Distribution and Marketing of drugs in Austria: overview
A Q&A guide to distribution and marketing of drugs law in Austria.
The Q&A gives a high level overview of distribution and marketing of drugs law, including pre-conditions for distribution; licensing; wholesale distribution; marketing to consumers; marketing to professionals and engagement with patient organisations.
To compare answers across multiple jurisdictions, vist the Distribution and Marketing of Drugs Country Q&A Tool.
This Q&A is part of the global guide to Distribution and Marketing of Drugs.
Pre-conditions for distribution
The distribution of drugs is governed by the Austrian Medicinal Products Act 1983 (AMG). Generally, a marketing authorisation that is effective in Austria is required to distribute drugs there. There are certain exceptions, for instance for compassionate use, herbal drugs, certain homeopathics, and parallel imports.
There are four procedures that can be used to obtain a marketing authorisation that is valid in Austria. These are the:
Mutual recognition procedure.
Austrian national procedure.
A marketing authorisation under the centralised procedure is valid throughout the EU, while the decentralised procedure, the mutual recognition procedure and the national procedures enable the applicant to obtain national marketing authorisations.
The following drugs can be distributed without a marketing authorisation, provided they have been properly registered with the Austrian regulatory authority:
Herbal medicinal products.
Drugs that are prepared in a pharmacy solely from compounds that are identified in the Austrian Pharmacopoeia, do not require a prescription and are distributed by the pharmacy that prepares them.
Named patient use programmes are allowed if an authorised healthcare professional confirms that the drug is urgently needed to treat a life-threatening or serious condition, and the same result cannot be achieved with an authorised and available drug (section 8, para 1, no 2, Austrian Medicinal Products Act (AMG), which transposes Article 5(1) of Directive 2001/83/EC). Named patient use does not require notification or prior approval, and is the sole responsibility of the treating physician.
Compassionate use programmes are available in Austria. In contrast to named patient use programmes, which refer to treatment of a single individual, compassionate use programmes are implemented for groups of patients. Section 8a AMG and the Federal Office for Safety in Healthcare (BASG) Guidelines set out the following conditions for compassionate use programmes:
The centralised procedure must be available for the drug in question.
The patient group must suffer from a debilitating or life-threatening disease.
The patient group cannot be treated satisfactorily with a drug that is authorised in Europe.
The drug is either the subject of an application for a centralised marketing authorisation or undergoing clinical trials in the European Economic Area (EEA) or elsewhere.
Data from a mature randomised phase III trial is available (in exceptional circumstances, data from phase II trials will be sufficient).
The applicant must confirm that they will make the drug available to patients in the time between the approval of the marketing authorisation application and the introduction of the drug to the market.
Compliance with pharmacovigilance requirements.
Compassionate use programmes are not available for drugs which have already been authorised under the centralised procedure, even if the symptoms and patient populations differ from those specific to the marketing authorisation. Conversely, the existence of a national authorisation in another member state of the EU does not prevent implementation of a compassionate use programme in Austria.
Compassionate use programmes are subject to approval by the BASG. The application for a compassionate use programme can either be submitted at the same time as an application for marketing authorisation, or earlier, provided that the applicant declares their intent to file an application for marketing authorisation in the near future.
Only authorised manufacturers or wholesalers of the drug in question under the Austrian Trade Code, owners of Austrian public pharmacies, and pharmaceutical companies that are established within the EEA and authorised to distribute the drug in question can apply for a marketing authorisation. Generally, each type of drug, composition, strength, and use requires a separate application. The Austrian Medicinal Products Act (AMG) contains detailed provisions regarding the documents needed for an application. Application forms are available at www.basg.gv.at/arzneimittel/formulare/nationale-zulassung/.
During the authorisation procedure, the regulatory authority assesses the drug for compliance with the provisions of the AMG. In particular, it determines whether the benefits of the drug have been proven to outweigh the risks (efficacy-safety balance), and will only grant a marketing authorisation if this is the case. Sometimes, marketing authorisations are granted subject to further conditions to ensure the protection of human or animal health or drug safety. The regulatory authority can also require the drug to be distributed in certain package sizes, if this is necessary to ensure therapy-appropriate use.
