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

Baker, Brook b.baker at neu.edu
Fri Oct 29 13:39:53 PDT 2010


It's interesting to see how the International Policy Network doesn't take
sides on issues.

Access to medicines activists oppose dangerous and fraudulent medicines no
matter where they are produced or by whom.  We cannot fail to note, however,
that Big Pharma has touted its superior quality for years and attempted for
four decades to question the quality of authentic generic equivalents both
directly and more recently through misleading anti-counterfeiting campaigns
discussed further below.

It's factually misleading to argue that the GSK whistleblower is an
admirable case of "self-regulation."  Self-regulation would have meant that
GSK would have taken the messages of its quality control manager seriously,
not continued to produce contaminated and substandard products, not have
covered up and continued to sell the same inferior products for years, not
have fired the whistleblower, and not have dragged out the investigation for
several years.  

On the other hand, Mr. Harris is correct that strong regulatory measures to
detect and redress blatant violations of law are important, but industry
often finds that it is better to profit and pay fines after the fact many
years later than to engage in scrupulously honest and proper business
practices throughout.

Likewise, Mr. Harris is correct that it is important for drug regulatory
authority activities - so called pharmcovigilence - to be strengthened in
developing countries.

However, rich countries and Pharma, rather than helping developing countries
build drug regulatory capacity, have mounted a massive campaign to use the
sledge hammer of IP enforcement instead of the screwdriver of registration,
supply chain security, and quality control monitoring to address the very
real problem of dangerous and fraudulent medicines.  In ACTA, IMPACT,
SECURE, and elsewhere, anti-counterfeiting pundits, including those from
International Policy Network, have steered the tanker of hyper-active IP
enforcement under the false banner of consumer safety.

Likewise, the industry and its trade representative supporters, refuse to
acknowledge that it is the supra-competitive pricing of on-patent medicines
that makes actual counterfeits (medicines that fake the trademark of the
brandname company) such a problem.

So I point a finger at Big Pharma both for its knowing failure to
self-regulate its own substandard manufacturing practices, as in the GSK
case, and its self-serving use of profit-maximizing, anti-counterfeiting
campaigning that confuses and misdirects the global strategy needed to truly
redress the trade in unsafe and fraudulent products.


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




On 10/28/10 7:17 AM, "Julian Harris" <julian.harris.81 at gmail.com> wrote:

> 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
>> MSF
>> 
>> --------------------------------------------------
>> 
>> 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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>>> Ip-health mailing list
>>> Ip-health at lists.keionline.org
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>>> 
>>> 
>>> 
>> 
>> 
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