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CAPE TIMES TUESDAY, NOVEMBER 15, 2011
‘Pharmaceutical firms use Indians as guinea pigs in thousands of trials’
Andrew Buncombe
and Nina Lakhani
The Independent
LONDON: Western pharmaceutical
companies have seized
on India over the past five years
as a testing ground for drugs.
Since restrictions on drug
trials were relaxed in 2005, the
industry in India has swollen to
the point where today more
than 150 000 people are involved
in at least 1 600 clinical trials,
conducted on behalf of British,
CLOSER CO-OPERATION
Parties
entertain
Cope’s
talks plan
Shanti Aboobaker
Political Bureau
OPPOSITION parties have
cautiously come out in support
of Cope leader Mosiuoa
Lekota’s invitation to attend a
round-table discussion on
closer co-operation between
them.
The discussion, for which
most parties have confirmed
their attendance, is due to take
place in Cape Town later this
month.
But while there is agreement
from opposition parties
that the government and the
ruling party are in crisis,
many said yesterday that an
alliance was not on the cards
because of the disparate political
philosophies they held.
Lekota said he had
approached IFP leader Mangosuthu
Buthelezi first, and then
UDM leader Bantu Holomisa.
It is understood Lekota and
Buthelezi have been in extensive
discussions recently.
Lekota said he had
approached DA leader Helen
Zille but that “at no stage did
we focus on the DA in
particular”.
DA federal chairman
James Selfe said: “We’ll certainly
attend and listen carefully
to what is on the table,
but we will attend with a
degree of scepticism.
“I don’t think all the opposition
parties have much in
common, except that they’re
opposition parties.
“There are fundamentally
different political philosophies,”
Selfe said.
“The reality is, in South
Africa (political co-operation)
is necessary and overdue, but
it is counter-productive to
Barbara Maregele
FORMER President FW de
Klerk has questioned why
racial classification was still
needed for Census 2011.
This after he needed to be
enumerated on the last day of
the census at his office in the
Zeezicht Building in Tygerberg,
yesterday.
Wearing his bright yellow
census suit, Statistician-General
Pali Lehohla called a
media conference where De
Klerk confirmed that he had
been counted.
“I was overseas during
the main days of the enumeration,
but forms were left for
me with a number I could
call once I got back,” he said.
De Klerk said: “The information
gathered shouldn’t be
misused to reinstitute race
in South Africa. The time
has arrived for us put aside
race and work together irrespective
of your race or
colour. We should not put
people in boxes. There is a
place for racial classifications,
I’m not suggesting that
we should ignore the reality
of race in our country
either.”
He pointed out that unlike
‘At least 1 730
people died
during or after
such trials’
US and European firms including
AstraZeneca, Pfizer, and
Merck. There may be more.
Some estimates suggest the
start with the opposition
rather than discussions over
what values we’d like to see in
the South African government
… to see if these philosophies,
values are shared by everyone,
including the governing party
He cautioned against speculation
on what form “co-operation”
would take, saying only
that the DA would “go and listen”
to what Lekota had to say.
“But I am not sure about
coalescing with the Freedom
Front Plus (FF+) and Azapo.
This thing has got to be valuesdriven.
We have got to stand
for something, not against
something.”
Zille confirmed that she
had spoken to Lekota last
week to discuss the meeting
later this month of opposition
parties but there had been no
overtures made by Cope to
merge with the DA in the same
vein as the ID had.
ACDP leader Kenneth
Meshoe said their policies
were too disparate for a coalition
with Cope. “It does not
mean parties (that) stand
alone cannot chip away at the
ANC’s support base.”
The FF+ confirmed its
attendance at the discussion
but said a coalition would be
“complicated” with the proportional
representation system.
“We are open to discuss
what’s best for South Africa,
and how we get the most to
vote against the ANC,” said
FF+ leader Pieter Mulder.
Moloto Mothapo, ANC parliamentary
caucus spokesman,
said: “They (Cope) have been
gravitating towards the DA since
their formation, and therefore
this talk of (a) united opposition
is a lame excuse to jump into bed
with their masters (DA).”
fully transformed states,
South Africa needed to
improve the quality of delivery
to everyone. “The census
is important, especially as a
country in transformation.
How else would we measure
if things like backlogs have
grown or decreased or if
inequality is growing or
decreasing and to fulfil promises
and expectations that
were put in place when we
started as a democratic state
in 1994.
industry may be worth as
much as £189 million (R2.4 billion).
