Both developed and developing countries vigorously questioned the WHO Secretariat during the WHO's Executive Board meeting on 26 May on its publications policy and called for further discussion on the matter. Among the questions raised at the WHO's 123rd Executive Board meeting were the need and rationale for the new publications policy, what the present policy is, and what will be the criteria for determining which issues have "policy implications for the Organisation" and which comprise "controversial health related issues" and thus have to go through additional clearance by the Director-General's Office. Other concerns raised included how the centralisation of the clearance process may remove the clearance authority of the WHO's regional directors, the broad definition of the term "publications" as it covers "materials that are issued by WHO to the public in whatever format and through whatever channel" including advocacy and training materials, and how the policy will affect timely support by WHO to countries. Concerns about "self-censorship" as a result of the policy and transparency in the process were also raised. A comment was also made that insisting on "evidence-based" publications was not always possible in the medical field. Many delegations called for the need to have more discussions and to assess the implications of the policy before it was implemented. However, it is not clear whether the policy will be subject to further discussion and what the Secretariat intends to do about the various concerns and clarifications raised, since the meeting "noted" the Secretariat's report, following what some persons who follow WHO processes closely now call a "trust-me" speech by the WHO Director-General Dr. Margaret Chan. Some delegations indicated that they intend to follow up on the matter, as they were dissatisfied with the explanations provided. They said that, in particular, the explanation did not specifically address what criteria will be used to determine publications containing issues that have "policy implications for the Organisation" and what constitutes "controversial health-related issues" (which require clearance from the Director-General's office) and why the differential treatment of publications was needed. The WHO's publications policy, contained in two Secretariat's reports, "WHO Publications" (EB 122/20 dated 6 December 2007) and "WHO publications policy: guidance on implementation and evaluation" (EB 123/7 dated 14 April 2008), has become the subject of controversy. Many believe that the policy is due to pressure from the US. "IP Watch" reported on 28 September 2006 that William Steiger, special assistant to the secretary for international affairs at the US Department of Health and Human Services, wrote to Acting WHO Director-General Anders Nordstrom asking Nordstrom to withdraw a WHO publication on IPRs and public health and calling for a "full review" of the WHO's publication policy at the Executive Board meeting in January 2007. [The publication, entitled "The use of flexibilities in TRIPS by developing countries" was one of the 22 studies commissioned by the WHO Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH), which was published by the WHO and South Centre in April 2006. The CIPIH secretariat had given the go-ahead to publish the study.] Prior to the 26 May Board meeting, serious concerns on the new policy were raised by many NGOs, as well as a senior member of the US Congress. Fifty-three NGOs in a letter dated 15 May wrote to the WHO Director-General urging her to reconsider the policy, adding that the policy, if implemented, will result in a tendency towards "self-censorship" by WHO and its staff. The letter also expressed concern that the policy will hamper timely advice and support by WHO headquarters and regional offices to member states over important issues such as the application of intellectual property rights and the use of TRIPS flexibilities, other trade and health matters, reproductive health care and other issues. The Chair of the US House of Representatives' Oversight and Government Reform Committee, Henry Waxman, sent a letter dated 19 May 2008 to Dr Chan, urging the WHO "to minimise the possibility of inappropriate political interference with the publication process", and expressing hope that WHO's new publication policy will be "designed in a manner that is not politicised and continues to prioritise scientific and intellectual freedom." The new publications policy requires publications "that describe the workings of a particular government or national health service or that have policy implications for the Organisation or address controversial health-related issues" to go through "additional clearance by the Director-General's Office" while the final text of all other publications can be cleared by the "relevant Assistant Director-General or Regional Director before publication." (paragraph 13 of EB 122/20). This requirement is also applicable to "any article, book chapter or invited commentary relating to WHO's work that is to be submitted by a staff member for external publication" (paragraph 9 of EB 122/20). The policy defines "publication" in footnote 2 of EB 122/20 as "information products, i.e. materials that are issued by WHO to the public in whatever format and through whatever channel. It excludes materials internal to WHO." Paragraph 3 of EB document 123/7 further defines information products as "written or illustrated works that the Organisation makes publicly accessible. Examples include documents on the website and journal, articles, guidelines, reports, training materials and advocacy materials in any format (printed, web, CD-ROM/DVD or audiovisual), whether