Info Service on Health Issues (Jan15/02)
WHO: Importance of health system and primacy of WHO stressed
Geneva, 26 January (K M Gopakumar and Chee Yoke Ling) – Governments at the Special Session of the World Health Organization’s Executive Board on Ebola stressed the importance of resilient health systems and the primacy of the organization in responding to disease outbreaks and other health emergencies.
The special session that took placeon 25 January at the WHO headquarters in Geneva adopted a resolution co-sponsored by more than 59 Member States, which was initially proposed by the United States of America and South Africa. This is titled: “Ebola: Ending the current outbreak, strengthening global preparedness and ensuring WHO capacity to prepare for and respond to future large-scale outbreaks and emergencies with health consequences.”
(For details of the resolution please see: http://apps.who.int/gb/ebwha/pdf_files/EBSS3/EBSS3_CONF1-en.pdf)
The resolution incorporates most of the proposals in a WHO Secretariat’s paper and also contains additional paragraphs to call on the Member States to take measures at the national and international level to respond to Ebola and other future health emergencies.
(Details of the Secretariat’s paper are in “Ensuring WHO’s capacity to prepare for and respond to future large -scale and sustained outbreaks and emergencies (EBSS/3/3)” available at: http://apps.who.int/gb/ebwha/pdf_files/EBSS3/EBSS3_3-en.pdf)
The special session on Ebola was convened with following objectives:
This was against the background of criticism on WHO’s initial weak response to the Ebola outbreak.The crisis also exposed the Organization’s structural constraints such as the budgetary constraints due to heavy dependence on voluntary funds from Member States instead of assessed contributions, which virtually eliminates the freedom to divert existing resources to respond to outbreak of diseases or other health emergencies.
Further, it also exposed the unidirectional approach of WHO to focus on norms and technical standards without adequate funding for emergency operations and health system development. According to the Peoples’ Health Movement there was a 50% budget cut of WHO’s outbreak and crisis response from USD 469 million in 2012-13 to USD 228 million for 2014-15 (http://www.twn.my/title2/resurgence/2014/290-291/cover01.htm).
Some of the critics even suggested the creation of a new United Nations body to respond to emergency situations. The World Bank subsequently attempted to appropriate the ideas of the creation of an emergency fund and a global health work force.
WHO Member States stressed the need for a resilient health system approach for effective emergency intervention in case of diseases outbreak or other health emergencies. They also stressed the primacy of WHO in dealing with diseases and health emergencies.
Thus the Member States rejected the emergency preparedness strategies which focus only on regulatory aspects to contain diseases outbreaks and health emergencies without investing in building health systems such as infrastructure, access to health products, health workforce etc.
The three worse affected countries (Guinea, Liberia and Sierra Leone) during the current Ebola crisis have a fragile health system due to various reasons including armed conflicts and structural adjustment programmes.
Apart from its concrete provisions, the newly adopted resolution is widely observed as a political signal to ensure the primacy of WHO in health issues. WHO has come under attack for its slow response to the Ebola crisis. Critics pointed out that even though the confirmation of the Ebola outbreak was made in March 2014, WHO started acting in a decisive way only in August 2014 by declaring it as a “Public Health Emergency of International Concern”. Some critics also point out that there was no discussion, not even a mention, of Ebola during the 66th World Health Assembly in May 2014.
The resolution reaffirms WHO’s mandate of coordination of international health. It contains 18 preambular paragraphs and 57 operational paragraphs (OP). The OPs deal with the following clusters of issues:
OP3 states: “WHO’s role as the lead agency of the global health cluster, including its role to ensure the timely declaration of appropriate response levels to humanitarian emergencies with health consequences and calls on Member States and relevant actors in humanitarian situations with health consequences to support WHO in fulfilling its role as lead agency of the Global Health Cluster within its mandate”.
The resolution provides extensive powers to the WHO Director-General (DG) to take measures to respond in an emergency situation. It also provides an in-principle approval to create a fund for emergency as well as the creation of a global health emergency workforce.
Further, it also requests the DG to establish a panel of outside independent experts, for an interim assessment “on all aspects of WHO response, from the onset of the current EVD (Ebola virus disease) outbreak, including within UNMEER (UN Mission for Ebola Emergency Response), in implementing the Emergency Response Framework, and in coordination, including resource mobilization, and functioning at the three levels of the Organization, to be presented to the Sixty-eighth World Health Assembly”. (The 68th World Health Assembly will be in 2015.)
A developing country diplomat told Third World Network (TWN) that the resolution also includes the postition of developing countries that the preparedness to meet health emergency should go beyond the International Health Regulations and should also address the health system as a whole.
