[governance] Euractiv - ACTA: a flawed agreement

Riaz K Tayob riaz.tayob at gmail.com
Mon Mar 12 16:12:26 EDT 2012

[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!

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... ]



Published 08 March 2012 - Updated 09 March 2012

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.

/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 here 

*ACTA's flawed process: a problem because ACTA strengthens substantive 

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.

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.

*ACTA's flawed rationale: confusion between counterfeit and generic 

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.

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.

*Flawed outcome: ACTA's implications for access to medicines by chilling 
generic competition.*

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.

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.

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.

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.

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.

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 

*Future implementation: special concern for impact developing countries*

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.

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."

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