How do we license publicly funded medicines so that it will benefit the public?

Winne van Woerden

Cases of soaring drug prices are frequently reaching the news lately. The current system of medicine development does not achieve what it was intended for: to provide equitable access to affordable and effective medicines for the patients that need them. Publicly funded research institutions can be of major influence in changing this – but how? On November 5th, Wemos, Health Action International and Utrecht University organized the event ‘Licensing publicly generated knowledge: seeking a socially sustainable balance’ to have a meaningful discussion on the role of publicly funded research institutions in changing the current system of medicine development.

Changing a broken system

The fact that pharmaceutical companies can charge extremely high prices is because of the current system of medicine development: it consists of a complex web of (inter)national stakeholders from both public and private origin with divergent and sometimes conflicting interests. With each player having its own role, it is of utmost importance that transparent and appropriate agreements are in place, and all those involved acknowledge each other’s piece in the puzzle.

 

Open dialogue with experts

Having an open dialogue to explore possible ways to fix what is broken is vital to achieve a system that provides equitable access to effective medicines for all. That’s why  the organisers decided to set up the event. The panel included representatives of many parts of the field*, with a specific focus on those linked to universities.

 

Universities as an essential piece of the puzzle

One of the main discussion points was the way publicly funded research institutes, like universities, license their knowledge to pharmaceutical companies: How can licensing publicly funded knowledge contribute to achieve fairer prices of medicines?

 

Ella Weggen from Wemos emphasized the essential role publicly funded research institutions play in the process of medicine development by referring to the report ‘Overpriced’, recently published by SOMO and Wemos. In 2017, approximately EUR 780 million of Dutch public funding was spent on biomedical Research & Development (R&D), with a further EUR 55 million worth of funding coming from the EU. Such public investment should contribute to medicines that are affordable and widely accessible. However, this is not the case.

 

“With the report, we wanted to debunk the mantra that high prices are needed because the industry pays for everything in medicine development itself, including for clinical trials. Our report shows how a lot of knowledge leading to medical inventions is in fact publicly generated, reporting several cases where the private sector has used results of publicly funded research to develop medicines that are subsequently marketed at high prices. This undermines the principle of equal access to medicines and is threatening public health”, Weggen pointed out.

 

Later on, during the discussions, Victoria Defelippe from UAEM got back to this point, stating how approximately one third of R&D performed at universities, originates from public funding. This emphasizes how universities are a key player in the development of publicly funded medicines, which means they also have an essential role in ensuring public return on public investment.

 

Responsibility in socially responsible licensing

Earlier this year, the Dutch Federation of Academic Medical Centres (NFU), together with ZonMW, published a report on principles that academic medical centres and/universities should adhere to when transferring knowledge to pharmaceutical companies. The report lists 10 principles needed to make licensing agreements ‘socially responsible’, so they serve the interest of the public. The adherence of these principles by public research institutions could thus be a means to get to a system that guarantees public return on public investment.

 

While all speakers applauded the formation of the 10 principles, many expressed their concerns on how these principles will be adopted into everyday practice and wondered if they will eventually affect the prices of medicines. The consensus seems to be that, at least in theory, the NFU guidelines are very well fitted to ensure this public return on public investment through socially responsible licensing. Yet, both panellists and people from the public agreed that they are only the start of a long process, because they are not binding. Many, therefore, stressed the need for concrete actions to make them effective in the long run, both in and outside The Netherlands.

 

Aukje Mantel-Teeuwisse from the UU called on universities to “take responsibility”: “We see many successful public-private collaborations. However, we need to ensure that innovations reach patients in need of medicines in a sustainable way.” To achieve this, Jaume Vidal from HAI pointed out that universities and public research institutions must “proactively seek cooperation arrangements with the private sector, which do not involve the privatisation of knowledge through monopolies” as shown in the recently launched HAI report “Guidelines for socially responsible management of innovation”.

 

Victoria Defelippe made a strong argument adding that universities have a moral responsibility to ensure that medical breakthroughs originating from public funding in their academic laboratories, respond to the needs of the public – who already paid for this research through taxes. When speaking about the role of universities, André Broekmans from the UU pointed out that “we need to respect each other’s role”. And he raised an important question: “How can we guarantee there is enough expertise at universities, specifically at technology transfer offices, so that knowledge will be cultivated in such a way that it is useful for society?”

 

In the end, it’s all about politics

All in all, questions remain on who will be responsible for the implementation of socially responsible licensing and what the consequences will be if universities do not adhere to the principles. Jaume Vidal  said to be “encouraged by the set of guidelines for socially responsible licensing put together by NFU after a wide consultation process with stakeholders to which civil society was able to contribute.” He continued stating to expect “the same political will and decisiveness from parliament to make these guidelines not only operational, but enforceable by law.”

 

A conversation on the importance of the right political environment followed, with many voices from the public joining as well. As Frank Miedema from the UMCU put it: “Definitely, things can change, as we have seen in the past, and we need these discussions to do so.” He said these discussions are being heard, also in parliament. “In the end, it’s all about politics”.

 

*The speakers during this event were:

  • Prof. Dr. Frank Miedema, Chair NFU Social Responsible Licensing Principles Working Group, UMCU;
  • Ella Weggen, Senior Global Health Advocate at Wemos;
  • Jaume Vidal, Senior Policy Advisor at Health Action International

Panellists were:

  • Dr. André Broekmans, Board Member Utrecht Centre for Affordable Biotherapeutics;
  • Dr. Jennifer Sellin, Assistant Professor at Department of International and European Law, Maastricht University (TBC);
  • Victoria Defelippe, President at Universities Allied for Essential Medicines The Netherlands (UAEM NL)

The event was moderated by Professor Aukje Mantel-Teeuwisse from University of Utrecht and closing remarks were done by Professor Leufkens from the University of Utrecht.

 

For a recording of the event’s livestream and more information, read this news article.

Read more about our work on Access To Medicines.

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