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TWN Info Service on Health Issues (Apr16/08)
25 April 2016
Third World Network

WHO: Final FENSA negotiations to focus on private sector engagement

Geneva, 25 April (K M Gopakumar) – The resumed negotiations on the Framework for Engagement with Non-state Actors (FENSA) will focus on the World Health Organization’s engagement with the private sector.

The Open-Ended Intergovernmental Meeting (OEIGM) on FENSA is taking place on 25-27 April at the WHO Headquarters in Geneva. This meeting is expected to be the final round of negotiations that started in March 2015.  FENSA is expected to regulate WHO’s engagement with four types of non-state actors (NSA) viz. non-governmental organizations (NGOs), private sector, philanthropic foundations and academic institutions. (http://www.who.int/about/collaborations/non-state-actors/A_FENSA_OEIGM_5-en.pdf?ua=1)

[FENSA is part of WHO’s governance reform agenda launched in 2011. Until January 2015 the process was a Secretariat-led process. The Director for Partnerships and Non-State Actors and the Director for Coordinated Resource Mobilization at the WHO Director-General’s Office are leading the process from the Secretariat. In 2015 Member States took the helm by establishing the OEIGM to negotiate on FENSA.]

The document contains two parts: (i) an overarching framework setting out the common rules for all NSAs; and (ii) the specific policies for each category of NSAs. Apart from the FENSA text the OEIGM will also discuss and negotiate the resolution to adopt FENSA and a report by the external auditor on the implications of FENSA implementation.

Third World Network learnt that OEIGM would first focus on the FENSA text with an aim to finalize the negotiations.  During the past year Member States have reached consensus on most parts of the FENSA text.  However, consensus has yet to be reached on the critical aspects of the private sector policy, which sets the special rules of WHO’s engagement with the private sector.

Developed countries are pushing for an equal treatment of private sector with NGOs (with no distinction made with public interest NGOs) and resisting specific rules to prevent the undue influence of private sector on the WHO. This has led to a situation where there is a dilution of the provisions in the 2000 “Guidelines on interaction with commercial enterprises to achieve health outcomes” (http://apps.who.int/iris/bitstream/10665/78660/1/ee20.pdf?ua=1).

Interestingly the Executive Board in its 107th meeting in May 2000 only noted these Guidelines. Several observers say that the Secretariat has not implemented the Guidelines effectively. FENSA when adopted will replace these Guidelines.

For instance, Paragraph 24 of the Guidelines puts certain safeguards against accepting donations to fund the salary of WHO staff or consultants. It states: “Funds designated to support the salary of specific staff or posts (including short-term consultants) may not be accepted from commercial enterprises or other commercial sources if they could give rise to a real or perceived conflict of interest in relation to WHO’s work. All proposals must be referred to the Office of the Legal Counsel at an early stage.”

Further, Paragraph 25 states: “The acceptability of contributions from commercial enterprises to projects which have a staffing element should be reviewed in the light of other relevant guidance mentioned in this document.”

The draft FENSA private sector policy removes this restriction altogether and therefore it allows WHO to accept financial contributions from the private sector to finance salaries of WHO staff or short term consultants.

Similarly, Paragraph 20 of the Guidelines puts the following restrictions on accepting donations for the meeting.  It states: “For meetings convened by WHO, a contribution from a commercial enterprise may not be accepted if it is specifically designated to support the participation of any or all of the invitees (including such invitees’ travel and accommodation), regardless of whether such contribution would be provided directly to the participants or channelled through WHO.” It provides the exception that “Contributions may be accepted to support the overall costs of a meeting, subject to the provisions relating to avoidance of conflict of interest”.

Paragraph 6 of the FENSA private sector policy restricts the ban on such donations to only if it is directed to fund the travel and accommodation of specific invitees instead of “any or all” invitees. It states: “For meetings convened by WHO, a contribution from a private sector entity may not be accepted if it is designated to support the participation of specific invitees (including such invitees’ travel and accommodation), regardless of whether such contribution would be provided directly to the participants or channelled through the WHO.” Thus WHO can accept the financial resources from the private sector to cover the costs of all participants to a meeting convened by WHO.

Again, Paragraph 12 of the Guidelines creates a general obligation on the part of commercial enterprises to follow WHO guidelines as a requirement for engagement. It states: “Commercial enterprises working with WHO will be expected to conform to WHO public health policies in the areas of food safety, chemical safety, ethical promotion of medicinal drug products, tobacco control, and others”.

