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At Servier, we strive to develop medicines for the patients who need them. Putting patients first in our daily work is a commitment we take seriously and act on at every step of the medicine lifecycle. It is reflected in our R&D strategy, where we are driven by the quest to address unmet medical needs. With over 30 million patients affected by a rare disease in Europe and treatments often being limited or unsatisfactory leaving most patients without any specific therapeutic option, the necessity to direct our R&D towards that area is clear.
Our ambition is to develop medicines that will positively impact both the prognosis and patients’ quality of life, as well as to ensure that we are providing optimal care to people suffering from these rare diseases. Within Servier, this has translated into a focus on rare diseases in two of our therapeutic areas: oncology and neurological diseases. There, we have capitalized on our long-standing experience in neurosciences as well as our increased investment in oncology to strengthen our efforts to develop new therapeutic candidates which are promising to tackle unmet medical needs.
As the European Commission is looking to review the rules governing orphan medicines in Europe, it is essential to acknowledge the innovation which was spurred by Regulation (EC) No 141/2000 on Orphan Medicinal Products. This legislation brought more than 190 new therapies to patients in Europe, creating an environment conducive to research into rare diseases. We collectively need to ensure that the updated Regulation builds on this momentum without deteriorating the European research ecosystem. During the last 20 years, the technology and scientific knowledge have increased, our ambition for the next decade has to be to multiply the development of medicines and ensure access to them.
While at EU-level there has been a recent focus on industrial policy to ensure that the EU remains an attractive region for investment, it doesn’t appear to translate into the measures discussed within the context of the review of the pharmaceutical framework. In fact, those go in the opposite direction, threatening to deteriorate the competitiveness of the EU research-based industry. The industrial and pharmaceutical policy cannot be looked at separately if Europe wants to remain a serious hub for research. Adopting a holistic approach will be essential when reviewing the rules, ensuring that policies that are being negotiated will support the industry in developing medicines for those who rely on them.
Developing medicines to treat a rare disease requires a deep understanding of the disease mechanism, which cannot be separated from the development of the technology. Developers need to rely on a cutting-edge scientific knowledge and a strong research pipeline, which can only be fostered if scientific barriers are overcome. To that end, it is necessary to implement policies that will incentivize exploratory research, support clinical development and provide a predictable framework, allowing developers to adopt the long-term vision required for investing in R&D.
The review of the current legislation is a once-in-a-lifetime opportunity to establish a fit-for-purpose framework that will enable more research in Europe. Servier, alongside the rest of the innovative pharmaceutical industry is already working with stakeholders, and will continue to do so to ensure that the legislation that will be adopted puts in place the infrastructure needed to allow innovation to spur for the benefit of patients.