Germany is one of the most important European markets for pharma. With Germany advancing it digital health infrastructure, it is also a market where pharma’s digital patient services can play an important role in supporting patients and helping tackle issues such as medication adherence. For pharma, launching a digital patient service – either independently or with a partner – means understanding the local landscape. Here are three factors for pharma to consider when launching digital services in Germany.
Understand Local Market Regulations (e.g. DiGA)
The EU’s Medical Device Regulation (MDR) is the overarching set of regulations when it comes to digital health in Europe, defining what constitutes software as a medical device. It is, of course, vital to understand MDR and ensure that any digital program launched in Germany is compliant.
Beyond MRD, however, it is also important for pharma to understand Germany’s local regulatory framework. For example, in late 2019 Germany enacted the Digital Healthcare Act (‘Digitale Versorgung Gesetz’ or DVG) and created a clear pathway for developers to submit software to be classed as ‘DiGAs’ (Digitale Gesundheitsanwendungen). DiGAs can be prescribed by healthcare professionals to anyone with public health insurance and are eligible for reimbursement.
Even if a digital program pharma plans to launch in Germany is not considered a DiGA, it is important to understand the regulatory environment when it comes to issues such as content and navigating Medical, Legal, and Regulatory (MLR) reviews. In Germany, the Medicines Advertising Act (‘Heilmittelwerbegesetz’ or HWG) is a law that governs the advertising of medical products; understanding its scope and the specific guidelines is necessary for avoiding any compliance issues arising.
When partnering in the development of digital patient support, pharma should ensure that any potential partners have experience in the field of compliance.
Support the Latest Digital Health Advancements Such as eRx
One of the most recent developments in the German digital health landscape is the planned integration of electronic prescriptions (e-prescriptions or eRx). In May 2022, the Federal Ministry of Health (BMG) will make it advisory - and perhaps compulsory at a later date - for health providers in the states of Westphalia-Lippe and Schleswig-Holstein to issue e-prescriptions from September 2022. A national rollout is expected in 2023, making eRx the default for the 70 million people who have public health insurance in Germany.
You can read more about the rollout here: E-Prescription Roll-out in Germany: 6 Things Pharma Needs to Know.
One of the most crucial factors from pharma’s perspective is the effect eRx can have on refill rates and adherence. Not only does this hold the potential to improve patient outcomes, but it also has obvious benefits for pharma from a sales perspective as more prescriptions will be filled on time.
Rather than taking a back seat in driving the adoption of eRx, pharma can encourage uptake by supporting eRx in the digital services it offers to patients. By seamlessly integrating eRx functionality in its digital patient services, pharma can provide greater value to its patients in Germany. For example, our MyTherapy platform allows patients to not only scan e-prescriptions and store them in an eRx ‘wallet’ (so they can fill them at a local pharmacy), but also allows patients to fill them online easily and keep track of their inventory, helping ensure they never run out.
Localize PSPs to Suit Local Market Needs
It is easy to lump entire regions together when launching digital patient support; for example, Europe (and the EU bloc in particular) is often referred to as a singular entity. However, there are huge differences within European countries when it comes to healthcare, including different insurance systems, infrastructure, the prevalence of different diseases, and economic factors. Such differences combined heavily influence the challenges that patients face on a daily basis and the type of support that would be most beneficial to them.
In the UK, for example, we discussed how “negative beliefs about taking medications, the complexity of prescribed medication regimens, and the limited ability to cope with the underlying affective state, within challenging contexts, were mentioned as important reasons for non-adherence.”
In Germany, a recent study involving asthma patients identified “the perception that medications are all harmful (53.6% of the participants), the burden of medication co-payment (44.1%), positive perception about current health status (39.9%), feeling of depression (30.9%), and the fear of side effects (27.5%)” as reasons for non-adherence.
While there are certainly overlaps with the issues identified in the UK, it’s an example of how digital programs need to be adapted for each market. Features, functionality, and content should be carefully chosen to best address the most pressing needs identified.
Launch Digital Patient Services in Germany on MyTherapy
We partner with some of the biggest names in pharma to deliver digital patient services around the globe. By building on our MyTherapy platform, you can offer compliant, engaging, and localized patient services. By being a part of Shop Apotheke, we can also offer a seamless eRx experience to your patients in Germany, helping increase refill rates and tackle non-adherence. Click here to speak to us about how you can offer class-leading digital services to your patients in Germany.