Another important message in the resolution is in OP5 on the appointment of a special envoy on Ebola. OP5 states: “Invites the Director-General to consider assigning, immediately following the Special Session, for the duration of the outbreak, a Special Representative with the appropriate grade and authority to be responsible for all aspects of coordination at all three levels of the Organization and response for the current EVD outbreak”.
An observer told TWN that OP5 is a message for fixing the accountability of leadership of the health security division, which has allegedly failed to take note of the seriousness of the Ebola crisis.
WTO TRIPS Agreement flexibilities reaffirmed
During the weekend’s informal negotiations, a contentious issue was the reference to intellectual property rights and the flexibilities under international law in the preamble of the resolution.
The following were the 2 options in brackets indicating lack of consensus.
Draft preambular paragraph 13 (PP13) that had the support of developing countries read as follows:
[PP13 Reaffirming the right to use, to the fullest extent, the provisions contained in the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), the Doha Declaration on the TRIPS Agreement and Public Health, the decision of the General Council of the World Trade Organization of 30 August 2003 on the implementation of paragraph 6 of the DOHA Declaration on the TRIPS Agreement and Public Health, and when formal acceptance procedures are completed, the amendment to provide flexibility for the protection of public health]
To dilute PP13, the developed countries had proposed PP14 which read:
[PP14 Recognizing that the protection of intellectual property can be important in the development of new medicines]
The compromise that was adopted is as follows:
“Acknowledging that there is a linkage between addressing Ebola, including the control and elimination of neglected tropical diseases, and the global strategy and plan of action on public health, innovation and intellectual property and a pooled fund of global health research and development.”
(The WHO global strategy and plan of action on public health, innovation and intellectual property adopted by Member States in 2008 after intense negotiations explicitly reaffirms the TRIPS flexibilities to ensure public health.)
Below are the highlights of the operational paragraphs of the resolution.
Leadership and coordination
The resolution reflects the statements of Member States on the primacy of WHO and “recalls and reaffirms the constitutional mandate given to WHO to act, inter alia, as the directing and coordinating authority on international health work, and to furnish, in emergencies” (OP2). It further reaffirms WHO’s role as the lead agency of the global health cluster, including its role to ensure the timely declaration of appropriate response levels to humanitarian emergencies with health consequences and calls on Member States and relevant actors in humanitarian situations with health consequences to support WHO in fulfilling its role as lead agency of the Global Health Cluster within its mandate” (OP3).
Further, the resolution provides the mandate to the WHO DG to reallocate existing resources to enable an efficient and accelerated response to end the current Ebola epidemic (OP6).
The resolution in a way moved away from the International Health Regulations-based approach and recognised the need for maintaining health system. The resolution calls on Member States to further strengthen coordination on personnel, logistics, supplies, equipment and related infrastructure, with a view to accelerating the effective EVD response and converting it to longer-term health system strengthening, particularly in the most affected countries, building on the results of the WHO conference held in Geneva on 10-11 December 2014 on “Building resilient health systems in Ebola affected countries ”and the implementation of the International Health Regulations (IHR), and in this context requests the Director-General to give technical advice to the most affected countries for developing their country plans, to be discussed in an upcoming conference” (OP11).
It also encourages Member States to consider promoting health system strengthening and IHR core capacities for inclusion in the implementation of the health goal of the post-2015 Development Agenda”.
(The post-2015 Development Agenda negotiations will replace the Millennium Development Goals and incorporate the Sustainable Development Goals adopted in 2014. The negotiations are underway at the UN headquarters in New York, culminating in a Development Summit in September 2015.)
The resolution also calls on Member States to strengthen capacities to recruit, develop, train and retain health workforces in developing countries as well as to strengthen support for health care workers to enable local and regional surge capacity.
The resolution while calling on the importance of full implementation of IHR also recognises that that the “global preparedness needs continuous commitment to research and development, reliance on a multisectoral approach, strengthening health systems, economic development in developing countries and improved health status” (OP31).
Therapeutic Drugs and Vaccines
The resolution recognises the “… the good progress made to date, under the leadership of the WHO in the process of developing Ebola vaccines and requests the Director General to ensure the sustainability of the working groups on therapeutic drugs and vaccine clinical trial designs while they are needed, to ensure continued progress in the development of quality, safe, effective and affordable vaccines and treatments, while emphasizing the importance of completing the WHO work on emergency regulatory mechanisms and procedures ensuring patient safety, omitting results of this work to the most affected countries in West Africa as a first priority, with an accompanying distribution and financing plan, to be communicated to Member States as soon as it is ready” (OP33).
