Trends and developments
Are there any notable trends or recent legal developments in your jurisdiction’s pharmaceutical industry?
Effects of latest anti-corruption law implementation for healthcare sector In order to defend the healthcare system against bribery and corruption, new legislation providing for more rigorous and stringent penalties for bribery in the healthcare industry came into effect in Germany during mid-2016. The introduced criminal offences for bribes and corrupt practices involving healthcare professionals, which are punishable by a fine or up to three years’ imprisonment, for both healthcare professionals and also those offering the bribes.
In light of these anti-corruption provisions, the provision of unilateral benefits to healthcare professionals (eg, support of event participation of healthcare professionals, particularly passive participation) is under discussion. Thus, certain pharmaceutical companies, as well as a major German medical device industry association and its members, recently decided to cease supporting certain participation forms.
Implementation process of EU Regulations on Clinical Trials The EU Regulation on Clinical Trials on Medicinal Products for Human Use (536/2014) sets the legal framework for clinical trials and is likely to enter into force during the second half of 2019. German pharmaceutical legislature has already undergone some changes and will be implementing further ones in upcoming months. The Ordinance for Good Clinical Practice (implementing EU Directive 2001/20/EC) was repealed in the course of implementing the EU regulation, where the repeal comes into effect six months after publication of the Communication of the European Commission on the functioning of the EU-Portal and the EU-Database (Article 82 of EU Regulation 536/2014). The Ordinance on Proceedings on the Evaluation of Applications for Authorisation of Clinical Trials came into effect during mid-2017 and some will apply six months after the publication of the Communication of the European Commission on the functioning of the EU-Portal and the EU-Database (Article 82 of EU Regulation 536/2014.
What is the primary legislation governing medicinal products in your jurisdiction?
The legal framework for medicinal products in Germany mainly consists of:
- the Medicinal Products Act;
- the Ordinance for Active Ingredients of Pharmaceuticals; and
- the Ordinance for Good Clinical Practice (repealed six months after publication of the Communication of the European Commission on the functioning of the EU-Portal and the EU-Database (Article 82 of EU Regulation 536/2014).
These regulations include requirements for conducting clinical trials, manufacturing, marketing authorisation, labelling and packaging, distribution and pharmacovigilance, and the import and export of medicinal products. Regarding the advertisement of medicinal products, the following laws apply:
- the Advertising in the Healthcare System Act; and
- the Fair Trade Practices Act.
Are any legislative changes proposed or expected in the near future?
EU General Data Protection Regulation The EU General Data Protection Regulation (679/2016) provides new rules, in particular for the processing of special categories of personal data (Article 9). Special categories of personal data include:
- genetic data;
- biometric data for the purpose of uniquely identifying a natural person (implementing new terms);
- data concerning health; and
- data concerning a natural person's sex life or sexual orientation.
The new rules apply to pharmaceutical and biochemical research without exception, provided that processing of the relevant data is involved. Healthcare companies should be aware of the new rules under the regulation, which will become effective as of May 25 2018. Accordingly, new rules and processes must be implemented – for example, in relation to privacy notices, consent forms, data transfer agreements and privacy risk assessments. Although the regulation provides for harmonised conditions for the processing of special categories of personal data concerning health, national derogations of EU member states may apply.
Germany has implemented the Act to Adapt Data Protection Law to Regulation (EU) 2016/679 and to Implement Directive (EU) 2016/680, which comes in effect as of May 25 2018. Section 22 of the new act provides for further rules on the processing of special categories of personal data. For example, the processing will be lawful where it is necessary for the purposes of preventive medicine and for medical diagnosis.
Implementation process of EU regulations on medical devices Due to the new EU regulations with respect to medical devices (745/2017 and 746/2017) coming into force in May 2017 and applying by May 2020, 2,022 extensive adaptions to the medical devices legal framework are necessary. Therefore, the Federal Ministry of Health has initiated a national implementation process with all involved parties to identify issues and provide solutions for the legal framework for medical devices.
Which bodies regulate medicinal products in your jurisdiction and what is the scope of their powers?
The two primary federal regulatory authorities in Germany are:
- the Federal Institute for Drugs and Medical Devices (BfArM); and
- the Federal Institute for Vaccines and Biomedicines (PEI).
