Commercial sponsorship and The Cochrane Collaboration

Commercial sponsorship of health-related research is, of course, not an issue of concern uniquely to The Cochrane Collaboration. Many members of The Cochrane Collaboration have pointed out that external perception is also important. Any perception that for-profit commercial organisations, notably but not exclusively, the pharmaceutical industry and medical device manufacturers, were influencing the conclusions of Cochrane Reviews would damage a carefully nourished reputation for impartiality and scientific rigour.

This issue was discussed at length at the 11th annual Cochrane Colloquium in Barcelona in October 2003. A consultation document was disseminated during December 2003 with a request for views by 31 January 2004; 156 individuals or groups responded. Most were active members of The Cochrane Collaboration. The Steering Group met in Bergamo, Italy, from 29 February to 2 March 2004 and considered at length the very extensive and detailed documentation. An agreed policy document was disseminated on 6 April 2004. At that time, there was, for some questions, very clear consensus; for others, there was not. The Steering Group discussed unresolved issues at their meetings in Ottawa, Canada, on 1 and 4 October 2004, and in Providence, US, on 2 to 4 April 2005. They were also discussed at the annual general meeting during the 12th Cochrane Colloquium in Ottawa on 3 October 2004. Following these discussions, the policy document was amended in April 2005.

Background
Since the decisions taken by The Cochrane Collaboration are also of interest to others it may be helpful to describe, briefly, the structure of The Cochrane Collaboration. It is a highly devolved organisation that involves more than 10,000 people, in different capacities, worldwide. Most do not receive any payment for the work they do within The Collaboration. They are drawn to The Collaboration through a wish to commit, either as a professional or as a consumer, to a movement to provide more sound evidence on which healthcare decisions can be made. The formal structure of The Collaboration comprises Collaborative Review Groups (which produce systematic reviews), Centres (with responsibilities that include support for Collaborative Review Groups within their area of geographical responsibility), Methods Groups, Fields, a Consumer Network, an elected Steering Group, and a small Secretariat. The Secretariat, Steering Group and Advisory Group meetings, and key generic developments (e.g. software for information management, production of the Cochrane Handbook for Systematic Reviews of Interventions, and development of The Collaboration’s website) are all funded, in part or in whole, through royalties on sales of The Cochrane Library. Everything else (including support of Collaborative Review Groups and Centres) is funded through applications to other sources (often government agencies), and these sources are almost all in the country in which the entity is located.

There is substantial variation internationally in the amount of funding for support of Cochrane activity and, in some parts of the world, it is extremely difficult to access government or charitable funds. In some areas, there has recently been an important decrease in financial support for Review Groups and Centres. Therefore, an alternative option, of seeking funding from commercial sources, could be attractive to, say, Co-ordinating Editors of Review Groups, or Centre Directors, who otherwise face the prospect of curtailing productivity and/or making skilled and experienced staff redundant. Setting policy on issues as sensitive and important as sources of funding in as complex an organisation as The Cochrane Collaboration is never an easy matter, and may be even more difficult at this time.

Definitions
- By ‘commercial source’ we mean any for-profit manufacturer or provider of health care, or any other for-profit source with a real or potential vested interest in the findings of a specific review. Whilst government departments, not-for-profit medical insurance companies and health management organisations may find the conclusions of Cochrane Reviews carry financial consequences for them, these are not included in this definition. Also not included are for-profit companies that do not have real or potential vested interests in Cochrane Reviews (e.g. banks).
- By ‘sponsorship’ of a review, we mean a sum of money given to an author or group of authors to prepare, or update, a Cochrane Review. Such sponsorship could include not only commissioning of specific systematic reviews, but also, for example, funding of a sabbatical period to work on a Cochrane Review.
- We used the term ‘firewall’ in the consultation document. By this, we mean, figuratively, a fireproof wall put in place to ensure that, if a fire occurs, it is confined to one area. We used the term to indicate a clear barrier or separation between a source of funding and the use to which that funding is put, so as to prevent any influence by the funding source on the outcome of, say, a Cochrane Review.

Conclusions

1. There was overwhelming consensus that there should be a clear barrier between the production of Cochrane Reviews and any funding from commercial sources with financial interests in the conclusions of Cochrane reviews.

2. Thus, sponsorship of a Cochrane Review by any commercial source or sources (as defined above) is prohibited.

3. Other sponsorship is allowed, but:
- A sponsor should not be allowed to delay or prevent publication of a Cochrane Review.
- A sponsor should not be able to interfere with the independence of the authors of reviews in regard to the conduct of their reviews.
- The protocol for a Cochrane Review should specifically mention that a sponsor cannot prevent certain outcome measures being assessed in the review.

4. These rules also apply to ‘derivative products’ (containing Cochrane Reviews) so that commercial sponsors could not prevent or influence what would be included in such products.

5. To ensure the integrity (real and perceived) of the ‘firewall’, it is also prohibited for a commercial source or sources (as defined above) to sponsor Cochrane entities that produce Cochrane Reviews, that is, Collaborative Review Groups.

6. It was agreed that these same restrictions should apply to Fields and to the Consumer Network because of the close proximity of these entities to review production.

