[Ip-health] Civil Society Statement for Pre- ICDRA and ICDRA

Andrea Carolina Reyes Rojas asistenciatecnica.misionsalud at gmail.com
Mon Aug 25 10:27:06 PDT 2014

Dear members of IP - Health

Please find bellow a statement from civil society organizations regarding
the issues addressed by Pre-ICDRA, currently taking place in Rio de Janeiro
(24th-25th August). The statements calls for drug regulatory authorities,
WHO and Member States to act to ensure access to affordable biotherapeutic

ICDRA, which will allow the entrance only to regulators, will take place
from 26th to 29th August.

Best regards,

*Andrea Carolina Reyes Rojas*
Asistente Técnica
Misión Salud
www.mision-salud.org <http://www.mison-salud.org/>




We, the undersigned organizations, bring to the attention of Drug
Regulatory Authorities, WHO, Member States and other participants of Pre
and International Conference on Drug Regulatory Authorities (Pre-ICDRA and
ICDRA) and community in general the following concerns with regard to the
regulation of biotherapeutic products, particularly biocompetitors, and its
impact on access to affordable, safe and efficacious biotherapeutics.

1. The access to biotherapeutics can play an important role in the
fulfilment of the human Right to Health and peoples’ right to enjoy the
benefits of scientific progress and its applications. While, recognizing
the potential of biotherapeutic products in addressing critical health care
needs, due to its recent introduction in to the market, the therapeutic
efficacy and safety of many of them are yet to be fully established.

2. The exorbitant price of biotherapeutic 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 program in a sustainable manner and without
compromising the allocation of funds intended for other equally important
health services and technologies.

3. There is an increasing push from healthcare industry to promote
biotherapeutic products. In 2007 the global market of biotherapeutics was
around 100 billion USD. In 2012 it surpassed 170 billion and it is expected
to reach 250 billion USD by 2020. The promotion of biotherapeutic should
not be driven by market interests, but by the actual health needs of

 4. The main reason for the exorbitant price is the high degree of entry
barriers, which favors the commercial interests of the originator
pharmaceutical industry and eliminates effective competition aimed at
driving down the price. Generally speaking, there are two levels of
barriers around biotherapeutic products that reduce access: i) intellectual
property rights (patent and trade secret) and ii) unnecessarily stringent
regulatory framework. Since the patent protection on many biotherapeutic
products is about to expire, originator companies (mainly pharmaceutical
transnational corporations - TNCs) are making huge effort to build
unnecessary regulatory wall to prevent competition. This compromises the
access to biotherapeutics products and the possibilities and feasibility of
enhancing and strengthening national manufacturing capabilities.

5. The current WHO guidelines are based on the ICH standards, an exclusive
club of originator companies and drug regulatory authorities of US, EU and
Japan, for the regulation of biosimilar medicines. The WHO Guideline
creates an entry barrier by insisting on comparative exercises and/or
studies with the originator product as a precondition to approve a
biotherapeutic products/biosimilar. This compromises access to affordable
biotherapeutic products as in the case of mainstream pharmaceutical
products (small molecules) by curbing the possibility of effective

6. In the light of historic evidence on these medicines, accumulated
scientific and regulatory experience we call upon Governments and
Regulatory Authorities to establish regulatory frameworks that facilitate
access to affordable, safe and efficacious biotherapeutic products.  In
other words the regulation cannot pose a new barrier to competition and
access to affordable biotherapeutic products. Quality is not an end in
itself and the regulation becomes meaningless to people if it impedes
access to affordable medicines.

7. In this regard we draw the attention of Pre-ICDRA and ICDRA participants
to the World Health Assembly Resolution on access to biotherapeutic
products, adopted in May 2014 (WHA 67.21). The resolution urges Member
States “to work to ensure that the introduction of new national
regulations, where appropriate, does not constitute a barrier to access to
quality safe, efficacious and affordable biotherapeutic products, including
similar biotherapeutic products”. And also requested WHO Director General
to update the 2009 WHO Guideline taking into account the technological
advances for the characterization of biotherapeutic products and
considering national regulatory needs and capacities.

8. We congratulate the initiative of the Government of Colombia and other
Governments to make use of an abbreviated regulatory pathway for the
approval of biotherapeutics/biosimilar that prioritize public health needs.
We urge the Colombian Government to resist the pressure from pharmaceutical
TNCs and their home governments like USA and to implement abbreviated
pathway at the earliest.

9. Further we also note that there is an attempt to devise different
International non-proprietary names (INN) system for biologics, which would
give different INNs to follow-on biotherapeutic products (generic). This
would seriously affect the possibility of inter-changeability and limit the
access and competition.

Against this background we call upon the Regulatory Authorities, WHO and
Member States:

·       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.

·       To ensure a regulatory framework which facilitate effective
competition in the biotherapeutic market instead of making the regulation
an unnecessary technical barrier itself.

·       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.

·       To stop attempts for the creation of separate INN regime for
biotherapeutic products/medicine.

·       To insist for the full disclosure of data and relevant information
on clinical trials and manufacturing process by the originator companies.

·       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.


ABIA - Associação Brasileira Interdisciplinar de Aids (Brazil)

Alianza LAC - Global por el Acceso a Medicamentos

All India Drug Action Network (AIDAN) (India)

Centro de Información de Medicamentos de la Universidad Nacional de
Colombia (CIMUN) (Colombia)

Colegio Nacional de Químicos Farmacéuticos de Colombia (Colombia)

Comité para la Veerduria Cuidadana en Salud – CVCSs (Colombia)

Federación Médica Colombiana (Colombia)

Fundación GEP (Argentina)

Fundación IFARMA (Colombia)

Health Action International (HAI)

Misión Salud (Colombia)

Observatorio del Medicamento de la Federación Médica Colombiana –
Observamed (Colombia)

REDLAM - Red Latinoamericana por el Acceso a Medicamentos

Peoples’ Health Movement (PHM)

Third World Network (TWN)

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