The regulatory authority must either grant or refuse marketing authorisations within seven months from receipt of the completed application (within 45 days, for parallel import applications).
Marketing authorisations are initially valid for five years, and can be renewed. Renewed authorisations are usually granted for an unlimited period of time, although the regulatory authority can limit the validity to five years, for pharmacovigilance reasons. If the drug is not launched within three years from the grant of the marketing authorisation, or not marketed for a continuous period of three years after its launch, the marketing authorisation expires.
The regulatory authority in charge of the authorisation procedure is the Federal Office for Safety in Healthcare (BASG).
The mutual recognition procedure and the decentralised procedure allow the applicant to obtain authorisations in multiple member states more rapidly, and with less administrative burden, by relying on the recognition of a first assessment performed in one member state. The mutual recognition procedure is available for drugs that have already been licensed in another European Economic Area (EEA) country, and essentially asks that other member states recognise an earlier authorisation, whereas the decentralised procedure can be used for drugs that have not yet been licensed anywhere in the EEA.
In addition, a simplified procedure is available for parallel imports. The applicant can obtain a parallel import licence, provided that:
The drug corresponds to a drug that is licensed or registered in Austria.
The drug is imported from a member state of the EEA.
The drug's evaluation of safety and efficacy can be used without any risk to health.
Finally, there is a simplified procedure for generic drugs which allows the applicant to rely on a reference drug's documentation to obtain a marketing authorisation. The applicant can also use this procedure if the reference drug is not licensed in Austria but in another EEA country.
An Austrian wholesale licence enables the holder to both obtain drugs from a marketing authorisation holder who is established outside of Austria, and to distribute the drugs outside of Austria. Therefore drugs can be distributed from Austria without physically entering Austria. Even so, the wholesaler must maintain an office and have personnel in Austria to fulfil the obligations under the Austrian Medicinal Products Act (AMG) with respect to documentation, reporting of complaints, and so on.
The applicant can file an appeal against the Federal Office for Safety in Healthcare's (BASG) decision with the Federal Administrative Court. There is further recourse available to the Supreme Administrative Court or the Constitutional Court if the decision of the Federal Administrative Court touches on a material question of law or violates the constitutional rights of the applicant.
The official fees are determined by the Federal Office for Safety in Healthcare (BASG) in its fee regulation, which is available at www.basg.gv.at/ueber-uns/tarife/. This regulation is usually modified once a year. Fees currently range from EUR1,000 for a parallel import licence, to EUR50,000 for obtaining a marketing authorisation under the decentralised procedure where Austria is the reference member state. A marketing authorisation under the national procedure for a new active ingredient presently costs EUR10,700. Annual fees vary between EUR300 and EUR2,900, depending on the type of marketing authorisation.
Distribution to consumers
Prescription drugs can only be distributed to consumers by public pharmacies. Operation of a public pharmacy requires a licence (Austrian Pharmacy Act 1906). In addition, some physicians are entitled to dispense prescription drugs if they have the appropriate licence under the Austrian Pharmacy Act (see Question 10 below).
Most over-the-counter (OTC) drugs can only be distributed to consumers by public pharmacies or physicians that are entitled to dispense drugs. However, some OTC drugs can be distributed to consumers by drugstores or by other professionals (for instance contact lens fluids by opticians).
If there is no public pharmacy in a municipality and the nearest public pharmacy is more than six kilometres away, physicians can apply for a licence to dispense prescription and over-the-counter (OTC) drugs to consumers. In addition, hospitals with in-house pharmacies can dispense drugs to their patients.
Drugs for human use can only be prescribed by physicians and dentists. Some prescriptions are required to be approved by a physician of the Austrian social security administration in order to receive reimbursement for the drug. In emergencies, pharmacies are permitted to distribute prescription drugs without a prescription, in the smallest available package.
While cross-border distance sales of over-the-counter (OTC) drugs to Austrian customers have been allowed for a couple of years, distance selling of drugs by Austrian pharmacies was prohibited until very recently. This changed on 25 June 2015, when a provision permitting distance sales of OTC drugs by Austrian pharmacies came into force.
