Life Sciences 2024 Comparisons

Austrian medicinal products law is strongly determined by EU legislation. However, at a national level, the Austrian Medicinal Products Act (Arzneimittelgesetz, or AMG) constitutes the primary legal basis with regard to pharmaceuticals (“medicinal products”) for human use. It implements the main EU legal acts in this respect – specifically, Directive 2001/83/EC. Since 28 January 2022, medicinal products for veterinary use have been governed by the Regulation on Veterinary Medicinal Products (Regulation (EU) 2019/6) which, since January 2024, has been complemented in Austria by the new Austrian Veterinary Medicinal Products Act (Tierarzneimittelgesetz).

Specific provisions in relation to medicinal products can also be found in other Austrian laws, such as the Austrian Pharmaceutical Products Import Act (Arzneiwareneinfuhrgesetz, or AWEG) or the Austrian Prescription Act (Rezeptpflichtgesetz). Furthermore, the manufacture and distribution of medicinal products is governed by several national ordinances (Durchführungsverordnungen), which are based on the AMG, including the Medicinal Products Operations Ordinance (Arzneimittelbetriebsordnung, or AMBO).

Medicinal products law is also increasingly regulated by directly applicable EU regulations – for example, Regulation (EC) 726/2004 (see 3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceutical and Medical Devices), Regulation (EU) 536/2014 (“Clinical Trials Regulation”, or CTR), and Regulation (EC) 1394/2007 (“Advanced Therapy Medicinal Products Regulation”, or ATMPR).

As of 26 May 2021, medical devices have mainly been governed by the Regulation (EU) 2017/745 (“Medical Devices Regulation”, or MDR), which is complemented by the Austrian Medical Devices Act 2021 (Medizinproduktegesetz, or MPG) providing for rules regarding the safety, functionality and quality of medical devices with regard to their construction, operation, use and maintenance. Since 26 May 2022, in vitro diagnostic (IVD) devices have been governed by Regulation (EU) 2017/746 (“In Vitro Diagnostics Regulation”, or IVDR), which is likewise complemented by the MPG. The MPG came into force on 1 July 2021 for medical devices and on 26 May 2022 for IVD devices.

The competent national authority for medicinal products, medical devices and IVD devices is the Austrian Federal Office for Safety in Healthcare (Bundesamt für Sicherheit im Gesundheitswesen, or BASG). The BASG is responsible for the approval and control of medicinal products in Austria, as well as for the control and approval of clinical trials (see 2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial). Together with the competent European agencies, the BASG further monitors nationally the medicinal products, medical devices and IVD devices already on the market with regard to their efficacy, safety, production, transport and storage.

Decisions by regulatory bodies qualify as specific administrative acts (Bescheide), which can be challenged by the addressee – or by a third party having a legal interest, if applicable – by lodging an appeal with the regulatory body that has issued the administrative act. The decision on the appeal is made by the competent administrative court.

Appeals against administrative acts must be made in writing and – unless regulated otherwise in the respective regulation – filed within four weeks of the date of the decision to be challenged. There is no legal obligation for the appellant to be represented by an attorney.

In Austrian medicinal products law, various criteria exist on the basis of which medicinal products are categorised and regulated differently. By way of an example, the AMG distinguishes between medicinal products that are available for the patient only upon prescription and over-the-counter (OTC) medicinal products available without prescription. Medicinal products requiring prescription may not be advertised to the general public (“lays”) but, rather, only to healthcare professionals under the preconditions laid down in the AMG.

The AMG makes another relevant distinction between medicinal products that are, in principle, subject to marketing authorisation – known as “medicinal specialties” (Arzneispezialitäten) – and medicinal products not subject to such authorisation. Furthermore, the AMG differentiates on the basis of the material composition of a medicinal product (eg, biological medicinal products, herbal medicinal products, radioactive medicinal products, or homeopathic medicinal products).

Likewise, medical devices may be qualified by the Ministry of Health as requiring a prescription or as only available through certain specialised dealers. Prescription-only medical devices may not be advertised to the general public either. However, in practice, the vast majority of medical devices are freely available and not qualified as prescription-only, or are exclusively available in specialist stores.

There is also an essential distinction between IVD devices – to which the IVDR applies – and other medical devices, which are subject to the MDR. In addition, the MDR and IVDR differentiate on the basis of the purpose or use of a medical device (eg, active device, implantable device, invasive device, or single-use device) and its inherent risks (Class I, IIa, IIb, III for medical devices/Class A, B, C and D for IVD devices).

The regulatory system for clinical trials of medicinal products underwent a comprehensive restructuring as of 1 February 2022, aimed at further harmonising the rules on the conduct of clinical trials within the EU member states. The legal framework of clinical trials on medicinal products is now essentially defined by the CTR, thereby replacing the former system for clinical trials based on Directive 2001/20/EC. Supplementary provisions for national implementation and within the scope of so-called opening clauses of the CTR have been introduced into the Austrian legal system through the AMG by an amendment in Federal Law Gazette I 2022/8.

If genetically modified organisms (GMOs) are used for therapeutic purposes – as defined in Section 4(24) of the Austrian Gene Technology Act (Gentechnikgesetz, or GTG) – in the course of a clinical trial, a prior permit according to Section 74 of the GTG must also be obtained.

Clinical trials of medical devices (known as “clinical investigations”) are mainly regulated by the MDR and clinical trials of IVD devices (known as “performance studies”) are regulated by the IVDR. Supplementary provisions have been included in the MPG.

For non-interventional studies, the provisions of the CTR and the MDR/IVDR do not apply. Instead, there are specific national provisions in the AMG and the MPG for these studies, including provisions concerning data protection and inspections by the BASG. The following may also apply:

• general provisions of civil, criminal and data protection law; or
• specific rules for clinical research under, for example, the Austrian Hospital and Sanatoria Act (Krankenanstalten- und Kuranstaltengesetz, or KAKuG) or the Austrian University Act 2002 (Universitätsgesetz, or UG).

Since 31 January 2023, all new applications for clinical trials of medicinal products must be submitted in accordance with the CTR. The authorisation procedure is initiated by the sponsor sending the application dossier to the EU member states concerned via the EU portal, known as the Clinical Trials Information System (CTIS). The reporting member state must then carry out a validation within ten days and notify the sponsor via the portal of the results. In Austria, the BASG is responsible for the validation procedure, whereby the ethics committee can issue an opinion on certain parts of the application (Section 31, paragraph 4 of the AMG). The validation procedure is followed by the evaluation procedure, which is divided into the following two parts.

• In Part I, a co-ordinated assessment of the application between the reporting and concerned member states takes place, in which aspects of the clinical trial – such as whether it is minimally interventional, the expected therapeutic and public health benefits, and the risk of harm posed to the trial subjects – are evaluated. The assessment report must be prepared and submitted within 45 days of validation; however, this term may be extended under certain conditions. The responsibilities regarding Part I of the assessment procedure are divided nationally between the BASG and an assessing ethics committee (Section 35 of the AMG).
• Part II of the evaluation procedure includes the aspects that are to be assessed nationally by each member state – for example, requirements for informed consent, patient recruitment, and subject insurance. The evaluation report must also be submitted within 45 days of validation. In Austria, the responsibility for preparing the assessment report in Part II is assigned to the evaluating ethics committee.

The decision to authorise the clinical trial must then be taken by each member state within five days of the conclusion of the evaluation procedure. If a timely notification is not made, the conclusion regarding Part I of the assessment report is automatically deemed to be the decision of the respective member state.

The approval of a clinical investigation into a medical device for the purposes of the conformity assessment referred to in Article 62, paragraph 1 of the MDR essentially follows the MDR. Depending on the type of investigation, different procedures are provided for (eg, authorisation procedure/notification procedure/instruction procedure).

