And what if health was a “common good”?
In this case, a resource belonging to all could not be entrusted to public or private management alone. Only new types of hybrid institutions involving stakeholders (drug manufacturers, users, etc.) are capable of addressing current health-related challenges, which have been particularly marked since the outbreak of the HIV/AIDS pandemic.
Among today’s public health issues, broad and equitable access to drugs and the development of treatments for neglected diseases are some of the top priorities.
One of the main obstacles to the emergence of new players in the closed health sector are the invisible barriers erected in the mid-1990s.
Indeed, the WTO's 1994 Agreements on Intellectual Property opened up a new drug market monopolized by major pharmaceutical groups.
“For developing countries, a number of production units for locally manufactured generic drugs were closed, due to a very restrictive interpretation of intellectual property, following intensive lobbying by the pharmaceutical industry”, said Jean-François Alesandrini, Senior Advisor, External Affairs and Executive Office, at the Drugs for Neglected Diseases Initiative (DNDI), during a conference organized by AFD in Paris in early 2019.
For further reading: An Unpatented Drug to Finally Beat Sleeping Sickness
Yet the efficacy of traditional pharmaceutical models in meeting the needs of the poorest populations has regularly been called into question. The major laboratories, for their part, have said their activities were unprofitable, despite the sometimes exorbitant prices for new drugs for certain diseases, such as cancer and hepatitis C.
This is why the DNDI foundation has sought to improve access to treatments for neglected diseases (sleeping sickness, pediatric HIV) for the poorest populations. The foundation was first launched in 2003 by five public research institutes from India, Brazil, Kenya, Malaysia and France, along with Doctors Without Borders and the Institut Pasteur, and supported by the World Health Organization.
Agence française de développement (AFD) has been actively supporting this initiative with financial backing since 2006.
The initiative is shaking up the drug manufacturing industry by, for example, developing an anti-malaria drug costing less than a dollar, with the giant company specializing in the drug, Sanofi.
Without deviating from international clinical research standards, DNDI products are tailored to patients’ health needs. They are affordable, distributed at cost without patents, and are destined to benefit as many people as possible – as well as the poorest. Based on these requirements, DNDI has deployed four clinical platforms to strengthen research and development potential in countries forgotten by patents.
For further reading : DNDi, a Distinctive Illustration of Commons in the Area of Public Health
Out with the logic of intellectual property
As shown by the development of Fexinidazole (see box below), a new drug against the ravages of the “forgotten” sleeping sickness disease, DNDI deploys a model close to the logic of the Commons. It is based on a variety of natural resources (groundwater, pastureland) and information resources (open source software, open-access encyclopedias, etc.).
For DNDI, drugs for neglected diseases are a fundamental resource, which needs to be developed and protected.
Exclusive intellectual property is replaced by a “bundle of rights”, i.e. a set of legal tools between partners, which promote shared information and remove exclusivity clauses. In this respect, the coalition and its members use a unique model of open and common innovation. Since it was set up, DNDI has delivered eight new treatments, which are all essential in the race for good health for all.
THE FIGHT AGAINST SLEEPING SICKNESS, AWAKENED
In November 2018, the European Medicines Agency approved the registration of Fexinidazole, a new drug for sleeping sickness.
In December of the same year, the regulatory agency of the Democratic Republic of Congo registered this new chemical entity, which will stem, or contribute to eliminating, this disease transmitted by tsetse flies and identified as one of the oldest tropical diseases. The conditions under which this molecule was produced were unique in many ways and demonstrate the power of innovation “in common,” in the field of public health.
Some 65 million people, mainly living in the poorest and most remote rural regions of Sub-Saharan Africa, are potential victims of sleeping sickness.
Following a phase of fever, the disease evolves towards an incurable neurological stage, which can lead to coma and death if untreated. The sick and their families are immediately stigmatized, weakened, and unable to work, which plunges them deeper into poverty.
The only treatment available to date comprised 14 infusions, combined with seven days of oral treatment, requiring hospitalization. Only a painful and complex lumbar puncture made it possible to determine the stage of the disease.
The medication was difficult to transport and store and created major problems in areas not easy to access. Fexinidazole, which is in pill form, is a major breakthrough in the treatment of the disease.
Collaborative and open platform
This molecule is the result of an unprecedented public-private partnership: DNDI, the pharmaceutical operator Sanofi and experts from a variety of countries have worked together on an open research platform.
For a decade, the HAT platform, located in the Democratic Republic of Congo, set up or refurbished clinical trial centers, trained healthcare workers and transferred technologies and know-how. With the DNDI team, Congolese health professionals were able to conduct clinical trials and build clinical data. This data was used to create a regulatory manual, which was evaluated and validated by the European Medicines Agency.
In this way, Fexinidazole was born.