WHO's Director General Dr. Gro Harlem Brundtland recently responded to HAI's letter issued during the 52^nd World Health Assembly which criticised WHO's increasingly close contact with the pharmaceutical industry and the lack of guidelines supervising such interactions.

In her response, which you will find reproduced below, Dr. Brundtland describes how the organisation plans to protect its independence while encouraging partnerships. HAI believes her response raises a number of concerns. HAI has summarised its conclusions about her letter in a brief response (also reproduced below). We would welcome your reactions to our interpretations as well as to Dr. Brundtland's response.

(Received 22 June 1999)

Dear Mr van der Heide,

Thank you for your letter of 18 May 1999 about WHO's relationship with the pharmaceutical industry.

Last year on taking office, I pledged that WHO would change to become more effective, more accountable and more receptive to a changing world. We need to work with all sectors of society to place health at the top of national and international agendas. We need to reach out to the NGO community, to the media, to educational institutions and the commercial sector to get our messages across and to make health everybody's business.

Our new roundtables with industry have, for example, explored how we can provide drugs and vaccines to the most vulnerable populations. And as you know, the roundtable with the public interest NGO's involved in the pharmaceutical sector, including HAI, have led to much closer collaboration in the areas of access to essential drugs and ethical promotion of medicinal drugs.

In developing partnerships, WHO's position as an impartial holder of health values will be ensured. We will work on the basis of mutual respect, trust, transparency, and shared benefit, with public guidelines to ensure the avoidance of conflict of interest. We are just completing our internal work on an updating of guidelines for our relations with commercial enterprises.

Thereafter, WHO will use them on an interim basis while we consult widely with our Members and external partners for comments and views. HAI will be included in this consultation, along with other public interest organizations.

The new Committee on Private Sector Collaboration comprises senior representatives from each of the nine headquarters clusters and the legal office. It is chaired by a senior policy adviser in my office. It has been elaborating the draft of the updated guidelines, as well as reviewing some outstanding cases relevant to their preparation. Once the guidelines are in place, it will review those cases where there are any uncertainties or new issues arising. It will make recommendations to me.

On the specific cases you mention, I do not wish to rule out the possibility of secondments to WHO from pharmaceutical companies. Our guidelines will cover the strict conditions that we apply. In the case of the secondment to the Tobacco Free Initiative, the company had no interest in the area of smoking cessation, the person seconded brings to the project a specific and needed expertise for a time limited period, and the person is specifically excluded from involvement in activities in which the company from which she is on secondment could have any interest. Finally, there are clear undertakings on confidentiality, and on the person involved not seeking or accepting instructions from anyone outside WHO, specifically the company from which she is on secondment.

As regards the new principles for treatment guidelines, the clusters concerned are currently working on establishing a new methodology for the development of clinical guidelines. It is expected that the new methodology will be applied throughout the Organization, and will give broader emphasis to the evidence base of recommendations and consider cost-effectiveness of guidelines and other public health implications. Avoidance of conflict of interest in the preparation of such guidelines is addressed in the updated guidelines on interaction with commercial enterprises referred to in the preceding paragraphs.

I welcome your suggestion to discuss these issues further in the context of the WHO-NGO roundtable process.

Yours sincerely,

Gro Harlem Brundtland, MD, MPH

Director-General

Making WHO sponsorship more transparent

HAI is pleased that its letter seems to have helped make discussion about WHO's growing private sector partnerships more public. The network is further encouraged that Dr. Brundtland's response signals a new commitment to an improved system of oversight about partnerships and sponsorship arrangements affecting the organisation's work. It must be remembered that HAI's letter was originally written partly due to the fact that the secondment of a staff member from industry became known only through informal channels and was never officially announced by WHO.

In her letter, Dr. Brundtland promises that "in developing partnerships, WHO's position as an impartial holder of health values will be ensured." However, the guidelines framing WHO's work on sponsorship remain unpublished and it remains to be seen how substantial they are in preventing conflicts of interest that may have consequences for health.

Looking at the press coverage surrounding WHO's involvement with the WHO/ISH guidelines on hypertension, one must question if WHO has sufficient mechanisms in place currently to protect its reputation. HAI has learned that Dr. Brundtland wrote to assure a group of doctors that criticised the hypertension guidelines process and conclusions that the hypertension guidelines would be reviewed according to the new policy. However, sources have informed HAI that approximately 600,000 copies of the current version have already been printed for distribution among primary health care personnel around the world.

WHO's upcoming guidelines and oversight

HAI is pleased to hear that once the guidelines are published they will be circulated for review among the Member States as well as other external partners. HAI is named as one organisation that will take part in this process, and it in turn, will distribute them to all interested partners cooperating with its international network.

Dr. Brundtland reports that a new Committee on Private Sector Collaboration has been organised that has worked on the upcoming guidelines and reviewed relevant cases related to their aspects. This committee, she says, will be given the task of "reviewing those cases where there are any uncertainties or new issues arising." One great weakness of this oversight committee is that it will have no independent representation, as any audit committee should. HAI would also like to know if this committee has any dedicated executive function, compliance officers or support staff.

Instead of this plan, HAI calls on WHO to create a committee independent of the WHO with the mandate to look at cases involving possible conflict of interest. Because of the sensitivity of some sponsorship activities, HAI also believes it would be insufficient to have only a few independent members of a WHO-centred committee. The reports of the committee charged with examining these private sector collaborative arrangements must be made public for further transparency.

Conflict of interest regarding secondments

It is with deep concern that HAI learns that Dr. Brundtland remains in favour of secondments to WHO from pharmaceutical companies. She assures HAI that such decisions will be strictly guided by the upcoming guidelines. She also claims that the current secondment to the Tobacco Free Initiative holds no potential conflict of interest. One wonders how such a statement is possible. Practically speaking, why would a pharmaceutical company agree to pay for a staff member to go and work with WHO and even excitedly announce the placement within its own company, if it thought it had nothing to gain from the arrangement?

HAI requests Dr. Brundtland to publicly disclose the negotiations around this particular arrangement. For example, did WHO ask Merck to send a staff member for secondment or did the company make the initial offer? Why did WHO believe that it could not find someone within its own ranks to fill this position or hire an outside consultant? If WHO believes that secondments are necessary because of budgetary problems within the organisation, this creates a very slippery slope as many dubious practices could be justified on these grounds. HAI continues to see a serious conflict of interest involved in secondments and plans to monitor this situation closely.

NGO discussions on sponsorship

Significantly, Dr. Brundtland has offered to discuss sponsorship issues within the WHO-NGO Roundtable process. This is a reversal from WHO's earlier position that it did not want to include sponsorship arrangements within the agenda items discussed by the group. HAI and its NGO partners have worked hard in the past few months to raise this issue again and again in public fora with WHO. It is a step forward that WHO now accepts the need to discuss openly its rules regarding sponsorship.

HAI urges WHO to finalise its guidelines on private sector collaboration as quickly as possible and to distribute them widely for comment. HAI will study them closely and share them with interested partners. After consultation with its members, it will send a critique of these guidelines to Dr. Brundtland.

As Dr. Brundtland's response reveals, WHO is still in the process of establishing a solid basis on which to judge its potential collaboration with the private sector. HAI encourages all interested parties to take part in this debate on sponsorship as the organisation develops its policy in this extremely important area.

Bas van der Heide

Coordinator, HAI Europe

Go to HAI's original letter to Dr. Brundtland

Go to NGO statement of support to HAI's letter