1. Canada and the Anti-Counterfeiting Trade Agreement (ACTA)
Joel Lexchin MD
School of Health Policy and Management
York University
Toronto Canada

2. Presenter Disclosures
Joel Lexchin
(1) The following personal financial relationships with commercial interests relevant to this presentation existed during the past 12 months:
No relationships to disclose

3. What Gets Counterfeited
Money, documents (passports)
Consumer goods
Art, toys, clothing, software, drugs, watches, electronics, handbags, shoes
Parts in military planes

4. Counterfeit Goods Market value for counterfeit goods worldwide
$ billion per year but source of this figure is murky
Job losses
750,000 US jobs but source of this figure is murky
Counterfeiting in Canada
$20-30 billion according to Canadian Manufacturers and Exporters but no source given for figure

5. Anti-Counterfeiting Trade Agreement (ACTA)
Multinational treaty for purpose of establishing international standards for intellectual property rights enforcement
Targets of agreement are counterfeit goods, copyright infringement on Internet
Creates a new governing body outside existing forums, e.g., WTO, WIPO (World Intellectual Property Organization), UN

6. ACTA Development First developed by Japan and US in 2006
Canada, EU and Switzerland joined preliminary talks through 2006 and 2007
Official negotiations started in June 2008 with Australia, Mexico, Morocco, New Zealand, Korea and Singapore joining
Negotiations done in secret
No formal public input

8. ACTA and Counterfeit Drugs
The main public health concern is drugs that are deliberately made with poor quality
No active ingredient
Wrong active ingredient
Dangerous ingredients
ACTA however would target products that violate intellectual property rights
Disputes over validity of patents
Disputes over trademarks
Would allow seizure of goods in transit through a third country

9. What Happened In Europe
December 2008
Dutch customs authorities seized a cargo of 500 kilos of Losartan (blood pressure medication) that was in transit in Rotterdam while on route from India to Brazil, held it for 34 days and then sent it back to India
Not under patent in either India or Brazil so lawful to make in India and lawful to sell in Brazil
Stopped because of EU regulation allowing companies to make claims that products in transit ”might” violate intellectual property rights
Total of 19 such incidents in Europe

10. ACTA Enforcement Measures
Damages (ACTA art. 9.1)
Can exceed any real economic loss suffered by the right holder
Can work as a constraint for generic competitors to explore the inherently grey area of IPR infringement.
Provisional measures (ACTA art. 12)
Allows rights holders to issue an injunction or request seizure of generics at short notice, without the other party being heard and without a full juridical review by the court
Insufficient abuse deterrence (ACTA art. 12.5, 18)
Does not provide sufficient mechanisms to adequately deter abuse of enforcement provisions by rights-holders

11. ACTA and Developing Countries
Although only negotiated by a small number of countries ACTA’s IPR enforcement standards designed to be expanded and become global norm
Developing countries will not use the available room for implementation to adapt standards to local needs
Risk of chilling generic competition is even greater in the absence of proper competition laws to punish abuse
Resulting higher prices will have an unacceptable impact on access and affordability of life-saving medicines
Costs associated with the implementation are substantive and present a burden and opportunity cost on the limited public budgets of developing countries

12. Canadian Government & Secret Negotiations
“It is accepted practice during trade negotiations among sovereign states to not share negotiating texts with the public at large, particularly at earlier stages of the negotiation. This allows delegations to exchange views in confidence facilitating the negotiation and compromise that are necessary in order to reach agreement on complex issues”

13. Canada & ACTA April 2009 Roundtable Consultation
Some participants suggesting that the ACTA was not the appropriate venue for addressing issue of counterfeit pharmaceuticals and expressing concern that it could detract from efforts in other multilateral organizations, such as the World Health Organization
Canadian officials highlighted Canada’s demonstrated commitment to the issue of public health
Work on falsified medications could continue in other fora
BUY no other fora identified

14. Canada & ACTA June 2009 stakeholder consultation
Concern about seizures as in Europe
Canadian Border Services Agency confirmed the unlikely occurrence of a similar situation within the Canadian jurisdiction
Canada’s position is that the key ACTA obligations should be limited to trademark counterfeiting and copyright piracy
Other government positions
ACTA can make contribution to the fight against counterfeit medicines by establishing international standards for trademark enforcement, but only as a part of Canada’s broader approach (ACTA won’t deal with issue of quality of drugs)
Not in favour of removing pharmaceuticals since ACTA is a non-sectoral agreement, and removing pharmaceuticals would result in lower sectoral enforcement standards

15. Rx&D (Canada’s Research-Based Pharmaceutical Companies) and ACTA
“Counterfeit pharmaceutical products are a serious public health and safety concern with potentially life threatening consequences…The life-threatening phenomenon created by counterfeit pharmaceuticals…underscores the importance of this issue within these consultations”
Doesn’t define what Rx&D considers to be counterfeit medications

16. Current Status of ACTA
Oct signed by Australia, Canada, Japan, Morocco, New Zealand, Singapore, South Korea and United States
Switzerland has not signed
2012 signed by Mexico, EU and 22 Member States in EU also signed
July 4, 2012 European Parliament rejected treaty by 478 to 39 with 165 abstentions so neither EU nor Member States will join
Japan only country so far to ratify
Six countries need to ratify treaty for it to take effect
Four of the remaining 7 countries need to ratify (assumes that the US will ratify)

18. Canadian Position on Signing
Ed Fast, Minister of International Trade and Minister for the Asia-Pacific Gateway
“We all have an interest in combatting counterfeiting and piracy because these activities cost billions of dollars each year in revenue and trade losses, which translates into higher prices, lost income and lost jobs for people employed in a range of industries—from film and pharmaceuticals to electronics. Counterfeit goods also pose a real threat to the health and safety of people because the producers of goods such as drugs and auto parts evade the rigorous rules, standards and guidelines that are in place to protect consumers.”

19. ACTA Ratification
March 1, 2013 Canadian government introduced Combating Counterfeit Products Act that would allow Canada to ratify ACTA
March 1, 2013 US released 2013 Trade Policy Agenda report
“The United States continues to encourage Canada to provide for deterrent level sentences to be imposed for IPR violations, as well as meet its Anti-Counterfeit Trade Agreement (ACTA) obligations”
Currently Canadian legislation is being reviewed by Industry Committee

20. ACTA in Context Canada & South Africa Canada & Doha
Canada & Canada’s Access to Medicines Regime
Canada & Noncommunicable diseases
Canada & TRIPS exemption extension

21. Conclusions
ACTA will do nothing to combat drugs that are deliberately falsified or substandard
ACTA might have a chilling effect on the production of generics
ACTA could result in seizure of generic drugs that are in transit (although not in transit through Canada)
Canada seems to be following US lead on ACTA
ACTA is in line with Canada’s position around stronger IP versus better access