Sergii Dmytriiev, is the Policy and Advocacy Director for 100% LIFE, our campaign partner in Ukraine. He explains why it took 5 years to stop overpaying for a HIV drug – even when patent barriers didn’t legitimately exist.
“In November 2020, Ukraine finally shifted from the overpriced branded version of darunavir (DRV) to the more affordable generic version of the same medicine.
Janssen’s patents were unmerited, and even though granted still didn’t prevent generic competition. Yet despite this, it took five years of continuous advocacy. Our persistence paid off, but the length of time it took is testament to how determined Janssen was to hold onto its unjustifiable monopoly and profits, at the expense of Ukraine’s health budget and peoples lives.
Janssen has been over-charging Ukraine since 2011.
In order to monopolize the compound the company had applied for secondary patents on the drug, attempting to layer intellectual property (IP) protection around the drug. A 2016 patent search by 100% LIFE discovered that the patents (intermediary and process patents) did not prevent generic competition, DRV can be produced without using those technologies.
In order to prevent further overspending on DRV, we reached out to all involved:
- To generic manufacturers urging them to enter the Ukrainian pharmaceutical market with darunavir, introducing competition.
- To the Ukrainian procurement agency with results of the patent search, demonstrating that no patent barriers to generic procurement were actually existence.
- Simultaneously, we contacted Janssen calling for the company to extend its voluntary license (VL) for DRV to the territory of Ukraine, as another route to inviting legitimate generic competition.
For about 3-4 years we were trying to break a vicious cycle where generic manufacturers and procurement agencies were hesitant to supply or procure DRV for Ukraine, worrying that it could cause problems with Janssen. The originator company exploited this situation by claiming that DRV couldn’t be made without the technologies the patents related to; insisting on its monopoly for the medicine; and refusing to authorize generic entry (e.g through a VL or otherwise) even though its DRV patents were not blocking. Luckily, we figured out a strategy that changed the situation for better.
100% LIFE is the recipient of a Global Fund grant, with a responsibility for purchasing HIV medicines. In Summer 2020 we announced a call out for companies to bid to for a small procurement of DRV, and allowed participation of generic manufacturers on the grounds that there are no blocking patents for the medicine in Ukraine.
Despite objections from Janssen, a European pharmaceutical company was granted the contract and its product became the first generic DRV ever procured in Ukraine.
When the news reached the Ukrainian procurement agency and a wide range of generic manufacturers, it significantly reduced their previous concerns. As a result, in Autumn 2020, the procurement agency allowed generic manufacturers to participate in a call for proposals for ongoing DRV supply, and three generic competitors submitted bids.
Generic competition has reduced the price for DRV, from around $7.25 – 7.50 (USD) per 600mg pill for Janssen’s version, to approximately $2.5o for quality-assured generics – a third of the price.
This price reduction is expected to only be the start. As more manufacturers compete the price will continue to come down. Savings can and should be used for the expansion of treatment, diagnostics and medical services for Ukrainian patients.”