The change (detailed below) initially looks like a takeover by regulators and I’m sure many will paint it that way. However, I see it as a correction of the balance of power in the ICH, the ICH has been criticized for being industry leading and controlled, and the guidance produced has a detrimental effect on world trade. Furthermore, as the guidance is produced by the ICH and filters through the regulatory systems of members in law, and in non-ICH member states that perceive it as a gold standard, strict standards become very difficult for small local manufacturers to meet. These smaller manufacturers often provide generic drugs for local markets in less developed countries. Therefore, they are forced out of their own markets and definitely excluded from ours.
In effect the industry influence at the top of this funnel was seen as detrimental and protectionist I think the WHO has commented on this in the past they are a non-voting observer of ICH proceedings this rebalancing of ICH will be instrumental in addressing this probably valid criticism.
Also, since the industry partly pays for ICH and votes on its policies, the industry associations thought they must have accepted the change or it wouldn’t happen.
The details
The six official parties to the ICH agreed to new governance principles that better define the roles of regulators and industry within the ICH. This action will highlight ICH’s longstanding premise that regulators have ultimate responsibility for ensuring the protection of public health, in addition to their competence to issue regulatory guidance.
ICH will continue to be driven by consensus and will strive to remain at the forefront of scientific and technical advances in the pharmaceutical field. This will require the continued close cooperation between regulatory experts and the pharmaceutical industry that has been instrumental in providing the best scientific and technical information in ICH product development, but with some changes. In future, EWGs will be chaired by a representative of the regulators who will be responsible for ensuring regulatory oversight as well as the integrity of the entire process. In addition, ICH’s current four-step procedure for work products will be revised to provide a clear distinction between the gathering of scientific and technical information in a “white paper” by experts, and the development of this document. in a regulatory ICH guideline by regulators
In circumstances where regulators and industry may not have the same interests or priorities with respect to a particular harmonization activity, the new principles allow ICH to proceed with a proposed topic for harmonization provided it has the support of the three ICH regulatory parties, regardless of whether this issue is supported by industry parties.
The current Step 3 public consultation procedures will be maintained within the three regulatory parties, as well as through the ICH, observers and WHO contact points. Transparency will be further increased by posting information about the ICP process on the IPC website, including the posting of “white papers”. These principles will be incorporated into the revised Rules of Procedure to be adopted at the next meeting of the ICH Steering Committee.
