[Ip-health] Pharma-funded patients’ groups pushing industry agenda on biosimilars

Andrea Carolina Reyes Rojas asistenciatecnica.misionsalud at gmail.com
Mon Sep 1 16:32:58 PDT 2014


*Pharma-funded patients’ groups pushing industry agenda on biosimilars*

Rema Nagarajan, TNN | Aug 29, 2014, 05.13PM IST

NEW DELHI: Civil society groups working to improve access to medicines have
protested against the participation of NGOs, especially patients' groups
receiving substantial funding from pharmaceutical companies, in the meeting
on quality and safety of biosimilars which was held before the
International Conference of Drug Regulatory Authorities (ICDRA) in Rio,

Biosimilars is a biological medicine that is similar to another biological
medicine that has already been authorized for use. The regulation of
biotherapeutic products particularly biocompetitors and its impact on
access to affordable safe and efficacious biotherapeutics has been a
subject of controversy as pharma multinationals holding patents on an
original biological medicine have been arguing that biosimilars by
definition are not likely to be identical to the originator biologic.

However, civil society groups working on increasing access to medicines
have argued that pharma companies were using this argument to keep out
cheaper copies of biologics which are going off patent from coming to the
market. These groups pointed out that the main reason for biotherapeutics
being exorbitantly prices was the high degree of entry barriers, which
favoured the commercial interests of the originator pharmaceutical industry
and eliminated effective competition aimed at driving down the price. While
the ICDRA conference is restricted to government officials and drug
regulatory authorities of WHO member states, the pre-conference meeting on
biosimilars taking place at the same location was open to industry to
engage in a discussion on biosimilars.

Some of the patient groups who were part of the pre-conference meeting were
ABRALE - theBrazilian Association of Lymphoma and Leukemia, founded in 2002
by a group of patients and families, International Alliance of Patient
Organisations (IAPO) and Alliance for Safe Biologicscomprising diverse
healthcare groups and individuals, from patients to physicians,
biotechnology companies that develop innovative and biosimilar medicines.
All three receive significant funding from multinational companies
including GSK, Medtronic Foundation, Johnson & Johnson, Merck, Novartis,
Pfizer and so on.

In a position paper on patients' groups and industry funding titled
"Unhealthy Influence" brought out by Health Action International (HAI)
Europe, a non-profit which campaigns for access to and rational use of
medicines, HAI pointed out that patients' groups like IAPO offered
pharmaceutical industry credibility by taking positions that were harder to
refute coming from a patients' organization than from a company. It further
stated that often such patients' groups refrained from criticizing the
industry even when they acted against the interest of the patients the
group claimed to represent. HAI also talked about the difficulty in
assessing pharma influence on patients' groups due to widespread failure to
publish accounting/financial data of these groups.

On patients' groups at the pre-ICDRA meeting, Marcela Vieira of ABIA
(Brazilian Interdisciplinary Aids Association ) said, "Unfortunaly all NGOs
that were invited by the organizers to speak at the Pre-ICDRA are heavily
funded by the big pharma. ABRALE receives more than half of its annual
budged from multinational pharmaceutical companies. That raises questions
about which interests they are actually defending, if it is the best
interest of the patients or the commercial interests of their funders." She
went on to to say that in topics such as intellectual property, which is a
known barrier to access to medicine, it was very difficult for
access-to-treatment activists to see a patient group calling for greater
protection of intellectual property of biotherapeutics, as ABRALE did in
their intervetion at Pre-ICDRA.

K M Gopakumar of Third World Network, a non-profit international network of
organizations and individuals involved in issues on development and the
Third World also participated in the pre-ICDRA meeting. Gopakumar said that
it was unfortunate that Pre-ICDRA conference speaking slot were given to
only those NGOs, which are receiving funds form pharmaceutical
transnational corporations. "This gives an opportunity for pharma to convey
the message suitable to the industry interest as NGO's voice. In this case,
the message was often conveyed as messages from patient's groups. WHO
should not facilitate the backdoor entry of pharma voices through pharma
funded NGO. WHO should respect genuine civil society voices," said

The ICDRA conference ended on Friday with the civil society groups issuing
a statement seeking the intervention of the WHO and member states to ensure
a regulatory framework which facilitated effective competition in the
biotherapeutic market instead of making the regulation an unnecessary
technical barrier itself.

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

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