The scope of both bodies’ powers is similar; however, the BfArM is competent for finished medicinal products and medical devices, whereas the PEI is responsible for biomedicines and vaccines.
The scope of powers of both bodies is as follows:
- licensing of and marketing authorisation for products;
- authorisation to conduct clinical trials;
- dispensing scientific advice before submission of applications for marketing authorisation or clinical trials;
- manufacturer-independent official experimental batch release testing (for the PEI);
- collecting and evaluating reports of adverse reactions to medicinal products (ie, pharmacovigilance);
- improving the safety of medicinal products by recording and assessing risks;
- implementing and coordinating necessary measures to prevent public and animal health hazards;
- monitoring the legal traffic in narcotic drugs and precursors; and
- undertaking fundamental and applied research (relating to the groups of medicinal products within the scope of the PEI).
In addition, local authorities of the German federal states are competent to supervise and audit pharmaceutical entrepreneurs in relation to good manufacturing practices, wholesale and distribution of medicinal products.
Are any other legal regimes applicable to the trade of medicinal products (eg, competition, international trade, data protection, consumer protection)?
Competition The Act Against Restraints of Competition is the relevant German legal regime applicable to trade and competition. It applies to medicinal products and includes prohibitions against behaviours restricting competition and abusive market behaviour, as well as provisions governing merger control and the award of public contracts.
International trade Licences for the import of medicinal products from countries outside the European Economic Area are regulated under the Medicinal Products Act.
Data protection Data protection rules and regulations are crucial, with particular regard to clinical trials and the processing and use of data resulting from such trials.
Consumer protection The overall purpose of the German legal regime on the pharmaceutical sector is to protect the health and wellbeing of consumers. In this regard, it is the legislature’s duty to guarantee maximum security at all stages of the medicine production and distribution chain and to provide accurate information on the pharmaceutical products placed on the market.
Are any medicinal products exempt from regulation (eg, complementary and alternative medicines)?
Under German law, the requirement for authorisation does not apply to:
- specific types of medicinal product listed under Section 21(2) of the Medicinal Products Act, including:
- therapeutic allergens manufactured on the basis of a recipe for individual patients; and
- medicinal products intended for use in clinical trials on humans; and
- homeopathic and traditional herbal medicinal products. These must be authorised, but solely through a simplified registration procedure with the BfArM.
What is the authorisation procedure for the manufacture of medicinal products in your jurisdiction?
Every production facility in Germany must obtain authorisation to manufacture medicinal products. The application for authorisation must be filed (along with relevant documents) before manufacturing operations commence. As part of the application process, the competent authorities inspect the manufacturing site in order to ensure compliance with the necessary safety and quality standards and that the actual circumstances comply with the information disclosed in the filed documents.
If any defects are detected during the application procedure, the manufacturer will be asked to remedy them within a given period, which may consequently extend the application procedure.
The authority may provide guidance before an application is filed. On request, it must even provide information and assistance before and after the formal application procedure (Section 71c of the Administrative Procedure Act). In most cases the authority decides on an application within three months of receipt (Section 17(1) of the Medicinal Products Act).
The granted manufacturing authorisation is limited in scope: it applies only to the specific site, the respective medicinal product and the specific dosage form covered in the application. However, manufacturing authorisation holders may wholesale the medicinal products covered by the authorisation. Manufacturers undertaking any distribution activities with their own products must comply with good distribution practices.
What is the fee for obtaining authorisation?
The fee for obtaining a manufacturing authorisation is set by the authority on a case-by-case basis.
What is the validity period for authorisation?
The manufacturing authorisation is usually granted for an unlimited period.
How robust are the standard good manufacturing practices followed in your jurisdiction?
It is the competent authority’s duty to monitor manufacturers’ compliance with the German and EU good manufacturing practices. The authority is empowered (Section 64 and following of the Medicinal Products Act) to act as required in order to enforce compliance, including by:
- inspecting the premises;
- reviewing documents relating the manufacturer’s products;
- demanding all necessary information relating to the manufacturer’s operations; and
- demanding samples, if necessary for monitoring reasons.
