[Pharm-policy] Brook Baker: THE IMPORTANCE OF COMBO-DRUGS: ANOTHER ARGUMENT FOR COMPULSORY AND VOLUNTARY LICENCES

[James Love]

-------- Original Message --------
Date: Thu, 9 Aug 2001 19:31:34 -0400 (EDT)
From: "Brook K Baker" <B.Baker@neu.edu>

                      THE IMPORTANCE OF COMBO-DRUGS:
          ANOTHER ARGUMENT FOR COMPULSORY AND VOLUNTARY LICENCES

                              Brook K. Baker
                              August 9, 2001

     CIPLA has once again stirred the imagination and hopes of treatment
activists and people living with HIV/AIDS by formulating a new three-in-one
anti-viral tablet combining stavudine, lamivudine, and nevirapine.  The
public announcement of this breakthrough emphasized the cost advantage of
the new combo-medicine, only slightly more than a $1 a day.  However, the
CIPLA breakthrough should be analyzed in other terms as well, namely ease
of compliance.  Emphasizing true ease of use is especially important given
disinformation campaigns by Big Pharma and G-7 governments (remember Andrew
Natsios) about the "complexities" of multi-pill AIDS treatment and the
unlikelihood of "ignorant," "watchless," and uneducated Africans being able
to comply with multi-pill treatment regimes.

     Lost in the midst of this racial slander are the barriers that
pharmaceutical patent-holders erect against easier to use combo-medicines.
In this context, it is important to remember that HIV medicines are
individually patented and that patent-holders have an perverse economic
interest in avoiding the creation of combo-medicines.  Let's take the CIPLA
example.  Britain's GlaxoSmithKline holds the patent for lamivudine,
Germany's Boehringer Igelheim the patent on nevirapine and the US's
Bristol-Myers Squibb the patent on stavudine.  Nothing in principle
prohibits these three companies from entering into voluntary
cross-licensing agreements to produce a three-in-one anti-viral tablet.
However, in practice, they do not want to dilute individual brand
recognition, nor do they want to indirectly promote the products of a
competitor.  Although GlaxoSmithKline will combine its own HIV products,
neither they nor their competitors will combine medicines with other
manufacturers.  As a matter of fact, none of the major manufacturers
currently cross license their medicines.  As a consequence, doctors and
patients are left with the unwieldy task of prescribing and taking multiple
tablets a day, and then monitoring compliance with overly complicated
treatment regimes.

The logic of single-medicine pills makes sense in the twisted world of
global pharmaceuticals, where maximizing profit, maintaining competitive
advantage, and promoting brand recognition prevail, but it does not make
sense in the actual lives of AIDS patients in developing countries where
simpler regimes are crucially important.  Combo medicines can be
distributed more easily and reliably; they can ease patient compliance; and
they can even reduce risks of resale of drugs by desperately poor patients
who might otherwise be tempted to resell part of their treatment regime in
the hope that one out of three medicines might be enough.  One three-in-one
pill twice a day will also be easier for health aids to monitor if directly
observed therapy is instituted on a broad scale.

To pursue the combo-medicine option, generic manufacturers and developing
countries should simultaneously seek multiple voluntary and/or compulsory
licenses so that they can manufacture and register three-in-one medicines.
Obviously, the desirable combinations will change over time in response to
new discoveries and to assessment of emerging drug resistance, if any.
However, the significant cost advantage of high quality generic medicines
will be matched by an equally important combo-drug benefit if treatment
advocates and developing countries vigorously pursue voluntary and
compulsory licenses.  Accordingly, activists must act not only to reduce
monopoly pricing barriers, they must also act to eliminate the irrational
single-medicine regime which unnecessarily complicates treatment and drug
protocol complicance.   Demands for multiple licenses that permit
combo-medicines are an important tool in the campaign for access to
affordable and easily usable HIV/AIDS medicines.