Market environmentBusiness performance
Digitalisation in Germany’s healthcare sec-tor is gaining momentum. Following the launch of electronic patient records, which should be available to all policyholders by the beginning of 2021, the Federal Ministry of Health also intends to quickly push for-ward with telemedicine. A key issue here is the electronic prescription: The electronic prescription enables innovations in telemedical treatment. On the basis of new regulations, it should also be possible to use prescriptions in electronic format in the supply of drugs.
Market growth in Germany 1
Europe’s largest drugs market, Germany, increased in 2018 by about 6 percent to EUR 43.9 billion. The market share of the pharmacies amounts to 86 percent; 14 percent of the sales are generated through hospitals and clinics. Pharmacy sales of prescription drugs (Rx) rose by 5.5 percent to EUR 30.8 billion in 2018 and in the field of non-prescription (OTC = over-the-counter) drugs they rose by 3.4 percent to EUR 5.1 billion. The prescription drug (Rx) mail-order share of the pharmacy channel amounts to just under 1 percent, whereas the OTC mail-order share comes to 17.9 percent. Mail-order sales in-creased overall by 5.5 percent to EUR 1.2 billion in 2018. The OTC segment accounts for 76 percent of mail-order sales – considerably more than the Rx business. The OTC mail-order segment reported an increase of 8.1 percent, whereas the Rx mail-order business declined by 1.6 percent.
1 IQVIA™ market report on the development of the German pharmaceutical market in 2018
Coalition agreement in Germany
The coalition agreement between the CDU/CSU and SPD of 12 March 2018 includes a memorandum of understanding on the implementation of a ban on mail-order sales of prescription drugs (Rx). Based on reports and statements by former German governments, the Zur Rose Group is still convinced that this plan is un-constitutional and incompatible with European law. Several parties, experts and associations publicly oppose a ban on mail-order prescription drugs.
On 11 December 2018, Federal Health Minister Jens Spahn presented an alternative proposal to the ban on mail-order prescription drugs. This stipulates that the mail-order business in prescription drugs in Germany and the granting of bonuses by mail-order pharmacies from other EU Member States will also be allowed in the future. The Zur Rose Group welcomes this proposal, which continues to allow patients freedom of choice when it comes to the purchasing channel. In response to the cornerstones of the Federal Ministry of Health, the Federal Union of Ger-man Associations of Pharmacists (ABDA) presented a resolution at its general meeting on 17 January 2019, prioritising the call for equal prices over the ban on mail-order business. The Zur Rose Group is monitoring further developments and will analyse all proposals in order to initiate necessary measures where required.
On 10 May 2018, the German Medical Association decided to liberalise remote treatment, thus paving the way for the ex-pansion of telemedicine in Germany. In the future, consultations and treatment via communication media will also be permitted in individual cases before any initial consultation, if this is medically justifiable and medical ethics are adhered to. Patients also need to be informed about the specific features of stand-alone telemedical contact. This could give a boost to telemedicine in Germany, because legal grey areas would be eliminated and doctors would be given more room for manoeuvre. By the end of 2018, almost half of all regional medical associations had already incorporated the new regulation into their legally binding professional code and had it approved by the responsible supervisory bodies. The issues of prescription and referral in the context of telemedicine were referred to the board of the German Medical Association for further discussion. However, according to Federal Health Minister Jens Spahn, it is the electronic prescription that makes telemedicine a successful project in the first place.
Law for more safety in the supply of medicines
The draft bill of a law for more safety in the supply of drugs (GSAV) drafted by the Federal Ministry of Health of 14 November 2018 states that the electronic prescription (e-prescription) enables innovations in telemedical treatment and is designed to relieve the burden on doctors, pharmacists and patients in Germany. Therefore, any self-administration, consist-ing of the statutory health insurance companies and the Association of Statutory Health Insurance Doctors, is under an obligation to create the necessary regulations for the use of the e-prescription. In particular, the regulations that up to now provided for the prescription of drugs exclusively on paper are to be modified. To this end, the Ministry sets a period of seven months after the entry into force of the law. According to Federal Health Minister Jens Spahn, the legislative change will take effect in 2020 at the latest. On the basis of the new regulations, prescriptions only in electronic format will also be able to be used in the supply of drugs. As a result, also projects with alternative technical solutions can be carried out even before the widespread introduction of electronic prescriptions in the telematics infrastructure.
In addition, the bill provides that in future pharmacies will be able to deliver prescription drugs even after an obviously sole remote treatment – the existing ban on remote prescriptions is thereby repealed. Prescriptions which are issued without prior direct contact between doctor and pharmacist may not so far be supplied by pharmacies, as a result of regulations dating from November 2016.
Digital Single Market Strategy
Acceptance of digital solutions for health and care remains low in the European Union and varies widely among Member States. The European Commission is therefore seeking to provide its citizens with access to secure, high-quality digital services in these fields. As part of the Digital Single Market Strategy (DSM), a digital service infrastructure for e-health is to be established in Europe. In the future, citizens should be able to securely access and share their health data. Healthcare providers, such as doctors and pharmacies, will be given the opportunity to share this information EU-wide to facilitate targeted and rapid research, diagnosis and treatment for patients. Digital services and data in healthcare are designed to enable citizens to act in-dependently and access personalised medical care.