Very few countries on the continent have legislated for such technologies that improve patient health without human intervention. However, the importance of digitization during the pandemic has been demonstrated and the pharmaceutical sector must work to be at the forefront when regulations flourish. 

 Digital therapies consist of scientifically proven hardware or software that treats the patient without medical intervention

Photo: Digital therapies consist of scientifically proven hardware or software that treats the patient without medical intervention. Credit: orzalaga – Pixabay  

By José Manuel Blanco 

In the Spanish market there are glucose measurement systems that help patients to monitor their blood sugar levels and decide whether or not they need to inject insulin. There are also pumps that inject this insulin continuously, but they cannot yet measure the person’s blood sugar levels and automatically supply the hormone in the event of hyperglycaemia peaks. Perhaps the day will come soon when scientifically supported hardware and software will be able to detect such peaks without human intervention and take action. This would be just one example of the promising digital therapies, which represent an attractive future for the pharmaceutical industry.  

Digital therapeutics are the most advanced step in digital medicine. They treat us without the need for a human to monitor the process, unlike digital health applications, which monitor our body and alert us when something is wrong so that we go to the doctor (for example, a wearable device that records our vital signs), and medical devices (such as the examples in the previous paragraph).  

Where digital therapies are currently  

Opinno’s Senior Strategy Consultant specialized in digital health, Xavier Beltri, explains that most of these digital therapies are aimed at the central nervous system and based on cognitive behavioural therapy used by psychologists in order to change the way people act and think.  

In 2014, the International Medical Device Regulators Forum (IMDRF) was formed, a pioneering group of health experts that began working on the concept of Software as a Medical Device, equivalent to digital therapies. In 2016, the Food and Drug Administration (FDA) regulated the technology. “From that moment on, from Europe, certain governments joined such as Germany, Belgium and the United Kingdom,” explains Beltri.  

The FDA led the way for digital therapies in 2016, a path that can now serve European countries such as Spain and the European Union as a whole

Photo: The FDA led the way for digital therapies in 2016, a path that can now serve European countries such as Spain and the European Union as a wholeCreditIrwan iwe - Unsplash 

The European Medicines Agency (EMA) does not yet have a strong position on these therapies: they are classified as “medical devices”, but there is no specific regulation for standalone software (software that works independently). As Beltri explains, there are two obstacles to this. The first is establishing the clinical requirements for these therapies. “The FDA in the U.S. is doing very well,” Beltri explains. For Software as a Medical Device, the U.S. agency asks for scientific validity (on what scientifically studied principle they are based, with beneficial changes for the person), the proper functioning of the software and a representative sample of patients.   

The second is the so-called “reimbursement,” who pays the pharmaceutical companies when these treatments are prescribed at the doctor’s office. “It is unlikely to be the patient,” warns Beltri, since a strong credibility campaign would have to be carried out in order to make them trust applications as if it were a traditional drug treatment. That is why, in Europe, the administration should be the main reimburser. This is the scenario that the continent’s pharmaceutical companies want.  

Digital therapies under way in Europe 

Germany is one of the most advanced countries in digital therapies. Beltri explains the process for their development in the country. First, the pharmaceutical sector must base its therapies on clinical studies and, when submitting them to the authorities, ensure that they comply with patient data protection (GDPR in Europe) and clinical validation.  

Then, the administration checks whether the therapy is beneficial for the country, like a traditional pharmacological treatment: better price, fewer side effects… Finally, it is time to confirm whether the state would be responsible for the reimbursement, which companies can obtain within one year.  

The situation is not the same in the rest of the continent. “We are in the process,” sums up Beltri, who again cites the United Kingdom and Belgium, as well as Italy, as other countries “that are moving in this direction.”  

Spain, on the other hand, “is on stand-by; the country still does not have a specific regulation for digital therapies.” Some Spanish companies and institutions are developing successful digital therapeutics products: Braingaze is a digital therapy focused on children with attention deficit hyperactivity disorder (ADHD), scientifically validated by the University of Barcelona and in which Sanitas and the hospitals Clínic and Sant Joan de Déu of the Catalan capital are collaborating.  

With this therapy, a child plays on a tablet and a webcam observes them to check whether they look at the screen and interact with it. “An algorithm measures the degree of involvement or interaction that the user has with the game. Depending on whether the user is distracted or not, the difficulty of the game increases or decreases in order to maintain that level of attention constantly,” explains Beltri, who adds: “They have managed to demonstrate that they increase attention levels in children with ADHD. It is very beneficial to stop medication thanks to digital therapies.” 

Small pharmaceutical companies operating in Spain should start working with a digital health approach to prepare for when Spanish legislation moves forward

Photo: Small pharmaceutical companies operating in Spain should start working with a digital health approach to prepare for when Spanish legislation moves forwardCreditNational Cancer Institute – Unsplash  

Preparing for when digital therapies become regulated  

While big pharmaceutical companies invest in startups that already have an idea up and running, Opinno is currently working with small and medium-sized pharmaceutical companies based in Spain, some of them with an international presence. “We approached them to start with a [a focus on] digital health, something more informative, that can help patients to learn about their pathology and better manage their day-to-day life with the doctor, so that they have this two-way relationship through an application that gives them information, both to them and to the doctors,” explains Beltri.  

The benefit is manifold: with a digital health application, pharmacists get the day-to-day needs of patients and can help them. At the same time, they help doctors, who in turn monitor the daily activity of their patients.  

In addition, the pharmaceutical companies obtain basic information to later generate digital therapies and prepare for the future regularization of digital therapeutics. “Depending on what they learn, on what they gain, they will be positioned when digital therapies are regulated in Spain.” 

Beltri warns that there are areas in which it is more difficult to carry out this approach: “You cannot treat cancer patients with digital therapies. You can treat the state of mind, their knowledge of the pathology, give them a closer link between them and their doctor.” 

The consultant summarizes that “we have a long way to go, but the pandemic has been a catalyst for the digitization of healthcare.” Now it must be the pharmaceutical companies that work to be ready for the day when the regulations become a reality.  

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