[Ip-health] Drug quality problems for GSK and BMS

Julian Harris julian.harris.81 at gmail.com
Thu Oct 28 04:17:44 PDT 2010

It's a great shame when this issue is reduced to "Western Pharma" v
"Southern" Generics and analysts simply take sides in an unsavoury
geo-political battle.

The case below appears to show that the system in the USA is working - a
company has been found culpable, and the matter has been successfully
resolved in the courts. And it was instigated by a GSK whistleblower - a
case of self-regulation.

Independent courts, a strong rule of law and (relatively) low corruption
ensure that companies or individuals who harm or risk harming others are
accountable - ensuring that the standard of products on sale is generally
extremely high.

Compare this to countries where reports constantly reveal extremely low
standard of products, especially in medicines. The likelihood of these cases
being successfully resolved is far, far less.

Even In Russia, for example, a leading pharma company that had been
blatantly faking medicines was fined just a few thousand dollars - around
0.2% of the GSK amount, even though the crime was significantly worse.

Meanwhile in areas where over a third of medicines are substandard (such as
parts of sub-Saharan Africa), people have very little legal protection of
the kind that the GSK case demonstrates. To dismiss this by pointing fingers
at a "Big Pharma" company is extremely disappointing.

Julian Harris
International Policy Network

On Thu, Oct 28, 2010 at 7:28 AM, <pierchir at club-internet.fr> wrote:

> Dear all,
> More details in the New York Times
> http://www.nytimes.com/2010/10/27/business/27drug.html?pagewanted=2
> Glaxo to Pay $750 Million for Sale of Bad Products
> (...) This was GlaxoSmithKline's premier manufacturing facility, producing
> $5.5 billion of product each year. But Ms. Eckard soon discovered that
> quality control was a mess: the water system was contaminated; the air
> system allowed for cross-contamination between products; the warehouse was
> so overcrowded that rented vans were used for storage; the plant could not
> ensure the sterility of intravenous drugs for cancer; and pills of differing
> strengths were sometimes mixed in the same bottles. (...)
> Pierre Chirac
> --------------------------------------------------
> From: "Baker, Brook" <b.baker at neu.edu>
> Sent: Wednesday, October 27, 2010 4:05 PM
> To: <Ip-health at lists.keionline.org>
> Subject: Re: [Ip-health] Drug quality problems for GSK and BMS
>> It's deeply ironic given Big Pharma's constant screel about poor quality
>> generic medicines and how we need increased IP enforcement and
>> anti-counterfeiting measures to address quality and safety concerns that
>> its
>> own house is so out of order.  Not only is Big Pharma constantly pilloried
>> and fined for off-label drug promotion, hiding negative clinical trials,
>> and
>> cheating on pricing, but it is also apparently engaged in foot-dragging
>> and
>> cover-ups when quality-control issues arise at its own manufacturing
>> facilities.
>> Maybe PhRMA (and the European Commission and the USTR) could explain how
>> ACTA's focus on IP enforcement would help address quality-related
>> malfeasance by its patent/data/trademark protected members.
>> 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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