sold or distributed free of charge". The policy documents also mention the aims of having evidence-based publications, reducing costs, publishing fewer titles and reducing hard copies while disseminating WHO's publications more through electronic means. A "policy coordination group" (which will report to the DG) is to be set up to oversee implementation of the policy. There will be forms for executive and production clearance, which will be incorporated into the approval process management tool. Those responsible for clearing a product must check for technical accuracy and conformity with the Organisation's policies, and they must recognize when to refer the products to the DG's office for additional clearance where it concerns controversial health-related issues and policy implications for the Organisation. According to the new policy, there will be categories of products wherein a specific category will trigger the relevant pathway for content development, production, dissemination and the appropriate criteria for clearance. For example, if a product concerns guidelines, then it must be developed according to the procedures put in place in the Guidelines Review Committee, whereas advocacy materials must be created in accordance with standards set by the Department of Communications in HQ. A master list of planned publications will also be prepared for executive approval at the beginning of each biennium (EB 122/20). According to the Secretariat's report (EB 123/7), the policy will be regularly evaluated. A full report on the implementation of the policy will be submitted to the Executive Board at its 129th session in 2011. Indonesia, on behalf of members from the South East Asian Regional Office (SEARO), expressed concern that the policy defines "publications" very broadly, adding that it takes away the authority of clearance from the Regional Director and centralises it to the DG on issues that are controversial and that have policy implications. Indonesia sought clarification as to what issues were considered to be "controversial health related issues" and to whom are the issues are controversial? Indonesia added that the policy would result in difficulties in providing timely information in case there are new controversial issues emerging. It sought clarification as to whether the master list prepared at the beginning of each biennium would hamper the ability to deal with new issues. Indonesia urged the matter to be discussed thoroughly and for an assessment of the implications before the policy is implemented. Brazil said that it has doubts on the need for a new publications policy as it was not yet recognised that the present policy is unsuccessful. It had concerns with regards to the criteria that will be applied to determine which topics have policy implications and concern controversial health related issues. It did not see any reason to implement this policy, which may result in self-censorship. It believed that "controversial health-related issues" should be debated openly, as one of the objectives of the WHO is to provide information without any interference or political pressure from member states. Brazil added that prior to implementing the policy and given its importance, the policy should be subjected to discussion, which should be informed as to the necessity of the policy, how to resolve the issue of what is controversial, how other international organisations deal with this issue, and the difference between the present and the proposed policy. Djibouti, on behalf of the Eastern Mediterranean Regional Office, said that the WHO's greater stress on electronic publication must not run counter to access to information, as access to electronic information is limited in developing countries. It added that assessing the impact of information products produced is not an easy task as it requires broad research to identify whether WHO's publication has been used for the development of a policy. Slovenia, speaking on behalf of the EU, said that implementation and evaluation of WHO's policy should be in line with WHO's normative mandate, focused on evidence-based documents. It also called for a wide accessibility to WHO's documents. Slovenia stressed the importance of transparent and unbiased publications. It also sought explanation as to what is the criterion for approval of publications, stressing the need to avoid censorship with respect to what may be considered as controversial issues. Sri Lanka, aligning itself with Indonesia's statement, expressed hope that regional offices will retain a certain degree of independence in order to respond to countries' needs. It added that regional offices need to have adequate representation in the policy coordination committee. It wanted further discussion before the policy is implemented. Afghanistan emphasized the need for scientific documents to be published without censorship and for member states to allocate resources for translating the publications into local languages. Malawi said that while it appreciated "cost-effectiveness", this should not be at the expense of access and should take into account capacity constraints. It proposed that further work on the policy be considered. Oman also expressed a need to study the situation before taking a decision and for the information to be disseminated in other languages besides the official languages. South Africa requested more information as to what were the Terms of Reference of the policy coordination group mentioned in document EB 123/7, how it would function and its relationship between the production and clearance mechanisms. Zimbabwe stressed the need for "editorial freedom" and transparency and said that cost-effectiveness