By Leena Menghaney, The Hindu | March 4, 2017
In 2014, an Indian pharmaceutical company was globally the first to receive approval to market a biosimilar, thereby affordable version, of the breast cancer drug Trastuzumab. Almost immediately, Swiss pharmaceutical company Roche, innovator of the drug, filed a suit against the Indian Food & Drug Administration (FDA) to block its sale. The action firmly put their profits ahead of the lives of women with breast cancer.
Roche effectively embroiled India’s drug regulatory body and biosimilar producers in a long-drawn, expensive and increasingly complex litigation to try and prevent the marketing of potentially affordable versions of the cancer drug from competitors. The suit was aimed at questioning the ability of the Indian FDA to register biosimilars and made frivolous assertions regarding copyright infringement of its package insert by competitors.
After a wait of over three years, the Delhi High Court’s decision last week lifts some of the uncertainty surrounding the sale of the more affordable versions of the breast cancer drug in India. The court ruled that in view of the fact that the appropriate authority has approved the package insert and the drug for all three indications (metastatic breast cancer, early breast cancer and gastric cancer), the competitors should be permitted to sell Trastuzumab.
Young women in their thirties being diagnosed with breast cancer benefit from Trastuzumab as it reduces the risk of recurrence. Most patients struggle to pay for their surgery and chemotherapy and Roche was charging a staggering ₹10 lakh for 17 cycles of the medicine.
For poorer patients, this meant that despite a grant of partial treatment costs under the Prime Minister’s National Relief Fund (PMNRF), patients still fell short of money. Often, poor women diagnosed with breast cancer were not even told about the treatment option. One oncologist described it as being cruel to tell his patient that there was a drug that could potentially save her life but priced out of reach.
In South Africa, women like Tobeka Daki, a breast cancer patient who died fighting Roche, were denied a chance of survival, not for medical reasons but because Roche’s charged U.S. $38,365 for Trastuzumab.
Striking a chord
Roche’s attempts to prevent price reduction or competition in different countries has struck a chord with women, cancer groups and treatment activists around the world. It exposes the lengths that the Swiss corporation will go to protect its monopoly and profiteering, despite the immense human cost. Last month, there were demonstrations in South Africa — with patients and treatment activists chanting #RocheGreedKills — adding their voices to the growing chorus of outrage.
Many of us who have worked on access to cancer medicines know that competition is the most effective tool to bring down prices of essential pharmaceuticals. Today, distributors in India are offering a vial of Trastuzumab (440 mg) at ₹30,000, something that Roche marketed at over ₹1 lakh in 2012. Competition from other generic companies is set to enter the market. Health economists have shown that a year’s worth of Trastuzumab can be produced for only ₹16,000 (U.S. $240) and stiff competition among Indian manufacturers will start bringing the prices down further.
By no means is the battle for affordable Trastuzumab over. The drug needs to be included in the essential medicine lists (EML) of State governments so it is procured and available to women being treated in the public sector in hospitals like Safdarjung and AIIMS. In the private sector, hospitals are overcharging women with breast cancer being treated in their facilities — making over ₹10,000 on each vial administered — and not allowing them to source the drug independently at a lower cost directly from the distributor. Pharmaceutical companies are complicit in the malpractice as they choose to keep the retail prices high, offering a huge cut to the hospital for prescribing their brands.
Every day, women with breast cancer who cannot afford the drug contact me. It is appalling that private hospitals are preying on the vulnerability of women sick with cancer and the government does little to address the problem.