The regulatory regimei Classification
If a company is not sure whether a product qualifies as a medicinal product, it can ask the Borderline Counsel established at the Ministry for Health to issue an expert opinion on whether such a product would be classified as a medicinal product or not. In practice, these questions are normally clarified via civil proceedings based on the Unfair Trade Practices Act. The leading cases relate mostly to food supplement products, and whether such products, because of their presentation, can be considered as medicinal products. The Supreme Court held that the definition of 'presentation medicinal products' has not changed, even if the German wording of Directive 2004/27/EC would indicate that it has. Thus, products having disease-related claims still need a marketing authorisation. The Supreme Court classified the following product name and references as disease-related claims triggering the applicability of the Medicines Act (even for products that have been clearly promoted as an 11 The Supreme Court has dismissed the argument by the defendant that it clearly labelled the product as an additive to animal feed. It is not sufficient that in a print advertisement the product category is mentioned only on the displayed product, if based on the claims an average consumer is under the impression that a medicinal product is being advertised. Claims relating to 'natural detoxification', 'for detoxification in the health area for reducing disease related factors' and 'soft detoxification for travelling' are medical claims, and therefore the product classifies as a presentation medicinal product. The Supreme Court made it clear that a product can never from a legal perspective fall under the definition of a medicinal product as well as under the definition of a medical device.
In another case, the Supreme Court had to decide whether a cigarette dummy for supporting nicotine withdrawal would classify as a medicinal product, a medical device or food. The plaintiff argued that the substances contained in the nicotine dummy – menthol and valerian – must be considered as a food, because they are digested and the dummy is not intended for treatment of nicotine abuse but for modifying smoking habits because the device simply engages the hands and the mouth. The Supreme Court refused the argument by stating that the substances are only inhaled and not digested through the gastrointestinal tract, because the molecules of food products must be digested, and digestion means passing through the gastrointestinal system. The Supreme Court also classified the product as a medicinal product because of its claims, which mentioned that the product was developed by a 'pharmaceutical faculty' and can only be purchased via a pharmacy, and reduces stress and nervousness, which are disease-related side effects in the case of nicotine withdrawal. Therefore, the defendant clearly presented the product as a medicinal product.ii Non-clinical studies
In 2006, the Ministry for Health issued an Ordinance with respect to Good Laboratory Practices (GLP). The Ordinance requires that pharmaceutical companies conducting non-clinical studies notify the Federal Office before starting the respective tests, and conformity must be proven in the context of an audit by the Federal Office. When such tasks are outsourced, the pharmaceutical company has to ensure by way of a written contract that the institution conducting the test complies with good clinical practices and was audited by the Federal Office prior to conducting such a study. Of course, inspections can occur without notice. The Federal Office has issued guidance with respect to the conduct of GLP inspections, stating, inter alia, that the OECD principles of GLP and Directive 2004/10/EC are the basis for evaluation of compliance. The audited company has the right to comment and to provide action plans with respect to corrective measures.
The use of animals in the development of a medicinal product is regulated by the Act on the Conduct of Research on Living Animals, which entered into force on 1 January 2013. Article 6 lays down the leading principles for conducting animal experiments:
- animal experiments must comply with state-of-the-art scientific methods;
- the assumption to be proven as well as the procedure must be sound and in accordance with state-of-the-art scientific methods;
- animal experiments are only allowed in the context of projects;
- experiments are only allowed to be conducted in institutions of registered users, except if there is a scientific reason for deviating, and must be approved by the relevant authority;
- the animals must be in a suitable condition of health;
- the experiment must be conducted so as to cause the minimum pain, suffering, distress or lasting harm; and
- experiments shall only be conducted with animals that have the lowest capacity for suffering harm, distress or pain.
In addition, the law foresees that there should be a commission at a national level supporting the relevant ministry with respect to issues relating to such experiments. A person conducting an animal experiment without having the necessary approval can face an administrative fine of up to €10,000, or up to €20,000 in the event of recidivism. Fines can also be imposed in cases of negligence.iii Clinical trials
Neither the Medicines Act nor the Medical Devices Act require the sponsor to be established in Austria, but if the sponsor is established outside the EEA, a legal representative has to be appointed. Whether such a representative must actually be nominated depends on the institution in which the clinical trial is conducted. Ethics committees specifically focus on whether the insurance is indeed sufficient to adequately cover the risks of the trial. The Medicines Act requires that Austrian law must apply to the insurance contract, the subject must be able to file a claim in Austria and the Austrian judgment must be enforceable in the country in which the sponsor is established. In addition, the ethics committees are rather reluctant to accept any compensation of clinical trial subjects going beyond the actual travel cost for participating in the clinical trial.
