IP licensing: universities pushed to ensure fair access to medicines

Universities are coming under increased pressure from big healthcare funders such as the Gates Foundation in the US and the Wellcome Trust in the UK, as well as from national funding bodies, to make sure that when they license their medical discoveries, these agreements include clauses to make the treatments available in low- and middle-income countries.

Several universities in the US already include this in their licenses, while a new European Union-funded programme, IMPAC3T-IP, is encouraging universities to include fair access to their healthcare IP. A group of leading universities in the UK are discussing a similar move.

The initiatives aim to reform a university licensing system that has historically made it difficult for healthcare innovation to reach people in low-income countries. About a third of new healthcare technologies originate in university labs, a sign of how influential academic institutions are in shaping innovation in public health.

But university licensing models have typically prioritised exclusive deals with large pharmaceutical companies, often restricting access to life-saving treatments in poorer countries. The result is that diseases like malaria, tuberculosis and Aids cause more deaths in developing countries as compared to wealthier countries where treatments are widespread.

There are a handful of well-known cases where this was overcome, such as when the University of Oxford succeeded in persuading UK pharmaceutical group AstraZeneca to agree to making its covid-19 vaccine available to low-income countries at no profit. But the practice is still not widespread, and proponents argue that publicly funded universities should do more.

“We are trying to bring together some tools and share practices,” says Lisa Cowey, technical coordinator for the IMPAC3T IP programme at Meta Group, a knowledge transfer advisory firm. “We have things like frequently asked questions for funding agencies and universities to get them going. We have lots of examples of how other people are approaching this through policy and principle.”    

Negotiating equitable access in licensing agreements is difficult, which explains the reason that not more universities have adopted it. Because it is expensive to bring medical technology to market, universities often rely on exclusive licenses with big pharmaceutical companies to secure investment. These companies don’t often want to commit to equitable access at such an early stage of the technology.

“When you talk to the universities, they say this is really hard. Companies don’t want to do it. It is extra work for them,” says Cowey. “Pharma companies have so much power when it comes to negotiating an early-stage license for the university. Universities have said it just didn’t work.”

The fact that universities are trying to license technology at such an early stage makes the job even harder. “We know a lot of universities have struggled with how to actually incorporate language into a license, especially for early-stage technologies, that is meaningful and that is not going to scare away potential partners,” says Andrew Goldman, senior advisor at Medicines Patent Pool, a United Nations-backed public health body that works with organisations to license technology with affordable access in mind.  

Early success in the US

Including such language in licensing agreements is more common at US universities. As early as 2001, a group of Yale University students worked with charity Médecins San Frontiéres to persuade the university and pharmaceutical company Bristol-Myers Squibb to allow generic production of a HIV/Aids drug in sub-Saharan Africa.

More recently, University of California, Los Angeles worked with the Medicines Patent Pool and student group Universities Allied for Essential Medicines, to expand its equitable access licensing language. Terms were strengthened to require licensees to submit a plan at the time of regulatory approval showing how they would achieve affordable access for the licensed product in low- and middle-income countries.

This licensing template has been adopted by several other universities in the US including University of California, Berkeley and Columbia University. Orin Herskowitz, executive director of Columbia Technology Ventures, the tech transfer office of the US university, says that although the office had global access clauses for life science agreement templates for more than a decade, the clauses drafted by the University of California, Los Angeles and the Medicines Patent Pool were “more robust and well developed than the one we had been using.”

A year and half ago, Columbia University switched over to using the new template. “It has been broadly accepted by most of our licensees,” says Herskowitz. It is, however, too early to tell if the license terms are effective because it can take several years for pharmaceutical companies to develop drugs to the point of regulatory approval.        

Soft approach

In the case of the licensing language that University of California, Los Angeles adopted, the Medicines Patent Pool worked with the university to come up with a “non-prescriptive approach”, says Goldman, which does not stipulate what the licensee’s strategy or timeline should be for how it will ensure equitable access.

“It doesn’t say you must achieve pricing at ‘x’. The idea is actually to spark the conversation and require the thinking about access,” says Goldman.    

The licensing template also gives the licensee plenty of time to submit a plan. Licensees need to submit a proposal when they are close to regulatory approval, which could be a decade after the license from the university has been made.

“If you put the obligations too early, it just adds a layer of complexity for the preferred partner. They may be more hesitant to take that license if they feel that they have to be thinking about these other issues, when they first need to prioritise making it through the trials and so forth,” says Goldman.

Universities may have to start pushing more in licensing negotiations as more donors require global access terms. The Gates Foundation in the US and the Wellcome Trust in the UK are examples of charitable organisations that make equitable access a condition of their funding. The National Institutes of Health (NIH), the US public body that funds medical research, announced in January this year that it would make equitable access a condition of NIH-owned inventions.   

Opting for lower royalties

In some cases, the universities have done more on their end to ensure equitable access. French research organisation Pasteur Institute, for example, charges lower royalty rates in poorer countries as part of its licensing agreements.     

Other universities are retaining rights that allow them to partner with alternative suppliers, such as generic drug suppliers, to ensure affordable distribution in lower income countries.

Despite growing momentum, equitable access licensing remains low in Europe. Few funding agencies require it as a condition of their grants. The IMPAC3T-IP programme works with funding agencies to educate them on the issue. The European Commission is now interested in making equitable access a condition of its funding.

“We have quite a lot of national funding agencies who are interested in learning how they can do this,” says Cowey. “It feels to me like it is a good time, and it is starting to gather strength.”

In the UK, several universities, such as the University of Oxford and University College London, already include equitable access clauses in licensing agreements. But supporters of equitable access would like to see wider adoption and are targeting influential university groups to adopt equitable terms. The Universities Allied for Essential Medicines is in discussions with TenU, a group representing 10 leading research universities globally including Oxford and Cambridge, to adopt standard practice for licensing agreements.

Monty Dunn, European coordinating committee member for Universities Allied for Essential Medicines, has tried to persuade TenU to adopt licensing terms for global access to healthcare IP in its guidelines. While TenU has guidelines for best practices, such as how much equity universities should take in spinouts, it has so far not adopted best practice for licensing language to achieve equitable access.

“A lot of this is just about norms. If TTOs [tech transfer offices] see their fellow TTOs doing the same thing and saying this is best practice, it is much easier to start doing it themselves than if they have to be the first ones to do so. Which is all the more reason that if TenU were to publicly say we’re all doing this, it becomes a much more normal thing for other TTOs to do,” says Dunn.

TenU plans to host an event later this year to discuss how to go forward. “TenU is very supportive of equitable access clauses,” says Ananay Aguilar, head of the organisation. “The majority of universities in TenU are thinking about how to do this or have already experimented with different ways of doing this.”

Building on its success in the US, Medicines Patent Pool has had talks with several European universities about adopting licensing terms. It recently worked with the Barcelona Institute for Global Health in Spain, for example, to adopt access language. Interest is high among medical colleges in the Netherlands and Belgium, says Goldman.

“What we are hoping is that this language becomes a norm,” he says.