An application for authorisation must be submitted electronically to the BASG. Upon receipt of the application, the BASG must carry out the validation within ten days.

With regard to Class I investigational devices or Class IIa/IIb non-invasive devices, the clinical investigation may be commenced immediately after validation ‒ provided that the BASG has confirmed proper notification and the ethics committee has given a favourable opinion (ie, notification procedure).

In the case of other investigational devices (Class III investigational devices or Class IIa/IIb invasive devices), the clinical investigation may only commence after notification of the authorisation by the BASG ‒ again with the prerequisite that a favourable opinion by the competent ethics committee must be provided. The decision about the authorisation must usually be communicated to the sponsor within 45 days of validation (ie, authorisation procedure).

For clinical investigations of medical devices that already bear a CE marking, thereby confirming conformité européenne (“European conformity”), a different procedure applies under certain conditions (Article 74 MDR). The sponsor must notify the BASG of the conduct of such investigation at least 30 days before it begins. In this case, the BASG will confirm the notification without further subsequent assessment (ie, information procedure).

Clinical investigations of medical devices for other purposes than the demonstration of conformity are also subject to prior approval by the BASG if they have an impact on the diagnostics and/or therapy of a trial subject (Article 82 of the MDR, in conjunction with Section 13, paragraph 3 of the MPG); otherwise, it is only necessary to conduct an information procedure.

For performance studies on IVD devices, the provisions of the MPG are largely applicable mutatis mutandis – although there are certain exceptions (see Article 66 et seq of the IVDR and Section 36 of the MPG for comparison).

For medicinal products, information on clinical trials initiated under the CTR as of 31 January 2022 (including the start and end dates of the trial, details of the sponsor, and trial results) is publicly available on the EU Clinical Trials website. Information on clinical trials initiated under the former system of Directive 2001/20/EC (before 31 January 2022) may still be accessed via the EU Clinical Trials Register.

For clinical investigations and performance studies under the MDR and the IVDR, no publicly accessible register is currently provided at EU or national level. However, information on such trials will be accessible via the EUDAMED database as soon as the entire EUDAMED system has been declared fully functional.

At national level, the option to provide for the maintenance of a (publicly accessible) register for non-interventional studies of medical devices via ordinance was not exercised by the legislator.

In Austria, it is not generally prohibited to conduct the consent procedure remotely or to remotely supervise certain tasks/procedures carried out at home by a physician. Remote access to source data for the purpose of monitoring is also permissible; however, this only applies to original electronic medical records and where a correspondingly validated record system is being used.

In December 2022, a recommendation paper on decentralised (remote) elements in clinical trials was published by the EU Decentralised Clinical Trial (DCT) project team, comprising experts from the Clinical Trial Coordination Group, the Clinical Trial Expert Group, European Medicines Agency (EMA) scientific committees, EMA working parties, and EMA staff. This document also includes guidance concerning national provisions on the use of online tools in clinical studies within the EU.

As regards special measures due to COVID-19, see 11.2 Special Measures Relating to Clinical Trials.

Clinical studies involve the processing of patients’ contact and health information, which may qualify as personal data as defined by Article 4(1) of the General Data Protection Regulation (EU) 2016/679 (GDPR). To the extent that patients are identified or at least identifiable in data resulting from the clinical trial, these data sets must also be qualified as personal (sensitive) data.

The processing of personal data in the context of a clinical trial is generally based on the patient’s consent pursuant to Article 6, paragraph 1(a) in conjunction with Article 9, paragraph 2(a) of the GDPR. Accordingly, any disclosure of personal data to third parties must be covered by this consent.

The processing of personal data (including sensitive data) within databases is subject to compliance with the GDPR, (potentially) the Austrian Research Organisation Act (Forschungsorganisationsgesetz, or FOG) and the Austrian Data Protection Act (Datenschutzgesetz, or DSG).

The distinction between medicinal products and medical devices is made in accordance with the product definitions as set forth in the AMG (Section 1, paragraph 1) and the MDR (Article 2(1)).

“Medicinal products”, within the meaning of the AMG, are substances or preparations of substances that either:

• are intended for use in or on the body and as agents with properties to cure or alleviate or prevent diseases or pathological complaints (so-called presentation medicinal products); or
• may be applied in or on the body or administered to a human (so-called functional medicinal products) with a view to either:
1. restoring, correcting or modifying physiological functions by a pharmacological, immunological or metabolic action; or
2. making a medical diagnosis.

According to the MDR, the term “medical device” means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means:

• the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;
• the diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability;
• the investigation, replacement or modification of the anatomy or of a physiological or pathological process or state; and
• for providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations.

Furthermore, devices for the control or support of conception, as well as certain products specifically intended for the cleaning, disinfection or sterilisation of devices will be deemed medical devices.

The distinction between medicinal products and medical devices can be made, in most cases, on the basis of the principal mode of action of the product (see Article 1, paragraph 6(b) of the MDR). A product with an essentially pharmacological, immunological or metabolic action is not to be classified as a medical device. The principal mode of action of medical devices is mostly of a physical or mechanical kind.

In the case of diagnostic devices, distinction must be made on the basis of the nature of the product (substance/instrument, apparatus, etc) and the place of application (in vivo or in vitro).

In Austria, manufacturers of products (or their representatives) may initiate a procedure with the BASG, whereby questions concerning the product classification ‒ including the demarcation between the medicinal product and the medical device status of the product ‒ will be clarified (Section 10 of the MPG and Section 49a of the AMG).

Within the meaning of the AMG, the term “biological medicinal products” comprises:

• certain immunological medicinal products;
• certain medicinal products manufactured by using human blood or blood plasma as a starting material; and
• medicinal products listed in Annex I(1) and (1a) Regulation (EC) 726/2004, such as:
1. medicinal products developed by means of recombinant DNA technology, controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes (including transformed mammalian cells), or hybridoma and monoclonal antibody methods; and
2. ATMP.

Austrian law does not provide for a marketing authorisation procedure specific to biological medicinal products. However, for medicinal products listed in Annex 1(1) and (1a) Regulation (EC) 726/2004, a central marketing authorisation according to said regulation is mandatory. In addition, differences with regard to the required application documents may arise for different types of biological medicinal products.

Furthermore, the AMG contains specific provisions for certain immunological medicinal products, as well as medicinal products manufactured by the use of human blood or blood plasma. According to Section 7, paragraph 8 of the AMG, for example, blood and blood components intended for direct transfusion are exempt from the obligation to obtain a marketing authorisation. Also, there may be an additional requirement of a batch release as a prerequisite for supplying certain biological medicinal products in national Austrian law (see Section 26 of the AMG). Lastly, specific provisions for so-called biosimilars can be found in Section 10, paragraph 6 of the AMG.

A national marketing authorisation of a medicinal product is generally granted by the BASG for a period of five years (Section 20, paragraph 1 of the AMG). An extension of the marketing authorisation (at the request of the marketing authorisation holder) is valid without a time limit, unless the BASG again sets a time limit of five years for reasons of pharmacovigilance.

If an authorised medicinal product has not actually been placed on the domestic market within three years of the marketing authorisation being granted, or has not been on the market for three consecutive years, the marketing authorisation may expire in accordance with Section 22 of the AMG (the so-called sunset clause). In certain cases, the marketing authorisation must also be revoked. Similar rules apply according to Regulation (EC) 726/2004 with regard to the period of validity of marketing authorisations for medicinal products authorised under the centralised procedure.

