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[If anyone is concerned about ACTA and the rentier class that drives
the agendas of the first world, see below for how these Intellectual
Property Rights issues play out in arguably a more fundamental
right, the right to health... all this hullabaloo when under WTO
TRIPs agreement, developing countries have the right to issue a
compulsory license (to copy) on any IPR, which was confirmed by a
WTO declaration (after Big US Pharma vs Mandela!).. so this was an
instance of developing countries arguing for the right to use legal
rights! <br>
<br>
So after strengthening these rentier forces over the years, the
demands for ACTA have come to full bloom that would make things
harder than they are ... I guess its time once again for a "Welcome
to the Third World" as the transparency and accountability in the
formulation of ACTA would make any Tin Pot dictator green with
envy... especially as it has democratic "legitimacy" served sans
transparency... ]<br>
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<p class="MsoNormal"><span lang="ES-AR"><a moz-do-not-send="true"
href="http://www.euractiv.com/health/acta-access-medicines-flawed-process-rationale-agreement-analysis-511408">http://www.euractiv.com/health/acta-access-medicines-flawed-process-rationale-agreement-analysis-511408</a><o:p></o:p></span></p>
<p class="MsoNormal"><span lang="ES-AR"><o:p> </o:p></span></p>
<p class="MsoNormal"><span lang="ES-AR">Euractiv </span><o:p></o:p></p>
<p class="MsoNormal">Published 08 March 2012 - Updated 09 March
2012<o:p></o:p></p>
<p>The Anti-Counterfeiting Trade Agreement (ACTA) has been
characterised by a flawed process of negotiations based on a
flawed rationale, which has resulted in a flawed agreement,
argue Sophie Bloemen and Tessel Mellema from Health Action
International Europe. One of the concerns now is that – designed
to be a global norm-setting instrument - ACTA could deter
generic competition of medicines around the world.<o:p></o:p></p>
<p><em>Sophie Bloemen is advisor and Tessel Mellema is project
officer to Health Action International Europe. Both work on
HAI’s trade, innovation and access to medicines campaigns. The
following is a summary of a policy brief that can be found <a
moz-do-not-send="true"
href="http://haieurope.org/wp-content/uploads/2012/02/27-Feb-2012-HAI-Europe-Policy-Brief-ACTA-and-Access-to-Medicines.pdf">here</a>.</em><o:p></o:p></p>
<p><strong>ACTA’s flawed process: a problem because ACTA
strengthens substantive rights</strong><o:p></o:p></p>
<p>Contrary to the claims of its proponents, ACTA not only
enforces existing Intellectual Property Rights (IPRs), it
strengthens the substantive rights of IP rights holders and goes
well beyond the European Union (EU) acquis and the TRIPS
Agreement. This expansion of rights makes ACTA’s lack of
transparency and accountability even more urgent: ACTA
negotiations have not only bypassed existing multilateral
institutions, like the WTO and WIPO, but also the European
Parliament, and the voice of broader public interest groups.<o:p></o:p></p>
<p>Further, the establishment of the ‘ACTA Committee’ - designed
to function as a new plurilateral institution and to operate
behind closed doors - gives rise to serious concerns for the
future accountability and transparency of global IPR enforcement
norm-setting.<o:p></o:p></p>
<p><strong>ACTA’s flawed rationale: confusion between counterfeit
and generic medicines</strong><o:p></o:p></p>
<p>The rationale behind ACTA, adopting the label
‘anti-counterfeiting’ and linking it to public health, is
frankly misleading. ACTA not only deals with counterfeits and
pirated products, but targets many other kinds of IPR
infringements. This contributes to a damaging confusion between
crucial legitimate generics and counterfeit
medicines. Counterfeit medicines are defined by the World Health
Organisation (WHO) as ‘medicines that are illegally and
deceptively mislabeled with respect to identity and/or source’.
