Source: Health GAP
Professor Brook K. Baker
7 May 2012
According to Inside US Trade (May 3, 2012), the Pharmaceutical Research
Manufacturers of America (PhRMA) is “actively engaging with the Office of
the U.S. Trade Representative and Congress to provide concrete data in
support of its recommendation that the ‘access window’ envisioned in the
USTR’s access to medicines proposal in the Trans-Pacific Partnership (TPP)
talks should be six years long.”
PhRMA’s preposterous recommendation is based on a confidential study of 896
marketing approval filings by large pharmaceutical companies in 15 emerging
economies between 2000 and 2010 (Argentina, Brazil, China, Egypt, India,
Indonesia, Malaysia, Mexico, Russia, Saudi Arabia, Singapore, South Africa,
South Korea, Taiwan, and Turkey). These decisions were alleged made based
on three main factors: country-specific regulatory reasons (presumably
idiosyncratic registration procedures and practices), product-specific
characteristics (including the need to carry out additional clinical
trials), and most importantly commercial considerations (including not
having distribution systems for launching a product, low patient numbers or
low purchasing power, and the like).
The PhRMA study revealed that 78% of marketing approval applications were
filed within two years of first approval, that 87% were filed by the end of
year three, that 89% were filed by the end of year four, and that 93% were
filed by the end of year six. Rather than evidence any desire to actually
speed up the registration process, PhRMA did not propose a 2-year window,
which would have been sufficient for 4-our-of-5 applications; instead it
tacked on four additional years to pick up a few stragglers.
This long period of delay is even more unconscionable when taking into
account that the US proposal on the access window allows applicants to
initiate requests for marketing approval based on “any information available
to the applicant,” including evidence of prior approval of the product in
another Party (country) (Art. 9.8(a)). Given that the US is proposing
harmonization of registration standards, application forms, and procedures
and that it is further seeking law reform that would allow so called
“reliance registration” – where the applicant could rely in whole or in part
on the fact of prior registration in the US – the claimed problem of
“country specific regulatory reasons” flies out the window.
The possibility of initiating requests for marketing approval without a
complete dossier, blows apart another excuse drug companies have used to
justified delayed registration, namely the need to conduct in-country
clinical trials. Companies can initiate applications and still proceed with
the small clinical trials that are required in only a handful of countries.
Likewise, if companies needed to conduct additional clinical trials because
of discovery of post-marketing side effects or because of epidemiological
variations in countries of registration (for example because of dangers of
immune suppression), those trials too could be carried out after the
initiation of applications.
Another undesirable quirk in the U.S.’s proposed access window that PhRMA
will surely exploit is that there is currently no time limit within which an
applicant must finalize its registration dossier and prosecute its request
for marketing approval. Accordingly, under the existing proposal, a PhRMA
company can delay filing for six years, file only what it has, wait and
conduct clinical trials at its leisure, and delay finalization of its
application as long as it wants – this is the speedy system that the USTR
and PhRMA hope to foist on trading partners!
The last excuse standing for PhRMA is “commercial considerations” – the only
real reason in the whole bunch. PhRMA prefers to seek marketing approval
when it is poised to exploit a market and maximize its monopoly profits.
Drug companies obviously prioritize sales in the rich countries of North
America, Europe, and Japan, where they make the vast bulk of their sales.
Thereafter, they rolls out their products in so-called pharmemerging
countries with large populations and growing middle classes. Patients in
poorer and smaller countries wait the longest for life-saving and
Drug companies want the data exclusivity and patent-registration linkage
provisions in the US TPP proposal precisely because they give PhRMA
companies data monopolies exactly when they want them – when they make up
their own sweet mind to enter a country’s market – not one minute sooner nor
one minute later. Moreover, they get these data monopolies even if they
have neglected to secure patent monopolies.
The US access window is a farce – or more accurately a sham. It gives
pharmaceutical companies multiple paths to marketing approval (reliance or
non-reliance) whereby they can lengthen patent monopolies with patent term
extensions and gain ironclad data monopolies as well. Rather than actually
expedite registration, PhRMA and the US are colluding to make sure that
companies can follow their historic practice of picking and choosing where
and when to register – instead of expeditiously and simultaneously
introducing life-saving and life-enhancing medicines to patients on an
equitable basis throughout the world. As if the entire access window were
not cynical enough, now PhRMA wants to add to insult of a six-year delay to
the chimera of deceit.
The entire access window is deeply problematic and TRIPS-plus. Countries
should not succumb to US demands for lengthened patent monopolies and new
data monopolies that will further exclude and delay generic competition.
The access window is an access trap, and the PhRMA charm campaign shrouded
as an empirical study should be seen for what it is – a shameful sham.
Professor Brook K. Baker
Health GAP (Global Access Project)
Northeastern U. School of Law
Program on Human Rights and the Global Economy
400 Huntington Ave.
Boston, MA 02115 USA
Honorary Research Fellow, University of KwaZulu Natal, Durban, S. Africa