What are the consequences of failure to obtain manufacturing authorisation and/or follow good manufacturing practices?
The authority may refuse to grant manufacturing authorisation for certain reasons set out in Section 14 of the Medicinal Products Act (eg, non-compliance with good manufacturing practices). Without manufacturing authorisation, the company is not allowed to manufacture the relevant medicinal product.
If any defects are detected after manufacturing authorisation has been granted, the authority is empowered to undertake various measures, including issuing necessary directives to rectify or prevent any infringements. In order to do so, the authority may:
- suspend or withdraw manufacturing authorisation;
- stop the manufacturing process; and
- seize and withdraw medicinal products from the market (Section 18 of the Medicinal Products Act).
How are the distribution and storage of medicinal products regulated?
The Medicinal Products Act regulates the common methods of distributing medicinal products and certain special distribution methods.
The standard distribution chain begins with the so-called ‘pharmaceutical entrepreneur’ (usually the marketing authorisation holder). The medicinal products may be provided by the entrepreneur only to the following recipients (Sections 43, 47, 47a-b, 50-53, 74a-76 of the Medicinal Products Act):
- other pharmaceutical entrepreneurs;
- wholesalers (Sections 4(44), 47 and 52a of the Medicinal Products Act; wholesale authorisation is required if the wholesaler does not hold manufacturing authorisation); and
- certain named groups under specific circumstances, in particular physicians and hospitals (Section 47(1)(1)(2-9) of the Medicinal Products Act).
Distribution to consumers almost always passes through a pharmacy, as in Germany almost all pharmaceuticals are pharmacy-only products. Within pharmacy-only products there are both prescription-only and over-the-counter products. Prescription-only products may be sold solely on prescription basis. Over-the-counter medicinal products do not require a prescription, whether or not they pharmacy-only restricted (as specified in Section 44 of the Medicinal Products Act). Non-pharmacy-only products may be distributed commercially and sold to consumers without restrictions.
In addition, the Ordinance on the Retail of Medicinal Products (implementing the EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01)) applies to storage and distribution.
Import and export
How are the import and export of medicinal products regulated?
In respect of this topic, a distinction must be drawn between wholesalers based in Germany which import products into the German market and those based outside Germany.
Companies based in Germany that hold a wholesale authorisation solely require an import licence for medicinal products that are imported from third countries, whereas imports from other European Economic Area (EEA) member states are already covered by the wholesale authorisation.
An import licence is not required when importing into the German market from an EEA member state, but is required for imports from third countries (Sections 72(1)(1) and 73(1)(2) of the Medicinal Products Act). The importing company must also obtain a certificate confirming that the active pharmaceutical ingredient was manufactured in accordance with manufacturing principles similar to EU pharmaceutical manufacturing and monitoring principles (Section 72a of the Medicinal Products Act).
An import licence or any similar authorisation does not replace or supersede the marketing authorisation or any respective registration in Germany. Thus, the import of medicinal products is permitted only where marketing authorisation for the German territory has been obtained with respect to the product.
The fee for an import licence or certificate ranges from €400 to €25,500, depending on the specific case.
Are parallel imports permitted in your jurisdiction?
Parallel imports of nationally authorised medicinal products must obtain their own marketing authorisation for Germany. The importer may benefit from a simplified procedure in this regard, provided that the parallel-imported medicinal product has the same components, formulation, indication and therapeutic effect as the equivalent product already distributed in Germany. Centrally authorised medicinal products may already be marketed in all member states of the EEA and therefore require no new national marketing authorisation in order to be exported by a parallel distributor to another EEA member state. Only the European Medicines Agency notification procedure for parallel distribution need be observed.
In practice, the original pharmaceutical entrepreneur may exercise its IP rights (eg, patents and trademarks) to challenge parallel imports, provided that the relevant IP right is not exhausted (exhaustion occurs when the product is placed on the EEA market by or with the consent of the rights holder).
Sale and purchase
What rules govern the dispensing, sale and purchase of medicinal products?
