US drugmaker Gilead Sciences has been heavily criticised for securing “orphan status” for a new drug which is seen as a potential coronavirus treatment.
Yesterday the US Food and Drug Administration (FDA) gave Gilead the designation for experimental treatment Remdesivir, which was last week mentioned as a possible cure by president Donald Trump.
Under the orphan drug regulation companies have a seven-year market exclusivity period for a treatment, which effectively amounts to a monopoly on sales and price.
In addition, companies get tax breaks for developing treatments for rare diseases that affect fewer than 200,000 people.
Health activists hit out at Gilead today. Ellen ‘t Hoen, director at non-governmental organisation Medicines Law & Policy, told the Financial Times that the move was “the most blatant abuse of the orphan drug act I have ever seen”.
Zain Rizvi, a researcher in medicines access at advocacy group Public Citizen, added: “It is absolutely ridiculous, and shows the lengths pharmaceutical companies are willing to go to cash in from a crisis”.
Gilead had been giving emergency access to the drug to a variety of health agencies around the world, but on Sunday the firm released a statement saying that it would no longer do so due to an exponential increase in compassionate-use requests for the drug.
The firm said it had paused access to the drug while it works on expanding its programmes to more patients.
Other drug companies have taken a different approach to Gilead, with the Financial Times reporting yesterday that fellow pharmaceuticals giant Abbvie had dropped its patent rights for Kaletra, another potential treatment for the disease.
There are currently no approved treatments or preventive vaccines for COVID-19, the disease caused by the coronavirus, with most patients only receiving supportive care such as breathing assistance in serious cases.
In a statement, Gilead said: “If remdesivir is proven to be safe and effective to treat Covid-19, we are committed to making Remdesivir both accessible and affordable to governments and patients around the world”.
Remdesivir was first developed by Gilead in order to treat Ebola, but subsequently proved to be effective for treating respiratory illnesses such as SARS and MERS.