Between 2007 and 2010, at
least 1 730 people died in India
while, or after, participating in
such trials. Many of those people,
often only eligible for the
studies because they were ill,
might have died anyway.
Campaigners say the industry
is wide open to other
abuses. While there is no doubt
many crucial trials are carried
out according to the appropriate
guidelines, activists say a
FW queries census race question
YOU COUNT: Former President FW de Klerk shares a light
moment at his Tygerberg office with Statistician-General Pali
Lehohla after he was enumerated. Picture: ROSS JANSEN
HORSE-TRADING: President Jacob Zuma is welcomed to the Al-Mushrif Palace by Sheikh Khalifa bin Zayed Al-Nahyan, President of the United Arab Emirates (UAE)
and ruler of Abu Dhabi. President Zuma, who is on a state visit to the UAE, has asked the UAE to review its ban on the import of South African horses and meat produce.
The UAE suspended direct imports of horses from South Africa after the outbreak of African Horse Sickness in 2004 and since then all exports had to be routed via
the EU or Mauritius, which increased costs by about 150 percent and made South African horses less competitive. The Middle East was South Africa’s biggest
trading partner for horse exports.
Controversial Secrecy Bill to be put to vote next week
THE Protection of State Information
Bill will finally be put
to the vote in the National
Assembly next Wednesday
after a further delay of a week,
ANC MP Luwellyn Landers
confirmed yesterday.
Amid widespread confusion
about the process, Landers
said the hour-long debate
on the state secrecy legislation
would proceed as scheduled
tomorrow.
But following this, the ad
hoc committee that drafted the
bill will then be reconvened to
consider a technical issue and
a set of new proposals, both
raised by IFP MP Mario Oriani-Ambrosini.
“Apparently he demanded
that legally the ad hoc committee
must approve minutes,”
Landers said.
“We thought that since
there is already talk of a Constitutional
Court challenge, it
“Looking at the costs
involved in the general census
the 10-year period is sufficient,
but I do think there
are so many trends that may
influence politics.”
Lehohla said the census
was a good reflection of how
South Africa really functioned.
He said plans were
under way to compile the full
results of the census which
was expected to be released to
the public by November 2012.
barbara.maregele@inl.co.za
lack of oversight has led to
numerous situations where
poor, sometimes illiterate individuals
are used in the trials
without giving proper
informed consent – that is,
without fully understanding
what they are signing up for.
Among some of the incidents
confirmed by an investigation
by The Independent
were:
● The recruitment of hundreds
of tribal girls without
parental consent for an immu-
‘If they played
by the rules,
there should be
no debate’
is better to err on the side of
safety.”
The committee is expected
to meet on Thursday, and further
sessions could be scheduled
depending on how much
time is needed to consider Oriani-Ambrosini’s
proposed
amendments, which number
more than 100.
Oriani-Ambrosini said the
ANC’s decision to proceed
with the debate before the
committee sits was not correct
in terms of parliamentary
rules. “If they played by the
JOHANNESBURG: Nationalisation
must be taken forward,
the National Union of
Mineworkers (NUM) has
said.
“Clearly the status quo
cannot be maintained. The
people and economy must
benefit from the minerals in
our motherland,” NUM general
secretary Frans Baleni
said after a meeting of the
union’s national executive
committee in Johannesburg
yesterday.
The union was hoping for
a positive outcome from
research being done by the
ANC on nationalising mines,
he said.
The union’s executive
committee had discussed
what he termed “the triple
evil”. These were unemployment,
inequality, and
poverty.
Corruption, which often
went together with the
“triple evil”, did not occur
only in government. It was
also present among trade
unions, he said.
“Corruption has engulfed
our society.”
Baleni called on the ANC
nisation study sponsored by
the Bill and Melinda Gates
Foundation. Several girls died.
The study was halted.
● The use by drug companies
of survivors of the world’s
worst poisonous gas disaster in
Bhopal as “guinea pigs” in at
least 11 trials without proper
informed consent.
● The completion by doctors
at a government hospital
in Indore of dozens of private
trials that a police investigation
found “violated the ethical
rules, there should be no
debate.”
His proposals and recent
comments by Deputy President
Kgalema Motlanthe
notwithstanding, the bill is
expected to be put to the vote
next week in the same form in
which it was approved by the
committee in early September.
