Developing new treatments is a lengthy, complex and high-risk process – it takes 10-15 years and costs, on average, over €1-2 billion1 to bring a new treatment to the market, and roughly 90 percent of compounds fail in clinical trials.2 But scientific and technological progress is yielding innovative treatments for patients at a faster pace than ever before.3 So, to ensure that groundbreaking science, such as cell and gene therapy, stays in Europe where patients can quickly benefit from it, we need strong and predictable intellectual property (IP) and regulatory incentives, which attract R&D investment and foster collaboration among academia, medical institutions, and the industry.
Unlocking innovation: The vital role of intellectual property in academic research
Universities across Europe are at the forefront of early research into diseases, experimenting with novel approaches for the next generation of treatments. However, this initial research has a long way to go before it is translated into safe and effective treatments.
Dr. Thomas De Beer, professor at the Faculty of Pharmaceutical Sciences of Ghent University, recently discussed the crucial role of a predictable IP framework for patenting their ideas and inventions. By licensing their patents, universities can reinvest and fund new research. At the same time, early ideas can be developed into safe and effective treatments as industry partners take on the risk and uncertainty of scaling up the innovation and bringing it to patients.4
Dirk De Smaele, J&J global head and vice president Therapeutics Development & Supply, and his team of researchers based in Beerse, collaborate with universities to bring medical innovation to patients. In his experience, academia and industry have different but complementary scientific expertise, making their collaboration extremely valuable.5 Working together, they are able to take medicine from the bench to the bedside of patients.
In his view, the role of IP in fostering transparency and collaboration between different partners is often overlooked. It is thanks to IP that innovations are fully disclosed to the public, facilitating access to the latest scientific data and ultimately speeding up the advancement of science and technology. 6
Clinical trials are the cornerstone of the R&D process, where the safety and efficacy of new treatments are tested in patients. To enable timely access and offer new opportunities for patients in Europe, it is therefore important that medicines are researched and developed in Europe as well. Clinical trial activity in Europe accounted for 19.3 percent of the global share in 2020 (down from a 25 percent average over the last 10 years).7 This erosion could delay patient access to innovation and, in the longer term, to generic medicines.
A strong research ecosystem is needed to reverse the decline in clinical trials and make it possible for EU patients to trial potentially life-saving developmental treatments ahead of marketing authorization.
Clinical trials require close cooperation between many stakeholders – hospitals, academia, governments and industry – to conduct rigorous research, expand the knowledge base, achieve accurate results, and ultimately benefit patients and the health care system as a whole. And the regions with the most stable and predictable IP and regulatory frameworks for such a complex process demanding time, expertise, and resources could have a comparative advantage.
Destabilizing the IP framework, says Dr. Thomas De Beer, would not enhance patient access to medicines, but it could ultimately delay patient access to cutting-edge science and innovation.
The last major updates to our general pharmaceutical framework were in the early 2000s. Its ongoing revision should work for everyone, help to make the EU the place where innovation will thrive, and where no patient will be left behind.
CP-426040 Date of preparation Nov 2023
Visuals were created and produced by POLITICO Studio
- Sun, D., Gao, W., Hu, H., & Zhou, S. (2022). Why 90% of clinical drug development fails and how to improve it?. Acta pharmaceutica Sinica. B, 12(7), 3049–3062. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9293739/#:~:text=Drug%20discovery%20and%20development%20is,approved%20for%20clinical%20use1 Last Accessed Nov2023
- David W. Thomas, Justin Burns, John Audette, Adam Carroll, Corey Dow-Hygelund and Michael Hay. Informa, Amplion, Biotechnology Innovation Organization (BIO). Clinical Development Success Rates 2006-2015. Available at: https://www.bio.org/sites/default/files/Clinical%20Development%20Success%20Rates%202006-2015%20-%20BIO,%20Biomedtracker,%20Amplion%202016.pdf. Last accessed Nov 2023
- Suddenly, It Looks Like We’re in a Golden Age for Medicine – The New York Times www.nytimes.com/2023/06/23/magazine/golden-age-medicine-biomedical-innovation.html last accessed Nov 23
- Interview published by Politico and funded by Janssen. (2023). “IP: Unlocking collaboration between academia and industry”. Available at: https://www.politico.eu/evolution-of-health-care/#videos Last accessed Nov 2023
- Interview published by Politico and funded by Janssen. (2022). “How intellectual property drives innovation”. Available at: https://www.politico.eu/evolution-of-health-care/#videos Last accessed Nov 2023
- Interview published by Politico and funded by Janssen. (2022). “How intellectual property drives innovation”. Available at: https://www.politico.eu/evolution-of-health-care/#videos. Last accessed Nov 2023 [1] Factors affecting the location of biopharmaceutical investments and implications for European policy priorities. Report by Charles River Associates Oct 2023, Available at: https://www.efpia.eu/media/676753/cra-efpia-investment-location-final-report.pdf Last accessed Nov 2023
- Factors affecting the location of biopharmaceutical investments and implications for European policy priorities. Report by Charles River Associates Oct 2023, Available at: https://www.efpia.eu/media/676753/cra-efpia-investment-location-final-report.pdf Last accessed Nov 2023
