Source: The Times of India
11 June 2014
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
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
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.