Motlanthe last week told
reporters that there could perhaps
be a “meeting point”
between the media and the
ANC on the contentious issue
of a public interest defence.
Noting firm threats of a
constitutional challenge, he
also promised that the ANC
would not use its majority
muscle to “ram” contestable
legislation through Parliament.
But well-placed sources
in the ruling party have since
explained that Motlanthe was
not mooting the inclusion of a
conventional public interest
Mines must benefit
the people, says NUM
and trade unions to compel
members to declare any
business interests, saying
this would reassure those
bidding for tenders.
Those in decision-making
positions should declare
their interests and leave
these posts when it became
clear that a deal would benefit
members of their
families, Baleni said.
The union was also concerned
about people who
were misleading the working
class by claiming to be one of
them, when it was evident
from their lifestyles that this
was not so.
Asked about the suspension
of ANC Youth League
leader Julius Malema,
Baleni said the ANC should
be seen to be leading.
“We fully respect the
ANC in enforcing internal
discipline. We accept the outcome
of the internal disciplinary
committee.
“No one should be
allowed to pronounce on
policies that have not been
debated internally.
“No one must feel he is
above the ANC.” – Sapa
guidelines”. The doctors who
conducted the trials decided
that not one of 81 cases in
which a participant suffered
an adverse effect was linked to
the treatment. New trials were
stopped. A whistle-blower was
fired.
Earlier this year India’s
Health Minister, Ghulam Nabi
Azad, told parliament that 10
foreign drug companies had
made payments to the relatives
of 22 individuals who had died
during or following trials in
defence in the bill.
Such a provision would
allow those prosecuted for publishing
classified information
– a crime punishable with up
to 25 years in prison – to
argue that they had done so for
the greater good.
Instead, he was referring to
the possibility of approaching
a court with classified information,
and arguing that it
was in the public interest to
allow publication.
This option already exists
in the current version of the
bill.
The ANC suggests however
that the bill could still undergo
changes when it comes before
the National Council of
Provinces next year.
This would add another
turn to the already troubled
passage of the legislation
which has arguably garnered
more opposition than any post-
2010. The payments came to an
average of £3 000 for each individual.
The companies that
made the compensation payments
were Pfizer, PPD, Bristol-
Myers Squibb, Amgen, Bayer,
Eli Lilly, Quintiles, Merck
KGaA, Sanofi-Aventis and
Wyeth, which is now part of
Pfizer. Most of the companies
declined to provide details of
the compensation.
Drug companies insist they
always adhere to regulations.
The Association of the British
apartheid law.
Critics, including Cosatu,
say it places too much power
in the hands of the security
agencies, sacrifices transparency
and media freedom
for excessive state secrecy
and fails to protect whistleblowers.
The bill was originally set
down for debate in late September
but withdrawn from
the parliamentary programme
by the ANC to allow for further
consultation.
The Democratic Alliance
said last week the ruling
party’s attempts at consultation
turned out to be a farce,
and had only reached five
provinces.
But the office of the ANC
chief whip said the party
could still hold public meetings
on the bill once it had
been sent to the National
Council of Provinces. – Sapa
ENVIRONMENTAL IMPACT ASSESSMENT (EIA)
PUBLIC PARTICIPATION PROCESS: PROJECT INITIATION PHASE
DEA&DP EIA Application Ref. No: E12/2/4/2-F4/16-3024/11
WCDM Atmospheric Emissions License Ref. No.: 12/3/1/11 (WC/WC/010)
DEA Waste Management License Ref. No.: 12/9/11/L639/9
NEWS
Greater
clarity on
FDI ‘in
next year’
Project Description and Location:
Afrisam proposes to construct a cement plant, limestone and clay quarries and associated infrastructure in the Saldanha area, Western Cape.
The approximate locations of the proposed project components are indicated below.
• The construction of a cement plant located at Saldanha (near the ore loading terminal, adjacent to Saldanha Steel), which consists of a
grinding and packing facility, and a clinker manufacturing plant;
• Limestone and clay quarries parallel to the coast between Saldanha and Portion 2 (Portion of Portion 1) of the farm Trekkossenkraal 104;
• The construction of a transport corridor (road or conveyor) to transport limestone and clay from the proposed quarries to the proposed
cement plant; and
• The establishment of two conservation areas.