Austrian pharmacies that would like to engage in distance selling of drugs must register with the Federal Office for Safety in Healthcare (BASG) and fulfil the requirements set out in the implementing regulation. In particular, they must operate a physical point of sale and mail the drug from there to the customer, provide telephone consultation, maintain a quality management system, dispense the drugs without delay and only in quantities for personal use. Distance selling is only allowed for OTC drugs that are licensed in Austria. BASG administers a register of all pharmacies that are authorised for distance sales. The pharmacies must display a common logo on their website which functions as a link to the BASG register.
Only European Economic Area (EEA) pharmacies can offer distance sales to Austrian customers. Cross-border distance selling is only permitted for OTCs that are licensed in Austria. Distance selling of prescription drugs is not permitted in Austria. This includes distance sales by Austrian pharmacies to customers in countries that allow distance selling of prescription drugs.
Non-compliance with the laws regarding distribution of drugs is an administrative offence. Decisions imposing a fine can be appealed to the Regional Administrative Court. There is further recourse available to the Supreme Administrative Court or the Constitutional Court if the decision of the Regional Administrative Court touches on a material question of law or violates constitutional rights.
The supply of prescription drugs without prescription, or by someone who is not authorised to sell prescription drugs, is subject to an administrative fine of up to EUR3,600. Drugs which are unlawfully kept for sale, offered or supplied, and any revenues from such sales, are subject to forfeiture.
The violation or attempted violation of the provisions of the Austrian Medicinal Products Act (AMG) regarding distribution of drugs to end users (for instance violation of the rules regarding distance selling or disposal of drugs to end users) is subject to an administrative fine of up to EUR7,500, or up to EUR14,000 for repeat violations.
Furthermore, violation of any of the above provision entitles competitors and certain organisations to file an unfair competition complaint in court, asking for an injunction (including interim relief), damages and publication of the judgment.
Drug wholesalers must obtain a trade licence for the wholesale of drugs (Austrian Trade Act 1859), and a wholesale licence from the Federal Office for Safety in Healthcare (BASG), under the provisions of the Austrian Medicinal Products Act (AMG). An Austrian wholesale licence is not required if the wholesaler already has a wholesale licence in another member state of the European Economic Area (EEA).
In order to obtain (and to maintain) a permit, a wholesaler of pharmaceuticals must fulfill the requirements set out in the Austrian Pharmaceutical Products Regulation 2009 and the European Commission Guidelines on Good Distribution Practice of medicinal products for human use (GDP). In particular, wholesale distributors must maintain a quality system with competent personnel and on suitable premises. In addition, there must be adequate documentation available on site. The wholesale distributor must also implement a system that ensures that complaints are recorded and examined, and that products can be recalled without delay if necessary. The wholesale distributor must designate a responsible person with appropriate skills and education who is responsible for the compliance of the wholesale distributor with all applicable legal provisions, who should be immediately contactable.
The AMG contains a list of recipients to which drug wholesalers can dispense drugs. For example, they are permitted to sell drugs to:
Pharmacies or hospitals with in-house pharmacies.
Drugstores and professionals who are permitted to dispense drugs.
Manufacturers for the sole purpose of manufacturing drugs or if they hold a trade permit that entitles them to sell drugs.
Other drug wholesalers.
It is prohibited to dispense drugs to recipients that are not mentioned in the list. This includes hospitals without in-house pharmacies or physicians who are entitled to dispense drugs. They are both required to obtain their supplies from public pharmacies. In some cases, the regulatory authority will allow direct supply to hospitals without a hospital pharmacy, provided a public pharmacy is involved in the ordering process.
Wholesale licences are issued by the Federal Office for Safety in Healthcare (BASG). The wholesaler must file an application with the BASG, which then inspects the premises and makes a decision based on the results of the inspection. The decision must follow within 90 days from receipt of the application, unless the application is incomplete, in which case the applicant is ordered to submit additional information.
The BASG must carry out routine inspections at least every five years. The persons carrying out the inspections are entitled to enter the premises, take samples and inspect the files. The BASG can revoke the licence or impose further conditions if necessary. It can shut down the premises where there is a serious danger to human health.