In respect of dispensing medicinal products to consumers, a distinction must be drawn between the following medicinal products:
- prescription-only products are available only on a prescription by a physician for the specific product and are available only to consumers in pharmacies (Section 48 of the Medicinal Products Act);
- pharmacy-only products are available to consumers solely in pharmacies, whether with or without prescription depends on the specific product (Section 43 and following); and
- over-the-counter products are available to consumers without prescription; however, most are nonetheless pharmacy-only products and few are available outside pharmacies (Section 43, 44 and following).
As a general rule, most medicinal products in Germany are pharmacy-only products, whether they are prescription-only or over-the-counter products.
Are there any restrictions on the online sale and purchase of medicinal products?
Over-the-counter products may be sold online.
In respect of prescription-only products, only public pharmacies based in Germany may market medicinal products online in addition to their regular pharmacy activity (Section 43(1)(1) of the Medicinal Products Act, Section 11a of the Pharmacy Act).
Non-German EU pharmacies may market medicinal products online to the German public within the requirements of Section 73 of the Medicinal Products Act. However, this was allowed for prescription-only products only subject to the statutory pricing requirements (Section 78 of the Medicinal Products Act, ordinance on pharmaceutical product pricing). This changed in October 2016 when the European Court of Justice’s (ECJ) held in Doc Morris that the German price-setting system for the online supply of prescription-only medicinal products by foreign pharmacies was unlawful.
The ECJ judgment resulted in a draft law intending to prohibit the online distribution of prescription-only medicines in general in Germany, which subsequently failed.
Named patient supply
What rules govern named patient supply of pre-launch medicinal products?
The Medicinal Products Act does not explicitly cover named patient supply (ie, voluntary supply of a promising unlicensed medicinal product in response to a bona fide unsolicited order by a physician for use by an individual patient under the physician’s responsibility). The pharmaceutical manufacturer is free to supply any such product to the ordering physician.
This is not to be confused with compassionate use programmes, which are explicitly permitted (Section 21(2)(6) of the Medicinal Products Act, Section 1(2) of the ordinance on hardship situations with medicinal products).
Further, named patient compassionate use is also permitted (Section 73(3) of the Medicinal Products Act). As-yet unauthorised medicinal products in Germany may be imported by a German-based pharmacy from a state where the product is marketed and may be provided in a small quantity to individual patients for personal use. The patient’s physician must provide a prescription.
What is the authorisation procedure for conducting clinical trials in your jurisdiction?
The standard application procedure for clinical trial authorisation is as follows:
- The applicant submits an online request form to the European Medicines Agency for a EudraCT number for registration of the clinical trial (required for all clinical trials conducted in the European Union). The applicant will receive the number by email.
- The applicant (or its legal representative with a permanent place of business in the European Economic Area) submits a formal application to Federal Institute for Drugs and Medical Devices (BfArM) or the Federal Institute for Vaccines and Biomedicines (PEI), as the case may be (Section 42(2) of the Medicinal Products Act). The application must be submitted along with certain documentation, including:
- the EudraCT number;
- the study protocol;
- the active pharmaceutical ingredient dossier;
- proof of insurance;
- informed consent forms;
- sponsor details;
- details on the principal investigator and principal institution; and
- inclusion criteria regarding study subjects (Section 40 and following of the Medicinal Products Act and the Ordinance for Good Clinical Practice).
- The applicant submits an application for approval with the responsible ethics committee of the competent German federal state (Section 42(1)(2) of the Medicinal Products Act).
- After receipt of the aforementioned approvals, the competent supervising authority of the federal state is notified of the clinical trial (Section 67(1)(1)(5) of the Medicinal Products Act).
In future, the approval procedure will change due to the new EU Regulation on Clinical Trials (536/2014, CTR) and respective German provisions, which will both likely apply by the second half of 2019. Applicants will be able to submit a single application dossier to the EU-Portal. The submitted application dossier will be accessible through the EU-Database to all EU member states in which the applicant wishes to conduct the concerned clinical trial.
How robust are the standard good clinical practices followed in your jurisdiction?
Very robust. No marketing authorisation is granted where any infringement of good clinical practices is detected and not remedied.
Marketing authorisation depends on (among other things) adherence to good clinical practices, which must be confirmed by documentation in the application dossier.
Reporting, disclosure and consent
What are the reporting and disclosure requirements for the results of clinical trials?