The placing on the market of medical devices is not subject to a marketing authorisation; however, the manufacturer must perform a conformity assessment procedure (see 3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices). According to Article 56 of the MDR, certificates of conformity issued by the notified bodies will be valid for the period they indicate, which must not exceed five years. Upon application by the manufacturer, the validity may be extended for further periods (of no more than five years), based on a re-assessment. The CE marking will be suspended, restricted or withdrawn if a notified body finds that the requirements of the MDR are no longer met by the manufacturer.

Marketing Authorisation for Medicinal Products

There are, in practice, four different procedures for obtaining a marketing authorisation for medicinal products.

• For medicinal products according to Annex I Regulation (EC) 726/2004 (eg, ATMP), marketing authorisation must be obtained via the centralised procedure. Under certain conditions (see Article 3, paragraph 2), the centralised procedure is also available for other medicinal products. A marketing authorisation obtained under the centralised procedure is issued by the European Commission and is valid in all EU member states. Applications must be submitted to the EMA.
• For other medicinal products, marketing authorisation may be obtained under the national procedure according to Sections 7 et seq of the AMG via application to the BASG. The BASG is also the competent authority for issuing the national marketing authorisation, which is only valid on Austrian territory.
• Where a national authorisation already exists in a member state, it may be extended to the territory of other member states through a mutual recognition procedure (Section 18a of the AMG).
• For medicinal products that cannot be authorised under the centralised procedure, a marketing authorisation in different EU member states may be applied for through a decentralised procedure (Section 18a of the AMG).

Variations to marketing authorisations

Variations to marketing authorisations are governed by Regulation (EC) 1234/2008 for all types of authorisations. Depending on the degree of health risk and the impact on quality, safety and efficacy, either a simple notification procedure, a notification obligation with a prohibition reservation or a prior authorisation procedure is required. In contrast, applications for authorisation extensions (eg, in the case of relevant changes to the active substance) must be evaluated according to the same procedure as the application for the original authorisation.

Transfers of marketing authorisations

Transfers of marketing authorisations obtained under the centralised procedure must be applied for with the EMA according to the procedure set down in Regulation (EC) 2141/96. Otherwise, the procedure is governed by Section 25 of the AMG according to which a declaration of waiver of the authorisation by the previous marketing authorisation holder and a declaration of acceptance by the transferee must be submitted to the BASG.

Medical Device and IVD Device Compliance

Placing medical devices and IVD devices on the market is not subject to obtaining a marketing authorisation. Medical devices or IVD devices, however, may only be placed on the market or put into service if they comply with the MDR/IVDR. Specifically, they must meet the general safety and performance requirements, taking into account their intended purpose. Also, an assessment of the conformity of the device must be conducted and a corresponding declaration of conformity issued. Depending on the risk classification of a medical device, a notified body must be involved in the process. Conformity with the applicable requirements is indicated by CE marking of the product. Transfers of CE markings are not provided for in the MDR/IVDR.

Medicinal Products

As far as medicinal products are subject to a marketing authorisation, the marketing authorisation is a prerequisite for lawful placing on the market in Austria. For this reason, opportunities to supply such medicinal products to patients without any marketing authorisation are limited. Nevertheless, there are a number of exceptions to this principle. The following are among the exceptions to the authorisation requirement.

• Named Patient Use (Section 8, paragraph 1(2) of the AMG) – no marketing authorisation is needed if a physician or dentist authorised to practise independently in Austria certifies that:
1. a medicinal product is urgently needed to prevent a threat to life or serious damage to the health of a specific patient; and
2. this threat or damage cannot be prevented with an authorised and available medicinal product according to the state of the art.
• Compassionate Use Programmes (Section 8a of the AMG and Article 83 of Regulation (EC) 726/2004) – marketing authorisation is not needed within Compassionate Use Programmes, which may be established (subject to prior approval by the BASG) for a defined group of patients suffering from a debilitating chronic or severe disease or whose disease is life-threatening and cannot be satisfactorily treated with an authorised and available medicinal product.
• Clinical trials (Section 8, paragraph 1(1) of the AMG) – medicinal products intended for the use in non-clinical or clinical studies or clinical trials do not need a marketing authorisation.
• Hospital exemption (Section 7, paragraph 4 of the AMG and Article 28 of Regulation (EC) 1394/2007) – ATMP that are manufactured on a non-routine basis in Austria on the basis of an individual medical prescription specifically for a particular patient, in order to be used on that patient in an Austrian hospital under the exclusive professional responsibility of a physician, are not subject to a marketing authorisation.
• Officinal and magisterial medicinal preparations (Section 7, paragraphs 2 and 3 of the AMG) – certain medicinal products manufactured in pharmacies are not subject to a marketing authorisation.

Further exemptions are listed in Sections 7 et seq of the AMG.

It should be noted that a marketing authorisation is a prerequisite for placing medicinal products on the market, but not for their use. For this reason, medicinal products can, in principle, be used on patients beyond the scope of their marketing authorisation (off-label use). In this context, however, there are increased obligations on the part of the physician to provide information to the patient.

Medical Devices and IVD Devices

With regard to medical devices and IVD devices, the MDR/IVDR provide for exemptions from the obligation of CE marking for custom-made devices, investigational devices and devices for performance studies (Article 20 of the MDR and Article 18 of the IVDR). Furthermore, the placing on the market and putting into service of a medical device for which no conformity assessment has been carried out may be authorised by the BASG in specific cases upon request for reasons of public health or patient health and safety (Article 59 of the MDR, Article 54 of the IVDR and Section 12 of the MPG).

As per the above-mentioned definition of Named Patient Use, if a physician or dentist authorised to practise independently in Austria confirms that a medical device is required for a specific patient in order to avert a danger to life or a serious impairment of health ‒ and that the treatment cannot be expected to be successful with a medical device for which conformity assessment procedures have already been carried out ‒ then such authorisation is not necessary. The same applies to medical devices used in connection with certain deployments of the Federal Armed Forces (Section 12, paragraphs 2 and 3 of the MPG).

Finally, under certain conditions there are far-reaching exemptions from the obligations of the MDR/IVDR for in-house products that are manufactured and used only in healthcare facilities (Article 5, paragraph 5 of the MDR/IVDR and Section 9 of the MPG).

Medicinal Products

Holders of a marketing authorisation for a medicinal product must operate a pharmacovigilance system (Section 75i et seq of the AMG). Within the framework of this system, the holder must, among other things:

• appoint a pharmacovigilance officer;
• keep a pharmacovigilance master file;
• operate a risk management system;
• monitor the results of risk minimisation measures;
• monitor pharmacovigilance data; and
• subject the pharmacovigilance system to regular audits.

The applicable law also provides for reporting obligations (Section 75j of the AMG, Article 28 of Regulation (EC) 726/2004 and Article 107 of Directive 2001/83/EC) and information obligations of the holder (Section 75m of the AMG). In addition, holders are obliged to regularly prepare periodic safety update reports (PSUR) and transmit them electronically to an archive maintained by the EMA.

Other obligations of the holder include the following:

• The holder must inform the BASG about the date of actual placing on the market of a medicinal product, as well as a temporary or permanent removal from the market (Section 21 of the AMG).
• The holder must ensure that complete documentation of all activities related to the marketing authorisation or the medicinal product is available at all times (Section 24b of the AMG).
• If there are concerns regarding the risks of the medicinal product, the holder may face additional requirements or conditions imposed by the BASG, such as the performance of post-authorisation safety studies. If findings on the disease or clinical methodology indicate that previous assessments of efficacy may need to be significantly corrected, an efficacy study must be imposed (Section 19a of the AMG).

