After weeks of planning, the World Health Organization formally launched a voluntary pool to collect patent rights, regulatory test data, and other information that could be shared for developing drugs, vaccines, and diagnostics to combat Covid-19.
The effort reflects rising concern that some Covid-19 medical products may not be accessible for poorer populations – in any country. By establishing a voluntary mechanism under the auspices of the WHO, the goal is to create a pathway to attract numerous governments, as well as industry, universities and nonprofit organizations.
Nonetheless, the initiative, which the WHO has called a “Solidarity Call to Action,” is getting off to a rocky start. So far, only three dozen countries have committed to joining. And notably, the pharmaceutical industry has dismissed the notion, which underlies concerns that such a project is unlikely to succeed without widespread involvement. So let’s sort out a few issues to help understand whatever happens next.
Why was a voluntary pool suggested in the first place?
The plan emerged from moves by countries to consider compulsory licensing for unaffordable drugs. A country may grant a license to a public agency or a generic company, allowing it to make a patented medicine without the consent of the brand-name maker that owns the patent. This right was memorialized in a World Trade Organization agreement. But the pandemic has ratcheted up this sort of activity. In recent months, several countries took steps to make it easier to issue compulsory licenses.
In some cases, however, drug makers have reached voluntary licensing deals with generic companies to produce and sell certain medicines in other countries. The voluntary pool of the sort envisioned by the WHO goes much further, though, by seeking to pull in technologies from a larger number of players, rather than on a drug-by-drug, country-by-country basis. In doing so, the WHO hopes to create more equitable access and avoid the sort of disjointed affordability that has typified some efforts.
Are more countries expected to join? And what happens if many do not?
So far, the countries that signed on to the initiative represent a mix of small and large economies or populations. The list includes Argentina, Bangladesh, Belgium, Belize, Bhutan, Brazil, Chile, Dominican Republic, Ecuador, Egypt, El Salvador, Honduras, Indonesia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Mozambique, Norway, Oman, Pakistan, Panama, Peru, Portugal, South Africa, Sri Lanka, Sudan, The Netherlands, Timor-Leste, Uruguay, and Zimbabwe.
But many of the wealthiest countries are absent, at least for now, such as France, the United Kingdom, China, Russia, India, Germany, Canada, and Saudi Arabia. The most notable absentee is the U.S., which is not surprising, since the Trump administration has fought against the proposal. Successive U.S. administrations, actually, have regularly sided with the pharmaceutical industry on patent issues, in particular, singling out countries that pursue compulsory licensing.
Moreover, the Trump administration has announced plans to end the U.S. relationship with the WHO. Although more countries are expected to join the initiative, experts say a lack of too many countries with large economies and populations could undermine efforts to ensure Covid-19 products are available widely enough to eradicate the virus.
If this is a voluntary project, why is the pharmaceutical industry opposed?
That’s a good question. The issue comes down to intellectual property, or what is more commonly referred to as patents. The pharmaceutical industry has long argued that compulsory licensing eviscerates their patent rights, but drug companies have tried to soften often harsh criticism of their pricing policies by issuing voluntary licenses to generic drug makers to manufacture certain medicines. Gilead Sciences has done this with HIV and hepatitis C medicines, and more recently, remdesivir, its experimental medicine for Covid-19.
The WHO does not have authority to sidestep patents, but industry is suspicious that countries will eventually be allowed to trample on patent rights. Earlier this week, Pfizer chief executive officer Albert Bourla called the pool “nonsense” and “dangerous.” Some goals described in the WHO announcement “might be good things (for patients), but it’s not at all surprising that pharma firms would bristle at these recommendations,” said Ken Shadlen, a political scientist at the London School of Economics, who studies the global pharmaceutical industry and patent issues.
Some industry executives have noted an existing nonprofit called the Medicines Patent Pool is already in place. So why create a new pool?
The Medicines Patent Pool was created about a decade ago with backing from Unitaid and, until now, has focused on reaching licensing deals for ensuring accessibility of HIV, malaria and tuberculosis drugs in mostly poor countries. Two months ago, in fact, the MPP formally expanded its scope to include Covid-19 medical products, which is why industry executives say the WHO pool is unnecessary. But the new WHO pool is established to more readily work with multiple players to share knowledge about research, development and production.
“The mechanism exists today, but what does not exist today is the sharing of knowledge,” said Gregg Alton, a former chief patent officer at Gilead Sciences, during a forum on Friday that was sponsored by the WHO. “I think it would be fantastic to see the industry come forward and commit to working with the MPP or other mechanisms… We can’t wait for the typical development timeline of a vaccine or therapeutic. This is an opportunity to see this pooling of knowledge and sharing of data and IP, and break down barriers, which can expedite that development and allow the breakthroughs to come.”