At a meeting in Japan last month the International Conference on Harmonisation (ICH) approved changes that give it the power to push through policies that are opposed by industry. The move, which strengthens the position of regulators, is viewed by some as a necessary power shift.
“The change initially looks like a power grab by the regulators and I am sure many will paint it in this light, however I see it as a correction to the power balance at the ICH,” Damien Bove, a drug development and regulatory consultant, told in-PharmaTechnologist.com.
At the meeting in Fukuoka the ICH approved changes that allow it to further harmonise topics backed by all three regulators, even if the proposal lacks industry support. The model is seen as a way to lessen the, possibly negative, influence industry bodies have on the ICH.
Critics of the ICH have described it as being “industry lead and controlled,” Bove said, and these dissenting voices view the influence of commercial groups as “detrimental and protectionist.”
The claims of protectionism stem from ICH standards, which are, to some extent, influenced by Western firms, filtering down to apply to pharmaceutical manufacturers in emerging markets.
Bove said: “These smaller manufacturers often provide generic drugs for local markets in less developed countries, so are squeezed out of their own markets and most definitely kept out of ours.”
The criticisms are, Bove said, “probably valid”. Changes to governance principles re-balance the ICH and are, in Bove’s view, central to tackling claims that industry has a negative influence on the decision making process.
New governance principles agreed at Fukuoka mean a regulatory representative will head each ICH Expert Working Group with responsibility for ensuring regulatory oversight and the integrity of the process.
The new governance principles at the ICH still allow for industry input during the development of topics for harmonisation. Industry input is ‘instrumental’ in developing scientific and technical thinking, the ICH said, but the body has made ‘some changes’ to the harmonisation process.
As well as the changes discussed above, the ICH will make a ‘clear distinction’ between work done by industry and regulators. Industry will support the collation of information into a technical document. Regulators will then develop this into the ICH guideline.
While the moves seemingly lessen the influence of industry it seems likely it agreed to the new governance principles. “As industry partly pays for ICH and votes on its policies through industry associations they must have accepted the change or it would not happen,” Bove said.