TRIPS limits its definition of what constitutes counterfeit to
clear cases of such fraud: the use of a sign that is identical
to the brand owner’s trademark. It is only this specific type of
IPR infringement that can be directly linked to trade in
dangerous counterfeits, patent infringement and civil trademark
infringement have in principle nothing to do with this.<o:p></o:p></p>
<p>By conflating specific IPR enforcement measures to combat
counterfeits with other types of IPR enforcement, the risk of
right-holders using these measures to target legitimate generics
is increased. This risk should not be taken lightly: the lesson
learned from the DG Competition Pharmaceutical Sector inquiry in
2009 is that IPR enforcement provisions have been abused to
delay generic competition and hamper innovation. This has cost
European health budgets and consumers billions of extra euros.
The increase in global IPR enforcement proposed by ACTA does not
therefore serve public health or EU consumers by definition.<o:p></o:p></p>
<p><strong>Flawed outcome: ACTA’s implications for access to
medicines by chilling generic competition.</strong><o:p></o:p></p>
<p>Although the exact impact of ACTA measures will depend on how
signatory States use the limited space awarded for
implementation, it is certain to have a chilling effect on
generic trade. This happens especially when the threat or risk
of sanctions or litigation becomes too high for generic
companies or producers of active ingredients to engage in the
production or trade of legitimate generics. ACTA offers IP
right-holders several such far-reaching enforcement rights.<o:p></o:p></p>
<p>As mentioned, the scope of enforcement measures goes way beyond
counterfeiting – which is the willful use of an identical
trademark. For example, in ACTA’s section on general civil IPR
enforcement measures, patents are still in by default. Moreover,
civil trademark infringements are included as a ground both for
civil IPR enforcement measures and to detain generics at the
border - whether destined for export, import or just passing in
transit.<o:p></o:p></p>
<p>The lesson learned from Dutch & German seizure cases (2009)
is that customs authorities’ capacity to stop generics should be
limited to cases of alleged counterfeiting. A broader scope
strengthens IP right-holders’ substantive rights and increases
the risk and threat of right-holders abusing their right to
request the detainment of goods at the border to hamper trade in
generics. <o:p></o:p></p>
<p>Another problem is that ACTA’s broad third party liability puts
a large group of third parties at risk of criminal and civil
enforcement measures: this group may even include suppliers of
active ingredients for generics or NGOs procuring legitimate
generics for treatment. This could act as a significant
deterrent to anyone involved in the provision of affordable
generic medicines.<o:p></o:p></p>
<p>Both the broad scope of IP rights, and broad third party
liability, makes ACTA’s bias in favour of IP right-holders of
great concern. Especially since this bias is mirrored by an
absence of sufficient abuse-deterrence mechanisms. Two biased
enforcement provisions stand out in their potential chilling
effect on generic competition: Firstly, ACTA puts parties
involved in generic trade at risk of very high damages.<o:p></o:p></p>
<p>This risk may work as a disincentive for competitors to explore
the inherently grey area of IP infringement. Secondly, ACTA
provides the right-holder with the strong weapon of provisional
measures - allowing them to issue a prompt injunction or request
seizure of generics, without the other party being heard and
without a full judicial review by the court - while providing
hardly any procedural guarantees for the defendant.<o:p></o:p></p>
<p><strong>Future implementation: special concern for impact
developing countries</strong><o:p></o:p></p>
<p>Considering ACTA’s new IPR enforcement standard is intended to
become the global norm, concerns become all the more immediate.
It is likely that developing countries will not use the
available room for implementation to adapt standards to local
needs, as there will be pressure not to do so from ACTA’s main
drivers. The risk of chilling generic competition is even
greater in the absence of proper competition laws to punish
abuse and the resulting higher prices will have an unacceptable
impact on the affordability of medicines. Finally, the costs of
implementation of this new body of law will present a burden for
the limited public budgets of developing countries. <o:p></o:p></p>
<p>Increasing IP right-holders’ rights requires a transparent and
participatory approach with a clear view on the interests that
the EU wishes to protect by such expansion and the impact on
society. Instead, ACTA uses a blurred rationale and an
undemocratic and opaque process to establish a global new
standard of IPR enforcement, which is already reason for serious
concern. In addition ACTA offers IP right-holders several
far-reaching enforcement rights that could have a chilling
effect on generic competition, crucial for ensuring access to
affordable medicines around the world. The conclusion can only
be that ACTA is unacceptable and the EU should not ratify it."<o:p></o:p></p>
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