LONDON — Amid fears the world will be plagued by coronavirus until effective immunization is widespread, the scramble for a vaccine has become the most important race in the world.
While an effective vaccine is far from guaranteed, there are dozens of projects ongoing across the world. Governments have funded a huge bulk of the costs of this research.
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Though some world leaders have called for any successful vaccine or treatment to be a “global public good,” and many leading funders have committed to an equitable access agreement, some advocates for access to medicines fear that states’ more competitive instincts will emerge if a viable product is produced.
Some health advocates suggest that governments will allow monopolies of COVID-19 products to emerge, allowing corporate profiteering and preventing low-income countries from affording a vaccine.
They are calling for governments to take stronger measures to ensure a vaccine will be accessible to lower-income countries. This debate — set to be one of the most important in global politics and development during the pandemic — is riddled with technical terms.
Devex asked experts to explain some of the terminology and why it is important for development professionals to understand.
Conditions
Governments often attach conditions to funding they provide. Conditions on medical research financing can be used to ensure that “work that is being carried out with public funding also remains available to the public,” according to Ellen ‘t Hoen, a lawyer working with Medicines Law and Policy, a group focused on improving access to medicines.
Without conditions, government-funded innovations “become proprietary, and that means companies can keep and hold all the rights, and anyone else who wants to use or access those innovations to have to pay dearly,” ‘t Hoen added.
An example of a condition on a publicly-funded coronavirus vaccine would be to share data, information, and intellectual property to a COVID-19 pool, from which others can benefit.
Intellectual property
“Intellectual property is something that you create using your mind — for example, a story, an artistic work or inventions,” said Heidi Chow, senior campaigns manager at Global Justice Now.
“Medical discoveries are also considered to be intellectual property and intellectual property rights allow you to make money from the intellectual property you own,” she added.
Patents
Intellectual property is regulated in various ways depending on what it is — for example, writing is protected by copyright. Patents are used in the development of medicines to protect intellectual property. They have to be applied for and examined by a patent office to see if they meet required conditions.
“Patents are granted if you develop something that is new, truly innovative, that can be applied, produced and no one else has come up with it before,” ‘t Hoen said. “Then you get a 20-year patent, and in some cases this can be extended,” she added.
“During that period you have the right to exclude others from using your invention, so it creates a monopoly … For a medicine or vaccine produced in a monopoly, you have a very strong position to determine the price of a product,” ‘t Hoen explained.
Compulsory license
Governments can intervene in a patent if it is creating problems like shortages or high prices, and another party can be given the rights to the patent. This is done through issuing a compulsory license. It is also known as a “crown use license” in the U.K., or a “government use license” elsewhere.
“All governments have the right to override a patent ... even without the consent of the patent-holder,” Chow said. These are known as “step in rights.” A government does this for various reasons, including if it is unhappy with the behavior of the patent holder or wants to produce more of the product locally.
Patent free
Some access-to-medicines advocates have been calling for COVID-19 treatments and vaccines to be developed “patent free,” but ‘t Hoen called it an “odd term” which can mean different things.
It could mean that the company carrying out research and development will not apply for patents and will share all the knowledge it gains. Government intervention through a compulsory license can also end patents, but this can’t be done globally, according to ‘t Hoen.
Pooling
Donors and researchers committing to patent pools to share knowledge — a COVID-19 Pool is soon expected — would be another way to make medicinal products patent free, ‘t Hoen said.
The United Nations-backed Medicines Patent Pool, which ‘t Hoen helped establish and ran as executive director until 2012, holds all the licenses for antiretroviral drugs.
Licenses
A patent holder can give another organization the right to use a patent, through a voluntary license. The patent holder determines its own terms and conditions.
These can be royalty free, meaning nothing is paid on the license. For example, Gilead Sciences, a U.S. pharmaceutical company, has licensed its COVID-19 drug candidate, remdesivir, to five generic drug manufacturers in India and Pakistan to supply to 127 low- and middle-income countries. The licenses will be royalty free until the pandemic is declared over by the World Health Organization.
Licenses can also be pooled. In the Medicines Patent Pool, licenses are transparent, public, and meet public health criteria, according to ‘t Hoen. Sometimes, licenses for children’s medicines are royalty free while the adult versions are paid for.
“Those are all voluntary licenses in the sense that the companies … ultimately make the decisions themselves to do that,” ‘t Hoen said.
Transparency
“The transparency debate relates to being able to determine what is a fair price, meaning a reasonable return on investment, not profiteering, and a price that is affordable to people in communities that need to have access to it,” ‘t Hoen said.
“To be able to access that, you need to know what prices are being paid where but you also need to know what the costs are for the development of a product and who has paid that cost,” she said. “Because if you deal with a product that a government has already paid for in terms of the research and development bill, then a high price cannot really be justified because the cost has already been taken up by the public sector.”
Chow gave a further campaigning perspective. “When governments are negotiating with big pharma, they often do so with very little information about what other countries are paying and assessing what is a fair price,” she said. “Price transparency is a demand that these final prices should be publicly available.”
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