Reform and WHO: The continuing saga of FENSA

A year after WHO launched its 'reform' programme in 2011, the WHO secretariat began working on a comprehensive policy to regulate engagements between WHO and non-state actors or NSAs (academics, NGOs, philanthropies and private sector entities etc). The framework document that emerged has been dubbed FENSA (Framework of Engagement with Non-State Actors). KM Gopakumar charts the continuing debate over this document.

THE recent 68th session of the World Health Assembly (WHA), the top decision-making body of the World Health Organisation (WHO), spent considerable time in negotiations aimed at reaching a consensus on a Framework of Engagement with Non-State Actors (FENSA). This framework is to set norms for the regulation of WHO's engagement with non-state actors (NSAs), viz., non-governmental organisations (NGOs), the private sector, philanthropic foundations and academic institutions.

The origin of FENSA goes back to the WHO reform programme, which was launched in 2011 at the 64th WHA. Under the reform programme, the WHO secretariat had proposed 'a multi-stakeholder forum for global health. The purpose of such a forum will be to increase engagement (particularly of those whose voices are less heard in current settings) and to increase trust'. Participation in the forum would be open to WHO member states, civil society, the private sector, academia and other international organisations. The forum was intended to shape decisions and agendas. 

However, the proposal for a multi-stakeholder forum was eventually dropped and in its place came proposals for FENSA. In January 2012 the WHO Executive Board agreed on a Chair's summary which stated: 'Further discussion will be required on WHO's engagement with other stakeholders, including different categories of nongovernmental organisations and industry, and the proposals to review and update principles governing WHO relations with nongovernmental organisations, and to develop comprehensive policy frameworks to guide interaction with the private-for-profit sector, as well as not-for-profit philanthropic organisations.'

Since then the WHO secretariat has been working on developing a comprehensive policy to regulate engagements between WHO and NSAs. However, the secretariat's attempts to stick to the status quo and reluctance to address critical issues like conflicts of interest paved the way for a member-state-led negotiation process through an open-ended intergovernmental meeting (OEIGM) on 30 March-1 April 2015. The OEIGM was followed by a couple of rounds of informal consultations prior to the 68th WHA. 

At the WHA itself (18-26 May), formal and informal negotiations on FENSA took place over seven days. As these negotiations could not resolve differences among WHO member states (MS), the WHA decided, through a resolution, to continue the talks.

The WHA resolution welcomed the consensus reflected in many parts of the FENSA text, including in its introduction, rationale, principles, benefits of engagement, risks of engagement, non-state actors, and types of interaction. The resolution requested the WHO Director-General (DG) 'to convene as soon as possible, and no later than 15 October, an open-ended intergovernmental meeting on FENSA to finalise the draft framework of engagements with non-State actors on the basis of progress made' during the 68th WHA.

This OEIGM took place on 8-10 July. Even though the meeting achieved consensus on certain aspects of FENSA, such as FENSA's relations with existing WHO policies and the provisions related to official relations with NGOs, business associations and philanthropic foundations, there was no agreement on many critical issues like conflicts of interest or secondments from NSAs to WHO.  Therefore it was decided to continue with informal negotiations until resumption of the OEIGM in December.

As mentioned above, FENSA is meant to regulate WHO's engagement with NGOs, the private sector, philanthropic foundations and academic institutions. Currently, two principal documents regulate WHO's relations with NGOs and the private sector, viz., the Principles Governing Relations Between the World Health Organisation and Nongovernmental Organisations (NGO Guidelines), and the Guidelines on Interaction with Commercial Enterprises to Achieve Health Outcomes (Private Sector Guidelines).  While the first document was adopted by the WHA in 1988, the second was only noted by the Executive Board. Apart from these documents, WHO's partnerships are regulated through the WHO Partnership Policy adopted at the 63rd WHA. None of these are negotiated documents, however. Further, they provide a great degree of discretion to the WHO secretariat for engaging with NSAs in a non-transparent manner without effective oversight by MS.

