[Ip-health] Intl civil society groups call upon ICDRA participants to ensure access to affordable biotherapeutic products

K.M. Gopakumar kumargopakm at gmail.com
Sun Aug 31 23:14:50 PDT 2014

 Intl civil society groups call upon ICDRA participants to ensure access to
affordable biotherapeutic products   Ramesh Shankar, Mumbai
 Monday, September 01, 2014, 08:00 Hrs  [IST]

A group of international civil society organizations including All India
Drug Action Network (AIDAN)  from India have called upon drug regulatory
authorities, WHO, Member States and other participants of the ongoing Pre
and International Conference on Drug Regulatory Authorities (Pre-ICDRA and
ICDRA) to act to ensure access to affordable biotherapeutic products. They
also called for a regulatory regime in the world which facilitates
competition and price reduction.

While the Pre ICDRA was held from 24-25 of August, the ICDRA was organised
from 26 to 29, August.

Stating that it is time to act to ensure access to affordable
bio-therapeutic products, the civil society organisations said that the
access to bio-therapeutics can play an important role in the fulfillment of
the human right to health and peoples’ right to enjoy the benefits of
scientific progress and its applications.

The exorbitant price of bio-therapeutic products places them beyond the
reach of millions of people who need them. In addition, exorbitant price
also makes it impossible for governments to include biotherapeutic products
in the public health programme in a sustainable manner and without
compromising the allocation of funds intended for other equally important
health services and technologies, it said.

The civil society organisations in their Pre-ICDRA and ICDRA statements
called upon the participants to ensure enjoyment of right to health and
right to enjoy the progress of science and technology through appropriate
regulation of biotherapeutics and do not view regulation as an end in
itself; to implement the directions provided in the WHA 67.21; to develop
an appropriate regulatory framework for biotherapeutic products that ensure
universal access to affordable, safe and efficacious biotherapeutic
products; and to ensure a regulatory framework which facilitate effective
competition in the biotherapeutic market instead of making the regulation
an unnecessary technical barrier itself.

The civil society organisations also called upon the participants to review
WHO Guidelines on biotherapeutic products/medicine based on the accumulated
scientific and technology advancement, in a transparent manner with utmost
care for avoidance of conflict of interest and including representative
Governments in the setting and discussion process. Besides, they also
called upon the participants to stop attempts for the creation of separate
INN regime for bio-therapeutic products/medicine; to insist for the full
disclosure of data and relevant information on clinical trials and
manufacturing process by the originator companies; and to make sure that
regulatory framework is guided by public health needs and to move away from
the corporate driven regulatory norms and setting process.

Some of the signatories to the statement include Associação Brasileira
Interdisciplinar de Aids (Brazil), Centro de Información de Medicamentos de
la Universidad Nacional de Colombia (CIMUN) (Colombia), Fundación GEP
(Argentina), Health Action International (HAI)Third World Network (TWN),


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