Further it request the WHO DG “to evaluate the current status of the epidemic and to disseminate information as to the most critical research studies to complete; and requests the Director-General in consultation with technical experts and Member States regulatory agencies to develop guidance on the value and limitations of the data obtained from the clinical trials, giving the particular attention to ethics, quality, efficacy and safety” (OP34).
Research and Development
The resolution “Recognizes the urgent need to encourage and maximize efforts on scientific, epidemiological and biological research, including the sharing of samples and epidemiological data in accordance with national or regional legislation on Ebola, health technologies and promote cooperation in this field between countries, as a contribution to international efforts directed towards tackling the epidemic and for the aim of consolidating the scientific, medical and health capacities of the most affected countries, and the need for the global community to continue work on research and development, including for emerging and neglected tropical diseases” (OP43).
It also “recognizes WHO’s leadership role in supporting a prioritized research agenda for Ebola and calls on Member States and relevant actors to ensure that resources and efforts take into account and support, as appropriate, the prioritized research agenda” (OP 44).
It “recognizes further the need to incorporate lessons learned from the EVD outbreak into the evaluation of the global strategy and plan of action on public health, innovation and intellectual property and considers, as appropriate, the linkage to pooled funds for global health research and development to facilitate the development of quality, safe, effective, affordable health technologies related to the needs of affected countries and calls on Member States for securing sustainable financing for health research and development on emerging and neglected tropical diseases, including Ebola, and enhancing access to heal the products and medical devices to address the health needs of developing countries” (OP45).
It also “calls on Member States to continue to collaborate as appropriate, on models and approaches that support the delinkage of the cost of new research and development from the prices of medicines, vaccines, and other diagnostics for Ebola and other emerging and neglected tropical diseases, so as to ensure their sustained accessibility, affordability, availability, and access to treatment for all those in need” (OP46).
WHO Structure and Human Resources
The resolution provides wide powers to the DG to respond to the disease outbreaks and health emergencies and reaffirms that all relevant WHO authorities with respect to the administration, deployment and other human resource matters concerning preparedness, surveillance and response rest with the Director-General for outbreaks and emergencies with health consequences, and shall be exercised in a manner consistent with the principles and objectives of the WHO and the Emergency Response Framework” (OP37).
It underlines “it is essential in respect of health emergency response that the organization be capable of delivering on the complex and varying scale of health emergency response, emphasizing n particular systems for human resources, resource mobilization and financing, planning and information management, and ensuring unambiguous leadership and a coherent approach towards outbreak and health emergency operations for all levels of the Organization” (OP38).
Further it request the DG “ to take to take immediately necessary steps to draw up her plan in consultation with Member States through regular informal consultations, and with the Steering Committee of the Global Outbreak Alert and Response Network, with the following three elements, each of which are composed of comprehensive emergency response teams that can be promptly and efficiently deployed, for service in countries that request or accept such assistance, for adequate periods of time, and with adequate resources, and to report to the 68th World Health Assembly for its consider action and decision” (OP42).
The resolution Requests the Director General to take all necessary steps to ensure that, in the case of outbreaks and emergencies with health consequences, funding can be speedily reallocated and disbursed to areas of most need, without compromising the Organization’s programme priorities (OP47).
Further, it requests the DG to provide options on the size, scope, sustainability, operations and sources of financing for such a fund, and accountability mechanisms; including on possible internal sources of funding from within WHO’s existing programme budget, taking into account other relevant financing mechanisms and emergency funds already in operation or being considered, at regional and global level, taking into account the interim assessment requested in paragraph 53 and to report, through the Programme, Budget and Administration Committee, such options to the 68th World Health Assembly for its consideration and adoption (OP48).
OP52 Requests “ the Director - General to commission an interim assessment, by a panel of outside independent experts, on all aspects of WHO response, from the onset of the current EVD outbreak, including within UNMEER, in implementing the Emergency Response Framework, and in coordination, including resource mobilization, and functioning at the three levels of the Organization, to be presented to the Sixty-eighth World Health Assembly”.
The resolution requests “the Director-General to prepare options for establishing an IHR Review Committee panel of experts pursuant to past practice to conduct an assessment of the overall prevention, preparedness and response to the Ebola outbreak and the effectiveness of the IHR in facilitating that response, including what was implemented and what was not from the previous IHR review committee in 2011, and consideration given to steps that could be taken to improve the functioning, transparency, and efficiency of WHO’s response under the IHR in future outbreaks, in all countries, aiming at strengthening health systems” (OP53).
The resolution also invites the “Director-General to consider establishment of an ad hoc advisory group under the auspices of the Executive Board, composed of operations experts from relevant stakeholders, including affected countries, to provide advice on administrative and logistical support to the Director-General as needed in the case of future outbreaks or emergencies with health consequences (OP54).+