Reporting and documentation of clinical trials are regulated by Section 42b, 67a (2) Medicinal Products Act and the Ordinance for Good Clinical Practice (Section 12).
With respect to medicinal products requiring marketing authorisation, the pharmaceutical entrepreneur must publish reports on all results (including unfavourable results) of confirmatory clinical trials substantiating the efficacy and safety of the product within six months of the grant or modification of the marketing authorisation. In addition, the sponsor must submit a summary of the clinical trial report to BfArM or the PEI.
In future, all relevant information in connection with clinical trials shall be submitted to the EU-Portal/EU-Database. The information is then publicly available via these two databases (Article 81(4), EU 536/2014) – with exceptions (eg, personal data of trial subjects). The European Medicines Agency defined criteria for determining any data that requires protection and thus will not be publicly available.
What are the informed consent obligations with respect to clinical trial subjects?
Consent must be given in writing, after the clinical trial subject has been informed of the nature, intent, risks and importance of the clinical study.
Clinical trial subjects must also consent to the purpose and extent of the collection, storage, processing and use of their personal and sensitive data in the course of the clinical trial, as well as potential processing by third parties during or after the term of the clinical study.
What are the insurance requirements for clinical trials?
Clinical trial subjects participating in a clinical study must obtain specific insurance coverage appropriate to the risks involved. The insurance coverage must be at least €500,000 for death or permanent inability to work.
What data protection issues should be considered when conducting clinical trials?
The collection, processing and use of personal or special categories of personal data is generally permitted only where such processing is permitted or ordered by law, or the data subject has given prior consent to the processing. Stricter rules apply where special categories of data – such as health data, biometric data – are processed.
Informed consent must be obtained from each clinical trial subject before participation in any study. The informed consent form must cover several topics, including the nature, intent, risks and importance of the clinical study. Consent forms are part of the dossier that must be provided to the authority in the course of the marketing authorisation procedure.
The pharmaceutical entrepreneur, as sponsor of the clinical study, is the data controller and must take into account that the clinical trial subject may revoke consent at any time. The clinical trial subject also has a right to information at any time with respect to the type and amount of personal data processed by the sponsor or contract research organisation in the course of the clinical trial, provided that the data has not yet been anonymised. Consequently, the sponsor or contract research organisation must implement specific procedures to:
- provide the clinical trial subject with information on his or her processed personal data on request; and
- delete any such data on the clinical trial subject’s request.
Various issues should be considered with respect to data protection for biomaterial samples, including:
- data protection issues regarding the personal data in connection with the sample;
- proprietary issues regarding the samples itself; and
- the subject’s personal privacy rights to the sample’s further use by the sponsor, contract research organisation or any third parties.
Article 35 of the General Data Protection Regulation requires a data protection impact assessment (PIA) before processing special categories of data. A company must assess the impact of the envisaged processing operations on the protection of personal data. The PIA will in particular include a systematic description of the envisaged processing operations and the purposes of the processing, including, where applicable, the legitimate interest pursued by the company. It will also consider the risks to the rights and freedoms of data subjects. Assessment will be documented.
Where personal data is transferred to third parties in the course of a clinical trial, appropriate data transfer agreements should be put in place, in particular where the recipient is located outside the European Economic Area.
Specific data retention rules apply in the course of and after the term of a clinical study (Section 40 of the Medicinal Products Act and the Ordinance for Good Clinical Practice).
The law imposes notification obligations in case of data breach involving special categories of personal data, provided that there is a threat of serious harm to the data subjects' rights or legitimate interests. Where special categories of personal data are unlawfully disclosed, the data controller must immediately notify the responsible authority and the data subjects.
What is the marketing authorisation procedure for medicinal products in your jurisdiction?
There are several procedures to obtain marketing authorisation for the German territory:
- a centralised EU procedure with the European Medicines Agency (mandatory for certain kinds of medicinal product);
- a national procedure with the Federal Institute for Drugs and Medical Devices (BfArM) or the Federal Institute for Vaccines and Biomedicines (PEI);
- a mutual recognition procedure through the BfArM or PEI, where authorisation has already been obtained in another EU member state; and
- a decentralised procedure through the BfArM or PEI to designate a so-called ‘reference member state’.
