Worried about COVID-19? During the outbreak, it is challenging for patients to seek in-person medical care. Self-quarantine is an important tool in managing disease transmission, especially among patients who are vulnerable to the risk of infection. This is where telemedicine becomes essential to ensure that patients have access to medical care and to boost community support. In times of a global public health emergency like the COVID-19 outbreak, healthcare systems should lean on remote medical check-ups, e-prescriptions and postal delivery of medicines in situations of quarantine and to tackle the further spread of the disease. Healthcare systems should expand beyond traditional healthcare tools and leverage existing telehealth tools to direct people to the proper level of healthcare for their medical needs (both to address their medical condition and to screen for COVID-19). Moreover, state administrations should make a historic effort to at least temporarily lift restrictions on telehealth usage (where such exist) to assist in the efforts to reduce patients' exposure to the virus and to ensure public health and safety.
How adequate is the current legislation in CEE? Are emergency aid legislative packages needed? We asked our specialists in Austria, Bulgaria, the Czech Republic, Poland and Romania how their local laws regulate the distribution of health-related services via electronic and telecommunication technologies.
Does the legislation in your jurisdiction regulate remote, online medical check-ups (via cameras / Skype sessions) and e-prescriptions of medicines?
Austria: In Austria, Section 49 (2) of the Medical Act regulates how doctors must fulfil their treatment mandate: "The doctor must carry out his profession personally and directly, if necessary, in cooperation with other doctors". Remote diagnosis, distance treatment or distance consultation was – based on this section – said to be prohibited. In fact, it is not explicitly regulated, and remote medical check-ups are on the up-and-coming. E-health (remote diagnostics etc.) was even included in the current program of the Austrian Federal Government.
Electronic prescriptions are, however, legally permissible. Starting in two pilot regions in Carinthia in April 2020, drug prescriptions throughout Austria are to be digitised by May 2022. The e-prescription can also be issued without patient contact (for example, for long-term medication or for homes).
Czech Republic: There is no legislation regulating remote, online medical check-ups under Czech law. As for the regulation of e-commerce with medicines, the Czech Act on Medicines and the Prescription Decree regulate so-called e-prescriptions. It has been possible to issue e-prescriptions since 2011 and they are obligatory (with some exceptions) since January 2018. E-prescriptions are centrally registered in the information system operated by the Czech State Institute for Drug Control.
Bulgaria: The Bulgarian legislation is a bit complex. For instance, medicinal products, which are paid by the National Health Insurance Fund, cannot be prescribed via e-prescription, but an electronic prescription issued in a Member State could be acceptable. As for online medical check-ups, the situation is similar to the Czech Republic: there is no explicit regulation, although distance medical check-ups are performed as special campaigns by various hospitals and are widely reflected by the media.
Poland: In Poland, the Medical Activity Act allows medical activity involving online/remote health services to be conducted since 2015. It is called telemedicine. Among other things it allows patients to seek consultation and obtain a diagnosis without having to visit the doctor's office. Doctors are responsible for the health services provided in this way. Their task is to provide patients with the greatest possible safety. In Poland, telemedicine is helpful in diagnosing and monitoring the health status of patients with chronic conditions such as asthma, cardiovascular disease, diabetes, mental illness and stroke. Telemedicine is mainly intended for patients who are not mobile or who live in rural areas where access to healthcare is difficult.
Under the amendment of the Polish Pharmaceutical Law, prescriptions can now be issued in electronic or paper form. E-prescriptions are given to patients by e-mail, SMS or as an information printout. The Regulation of the Ministry of Health on prescriptions contains detailed requirements concerning prescriptions. These regulations exclude cross-border prescriptions, which are acceptable only in paper form.
Romania: Online medical check-ups (via cameras / skype sessions) are not possible under Romanian legislation, as the law requires any medical decision to be made through personal and unmediated examination of the patient by the respective physician. A remote investigation or medical intervention is permitted only if the patient is directly assisted by his/her physician and the purpose of the investigation is to help the physician determine the diagnosis, to establish the treatment or to take any other medical measure necessary to finalise the medical act or the medical intervention in case of surgeries.
E-commerce with medicines is currently allowed in Romania as of April 2019, provided that the pharmacy meets certain requirements, among which are the existence of a specific authorisation, the existence of additional space for the online activity, the existence of a pharmacist responsible for the online sale, and specific requirements with respect to the website. Moreover, prior contact between the patient and the pharmacist is required in order for the patient to buy medicines (such as live chat or other interactive means).
