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), etc.