Generics are more than 50% of global prescriptions, equal participation in all aspects of management and standards-setting in International Conference on Harmonization best serves public health.
LISBON, PORTUGAL (November 10, 2014) - Statement by David Gaugh, International Generic Pharmaceutical Alliance (IGPA) Management Committee Representative:
“The International Generic Pharmaceutical Alliance (IGPA) met yesterday with the Steering Committee of the International Conference on Harmonization (ICH) to present details on the IGPA request to gain ICH Executive Board membership. IGPA member associations represent companies making more than half of prescriptions worldwide. IGPA also represents companies that have moved into developing and manufacturing biosimilar medicines.
Having participated in ICH since 1997, we have the utmost respect for ICH and what it has accomplished. What we seek now is a seat on the ICH Executive Board (formerly the Steering Committee). The Executive Board will perform the executive function for ICH. The ICH executive function has historically been performed by global regulators and brand pharmaceutical industry representatives, without the beneficial input that the generic industry can provide. Even administrative decisions can significantly impact the outcome of a proceeding. We believe the generic industry should be a full part of those discussions and decisions.
If IGPA is permitted to join the ICH Executive Board, it would fully participate in all decisions relating to ICH management and harmonization of global drug quality, safety, and efficacy standards. We would like to be full participants so that we can help ICH to represent public health in the 21st century.
We were grateful for the opportunity to address the Steering Committee. We are optimistic about what we heard at today’s meeting, and we look forward to contributing our scientific expertise to all important ICH discussions as a member of the ICH Executive Board.”