ISLAMABAD: The Supreme Court intends to examine the Oct 7, 2016, Sindh High Court (SHC) verdict of re-fixing the price of an essential medicine used for treatment of fatal disease Hepatitis C under the patent laws that permit the federal government to allow local manufacturing of patented medicines.

The retail price of generic substitute of 28 tablets of Sofosbuvir Tablets 400mg was approved by the government at Rs5,868 through a notification of Feb 9, 2016, whereas the price of the original brand Sovaldi (Sofosbuvir 400mg) through licensed importer M/s Ferozsons Laboratories Ltd is Rs32,300.

A three-judge bench of the Supreme Court, headed by Chief Justice Mian Saqib Nisar, decided on Wednesday to consider whether the SHC order was in consonance with the law, especially Section 58 of the Patent Ordinance, 2000.

While granting the leave to appeal, the Supreme Court decided to consider whether provisions of Drugs Act, 1976, and Drugs Regulatory Authority of Pakistan (DRAP), 2014, as well as the policy issued by the federal government for fixation of drug prices had been validly construed and dilated upon by the SHC.

The SC directions came on a set of appeals moved by the federal government and several pharmaceutical companies namely Getz Pharma Pvt Ltd, Ferozsons Labo­ra­tories Ltd, CCL Pharmaceu­tical Pvt Ltd, AGP PVT Ltd, Hilton Pharma Pvt Ltd etc.

The petitioners claimed in their petitions that two separate systems, one under the Drugs Act/DRAP Act and provisions of Patent Ordinance, 2000, with different objectives and purposes could not be linked for fixation of the maximum retail price of medicines.

According to SHC judgment 13 million people suffer from deadly Hepatitis C in Pakistan, making the country second in the world on account of prevalence of this fatal disease.

In its judgment, the Sindh High Court had ordered the government that while access to affordable medicines was a fundamental right of the people, protected under Article 9 of the Constitution, prices of the essential drugs should not be fixed unless flexibilities under Section 58 of the Patent Ordinance were fully exhausted in a transparent manner.

Section 58 of the Patent Ordinance allows the federal government to permit manufacturing of the patented medicines even without the consent of the owner of the patent in view of public interest, national security, nutrition, health or the development of vital sectors of national economy.

The Sindh High Court, besides declaring as legal the price fixation of generic substitutes of Sofosbuvir 400mg at the rate of Rs5,868 because appropriate procedure of price determination in relation to neighbouring countries had been followed, had also ordered the federal government to further bring down the price of the medicine in accordance with the law.

Deputy Attorney General Sajid Ilyas Bhatti claimed before the Supreme Court that the price of the medicine had been fixed while keeping in view the interest of the general public especially patients.

He said that the high court in its verdict dilated upon points and facts which were never raised before it during the course of arguments and the court rather misunderstood facts and provisions of Section 58 of the Patent Ordinance 2000.

The guidelines laid down by WHO for separating intellectual property systems and drug regulatory system was applicable to Pakistan, Bhatti said, adding that provisions of the patent laws had not been attracted since these had not been discussed in the high court.

The government’s petition argued that the high court judgment was of arbitrary nature and, therefore, not sustainable in the eyes of the law, adding that if leave to appeal was not accepted, the interest of the general public would be seriously jeopardised, causing irreparable loss to the general public.

The case will be taken up again on Thursday.

Published in Dawn, April 13th, 2017