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E-DRUG Brundtland and HAI responses on drug industry sponsorship
[Moderators Comment I suspect that the corrrespondence reported in this and
previous postings is among the most important that will appear in E-DRUG.
The role that WHO will play in the future balancing the interests of
consumers and the pharmaceutical industry is critical for the future. When
an industry executive was appointed to be an executive director of the
cluster in WHO which deals with pharmaceuticals concerns were expressed. How
Dr Brundtland handles the issues of partnerships and sponsorship will
determine how she and WHO will be assessed. Richard Laing Co-Moderator]
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13 July 1999
Dear Colleagues,
WHO�s Director General Dr. Gro Harlem Brundtland recently responded to HAI�s
letter issued during the 52nd 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.
This letter and response will also be posted on HAI�s website.
(http://www.haiweb.org)
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Letter from Dr. Gro Harlem Brundtland regarding WHO�s relationship with the
pharmaceutical industry
(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
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Response from HAI:
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
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