Under the standard national procedure, the pharmaceutical company must apply to the BfArM or PEI (depending on the product) in accordance with Article 8(3) of EU Directive 2001/83/EC. The BfArM provides an online brochure containing additional information on the form and contents of the application. The authority usually decides applications within seven months (Section 27 of the Medicinal Products Act). The BfArM is obliged by law to provide guidance and information on the application procedure on request (Section 71c of the Administrative Procedure Act).
What criteria are considered in granting marketing authorisation?
The pharmaceutical entrepreneur must provide proof of the pharmaceutical quality, efficacy and safety of the respective product (Section 22 Guideline on Medicine Testing).
What is the fee for obtaining marketing authorisation?
The applicant must pay the costs of examining the application and granting authorisation after the BfArM or PEI issues its decision. The amount is set on a case-by-case basis in accordance with the respective cost ordinance on medicinal products (Section 1 of the Medicinal Products Act).
What is the validity period for marketing authorisation?
The first authorisation granted by the BfArM or PEI is usually valid for five years and may be renewed at least six months before expiry. The renewal is valid indefinitely. However, the authority may revoke, suspend or withdraw the marketing authorisation at any time due to (among other things) safety reasons or the marketing authorisation holder not placing the product on the market within three years of receiving authorisation.
The renewal fee varies from around €1,500 to €5,000.
What are the consequences of failure to obtain marketing authorisation?
The pharmaceutical company is not allowed to place the medicinal product on the German market.
What post-market monitoring mechanisms are in place to ensure the ongoing safety and efficacy of medicinal products after marketing authorisation has been granted?
The marketing authorisation holder must set up and operate a pharmacovigilance system (Section 63b of the Medicinal Products Act) which includes:
- nominating a local person responsible for setting up and managing the system (Section 63a of the Medicinal Products Act);
- submitting regularly updated safety reports;
- keeping records of all cases of suspected side effects and adverse events;
- recording every case of serious suspected adverse reaction and reporting such reactions to the Federal Institute for Drugs and Medical Devices (BfArM) or the Federal Institute for Vaccines and Biomedicines (PEI) (as the case may be) and to European Medicines Agency within 15 days of acquiring such knowledge;
- sending information letters and so-called ‘red hand letters’ (Rote Hand Briefe) to healthcare organisations about newly identified major risks and measures to reduce such risks; and
- conducting non-interventional post-authorisation safety studies if requested by the competent authority.
The BfArM or PEI may impose further conditions on the marketing authorisation holder when granting the authorisation.
What data protection issues should be considered when conducting pharmacovigilance activities?
Reporting adverse events
When an adverse event is reported, it is important to collect certain personal data (eg, name and address) to meet the pharmacovigilance requirements (ie, having an identifiable patient and reporter). Thus, individual case safety reports must contain certain minimum information. Information relating to the patient should be as complete as possible, although in accordance with local privacy laws.
Data subjects (ie, persons experiencing an adverse event and those making the adverse event report) must be notified of what personal data relating to them is being collected, who is collecting it, the purpose of collection and the recipient of the personal data (no individual names are required; it is generally sufficient to identify the receiver, such as the health authorities).
This information should be set out in a clearly written data protection notice that can easily be understood. However, different channels of adverse event reporting (eg, telephone, email and in person) may require different types of data protection notice.
Regardless of whether the data subject is the person who suffered the adverse event or the person reporting it (eg, healthcare professionals or a relative of the patient), in principle it is not necessary to obtain consent from the data subject in order to process personal data relating to the data subject for the purposes of pharmacovigilance. This is because the processing is based on legitimate legal purposes (ie, purposes of preventive medicine, medical diagnosis and healthcare). However, in all instances the data subjects should be informed as soon as possible of the collection and use of their personal data.
Follow-up of pharmacovigilance data All correspondence with a reporter requires a data protection notice (attached to follow-up request forms or adverse event forms sent to the reporter for completion). However, consent should always be obtained from the patient to follow up with his or her relevant healthcare professional.
Standards on data retention and redaction of personal data (ie, data minimisation) and general data protection standards apply in respect of data entry and data transfers, access, rectification and objection rights.
