[Ip-health] PhRMA's Sham Charm Campaign on TPP Access Window

Baker, Brook b.baker at neu.edu
Mon May 7 07:03:35 PDT 2012

PhRMA's Sham Charm Campaign on TPP Access Window
Professor Brook K. Baker, Health GAP
May 7, 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 life-enhancing medicines.

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
(w) 617-373-3217
(cell) 617-259-0760
(fax) 617-373-5056
b.baker at neu.edu

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