[Pharm-policy] March 5, 1st day of the Medicines Act trial

[James Love]

Pretoria,  South Africa. March 5, 2001.   Today was the first day of the
trial, and given how late it is how little sleep I have been getting,
this will be short.  Actually, it was the trial plus a host of press
conferences, marches and demonstrations.   I was in a court room most of
the day, but outside there was an impressive march to the US Embassy,
organized by TAC and a number of local South African trade unions,
churches and NGOs.  There were also, according to local news reports,
moving demonstrations in Cape Town and Durban.

The trial itself was surprisingly dramatic.  The presiding judge is
Bernard Ngoepe, who was the true star in today's proceeding.  The PMA
was represented by SA Cilliers, the government was represented by MTK
Moerane, and TAC was represented by Matthew Chaskalson.   The day began
with a discussion of TAC's application to be a "friend of the court" in
the proceeding.  With the world press watching, the PMA  launched a
stubborn attack opposing the TAC application, despite early signals from
the Judge that he considered AIDS an important issue and that he thought
the TAC members were interested parties in the lawsuit who should be
heard.  The South Africa government supported the TAC application, and
it appears as though it will be approved.

Next the PMA began presenting its case.  There were wide ranging
discussions of the PMA's complaints about the Medicines Act.  For
example, the PMA said it was unconstitutional to exclude employees of
the pharmaceutical industry members from bodies that provide oversight
to the pharmaceutical industry, and there was assaults on the policy of
generic drug substitution on various constitution rights grounds.  The
most controversial areas of discussion however concerned 15c of the
medicines act.

There were several surprising developments in the PMA case.  The PMA
said that South Africa law need not necessarily be consistent with
foreign treaties, that in South Africa exhaustion of patent rights is a
matter of common law, and that the US recognizes international
exhaustion of patent rights -- three admissions that seemed to undermine
the PMA case.   The PMA did a great job of explaining the benefits of
parallel trade -- it would give South Africa the ability to import
cheaper branded products from foreign markets, and it wasn't clear why
the government should not proceed, other than the fact that this would
lower company profits, a cause that the South African courts may not see
as particularly compelling, given the state of the AIDS crisis.

On the issue of 15c itself, the PMA made a strong case that as written,
15c would permit the importation or local production of generics.
Indeed, this was the major focus of the afternoon discussion.  The PMA
said that it was improper for the parliament to delegate "legislative"
authority to the Minister of Health, and said 15c did this by giving the
Minister the discretion to override rights in the patent law.  Here the
Judge focused on the language of 15c (a), and suggested that 15c (a)
already limited patent rights, and that any regulations adopted under
15c would simply reflect the limited authority of the patent laws, which
were then subject to 15c.  It seemed to me and several observers that
the Judge was suggesting 15c could indeed be used for compulsory
licensing, or many other things, and he that did not seem to have
problems with this.

This was quite encouraging, although the government is expected to take
a contrary view, that 15c cannot be used for compulsory licensing, later
this week.  The reversal of the roles of the parties are apparently due
to the belief that the issue of broadness of the delegation will be
important in determining if 15c will be upheld in its present form.

Finally, what is difficult to describe was the skill and authority of
the Judge in managing the proceedings, his grasp of the case, and the
way he was single handedly destroying the PMA case, by asking deft
questions and zeroing in on the key weaknesses of the PMA case.   The
only concern anyone had was that the government had not been questioned,
and it was only the first day of the trial.   That said, it would be
difficult to imagine a better first day for the government.

If the government or TAC could only give some space for a decision that
would both uphold 15c and permit it to be used for compulsory licensing,
it would be interesting to see where this goes.  On the other hand, if
as expected the government takes a hard line that 15c is only for
parallel imports, most of the hopes for cheaper generic antiretroviral
drugs will go unanswered, at least in terms of the medicines act.



-- 
James Love
Consumer Project on Technology
P.O. Box 19367, Washington, DC 20036
http://www.cptech.org
love@cptech.org
1.202.387.8030 fax 1.202.234.5176