Rights of appeal
Decisions of the BASG can be appealed to the Federal Administrative Court. There is further recourse available to the Supreme Administrative Court or the Constitutional Court if the decision of the Federal Administrative Court touches on a material question of law or violates constitutional rights.
Wholesale of drugs without, or in excess of, a wholesale licence, violating the condition of a wholesale licence, or any obstruction of the Federal Office for Safety in Healthcare's (BASG) inspection rights, are all subject to an administrative fine of up to EUR25,000, or up to EUR50,000 for repeat offences. In addition, the licence can be revoked if the violation has been repeated at least three times. Some less serious violations of the rules governing the wholesale distribution of drugs are subject to an administrative fine of up to EUR7,500, or up to EUR14,000 for repeat violations.
Violation of any of the above provisions entitles competitors and certain organisations to file an unfair competition complaint in court asking for an injunction (including interim relief), damages and publication of the judgment.
The Austrian Medicinal Products Act (AMG) provides the legal regime for the marketing of drugs. The term "advertising" encompasses the provision of information, market research, market development and the creation of incentives intended to increase the prescription, supply, sale or use of drugs. It includes activities such as dispensing of samples to physicians, promotional events, sponsorship, hospitality and reimbursement of travel expenses. Different rules apply depending on whether the advertising is directed at consumers or professionals.
Limits to marketing activities
Generally, where advertising is allowed, it is only permitted for drugs that are:
Authorised or registered in Austria.
Approved for parallel import.
Prepared by a pharmacy according to the instructions of a qualified physician or dentist.
Advertising for drugs that do not have a marketing authorisation in Austria is not permitted unless it is at a scientific event where the participants are mainly from outside Austria.
Any advertising must describe the properties of the drug objectively and without exaggeration, and cannot include information or illustrations which:
Attach to the drug an effect exceeding its true effect.
Give a false impression that success can usually be expected.
Contradict the labelling, instructions for use or summary of the product characteristics (SPC).
The Association of the Austrian Pharmaceutical Industry (Pharmig) provides a Code of Conduct and implementing ordinances, which are available at www.pharmig.at. The Pharmig Code of Conduct contains rules governing the provision of information regarding drugs, advertising of drugs (including via the internet), events, co-operation with specialist circles, institutions and patient organisations, raffles, benefits, and transparency. In addition, any violation of the advertising rules of the Austrian Medicinal Products Act (AMG) is also regarded as violation of the Pharmig Code of Conduct.
The Pharmig Code of Conduct is only binding for members of Pharmig (which include all major pharmaceutical companies in Austria). Under the Pharmig Code of Procedure, anybody can file a complaint against a Pharmig member. However, non-members must conclude a written agreement with Pharmig on the relevant proceedings before the complaint will be dealt with by the Pharmig Committee of Experts. Complaints against non-members will be forwarded to the Association of the Austrian Chemical Industry, which is a division of the Austrian Federal Economic Chamber. The members of Pharmig undertake not to bring the same matter before a court of law for the duration of Pharmig proceedings.
In addition, the Austrian Physicians Association and the Austrian Pharmacists Association have codes of conduct that apply to their members. There is also the Association of Austrian Manufacturers and Wholesalers of Medicinal Products (IGEPHA) Code of Conduct, which applies to the distribution of over-the-counter (OTC) drugs and is binding for the members of IGEPHA.
Marketing to consumers
Marketing activities that are directed at consumers must be designed in such a way that they are recognised as advertising and that the product is clearly identified as a drug. Advertisements and editorials must be separate from each other.
Any advertising directed at consumers must contain the following information:
The name of the drug and the active ingredient (provided the drug contains only one active ingredient).
Any information that is necessary for the reasonable use of the drug.
A clearly visible notice that the drug can have adverse effects and that the consumer must follow the instructions for use or consult a physician or pharmacist.
Additionally, for traditional herbal drugs, the notice that it is a traditional herbal drug, for use for certain symptoms or certain indications due to long-standing use.
Exceptions apply to advertisements that solely consists of the drug's name (reminder advertisements).
Advertising prescription drugs and registered homeopathic drugs to consumers is prohibited. Over-the-counter (OTC) drugs can be marketed to consumers, unless their name contains the same invented or scientific term as a prescription drug.
