In the latest effort to widen access to Covid-19 medical products, three dozen countries are being urged to reverse a decision to forsake compulsory licenses, a move that would make it possible to sidestep patents and pursue lower cost versions of drugs, vaccines, and diagnostics.
At issue is an amendment to a World Trade Organization agreement that was reached nearly two decades ago and memorialized the right for countries to pursue compulsory licensing. Under that agreement, a country may grant a license to a public agency or a generic drug maker, allowing it to copy a patented medicine without the consent of the brand-name company that owns the patent.
Three years ago, however, 37 countries opted out of the agreement, making them no longer eligible to import medicines that are manufactured and patented in another country, and where there is a compulsory license issued for exporting to other countries. Among them are the U.S., Canada, Australia, Japan, the U.K., and Switzerland, as well as the European Union, including France, Germany, and Italy.
In an open letter sent on Tuesday to those governments, several dozen advocacy groups and academic experts on health, law, and international trade argued that these countries should reverse course. As they see it, the countries may later find it difficult to gain access to needed medical products due to the complicated intersection of patents and global supply chains.
“It’s totally irrational for any country, even a rich country, to keep its own hands tied to meet the Covid-19 needs of its population by voluntarily shutting itself off from patented ingredients, components, and essential medical products and supplies,” they wrote. Among those signing the letter were Health Action International, Knowledge Ecology International, and BEUC, the European Consumer Organization.
They also maintained this “may prove critically important during the COVID-19 pandemic, as well as under future health emergencies.”
The advocates and academics further argued that these mostly wealthy countries, by maintaining their opt-out status, may also harm lower- and middle-income nations willing to use compulsory licenses. How so? By opting out, these countries are decreasing the potential market for Covid-19 medicines, vaccines, and diagnostics that are manufactured under a compulsory license elsewhere.
“As a result, manufacturers in countries (that) use compulsory licenses can expect to sell fewer quantities” of Covid-19 products, the letter stated. “This may prevent them from benefiting from economies of scale, which could mean they would have to charge higher prices or forgo production altogether.”
This could also benefit brand-name drug makers and others that hold patents on medical products, by the way. Why? Typically, these companies would like to avoid the sudden added demand that can occur if a country issues a compulsory license because this creates a new market for alternative suppliers.
To what extent any of these countries will reverse course and embrace the compulsory licensing provisions remains to be seen. In the U.S., successive administrations have often pressured other governments to forsake compulsory licensing. And many of the biggest global drug makers are based in several of the wealthiest nations, suggesting they would lobby against any changes.
In any event, the letter was sent as more attention is focused on access to Covid-19 medical products.
On Monday, the World Health Organization director-general endorsed the idea of creating a voluntary pool to collect patent rights, regulatory test data, and other information that could be shared for developing drugs, vaccines, and diagnostics.
The notion was backed by Unitaid and the Medicines Patent Pool, a United Nations-backed agency that licenses HIV, tuberculosis, and hepatitis C treatments from drug makers in order to provide access in lower-income countries. The agency expanded its mandate to include Covid-19 products and contribute to the pool.
That move occurred after a growing number of countries took steps to use — or make it easier to use — compulsory licenses. Among them were Canada, Germany, Ecuador, and Chile. At the same time, efforts made by government officials in Israel and lawmakers in the Netherlands prompted two manufacturers — AbbVie (ABBV) and Roche (RHHBY), respectively — to widen access to products.