrument. It was now reviewing the text in order to make an informed decision on signature. Her country was committed to international tobacco prevention activities, such as the Global Youth Tobacco Survey, which covered 150 countries, to prevent future death and disease. The United States was gratified to see its own tobacco control activities emulated and built upon in many other countries, and it intended to continue its leadership role in research and technical assistance. The Convention and the global dialogue on tobacco control had already borne fruit in many countries. Referring to document WPRlRC541l 0, she requested a change in the wording of action I, replacing 'ensuring' with 'seeking', to leave each Member State to take its sovereign decision on the matter. While she commended countries that had signed the Convention, the speaker held that flexibility was needed for countries that had not yet decided to sign. She agreed with the other actions set out on page 5 of the document, with the exception of action 2 which, as the representative of Japan had observed, ran counter to the understanding that discussion of protocols was to be considered by the Conference of the Parties (article 33), and not before then. Dr CUTTER (Singapore) said that for many years his country had been implementing policies consistent with those covered in the major provisions of the Convention, such as a ban on all tobacco advertising. It had been increasing taxes for over 20 years. Tobacco companies had been driven to introduce ever smaller packets of cigarettes, to keep prices attractive, so there would soon be a ban on small packets of cigarettes. Cigarette packets would have to bear graphic messages against smoking. The prevalence of smoking in Singapore had fallen from over 20% in the 1980s to 13.8% in 2001. The ministry of health was preparing for imminent signature of the Convention. Dr LOPEZ (Philippines) said that the Philippines had been active at the global level and within
ASEAN during preparation of the Convention. The Tobacco Regulation Act of 2003 mirrored the
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salient provisions of the Convention, especially as regards banning of advertisements within a given time frame. The government was working on implementation of the Tobacco Act, with assistance from WHO. The Department of Health had excluded the tobacco industry from participation in its tobacco control initiatives. With regard to signature of the Convention, the Government was currently investigating whether the Secretary of Health could be granted full powers to sign. The Philippines intended to sign the Convention as soon as possible. At the suggestion of the Philippines, the ASEAN Senior Officials Meeting on Health Development had investigated the convening of a joint meeting of senior economic and health officials. That meeting would address how to tobacco could be removed from trade liberalization in the 10 ASEAN countries. The Government of Malaysia would implement that initiative before the year ended, and the Philippines would provide all the help it could. He asked representatives from ASEAN countries to commence discussion with trade officials in their countries in order to advance tobacco control in the Region. Dr GRANGE ON (France) spoke of the long-established commitment of the French Government to tobacco control, and welcomed the adoption of the Convention. He noted that French Polynesia had started legislating against tobacco several years previously, and New Caledonia somewhat later, when it realized that 110 deaths every year, or 11.6% of all deaths reported, could be attributed to smoking. Policies were being put in place in New Caledonia to address the threat to public health posed by tobacco; although they were at the start of the process, these specific measures should help reduce the problem in the long run. Dr ENOSA (Samoa) said that his Government would sign the Convention before the end of the month and then ratify it. A WHO consultant had assisted in drafting legislation for tobacco control, which was being prepared for passage by the end of the year. He noted the concerns expressed by the representatives of Japan and the United States of America. Some of those issues had been accommodated in his country's legislation. Taxes on tobacco products had been increased and would probably be increased further. Dr MANN (Papua New Guinea) thanked WHO for its leadership in supporting adoption of the Framework Convention and for helping his country to participate fully in the work of the Intergovernmental Negotiating Body. The Ministry of Health had prepared the necessary submissions, so that the Government could endorse the Convention and give its approval for its representative at
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the United Nations to sign it. Recommendations had been made that the Council prepare the necessary instruments, so that Parliament could ratify the Convention, perhaps before the end of the year. He asked the Regional Committee to call for countries to stand together in implementation of the Convention, as the tobacco industry was aggressive and cunning. Member States should therefore adopt measures that were stronger than the text of the Convention. Dr MALEFOASI (Solomon Islands) said that Solomon Islands supported the call to ratify the Convention. The Ministry of Health was concerned about the increasing rate of smoking among schoolchildren and especially among girls. Although the Minister of Health had been empowered to sign the Convention, that had not been done owing to financial constraints. Draft legislation on tobacco control had been passed by the Cabinet in 200 I, but had not yet been presented to Parliament. The delay had allowed time for revision, to ensure that the key issues in the Convention were covered. Mrs PIERANTOZZI (Palau) said that her Government had been one of the first to sign the Framework Convention. The former Director of Public Health, Dr Caleb Otto, had been a tireless supporter of the Convention and had received the Director-General's award for his negotiations within the Pacific region. The Convention was now being ratified, and Congress had raised taxes on cigarettes recently. With regard to the actions proposed in paragraph 5 in Section 3 of Document WPRlRC5411 0, she agreed with other speakers that decisions should be taken by individual countries. Ms WARD (Australia) said that her country remained committed to reducing the health, social and economic harm wrought by tobacco use. The most recent national campaign had been the most intensive yet. The Convention was being considered within the country's treaty-making process. It was clear that concerted international action was required to reduce the harmful consequences of tobacco use globally, particularly to address those aspects of tobacco control that transcended national boundaries. Her Government supported inclusion of the priorities and policies of the Convention in the Regional Action Plan for Tobacco Control for 2005-2009. Australia strongly supp0l1ed WHO's Tobacco Free Initiative and, through its international aid agency, AusAID, supported regional programmes, including projects to reduce lifestyle-related risk factors. Tobacco use increased the burden of noncommunicable diseases in developing countries, and tobacco control was beginning to be integrated into regional and bilateral health projects. AusAID provided support to WHO's surveillance programme for noncommunicable diseases in the Pacific. Previous initiatives in the Region had included health promotion and a workshop at which regional representatives had shared views on including tobacco control in public health agendas.
