Below is the text of HAI's letter to WHO on its draft WHO Guidelines on Interaction with Commercial Enterprises.
For an overview of comments from other NGOs please check this page.
Re: draft WHO Guidelines on Interaction with Commercial Enterprises
Amsterdam, 22 December 1999
Dear Mr Aitken,
Thank you for including Health Action International (HAI) in the consultation on the draft WHO Guidelines on Interaction with Commercial Enterprises (version July 1999). Such guidelines are urgently needed. We are pleased to see that WHO is now addressing this important issue which affects the very foundation of its work.
Upon receipt of the guidelines on 11 October 1999 the text was posted on our website (http://www.haiweb.org/campaign/PPI/whoguidel-draft.html) and paper copies were distributed throughout our network. French and Spanish translations were never received, which limited the input available from part of our network and from many other respondents.
We see an inherent conflict between commercial goals and public health goals. WHO is the primary public health body in the world and it must ensure that public health interests are paramount. WHO can only do this by performing its functions independently from commercial influence. Industry partnerships and industry sponsorship without strong, enforceable, accountable and transparent guidelines for these relationships will undermine and destroy that role and responsibility. The main flaw of the draft guidelines is that they do not give sufficient guidance for a serious evaluation of the activities of potential and current commercial partners and therefore do not substantially reduce the problem of conflicts of interest.
While we understand the commitment WHO is trying to make by publishing guidelines to structure its interaction with commercial enterprises, we believe that there are fundamental questions that need to be answered first. The most important question is whether increased interaction with the commercial sector is a major way forward towards Health For All. WHO must be able to demonstrate that the poor directly benefit from this collaboration. Private sector initiatives rarely benefit the poor as much as they benefit specific diseases or health problems encountered by a section of the population, or of course, an industry itself.
We suggest that WHO organise a public meeting on the concept of partnership with commercial enterprises as the way forward in international health development agenda, where the health gains and risks of this approach can be properly discussed by all interested parties including public interest NGOs.
In the annex attached to this letter we indicate some of the areas where we think improvements can be made in the guidelines. We hope that these comments are helpful and look forward to further discussing them with WHO.
Yours sincerely,
Bas van der Heide
Health Action International
Comments on
WHO Guidelines on Interaction with Commercial Enterprises
(Preliminary version July 1999)
22 December 1999
These comments are structured under the following headings:
Relate the guidelines to WHO's objectives and functions
Mobilising resources is not a goal in itself but should be related to objectives, a plan of action, and a budget. By adopting a clear fundraising policy based on a global needs assessment WHO can avoid having donors ultimately set the agenda.
We recommend that WHO set up a blind trust in which donations can be received. The spending in this fund will be to the organisation as a whole, and not to a particular programme or activity.
Improve clarity and consistency
The wording of the draft in many cases lacks clarity and precision and this might lead to a range of interpretations. Notable are several references to the need for "health gains", with no indication of priorities in work; and to the need for "consideration" or "evaluation" , without saying how this is to be done.
Clarify procedure for assessment of interactions
The document does not define adequate mechanisms for monitoring and evaluating the activities of partner companies. In some key areas WHO has produced guidelines that could serve as a reference, e.g. the WHO Ethical Criteria for Medicinal Drug Promotion (1988), the interagency Guidelines for Drug Donations (1996) and the International Code of Marketing of Breast-milk Substitutes (1981).
The text distinguishes between commercial enterprises with activities unrelated to the work of WHO, those with activities incompatible with WHO's objectives and those with activities related to the work of WHO. It seems unlikely that any major commercial enterprise is engaged in work wholly "unrelated to the work of WHO": consider for example the role of banks in relation to third world debt.It is more likely that most enterprises have activities that are related to the work of WHO as well as activities more or less incompatible with WHO's objectives. These need to be properly weighed. We therefore strongly urge WHO to fully review every partnership with a commercial enterprise using the same criteria.
Direct and indirect interests are indeed difficult to see and predict. In addition the borders between different industry sectors are not very clear. For example Japan Tobacco, which derives 97 percent of its revenues from tobacco sales, has a pharmaceutical division that has been involved in the development of nelfinavir mesylate (Viracept), an anti-AIDS therapy. Japan Tobacco, has announced that it plans to work with the US based Corixa Corporation, a biotechnology research company, to develop a lung cancer vaccine .
In May this year we wrote to Dr Brundtland to express our concern about the decision to accept a secondment from a pharmaceutical industry representative in the Tobacco Free Initiative (TFI). Since that time HAI has learned of other activities within the same programme that can illustrate what we perceive to be conflicts of interest.
" Nicotine replacement medicines such as nicotine gum, patches, nasal spray and inhalers as well as non-nicotine medicines such as bupropion can double people's chances of succeeding. They need to be more widely available, but the cost needs to be reduced to bring them within the reach of smokers everywhere.".
More than one billion people smoke wordwide and the global market is expected to exceed US$750 million in 1999. Nicotine replacement products for smoking cessation were recently launched in China which has a smoking population of around 320 million. Smoking cessation is big business and public health, but these two things need to be kept clearly separated. A decision to add nicotine replacement therapy to the EDL may be in the interest of public health. But it would also be in the interest of those who produce these products. While the guidelines state that funds should not be sought or accepted from enterprises which have a direct commercial interest in the outcome of the project toward which they would be contributing, the WHO seems to ignore that policy for the Tobacco Free Initiative.
Introduce proper audit and reporting procedure
The application of these guidelines should regularly be subject to some independent review and audit. WHO could consider involving a multinational audit firm that specialises in social impact evaluating and reporting.
In their current form, the guidelines do not describe a procedure for reporting on the interactions covered by the guidelines. At least an annual report would be needed. This should contain an overview of the agreements with value, type of support, and project sponsored. The Committee on Private Sector Collaboration (CPSC) should report on the number of applications reviewed and accepted and rejected and why. We also think that all terms and conditions of any WHO corporate sector partnership should be accessible for anyone who wants to review them. The procedure should spell out how and where relevant documents can be reviewed.
Introduce outside representation in Committee on Private Sector Collaboration (CPSC)
Enforcement of the Code should be a concern of everyone associated with WHO.
Most of the enforcement is in the hands of the CPSC. Its composition is not spelled out in the document. We suggest to include consultation with a panel external to the WHO that could help to determine if a real or perceived conflict of interest is involved in any commercial partnership. Before entering into any partnership with the corporate sector in a given area the WHO could undertake general consultations with other players in the health community, including public interest NGOs, to discuss the reasons for this partnership.
Amsterdam,
22 December 1999