Advertisements that are directed at consumers must not contain any information that exceeds the authorised summary of the product characteristics (SPC). They can refer to the marketing authorisation or registration, provided such a reference is unlikely to create an erroneous view of the drug's safety or efficacy. In addition, the following elements/activities are prohibited:
Pictures of healthcare professionals or healthcare institutions.
Creating the impression that a medical consultation or surgery is unnecessary, in particular by offering a diagnosis or suggesting treatment through correspondence.
Suggesting that the effects of taking the drug are guaranteed, are unaccompanied by adverse reactions, or are better than, or equivalent to, those of another treatment or drug.
Suggesting that the health of the patient can be improved by taking the drug.
Advertising that is directed exclusively or principally at children.
References to a recommendation by scientists, health professionals or celebrities.
Suggesting that the drug is a foodstuff, cosmetic product or other consumer product.
Suggesting that the safety or efficacy of the drug is due to the fact that it is a "natural product".
Detailed description or presentation of medical history which could lead to erroneous self-diagnosis.
Inappropriate, alarming or misleading references to recovery reports.
Inappropriate, alarming or misleading use of pictorial representations of changes in the human body caused by disease or injury or action of a drug on the human body or parts thereof.
Encouraging mail-orders of prescription drugs.
The supply of specimens or free samples of drugs or gift coupons to consumers is prohibited. Raffles or prize competitions in connection with the supply of drugs are also prohibited. There are no rules that specifically address "buy-one-get-one-free" promotions, but it would appear that these are similar to offering a free sample, and are therefore not permitted.
While the Austrian Medicinal Products Act (AMG) does not contain any additional rules for internet advertising, the Association of the Austrian Pharmaceutical Industry (Pharmig) Code of Conduct dedicates an entire section to this topic and sets out the following rules:
The presentation on the internet must clearly name the pharmaceutical company that is running the website, or directly or indirectly supporting it, and which information on the website is addressed to specialist circles and/or to the general public.
Websites must be updated on a regular basis and checked for accuracy, and should provide up-to-date information.
Websites can contain non-promotional information on the medicinal products sold by the company for patients and the general public (including information regarding symptoms, side-effects, interactions with other substances, application, reports on clinical research, and so on). This information must be balanced, accurate and consistent with the summary of the product characteristics (SPC).
The website can contain a link to the complete, unmodified evaluation report as published by the Committee for Human Medicinal Products (CHMP) or by a competent national authority.
The website can contain links to other websites containing reliable information on medicinal products (websites of authorities, medical research institutions, patient organisations, and so on).
As well as the brand name, the international non-proprietary name (INN) must also be mentioned.
The website must always contain a reference to a physician or pharmacist for further information.
The Federal Office for Safety in Health Care (BASG) is in charge of supervising and enforcing the advertising restrictions of the Austrian Medicinal Products Act (AMG).
The Committees of Experts of the Association of the Austrian Pharmaceutical Industry (Pharmig) will act under the Pharmig Code of Procedure in case of complaints against members of Pharmig about violations of the Pharmig Code of Conduct.
BASG is entitled to request the submission of documents and to enter premises and inspect any documents that it deems relevant and to make copies of these documents. BASG can order any measures that are required to ensure conformity with the rules of the AMG.
Pharmig does not carry out any supervision, and acts only on complaints by members or non-members.
Rights of appeal
BASG decisions can be appealed to the Federal Administrative Court. Further recourse is available to the Supreme Administrative Court or the Constitutional Court if the decision of the Federal Administrative Court touches on a material question of law or violates constitutional rights.
Under the Pharmig Code of Procedure an appeal to the Committee of Experts of the second instance is available. The decisions of the Committee of Experts of the second instance are final.
The Federal Office for Safety in Health Care (BASG) can order any measures that are required to ensure conformity with the rules of the Austrian Medicinal Products Act (AMG). In addition, the violation or attempted violation of the advertising rules of the AMG is subject to an administrative fine of up to EUR25,000, or up to EUR50,000 for repeat violations. If such a violation is repeated three times or more, the marketing authorisation for the drug in question can be revoked. In addition, under the AMG some organisations can file for an injunction if the infringer has refused to sign an appropriate cease and desist declaration. Competitors and certain organisations can also file an unfair competition complaint asking for an injunction (including interim relief), damages and publication of the judgment.
