I attended the European Food Safety Authority Meeting on 5th March where the new rules on Conflicts of Interest and Declarations of Interest. were explained.
It was quite heartening to find that some of our concerns taken on board - although whether this will improve the quality and independence of EFSA's decisions remains to be seen. EFSA operates within a complex web of EU Regulations designed to expand the market for EU products. As we saw with the DHA claim last year - a chain is only as good as its weakest link. We hope the changes will strengthen our case for revisiting bad decisions. But maybe this is too big a can of worms to open?
The new rules claim to provide "a clearer and more transparent set of general principles applicable to all those engaging in EFSA’s work – scientific experts, staff, members of the Management Board and third party organisations" and will enter into force as of 1 July 2012, with a 4-month transition period.
The rules are quite complex and were illustated by three fictitious examples: Profs X,Y or Z and time will tell whether they really will make a difference to the quality of EFSA's work. The rules do seem to have been tightened up in relation to financial conflicts of interest, excluding anyone who employed by industry in the last 2 years (including full-time consultancy). However " In other instances, and depending on the interests concerned, an expert may be allowed to become a member of a Scientific Panel but not be eligible for consideration as Chair."
The rules relating to those working as consultants were less clear and seem to be graded according to the extent
"stronger measures concerning funding-related interests eg scientific experts managing research funding, 25% or more of which comes from the private sector in the year preceding the submission of their DoI, have restrictions placed on their ability to take part in EFSA’s scientific groups"
A distinction was made between publicly funded Food Safety Agencies (such as the FSA or the German BfR) and industry -funded bodies such as the International Life Sciences Institute (ILSI) ILSI claim that they are a food safety agency and that they hardly pay their consultants (just a tiny fee!). Interesting that the 'fee' becomes less and less important - its the role and what you can do with it that's important and what will be rewarded elsewhere.
EFSA is now going to randomly check Declarations of interest even though there is no legal requirement for this - the legal onus is on the scientist to declare honestly - so this comes down to the word that is so overused "trust'. So this is a welcome extra layer of protection which we were pushing for. The US FDA is stronger on this point and routinely devotes a certain proportion of funds to checking.
EFSA: "introduction of random sampling of DoIs to monitor for completeness and coherence with EFSA’s rules creation of the Committee on Conflicts of Interests, a body that will review decisions on interests subject to possible complaint or questioning"
I was especially concerned about the inclusion of 'intellectual' COI which could possibly rule out any good principled people just because they are members of an NGO such as Greenpeace of IBFAN. I think this is a total diversion from the financial COI. Intellectual COI and bias are dealt with on a case by case basis. The new rules also say you can't contribute to an opinion on your own work which is tricky too. I raised a concern that many experts in paediatrics will inevitably work on infant feeding but may have nothing to do with creating new formulas. Just because they might hold strong views on the importance of breastfeeding or the risks of formulas - should not mean that they are considered biased and excluded from giving an opinion on the safety of a formula or formula claim. What matters more is surely the financial conflict.
It was evident that EFSA was nervous about the Management Board and said that legally they have no power to insist on Declarations of Interest MB Members - because they are appointed by the EU Commission or Council.
One EFSA MB member, Jiri Ruprich has for the last 10-years been a member of the Danone Institute. In his declaration he says that from 01/2000 - 03/2011:
"member of CZ scientific committee of this nonprofit organization [Danone Institute]not member of any management body, no projects or financial support obtained, only plenary meetings once a year (not during last years) where mostly student/youth CZ sci projects are presented and discussed - invitation only for independent sci discussion checkable easily on appropriate web page of the CZ Danone Institute. Decision to abandon this membership to avoid possible alegations and to protect good name of the MB."
On 8 Mar 2012, at 11:20, Nina Holland wrote:
EU Commission shortlists ex-Monsanto employee for EFSA Management Board
8. March 2012 Brussels/ Munich
Corporate Europe Observatory/Testbiotech
The European Commission has recommended that one of Europe's chief food lobbyists – who is also a former Monsanto employee – sits on the management board of the European Food Safety Authority (EFSA). Testbiotech and Corporate Europe Observatory say that the appointment of Mella Frewen, lobby chief at FoodDrinkEurope (previously known as the CIAA) will create a conflict of interests for the food agency's management board.
Frewen has been the chief lobbyist at the food industry lobby group since 2007 where she actively lobbied to allow contamination of the food chain with genetically engineered plants which were not authorised in Europe. Christoph Then from Testbiotech said: “Appointing a food lobbyist with a past history of lobbying to allow contamination with genetically engineered plants would seriously undermine public trust in the European Food Safety Authority. There is simply no justification to have industry lobbyists on the board of EFSA.”
Another candidate selected by the Commission, Jiri Ruprich, is already a member of EFSAs Management Board despite having worked with the Czech Danone Institute´s scientific committee for more than 10 years. The list, brought to the attention of Corporate Europe Observatory (CEO) and Testbiotech, contains 14 names, seven of whom will be selected to serve a term on the Management Board. This means that half of the members of the management board will be replaced. The EU Council will make a final decision on the appointments in the next few months.
This week EFSA published details of how it would implement its new policy on conflicts of interest – including an improved definition of “conflicts of interest”, but tougher action is needed, including fundamental changes to EFSA's founding regulations,which are due for review later this year. Nina Holland from Corporate Europe Observatory said: “The regulation should be revised to ban industry lobbyists from EFSA’s management. Instead, there should be more representatives from consumer and also environmental organisations on the board.”
Some of the previous members of the Management Board have come under attack for conflicts of interest, especially its chair, Diana Banati. The new board members will be installed in the next few months. Research by CEO showed that individuals linked to industry occupied four places on the current management board [ref1]. The management board plays an important role in EFSA, approving its working program and deciding which scientists are selected for the expert panels. The Board is also crucial for establishing internal rules on conflicts of interest at the Authority.
Christoph Then, Testbiotech, email@example.com, Tel. 015154638040, www.testbiotech.org
Nina Holland, Corporate Europe Observatory (CEO), firstname.lastname@example.org, Tel. +32 (0)2 893 0930, Mobile: +31 (0) 6 302 85 042 , www.corporateeurope.org