The proposed project triggers several listed activities and notice is hereby given in terms of the:
• National Environmental Management Act (No. 107 of 1998) (NEMA) Environmental Impact Assessment (EIA) Regulations (as amended);
• National Environmental Management: Air Quality Act (No. 39 of 2004) (NEM: AQA) and
• National Environmental Management: Waste Act (No. 59 of 2008) (NEM: WA)
The following applications have therefore been submitted to the competent authorities, namely:
• EIA application to the Department of Environmental Affairs and Development Planning (DEA&DP);
• Atmospheric Emission License (AEL) application to the West Coast District Municipality (WCDM) and
• Waste Management License (WML) application to the National Department of Environmental Affairs (DEA).
AfriSam (Pty) Ltd is required to undertake the necessary authorisation processes prior to construction of the proposed project. Aurecon South
Africa has been appointed to undertake the required regulatory processes. A Background Information Document (BID) is available on request
or can be downloaded from the Aurecon website http://www.aurecongroup.com (click on South Africa, Public Participation links and
then “Proposed construction of the Afrisam Cement Plant and associated infrastructure”).
Interested & Affected Parties (I&APs) are required to notify Aurecon in writing should they wish to register as an I&AP for the proposed project.
I&APs have 30 days in which to register and/ or comment on the proposed project Please submit your name, contact information and
comments on/ before 14 December 2011 for attention: Nelis Bezuidenhout or Mel Pillay, Aurecon, P. O. Box 494, Cape Town, 8000;
Tel: (021) 526 6031; Fax: (021) 526 9500 or Email: Nelis.Bezuidenhout@aurecongroup.com or Mel.Pillay@aurecongroup.com
The proposed project triggers the following activities listed in terms of the following laws:
• NEMA (Act No. 107 of 1998) (as amended): Activities 9, 11, 12, 13, 18, 19, 20, 22, 23 and 56 in Listing Notice 1 (GN R.544 of 2010); Activities
5, 10, 15, and 26 in Listing Notice 2 (GN R.545 of 2010); and Activities 4, 10, 12, 13, 14, 16 and 19 in Listing Notice 3 (GN R.546 of 2010).
• NEM:AQA (Act No. 39 of 2004): Category 5 (Mineral processing, storage and handling): Subcategory 5.3: Cement production (using
conventional fuels and raw materials) in terms of GN 248 of 2010.
• NEM:WA (Act No. 59 of 2008): Activities 1, 2, 7, and 18 of GN 718 of 2009.
OM/03/08510146
5
Pharmaceutical Industry said:
“In order for a pharmaceutical
company to gain a licence in
the UK for a newly developed
medicine, the clinical trials,
wherever they took place, are
subject to a high level of
scrutiny by the UK regulatory
authorities. It would be of no
benefit to companies to conduct
clinical trials that were not of
the required standard, as any
medicine would not gain a
licence and not be made available
to patients.”
JOHANNESBURG: There
will be more certainty about
foreign direct investment in
South Africa within the next
year, Finance Minister Pravin
Gordhan said yesterday.
“Within the next year, we’ll
have a very clear legal
framework within which FDI
(foreign direct investment)
can operate,” the minister
told Business Unity SA’s
annual general meeting in
Johannesburg.
This would “give foreign
investors a clear and
consistent picture within
which to work”.
Gordhan made his
comment in light of confusion
created by the government’s
response to United States
giant Walmart’s R16.5 billion
acquisition of a controlling
stake in local retailer
Massmart.
Although he did not want
to comment specifically on
the Walmart matter, which is
before the Competition
Appeal Court, he said some of
the issues raised by the deal
were correct.
These included the
government’s wish to
promote procurement and
small businesses, and to
prevent job losses.
The National Treasury
had released a discussion
document on guidelines for
FDI, titled “A review
framework for cross-border
direct investment into South
Africa”.
Within the next year to 18
months, a clear policy
document on FDI would be
available. This would “clearly
identify what we see as
strategic industries where a
particular set of rules apply”
and other industries in which
government had no strategic
interests.
In those areas where the
government had strategic
interests, “there will be clear
and transparent and
consistent rules in terms of
which we would work as a
country and which we would
expect investors to
understand before they come
into South Africa as well”.
“Walmart now takes place
within that context”, Gordhan
said. – Sapa
See Business Report