Under the Association of the Austrian Pharmaceutical Industry (Pharmig) Code of Procedure, a decision establishing a violation of Pharmig's Code of Conduct must be accompanied by a warning and by an obligation for the company concerned to stop the behaviour that formed the basis of the complaint. In addition, the following sanctions can be imposed in combination:
In the case of a serious violation, a penalty of not less than EUR5,000, up to a maximum of EUR100,000 (repeat violations and violation of the provisions regarding events and transparency are usually deemed serious).
The penalty range is increased to EUR200,000 if the company concerned has committed three violations of the provisions regarding events and transparency within 24 months.
The violation can be publicised and the company concerned named in a Pharmig publication.
The parent company of the company concerned will be notified accordingly.
The Secretary General of the European Federation of Pharmaceutical Industries and Associations (EFPIA) will be notified accordingly.
Exclusion from Pharmig or termination of the Pharmig Code of Conduct Agreement, in which case the company will not be released from existing payment obligations or other imposed sanctions.
Marketing to professionals
Advertising directed at professionals can contain information that exceeds the summary of the product characteristics (SPC), but it must not contradict the SPC. Any documentation that is provided for advertising purposes must be accurate, up-to-date, verifiable and sufficiently complete to enable the recipient to form an opinion about the therapeutic value of the drug concerned. Quotations, tables and illustrations taken from medical journals or other scientific works have to be reproduced accurately, and must indicate the source. References to literature have to accurately report its essential content and indicate the source.
No gifts, pecuniary advantages or material benefits can be supplied, offered or promised to healthcare professionals, unless they are inexpensive and are relevant to medical or pharmaceutical practice.
The Association of the Austrian Pharmaceutical Industry (Pharmig) Code of Conduct explicitly prohibits companies from granting, offering or promising premiums, financial or material benefits to healthcare professionals in return for prescribing, dispensing or using a drug or recommending a drug to a patient. Furthermore, the Code of Conduct prohibits pharmaceutical companies from advertising through raffles in which the prize is exclusively subject to a random draw. Prize competitions, in which participation is subject to scientific and technical performance and in which the prize awarded to the winner is a benefit that is admissible under the provisions of the Code of Conduct, are permitted. The provision of drugs in the course of prize competitions is not permitted.
Under the Pharmig Code of Conduct, a non-interventional study must be set up, verified and authorised under the supervision of a medical department of the pharmaceutical company or, if this is unavailable, under the supervision of an appropriate medically qualified person. For the required documentation in the course of a non-interventional study, a financial consideration that meets the local standard and appears appropriate for the service provided can be paid, but this cannot represent an incentive for the prescription of a drug.
Pursuant to the Pharmig Code of Conduct, visits to physicians and hospitals should not seem unduly persistent with regard to frequency and the manner in which they are conducted. Furthermore, employees who work as medical sales representatives must be compelled by their companies to observe the standard practices in the trade.
A physician or a third party must not be granted, offered or promised any remuneration or benefit in kind to ensure that the physician agrees to receive a medical sales representative or accept information from members of other companies.
Provision of hospitality
The Austrian Medicinal Products Act (AMG) provides that hospitality must always be strictly restricted to the main objective of the event and must not be extended to persons other than health care professionals (for example, their family). Direct or indirect reimbursement of reasonable expenses for travel, accommodation and entry fees at solely business-related scientific events is permitted.
Under the Pharmig Code of Conduct, hospitality is only admissible in the course of events and business dinners for the purpose of an information exchange with members of specialist circles, and only to a reasonable degree, that is not lavish, and to the extent that is considered socially appropriate. The occasion for such hospitality must be documented. Under the Code, the following also applies to the organisation, implementation and/or support or assumption of costs for participants in symposia, scientific congresses, workshops, lectures and similar occasions:
These events must exclusively serve to provide scientific information and/or further specialisation.
Leisure-time activities and/or social programmes (for instance, theatre, concerts, sports events) must not be financed or organised for participants.
The attendance of the participants, the programme and the scientific and/or technical content of the event implemented must be documented.