The draft FENSA private sector policy limits the obligation to follow WHO guidelines to the private sector, including business associations, in case of engagement for advocacy.  Paragraph 33 of the FENSA text states:  “WHO encourages private sector entities to implement and advocate for the implementation of WHO’s policies, norms and standards. WHO engages in dialogue with private sector entities in order to promote the implementation of WHO’s policies, norms and standards. (ADD FOOTNOTE: Private sector entities working with WHO will be expected to conform to WHO’s public health policies in areas such as food safety, chemical safety, ethical promotion of medicinal drug products, tobacco control, non-communicable diseases, as well as health and safety at work”.)

Thus WHO can engage in activities other than advocacy, such as accepting financial resources or technical collaboration with a firm or business association, which do not follow the WHO guidelines in their specific areas of activities. It is worth noting here that many pharmaceutical companies have been accused of unethical promotion or marketing or medicines or lobbying against the use of TRIPS flexibilities clearly in contradiction with WHO’s Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property  (GSPOA).

Apart from this there is no consensus on stating the nature of the risks involved in the engagement with the private sector. The Guidelines clearly sets out these risks in Paragraphs 6, 7 and 8.  There is a proposal to include Paragraphs 6 and 7 as a single Paragraph 2bis in brackets (indicating there is no consensus in this regard) in the FENSA draft.

The proposed Paragraph 2 bis reads: “When establishing relationships with private sector entities, it should be borne in mind that WHO’s activities affect the commercial sector in broader ways, through for example, its public health guidance, its recommendations on regulatory standards, or other work that might influence product costs, market demand, or profitability of specific goods and services. Such activities include setting of norms for quality, safety, and efficacy of pharmaceuticals and related promotional practices, dissemination of information on pharmaceuticals; provision of guidelines for diagnostics and treatment or advice that might affect the market for individual products and product categories; establishment of chemical safety standards; and formulation of nutritional guidelines”.

Similarly one of the major risks of accepting financial resources from the private sector is that it may affect the norms and standards setting and policy formulation functions of WHO.  Therefore the overarching framework in Paragraph 6 requires that any engagement with NSAs “protect WHO from any undue influence, in particular on the process in setting and applying policies, norms and standards”.

However, in Paragraph 13 (a) of the FENSA private sector policy there is no consensus on a clear prohibition against receiving contributions, both financial and in-kind, for setting of policies, norms and standards. Paragraph 13 (a) states: “the contribution is not used for normative work; [and for activities leading to production of WHO guidelines or recommendations, including the work of expert working groups].

Another contentious issue is the scope of engagement with the private sector for technical collaboration. The definition of ‘technical collaboration’ under Paragraph 21 of the FENSA Overarching Framework comprises the following four activities viz. product development, capacity building, operational collaboration in emergencies and contributing to the implementation of WHO policies.

The Chair’s text proposal for Paragraph 36 of the FENSA private sector policy states: “Technical collaboration with private sector entities is encouraged. This collaboration must be in the interest of WHO and managed in accordance with the framework to protect WHO, and in particular, its normative work, from any undue influence and to ensure there is no  interference  with WHO’s  advisory function  to Member States.”  This allows WHO to collaborate with the private sector in the area of capacity building and implementation of WHO policies.  There are concerns that this opens the door to serious risk of conflict of interest and undue influence. Capacity building is the main channel of undue influence and the private sector can use capacity building to further their commercial interest. For instance, the private sector can use technical assistance and capacity building to push for a policy a gainst price regulation of medicines or for minimal use (even surrendering) of TRIPS flexibilities.

The first part of the FENSA text i.e. the overarching principles, are finalized except for the following issues:

  • The scope of flexibility for the WHO Director-General to not apply FENSA rules while engaging with NSAs in emergency situations.
  • The issue of secondments from NSAs: TWN learnt that there is a compromise to prohibit secondments from the private sector and to regulate secondments from other NSAs such as philanthropic foundations, academic institutions and NGOs. There is an informal agreement entrusting the Director-General to submit criteria and principles for secondment from these NSAs and also to bar secondments from NSAs from managerial and/or sensitive positions. However, there is no formal consensus on these proposals, which are currently reflected in the resolution. Similarly there is no consensus on the issue of implementation.
  • There is no consensus on allowing accreditation of NGOs to attend WHO’s governing body meetings without entering into official relations with WHO.
  • There is no consensus on the mode of implementation. The draft text proposes implementation of the FENSA in its entirety. The report of the External Auditor on the implications of implementation recommends a phase-by-phase implementation. Some developed countries would like to know the cost of implementation as a condition for the adoption of FENSA.

 


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