On Thursday, November 23, 2023 outgoing Minister Kuipers of the Ministry of Health, Welfare, and Sport (VWS) received a FAST position paper on drug repurposing in the Netherlands. This report suggests courses of action to enable a sustainable and reasonable revenue model for pharmaceutical companies to use drug repurposing as a fast route to new, affordable therapies for patients and society. An exemption for generic brand could encourage companies and academic groups to pursue drug repurposing efforts in areas with significant potential benefit for patients, rather than being limited to areas with exclusive market opportunities.

Drug repurposing involves redeveloping existing drugs for new therapeutic applications. This method of drug development offers huge potential for treating a wide range of, often rare, conditions. Drug repurposing is attractive to the healthcare sector because it involves unpatented (generic) drugs: they are already available, affordable and much is known about their safety. Given the enormous potential for patients and the possibilities of developing new affordable therapies, FAST calls for joint efforts to make drug repurposing more attractive. The Netherlands can take a leading position in this development.

Minister Ernst Kuipers: “Repurposing of existing drugs for conditions other than those they were originally developed for is good news for patients and can contribute to better treatment options. It also provides a great opportunity to work towards improved availability of medication at socially acceptable prices. I am therefore pleased with the proposal in the reform of the European  pharmaceutical legislation that makes it possible for the academic parties to play a greater role in this area. They can provide data to the EMA or the Dutch Medicines Evaluation Board, after which suppliers can include the new indication in their dossiers. To fully exploit the potential of drug repurposing, I also want to explore how the role of private parties can be expanded. Public-private collaboration is an essential part herein.”

No Sustainable Revenue Model

Investing in drug repurposing is not straightforward for generic manufacturers because it involves costs and offers no clear way to recoup those investments. Generic suppliers seeking to develop and market a new indication face disincentives in the healthcare system, such as low prices and substitution by other brands of the same product. The European Commission has proposed measures to promote drug repurposing, such as granting exclusivity upon market entry. However, these potential adjustments are insufficient to create a sustainable revenue model that encourages investment.

A Concrete Set of Options

The position paper outlines specific actions to make drug repurposing attractive to companies and academic groups. These include rewarding the discoverers of the new indication, granting the repurposed product a temporary exclusive position in the healthcare system, and providing a reasonable and socially acceptable reimbursement. The first option relies on agreements among healthcare parties, the second on adjustments to the preference policies of health insurers, and the third on a legal framework provided by the government. FAST considers the latter the preferred option as it offers a structural solution with maximal perspective and certainty for investors in repurposing. All options target a defined group of unprotected drugs for which the European Commission has also proposed incentive measures for repurposing. FAST aims to bring together stakeholders and, in close cooperation with the government, health insurers, physicians, and pharmacists, to further explore these options.

Collaboration with the Field

Given the enormous potential for patients and the opportunities to develop new affordable therapies, it is recommended that the government and parliament prioritize drug repurposing as a key policy area, taking into account the proposals outlined in this report.

About FAST

FAST (Centre for Future Affordable Sustainable Therapy Development) promotes the faster and smarter development, production, and availability of new therapies for patients in a forward-looking, sustainable, and affordable manner. FAST supports therapy developers (from both academic and commercial sectors) by providing access to relevant national and international knowledge and expertise. It also collaborates with stakeholders to identify and address opportunities and challenges throughout the development chain, devising and testing possible solutions. The needs and desires of patients are the primary focus. This approach aims to make the Netherlands a leader in drug development and an attractive location for high-quality pharmaceutical research, along with fostering high-quality production, business activity, and employment.