The NGO Guidelines recognise and regulate only one form of engagement, i.e., official relations. All other types of engagement are seen as unofficial and left unregulated. Currently, there are 202 NGOs in official relations with WHO. However, many of these NGOs are not 'free from concerns which are primarily of a commercial or profit-making nature', as required under the NGO Guidelines. Many of these entities are international business associations, have private entities in their governing bodies or receive financial support from the private sector. For example, at the 68th WHA the delegation of the Global Health Council, which is in official relations with WHO, consisted of many private sector representatives.

The Private Sector Guidelines provide detailed guidelines on facilitating engagement with WHO. Currently, WHO engages with 44 private sector entities. However, there is no information with regard to the nature of the private sector engagements. The Private Sector Guidelines also lack provisions on oversight by member states and safeguards against conflicts of interest.

The FENSA negotiations to date clearly bring out the divergent positions of MS on the issue. While there is no opposition in principle among MS with regard to WHO's engagement with NSAs, the majority, mainly developing countries, are worried about the implications of greater engagement especially with the private sector and with NGOs, philanthropic foundations and academic institutions controlled by the private sector. The fear is that such engagement could compromise the credibility, integrity and independence of WHO and prevent it from carrying out its constitutional mandate, i.e., the attainment by all peoples of the highest possible level of health. Therefore, developing countries have taken a cautious approach and pushed for robust firewalls and safeguards to protect WHO's credibility.

On the other hand, many developed countries, in particular France, the UK and the US, have pressed for greater engagement with NSAs, especially the private sector, and also sought to remove safeguards aimed at preventing the undue influence of the private sector and entities controlled by it. During the 136th session of the Executive Board in January, both France and the US had expressed their willingness to adopt the secretariat's version of the FENSA draft.

In short, the secretariat and developed-country MS often either seek to maintain the status quo or push for greater engagement, and oppose robust safeguards and firewalls surrounding such engagement. Facilitating greater engagement with NSAs without firewalls and safeguards risks enabling corporate capture of WHO. From this perspective, the FENSA negotiations present an important opportunity to reclaim international health governance from the undue influence of the private sector and corporate philanthropic foundations and NGOs controlled by it. The upcoming negotiations would thus determine the future direction of WHO.

The conditions in which NSAs can exert undue influence have in turn come about through the financial vulnerability of WHO. The following section explains this in detail.

Sources of funding

Some 80% of WHO's budget is financed by voluntary contributions. For instance, out of the approved 2016-17 budget of $4.385 billion, only $929 million comes from mandatory assessed contributions from member states. The remaining $3.456 billion is financed through voluntary contributions.

A substantial portion of voluntary contributions is in the form of specified voluntary contributions. Unlike assessed contributions and core voluntary contributions, specified voluntary contributions give the WHO secretariat no flexibility to use the financial resources to meet the prioritised programme set by member states. Instead, as their name suggests, these contributions are meant for specified purposes decided between the donor and the secretariat; member states as a whole have little say in this regard. In 2014 WHO received just over $2 billion in voluntary contributions, out of which almost $1.9 billion was made up of specified voluntary contributions.

WHO mainly uses assessed contributions to pay salaries and other establishment-related expenses. The organisation's programmes are to a great extent financed through voluntary contributions. Specified voluntary contributions give the donor the freedom to pick and choose programmes. As a result, WHO's programme implementation is at the mercy of donors and driven by the donors rather than by public health needs.

NSAs, especially philanthropic foundations like the Bill and Melinda Gates Foundation, prefer specified voluntary contributions to core voluntary contributions.  For instance, in 2014, the Gates Foundation's entire contribution of some $256 million to WHO was comprised of specified contributions. Over the last few years the Foundation has become the largest donor of voluntary contributions to WHO. In fact, in 2013 it was the single largest donor, with its contribution surpassing the US' total assessed and voluntary contributions.

