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MESSRS GETZ PHARMA (PVT) LTD. versus FEDERATION OF PAKISTAN

ection Section 7 (c) (vii) rug Drugs Act (XXXI of 1976), Section 12 - Drug Pricing Mechanism, CL4 (4) (i) Patent Ordinance Section 588 - SRO No. l01 (I) / 20I6 , History 92 2016 2016 Constitution of Pakistan, Arts 914 - rightto health - Scope was controversial in relation to pricing 'life-saving medicine' to treat hepatitis C - ultra low retail price of applicant medicine According to the notification under the notification authorities SRO No. 101 (1) 12016, dated 9 2 2016 - accuracy - where the drug was to be recovered, a large part of Pakistan's population suffers from hepatitis C (4% of the population) Is, even if public cleansing Was granted patent approval), the federal government had ample authority to sign section 588 of the Patent Ordinance 2000, to give local pharmaceutical companies the necessary licenses to manufacture drugs at very cheap rates - the High Court told authorities Identify and indicate these steps. He acknowledged that "access to affordable drugs has been granted and protected under the Articles 9 and 14 of the Constitution. Uthor ? powers were directed to hold the patent ordinance until 2001. The flexibility provided under Article 58 of the Act is not exhausted unless the "maximum retail price" for essential medicines is determined. Transparently - the High Court declared that notification SRO No. 101 ( I) / 2016, dated 2 2, 2016, fixing the "maximum retail price" of the pending drugs, as appropriate pricing procedures were followed in the neighboring countries. Notification issued to partial amendment of total 4 (4) (i) of drug pricing mechanism to federal and federal government

P L D 2017 Sindh 157 

Before Sajjad Ali Shah, C.J. and Zulfiqar Ahmad Khan, J

Messrs GETZ PHARMA (PVT) LTD. through Authorised Person—Petitioner

versus

FEDERATION OF PAKISTAN, through Secretary, Ministry of National Regulation . and Services and another—Respondents

Constitutional Petitions Nos.D-1040, D-1042, D-1043, D-1269 and B-1355 of 2016, decided on 7th October, 2016.

(a) Drugs Regulatory Agency of Pakistan Ordinance (I of 2012)-

—S. 7(c)( vii)—Drugs Act (XXXI of 1976), , S.12—Drug Pricing Mechanism, Cl.4(4)(i)—Patents Ordinance S.58—SRO No.l01(I)/20I6, dated 9-2-2016—Constitution of Pakistan, Arts. 9 14—rRightto health—Scope—Dispute was with regard to fixation of price of ‘life saving drug’ meant to cure Hepatitits-C—Petitioner was aggrieved of fixation of too low retail price of medicine in question by authorities under notification SRO No. 101(1)12016, dated 9-2-2016— Validity—Where drug was intended to heal, a large part of population of Pakistan suffering from Hepatitis-C (4.5% of population), in public interest (even if patent was granted), Federal Government had ample power to invoke S.58 of Patents Ordinance, 2000, to grant compulsory licences to local pharmaceutical companies to produce drug in question at lot cheaper rates—High Court directed the authorities to recognize and take steps to show that they had recognized that “access to affordable medicine was a fundamental right granted and protected under Arts.9 & 14 of the Constitution”—Authorities were directed that “Maximum Retail Price” for essential drugs not to be set unless flexibilities provided under S. 58 of Patents Ordinance, 2001, had been fully exhausted in a transparent manner—High Court declared that Notification SRO No. 101(I)/2016, dated 9-2-2016, fixing “Maximum Retail Price” of medicine in question, as appropriate procedure of price determination of the compound in neighbouring countries was complied with and Federal Government had residual authority to issue the notification in partial modification of Cl.4(4)(i) of Drug Pricing Mechanism—High Court also directed the authorities to adopt due process provided under Drug Pricing Mechanism and after giving opportunity of hearing, re-fix Maximum Retail Price of drug in question strictly in accordance with law—Constitutional petition was dismissed in circumstances, [pp. 166, 168] A & C

(b) Constitution of Pakistan—

—-Arts. 9 & 14—Right to health—Scope—Unlike 115 countries of the world, the Constitution of Pakistan does not explicitly recognize the ‘right to health’—Right to life is enshrined under Art. 9 of the Constitution and when it is read with Art. 14 of the Constitution, which grants right to ‘dignity of man ’ the same gives birth to the ‘right to health’ as a fundamental right—Such ‘right to health’ is also covered by several international human rights instruments, including International Covenant on Economic, Social and Cultural Rights (ICESCR) ratified by Pakistan on 17-4-2008, which recognizes the right of nationals to the enjoyment of the highest attainable standard of physical and mental health, [p. 166] B

Faisal Siddiqui and Abdul Sattar Pirzada for Petitioner.

Muhammad Aslam Butt, D.A.G, for Respondents.

Date of hearing: 25th August, 2016.

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