Rema Nagarajan,TNN | May 25, 2014, 06.23 AM IST


The World Health Organization is drawing flak from public health organizations for its participation in a pharmaceuticalindustry backed conference, which they say aims to serve only business interests. 

NEW DELHI: At the ongoing 67th World Health Assembly in Geneva, public health organisations have objected to the World Health Organization’s (WHO) participation in the International Conference on Harmonisation (ICH), which they describe as “a de facto standard setting body set up by transnational pharmaceutical industry to serve their business interests”. Raising the bar on manufacturing standards and using these standards to keep out companies from developing countries has been of great concern especially to the Indian pharmaceutical industry which exports 50% of its $10 billion annual generic medicine production.

A statement issued by Medicus Mundi International Network (MMIN) and People’s Health Movement (PHM) stated that while ICH sought to raise the bar on acceptable manufacturing standards and to globalise these; higher standards beyond a point, do not add to medicines quality and public health outcomes. “It adds to the cost of manufacturing and is a barrier to the entry of generics in low and middle income countries (L&MIC),” said the statement

International Conference on Harmonization (ICH) in which majority of the WHO member countries have no voting rights is dominated by pharmaceutical industry groups. The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), closely involved with ICH since its inception, hosts the ICH secretariat in Geneva. So, the two share the same address –15, chemin Louis-Dunant, PO Box 195, 1211 Geneva-20. IFPMA participates in the steering committee of the ICH as a non-voting member. Six voting members of the ICH steering committee include the European Federation of Pharmaceutical Industries’ Associations (EFPIA), the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Japan Pharmaceutical Manufacturers Association (JPMA). The WHO is just an observer in ICH.

The joint statement of MMIN and PHM on one of the agenda items at the world health assembly (WHA) on regulatory system strengthening said that ICH compromised the neutrality of the process of setting regulatory norms and standards and urged member states of the WHO to ask for disengagement of the WHO from ICH and for exclusion of the ICH from WHO Expert Committee meetings.

PHM also stated that ICH was an industry body and where industry and public interests were in conflict, the effort of the ICH would bend towards the interests of the corporations.

It also urged member states to call upon WHO to address the issue of unethical clinical trials in L&MIC by developing a global mechanism under the aegis of the WHO for registration of clinical trials and to monitor all ethical issues regarding these trials. “In many low and middle income countries, non-transparent procedures make it impossible to obtain accurate information about clinical trials,” said the statement.

In PHM’s commentary on the agenda on regulatory standards it suggested that WHO work with member states to develop a framework for regulatory oversight of the quality of Active Pharmaceutical Ingredients (APIs), the basic chemicals needed to manufacture drugs, since APIs are manufactured in different countries and national regulatory authorities might not have jurisdictional authority over them.