Medical Devices and IVD Devices

For medical devices and IVD devices, the MDR/IVDR require the manufacturer to plan, establish, document, implement, maintain and update a post-market surveillance system as part of the quality management system in a manner appropriate for the risk class and type of the product (Article 83 of the MDR and Article 78 of the IVDR). To this end, a post-market surveillance plan must be established (Article 84 of the MDR and Article 79 of the IVDR) and post-market surveillance reports must be prepared and updated (Article 85 of the MDR and Article 80 of the IVDR). Further obligations concern, for example, the preparation of PSUR (Article 86 of the MDR and Article 81 of the IVDR), the reporting and analysis of serious incidents and safety corrective measures (Articles 87 and 89 of the MDR and Articles 82 and 84 of the IVDR) and trend reports (Article 88 of the MDR and Article 83 of the IVDR).

On an EU level, a list of medicinal products under current evaluation under the centralised procedure is published monthly by the EMA. A list of all medicinal products that have received a marketing authorisation under the centralised procedure is provided in the “Union Register” published by the European Commission. This register includes information on the name of a product, the registration number, name and address of the marketing authorisation holder, the active substance, the therapeutic indication, and relevant documents – as well as suspended, withdrawn or refused marketing authorisations.

On a national level, the BASG keeps a public register of all medicinal products for which a national marketing authorisation has been obtained (Arzneispezialitätenregister). Any granting, variation, cancellation and transfer of a marketing authorisation must be entered into this register. Entries regarding the granting of a marketing authorisation include information on the authorisation number, the name of the product, the authorisation holder, prescription-only or narcotic status, and the composition of the medicinal product.

Furthermore, the BASG operates an internet portal on medicinal products for public information purposes. In addition to information on the granting of a marketing authorisation and the variation of a medicinal product, the BASG shall (inter alia) publish the technical information and approved directions for use, information on approved variations, and the conditions and constraints of marketing authorisations. Also, every expert opinion provided in the context of an application for marketing authorisation shall be published after all confidential information in the party’s commercial interest has been removed.

For products authorised via a mutual recognition procedure, information can be found in the MRI Product Index. Information on medical devices and IVD devices (including summaries of safety and clinical performance) and their manufacturers and importers, as well as certificates, may be publicly accessed via the EUDAMED database.

The core Austrian regulations concerning the protection of the legal supply chain against falsified medicinal products and active substances were implemented in the AMG by Federal Law Gazette I 2013/48 in implementation of Directive 2011/62/EU. These include, inter alia, the following (legislative) measures.

• The outer packaging of specific medicinal specialties intended for human use must bear safety features and a mechanism to detect possible tampering with the outer packaging (Section 17, paragraph 5 of the AMG) (see also the AMBO).
• The counterfeiting of medicinal products, active substances or excipients – as well as the stockpiling, exporting and importing of counterfeit medicinal products, active substances or excipients with the aim of transferring them to another person ‒ and the offering, procuring, transferring of such products are criminal offences punishable by imprisonment, as are the counterfeiting and falsification of commercial packages or other documents relating to medicinal products, active substances or excipients (see Section 82b AMG).
• There are increased obligations for entities involved in the distribution chain – for example, when a medicinal product is authorised, a manufacturer must attach written confirmation to the application that they have verified and established the active substance manufacturer’s compliance with Good Manufacturing Practice (GMP) by means of audits.
• Counterfeit medicines, active ingredients, excipients and related documents can be confiscated by the authorities (Section 82c of the AMG).

With regard to medical devices and IVD devices, Section 5 of the MPG prohibits the erection, installation, putting into service, or use of such products if there are reasonable grounds for suspecting or establishing that they are falsified. According to the MDR and the IVDR, importers of medical devices and IVD devices are obliged to inform the competent authority if they suspect such product to be falsified (Articles 13 and 14 of the MDR/IVDR). Authorities may confiscate, destroy or otherwise render inoperable falsified devices or IVD devices if it is necessary to protect public health (Article 93 of the MDR and Article 88 of the IVDR).

If certain facts indicate that falsified medicinal products, active substances, excipients or documents are being transported to or from Austria, the customs authorities are authorised to seize them. They shall immediately report the seizure to the competent public prosecutor’s office (Section 82d of the AMG).

With regard to medical devices and IVD devices, border controls may suspend the release of falsified products for free circulation on the community market on the basis of Article 27, paragraph 3 of Regulation (EC) 2008/765. In this case, they shall immediately notify the market surveillance authorities of such suspension.

The manufacture of medicinal products (including packaging, labelling and final release of the finished product) may only be carried out based on a manufacturing authorisation (known as an “operating licence”) to be applied for in accordance with the AMG.

The authorisation is granted by the BASG upon application, in which the applicant must provide details of:

• the nature, scope and location of the intended manufacturing activity;
• the nature, size, equipment, dedication and location of the premises (as well as their furnishings and equipment);
• the nature of the technical equipment; and
• the appointed Qualified Person (QP) (sachkundige Person) who needs to be appropriately qualified, experienced and reliable.

Another prerequisite for the manufacturing licence is a trade permit for the manufacturing of medicinal products. This is issued, in accordance with the Trade Act (Gewerbeordnung, or GewO), by the Trade Authority ‒ ie, the competent district administrative authority (Bezirksverwaltungsbehörde) at the intended manufacturing site. Such permit requires the nomination of a “managing director under trade law” (gewerberechtlicher Geschäftsführer) who is appropriately qualified (as further defined in the GewO).

The manufacturing licence will only be issued after a successful on-site inspection of the manufacturing premises by BASG in which the authority checks compliance with the requirements of the AMBO and that the quality of the medicinal products as required for the health and life of humans (or animals) is ensured on the basis of the provided facts. The statutory timeframe for issuing a manufacturing licence is 90 days from the submission of a complete application. Any additional requests by the authority or missing information identified in the inspection will lead to a clock-stop.

The manufacturing authorisation is granted for a specific site, for specific manufacturing activities and types of medicinal products as specified in the application, and – in principle – for an unlimited period. However, the authorisation remains subject to regular GMP inspections by the BASG, and can be withdrawn in the case of any detected and non-remedied deficiencies.

The manufacture of medical devices and IVD devices is not subject to a specific governmental authorisation. However, requirements as applicable to any manufacturing activity – for example, those under construction law and under trade law regarding operating plants – will apply.

In order to be able to carry out wholesale distribution of medicinal products, a wholesale dealer licence (WDL) is required (also called an “operating licence”). Such WDL is required not only if the respective entity actually carries out physical handling and storage of medicinal products, but also for selling and supplying medicinal products – even though the actual logistics are outsourced to a third party (likewise requiring a WDL itself).

The WDL is granted by the BASG upon application, in which the applicant must provide details of:

• the nature, scope and location of the intended distributing activity;
• the nature, size, equipment, dedication and location of the premises as well as their furnishings and equipment;
• the nature of the technical equipment; and
• the appointed responsible person (fachkundige Person) for wholesale distribution being appropriately qualified, experienced and reliable.

Furthermore, a trade permit is also required for the wholesale of medicinal products (see 4.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices). Such permit requires the nomination of a managing director under trade law who is appropriately qualified.

The WDL may only be issued after a successful on-site inspection of the wholesale distribution site by the BASG. The statutory timeframe for issuing a WDL is 90 days from the submission of a complete application. Any additional requests by the authority or missing information identified in the inspection will lead to a clock-stop.

The WDL is granted for a specific site and for specific distribution activities as specified in the application, and in principle for an unlimited period. However, the authorisation remains subject to regular Good Distribution Practice inspections by the BASG, and can be withdrawn in the case of any detected and non-remedied deficiencies.

For the distribution of medical devices, no licence comparable to the WDL is necessary. However, a trade licence and an appropriately qualified managing director under trade law are necessary.

Finally, according to Section 67 of the MPG, registration in the publicly accessible Medical Devices Register is mandatory for all persons or entities who are responsible for placing medical devices on the market for the first time in the European Economic Area (EEA) and who are domiciled in Austria.

