ISLAMABAD: After a long controversy and delay, the drug pricing committee (DPC) of Drug Regulatory Authority of Pakistan (Drap) on Friday finalised the price for hepatitis medicine.

At a meeting, DPC decided that the 28-tablet packet of sofosbuvir would be sold for Rs9,999. However, a summery will be sent to the Prime Minister Office for a final approval.

On December 22, the Supreme Court took a suo motu notice of the issue of the hepatitis drug pricing after which a meeting of the committee was convened on Dec 31. However, the meeting was postponed at the eleventh hour due to a lack of quorum. But there were rumours in Drap and the health ministry that the meeting could not be held because members of the DPC refusal to approve the price of the 28-tablet packet of Sofosbuvir at Rs26,000 as a company had already submitted to the apex court an offer to provide the medicine at Rs3,240. However, Drap denied the allegations and said the meeting would be held soon.

Drap committee finalises price of 28 tablets of sofosbuvir at 10,000

An official of the health ministry requesting not to be identified said nine companies were approved to participate in the bidding held on Friday to manufacture the medicine in Pakistan.

“In the meeting, it was decided to fix the price at Rs9,999. Though a company had submitted the lowest price of Rs3,240 to the Supreme Court, the firm was not approved. We considered only those companies which were approved for the manufacturing of the drug,” he said.

“As soon as the minutes of the meeting are signed, we will fix the price after which it’s the manufacturing will start,” he said.

Dr Kamran Qureshi, a postgraduate in pharmaceutical medicine from the University of Surrey, UK, told Dawn that it was very unfortunate that in a country like Pakistan where Hepatitis C was prevalent among poor people the price of sofosbuvir had been fixed at Rs9,999. “This means a patient has to spend Rs59,994 for the six-month treatment.”

Even the prime minister’s health insurance programme may not be able to cope with the magnitude and severity of Hepatitis C burden in the country. Drap probably wants to increase the economic burden on the poor, he said.

“Various international studies have clearly shown that the price of sofosbuvir should be somewhere between Rs3,500 and Rs6,000 for a one-month therapy. An analysis in 2013 showed that a three-month therapy of sofosbuvir’s manufacturing cost should be between $100-200 for three months,” he said.

The current price of raw material for sofosbuvir is between $1,500 and $2,000 per kg and if we take the formula of Drap for the price determination - cost of raw material +70pc of the cost of raw material - the monthly treatment cost should be less than the fixed price, he said.

Minister for National Health Services (NHS) Saira Afzal Tarar told Dawn that it was a very complicated issue as companies had been trying to manufacture the medicine for long and the ministry was making efforts to ensure that only quality product was manufactured in the country.

She said there was a huge difference in the prices submitted by the companies ranging from Rs9,999 to Rs1.9 million for the same medicine.

“After a detailed discussion, it was decided to accept the lowest offered price of Rs9,999. However, I have decided to send the summery to the Prime Minister Office for an approval,” she said.

Sofosbuvir, which is used to treat hepatitis C, was introduced in the United States in December 2013. The medication was approved by the US Food and Drug Administration (FDA) and has higher cure rates than the Interferon injection with minimal side effects. In total, six months of treatment is required for each patient.

Though the drug has a patent or copyright, there is a universal law called ‘Compulsory licensing’ under which any medicine can be manufactured anywhere. The law is used when the drug is not available or becomes impossible for the patients to buy because of the high price.

A number of companies showed an interest in manufacturing the drug in Pakistan after which Drap registered 16 firms.

However, Drap delayed the fixation of the price so the companies were not able to manufacture the medication.

Published in Dawn, January 16th, 2016