Commission Speech (SPEECH/11/656), 12 October 2011

EFSA - Ensuring the delivery of solid scientific advice through safeguarding the independence of EFSA

Speech by John DALLI, Commissioner for Health and Consumer Policy at the EFSA consultative workshop: "Independence and scientific decision-making processes"

Ladies and Gentlemen,

I am pleased to be here today to close the European Food Safety Authority's workshop on Independence and Scientific Decision-Making Processes. The common objective shared by all institutions in the run-up to EFSA's creation, was to establish an independent scientific body capable of offering independent and solid scientific advice.

That central element of independence remains as relevant today as it was ten years ago!

Let me first recall, very briefly, the foundations upon which EFSA was built:

First, the independence of the agency itself, and of its work, is ensured by various provisions in the Regulation that established the Authority in 2002.

Second, its independence is also assured by the transparency of the way it operates, through:

• the publication of scientific opinions including – where applicable – minority opinions;
• the publication of agendas and minutes of EFSA meetings; and
• the publication of the declarations of interest of the members of the Management Board and of the members of the Scientific Committee and Panels.

And third, EFSA has improved its communication, in particular on the issue of Declarations of Interest and potential Conflicts of Interest, and has created a specific section on independence on its website.

If an expert fails to report a relevant interest, it is important that an ex post review system is in force and appropriate and coherent actions are really taken, concerning both the person in question and the related output. This tool was introduced by EFSA and is working now!

EFSA has also developed a breach of trust policy and, so far, it is the only one of the agencies under the supervision of the Commission's Health and Consumers Directorate General to have done so.

Finally, EFSA has developed a new IT tool, which constantly monitors the Declarations of Interests process. This is an effective tool which I would encourage EFSA to share with the other agencies.

All these efforts are collectively producing tangible results!

In the past years, progress has not only been made in one agency, but by all relevant agencies and non-food Scientific Committees.

Indeed, the agencies have upgraded their policies on independence:

• the European Medicines Agency (EMA) adopted a new policy in October 2010;
• the European Centre for Disease Prevention and Control (ECDC) followed suit in November 2010 and is now awaiting the reply of the European Data Protection Supervisor; and
• EFSA has presented its revised policy for consultation.

All these changes constitute significant progress and further contribute to the strengthening of the independence of the scientific advisory process.

From the Commission's side, we have created a task-force to identify best practices and options for further improvement of the Declarations of Interest and Conflicts of Interest procedure.

The Commission is, however, well aware of the possible impact that further obligations in relation to Declarations of Interest might have on the experts' availability and motivation.

Unfair requirements or extreme heavy procedures might lead to problems in attracting the required expertise, or might serve to de-motivate experts. This could be a serious area of concern given that excellence is key to the value of the advice and, ultimately, to our science-based EU policies.

All Declaration of Interest systems rely on written information which candidates, or experts, are expected to provide openly and in full. Requirements for such information must be pitched at the right level so as to enable thorough scrutiny.

Preventing scientists from having any ties whatsoever with industry, or parties with particular interests, is not only unrealistic, but could very well have a negative impact on the level of expert advice we receive.

Therefore, declaration-of-interest forms are only one of the components of independence. Their publication helps to ensure that interests are declared in an accurate manner, as any failure to do so may be spotted by third parties.

We must also remember that scientific advice is always the result of collegial discussion – not an individual process.

A further guarantee lies in the fact that scientific outputs are, ultimately, endorsed or adopted by a majority.

This, together with the multidisciplinary presence in Committees and Panels, ensures the independence of scientific outputs.

AND finally let us not forget, that the perception of independence is often as important as the independence itself. Take, for example, GMOs or aspartame in relation to EFSA's work; or electromagnetic fields or fluorides in drinking water under the remit of the non-food Scientific Committees.

Negative perceptions arise and endure despite the fact that a robust Declarations of Interest and Conflicts of Interest procedure is in place and is thoroughly applied.

Clearly, agencies and the non-food Scientific Committees are most likely to be challenged in sensitive areas with strong political engagement of stakeholders.

But as outlined before, considerable efforts have already been made to adapt the systems of the agencies and of non-food Scientific Committees to increasing demands and levels of scrutiny.

Increased transparency throughout the whole process, excellence, collegiality and a solid scientific output are four essential tools for challenging and balancing the scientific debate and for guaranteeing the independence of scientific outputs.

However, all our efforts are not – and never will be – 100% infallible!

Another important point that we should keep in mind is that agencies are independent, but they are accountable.

"Watchdog" functions are in place for this purpose:

• The agencies are submitted to the agencies' internal audit and the Commission's Internal Audit Service (IAS).

In addition, the agencies' Executive Directors can commission external evaluations whenever considered necessary, and all founding regulations provide for an external evaluation of the functioning of the agency every 5 to 6 years. In this respect:

• EFSA hhas been monitoring the effectiveness of implementation of its policy of independence via an external review, demonstrating that the procedures are rigorously and impartially applied with an estimated margin of error between 1% and 2%.
• EFSA was audited by the Internal Audit System of the Commission (IAS) in 2009 and it concluded that EFSA's Declarations-of-Interest and Conflicts-of-Interest policy was satisfactory and well implemented.
• EFSA's policies have been checked and compared to those of other EU and international organisations.

In conclusion I can underline that over the years the independence provisions have been strengthened considerably and have contributed significantly to the fact that EFSA's reputation is one of a truly independent body offering solid scientific advice.

EFSA's rigorous scientific output has been the very backbone of many of our legislative initiatives. It has also been the basis of our risk management decisions, some of which have dealt with very serious threats to the food chain – the recent E. coli crisis being a very good example.

But despite all this impressive progress, we must never rest on our laurels – especially when dealing with issues of food safety which have a direct impact on the health of citizens.

We have to remain vigilant and keep doing our outmost to further improve our systems.

We must continue to safeguard the independence of our scientific advice and ensure that it keeps improving.

This path has clearly proven its value over the years – and this is precisely the path we will continue to follow.

Thank you.