A Precious Breath

Pharma manufacturers and importers petition the court for a hike in inhaler prices

Karachi: With the arrival of winter, some pharmaceutical companies have requested a decree from the Sindh High Court (SHC) for the hike in price of therapeutic inhalers used by asthma patients to manage their ailment. A major pharmaceutical company, as well as medicine manufacturing and import companies, have filed lawsuits in court challenging the maximum retail prices set by the Drug Pricing Committee (DPC) of the Drug Regulatory Authority of Pakistan (DRAP) for budesonide 200 mcg and 400 mcg.

Plaintiffs have claimed in lawsuits referring to various provisions of the Drug Pricing Policy 2018 that the DPC, at its 49th meeting in 2021, set much lower MRPs for the drugs than the basket countries mentioned in the Policy.

According to the lawsuits, the policy requires that the originator brand of a New Chemical Entity (NCE) and a New Biological Entity (NBE) in a specific dosage form, strength, and delivery system be based on the average price of the same dosage form and strength of the same brand in India and Bangladesh. If the originator brand is only available in one of these countries, the MRP shall be set at its par after taking exchange rate parity into account.

If the originator brand of NCE or NBE has not been marketed in India or Bangladesh, the maximum retail price shall be set at the same level as the average retail price of a basket of countries, namely Indonesia, the Philippines, Lebanon, Sri Lanka, and Malaysia. If the originator brand is not available in all of these countries, the MRP shall be set at the average retail price in the countries where the originator brand is available; or, if not available, the prices shall be verified from any of the independent sources via IQVIA Consulting & Information Services, which maintains trade price information globally.

The Searle Company Limited, one of the plaintiffs, stated that it complied with the policy and obtained reference prices for the originator brands SYMBICORT INHALER and SYMBICORT TURBUHALER from IQVIA Consulting & Information Services’ India and Bangladesh offices. According to IQVIA’s respective regional offices, the stated brand is available in India but not in Bangladesh. The IQVIA-certified proforma for verification of reference prices of the originator brands in India and non-availability of the stated brands in Bangladesh was submitted directly to the Division of Costing and Pricing, DRAP, in accordance with the format and procedure outlined in Paragraph 3 (iii) of Drug Pricing Policy, 2018.

According to the Searle, it is evident from the IQVIA Proforma that the reference drug prices of the originator brand SYMBICORT INHALER (60 doses) in India are PKR 1062.32 and 60 doses of SYMBICORT TURBUHALER are PKR 1344.16, which are higher than the prices fixed by the DPC for its finish import products FORPACK DISCAIR INHALATION POWDER 12mcg/200mcg (PKR 604) and FORPACK DISCAIR INHALATION POWDER 12mcg/400mcg (PKR 707).

The company argued that it is highly unjustified and inexcusable on the part of the Division of Costing and Pricing, which blatantly ignored the prescribed pricing mechanism for new products as laid out by the Drug Pricing Policy 2018, and the DPC fixed prices far lower than the justified prices.

It went on to say that, rather than maximum retail prices, IQVIA provides reference trade prices for originator brands from reference or basket countries. And it is necessary to use common sense and logic to project the proposed trade prices of generic formulations in Pakistan based on the trade prices of the reference brands in the country of origin. This means that the formulations’ maximum retail price can be extrapolated by adding the applicable markup rate and various taxes and levies.

Failure to follow the pricing mechanism and the IQVIA-certified prices, according to the company, had severely harmed its ability to conduct viable business and ensure the supply of life-saving products to patients. The company is unable to import, distribute, and sell the products in Pakistan with a reasonable economic margin to ensure a continuous supply of life-saving drugs in the market due to unjustifiedly low prices, it added.

The company sought a court declaration that the DPC’s prices are illegal and void, as well as an order directing the DRAP, its Division of Costing and Pricing, and the DPC to fix drug prices in accordance with Drug Pricing Policy 2018, and setting aside the DPC’s proceedings and decision at its 49th meeting on October 6, 2021. The company further sought court’s injunction for the DPC for de novo determination of MRP of its drugs under the Policy.