As required by EU legislation, the clinical trial must be approved by the Federal Office as well as by an ethics committee. In 2017 the Federal Offices received 235 applications for the conduct of clinical trials at the various stages. In the case of a multicentre study, the leading ethics committee must be specifically authorised to handle multicentre clinical trials. Although not specifically imposed by the Medicines Act, the authority normally requires a leading investigator to be appointed.
With respect to consent, the majority of ethics committees have agreed on a common consent form with respect to medical and medical devices trials, and a deviation from such a consent form must be specifically discussed in the application. There is also a specific template when genetic testing is involved. It is generally prohibited to conduct clinical trials on prisoners, conscripts and persons held in a special institution under the Hospitalisation Act.
Concerning safety reports, the rules as implemented in Austria are in line with EU legislation. The Federal Office has published several forms on its website. The rules discussed above also apply in the case of investigator-initiated studies, which are not treated differently. With respect to clinical trials relating to medicinal products containing genetically modified organisms, the Ministry for Health is in charge.iv Named-patient and compassionate use procedures
The Federal Office distinguishes between compassionate use, named-patient use and off-label use. According to the understanding of the Federal Office, named-patient use is regulated by Article 5 of Directive 2001/83/EC and is implemented via Article 8(1) No. 2 of the Medicines Act. Article 8(1) No. 2 stipulates that no marketing authorisation is needed if a physician or dentist has confirmed that the medicinal product is used for treating a life-threatening disease or for a disease resulting in severe health damages and, according to the most up-to-date methods, no accurate treatment can be achieved with a product authorised in Austria. Named-patient use always relates to one specific person.
This is also the difference with the compassionate use programme that relates to a group of patients, where the individual names are unknown. In addition, the compassionate use programme can only relate to products covered by Regulation (EC) No. 726/2004. An application can only be filed in conjunction with a protocol discussing the therapeutic treatment, and approval will be granted for one year. The Federal Office has specifically emphasised that it aligned the format and content of applications to those of German applications. The Federal Office will charge a fee of €530 if the report by the Committee for Medicinal Products for Human Use (CHMP) is already enclosed; without the report, the fee increases to €1,590.
Concerning off-label use, the Federal Office states that no definition is contained in the Medicines Act and it should be understood as the use of a medicinal product in the context of a medical treatment outside the approved summary of product characteristics. Off-label use is not prohibited per se but the sole responsibility rests with the physician, who has more stringent information obligations as well as an enhanced duty of care. Physicians must also specifically justify via the Federal Office why off-label use should take place.v Pre-market clearance
A marketing authorisation is issued by the Federal Office but the actual scientific review is carried out by the Medical Surveillance Agency, which is a limited liability company wholly owned by the Austrian state. Austria also handles the granting of marketing authorisations for Liechtenstein. Applicants for marketing authorisations must be established within the EEA, but there is no requirement that an EEA applicant must be specifically located in Austria or that such an applicant should appoint a local agent. All relevant forms for obtaining a marketing authorisation can be downloaded from the Federal Office website. General conditions for obtaining a marketing authorisation are as follows:
- according to the most up-to-date information and practical experience, the medicinal product must not be harmful when used;
- the ingredients (active substances as well as excipients) must be harmless and this must be proven scientifically;
- the product must be state of the art;
- any description of the medicinal product and the product per se must not be misleading; and
- its efficiency must be sufficiently proven and the labelling must comply with the relevant regulations.
The Federal Office must decide within 210 days whether to grant a marketing authorisation; however, the actual handling time for applications is currently not published. If Austria is acting as a reference member state (RMS) in the mutual recognition procedure for new active substances, the Federal Office charges €41,626; when acting as an RMS in the decentralised procedure it charges €52,959. If Austria is acting as a concerned member state (CMS), then in both cases the Federal Office charges €7,202.
With respect to homeopathic products as well as traditional herbal medicinal products, a simplified registration procedure applies if the products are only used orally or externally and comply with all the other obligations imposed by the relevant EU provisions. Pharmacy-own medicinal products are also covered by a simplified registration procedure.
