EU Ombudsman: EC Should Work to Determine Conflicts of Interest

The European Commission should take additional steps to ensure that experts sitting on scientific committees that make decisions on medical products are truly independent.

That’s the recommendation of EU Ombudsman Emily O’Reilly following an inquiry into a complaint filed by a nongovernmental organization representing women who received faulty breast implants manufactured by the now defunct Poly Implant Prothèse.

The NGO was unhappy with some of the conclusions made in a 2014 report on whether women with the implants should undergo preventive surgical removal. The group maintained that an expert had a conflict of interest and should not have participated in drawing up the report.

O’Reilly determined the expert had not declared all of his interests; however, upon the EC’s request, he produced evidence indicating he did not have conflicts of interest.

O’Reilly adds that the EC was correct when it determined that the expert did not have a conflict of interest in this case; that said, the NGO also was right to be concerned that the commission did not initially have the necessary information to ascertain the expert’s independence.

Moving forward, the commission should verify the independence of members of the Scientific Committee on Emerging and Newly Identified Health Risks and external experts when they are appointed, O’Reilly says.

Her decision does not deal with the scientific conclusions in the report.

PIP was exposed in 2010 for making and selling breast implants from industrial-grade silicone instead of from medical-grade silicone. More than 400,000 women received the implants in 68 countries before they were pulled from the market that same year.

Read the ombudsman’s recommendation here: www.fdanews.com/11-15-EU-PIP.pdf. — Jonathon Shacat