See 1.3 Different Categories of Pharmaceuticals and Medical Devices.

The importation and transfer of “pharmaceutical products” (Arzneiwaren) is regulated under the AWEG. In this context, it should be noted that the term “pharmaceutical products” is not identical with the term “medicinal product” as defined in the AMG or Directive 2001/83/EC – rather, it is based on the customs tariff regulations of Regulation (EEC) 2658/87. The AWEG therefore does not apply to all medicinal products. Also, medical devices are explicitly excluded from its scope (Section 1, paragraph 2 of the AWEG).

Provisions for parallel imports of medicinal products are regulated in the AMG (in particular, Section 10c). Products that have been authorised for parallel import are exempt from the notification obligation under the AWEG. Furthermore, obligations for importers and exporters are provided by the AMBO (see, for example, Section 4a). Specific provisions for the importation of investigational medicinal products are regulated in the CTR (Articles 61 and 63). The transfer of investigational medicinal products within the EEA (and Switzerland) is exempt from the notification obligation under the AWEG (Section 6, paragraph 2 of the AWEG).

The BASG is competent to issue import certificates and receive notifications under the AWEG and to supervise compliance with the AMG, the AWEG and the CTR. In addition, certain powers are granted to the customs administration under the AWEG.

General and specific obligations with regard to the importation of medical devices and IVD devices are laid down in the MDR/IVDR (see, in particular, Articles 13 and 60 of the MDR and Articles 13 and 55 of the IVDR) and enforced by the BASG as the competent authority.

According to Section 4 of the AWEG, the following entities are entitled to apply for an import permit or carry out an importation notification for pharmaceutical products:

• public pharmacies;
• hospital pharmacies; and
• companies authorised to distribute pharmaceutical products in a state within the EEA.

The entitlement to apply for a parallel import authorisation is granted to the following entities, according to Section 9 of the AMG:

• professionals authorised to manufacture or wholesale the medicinal product concerned;
• operators of domestic public pharmacies; and
• pharmaceutical companies established within the EEA that are authorised to place the medicinal product concerned on the market.

Depending on their activities (eg, repackaging), importers may be subject to the operating licence requirement of Section 63 of the AMG (see also 4.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices and 5.1 Wholesale of Pharmaceutical and Medical Devices).

The MDR and the IVDR do not provide for specific legal requirements to act as the importer of record of medical devices or IVD devices. However, they define the importer as “any natural or legal person established within the Union that places a device from a third country on the Union market”. Importers must register in accordance with Article 28 of the MDR/IVDR.

Under the AWEG, importation of pharmaceutical products from a state outside of the EEA is subject to a prior importation permit issued by the BASG. Importation of pharmaceutical products from a state within the EEA must be notified to the BASG in advance.

Section 11 of the AWEG, however, provides for extensive exceptions to these requirements, including exceptions for:

• medicinal products for which a marketing authorisation or an authorisation for parallel import has been obtained;
• medicinal products for Named Patient Use;
• medicinal products for use in a Compassionate Use Programme;
• medicinal products needed in event of emergencies; or
• medicinal products for personal use, in an amount corresponding to the usual personal needs of the traveller concerned.

Parallel importation of medicinal products is subject to a prior authorisation by/notification to the BASG in accordance with Section 10c of the AMG (see also Article 57, paragraph 1(o) of Regulation (EC) 726/2004 for medicinal products authorised under the centralised procedure).

The importation of medical devices and IVD devices does not require any specific authorisation under the MDR/IVDR or the MPG.

Which products are subject to the restrictions under the AWEG is determined by the classification of goods according to the tariff and statistical nomenclature of the EU pursuant to Regulation (EEC) 2658/87. Only products that fall under the subheadings of the combined nomenclature taxatively listed in Section 2(1) of the AWEG (eg, subheading 3002 20, 3002 30, 3004) are to be considered “pharmaceutical products” within the meaning of the AWEG.

Austria is a member of the WTO. Furthermore, as a member state of the EU, Austria participates in free trade agreements concluded by the EU member states. It is worth noting that the current EU sanctions against Russia do not provide for trade blocs of medicinal products and medical devices.

Medicinal Products

The price basis of a medicinal product is the manufacturer’s factory or depot selling price (Fabriksabgabepreis/Depotabgabepreis, or FAP/DAP). Furthermore, the respective “mark-ups” (wholesale and pharmacy mark-ups, regulated by law) and VAT are added to this price. The FAP/DAP can be freely determined by the company authorised to distribute and the Ministry of Health needs to be informed of this price.

For those medicinal products that are included in the list of reimbursable medicinal products, the so-called Reimbursement Code (Erstattungskodex, or EKO), the “EU average price” is relevant. This average price constitutes the maximum possible FAP/DAP for reimbursable products. For the purpose of calculating the EU average price, the Price Commission of the Ministry of Health considers the medicinal products with the same active ingredient, active ingredient strength, dosage form and identical (or approximately identical) package size.

The determination of the EU average price by the Price Commission takes place six months after the application for inclusion in the EKO is submitted. This is repeated 18 months after the first price determination and 24 months after the second price determination. The Price Commission can initiate a new price determination 18 months after the third price determination.

In the case of medicinal products that are not included in the EKO but exceed an annual turnover of EUR750,000 at the expense of the public health insurance (based on the FAP, in the previous 12 months), the Umbrella Organisation of the Austrian Social Insurance (Dachverband, or DVB) must immediately notify the Price Commission, which then has eight weeks to determine an EU average price for the medicinal product. If the determined EU average price is lower than the applied price, the company authorised to distribute must reimburse the difference to the social insurance institutions within six months of the date on which the sales threshold was exceeded.

The DVB applies the principles of price determination in accordance with the rules of procedure for the issuance of the EKO, as well as the economic evaluation criteria of the Therapeutic Products Evaluation Commission, and negotiates the reimbursement price with the manufacturer on this basis. Once an agreement has been reached, the reimbursement price specified in the EKO is binding, albeit subject to adaptation in accordance with the EU average price. If, on the other hand, a medicinal product is removed from the EKO by decision of the DVB, the companies authorised to distribute the drug have the option to appeal to the administrative court.

Furthermore, specific price regulations apply if a successor product with the same active ingredient (generic or biosimilar) is available in the EKO.

Generics

With regard to generics, the price of the first generic successor product must be at least 50% below the price of the original branded product whose patent protection has expired. The price of the second generic successor product must be 18% lower than the price of the first successor product, and the price for the third successor product must be 15% lower than the price of the second successor product. The price of the original product must be reduced by at least 30% within three months of the inclusion of the first generic product in the EKO. If there is a third successor product, all other providers must reduce the price to the price of the third product. Additional successors must offer price reductions of at least EUR0.10 in order to be included in the EKO.

Biosimilars

With regard to biosimilars, the price of the first successor product must be at least 38% lower than the original product. The price of the second successor product must be at least 15% lower than that of the first successor product, and the price of the third successor product must be at least 10% lower than that of the second successor product. After that, the same regulation applies as for generics (ie, the original product must reduce its price by 30% within three months, etc).

Medical Devices and IVD Devices

No legal price control mechanisms are available, in principle, for medical devices and IVD devices.

The price of a medicinal product can in principle be freely determined by the company authorised to distribute it but is limited by the EU average price of said product (as further detailed in 7.1 Price Control for Pharmaceuticals and Medical Devices).

No legal price-control/price-setting mechanisms are available, in principle, for medical devices and IVD devices.

Medicinal Products

The Austrian General Social Security Act (Allgemeines Sozialversicherungsgesetz, or ASVG) states that, in case of illness, the insured person is entitled to health treatment comprising the provision of remedies (Heilmittel) ‒ a term that includes medicinal products, in particular. According to the ASVG, the medical treatment must be sufficient and appropriate, but it must not exceed the extent of what is necessary.

