Professor Paul Smits, Dean and Vice Chairman of Radboud University Medical Center in the Netherlands, shares his insights into the strengths of the country’s research climate and the challenges posed by the increasingly high cost of innovative drugs on the healthcare budget. Prof. Smits highlights the benefits that could be derived for research outcomes from the creation of comprehensive and secure national registries.
Could you please introduce yourself to our readers around the world, with reference to your current research interests, educational responsibilities, and involvement in associational life?
After completing my training as an internist and my PhD, I focused on clinical pharmacology and fundamental pharmacology, becoming a Professor in Clinical Pharmacology. My core responsibility now is as Dean and Vice Chairman of the Radboud University Medical Center. In this position, I work extensively with the other seven university medical centers in the Netherlands to further our three core tasks of patient care, research, and integrated education. Along with the deans of the other medical centers, we discuss how to better organize the current system and encourage even more fruitful collaborations between our organizations. I am also a member of the Health Council and the Scientific Association of Internal Medicine, as well as head of the Galenusprijs (Prix Galien) jury for the Netherlands.
Finally, I am director of the Dutch Clinical Trials foundation, which also works with the university medical centers in achieving the common goal of improving the climate for clinical research and trials in the Netherlands. Our main goal at this time is to have an impact on healthcare, the treatment of patients, medical technology, and drugs, with clinical researching playing a pivotal role in these domains. Facilitating clinical research locally will lead to higher quality patient care. However, clinical research is hampered by regulations, and we advocate for a climate where investigators and the pharmaceutical industry can undertake more fruitful partnerships with university medical centers to bring results.
The Netherlands is famous for its research infrastructure – institutes, university hospitals, and public private partnerships. Given this strong foundation but increasing global competition, how would you assess the strength of pharmaceutical research in the Netherlands today?
Overall, the quality of research in the Netherlands is fantastic, given the excellent researchers in the country as well as our top notch university medical hospitals and centers. All the university medical centers in the country have this high level of excellence in the country proving a 1,65 ranking quality where 1 is the best standard, and, over the past years, the university medical centers have taken more of a lead in clinical research, with the Ministry of Health and the Ministry of Education providing additional funding to promote this growing UMC presence in clinical research and trials.
The secret that lies here, is that in the Netherlands we have a lot of investigator initiated research and original ideas that stem from the clinical experts and fundamental researchers themselves. As such, we can implement an active rather than a reactive way to doing clinical trials, which is an interesting model for the pharmaceutical market.
What are some of the key changes that have occurred in recent years in the innovative drug space?
A key change the Netherlands has undergone in the past years is the pulling back of big multinational pharma companies, with Organon being acquired and MSD closing down its R&D facilities in Oss. On the other hand the Netherlands now hosts many innovative spin off companies in biotech, medical technology, and chemistry, but we still have to wait on larger successes from many of these young companies. Perhaps, for example, some of these companies could become candidates for the Galenusprijs (Prix Galien) in the future.
What has been the impact locally of the increasingly high cost of innovative drugs?
The cost of drugs has become a more important topic of discussion on a wider level in our society, and I see this also impacting the Prix Galien locally, as one example. The costs of these innovative drugs are more than often very expensive, so we also take into consideration drug cost when awarding our prize since it would not be fair for patients if innovative drug prices are so exorbitant that they cannot afford to be used. Now, of course, the most innovative discovery should be the winner of these types of prizes, but we are also now considering cost.
Given the Netherlands current healthcare system, the most innovative and most expensive drugs have been moved to the hospital budget, and the restricted budget for care means that if a hospital treats patients above the given threshold, no reimbursement is received. Last year we had 20 million euros in costs that were not insured by the government, which creates a very tough situation for doctors in prescribing the most innovative drugs to help patients. In my opinion, these expensive drugs should be taken out of the hospital budget, and we hope that the Ministry will do this by the end of the year.
Fundamental research in the Netherlands is very strong, but the vast majority of this research is not translated into concrete medicines or products. What can be done in the Netherlands to address this challenge?
Extra investment from the government’s side will help significantly, in both the stages linking fundamental research and applications, as well as public private partnerships. Working in collaboration with the government on the right agenda will be the main task in bringing more results from our strong research capacities, although this is a major challenge globally for the innovative drug research community.
What overall then are the main challenges and bottlenecks that the Dutch innovative life science and research community is facing right now?
The budget dedicated to life sciences in the Netherlands has been declining, as well as budgets from the EU, even given the EC grants and the Horizon 2020 funding. With the available funding, a problem arises in that many researchers invest a substantial amount of time in writing grants, with only four percent of these grants being successful. We should thus focus on higher success fractions for the future total success of the pipeline.
In terms of global recognition in the life sciences, the Netherlands often tends to lag behind in comparison to their neighbors. How would you explain the reputational gap regarding the Netherlands, and how can more research be recognized out the Netherlands?
We should focus on what our specific niche should be within the larger research world. We need to focus on the mechanism of action and investigative initiated research, as well as have more public relations exercises for this specific niche. Even though we are a small country and do not have the same number of inhabitants as the Germany or UK, this does not mean we should not have a significant impact on clinical trials and research for the world. Our specific expertise in terms of infrastructure, bio-banking, imaging, as well as all areas related to the translational part and mechanistic aspect of research should be put in stronger focus.
In the next five years, for the next time we come back, what would you have liked to accomplished in your variety of roles?
We hope that all the blockades that we are experiencing at the moment in terms of clinical trials and research will not be an issue five years from now. While trying to facilitate research, new issues constantly arise and new solutions are needed. Although the Netherlands already boasts a very strong networking program and cooperation between the university medical centers, I believe that the nation would benefit greatly from a system where all patient and medical data is connected in a secured fashion. The ability to bring together meaningful data to increase research outcomes from the eight UMC’s could be great challenge but also an amazing power to have. This is a feasible goal, but it will require a great deal collaboration over the next five years.