Parallel-imported products are only allowed to be distributed if a parallel import licence has been granted by the Federal Office. The application must include:
- information on the name and marketing authorisation number of the product authorised in Austria;
- the state in which the parallel-imported product is authorised and marketed;
- the name and marketing authorisation number of the product to be parallel-imported;
- the name and address of the marketing authorisation holder established in the exporting country;
- a description of the packaging;
- the name and address of the person responsible for relabelling and repackaging; and
- a declaration that, for instance, the summary of product characteristics, packaging and labelling do not deviate from the product authorised in Austria.
The Federal Office has to decide within 45 days with respect to a parallel import application. For obtaining a parallel trade licence as well as a registration of a homeopathic product, a fee of €1,059 is charged.
With respect to generic products and biosimilar products, the provisions comply with the respective EU legislation; however, the fees are substantially reduced. For instance, if the Federal Office acts as an RMS in the decentralised procedure, the fees are reduced to €39,189; with respect to biosimilars in a national procedure, they are reduced to €7,414. If Austria acts as a CMS for Liechtenstein, the fees are the same for decentralised procedures and mutual recognition procedures, namely €1,431 (if Austria already acts as a CMS or RMS in this procedure).
Products meeting an unmet need are not regulated differently from 'ordinary' medicinal products.
The Medical Devices Act does not require authorisation by an authority, but relevant products must be examined by notified bodies. It is a requirement, however, that certain devices are registered prior to use, for instance, pacemakers, implantable cardiac defibrillators and loop recorders. Because notified bodies are private bodies, the fee depends on the negotiating power of the entity submitting a dossier to a notified body.vi Regulatory incentives
The Austrian legislation does not provide any other incentives as adopted at EU level.Patents and supplementary protection certificates
With respect to medicinal products, the Medicines Act specifically states that a patent or supplementary protection certificate (SPC) does not hinder the review by a marketing authorisation of a generic product. Also, the non-marketing of a product because of an existing patent or SPC would not automatically result in the withdrawal of the marketing authorisation of the generic product after three years of non-marketing, according to the sunset clause.Data protection
The Highest Administrative Court stated that under the old data protection rules, there would not be a violation of innovator rights if the Federal Office evaluated an application before the data exclusivity expired but granted a marketing authorisation only one day after that period elapsed. Under the new provisions, the Federal Administrative Court ruled for the first time that an innovative company can challenge a Federal Office decision to grant a generic marketing authorisation by directly referring to data protection rights as granted by the Human Use Directive.
Medical devices companies can only rely on the general instruments such as patent protection, utility model protection or the Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure as implemented in Austria, but not on data protection.vii Post-approval controls
With respect to pharmaceutical companies, the relevant rules, for example, for staffing, risk management and post-approval testing, can be found in the Regulation governing the activities of companies producing, controlling or placing medicinal products on the market, the Pharmacovigilance Ordinance and the Medicines Act, and with respect to medical devices in the Regulation for the establishment, manufacturing, use and maintaining of medical devices as well as the Vigilance Ordinance. In essence, the pieces of legislation concerning the manufacturing and distribution of such products provide only general guidelines except with respect to the qualification of persons being entrusted with certain tasks, for instance, the qualified person. Also, the Federal Office makes it clear that the appropriate measures with respect to risk management, post-approval testing, etc., depend on the harmfulness of the product and must either be dealt with appropriately by the dossier or by the quality assessment of medical devices.
Transfer of ownership must be notified to the Federal Office accompanied by two statements, namely that the original marketing authorisation holder will waive any rights with respect to the marketing authorisation and that the new owner will take over any and all obligations with respect to that marketing authorisation. Of course, the statements must be accompanied by the relevant documents with respect to a variation. Only after receipt of these statements will the company taking over be considered as the marketing authorisation holder. For medical devices, no specific rules apply. The notified body must be informed that the CE marking can be accordingly amended, and if the new owner is situated in Austria, the register of medical device manufacturers must be informed.
In cases of renewal of a marketing authorisation, the Medicines Act foresees a strict deadline by which an application can be filed – at the earliest, four years from the moment the marketing authorisation became legally binding, but at the latest nine months before the five-year term elapses.viii Manufacturing controls
According to Section 63 of the Medicines Act, the manufacturing, distributing or controlling of medicinal products needs an authorisation from the Federal Office. The following information must be provided with the application:
- the kinds of tasks envisaged, the production volume and the place where such activities will be conducted;
- the building's condition, size of the facility, zoning classification, equipment and the exact location; and
- a description of the technical equipment and, if needed, the name of the qualified person.