Austria is one of the few EU countries in which the costs of reimbursable medicinal products prescribed by a physician are, in principle, covered in full for the patients insured in the public insurance system. Patients only have to pay a flat fee (“prescription fee”) in pharmacies. Exemption from the prescription fee is possible under certain conditions.

Medicinal products that have been included in the EKO can be prescribed at the expense of the health insurance institutions (see 7.1 Price Control for Pharmaceuticals and Medical Devices). Other medicinal products are only reimbursed in medically justified individual cases.

Medical Devices and IVD Devices

Regarding medical devices and IVD devices, no system comparable to the EKO exists. The Austrian Social Security Act does not refer to “medical devices” as such but to Heilbehelfe and Hilfsmittel (therapeutic aids), which are reimbursed ‒ subject to a 10% deductible (or a current minimum of EUR40.40) ‒ if they are prescribed by a physician. Typically, medical device/IVD device manufacturers sign contracts with the social insurance institutions in order to avoid the social insurance institutions requesting a cost estimate in advance regarding devices if no contract between the social insurance institutions and the manufacturer is in place.

Medicinal Products

Any entity authorised to distribute a medicinal product approved and available in Austria may apply for inclusion in the EKO. The medicinal products undergo a pharmacological, medical-therapeutic and health economic evaluation with regard to their eligibility for reimbursement. In this process, the DVB is supported by the Medicines Evaluation Commission (Heilmittel-Evaluierungs-Kommission, or HEK), an independent advisory body that is not bound by instructions. The HEK’s recommendations form the basis of the DVB’s decisions.

The EKO is divided into three areas (known as “boxes”).

• The Green Box contains medicines that the health insurance institutions reimburse to the socially insured without special authorisation. These are freely prescribable.
• The Yellow Box includes those drugs that the social insurance institutions consider to have a significant additional therapeutic benefit for patients, but which were not included in the Green Box for medical or economic reasons. For these medicines, health insurers reimburse the insured if the prescription has been approved by their chief medical office (dark yellow area RE1). In some cases, a retrospective control is also accepted (light yellow area RE2).
• The Red Box contains medicinal products for a limited time while the company’s request for inclusion in the EKO is being reviewed. During this period, the costs are covered only if there is approval from the chief medical office of the social insurance institutions.

Finally, even the so-called “no-box” medicinal products – ie, products for which no application has been made to be included in the EKO – can be reimbursed if the individual prescription has been approved by the chief medical office. As this option is usually chosen for very expensive medicines, the Austrian legislator has introduced a requirement that the EU average price will be relevant to these products if turnover exceeds EUR750,000 (see 7.1 Price Control for Pharmaceuticals and Medical Devices).

Changes within the boxes and deletions from the EKO are possible both at the request of the company authorised to distribute the product and the DVB (supported by the HEK’s recommendations).

If the social insurance institution refuses reimbursement in an individual case, the patient can file an action before the civil courts. In these proceedings, the court reviews the social insurance institution’s decision typically with the help of a specific expert and is entitled to decide on the reimbursement. The court’s decision may be challenged before the Higher Regional Court and, eventually, before the Supreme Court.

Medical Devices and IVD Devices

Regarding medical devices and IVD devices, no system comparable to the EKO exists. For reimbursement of medical devices and IVD, see 7.3 Pharmaceuticals and Medical Devices: Reimbursement From Public Funds.

Essentially, retailing of medicinal products may only be undertaken by pharmacies. Medicinal products requiring prescription may only be provided to patients upon prescription by a physician.

So far, the aut idem rule has not been implemented into Austrian law. Pharmacists are required to dispense to the patient the actual medicinal product prescribed (even if, for example, a generic product is available). The pharmacist can only offer the patient a pharmaceutical equivalent if the prescribed product is not available in the pharmacy.

Medical devices and IVD devices are not pharmacy-only products.

For medical apps that qualify as medical devices, the MPG as well as the MDR constitute the major regulatory framework.

Software (including apps) qualifies as a medical device if:

• it is intended for human use, as determined by the manufacturer;
• it is intended – alone or in combination – to fulfil one or more of the specific medical purposes listed in Article 2(1) of the MDR (see 3.1 Product Classification: Pharmaceuticals or Medical Devices); and
• it does not achieve its principal intended action by pharmacological, immunological or metabolic means – in or on the human body – but may be assisted in its function by such means.

Guidance on the qualification and classification of software in Regulation (EU) 2017/745 and Regulation (EU) 2017/746 is provided in the “MDCG 2019–11”.

In addition, medical apps may also be qualified as an “accessory of a medical device”, according to Article 2(2) of the MDR. An accessory of a medical device is “an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s)”.

The term “telemedicine” is not defined by Austrian law. The Ministry of Health defines “telemedicine” as the provision or support of healthcare services using information and communication technologies, where either the patient and healthcare provider or two different healthcare providers are not present at the same location. In the legislative materials to the most recent changes in the Austrian Physicians Act 1998 (Ärztegesetz, or ÄrzteG), the legislator states that “telemedicine is a multi-layered term that encompasses very heterogeneous automated medical services, but also processes in the healthcare system of a predominantly administrative nature”.

The legal permissibility of telemedical services must be assessed on the basis of Section 49, paragraphs 1 and 2 of the ÄrzteG, according to which the medical profession must be practised lege artis as well as “directly and personally, but also by using telemedicine”. The permissibility of telemedical applications in an individual case needs to be judged on the basis of whether the physician can obtain all the information necessary to clarify the state of health via the digital channel and whether the requirements of Section 49 of the ÄrzteG, as well as all other medical professional duties, are therefore fulfilled. In the context of telemedicine, the consideration of the “distance” factor must be taken into account as a significant deviation from a conventional setting.

According to the current specifications of the Austrian Health Insurance Fund (Österreichische Gesundheitskasse, or ÖGK), which is the largest Austrian health insurance fund, telemedical services may only be reimbursed if the patient concerned has already been treated personally by the specific physician conducting the telemedical service.

Furthermore, as regards the applicable legal framework for telemedicine from a data protection point of view, the GDPR, the DSG and the Austrian Health Telematics Act 2012 (Gesundheits-Telematikgesetz, or GTelG) must be observed.

There are no special regulations for the promotion and advertising of medicinal products and medical devices on online platforms available in Austria. Therefore, the general requirements and restrictions (eg, prohibition of lay promotion for prescription-only medicinal products or medical devices) as set out in the AMG (for medicinal products) or in the MPG and MDR/IVDR (for medical devices/IVD devices) apply.

Every person insured in the Austrian public social insurance system receives an “e-card”, which provides information regarding the health insurance coverage of the respective person. Austria further provides for an optional, free-of-charge central digital health solution known as the Electronic Health Record (Elektronische Gesundheitsakte, or ELGA).

An electronic prescription (e-Rezept) is available in Austria for prescriptions issued for medicinal products at the expense of the social insurance institutions. These are no longer issued on paper, but electronically, and saved in the e-card system. The respective medicinal product can be collected at the pharmacy either with the e-card or the respective e-prescription code or the e-prescription ID. Paper prescriptions are still used for medicinal products that are not reimbursed by the social insurance institutions.

Electronic medication (e-Medikation) is an optional, free-of-charge application of ELGA that can be used to prevent unwanted interactions and multiple prescriptions of medications. Physicians and pharmacists thus have a better overview of which medications have been prescribed and dispensed for a patient. Patients can opt out of ELGA and e-Medikation.

The online sale of medicinal products is only permitted for pharmacies complying with the requirements set forth in the AMG and the corresponding Distant Selling Ordinance (Fernabsatz-Verordnung). The Ordinance sets out the quality criteria pharmacies must comply with if they wish to sell medicines via the internet.

