EC, EU and WHO share 'need to know' private drug data

22-Sep-2015 - Last updated on 23-Sep-2015 at 12:03 GMT

The three organisations have been collaborating since the International Conference on Harmonisation

European regulators and the WHO have begun sharing confidential information about drug applications, quality, and inspections under a new agreement.

The European Commission, European Medicines Agency and World Health Organization said they started to “step up cooperation” on EU medicines to help protect global public health on September 1.

The organisations will share information not known to the public about the safety, quality and efficacy of on-the-market pharmaceuticals and drug candidates under review.

This includes post-authorisation pharmacovigilance data, especially adverse reactions and periodic safety update reports. It will also cover information in new drug applications on scientific advice, orphan medicine designation, marketing authorisation and post-authorisation activities of significant public health interest.

The groups will also swap data related to inspections, manufacturing facilities and clinical research, especially applications for clinical studies in children.

The collaboration will speed access to new medicines, avoid duplication of assessments and improve the safety of medicines, the organisations said.

Trade secrets

In a letter to Marie-Paule Kieney, WHO Assistant-Director General, the heads of the EMA and EC wrote that confidential information may be shared with people within each organisation “who have a need to know,” including staff at DG Santé, EMA, and WHO, as well as “national experts on secondment,” members of their scientific committees, European national regulators, and consultants.

The agreement does not overrule limits on information-sharing from “specific interests” or “legal obligations,” said the letter, including “commercial, industrial or professional secrecy.”

“In some cases, exchange of information under this arrangement may be subject to prior authorisation from third parties concerned, including the person and/or organisation from which the information emanated,” wrote EC Health and Food Safety head Ladislav Miko and Deputy Executive Director of the EMA, Andreas Pott.

The arrangement follows previous data-sharing agreements between the WHO, EC, and EMA, including the International Conference on Harmonisation and the International Pharmaceutical Regulators Forum.