[Ip-health] MEPs questions to the Commission on ACTA and access to medicines
malini.aisola at keionline.org
Thu Jun 3 14:36:56 PDT 2010
Below are 3 written questions that some members of the European
Parliament have posed to the Commission about whether ACTA may undermine
access to medicines and constrain future policy options.
1. Written question by MEPs Yannik Jadot, Carl Schlyter, Christian
Engstrom, Sandrine Belier, June 3, 2010
Does ACTA undermine delinkage of medicine prices and R&D costs?
The 63rd World Health Assembly in May 2010 gave the WHO a
mandate to identify new financing and incentive mechanisms for
R&D, examine proposals that de-link the price of health products
from costs of R&D including through the award of innovation
inducement prize funds, new open source drug development models,
and to explore instruments for global coordination and norm
setting such as a Biomedical R&D Treaty.
ACTA norms for injunctions and damages may foreclose new
"liability rule" approaches for IP that operate within a policy
framework that de-links R&D costs from product prices. The ACTA
text conspicuously lacks legally binding references to the Doha
Declaration on TRIPS and Public Health, and the WHO Global
Strategy and Plan of Action on Public Health, Innovation and
Intellectual Property (WHA61.21) in ACTA.
We remain troubled by the absence of policy coherence
reconciling ACTA's focus on enforcement at any cost with
obligations under the Doha Declaration to interpret and
implement the TRIPS Agreement "in a manner supportive of WTO
members' right to protect public health and, in particular, to
promote access to medicines for all."
We note that the "Council Conclusions on the EU role in Global
Health" endorses "exploring models that dissociate the cost of
Research and Development and the prices of medicines in relation
to" the Global Strategy. ACTA may constrain future policy
options to implement such policies.
Can the Commission provide an answer regarding the obvious lack
of policy coherence and an assessment of whether the EU's being
party to ACTA and its negotiating positions in this context are
consistent with its obligations under the other international
2. Written question by MEPs Yannik Jadot, Carl Schlyter, Christian
Engstrom, Sandrine Belier, June 3, 2010
Lack of safeguards in ACTA undermining access to medicines
In the WTO TRIPS Council, the enforcement of intellectual
property is a topic of formal discussions, including but not
limited to discussion of ACTA. The WTO is also the forum at
which India and Brazil are pursuing consultations with the EU
over the seizures of in-transit generic drugs on the grounds of
alleged patent infringement.
In our reading, ACTA pursues heightened enforcement but without
the balance and safeguards embodied in the TRIPS Agreement, such
as Article 1, 6, 7, 8, 30, 31, 40, 41, 42 and 44.2 of the TRIPS.
Certain measures in ACTA may present barriers to trade in
legitimate generic medicines, by failing to provide protections
for goods-in-transit where national patent landscapes differ,
allowing inappropriate seizures of medicines on mere allegations
that trademarks are similar, providing brand name companies with
inappropriate access to confidential information about suppliers
or customers, or by introducing new global norms on third party
liability and criminal sanctions for aiding and abetting
infringement that will deter distributors and customers from
working with legitimate generic firms. Collectively these news
norms may frustrate the ability of countries to avail themselves
of TRIPS flexibilities needed to ensure access to medicine, and
present a conflict with the recently adopted "Council
Conclusions on the EU role in Global Health." (e.g. para 16. a.)
Will the Commission fulfil the EP's March 10 request for an
impact assessment of ACTA and "consult with Parliament in a
timely manner about the results of the assessment"?
Specifically, will it address access to medicines including the
concerns we have put forth? How will the Commission reconcile
the EU's stated commitments to promote global health with what
is being pursued in ACTA?
3. Priority written question by MEP Ska Keller, May 31, 2010
ACTA and ongoing WTO dispute settlement proceedings
India and Brazil have initiated action against the EU over the
seizures of generic drugs in transit through the WTO dispute
settlement process. I hope that the matter will be resolved in
this initial phase during the period of consultation.
Is the Commission aware of concerns voiced by India during a
Greens/EFA briefing on ACTA on May 4, related to proposed TRIPS
plus provisions in ACTA that could threaten legitimate trade in
generic medicines and global public health?
How can the Commission pursue such provisions in ACTA that
clearly breach commitments under the Doha Declaration on the
TRIPS Agreement and Public Health and the "Global strategy and
plan of action on public health, innovation and intellectual
property", WHA Resolution 61.21 and are obviously linked to the
dispute settlement proceedings against the EU?
How will the Commission ensure that these unjustifiable
provisions being pursued in ACTA and that would endanger access
to medicines, will stop immediately? In the March 10 Resolution
on the transparency and state of play of the ACTA negotiations,
we clearly asked the Commission to limit the ACTA negotiations
to combating only counterfeiting. I want to know if patents are
still being considered within the scope of ACTA. I also want to
know whether the Commission has made any effort to consult with
public health groups to understand their concerns regarding the
impact proposed ACTA provisions could have on innovation and
access to medicines.
Knowledge Ecology International
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