Camille Saettel is an attorney at law, partner at Thewes & Reuter, and author of the book “Droit luxembourgeois des médicaments” published in January 2021 by Larcier. In a context where the fight against Covid-19 has placed the health sector at the heart of current events, and highlighted the major role of biotechs, it has become pressing to understand the elements that make up the ecosystem favourable to their development. Interactions with traditional laboratories known as big pharma occupy a primordial place in this context.
Camille will describe the current regulatory context of the pharmaceutical sector on February 18th during a webinar organized by the Luxembourg Pharmaceutical Association (APL). Join the event and get your “Silicon” ticket as she shares more about the place of startups in the health technology sector, and the regulatory and legal dynamics applicable to this innovative sector.
Why write a book on drug law in Luxembourg and why today? What has fundamentally changed?
The writing of the book started before the current health crisis. The project was born out of the observation that pharmaceutical regulation was complex and not accessible, while paradoxically the sector is subject to very strong regulation. The lack of accessibility and the lack of knowledge of the regulations (especially on how to build a file in terms of clinical trials, MA or price request) can hinder the development of this industry. The book is therefore intended to provide regulatory support to professionals in the pharmaceutical sector.
I hope that it will also be of interest to patients and the general public. The health crisis has demonstrated the key role of the pharmaceutical industry in the development of innovative treatments. This book also aims to help them better understand this industry.
Can the evolution of drug law also open doors for new companies attracted by healthtech? What niches or opportunities should be seized?
Absolutely. It can be said that the development of new technologies in the field of health has created new perspectives, both medical and commercial.
The areas of innovation in healthtech are very broad, covering innovative medicines as well as medical devices and extend to the digital health sector (e-health).
The health crisis has put biotechs in the spotlight and demonstrated their agility. This should accelerate the growth of this sector. Mobile health (mHealth) applications are also booming, and this growth could be further accelerated by the possible support of “digital drugs” in the short to medium term. The pandemic has also demonstrated the benefits that health can derive from digital platforms. Digital health offers interesting opportunities for startups since their development cycle is much faster than that of a drug.
The peculiarity of biotech in the startup landscape needs to be well understood. They are not startups like others, since they have a much longer development time. We are talking about 10 years for a drug, and 3 to 5 years for a medical device. This particularity encourages collaboration with the largest laboratories. To come back to a current example, it is the alliance between big pharma and biotech that has allowed such a rapid arrival of vaccines against Covid-19. Biotechs use their agility and mobilize most of their resources to implement dynamic R&D. Big pharma is taking over in the clinical test and production phase, relying on its own financing and production resources. The success of the healthcare technology sector depends in part on the symbiosis between these two types of players.
Innovative pharmaceutical companies rely on the digital model. Does this induce more risks for the patient, particularly in terms of DPR and protection of sensitive health data?
Yes, but not only. The first obvious risk is the risk to health. It is important to guarantee the reliability of the products developed. Medicines are subject to a very strict regulatory framework, which guarantees their safety and efficacy. The regulatory framework for medical devices and in vitro diagnostic medical devices has also just been strengthened. The risk weighs primarily on products that fall outside the regulatory framework, which must guarantee that patients are properly informed and avoid any deception regarding their purpose through incorrect health claims.
Confidentiality of health data or expectations in terms of cyber security are also essential points in the regulations applicable to various health technology products. Generally speaking, the sector is complex and involves cross-cutting regulations. We can expect to see new issues emerge (deontology, ethics, medical responsibility). The legal challenge is commensurate with the stakes and expectations of the sector.
What advice would you give to a pharma tech company wishing to commercialize an innovative concept, protocol or treatment?
I would say to it: Find out about the regulatory framework. The field of health technologies is becoming more and more sophisticated and the boundaries are getting thinner and thinner between medical devices, applications, connected objects in the field of wellness and those in the field of medicine.
It is important to clearly identify your sector, and whether you are subject to a regulated or unregulated sector. It is important to know if the health software or application under development falls under the status of a medical device. This question has important consequences on the product development cycle and its funding constraints. It should not be forgotten that, in health more than elsewhere, a large part of the value of a drug comes from the fact that it has followed a very long path to market authorization.
No regulatory step should be overlooked at the risk of suffering a setback when it comes time to sell its discovery or bring in an investor.
You are also a lawyer specialized in intellectual property. How can we reconcile innovative concepts, collaborative work (university, companies, laboratories…) digital and intellectual property of each?
When it comes to innovation, intellectual property issues are paramount.
In the pharmaceutical field, patents are the preferred protection tool. It is essential to the industry since it allows a return on the investments that have been made in R&D. I stress the importance of the patent since the value of this instrument is often misunderstood. The patent offers exclusive exploitation rights in exchange for a certain publicity of the invention. It is therefore as essential for the viability of the industry, without which there is no innovation, as it is for the stimulation of scientific research.
The negotiation of partnership, co-ownership and license agreements are crucial steps in the development and exploitation of an innovative product. Innovative health products are diverse, and an invention may involve several types of intellectual property rights that must be properly identified. It is more than advisable to seek professional advice on these aspects.