The venue must be appropriate for the purpose of the event, located in the home country and be chosen based on objective factors rather than the recreational value of a conference venue.
The organisation, implementation and/or support of or the assumption of costs for participation in international events is only admissible if the majority of participants come from a different country than that in which the member company of Pharmig is based, or the necessary resources or specialised knowledge are available at the event venue, and in view of this there are appropriate logistical reasons for choosing a venue in a different country.
The invitation of persons as participants or speakers to events cannot be made dependent on the recommendation, prescription or distribution of specific drugs.
In the case of services being provided by healthcare professionals within the framework of events, pharmaceutical companies must ensure that all potential conflicts of interest are disclosed to the organiser and the participants in a suitable manner prior to the event starting.
If pharmaceutical companies distribute information regarding the content of an event, they must ensure that it is accurate.
Transfers of value granted in connection with events, such as admission and attendance fees, travel costs and costs for overnight accommodation, and fees for services rendered and consulting provided, must be disclosed according to the new transparency rules of the Pharmig Code of Conduct.
Advertising in printed matter, in electronic form or via means of telecommunication must contain the essential information about the drug in question in accordance with the summary of the product characteristics (SPC), provided an SPC was published for the drug. Any documentation that is provided for advertising purposes must indicate the date when the documentation was compiled or last modified.
The general rules of the Unfair Competition Act 1984 (UWG) apply to comparative advertising of drugs. Strict standards must be observed irrespective of whether the advertisement is directed to consumers or healthcare professionals.
The Austrian Medicinal Products Act (AMG) explicitly states that information which is incorrect or likely to be misleading cannot be given in connection with the distribution of drugs. The following is regarded as especially misleading:
If it is suggested that the drug has effects which are not sufficiently confirmed by scientific findings or practical experience.
If it is suggested that its effects are guaranteed, or that normal or prolonged use will not lead to any adverse reactions.
If the name or design is likely to be confusing.
The Association of the Austrian Pharmaceutical Industry (Pharmig) Code of Conduct states that references to brands of competitors can be made if permission has been granted to do so, or if such reference is admissible according to the provisions of the Unfair Competition Act (UWG). It is prohibited to imitate typical advertising features of competitors, the presentation, packaging or labelling of competitor products, or to publish advertisements that are misleading or damaging to their reputation.
With respect to generic drugs, a comparison to the price of the original product is permitted. Advertisements can mention the equivalence of the generic and the original drug, provided that no unfair advantage is taken as to the original product's or its manufacturer's reputation.
Discounts are generally allowed. Rebates in kind are allowed if they are granted to wholesalers or hospitals. Furthermore, rebates in kind that are granted to health care practitioners are allowed, provided they relate to drugs that are not included in the Reimbursement Code of the Federation of Austrian Social Insurance Institutions. Rebates in kind for drugs included in the Reimbursement Code that are granted to health care practitioners are prohibited.
Authorisation holders can provide free-of-charge samples of authorised drugs to healthcare providers, if so requested in writing. Samples can only be supplied in a package that is no larger than the smallest presentation on the market, with a clearly legible and irremovable notice attached with the wording unverkäufliches Ärztemuster ("free medical sample – not for sale"). Samples of drugs containing psychotropic or narcotic substances are not permitted.
Samples can only be provided as follows:
Within a period of one year following the launch of the product in Austria, only in a quantity sufficient to evaluate the treatment success in a maximum of ten patients and overall not more than 30 samples per drug per recipient.
After expiry of this period, only two samples per request, and overall not more than five samples per drug per year and recipient.
The authorisation holder is obliged to keep records of the type, timing and amount of their sampling activities and to provide these records to the Federal Office for Safety in Health Care (BASG) on request.
Sponsorship of professionals
Both the Austrian Medicinal Products Act (AMG) and the Association of the Austrian Pharmaceutical Industry (Pharmig) Code of Conduct prohibit donations and subsidies to individual healthcare professionals. However, according to the Pharmig Code of Conduct, it is allowed to provide donations and subsidies to institutions, organisations or establishments which predominantly comprise healthcare professionals for the purpose of training/education, research or support of the healthcare system or within the framework of scientific or specialist activities. When making financial donations or providing subsidies, pharmaceutical companies are required to keep records and to disclose them on the internet under the new transparency rules of the Pharmig Code of Conduct. The provision of donations and subsidies by pharmaceutical companies must not be linked with conditions relating to the recommendation, prescription or administering of medicinal products.