The financial contribution of NSAs to WHO is therefore far from negligible. Just 20 contributors - 11 of which are NSAs - account for 80% of all voluntary contributions. In 2012 WHO received contributions totalling $417 million from 212 NSAs, which represented 25.5% of total income. Of this amount, $79 million came from NGOs, $25 million from the private sector, $310 million from philanthropic foundations, and $4 million from academia. (The contributions of NGOs also include donations from international business associations.) 

Even though all these contributions are now documented in WHO's budget web portal, the agreements between the donors and WHO are not in the public domain. There is no information on the exact purpose or use of these financial resources.

A recent proposal by the WHO Director-General for a 5% increase in assessed contributions was dropped due to opposition from developed countries. Therefore, the only option before the WHO secretariat is to enhance its dependence on voluntary contributions. According to a secretariat document, the strategy to overcome the dependence on a few donors entails 'broadening and deepening the existing contributor base, with an initial focus on member states'.

Funding is the traditional means deployed by the private sector to influence an international organisation's activities. In WHO there is no regulation currently in force to prevent donor-driven programme implementation.

The WHO reform process has imposed the restriction that a programme cannot accept resources beyond the approved budget, but this restriction does not provide any safeguard against donor-driven programme implementation. Another restriction is that 'funds may not be sought or accepted from enterprises that have a direct commercial interest in the outcome of the project toward which they would be contributing, unless approved in conformity with the provisions on clinical trials or product development'. Further, 'caution should be exercised in accepting financing from commercial enterprises that have even an indirect interest in the outcome of the project (i.e. the activity is related to the enterprise's field of interest, without there being a conflict as referred to above)'. Notwithstanding this, the lack of effective restrictions on NSAs' specified contributions makes WHO vulnerable to being held hostage to corporate agendas. The FENSA proposal to put a ceiling on voluntary contributions from the private sector is still the subject of disagreement among member states. The same can be said of another proposal to ensure transparency with regard to the purpose of funding.

Concerns over private sector engagement

The concern about WHO's engagement with the private sector and entities controlled by the private sector (hereafter private sector) stems from the apprehension that the private sector would exert undue influence on WHO and also use the engagement to whitewash unethical business practices. Engagement with WHO can be exploited to achieve commercial and competitive advantages and to prevent public health measures which affect the interests of the private sector. Such engagement bears the danger of influencing norms and standard-setting processes in order to create barriers to entry into a particular market and protect commercial interests.

Over the last few years there have been many instances which lend credence to such fears. For example, in 2006, the WHO secretariat, without obtaining the consent of member states, set up a public-private partnership (PPP) called the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) to promote enforcement of intellectual property rights and target generic medicines. It was only the intervention of many developing countries like Brazil, Egypt and India which eventually forced WHO to informally disassociate itself from IMPACT.

Similarly WHO's association with the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has resulted in rigging of norms and standards to favour the big transnational pharmaceutical corporations. According to a paper by Ayelet Berman, a researcher who has worked extensively on ICH issues, the ICH standards 'have been to the detriment of entities, companies and countries that lack sufficient resources, and have advantaged resourceful companies and countries. In practice, this means that they have benefited larger, privately held, export-oriented companies, and have been to the detriment of smaller, locally oriented, or governmentally funded companies/entities'.1

Berman further states that 'in certain contexts, they have promoted the commercial interests of the multinational pharmaceutical industry over the interests of patients in receiving much needed medicines or treatments'.According to her, 'the [ICH] members are the main beneficiaries, non-members have been subject to distributional effects that are to their detriment'.2

It has now emerged that many members of WHO's Expert Committee on Biological Standardisation who drew up the WHO guidelines on biosimilars - drugs which fall under an important new category called biotherapeutic medicines - were part of an ICH expert panel on biosimilars and imported ICH norms into WHO. The WHO guidelines have come under criticism for creating entry barriers in the market for biosimilars. A resolution adopted by the 67th WHA in 2014 requested the WHO Director-General 'to convene the WHO Expert Committee on Biological Standardisation to update the 2009 guidelines, taking into account the technological advances for the characterisation of biotherapeutic products and considering national regulatory needs and capacities'.