should not hamper access and dissemination. South Africa and Zimbabwe also supported the statements made by Malawi and Brazil. The United States said that the publications policy must be widely understood and implemented nationally, regionally and at the headquarters level. It expected the DG to monitor implementation of the policy, adding that the DG should establish an Executive Secretariat to look through the publications. It added that disclaimers do not obviate the need for the publications policy. Kenya said that it was necessary for the policy to ensure the independence of the DG, adding that in medicines there may not be evidence on everything and thus there was a need to assess using "evidence" as a criteria. The policy should be flexible in responding to the challenges of global health. Canada, associating itself with the statement by the EU, stressed the need to balance between excessive centralization and bureaucratization with flexibility. It added that "transparency" was a critical element. Responding to the concerns and questions raised, Dr. Tim Evans, WHO's Assistant Director-General for Information, Evidence and Research said that the process approval was intended to develop greater awareness, responsibility and accountability of all those involved in the process, make the approval process faster, avoid duplication and produce materials in line of the Organisation's strategic objectives and priorities. He added that the master list will periodically be updated. With regard to executive clearance, he said this is "not a new clearance mechanism". He added that access to publications will not be "compromised". WHO's legal counsel Gian Luca Burci said that there are some issues with regard to correctness of terminology, expressions and references to political and legal status of states and taking care of the accuracy of these descriptions falls under the corporate responsibility of senior management. He added that there is already a review mechanism but the policy is important to strengthen the programmes. Dr. Chan said that this is not a "new policy", adding that WHO has a policy that moved from centralisation to decentralisation but it is important to review the policy, thus the issuing of the new documents. She said that she guarded her "editorial independency with jealousy" and there is "no question of censorship", adding that they will base documents on best evidence possible, consistent with the WHO's core functions. She added that the publications have to be "peer reviewed" but this also has problems, i.e. it can be "incestous" depending who is on the peer review committee. She said that there is no question of favouring vested interests or staff members, and documents were produced to serve the interests of countries. She added that she had to do a balancing act and walk a fine line. On the clearance process she said that it is a means to demonstrate accountability of senior management, and regional directors should have prerogative to decide what documents are important without undue cumbersome process. She added that in her short stint in WHO, there have been several embarrassments with regard to names, maps and boundaries mentioned in publications, and some publications have to come back to the HQ for her review, so that she does not have "political difficulties." After the Board meeting, Sarah Rimmington of Essential Information (one of the NGOs following the issue) said that several countries, including Brazil, Indonesia on behalf of South-East Asia and Slovenia on behalf of the EU, had raised concerns that the WHO publications policy would lead to censorship of undefined "controversial topics". "Several countries also asked that the policy be placed before all member states of the WHO for approval before implementation. Director-General Dr. Margaret Chan and the WHO Secretariat responded by asserting that they would jealously guard WHO's independence. "The issue at stake, however, is not the personal integrity of anyone within WHO. What matters is whether the agency will become overly centralised and bureaucratised and, most importantly, how and whether WHO will approach 'controversial' topics. "Centralised review will give corporate and ideological interests an opportunity to protest against WHO publications, with profit or ideological motivations dressed up in the garb of scientific argument. Moreover, the requirement that undefined 'controversial' topics require centralised review inevitably will mean that country officers and others will steer away from such issues, no matter their importance." Rimmington said that it is worth reflecting on important public health issues that might reasonably be considered controversial. A partial list would include: alcohol, diet and nutrition, sugar consumption, tobacco, chemical exposure, climate change, family planning and reproductive health issues (for example, birth control, abortion and sex education), health interventions targeting sex workers, intellectual property and medical R&D, traditional medicine, the prices and advertising/marketing of medical products, rational use of medicines, malaria control, treatment of malaria, TB, HIV/AIDS and mental illness, car and traffic safety, disaster relief, air pollution, arsenic, bio-terrorism, baby food marketing, clinical trial conduct, gender-based violence, genetically modified food, pesticide use, health insurance systems, healthcare user fees, wealth inequality and health, and medical waste. She commented: "Just to see such a list is to understand the need for a re-think. Hopefully, Member States and the Secretariat will agree on such a review - and make appropriate revisions - in the near term."