[Ip-health] Summary of ACTA consultations with G of Canada on 30 June

[Rachel Kiddell-Monroe]

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[ Picked text/plain from multipart/alternative ]
http://www.international.gc.ca/trade-agreements-accords-commerciaux/fo/summ=
ary-resume.aspxAnti-Counterfeiting
Trade Agreement (ACTA)ACTA and Issues Related to Pharmaceuticals and
Counterfeit MedicinesSummary of Discussions

On June 30, 2009, Foreign Affairs and International Trade Canada (DFAIT)
conducted a stakeholder consultation on the Anti-Counterfeiting Trade
Agreement (ACTA), as it pertained to counterfeit and substandard medicines.
The purpose of the consulation was to continue discussing the issues relate=
d
to counterfeit and substandard medicines, which were raised at the previous
consultation on April 6, 2009. A range of interested stakeholders were in
attendance, including representatives from academia, industry, and
non-governmental organizations. The roundtable was chaired by Canada=92s AC=
TA
chief negotiator Mr. Douglas George, Director, Intellectual Property, at
DFAIT. In addition, government representatives from Industry Canada, Canada
Border Services Agency (CBSA), Royal Canadian Mounted Police (RCMP), Health
Canada, and Public Safety Canada also participated.

Before opening the dialogue, the Chair gave a brief update on the progress
of the ACTA negotiations, summarized the issues related to pharmaceuticals
which were discussed at the previous ACTA consultation, and discussed
Canada=92s approach to some of these topics.

Although there have not been any formal rounds of negotiation since last
December, the negotiating participants met in Geneva on June 11, 2009 and
confirmed their intention to move forward. The parties agreed on the
importance of public transparency throughout the negotiation process. Also,
it was decided that the next round of formal negotiations would be held in
Morocco in July, with Parties aiming to conclude the agreement in 2010.

Government officials addressed three issues related to medicines that arose
at the previous consultation: the issue of in-transit seizures of generic
pharmaceuticals; the role of ACTA in addressing the problem of counterfeit
and substandard medicines; and the proposal to include a =93de minimis=94
exception in the ACTA. The Chair presented these issues with contributions
from other government departments as summarized below.

First, several stakeholders at the previous consultation had expressed
concern over the recent seizures of generic medicines in the European Union=
.
While the specifics of these incidents remain unclear, CBSA confirmed the
unlikely occurrence of a similar situation within the Canadian jurisdiction
due to Canada=92s differing legislation and practices. Further, Canada=92s
position is that the key ACTA obligations should be limited to trademark
counterfeiting and copyright piracy.

Second, counterfeit and substandard medicines are a global problem. The ACT=
A
can make a contribution to the fight against counterfeit medicines by
establishing international standards for trademark enforcement, but only as
a part of Canada=92s broader approach. While some stakeholders have propose=
d
the removal of medicines from the scope of the ACTA, ACTA is a non-sectoral
agreement, and removing pharmaceuticals would result in lower sectoral
enforcement standards. It was also recognized that the ACTA would be open t=
o
further accessions in the future, which would enhance its ability to combat
the trade of counterfeit medicines.

Finally, the proposed =93de minimis=94 clause evoked divergent reactions fr=
om
stakeholders at the previous consultation. While some deemed the clause
essential to ensure ACTA does not become intrusive, others felt its
inclusion created a problematic loophole. Canada supports the inclusion of =
a
=93de minimis=94 clause providing an exemption for personal use, as the
objective of the ACTA is to combat large-scale counterfeiting and piracy. I=
n
addition, health and safety regulations would continue to apply to any
pharmaceutical product entering Canada.

After presenting the main issues that arose at the previous consultation,
and Canada=92s respective positions, the Chair opened the discussion to all
participants, inviting them to share their views, comments, and concerns.
The following sections summarize the main themes discussed:
Scope of ACTA

Several participants expressed concern that a future agreement would extend
to all intellectual property rights recognized under TRIPS, rather than
remain limited to matters of trademark counterfeiting and copyright piracy.
There was apprehension that the agreement would include patent enforcement
within its scope. Canada supported an ACTA which emphasizes trademark and
copyright enforcement.

Stakeholders questioned whether the definition and application of =93in
transit=94 had been determined at the ACTA negotiations. It was noted that
although =93in transit=94 provisions were under discussion, there had not b=
een a
consensus on their inclusion as yet.

Many stakeholders expressed unease over the possible definition of
=93counterfeit=94 under an ACTA. There was general concern that an agreemen=
t
would define =93counterfeit=94 broadly enough to cover patent infringements=
, and
thereby also encompassing generic medicines. Many stakeholders asserted tha=
t
the ACTA could not deal with problems related to the quality of medicines.
The Chair having previously stated that the ACTA would be but one means to
combat this problem, restated that pharmaceuticals would not be the focus o=
f
the ACTA. In addition, he reaffirmed Canada=92s commitment to the Doha
Declaration on the TRIPS Agreement and Public Health.
The Proposed =93de minimis=94 Clause