In 2010 a report of the WHO Expert Working Group on Research and Development and Coordination was leaked to the pharmaceutical industry. One of the members of the Expert Working Group openly asked the WHO Executive Board members to reject the report, citing lack of transparency in the process.3 This has led to the setting up of a Consultative Expert Working Group.

Another instance of corporate links relates to the work of WHO's Strategic Advisory Group of Experts (SAGE) on Immunisation. SAGE recommends the types and quantities of vaccines member countries should purchase for pandemic contingencies. According to a 2009 report in Danish daily Information, based on documents acquired through the Danish Freedom of Information Act, SAGE member Professor Juhani Eskola's Finnish institute, THL, received almost _6.3 million from pharmaceutical giant GlaxoSmithKline (GSK) for vaccine research in 2009. GSK produces the H1N1 vaccine Pandemrix, which the Finnish government - following recommendations from THL and WHO - purchased for a national pandemic reserve stockpile.4

The above instances clearly show the influence of industry on WHO. There is growing worry that in the absence of robust safeguards against undue corporate influence, the credibility and independence of WHO would be at risk.

The draft FENSA text does explicitly exclude WHO engagement with the tobacco and arms industries. Nonetheless, there are also other industries, such as the food and beverage and alcohol industries, which indulge in activities that may have negative implications on public health. Therefore, paragraph 44bis of the FENSA draft is concerned with extra caution to be exercised with regard to WHO's engagement with certain industries other than the tobacco and arms industries, such as food and beverage, alcohol and breastmilk substitutes. However, the developed countries are against explicitly naming these industries and prefer to have a general clause on extra caution without mentioning any particular industry.

Collaborations and partnerships

The vulnerability of WHO is further increased by collaborations and partnerships with NSAs. Recently adopted major strategies of WHO envisage partnerships as a mode of implementation. These include the Global Strategy for the Prevention and Control of Noncommunicable Diseases, Global Plan of Action on Antimicrobial Resistance, Neglected Tropical Disease (NTD) Initiative and Global Vaccine Action Plan. The list of partnerships and collaborations provided on WHO's NSA webpage shows more than 83 such arrangements. However, certain collaborations or arrangements like ICH have not been listed.

There is no transparency with regard to WHO's external partnerships and collaborations.  The current partnership policy does not give any role to member states to examine numerous external partnerships WHO has entered into. According to WHO policy, the DG is to consult with the Executive Board before establishing a hosted partnership. However, there is no such condition imposed on external partnerships and collaborations. Often this provides a good cover for the private sector to exert undue influence.

For instance, while drug donations by industry for WHO's NTD initiative would help to address the NTD problem in the short run, this approach will not yield results in the long term. It does, however, serve the long-term interests of big pharmaceutical corporations in preventing implementation of new, non-patent-based research and development (R&D) models which could come up with innovative and accessible health products to combat NTDs in developing countries.

The last OEIGM in July has at least brought a degree of clarity on the relationship between FENSA and the WHO Partnership Policy. Member states reached agreement on paragraph 48 in the draft FENSA text, which states that 'The implementation of the policies listed below [including on partnerships] as they relate to WHO's engagement with non-State actors will be coordinated and aligned with the framework of engagement with non-State actors. In the event that a conflict is identified, it will be brought to the attention of the Executive Board through the [Programme, Budget and Administration Committee]'.

Further, paragraphs 48(a)(i) and (ii) state: '(i) Hosted partnerships derive their legal personality from WHO and are subject to the Organisation's rules and regulations. Therefore the framework of engagement with non-State actors applies to their engagement with non-State actors. They have a formal governance structure, separate from that of the WHO governing bodies, in which decisions are taken on direction, work plans and budgets; and their programmatic accountability frameworks are also independent from those of the Organisation. In the same way the framework applies to other hosted entities which are subject to the Organisation's Rules and Regulations.

'(ii) WHO's involvement in external partnerships is regulated by the policy on WHO's engagement with global health partnerships and hosting arrangements. The framework of engagement with non-State actors also applies to WHO's engagement in these partnerships.'

