E-DRUG: South African press statement re PMA case (2)
-----------------------------------------------------
>- [There was a rumour spread by PhRMA USA that PMA South
>Africa had suspended its case against the Dept of Health on Act 90
>of 1997 which enabled parallel import and compulsory licencing.
>The rumour is contradicted by the SA Dept of Health press release
>below. WB]
One doesn't wish to enter into a polemic verging on the purely political
but the above does not reflect the reality. PMA South Africa released a
statement on this issue which clearly specifies their intention and as
such certainly doesn't warrant classification as a " rumour " with all
its pejorative connotations.
The PMA statement followed on the earlier reported intention of the
Health Minister to revisit medicines control legislation, no specific
aspects up for likely review being cited however. A press report
consequent on this reads as follows :-
' " The Pharmaceutical Manufacturers' Association welcomes Health
Minister Mantombazana Tshabalala-Msimang's recent announcement that she
is taking advice on the pending medicines legislation " , the PMA said
in a statement.
" To help facilitate this process, present litigation between the two
parties will be temporarily suspended ", it added.
In a separate statement the Pharmaceutical Research and Manufacturers'
of America ( PhRMA ) said it had suspended a lawsuit challenging the
legality of the South African laws. '
Failing denial by either party the above certainly indicates that as
initiators of the case they intend to temporarily suspend the suit
pending the outcome of the proposed Health Ministry review.
Read that as one will, the issue becomes one of fact rather than rumour
as is imputed.
What is obvious here is a lack of proper communication in both
directions. The Minister's announcement ( at a Parliamentary Health
Portfolio Committee meeting ) as reported could be .. and was by
most interested parties outside government circles .. interpreted as
indicative that , amongst others, the contentious Section 15C, Act 90,
1997 would be one aspect for review consideration. Such interpretation
no doubt was the main factor leading to the PMA's statement and intended
actions.
The DOH release itself calls for comment as it raises important
issues.
>Pretoria- The Ministry wishes to put on record the following: The
>decision to review the South African Medicines and Medical Devices
>Regulatory Authority Act of 1998 was attributable to internal
>discussions with in the Department of Health and was not due to any
>existing litigation against the Government of South Africa.
It was nowhere suggested by the PMA that the decision was in any way
attributable to the court case.
>The only Act that was discussed with Parliamentary Portfolio
>Committee for review was the South African Medicines and Medical
>Devices Regulatory Authority Act 1998.
Indeed this is fact. However Section 15c of Act 90 of 1997 itself is
considered for current and future practical purposes to form an integral
part of the SAMMDRA Act. In view of the contentious nature of this
Section with its surrounding legal action it was perfectly valid to
assume that it would be revisited.
>There are currently no negotiations with the Pharmaceutical
>Manufacturers Association with respect to any litigation that the
>Pharmaceutical Manufacturers Association has brought against the
>Government of South Africa.
Such was never suggested and the PMA's stated intention to temporarily
suspend the legal action reflects that which is within their rights as
initiators of such action.
>With respect to the litigation the only acceptable position to the
>Government of South Africa would be the total withdrawal by the PMA
>and others, of the litigation against the Government of South
>Africa with regard to medicines legislation. The legal process
>therefore remains unchanged by any offers by the Pharmaceutical
>Manufacturers Association that falls short of this condition. The
>Government of South Africa will continue to build its legal defence
>in this case, and hope to conclude the case as rapidly as the
>courts will allow.
It is an axiom that all things are possible between two parties
exhibiting reason but this desirable position is hardly enabled by
statements like this. It would have been expected that a less obdurate
line would have been followed in view of the reported rapprochement
between the US and SA governments.
>As often stated before, it is the policy of the Government of South
>Africa that Act 90 will not allow the abrogation of the patent
>protection. The policy position of the Government of South Africa is
>that - as allowed by the Act 90 and international trade agreement,
>it may issue compulsory licences for , or parallel import medicines,
>in the public interest.
The problem lies not so much with the policy ( which has general, if
grudging from certain sectors, agreement ) but rather with the fact that
such is not clearly and unequivocally laid down in law as it well should
be. The language of Section 15C as written allows an interpretation
which goes far beyond that required to implement the stated policy
objectives. Indeed it would seemingly permit abrogation of patent law
with an open invitation to practise patent piracy.
Section 15C needs comprehensive revision to incorporate in clear
language the declared policy regarding compulsory licensing and parallel
imports, namely that any conditions laid down by the Minister will at an
absolute minimum be in strict and full accordance with the Trips
principles. It is important that such statement forms an integral and
entrenched part of the Act rather than as part of any supplementary
regulations or prescribed conditions promulgated under the provisions of
Section 15C.
Further, Section 15C is not very clear and seemingly deals solely with
parallel importation. The compulsory licensing aspect therefore needs to
be added.
Don Black
Interested Observer
E-mail: don@dbn.lia.net
-----
--
Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'.
Mail administrative requests to `majordomo@usa.healthnet.org'.
For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.