As at the previous consultation, discussions over the =93de minimis=94 exce=
ption
revealed a lack of consensus among stakeholders. Some felt that it created =
a
critical loophole, while others deemed that the limited resources of CBSA
should be devoted to dealing with large-scale problems. Officials had
previously asserted that Canada supported the =93de minimis=94 clause as it
ensures that the agreement focuses on limiting large-scale infringements. I=
n
addition, CBSA noted the need for balance within any ACTA. Without a =93de
minimis=94 clause essential medicine could be seized from a visitor to Cana=
da.
Although the medicine may be legitimately generic in the home country, it
might be deemed an infringement upon entry into Canada. The =93de minimis=
=94
clause would ensure that an agreement would not have such unintended
consequences.
A New Dedicated Counterfeit and Substandard Medicines Initiative Required

Many stakeholders expressed concern that the ACTA would have little impact
on the problem of substandard medicines. The majority of the discussion
focused on whether issues related to pharmaceuticals, such as counterfeit
and substandard medicines should be carved out of the current ACTA under
negotiation, to be treated in a separate multilateral agreement. Several
arguments were put forth to support this action: First, the ACTA would not
deal with the quality of drugs (substandards) and therefore, there should b=
e
a more comprehensive agreement regarding medicines only. Second, including
medicines in the ACTA agreement could lead to the perception that the issue
should be treated as having equal importance to other counterfeit products,
and third, treating medicines under the ACTA may lead to a broad definition
of =93counterfeit,=94 which may limit the use of generic medicines. Althoug=
h
there was significant support addressing substandard medicines more
comprehensively than possible under an intellectual property rights
enforcement treaty, some stakeholders expressed concern that carving
medicines out of the agreement would jeopardize the progress made on this
issue thus far. It was asserted that by excluding this issue from the ACTA,
the Parties may not start negotiations on this issue at all, leading to
weaker enforcement measures in regards to medicines. The Chair, having
asserted in his opening summary that an ACTA would be a non-sectoral
agreement, restated that the ACTA would but one forum for the treatment of
this issue and that it should be treated as complimentary to other tools.
Participation and Transparency in the ACTA Negotiations

Much of the dialogue focused on discussing the limited number of parties
involved in the ACTA negotiations. Several stakeholders felt that the ACTA
would be unable to successfully ensure a reduction in counterfeit and
substandard medicines if the negotiations did not include the major source
or destination countries. In addition, several participants pointed out tha=
t
the ACTA would alter global standards, affecting developing states even
though they were not present at the negotiations. Officials stated that
standards would only be changed among likeminded countries that have
negotiated and accepted the agreement. In addition, there had been little
progress made on enforcement of intellectual property rights at the relevan=
t
multilateral institutions due the unwillingness of developing states to
engage on the issue. Stakeholders inquired as to whether other countries
would be welcome to join the negotiations. The Chair advised that Canada=92=
s
understanding was that several parties had approached one of the ACTA
countries, but that it was unclear whether any formal requests to join had
been made. ACTA negotiating parties intended to discuss this issue at the
upcoming round of negotiations in Morocco. In short, the Chair reconfirmed
that a future agreement would not be exclusionary and that the intent of th=
e
ACTA was to create standards for Canada and other likeminded countries in
order to reduce the problem of counterfeiting and piracy.

The dialogue began and ended with calls for greater transparency into the
ACTA negotiation process. Participants asserted that it was difficult to
engage in the consultation process and give valuable feedback without acces=
s
to details and draft texts. Some stakeholders proposed the creation of a
consultative group, bound by confidentiality agreements, which could provid=
e
input on the negotiating texts. However, there was not a consensus among
participants on this suggestion.

In closing, the Chair reaffirmed his commitment to push for greater
transparency at the ACTA negotiations. He confirmed the importance of the
consultation process and invited stakeholders to follow up with any further
questions or comments they may have by contacting the Canadian negotiating
team with the contact information provided or by making an online
submission.

*Participants*
Amir Attaran =96 Canadian Research Chair in Law, Population Health and Glob=
al
Development Policy
Jody Cox =96 Canadian Generic Pharmaceutical Association
Alicia Duval =96 GS1 Canada
Mark Fried =96 Oxfam Canada
Michael Geist =96 Canada Research Chair in Internet and E-Commerce Law
Rachel Kiddell-Monroe =96 Universities Allied for Essential Medicines
Leah Littlepage =96 Canadian Intellectual Property Council
Emi MacLean =96 M=E9decins sans Fronti=E8res
Grant Perry =96 Canada=92s Research Based Pharmaceutical Companies / Les
Compagnies de Recherche Pharmaceutique du Canada.
David Skinner =96 Consumer Health Products Canada / Produits de Sante
Consommateurs du Canada

*Foreign Affairs and International Trade Canada*
Douglas George (Chief Negotiator)
Jennifer Graham
Jacob Kuehn
Don McDougall
Kyla Stockdale

*Industry Canada*
S=E9bastien Ar=E8s
Shelly Rowe
Matthew Senft

*Canada Border Services Agency
*Michelle Gillespie
Nicole Lefebvre
Chris Nelligan

*Royal Canadian Mounted Police
*Supt Graham Burnside

*Public Safety Canada
*Matthew Senft

*Health Canada*
Matthew Bown
Matthew Sanger
--
Rachel Kiddell-Monroe
President of the Board
Universities Allied for Essential Medicines (UAEM)
www.uaem.org
Tel 514 481 1186
cel 514 606 1186