7. The position on commercial funding of Methods Groups' activities was reviewed and reconsidered at the Steering Group mid-year meeting in Khon Kaen in April 2006. It was agreed that funding from a commercial source (as defined above) for activities of Methods Groups, or of their members, in producing Cochrane Reviews of healthcare interventions or tests, or supporting individual review groups, including peer review, is not permitted. Methodologists who have personally received remuneration or research funds from a commercial source in the previous five years should ensure that they have no involvement in reviews of interventions or tests in which the commercial source has a vested interest. The receipt and use of commercial funds by Methods Groups for other purposes must be declared in Methods Groups' Modules.

8. The situation with regard to Cochrane Centres is more complex than for other Cochrane entities. For example, Centres can be both close to review production (like Fields and the Consumer Network) but can also engage in methodological work (like Methods Groups). It was agreed, therefore, that a further, short, period of consultation should take place specifically in relation to the sponsorship of Cochrane Centres by commercial sources. [This was reviewed in April 2005: see Amendment 2 below.]

9. Some entities may find themselves in financial difficulty because of the need to shed current commercial funding. Therefore, although this policy is mandatory now in relation to any new funding, it will become mandatory in relation to existing sources of funding two years after the date of adoption, to allow time for entities to seek alternative sources of funding. If any entity has contractual obligations that mean that they cannot shed current commercial funding within the next two years, they should discuss this urgently with the Funding Arbiter.

10. The position of Funding Arbiter has been established, analogous to the Publication Arbiter. The Funding Arbiter is a Steering Group member and convenes a standing panel of four to give guidance on difficult cases.

11. The responsible Collaborative Review Group should refer any existing Cochrane Reviews that have been produced by a process that would no longer be permissible to the Funding Arbiter. A decision will be taken within the first twelve months of the implementation of this policy to consider what should happen to these Cochrane Reviews (e.g. whether they should be withdrawn from The Cochrane Library).

12. Authors of reviews should declare financial support for the review, private clinical practice (if relevant), stocks, legal advice, consultancies, involvement in primary research in the subject area of their review, and any other ‘competing interests’ that they judge relevant.

13. Such declarations will be described in the review. The declarations will not be published outside of the review itself, for example, with the abstract or plain language summary.

14. If an author has been actively involved in a study/studies that was/were eligible for their review, they should have, as a co-author, someone who was not involved in the study/studies. The co-author would not necessarily be the contact author for the review, but could act as a ‘guarantor’.

15. If a review has been done, or is proposed, by people who are employed by a pharmaceutical or medical devices company that relates to the products of that company, it will be referred to the Funding Arbiter. In such circumstances, The Cochrane Collaboration will insist on a multi-disciplinary review team with a majority of the team of authors not being employed by the relevant company.

16. People with a direct financial interest in a particular intervention should not be involved in a review of that intervention, either as authors, editors or peer reviewers.

17. It was agreed to establish a central fund into which unrestricted donations could be made. It was further agreed that there should not be a prohibition on donations from any single company or type of industry, but that all funding of activity in The Cochrane Collaboration should be in keeping with the principles of The Cochrane Collaboration.

18. There is an existing Collaboration policy on sponsorship of Colloquia. The Colloquium Policy Advisory Group have been asked to reconsider this in light of changes to the policy on commercial sponsorship, and to bring any recommendations for changes to this policy to the Steering Group.

19. Authors and Cochrane Review Groups should not receive royalties on sales of reprints of their reviews, since these sales are likely to have been made to commercial sources and might, therefore, be assumed to be equivalent to direct sponsorship of the review or Group. Therefore, the current policy that royalties on reprint sales go to The Cochrane Collaboration centrally, via the Collaboration Trading Company, will continue. When a central fund is established, the possibility that such income should go into it will be discussed.

20. John Wiley and Sons Limited should continue to be encouraged to make bulk sales of The Cochrane Library and derivative products to commercial sources.

21. All Cochrane Collaboration policies are kept under continual review, but these decisions will be formally reviewed after three years.

6 April 2004

Amendments made in April 2005
1. The position on commercial funding of Methods Groups’ activities is being reviewed and will be reconsidered at the Steering Group mid-year meeting in April 2006.

2. As a principle, there should be no direct funding of Cochrane Centres (or Branches of Centres) by commercial sources. This includes the funding of core and non-core functions of Cochrane Centres. Direct funding currently in place can continue, but should be phased out over the next five years. Therefore, from April 2010, any direct funding of Cochrane Centres from commercial sources is prohibited. Non-direct funding of non-core activities (such as translation) would, however, be permitted after 2010 from a central fund – see 17 above.

Amendments made in April 2006
1. The position on commercial funding of Methods Groups' activities was reviewed and reconsidered at the Steering Group mid-year meeting in Khon Kaen in April 2006. It was agreed that funding from a commercial source (as defined in this policy) for activities of Methods Groups, or of their members, in producing Cochrane Reviews of healthcare interventions or tests, or supporting individual review groups, including peer review, is not permitted. Methodologists who have personally received remuneration or research funds from a commercial source in the previous five years should ensure that they have no involvement in reviews of interventions or tests in which the commercial source has a vested interest. The receipt and use of commercial funds by Methods Groups for other purposes must be declared in Methods Groups’ modules (see Item 7 above).

The following text was removed from Item 7 when the amendment above was inserted:
It was agreed that commercial sources of funding to Methods Groups should not be prohibited. [This was reviewed in April 2005: see Amendment 1 below.] However, the Screening and Diagnostic Tests Methods Group needs to be considered as a special case because of its likely close involvement in the preparation and maintenance of Cochrane Reviews of diagnostic test accuracy. The Funding Arbiter (see below) should be asked to advise on those situations that are not clear-cut.