The Federal Office must grant an authorisation if the facility does not endanger human or animal health. However, the Federal Office is entitled to require trial operations to evaluate whether human beings or animals are endangered. The facility is normally inspected before an approval is granted. The Federal Office charges €1,054 per inspection day, if such an inspection occurs in Austria. For the approval itself, a fee of €3,177 is charged. A further prerequisite for obtaining a licence in accordance with Section 63 is that the company must engage a person that has passed the exam for the manufacturing of medicinal products, according to the Trade Act.
After having obtained a Section 63 licence, the facility is normally inspected at least every three years. The Federal Office has published guidance with respect to the conduct of an inspection and what is expected from the facility. In addition, the Federal Office publishes a list of companies to be inspected and provides the date the inspection occurred, when a clock stop is imposed and when the final report was issued. In 2018, approximately 196 inspections were announced, assigned to an inspector and partially conducted according to the Medicines Act and the Tissue Safety Act. With respect to the transfer of a manufacturing licence, there are no specific rules contained in the Medicines Act; however, this must be notified to the Federal Office. It would also be required that the trade licence be adapted accordingly.
With respect to medical devices, there is no specific authorisation needed under the Medical Devices Act for operating such a facility; however, a licence is needed under the Trade Act.ix Advertising and promotion
The relevant rules can be found in the Medicines Act; Pharmig (the industry association) has also issued a code of conduct for compliance with advertisement rules. In general, any and all advertising must comply with certain core principles, namely that the properties of a medicinal product are not exaggerated, the information or pictorial presentations do not indicate that the product has an effect exceeding its actual effect and that a success can be expected in any event. No advertising should be misleading, either for consumers or for healthcare professionals.
Violations of advertising rules can be enforced by the public authorities or by competitors via the Unfair Trade Practices Act or arbitrated under the Pharmig Code of Conduct. Advertising of prescription-only products aimed at laypersons is prohibited, but advertising of over-the-counter products is generally permissible, except if the product is reimbursed by the social security fund. This prohibition does not apply if the product was included against the will of the marketing authorisation holder. Advertisements for non-approved medicinal products or non-approved indications are permissible at scientific events mainly targeting non-Austrian professionals.
The Pharmig Code of Conduct has specific rules for advertising via the internet, for instance, requiring them to reveal even the indirect support of a website by a pharmaceutical company. Websites may generally contain non-promotional information on medicinal products, for instance, with respect to side effects or interaction with other substances, but must state that a physician or a pharmacist must be consulted. Links to a complete evaluation report published by the CHMP or to websites of national authorities, medical research institutions, etc., are also acceptable. With respect to advertisements aimed at healthcare professionals, the Code requires that an access system be implemented to ensure that only healthcare professionals have access to the information.
The industry association for medical devices (Austromed) has also published a code of conduct, which provides further guidance concerning the restrictions imposed by the Medical Devices Act. The Austromed Code of Conduct specifically stipulates that financial means designated for research purposes must be transferred to accounts supervised by independent bodies. The costs for accommodation and participation in a congress not organised by the medical device company can be taken over if the congress aims to provide scientific knowledge with respect to the product of the supporting company. The participating physician must provide a report about the knowledge gained, and this is considered as a possible reason for taking over the accommodation and participation costs. If the medical device company organises the congress or an educational event, physicians can only be invited if the invitation is issued to the department and not to the individual physician. It is envisaged that medical device companies shall not any longer directly support physicians, but only provide grants to organisations that arrange scientific events.x Distributors and wholesalers
Wholesalers and distributors also need a licence, according to Section 63 of the Medicines Act. Furthermore, the wholesale and distribution of medicinal products is a regulated trade, meaning that a company must employ a special managing director in the terms of the trade law, who must have passed an exam, covering, inter alia, legal and scientific aspects of trading with medicinal products. This person must (1) be in charge of compliance with the provisions of the Trade Act; (2) be hired for at least 20 hours per week; (3) be in possession of EEA citizenship or Swiss citizenship; and (4) be replaced within six months of his or her departure, although the period granted by the authorities is normally less than six months. If the trade is conducted without appointing such a person, a company can face a fine of up to €3,600. A fine is also imposed if such a person is appointed, but that person actually works less than 20 hours per week for the company.xi Classification of products
The Prescription Act provides the rules that apply when a product has to be classified as a prescription-only product or an over-the-counter product. The Act stipulates that the Ministry for Health must adopt a regulation concerning substances that can only be given out on prescription. When classifying such a substance, the Ministry has to take into account whether the labelling, the package leaflet, as well as the information provided by a pharmacist, indicates that the use of the product is associated with a low risk, by taking into account the duration of the intake as well as the affected target group. The Act also states that if a product is switched from being classified as a prescription-only product to an over-the-counter product, the data used for the switch cannot be relied upon for amending the respective regulation for one year. When evaluating such substances, the Ministry for Health is supported by the Prescription-Only Council, consisting of members of the Physicians' Chamber, the Pharmacy Chamber, social security funds, an expert for producing medicinal products and a pharmacologist employed by an Austrian university.
