Procurement Conditions, Hepatitis Control Programme, Government of Punjab

Procurement Conditions, Hepatitis Control Programme, Government of Punjab Aggrieved Person Case Laws Constitutional Law Healthcare Knowledge - Constitutional Law Lahore High Court Litigation & Arbitration PPRA Procurement Solutions - Constitutional Law Mr. Justice Shams Mehmood Mirza in his judgment has decided the issue regarding procurement conditions, hepatitis control programme, Government of Punjab in Writ Petition No. 10045 of 2016.

1. By this writ petition filed under Article 199 of the Constitution of the Islamic Republic of Pakistan, 1973, the petitioners seek to challenge the decision of the Grievance Committee rendered on 24.03.2016 dismissing the representation of petitioner No. 2.

2. Petitioner No.2 (Getz) is a drug manufacturing company and petitioner No.1 (Alfalah) is its authorized distributor. Getz imports and markets a drug called Uni peg-V (Unipeg) in Pakistan, which is statedly used primarily for the treatment of Hepatitis C. The Director General, Health Services through advertisement in the newspaper invited bids for procurement of a number of drugs/medicines, which included “Injection Peglated Interferon 180 mcg Alpha2a/120mcg Alpha 2b” (hereinafter referred to as Interferon). The procurement of the Interferon was sought in connection with the prevention and control of Hepatitis Control Program initiated by the Government of Punjab. Getz claims that Unipeg is biosimilar to Interferon in dosage form, strength, quality, performance characteristics and intended use. Clause 12 of the bidding documents required Bio equivalence/Bio Similarity study from World Health Organization (WHO) audited laboratory/DRAP authorized laboratory/ICH certified/audited laboratories (hereinafter referred to as the prescribed laboratories). It is an admitted position that Unipeg has not yet been certified by any of the prescribed laboratories and, therefore, does not fulfill the criteria mentioned in the bidding document. Alfalah applied for the bidding documents and feeling dissatisfied by insertion of clause 12 contained therein filed a suit for declaration and permanent injunction before the civil court at Lahore. The trial court on 15.12.2015 suspended the operation of clause 12 of the bidding document. On 07.01.2016, the Director General, Health Services again advertised for procurement of Interferon but this time it required prequalification of suppliers. In the second round, Getz obtained the bidding documents for prequalification instead of Alfalah. Clauses 10 and 11 of the bidding documents again required Bio equivalence/Bio Similarity study from World Health Organization audited laboratory/DRAP authorized laboratory/ICH certified/audited laboratories. Getz, it is claimed, tendered the prequalification documents on 22.01.2016 under protest. There were four other bidders in addition to Getz. The prequalification applications of Getz and another were, however, rejected on 17.03.2016 on the ground that their drugs did not meet the criteria mentioned in clauses 10 and 11 of the bidding documents whereupon a grievance application was moved by Getz on 18.03.2016 before the Grievance Committee, prequalification Hepatitis Control Program. On 19.03.2016, Alfalah, although not an applicant in the second procurement process, moved a stay application before the trial court in the suit earlier filed by it whereupon the trial court directed the respondents to comply with its earlier stay order dated 15.12.2015 and operation of order dated 17.03.2016 was suspended. The petition filed by Getz before the Grievance Committee was dismissed on 24.03.2016 on the ground that it had failed to comply with clauses No.10 & 11 of the bidding document, hence this writ petition.

3. During the pendency of this writ petition, CM No.1295 of 2016 was filed by intervener, Roche Pakistan Limited (Roche), which was pre-qualified in the second round of procurement and was later declared the successful bidder. This application was contested by the petitioners by filing their written reply. The said application was allowed on 14.04.2016 by this Court and the petitioners were directed to file the amended memo of parties reflecting the name of Roche as respondent No.5.

4. The respondents have filed their reply and parawise comments to the writ petition in which the stance of the petitioners has been controverted.

5. Learned counsel for the petitioners made the following submissions:

a. Alfalah being a distributor of the medicines manufactured by Getz can maintain this writ petition even though it did not apply for and participate in the pre-qualification of bidding advertised by the respondents in the second round.

b. The advertisement for prequalification of tenders for supply of Interferon was in violation of stay order dated 15.12.2015 passed by the trial court in the suit initiated by Alfalah. It was further submitted that this Court can take notice of the disobedience by the respondents of the order of the civil court.

c. Unipeg is registered with Drug Regulatory Authority of Pakistan (DRAP) since 2010 and is being sold throughout Pakistan. DRAP gave two years time to Getz for carrying out Bio-similarity Studies as per the guidelines of WHO on 20.10.2015 and as such the petitioner still has time available to it for complying with clauses No.10 & 11 of the biding documents.

d. Clauses 10 & 11 of the bidding document violate Article 148 of the Constitution of Islamic Republic of Pakistan, 1973 as the said clauses deviate from the Federal standards, which is not conducive for the inter-provincial trade.

e. Clauses 10 & 11 impede free competition as Roche has a monopoly over the medicine to be supplied to the respondents.

6. Learned counsel for the respondents, on the other hand, submitted that clauses 10 & 11 were not only not inconsistent with the Drug Regulatory Authority of Pakistan Act, 2012 (DRAP Act) rather they complied with the Federal standards provided therein. It was further stated that free competition was not stifled on account of inclusion of clauses 10 & 11 as five bidders participated in the prequalification process out of which two bidders were selected. Learned Assistant Advocate General submitted that drug manufactured by Getz did not comply with the Federal Standards contained in the DRAP Act. It was also alleged that the Government of Punjab included clauses 10 and 11 for pre-qualification of the contractors as it wanted to provide the best medicine for Hepatitis C, which disease was endemic in the province of Punjab.

7. Learned counsel for the intervener submitted that Roche applied for registration of its drug “Pegasys” which is the trade name of Pegylated Interferon and is approved by FDA, EMA and Swiss medic for treatment of Hepatitis B and C, which application was granted approval by the Ministry of Health. On account of disputes between Roche and Ministry of Health, Roche introduced “Ropegra” in Pakistan at a much more reduced price. Ropegra, it is claimed, is exactly the same substance as Pegasys and is imported from the same manufacturer, the only difference being that Ropegra is sold in vial form at a much lower price. A number of serious objections were raised on Unipeg with regard to its quality, safety and efficacy.

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