WHO's links to ICH under fire amid efforts to strengthen manufacturing regulations

To the casual observer, the International Conference on Harmonisation (ICH) could appear to be a fusty but uncontroversial group. Yet ICH's position in the highly charged debate over how quality standards affect the cost and availability of drugs--coupled with its links to the pharma industry--have made it a target of criticism. 

Nonprofit health advocacy groups Medicus Mundi International Network (MMIN) and People's Health Movement (PHM) are the latest to take aim at ICH, particularly the World Health Organization's (WHO) association with the group. In a joint statement at the 67th World Health Assembly (WHA) last week, the nonprofits urged member states to ask for WHO to sever its ties to ICH, which they view as a puppet of the pharmaceutical industry that cuts the availability of generics by raising quality standards too high.  

The statement was tied to WHA proposals to strengthen the regulatory system, one of which advocated giving increased support for the significant role ICH plays in promoting the exchange of information between regulators. MMIN and PHM fear naming ICH in the WHA resolution "may legitimize norms and standards not based in health needs but in trade protection." The Times of India picked up the story, emphasizing the links between the International Federation of Pharmaceutical Manufacturers and Associations and ICH. 

At WHA the resolution passed but with notable tweaks. ICH is still mentioned by name in one part of the document, but a line about WHO's "appreciation" for the group's role in setting global standards was redacted. Also, many references to "harmonization" and "convergence" were scrubbed from the document, with softer language like "cooperation" and "coherence" taking their place. A call for member states to implement guidance from ICH was also reworked, with the changes again making the language less forceful while emphasizing the role of national and regional groups. 

- read the nonprofits' statement (PDF)
- here's the Times of India's take
- and the WHA resolution (PDF)