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Member States should give tobacco control high priority. The Convention could give them leverage for promoting tobacco control. It should provide an impetus for the introduction of simple, cost-effective measures that could serve as a foundation for future activities. Dr SELUKA (Tuvalu) said his Government continued to support the Framework Convention. It hoped to sign it before the end of the year and to ratify it before June 2004. Subsequently, the country's tobacco policy would be defined, and the necessary laws to control tobacco consumption would be enacted. Dr W AQATAKIREWA (Fiji) recalled that his country had been part of the Global Youth Survey on Tobacco Use in 1999, which had shown that 13% of young people in Fiji were regular or established smokers. That alarming figure would be used as a benchmark in efforts to limit tobacco use. Deaths due to tobacco use constituted a significant part of mortality from noncommunicable diseases: currently, 300 deaths per year were estimated to be due to cigarette smoking. The Ministry of Health, therefore, fully supported the aims of the Convention. At the end of 2002, a WHO expert had given the Prime Minister and most members of his Cabinet, attended by the media, a briefing on tobacco use and its effects and had described the key objectives of the Convention. Immediately after adoption of the Convention in May 2003, the Cabinet had agreed to sign and subsequently ratify it. The signing would take place during a scheduled visit of the Prime Minister or the Minister for Foreign Affairs to Europe or the United States, to save costs - in any case well before the deadline of June 2004. Fiji was serious about limiting tobacco use. The Tobacco Act 1999 incorporated most of the objectives of the Convention. Furthermore, the tax on tobacco products had been increased still further in 200 I, and about 50% of the monies received from the tax was channelled to the Ministry of Health for use by the National Health Promotion Council for their programme activities. The Government had begun to review its tobacco legislation to bring it into line with the Convention. In response to his country's recognized weakness in enforcing its tobacco legislation, a new tobacco control enforcement unit was to be established within the Ministry of Health in 2004. The Government had made a budgetary commitment for that unit, the role of which was expected to complement that of the Health Promotion Unit and the National Health Promotion Council. Research and information were needed to ascertain the disease burden due to tobacco use in Fiji, in order to update information on the situation. The research, sanctioned by the National Health Research Council and with funding from the Ministry of Health, was expected to be completed in early 2004. Later in 2004, the Ministry would issue a paper on the economic outcomes of tobacco use and production, in view of the presence in the country of a cigarette company and tobacco farming.
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Mr KALPOKAS (Vanuatu) thanked WHO for its help in informing the country's population of the dangers of tobacco smoking. Like the representative of Tonga, his Government had been ready to sign the Convention in Geneva in May but had been thwarted. It was hoped that either the Prime Minister or the Minister for Foreign Affairs would sign it in New York City. Dr MATHESON (New Zealand) said that his Government had signed the Convention in Geneva in June 2003. His country was committed to the prevention and control of tobacco use and to completing the necessary actions that would allow it to ratify the treaty. He noted the difficulty that some of the small Pacific island countries were experiencing in signing and ratifYing the Convention and looked forward to working with WHO and donor agencies to assist them in that regard. The REGIONAL DIRECTOR, replying to comments, said that the representative of Tonga had raised an important issue. The ministers of virtually all the countries of the Region had been present in Geneva in May, but the Convention had not been ready for signing. He would discuss this with legal counsel. He noted the suggestions by the representatives of Japan and the United States of America regarding the first action proposed in Section 3 of Document WPRJRC54/1O. He agreed that the word "ensuring" could be replaced by "seeking". Countries with powerful tobacco industries would obviously find speedy ratification more difficult than others; however, in order that the spirit of the provision not be lost, perhaps the word "speedy" could be replaced by "as soon as feasible", or words to that effect. The representatives of Japan and the United States of America had also objected to the wording of paragraph 2, which was not consistent with discussions held at the Health Assembly. He agreed with them. In response, to the comment of the representatives of Japan and Palau that the decision to establish health foundations, as stated in the fifth proposed action, should be left to individual governments, he recalled that some had already done so. The phrase should be qualified by words such as "if possible" so as not to lose the value of the proposal. He assured the representative of Brunei Darussalam that the Secretariat would continue to keep Member States and the Regional Committee regularly informed of progress regarding the signature, ratification and implementation process. The REGIONAL ADVISER IN TOBACCO FREE INITIATNE said that Member States that could not travel to New York City to sign the Framework Convention before the deadline or did not have permanent missions to the United Nations could authorize the representative of another Member State to sign the Convention on their behalf. He presented a model document, in which the Head of
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State or the Minister for Foreign Affairs gave full powers for signature. In order for the authorization to be valid, it was essential that it read as follows:
"FULL POWERS "I, [name and title of the Head of State, Head of GovemlT'ent or Minister for Foreign Affairs of the authorizing State], "HEREBY AUTHORIZE [name and title of the representative of the other State] of [name of other State] to sign subject to ratification the Framework Convention on Tobacco Control, 2003 on behalf of the Government of [name of authorizing State]. "Done at [place] on [date]. "[Signature]"
WHO would facilitate discussions between States that wished to enter into such an arrangement. The CHAIRPERSON asked the rapporteurs to prepare an appropriate draft resolution for consideration by the Regional Committee. A minute of silence was observed to commemorate the victims of the terrorist attack in New York City on 11 September 2001.
The meeting rose at 17:35.