When governments invest in drug research and development (R&D) with pharmaceutical companies, they should ensure upfront that these drugs are affordable and widely available – and a global pandemic accord needs to provide high-level guidance on how to do this.

This is the view of the Drugs for Neglected Diseases initiative (DNDi), a non-profit group that has led a series of successful drug development partnerships since it was set up 20 years ago to find new treatments for people living with neglected diseases.

“During COVID-19, some governments put conditions on their R&D funding but they either didn’t use them or didn’t put in place the right conditions. And then you have some governments who did not put in place any conditions in relation to affordability or technology transfer,” DNDi’s Director of Policy Advocacy, Michelle Childs, told Health Policy Watch.

Yet an intense crisis such as a pandemic is precisely when governments should use their investment as leverage to make sure that the products developed are affordable and accessible.

DNDi has developed 12 treatments to address neglected diseases including sleeping sickness (human African trypanosomiasis), visceral leishmaniasis, Chagas disease, malaria and hepatitis C together with a range of partners including pharmaceutical companies.

This week, it published a paper in which it shares both its lessons and agreement templates to ​​show how to ensure that investment in R&D results in innovation and equitable access.

“You have to have a deliberate strategy, backed up by conditions negotiated at the early stage of R&D,” says Childs, one of the paper’s co-authors.

“Leverage counts to achieve these conditions. You have to bring something to that discussion. We bring partnerships and some funding. But governments bring a lot of funding and they could tie it to conditions to ensure effective outcomes.”

Whether governments are prepared to use this leverage to ensure future pandemic products are affordable and accessible “is a key test of how serious countries are about implementing equity”, says Childs.

“In the context of the pandemic accord, this is something they could do with their money. It is a test of how serious they are about really changing outcomes and really operationalising equity and moving from talking about it to turning it into action.” 

Addressing IP

For DNDi,  a first step is to address intellectual property (IP), which can be a barrier to access and affordability and follow-on research.

“We try to develop drugs as public goods, and we want to ensure that we can share the research and the knowledge,” says Childs. “So we make it clear to any partner that we won’t enter into an agreement unless we find a way to deal with intellectual property, if it exists or if it’s created, that allows us both to develop the treatment and secondly, to make that treatment affordable and available .”

DNDi defines IP widely as “technology”, including both the standard IP rights such as patents and copyrights, as well as confidential know-how and results. 

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), which represents all the major pharma companies, has made it clear that IP rights are important for its members to safeguard their investments.

But some IFPMA members have entered into agreements with DNDi. The organisation’s success, says Childs,  is that it deals with IP and access from early on in negotiations with partners. Through these partnerships, DNDi has been instrumental in the development of 12 treatments for neglected diseases.

Sometimes DNDi owns the IP, which means it can use, share and publish it as it wishes. But sometimes the IP is owned by a partner, and DNDi obtains those rights through licences – but it ensures additional commitments by the partner to ensure equitable and affordable access and further research.

Leverage

Successful partnerships are the result of sharing, says Childs – from expertise and resources to risk.

DNDi enters negotiations with partners with its own expertise and some funding for the development “so we de-risk elements and lower some of the costs for example around clinical development”, she says. 

“Secondly,  we aim for both affordable pricing and sustainability for the manufacturer in the definition of affordability in our licences, which is basically a cost-plus reasonable margin model. And we have a discussion with them about what is a reasonable margin in each case  – always subject to the condition that the treatment needs to be affordable for the places and the countries that need it,” she adds.

“We also work with the manufacturers and the countries to look at ways in which we can help them to optimise manufacturing processes to lower costs. ”

COVID mistakes

In contrast to a small outfit like DNDi, governments have far more resources – and thus leverage – in such negotiations. During COVID-19, governments – particularly the US and Europe – invested heavily in early drug development with pharmaceutical companies and the advance-purchase of goods, which both contributed to development costs.

But they either did not use or attach conditions to this investment to allow sharing of the technology or address affordability concerns and by the time COVID-19 vaccines were developed, there was a “late stage fire sale where everyone was scrambling for the products”, says Childs.

In preparation for the next pandemic, the pandemic accord currently being negotiated by World Health Organization (WHO) member states should contain an agreement for countries to apply such conditions to public funding to help countries in their negotiations with pharma and other partners and to ensure supply security and equitable access by retaining rights to share technologies when needed. 

Global coordination is needed

“There might be different partners and funders along the way from drug discovery to manufacturing and access,” adds Childs, so these conditions could guide the “handover of knowledge from one stage to another, as well as its transfer to different manufacturers in different regions”.

Mexico and Norway are currently championing the need for conditions to be placed on R&D  investment, she adds.

The WHO intergovernmental negotiating body (INB) currently negotiating the pandemic accord will need to decide what type of high-level conditions are put into the accord.

There are some hopeful signs in the zero-draft of the accord, which encourages countries to explore the terms and conditions of public financing on pandemic-related products, and whether obligations or requirements can be put on those products that are publicly funded.

But as those taking part in the INB stress at every meeting, “nothing is agreed on until everything is agreed”. It will be up to member states to ensure that public investment is tied to access and affordability.

Image Credits: Xavier Vahed/DNDi, Nur Sofi Iklima .