Smithkline Beecham Biologic... - Human Rights Commission of Sri ...
Smithkline Beecham Biologic... - Human Rights Commission of Sri ...
Smithkline Beecham Biologic... - Human Rights Commission of Sri ...
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<strong>Smithkline</strong> <strong>Beecham</strong> <strong>Biologic</strong>als, S.A. And Another V. State Pharmaceu... file:///C:/Documents and Settings/kapilan/My Documents/Google Talk ...<br />
Admittedly, where the specifications or conditions <strong>of</strong>fered conform substantially to those in the tender documents and<br />
vary in only minor details, a Tender Board is not precluded from accepting a Tender: See F. R. 697 (6) (b).<br />
Considering the broad policy <strong>of</strong> the condition and the critical and substantial nature <strong>of</strong> the mischief to which it is<br />
directed. namely, assurance <strong>of</strong> the quality <strong>of</strong> the product, I am <strong>of</strong> the<br />
46<br />
view that the requirement <strong>of</strong> registration was mandatory and could not be treated as a mere formality or technicality,<br />
or minor detail that could have been waived or ignored either by the Technical Evaluation Committee or by the<br />
Tender Board. The necessary consequence <strong>of</strong> a failure to comply with the condition relating to registration is the<br />
rejection <strong>of</strong> the tender. (See F.R. 697 (6) and Guidelines, Part 1, clause 134).<br />
If a Tender Board recommends a deviation <strong>of</strong> a non-critical nature from the tender conditions, the reasons for such<br />
deviation should be recorded clearly on the minutes <strong>of</strong> the proceedings. (Guidelines, Part 1, clause 133.) There is<br />
no record <strong>of</strong> the Tender Board having regarded registration as being a matter <strong>of</strong> a non-critical nature. The Tender<br />
Board does not recommend a deviation at all: On the other hand, it proceeds on the basis that registration is<br />
essential.<br />
In paragraph 14 (i) <strong>of</strong> his affidavit, the Chairman <strong>of</strong> the Board states that the decision was made "... in accordance<br />
with the relevant tender conditions and regulations taking into consideration all relevant matters including the price<br />
quoted, the past performance, quality <strong>of</strong> samples, delivery <strong>of</strong>fered and product registration." He was repeating the<br />
criteria set out in clause 29 (1) <strong>of</strong> the tender document which we have set out above. Whatever the alleged "past<br />
practice" may have been, there is no doubt that as far as this tender was concerned, registration was necessary,<br />
and therefore, the Tender Board, quite properly took that into account.<br />
The Chairman <strong>of</strong> the Tender Board states in paragraph 14 (i) <strong>of</strong> his affidavit dated the 5th <strong>of</strong> March 1997 that the<br />
Tender Board took past performance and quality <strong>of</strong> samples into account in arriving at its decision to award the<br />
contract for the supply <strong>of</strong> Rubella vaccine to Biocine S.P.A. The Technical Evaluation Committee does not in its<br />
report that samples were received from all the tenderers, but it states nothing with regard to their quality. Whereas<br />
SmithKline <strong>Beecham</strong> <strong>Biologic</strong>als S.A. had supplied that vaccine in the previous year, and had their product registered<br />
at the date <strong>of</strong> the opening <strong>of</strong> the tenders, viz. 3rd July 1996, Biocine S.P.A.had neither supplied<br />
47<br />
Rubella vaccine earlier, nor was its product registered at the relevant time. The Technical Evaluation Committee in its<br />
report said that the product <strong>of</strong> SmithKline <strong>Beecham</strong> <strong>Biologic</strong>als S.A., were registered, but stated that none <strong>of</strong> the<br />
other tenderers had registered their products. The Technical Evaluation Committee in its report stated that<br />
SmithKline <strong>Beecham</strong> <strong>Biologic</strong>als S.A., had been a previous supplier and in the column "Past Complaints" stated "No<br />
complaints". With regard to the other tenderers, including Biocine S.p.A., the Committee states that they were not<br />
previous suppliers and in the column "Past Complaints" states "Not applicable". The Managing Director <strong>of</strong> the State<br />
Pharmaceutical Corporation in his note dated the 9th <strong>of</strong> December 1996, which eventually persuaded the Tender<br />
Board to change its mind, states that "none <strong>of</strong> the items <strong>of</strong> Biocine, Italy have been purchased in the past", and<br />
"therefore" suggests that 25% (i.e. 1,125 million doses) be awarded to Biocine, Italy, as "a sample order". The<br />
Cabinet Appointed Tender Board decided to award a contract for supply restricted to 2 million doses to Biocine,<br />
Italy, for the stated reason that it was a "new supplier". In the circumstances, how could the Chairman <strong>of</strong> the Tender<br />
Board truthfully say that the Tender Board took account either <strong>of</strong> the past performance and the quality <strong>of</strong> the product<br />
<strong>of</strong> Biocine S.P.A.to whom the contract was awarded? The Tender Board was unable to recommend the acceptance<br />
<strong>of</strong> the Biocine S.P.A. bid. with confidence, and therefore recommends acceptance "on the basis that each<br />
consignment would be suitably tested before despatch to hospitals." The balance quantity <strong>of</strong> supplies are to be<br />
awarded to Biocine S.P.A." If the supplies <strong>of</strong> this vaccine are timely and in order and complied with quality assurance<br />
tests.<br />
In his letter dated the 1st <strong>of</strong> November 1996, the Managing Director refers to the fact that "two companies have<br />
submitted their samples for testing and. reports are awaited." The Cabinet Tender Board at its meeting on 10th<br />
December 1997 found itself, as it says in its minutes, "confronted with the matters mentioned in the note by MD/SPC<br />
to the CATB dated 9.12.1996." Although in his letter dated November 1 1996, the Managing Director <strong>of</strong> the<br />
48<br />
State Pharmaceutical Corporation acknowledged the fact that the three other companies which had quoted were<br />
"unfortunately ... not registered", in his note dated the 9th <strong>of</strong> December 1996 he stated that "Now the following two<br />
companies have registered: (1) Biocine S.p.A., Italy (2) Serum Institute India," The emphasis is mine.<br />
Although the Managing Director had recommended that 25% (i.e. 1, 125 million doses) be awarded as a sample<br />
order" to Biocine from whom no products had been previously ordered, and that 75% (i.e. 3,375 million does) be<br />
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