The pharmacies willing to engage in online sales need to be registered with the BASG for this purpose. Only OTC medicinal products may be sold online; the online sale of medicinal products requiring a prescription is not permitted.

The online sale of medical devices/IVD devices is subject to the provisions set forth in Article 6 of the MDR/IVDR – in particular, medical devices distributed via online channels must comply with all obligations set out in the MDR.

In Austria, ELGA is operated as a central electronic health record (see 8.4 Electronic Prescriptions). The GTelG contains special regulations for the electronic processing of health data and genetic data by healthcare providers (see Article 4(13) and (15) of the GDPR). In the context of health telematics, a healthcare provider is a professional who – as a controller or processor (as defined in Article 4(7) and (8) of the GDPR) – regularly processes health data or genetic data in electronic form for the following purposes:

• medical treatment or care;
• nursing care;
• invoicing of health services;
• insurance of health risks; or
• exercise of patient rights.

The Austrian Patent Act (Patentgesetz, or PatG) is applicable in this regard. Medicinal products, medical devices and IVD devices can be protected by patents, in principle, if they fulfil the requirements as set forth in the PatG. There are no special requirements with regard to patents for medicinal products and medical devices. In Section 2 of the PatG, however, it is clarified that no patent protection is available for certain biotechnological inventions (such as cloning) or surgical or therapeutic procedures and diagnostic procedures, owing to ethical and social factors.

The question of whether a second or subsequent medical use of a known product is patentable must be answered based on the principle requirements for patentability. In practice, the main obstacle to patentability might be the question of whether the subsequent indication is actually new.

New dosage regimes would not be patentable, even if these regimes make the medicinal product more effective. The discovery of the use for new patient populations might only be patentable if the new patient group can be clearly distinguished from the previously known group and therefore regarded as new (and where the use for this patient group is not already covered by the previous patent).

An Austrian patent is granted for a maximum of 20 years. The patent holder may, however, apply for a so-called Supplementary Protection Certificate (SPC) to extend a patent for ingredients of medicinal products for up to five years in accordance with Regulation (EC) 469/2009 concerning the SPC for medicinal products (SPCR).

Third parties may challenge the granted SPC on the grounds of invalidity according to Article 15 of the SPCR, whereby the application must be filed with the Austrian Patent Office (Section 5 of the Austrian Supplementary Protection Certificates Act 1996 (Schutzzertifikatsgesetz)). For details of an exemption from SPC protection, see 9.7 Procedures Available to a Generic Entrant.

Moreover, patented medicinal products that are suitable for use in children (ie, paediatric medicinal products) may be granted six months additional patent protection upon submission of a Paediatric Investigation Plan (PIP).

According to Section 22 of the PatG, the patent owner has the exclusive right to manufacture, place on the market, display or use the subject matter of the invention, or to import or possess it for the aforementioned purposes. Any infringement of that right without the consent of the patent owner constitutes a patent infringement.

However, the effect of the patent does not extend to studies or trials and related practical requirements, if these are necessary to acquire marketing authorisation, approval or registration under medicinal products law (as per the so-called Bolar provision implemented in the PatG in accordance with Directives 2004/27/EC and 2004/28/EC). Given that no marketing authorisation is required, no Bolar provision is available for medical devices.

The scope of protection of the patent is limited to the patent claims in the original patent application (rather than the entire content of the patent or the descriptions, which may nonetheless serve as interpretation guidance). In line with Section 22b of the PatG, the protection of a patent for biological material endowed with certain properties by virtue of the invention covers any biological material obtained from such biological material by generative or vegetative propagation in the same or a different form and endowed with the same properties.

In case of patent infringement, the patent owner is entitled to injunctive relief, removal of unlawful condition, damages/payment, and publication of the judgment. The PatG further provides the opportunity to ask for a preliminary injunction regarding the mentioned claims (except publication).

Injunctive relief may already be sought if the infringement is imminent – ie, if there are reasonable grounds to assume that a third party will interfere with the patent rights in the near future.

As mentioned in 9.4 Pharmaceutical or Medical Device Patent Infringement, studies, trials, and the resulting practical requirements therefrom are excluded from the effects of the patent as long as they are necessary for acquiring marketing authorisation, approval or registration under medicinal products law. The PatG does not otherwise differentiate between actual products that can be protected by a patent and, as such, does not contain any rules specific to medicinal products (with the above-mentioned Bolar exemption) or medical devices.

The defendant in a patent infringement case will typically try to claim that the patent in question is null and void – for example, that the patent was granted in error because the invention was not new or is not patentable.

According to Section 36 of the PatG, the owner of a newer patent can claim a licence to a prior third-party patent – and consequently avoid patent infringement – if the newer invention constitutes important technical progress of considerable economic significance and cannot be realised without such licence. In case the patent owner of the older patent refuses to grant such licence, the Patent Office can decide on the granting of a licence (including appropriate remuneration therefor) upon the application of the patent owner of the younger patent.

The PatG further provides for compulsory licences in the context of plant variety rights, in case of public interest (see 11.7 Compulsory Licensing of IP Rights for COVID-19-Related Treatments) or because the third-party patent-holder is not exercising its patent invention in Austria accordingly.

In Austria, the patent-owner and the exclusive licensee may file a patent infringement action. The exclusively competent court for patent infringement cases is the Vienna Commercial Court (Handelsgericht Wien) – the decision of which may be challenged before the Higher Regional Court Vienna (Oberlandesgericht Wien) and, ultimately, before the Supreme Court (Oberster Gerichtshof).

The remedies available include claims for injunctive relief, removal of unlawful condition, damages/payment and accounting, and publication of the judgment.

In cases where the defendant claims that the allegedly infringed patent is null and void, the court may assess that question at its own discretion in the first instance and can suspend the proceedings if it regards the nullity to be likely. In such cases, the defendant must file a revocation action with the Patent Office within one month; otherwise, the court decides without further considering such defence.

Generic medicinal products can be approved in a related approval procedure if there is no patent or document protection and can be offered on the market after the patent of the original product has expired. Owing to the aforementioned Bolar provision (see 9.4 Pharmaceutical or Medical Device Patent Infringement), studies or trials necessary to acquire marketing authorisation, approval or registration under medicinal products law do not infringe patent law and may therefore be carried out even though the patent is still in force.

Since 2019, an exemption from SPC protection – starting six months before the SPC expires – is available for generic production for the purpose of exporting and for generic production and storage for the first placing on the market in the EU. National patent offices must be informed about the production. An EU export logo (as applicable) must be indicated on the outer packaging for exports to third countries.

No patent linkage is in place – ie, the authorisation procedure for medicinal products and medical devices does not take patent protection into account.

Medicinal products and medical devices/IVD devices – in particular, their names, design and packaging – might be subject to trade mark, design or (eventually) copyright protection. Trade mark and design protection requires an application and registration, whereas copyright protection is granted from the date the copyrighted work is created.

In case the name, design or packaging is subject to such protection, the Austrian Trade Mark Act (Markenschutzgesetz, or MSchG), Design Act (Musterschutzgesetz, or MuSchG) and Copyright Act (Urheberrechtsgesetz, or UrhG) essentially provide for claims for injunctive relief, removal of unlawful condition, damages/payment, and publication of the judgment. Furthermore, trade mark, design and copyright infringement may even be criminally sanctioned (as a private prosecution offence). The laws provide for sanctions of imprisonment of up to two years or monetary fines of up to 360 daily rates (where the “daily rates” for payment of a fine are based on the individual situation/income of the convicted person).

