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/