Other promotional items or activities
Remuneration can be provided to a healthcare professional for services rendered to a pharmaceutical company (for instance for lectures, consulting, clinical trials, non-interventional studies). Under the Pharmig Code of Conduct, any such service must serve the purpose of training/education, research, support of the healthcare system or be provided within the framework of scientific and specialist activities. A written contract must be concluded which clearly indicates the service and remuneration to be provided, as well as the scope, type and purpose of the service. Remuneration can only consist of money, and must be proportionate to the service provided. Hourly fees can be agreed to compensate for the time spent in providing the service. Any expenses incurred, including travel costs, can be additionally reimbursed to an appropriate degree. Any fees and expenses for services rendered and consulting provided must be disclosed on the internet, under the new transparency rules of the Pharmig Code of Conduct.
See Question 26.
The provision of financial or material benefits to health care providers or institutions to induce them to order or prescribe a certain drug can be considered as bribery, which is a criminal offence.
Engagement with patient organisations
While the Austrian Medicinal Products Act (AMG) does not contain any rules regarding engagement with patient organisations, the Association of the Austrian Pharmaceutical Industry (Pharmig) Code of Conduct contains detailed rules for such engagement. Patient organisations are defined by the Code of Conduct as voluntary, non-profit-orientated associations which predominantly comprise patients and/or their families and/or patient organisations which solely represent the interests of patients and/or their families, and exist or were founded to protect their interests. Co-operation between patients' organisations and pharmaceutical companies is based on common interests, and has to take place in an ethical and transparent way.
Any support for patient organisations, other than inexpensive non-financial or indirect contributions, can only be provided under the conditions set out in the Pharmig Code of Conduct. In particular:
The support must solely serve the interests of the patients and/or their families.
The support can only be provided on the basis of a written agreement.
Pharmaceutical companies cannot influence the editorial work of the publications of patient organisations supported by them, without a justifiable factual reason (for example, in order to correct inaccuracies in content or scientific aspects).
Pharmaceutical companies must detail on their publicly accessible internet home page all the patient organisations they support, and must ensure contractually that patient organisations disclose to the public the relevant support transparently and clearly at all times from the outset.
The exclusive support of patient organisations and/or their programmes must not be required by pharmaceutical companies and/or granted by patient organisations.
Regarding events for members of patient organisations, patients and/or their families and other invited participants, the following rules apply:
The assumption of costs must be restricted to travel costs, room and board, as well as the original admission fee, and must be appropriate. Activities which have no factual and/or technical connection with the actual aim and purpose of the event must not be supported or organised by the pharmaceutical company.
At events taking place outside the country in which the pharmaceutical company is based, the organisation, implementation and/or support as well as the assumption of costs are only admissible if the majority of the participants come from a different country than the country in which the pharmaceutical company is based, or necessary resources or specialised knowledge are available at the chosen event venue and, in view of this, there are logistical reasons for choosing a venue in a different country.
Gabriela Staber, Rechtsanwältin (Attorney-at-law)
CMS Reich-Rohrwig Hainz
Professional qualifications. Austria, Rechtsanwältin; New York and Massachusetts, Attorney-at-law
Areas of practice. Life sciences; intellectual property; technology, media & communications.
Languages. English; German
Patricia Kaindl, Staatsanwältin (Public prosecutor)
Public Prosecution Office Vienna
Professional qualifications. Austria, Staatsanwältin (Public Prosecutor); Austria, ehem. Rechtsanwältin (former Attorney-at-law)
Areas of practice. Commercial and criminal law.
Languages. English; German
Egon Engin-Deniz, Rechtsanwalt (Attorney-at-law)
CMS Reich-Rohrwig Hainz
Professional qualifications. Austria, Rechtsanwalt (Attorney-at-law)
Areas of practice. Life sciences; intellectual property; technology, media & communications.
Languages. English; German