In addition to the remedies provided under the respective IP laws, Regulation (EU) 608/2013 enables the right-holder of products protected by specific IP rights (trade marks, designs, patents, SPC) to prevent counterfeit products from being imported. The respective right-holder can request the customs authorities to detain products believed to infringe the right-holder’s IP rights for further examination.

As a general rule, medicinal products may not be marketed under names that are misleading, particularly with regard to the efficacy and safety of the product (Section 6 of the AMG).

Furthermore, the EMA has issued the “Guideline Regarding the Acceptability of Names for Human Medicinal Products Processed Through the Centralised Procedure”. The BASG issued a similar guideline for nationally approved medicinal products (“Guideline on the Designation of Medical Specialties”, version 9/2021).

As per the AMG for medicinal products, both the MDR and the IVDR prohibit in their (respective) Article 7 the use of any trade mark, name or text in the labelling, instructions claims, marketing and promotion if it could mislead the patient regarding the medical device’s or IVD device’s intended purpose, its safety or performance.

The trade dress, design and packaging of medicinal products and medical devices may be protected by copyright and design rights – and, potentially, as trade marks – if the requirements for such protection are met and protection is sought for trade mark or design.

Data exclusivity (or dossier protection) is relevant for innovative (original) medicinal products. According to the data exclusivity rules, a generic applicant may not refer to the documents of an original medicinal product until eight years after the first approval of the original product in the EU. The generic product may be marketed for the first time only after a further two years (ie, after ten years in total) – this is known as the “8+2 rule”. If the marketing authorisation holder of an original product expands the authorisation to a new therapeutic indication within the first eight years of the first marketing authorisation, the data exclusivity period is extended from ten to 11 years (the “8+2+1 rule”) – meaning the generic entry will be delayed for another year.

For medical devices and IVD devices, this is not applicable as no marketing authorisation is required.

The COVID-19 pandemic resulted in a great number of new provisions in the Austrian legal system, which cannot be depicted in their entirety in this setting. However, with regard to medicinal products, medical devices and IVD devices, a number of special regulations can be highlighted.

Section 94d of the AMG provides for the authorisation of the Federal Minister of Health to establish complementary regulations to the general provisions of the AMG by ordinance in the case of epidemics and pandemics, if the necessary supply of medicinal products or active substances to the population is seriously and substantially endangered, and as long as special regulations are necessary owing to the specific situation. While this authorisation has been included in the AMG since 2005, a corresponding provision in the MPG was only introduced during the pandemic (now Section 81 of the MPG). The validity of such ordinances was initially limited to a maximum of six months and is now limited to a maximum of one year.

On the basis of these provisions, a number of implementing ordinances were issued in recent years, including an Ordinance on Provisional Measures to Ensure the Availability of Medical Devices (Verordnung betreffend vorläufige Maßnahmen zur Sicherstellung der Verfügbarkeit von Medizinprodukten, or VVMP), as well as several COVID-19 Medical Device Ordinances (COVID-19 MedizinprodukteV) and COVID-19 Medicinal Products Ordinances (COVID-19 ArzneimittelV).

As of 1 January 2024, however, the special COVID regulations mentioned above are no longer in force.

With regard to clinical trials of medicinal products, medical devices and IVD devices, the implementing ordinances mentioned in 11.1 Special Regulation for  Commercialisation or Distribution of Medicines and Medical Devices provided certain special regulations, but these are no longer in force.

Conditional Marketing Authorisation

With regard to medicinal products, Article 14-a of Regulation (EC) 726/2004 provides for a legal opportunity to obtain a “conditional marketing authorisation” if certain requirements are met. Specifically, the product in question must fulfil an unmet medical need, its benefit-risk balance must be positive, it must at least be likely that the applicant will be able to provide comprehensive data post-authorisation, and the benefit of the product’s immediate availability must outweigh the risk incurred by the fact that additional data is still required. The marketing authorisation holder must meet special obligations after the authorisation has been granted. The validity of a conditional marketing authorisation is one year, with the opportunity for annual renewal. During the pandemic, this procedure was applied in connection with the available COVID-19 vaccines and treatments.

Marketing Authorisation Under Exceptional Circumstances

The conditional marketing authorisation procedure is to be distinguished from that of the “marketing authorisation under exceptional circumstances” pursuant to Article 14, paragraph 8 of Regulation (EC) 726/2004. Such authorisation may be issued under exceptional circumstances if, for objective reasons, comprehensive data cannot be obtained even post-authorisation. In addition, Article 14, paragraph 9 of Regulation (EC) 726/2004 provides for the opportunity to request an accelerated assessment procedure if a medicinal product is of major interest from the point of view of public health and in particular, from the point of view of therapeutic innovation.

Marketing Authorisation in a Disaster

It should also be mentioned that Section 8, paragraph 1(4) of the AMG permits placing a medicinal product on the market in Austria even without marketing authorisation if it is to be used for the prevention of – or in connection with – a dangerous situation arising from a disaster, and success in this respect cannot be achieved with an authorised and available medicinal product. However, although this is an emergency regulation, it does not lead to (accelerated) approval. Once the particular conditions are no longer met, the product may no longer be placed on the market without marketing authorisation.

In light of the difficulties arising from COVID-19, GMP certificates for sites (as well as time-limited manufacturing and import authorisations) were automatically extended until the end of 2023. These are therefore no longer applicable.

At the EU level, several implementing regulations were adopted during 2021 that required an export authorisation for the export of vaccines against SARS-related coronaviruses and for the export of active substances used for the production of such vaccines. These have expired in the meantime.

The GTelG, which regulates the electronic transmission of health data and genetic data by healthcare providers, included temporary provisions until 30 June 2022 in order to combat the spread of COVID-19. These provisions facilitated identity verification of patients in the context of remote prescriptions.

For more on the possibility of remote management and conducting clinical trials, see 2.4 Restriction on Using Online Tools to Support Clinical Trials and 11.2 Special Measures Relating to Clinical Trials.

Even before the COVID-19 pandemic, the PatG provided for the possibility of granting compulsory licences to patented inventions in specific cases (see 9.5 Defences to Patent Infringement in Relation to Pharmaceuticals and Medical Devices). Pursuant to Section 36, paragraph 5 of the PatG, everyone is entitled to a non-exclusive licence to a patented invention for their business, provided that the granting of the licence is required in the public interest. This also applies to the federal administration, although the latter does not have to prove the operation of a business.

In order to obtain a compulsory licence, the licence applicant must first seek to obtain the patent-owner’s consent to the licence on market terms (Section 37, paragraph 1 of the PatG). If the patent-owner does not consent to such licence, the Austrian Patent Office will decide on the request of the licence applicant, and determine an appropriate remuneration for the compulsory licence. In the case of a national emergency or other circumstances of extreme urgency, the licence applicant will not be required to seek the patent-owner’s consent first, and the Austrian Patent Office may immediately grant a provisional authorisation to use the invention (Section 37, paragraph 3 of the PatG).

As far as is evident, no liability exemptions for COVID-19 treatments or vaccines were introduced into Austrian national law during the pandemic. The Vaccine Damages Act (Impfschadengesetz, or ISG) outlines the preconditions for a legal claim against the Austrian Federation to compensation for vaccine damages, irrespective of the existence of fault. Applications for compensation of damage caused by COVID-19 vaccinations may also be filed on the basis of the ISG. Moreover, damages can be claimed on the grounds of the general rules of civil law and on the grounds of the Product Liability Act.

As far as is evident, no manufacturing sites were requisitioned or legally converted owing to COVID-19 in Austria.

Special provisions regarding “emergency procurements”, deadlines and online negotiation options for procurement procedures, and exceptions to the opposition procedure in the context of procurements were implemented in connection with COVID-19. However, these changes to procurement procedures expired on 30 June 2023.