However, it is not clear whether it is the secretariat or member states or both that can bring before the Programme, Budget and Administration Committee any issues of conflict between FENSA and the policies or regulations listed in paragraph 48.

Conflicts of interest

Regarding the sensitive issue of conflicts of interest, even though there is mention of it in WHO strategies and guidelines, WHO has no comprehensive conflict-of-interest policy in place. There is no document in the public domain providing details on avoiding and managing conflicts of interest in WHO. According to public health researcher Judith Richter, in 2001 WHO commissioned a report by Eloy Anello from Nur University in Santa Cruz, Bolivia, titled 'Assessing Conflicts of Interest'.5 The report was made available to WHO staff for a brief period before being unceremoniously withdrawn. While no official explanation was given for the withdrawal, two senior staff members were said to have objected to the report. Subsequently two legal experts, Edgar Philippin and Jean-Marc Reymond, were commissioned to develop a training module on conflicts of interest, and they made a presentation titled 'Collaborating with the Private Sector: The Conflict of Interest Issue'. However, there was no continuing engagement by WHO with these scholars.6

Within the WHO secretariat a strong conflict-of-interest policy is viewed as an obstacle to partnership and collaboration with NSAs, especially with the private sector.7 As a result, there is no comprehensive policy to deal with individual and institutional conflicts of interest. For instance, the original proposal of the secretariat with regard to FENSA stated that 'the management of individual conflict of interest is not within the scope of the framework of engagement with non-state actors. The separate reform efforts in this area will, however, be closely coordinated with the implementation of the framework'.8 In other words, any reform would take place only after the adoption of FENSA.

Conflicts of interest are broadly classified into two types - individual conflict of interest and institutional conflict of interest. An individual conflict of interest arises when a staff, expert or consultant working for WHO uses his or her professional position to influence WHO's decisions. Policies or activities that could lead to direct or indirect financial or other benefits to the staff or staff's family members are detrimental to the interests of WHO.

An institutional conflict of interest arises when a staff, expert or consultant through his/her actions influences WHO to enter into an engagement with an NSA, especially with the private sector and philanthropic foundations, that puts the interest of the NSA above the public health interest of WHO.

The  draft FENSA text  submitted during the WHA states that 'individual conflicts of interest within WHO are those involving experts, regardless of their status, and staff members; these are addressed in accordance with the policies listed under paragraph 48 of the present framework'. Paragraph 48 lists three relevant documents: the Regulations for Expert Advisory Panels and Committees; the Guidelines for Declaration of Interests (WHO Experts); and the Staff Regulations and Staff Rules. These documents are inadequate to address conflicts of interest in an effective manner for the following reasons:

Firstly, these documents do not provide any clear guideline on how to avoid or effectively manage conflicts of interest. They merely stress on the aspect of declaration of interests and there is little guidance with regard to the process after the declaration. 

Secondly, the guidelines are implemented by different departments or divisions of WHO in varied ways. For instance, the Guidelines for Declaration of Interests by experts involved in WHO work seem to take the approach that a declaration is sufficient and that the secretariat is to decide whether there is a conflict of interest; there is no uniform practice of making such declarations public. For example, while the WHO's Expert Committee on Specifications for Pharmaceutical Preparations makes public its members' declarations of interests, the Expert Committee on Biological Standardisation does not - it simply states: 'Each Committee member had completed a declaration of interests form prior to the meeting. These were assessed by the WHO Secretariat and no declared interests were considered to be a conflict for full participation in the meeting.'

Thirdly, the latest draft of the Guidelines for Declaration of Interests has not been discussed with member states and it has major flaws. For instance, the latest version circulated to member states says that any money up to the value of $5,000 from a company is not treated as a serious conflict of interest. The current guideline which is in force states that there is no need to declare if the money is less than $10,000.

Fourthly, there is no detailed guideline in the Staff Regulations and Staff Rules to address the issue of conflicts of interest.

