A drug maker in Bangladesh has become the first company to sell a generic version of remdesivir, the latest sign of how the push to ensure widespread access to Covid-19 medicines and vaccines has become an urgent issue in poor countries.
Following an emergency decree issued by the Bangladesh government, Beximco Pharmaceuticals is donating copies of the Gilead Sciences (GILD) medicine to state-run hospitals free of charge, but will sell the intravenous treatment to private clinics. Moreover, the company is reportedly willing to export its version if other governments request the drug, although it does not have a license from Gilead to do so.
Beximco is able to take this step under provisions of a World Trade Organization agreement, which permits a “least-developed” country to grant a public agency or a company a license to copy a patented medicine without the consent of the patent holder. As a result, Bangladesh is not required to grant pharmaceutical patents until 2033.
“This reinforces our commitment to ensure access to breakthrough therapies, despite facing many challenges amid this unprecedented pandemic,” Beximco managing director Nazmul Hassan said in a statement. “We express our gratitude to the regulatory authority for their support in making this drug available to patients at the earliest possible time.”
Remdesivir has generated worldwide interest after U.S. officials last month discussed a preliminary analysis indicating the medicine helped seriously ill patients with Covid-19 recover faster, although complete results of the study, which was sponsored by the U.S. government, are not yet available. Globally, Covid-19 has infected 5 million people and claimed nearly 328,000 lives, according to the World Health Organization.
Given the extent of the pandemic, licensing has become a hot topic. Several countries — Canada, Germany, Israel, Ecuador, Brazil, and Chile — have moved in recent weeks to make it easier to issue licenses in the quest for access to lower-cost Covid-19 medical products. And several dozen advocacy groups and academics last month urged three dozen other countries to embrace the WTO provisions.
Compulsory licensing, however, has often been a flashpoint between the pharmaceutical industry and low- and middle-income countries. Cash-strapped governments have increasingly looked to licensing to ease their health care budgets and protect citizens who cannot afford costly medicines, but global brand-name drug makers argue that licensing eviscerates their intellectual property rights.
A famous battle occurred a few years ago between Novartis (NVS) and Colombia over the price of the Gleevec cancer drug. The government threatened to issue a license, prompting the company to enlist U.S. officials to pressure Colombian officials not to do so. Instead, the health minister unilaterally cut the price. Novartis filed suit, arguing that a health emergency did not exist, among other things.
Gilead, meanwhile, has attempted to avoid such quagmires by making licensing agreements with generic companies to supply poor countries and some middle-income nations with its drugs. The drug maker took this approach with its pricey hepatitis C treatments and again last month with remedesivr, striking deals with five generic makers in India and Pakistan to supply generic versions to 127 countries.
Beximco is not one of the companies that was issued a license by Gilead and, as a result, its plans could further widen availability of the medicine. However, a Gilead spokesman wrote us that the drug maker “cannot comment on or verify the authenticity or effectiveness” of the Beximco version of remdesivir since it is not manufactured by Gilead or one of its licensed partners.
“Considering it is a product that countries indeed will want to buy, (Beximco) can supply countries where there are no patent barriers, including those that have issued a compulsory license,” said Ellen ‘t Hoen, a senior researcher in the global health unit at the University of Groningen in the Netherlands and a former executive director of the Medicines Patent Pool.