E-DRUG: SA Pharmaceutical companies resume litigation
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[copied with thanks from DRUGINFO, the South African E-drug;
the newspaper article was posted on HEALTHGAP.
We discussed this court case in E-drug before (1998, 1999)
For non-South Africans: the SA parliament adopted a law (Act
90/1997) in 1997 which would allow the Health Minister inter alia to
permit parallel importing, generic substitution and licensing
dispensing doctors. The PMA and multinational drug companies
disputed the legality of the Act, and started legal action, so that
the Act could not be implemented until the courts had reviewed its
legality.
The government then "extracted" all drug regulatory articles and
made a new Act (SAMMDRA) which was passed in December
1998. That Act was incorrectly proclaimed in its entirety by the
President in May 1999, effectively causing a problem for the
continuity of drug control in SA. Industry and Dept of Health then
jointly asked the courts to set aside the SAMMDRA Act. (the Act
should have been promulgated in phases to allow the issuing of
supporting Regulations and Schedules).
The original Act 90 court case was still pending since 1998, and
recently DOH did not allow the PMA lawyers another extension of
filing their papers, so that PMA was forced to "resume" its legal
action on 31 July.
What is different now from 1998, is that the rights of countries to do
parallel import and compulsory licensing has been clearly
established. Even the USA government, effectively lobbying against
the Act in 1997/98, has now admitted that SA can do those things.
The court case is now on the legal wording of clause 15C which
allows the Minister of Health to permit parallel importing of drugs.
WB]
Hi all
At last some news on the Act 90 front. As I remember it, the PMA
offered to "conditionally suspend" their case against Act 90 (and in
particular the proposed new section 15C of Act 101, although there
were
"alternatives" mentioned if that did not suffice to persuade the court
that promulgation be blocked). The Minister countered with the
statement
that she intended taking SAMMDRA back to court, not Act 90
(while the two
are connected - remember the "parking bays", the one certainly
does not
"house" the other). Only early this year was there mention from
senior
members of the Department of Health about returning Act 90 to
Parliament.
All along, the story has been that a return affidavit from the PMA-
aligned complainants was expected, but that extensions had been
asked for
and allowed. I'm sure many will welcome a resolution to this issue.
If, as
is widely expected, the technical wording of section 15C is found to
be at
fault (rather than the principle of exhaustion of rights and the right to
engage in compulsory licensing), and the "alternate" complaints
are found
to be less persuasive, then the Minister can proceed with
promulgation of
the sections necessary to introduce mandatory offer of generic
substitution, the pricing committee (and through that hopefully the
elusive non-discriminatory exit price based on volume), and the
code of
marketing practice. The schedules can be simplified and
prescribing rights
given to other professionals registered under the Nursings and
Health
Professions Acts. Dispensing permits can be introduced, and the
training
programmes necessary for those not registered with the Pharmacy
Council.
Thereafter the Minister and her legal team can redesign section
15C to
make explicit mention of parallel importation and the safeguards
necessary
to ensure quality of the products so imported. They can also
consider,
perhaps with the experience of the first Patents Act application for a
medicine CL under their belts, whether a health-specific legal
instrument
is necessary to complement the Patents Act - perhaps one that
makes
explicit the steps that a Minister needs to take to declare a national
health emergency, and to invoke the TRIPS- compliant measures
to ensure
access to drugs in the face of such an emergency.
------- Forwarded message follows -------
Date sent: Wed, 02 Aug 2000 10:27:54 -0400
litigation
against Govt. of South Africa
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Pharmaceuticals resume litigation against Government on
Medicines Act
WOZA Internet (Johannesburg)
August 1, 2000
By Marjolein Harvey
Johannesburg - The Pharmaceutical Manufacturers' Association of
SA has
resumed litigation against the Medicines and Related Substances
Control
Act No 90 of 1997, arguing that it still undermines patent protection
for
pharmaceuticals.
The SA Medicines and Medical Devices Regulatory Authority Act
(Sammdra) -
the act housing act 90 of 1997 - would be returned to parliament for
extensive amendments, Health Minister Manto Tshabalala-
Msimang announced
in August 1999 and the PMA followed with a suspension of its
litigation in
September.
But PMA CEO Mirryena Deeb says the organisation has failed to
reach a
negotiated settlement with government and is forced to resume
litigation.
She said the PMA was dismayed that the minister's legal advisers
have
insisted the association files answering affidavits on legislation
which,
by their client's own announcement, is to change.
"Continuing litigation under these circumstances can only amount
to an
exorbitant waste of taxpayers' money funds that could be better
appropriated towards saving lives," Deeb said in a statement on
Tuesday.
"Underpinning the PMA's rejection of attempts to generally abrogate
patent rights is our unflinching belief that patent protection does not
stand in the way of access to medicines and healthcare."
She says there is evidence that countries with an absence of patent
protection still have a lack of access to quality healthcare.
"Many Asian, South American and African countries in the
absence of any
legal hindrance, are able to source their drugs from any supplier
internationally and are free to allow local manufacturing of any
drugs,
yet quality and affordable drugs are still not available to the people,"
says Deeb.
She says that sound economic policies and sufficient healthcare
funding,
government commitment and political will, adequate infrastructure
and
capacity are equally important for access to improve.
Interestingly, a leading health analyst predicted in September that
the
suspension would not last, saying the move may be only a calm
before a new
storm over the access to treatment.
"The suspension of the lawsuit might well be interpreted by SA as a
signal that they can begin the manufacture of cheaper versions of
the most
widely used drugs to treat HIV," associate executive director for
programmes and policy at the US Public Health Association
(Apha), Richard
Levinson was reported as saying by IPS.
"However, it seems likely that the drug companies might later
re-institute their suit, if the promised changes in relevant SA
legislation does not satisfy them," says Levinson.
"It seems unlikely that pharmaceutical firms will surrender their
profit
margins without a major battle. Therefore, this may be a lull before
the
storm," he said.
According to the World Health Organisation (WHO), drug
companies spend
nearly R400 billion on health research; but only 10% of that figure is
spent on diseases that affect 90% of the global population.
Research and development is claimed to be expensive - one
reason drug
companies are reluctant to expend efforts on products that will not
make a
profit. However, it is unlikely that drug makers would lose much
profit by
allowing poorer nations access to cheaper drugs, because they
represent
such a small proportion of the market.
"The PMA would ultimately prefer a negotiated settlement and
partnership
with government," says Deeb.
The health department could not yet comment on the matter at the
time of
writing.
Richard Jefferys
Access Project Director
AIDS Treatment Data Network, NYC
http://www.aidsnyc.org/network
E-Mail: atdn@aidsnyc.org