ACTA will hurt access to generics
Sean Flynn, associate director of the Program on Information Justice and Intellectual at the Washington College of Law, explains
Last week, the European Parliament rapportuer resigned over the Anti-Counterfeting Trade Agreement, or ACTA. His departure was only the latest dust-up over the agreement, which would set international standards for enforcing intellectual property rights for counterfeit goods, generic drugs and copyright infringement on the Internet (read here). ACTA, which would create a new governing body outside existing forums, such as the World Trade Organization, was signed by the US and seven other countries. Earlier this month, the European Union did as well, although the European Parliament must vote in June. Despite governmental support, various advocacy groups say ACTA contains some onerous provisions that would hurt, among other things, access to lower-cost medicines. We asked Sean Flynn, who is the associate director of the Program on Information Justice and Intellectual at the Washington College of Law, to explain…
Pharmalot: What’s at stake here?
Flynn: One of the most important things at stake in ACTA is the viability of open and transparent processes for international norm setting on intellectual property matters. ACTA represents a bold shift to a new ‘plurilateral’ negotiation process in which the negotiations among like-minded countries are held in secret to set rules that intend to become new global standards. This is a clear attempt to evade more open and democratic processes that would exist in a forum like the World Intellectual Property Organization. The same process is now being followed in the Trans Pacific Partnership Agreement (TPPA) and similar concerns are being raised there (see here). ACTA is particularly problematic in this respect because the administration is saying that it will not even send the agreement to Congress for approval, as any traditional trade agreement would be. There has literally been no public process in the creation of this wide ranging legislative minimum standards agreement.
Pharmalot: So who’s been driving this agreement?
Flynn: ACTA and other trade agreements are driven by a select group of industry stakeholders represented in formal advisory committees that advise the USTR and have ongoing access to confidential text and proposals that the rest of the US public cannot see. The Pharmaceutical Research and Manufacturers of America (PhRMA) chairs that advisory group, and is one of the most influential stakeholders in US trade policy. There is essentially no concern in ACTA shown for the interests of generic producers or of the consumers who rely on such products.
Pharmalot: Why have some opposed a TRIPS-plus deal? [EDITOR’S NOTE: The Trade Related Aspects of Intellectual Property Rights is an international agreement reached in 1994 and administered by the World Trade Organization. In 2001, a new round of talks were begun to clarify TRIPS and affirmed that the goal should be to 'promote access to medicines for all.]
Flynn: ACTA is TRIPS-plus by design. The agreement is forty some pages of intellectual property protection and enforcement rules that would raise minimum legislative standards beyond the existing TRIPS agreement.
Pharmalot: Okay, but why are those TRIPS-plus provisions considered problematic?
Flynn: For pharmaceutical issues, some of the most troubling provisions are actually related to trademarks. After a firestorm of protest from international access to medicines advocates, provisions that would have allowed in-transit seizures of medicines based on fictional patent rights were removed. But the agreement still allows in-transit seizures based on labeling complaints. This has been a problem in Europe, where legitimate generic drugs have been seized because border officials found thought that use of an INN (International Nonproprietary Name) rendered a label ‘confusingly similar’ to a brand drug. This is a symptom of the broader problem in ACTA. Throughout the agreement, it requires that border officials, police and other enforcement agents have greater authority to seize property without any hearing, with minimal suspicion and a lack of oversight. This, in turn, will negatively impact the international trade in generic medicines.
Pharmalot: Tell me about the patent exclusions, damages and infringements. What are the issues?
Flynn: There are two concerning issues with respect to remedies. First is that ACTA would encourage states to set damages based on the retail price of the protected good. But in many developing countries, the retail price is exclusionary. Think, for example, about the recent state of affairs where companies were demanding poor countries to pay over $12,000 for AIDS drugs that we now can purchase generically for $80. Should the damages on any potential infringement claim in Uganda against the $80 generic really be set at the $12,000 level? That is a bit absurd when no one can buy the $12,000 drug. Damages should be based on actual losses, not theoretical losses that assume that poor people are rich.
The second big issue for pharmaceutical supplies is the issue of intermediary liability. ACTA would require countries to hold suppliers liable for legitimate sales that are later used in counterfeit products. Thus, an API supplier might be held liable for selling active ingredients to a company that markets the product with an infringing label. Such rules may dissuade suppliers from dealing with legitimate generic companies, especially if these standards are aggressively enforced by ACTA governments.
Pharmalot
http://www.pharmalot.com/2012/01/acta-will-hurt-access-to-generics-flynn-explains/