Is it legal for pharmacies in your jurisdiction to accept a remote, online prescription from an EU doctor issued in accordance with the laws of the doctor's EU jurisdiction?
Bulgaria: Pharmacies in Bulgaria are in general obliged to fulfil prescriptions issued in another Member State. According to the law, such prescriptions could be electronically signed. They must contain certain mandatory information/data, including identification of the healthcare professional, identification of the prescribed product (e.g. international non-proprietary / pharmacopoeial name of the active substance, form, dosage, etc.). However, Bulgarian pharmacies are not allowed to fulfil prescriptions issued in another Member State if they prescribe medicinal products that are (or contain) narcotic substances or that may give rise to considerable risk of drug addiction.
Czech Republic: At the moment this is not possible in the Czech Republic. However, as of 1 April 2021, an amendment to the Act on Medicines will become effective, which will enable e-prescriptions from other EU Member States to be accepted in the Czech Republic.
Poland: Prescriptions from other EU countries can be used only if they are cross-border prescriptions issued on the basis of EU regulations or if they are ordinary prescriptions with a doctor's handwritten signature. Signature printout is not allowed. This excludes remote or online prescriptions from other EU countries. But we have some interesting news here: from 2021, Poland will be included in the cross-border e-prescription programme, which currently includes Finland and Estonia. We are very excited to trace the application of this programme.
Romania: Romanian law provides that prescriptions released to a patient in another EU Member State may be used in Romania in compliance with national legislation and any restrictions regarding the acceptance of individual prescriptions are prohibited, without distinguishing between online and hard-copy prescriptions. However, from a practical and technical point of view, at present it does not seem possible for a Romanian pharmacy to accept a remote, online prescription from a foreign (EU) doctor, mainly given that prescriptions in electronic form are regulated at the national level, have a standard form and are used within a specific online system managed by the national health insurance institution. Moreover, there is no integrated system at the EU level between Member States so that a Romanian pharmacy can access a digital prescription issued by an EU doctor. The current online system is only available at the national level.
Austria: Prescriptions from foreign doctors are nothing new in Austrian pharmacies. Foreign (e-)prescriptions, if they meet the criteria of the Austrian Compulsory Prescription Act (Rezeptpflichtgesetz), which the pharmacist must formally check, are accepted in an Austrian pharmacy.
Are pharmacies in your jurisdiction allowed to supply/deliver medicines by mail on the basis of remote, online prescriptions (i.e. supply and delivery on request of the patient)?
Austria: Austrian pharmacies can sell non-prescription medicinal products via the internet if they are registered with the Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen). The remote sale of prescription-only medicinal products is forbidden and therefore a punishable offence in Austria, regardless of whether the prescription was issued by an Austrian or foreign physician.
Bulgaria: According to the Bulgarian legislation, the online sale of POMs (prescription-only medicines) is generally prohibited. OTC's (medicines not requiring a prescription) can be sold online (and delivered by mail) by pharmacies or drugstores. A list of the websites offering OTCs online can be found on the website of the Bulgarian Drugs Agency.
Czech Republic: It's the same in the Czech Republic – only medicinal products without a prescription can be delivered to patients by mail. For now, the supply/delivery of medicinal products by mail on the basis of remote, online prescriptions is not possible in the Czech Republic. However, there is ongoing discussion about allowing it in the future. So, we do expect that the public discussion might lead to amendments in the legislation.
Poland: We have similar legislation. According to the Polish Pharmaceutical Law, delivering POMs by mail is not allowed. Therefore, mail-order pharmacies do not process remote prescriptions at all. In 2018, the Polish parliament rejected the amendment allowing for distance sale (including e-commerce) of POMs for people with a disability certificate. However, pharmacies may generally carry out distance sale of medicines for which no medical prescription is required.
Romania: Pharmacies in Romania are allowed to market online only medicines sold/released without a medical prescription, provided that the respective pharmacy meets certain requirements, including the existence of a specific authorisation, a pharmacist responsible for the online sale, prior contact of the patient with the pharmacist, etc. Prescription only medicine cannot be sold/released by online/electronic services.
By Iliyana Sirakova, Attorney at Law, Austria
Elena Todorova, Attorney at Law, Bulgaria
Monika Voldanova, Attorney at Law, Czech Republic
Paulina Klimek-Wozniak, Associate, Poland
Mara Moga-Paler and Amalia Surugiu, Senior Attorneys at Law, Romania, Schoenherr