With respect to the distinction between products intended only for hospitals or for outpatients, no specific provisions apply in Austria. This distinction is only relevant if such products may be reimbursed by the sickness funds, because they only have to pay for products that are prescribed in the outpatient scenario. The costs for hospital-only products are paid by the hospitals themselves.
The Medical Devices Act states that the Ministry for Health can issue a regulation with respect to products that, according to their low endangerment, could be directly distributed to laypersons, but because of the specific circumstances also need a prescription. The Ministry for Health issued one ordinance, namely with respect to magnetic resonance equipment. In addition, the Ministry has issued a regulation specifying which medical devices can be sold directly by any retailer (e.g., condoms or blood-pressure products), by chemists (e.g., light therapy products), or only in a pharmacy or by specialised retailers with a licence to sell medical devices according to the Trade Act.
For certain products, a prescription is needed because otherwise the medical device would not be reimbursed by the various sickness funds.xii Imports and exports
An importation approval is necessary for any medicinal products not covered by an EEC marketing authorisation. Imported products with a marketing authorisation from somewhere in the EEA but without a national marketing authorisation, and which are either re-exported, used for scientific purposes or for medical purposes, must be notified to the Federal Office. Products either centrally approved or with an Austrian marketing authorisation, or products being used in clinical trials being manufactured in the EEA or in Switzerland, can be freely imported without any approval by or notification to the Federal Office. The Importation Act also regulates the purchase of non-prescription medicinal products over the internet within the EEA. It is permissible for a private person to purchase non-prescription medicinal products from a pharmacy established within the EEA if this is done for private purposes – this is normally assumed if no more than three packages per medicinal product are purchased. Prescription-only products can only be purchased in a national public pharmacy where the pharmacy has to comply with strict documentation requirements controlled by the Federal Office.
Different rules exist for blood products because the import of such products must always be notified even if the products are approved within the EEA. Products imported in violation of this Act have to be either sent back or destroyed at the purchaser's expense. In addition, a fine of up to €3,600 can be imposed or, in the event of recidivism, up to €7,260. The Federal Office has far-reaching competence when dealing with imported blood products. Employees at the Office are specifically entitled to enter any premises where the products could be stored, and are also entitled to open any containers for taking samples. The Preparatory Parliamentary Materials to the Importation Act specifically stipulates that an inspection could also occur in customs warehouses when there is a risk that blood products could infiltrate the Austrian market.
No specific rules exist regarding medical devices.xiii Controlled substances
The import, trade and export of substances covered by Schedule I or II of the Single Convention on Narcotic Drugs, respectively Schedules III and IV of the Convention of Psychotropic Substances, is strictly controlled. Substances can only be purchased:
- for medical, veterinary or scientific purposes by entities with a trade licence with respect to the manufacturing of medicinal products or for wholesale, as well as a licence issued by the Ministry for Health;
- by a scientific institution after the supervising authority has confirmed that the possession of such substances is needed for scientific purposes;
- by the police and customs authority for training purposes; or
- by prisons that have facilities for the rehabilitation of prisoners for substance abuse.
Wholesalers have to apply for a licence every year, and it is only granted up to a certain maximum amount. Companies must file a report with the Federal Office by 31 January each year, and must justify when certain amounts are missing from the report.
Pharmacies are only allowed to provide controlled substances to end consumers based on a prescription issued by a trained physician. These products must always be stored separately from normal medicinal products and must be in locked containers. The authorities can also order special security measures for these products. Furthermore, only the Austrian Agency for Health and Food Safety is allowed to grow cannabis for producing medicinal products. This was recently confirmed by the Constitutional Court.
For the export of products covered by the Addictive Substances Act, specific export documentation must be provided; in particular, there must also be a request from the importing country stating that the products are needed.xiv Enforcement
Enforcement and the respective penalties are discussed in the various sections.