E-DRUG: HAI-Europe comments on ACTA stakeholder consultation EU
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(http://www.haiweb.org/22032010/DGTradeConsultationACTA.pdf )
HAI EUROPE Comments on ACTA stakeholder consultation
Summary
HAI Europe welcomes the opportunity to share our concerns about the
negotiation of a plurilateral Anti-Counterfeiting Trade Agreement (ACTA)
with the Directorate General for Trade of the European Commission.
Because ACTA will establish a global standard of intellectual property
(IP) enforcement, this agreement will have an impact on the developing
world as well as the countries currently in ACTA negotiations. This
potential for global reach makes many of the proposed provisions deeply
concerning.
ACTA negotiations lack legitimacy, transparency and a participatory
approach
The process through which the ACTA negotiations are taking place is
problematic. ACTA embodies a new model of global governance that
bypasses the normal procedures of multilateral international
institutions, the European Parliament and national legislatures.
The negotiations also fail to include the voices of the broader public
and consumers. Given the implications of ACTA for citizens on a number
of issues including access to knowledge and innovation, access to
medicines, privacy, and freedom of expression; democracy and
transparency should be central to this process. HAI calls on the EU and
the other parties to make the negotiating texts public, hold
negotiations at public venues, with an accreditation system that allows
civil society to attend and observe rounds[i].
Confusion between counterfeit and generic medicines
The name of the agreement, the Anti-Counterfeiting Trade Agreement, is
misleading as ACTA negotiations encompass the enforcement of all IP
rights, not limited to those related to counterfeiting, such as
trademark law. ACTA is pursuing stricter enforcement measures for other
areas of IP, such as copyright, patent law, geographical indication,
integrated circuits, designs, potentially undisclosed information, among
others.[ii]
Adopting the label 'anti-counterfeiting' is misleading because it refers
only to part of the substance that is under discussion, and moreover, in
the field of medicines, it contributes to a damaging confusion between
crucial generic medicines and counterfeit medicines. Counterfeit
medicines, defined as those that are illegally and deceptively
mislabelled as to source,[iii] are related to trademark law, but not
necessarily to patent law. Generic medicines, on the other hand, are
related to patent law, as generics have the same active ingredient as an
innovator product but use a different name, appearance or package.[iv]
Generics can only enter the market when there is no patent on the
original product or when the patent has ended.
ACTA addresses a broad spectrum of IP rights including trademark law and
patent law, and therefore, counterfeit and generic medicines. HAI is
concerned that the emphasis on the threat of 'dangerous counterfeits' is
being used to advance a wider IP monopoly enforcement agenda under the
pretext of public health.
ACTA or IP enforcement is not the appropriate way to address the real
health concerns about medicines quality, safety and efficacy
The dominant threat to public health from pharmaceuticals in developing
countries are the problems of sub-standard, adulterated, and
contaminated medicines that affect both branded or generic medicines.[v]
Substandard medicines are a very serious health problem, predominantly
in developing countries, and medicines may contain insufficient or
excessive active ingredient, no active ingredient, or contaminated or
substituted ingredients.[vi]
Halting the trade in unsafe medicines requires better regulation of the
pharmaceutical supply chain from producer to end user, particularly by
strengthening medicines regulatory authorities in developing
countries.[vii] About 20% countries around the world have a robust and
functional drug regulatory system. The systems are obsolete, invalid or
inoperable in another third of the world. The remaining systems fall
somewhere between the two marks.[viii] Clearly, adequate resources are
needed in these agencies to monitor, regulate and ultimately ensure a
safe supply of effective medicines of high quality at the national
level.
Counterfeiting is just one aspect of broader public health concerns
regarding medicines quality, safety and efficacy. Addressing the problem
of counterfeiting will not eliminate the remaining public health
concerns. Improving medicines regulation frameworks to facilitate access
to quality assured medicines is a more cost effective solution than
policies that are excessively focused on patent enforcement measures.
ACTA could chill generic competition and threaten the generics industry
Under ACTA, the position of the IP right-holder would be strengthened to
the detriment of generic competitors, effectively reinforcing market
exclusivity for IP right holders. Enforcement measures could limit the
flexibility currently available to countries under the WTO Agreement on
Trade Related Aspects of Intellectual Property (TRIPS) to protect
consumers through policies that embrace the national, regional or
international exhaustion of intellectual property rights.
The Pharmaceutical Sector Inquiry by DG Competition has shown that abuse
of the patent system by rights holders is a very real threat to generic
competition. These practices are to be feared even more when
strengthening the position of the right holder in environments without
strong competition law, as ACTA will do.
HAI is concerned that the EU will export its far reaching and
controversial regulations on enforcement of IP rights through ACTA and
that this will have a negative effect on access to medicines, especially
in the South.[ix] Injunctions, storage fees and information requirements
that would be imposed on alleged infringers could harm generic
competition, particularly where adequate safeguards or anti-abuse
provisions are lacking. The same holds true for criminal and financial
penalties for patent violations that hold manufacturers of active
pharmaceutical ingredients (APIs) liable.
The application of border measures[x] poses a particular threat to
generic competition where patent rights are enforced on shipments of
generic medicines while in transit. Border measures in the EU have
resulted in numerous seizures of medicines in transit through Member
States' borders in the last year.[xi] These cases include the detention
of a UNITAID/Clinton Foundation shipment of anti-retroviral medicines
passing through the Netherlands, destined for HIV positive
Nigerians,[xii] and the seizure of the antibiotic Amoxicillin in transit
through Germany, intended for the Republic of Vanuatu.[xiii] In these
cases, the private rights of patent holders effectively superseded the
right to access medicines for citizens in developing countries.
ACTA will impose the burden of enforcing private monopolies at public
expense
The implementation of enforcement measures represents significant costs.
The TRIPS Agreements recognize this and therefore state "nothing in this
part creates any obligation with respect to the distribution of
resources as between enforcement of IP rights and the enforcement of law
in general."[xiv] Implementation of ACTA will have significant
opportunity costs and therefore could undermine efforts to identify and
remove dangerous medicines in developing countries. The implementation
of these measures could force countries to channel government resources
into protecting the trademarks and patents of multinational companies.
Private rights are transformed into public responsibilities, where the
burden of enforcing these private rights falls on the public
authorities. Enforcing private rights can pose a significant financial
burden on developing countries and can supplant more pressing public
priorities. Customs officials, policy makers and lawyers need to be
trained to create the necessary national expertise. A more pressing
health priority is ensuring the quality, safety and efficacy of
medicines through proper regulation.[xv] Resources should be focused on
medicines regulatory agencies, but the current focus on IP enforcement
might actually drain capacities and resources from these agencies.