An institutional conflict of interest, on the other hand, is defined in the draft FENSA text as 'a situation where WHO's primary interest as reflected in its Constitution may be unduly influenced by the conflicting interest of a non-state actor in a way that affects, or may reasonably be perceived to affect, the independence and objectivity of WHO's work'. This is a departure from the traditional understanding of an institutional conflict of interest, which focuses on individuals, i.e., staff or other individuals in the organisation. Therefore, it is important that the text reflects the general understanding of institutional conflicts of interest involving WHO's staff, experts or consultants.

The FENSA draft defines an institutional conflict of interest as a case involving conflicting interests between WHO and an NSA. It also recognises that all institutions have multiple interests and WHO, while engaging with NSAs, would have both converging and conflicting interests. It further states that WHO aims to avoid allowing the conflicting interests of NSAs to exert or be reasonably perceived to exert undue influence over the organisation's decision-making process or prevail over its interests.

Further, the draft text states that for WHO, 'the potential risk of institutional conflicts of interest could be the highest in situations where the interest of non-state actors, in particular economic, commercial or financial, are in conflict with WHO's public health policies, constitutional mandate and interests, in particular the organisation's independence and impartiality in setting policies, norms and standards'. 

The main shortcoming of the text is that it does not provide any clear direction on the concrete steps to be taken to avoid or manage institutional conflicts of interest. Similarly, it does not provide any clear instance of individual or institutional conflict of interest. This gives ample scope for the secretariat to interpret and implement the provisions related to conflicts of interest in a non-transparent and ineffective manner.

In short, WHO recognises the need to avoid and manage conflicts of interest but does not have a comprehensive conflict-of-interest policy coupled with transparent procedures to address any such conflicts.

Faulty official relations policy

In order for an NGO to establish official relations with WHO, a collaborative work plan has to be submitted for the consideration of WHO's Standing Committee on Non-Governmental Organisations. Till recently the collaborative work plans between NGOs and WHO were not available in the public domain. It was only in 2015 that WHO removed the restricted status of the documentation submitted to the Standing Committee. However, the documentation has failed to follow a uniform pattern of disclosure, including disclosure of the source of funding like how much of their revenue is coming from commercial enterprises. The collaboration work plans drawn up prior to 2015 are not available in the public domain.

There is concern that some of the collaborative work plans that WHO has entered into will be used to pursue business interests.

For example, the Global Medical Technology Alliance is one of the NGOs in official relations with WHO. The members of the Alliance are national or regional medical technology associations which represent companies that currently develop and manufacture 85% of the world's medical devices, diagnostics and equipment. The joint work programme between the Alliance and WHO states: 'Promote the safe use of medical devices through compiling and distributing materials and training on the safe use and proper disposal of medical devices for health care professionals, through the Alliance member associations.' This implies that a trade association would work with WHO to promote use of medical devices, which would clearly result in economic benefits to the members of the association. It could also result in unnecessary promotion of the use of medical devices without adequate evidence and putting commercial interests above public health.

Likewise, the work plan of the Global Diagnostic Imaging, Healthcare IT and Radiation Therapy Trade Association states that it would collaborate with WHO in 'raising awareness of the importance of health technologies for better clinical outcomes and the value of health technology and assessment in the process'. Here again, such 'awareness raising' can be misused by this trade association to pursue commercial ends rather than public health goals.

In their documentation both the above organisations reveal that they are commercial organisations. 

Similarly, Health Technology Assessment International reveals that WHO will participate in planning and organising its regional policy fora, 'which will convene health technology assessment stakeholders to build partnerships focusing on the role of health technology assessment in decision-making and strengthening the evidence-based selection and rational use of health technologies'.

Such collaborations may fall within the 'risks of engagement' identified in the draft FENSA text. The text states: 'WHO's engagement with non-state actors can involve risks which need to be effectively managed and, where appropriate, avoided. Risks relate inter alia to the occurrence in particular of the following: (a) conflicts of interest; . (d) the engagement being primarily used to serve the interests of the non-State actor concerned with limited or no benefits for WHO and public health.'

The work plan of the Foundation for Innovative New Diagnostics states: 'The Foundation works to strengthen WHO leadership in the development of, and setting norms and standards for, diagnostics through representation on expert panels, and help with drafting diagnostics-related guidelines.'

This goes directly against the principles of engagement set out in the FENSA draft, which states that any engagement must 'protect WHO from any undue influence, in particular on the processes in setting and applying policies, norms and standards'.

The above illustrations clearly show that the collaborative plans for official relations could result in serious conflicts of interest and risks for WHO that would compromise its credibility, integrity and independence.

The most recent OEIGM in July addressed this concern.  It agreed to include in the FENSA draft a provision which clearly states that collaborative work plans 'shall be free from concerns which are primarily of a commercial or profit-making nature'. The relevant paragraph in the draft now reads: 'Official relations shall be based on a plan for collaboration between WHO and the entity with agreed objectives and outlining activities for the coming three-year period structured in accordance with the General Programme of Work and Programme budget and consistent with this framework. This plan shall also be published in the WHO register of non-State actors. These organisations shall provide annually a short report on the progress made in implementing the plan of collaboration and other related activities which will also be published in the WHO register. These plans shall be free from concerns which are primarily of a commercial or profit-making nature.'

However, in practice, much will depend on the interpretation of the phrase 'primarily of a commercial or profit-making nature'. According to an observer, this terminology needs further interpretation. In the absence of such an interpretation, the secretariat has the discretion to interpret the sentence such that it can continue with the existing practice. The observer cites the example of the existing Principles Governing Relations Between the World Health Organisation and Nongovernmental Organisations, which contain this exact terminology.

While safeguards against undue corporate influence in WHO's policy on official relations are welcomed, there is a fear that the policy would also hamper the participation of public-interest civil society organisations. This fear mainly arises from a footnote in the FENSA draft which states that 'Participation in each other's meetings alone is not considered to be a systematic engagement'. Systematic engagement is a prerequisite for an organisation to establish official relations with WHO. Another criterion is that 'Entities in official relations are international in membership and/or scope. All entities in official relations shall have a constitution or similar basic document, an established headquarters, a governing body, an administrative structure, and a regularly updated entry in the WHO register of non-State actors.' This can exclude a range of civil society organisations and social movements.

The broader concern, however, is that the official relations criteria, in particular the requirement for collaborative work plans, may undermine independent civil society monitoring of WHO activities, especially the governing body meetings. Collaborative work plans create a working relationship and could therefore compromise independent monitoring.


The FENSA negotiations are a crucial process which offers member states both challenges and opportunities to shape the future of WHO. Both the WHO secretariat and the developed countries are resisting any change and want maintenance of the status quo, if not more engagement with NSAs without effective safeguards and firewalls. This would endanger the credibility, independence and integrity of WHO.

The success of FENSA implementation will also depend on the availability of information in the public domain. In the absence of such information, the accountability of WHO becomes elusive. The transparency provisions of FENSA are still under negotiation. Unfortunately the FENSA negotiations have not attracted public attention and are happening behind closed doors.

Certain proposals have been advanced in the negotiations which have the potential to prevent the undue influence of NSAs, especially the private sector, on WHO. In the coming days, for these proposals to be incorporated into FENSA, they need the wide support of not only member states but also civil society organisations and public health activists.   

KM Gopakumar is a senior researcher with the Third World Network.


1   Ayelet Berman, 'The Distributional Effects of Transnational Pharma-ceutical Regulation',

2   Ibid.

3   Sangeeta Shashikant, 'WHO: Expert report on R&D financing triggers inquiry, consultations', South-North Development Monitor (SUNS), No. 6847, 22 January 2010 

4   F William Engdahl, 'WHO Scientists Corruption Scandals  Appear Endemic',

5   Judith Richter, 'Public-Private Partnerships and International Health Policy-making: How Can Public Interests Be Safeguarded?'

6   Ibid.

7   Ibid.


*Third World Resurgence No. 298/299, June/July 2015, pp 24-30