Pricing and reimbursement
Are there rules governing the pricing of medicinal products in your jurisdiction?
The so-called AMNOG procedure applies to the determination of prices for newly launched medicinal products. Under this procedure, the Joint Federal Committee first undertakes a mandatory cost/benefit analysis (Section 35b of the Fifth Social Security Code). The committee determines what (if any) additional benefit the new product provides. The pharmaceutical entrepreneur and statutory health insurance providers then undertake price negotiations based on the prior determined additional benefit and actual sale prices in other EU member states. The agreed price applies from the 13th month following the product’s placement on the German market; for the first 12 months the pharmaceutical entrepreneur may freely set the price.
Once the price has been set, the following rules apply to the entire distribution chain (ie, pharmaceutical entrepreneurs, wholesalers and community pharmacies):
- The Ordinance on Pharmaceutical Product Pricing applies to prescription-only medicinal products, setting margins for wholesalers and pharmacists. Thus, retail prices for prescription-only products must be uniform across Germany (Section 73(3) of the Medicinal Products Act).
- The Fifth Social Security Code (Section 130, 130a) sets compulsory discounts for public health insurance funds and pharmacies.
What is the structure for state reimbursement of medicinal product costs?
Over-the-counter products are not refundable.
Pharmacists who provide prescription-only products are generally reimbursed directly by public health insurance.
Regarding newly authorised medicinal products, only those that contain a so-called ‘additional benefit’ compared to similar products already on the market can benefit from a favourable reimbursement price. Such additional benefit is determined by the Joint Federal Committee during the mandatory cost/benefit analysis (Section 35b of the Fifth Social Security Code). The reimbursement price is then agreed between the pharmaceutical company and the health insurance funds on the basis of such benefit.
For products with no additional benefit, a maximum reimbursement rate is set.
For products with no comparable products already on the market, the pharmaceutical company agrees with the public health insurance fund on a price that does not exceed the cost of a comparable therapy.
Advertising and labelling
How is the advertising of medicinal products to healthcare professionals and the general public regulated in your jurisdiction?
Advertising to healthcare professionals Product-related advertising of prescription-only products is permitted only to certain healthcare professionals, in particular:
- pharmacists; and
- any other person who in the course of his or her professional activities may lawfully trade in medicinal products for human use (eg, pharmaceutical entrepreneurs, wholesalers and retail pharmacists (Section 10(1) of the Advertising in the Healthcare System Act)).
Advertising to the general public
Advertising of prescription-only products to the public is prohibited (Section 10 of the Advertising in the Healthcare System Act). Thus, any promotional activities by the pharmaceutical company that are aimed at the general public must contain no product-related information.
With regards to advertising in general, several other provisions apply:
- Medicinal products must not be advertised before marketing authorisation is obtained (Section 3a of the Advertising in the Healthcare System Act); thus, pre-launch advertising is prohibited.
- Medicinal products must not be advertised outside the scope or indication of the obtained marketing authorisation (ie, off-label use is prohibited).
- Misleading advertising is prohibited (Section 3 of the Advertising in the Healthcare System Act).
- The provision of gifts or any other advertising giveaways is prohibited (Section 7 of the Advertising in the Healthcare System Act).
In addition to the statutory provisions, the self-regulating industry codes of several pharmaceutical associations provide further details on this topic. In most cases these codes are even stricter than the statutory requirements.
Do any special rules apply to online advertising of medicinal products?
The abovementioned advertising rules also apply to online advertising.
In particular, online information or advertising concerning prescription-only medicinal products may be accessible only to healthcare professionals, meaning that restricted online access must be ensured (eg, password-protected access).
What are the packaging and labelling requirements for medicinal products?
Pursuant to Sections 10 to 12 of the Medicinal Products Act (implementing the labelling provisions of EU Directive 2001/83/EC), several compulsory statements must be included on the package, including:
- the name and address of the pharmaceutical entrepreneur;
- the name, amylum and formulation and dosage form of the medicinal product;
- the approval number;
- the batch number;
- the content of the package (ie, weight, size and number of units);
- the method of application;
- active ingredients;
- the expiry date; and
- the statements ‘prescription only’, ‘pharmacy medicines’ or ‘sample not for sale’ (as the case may be).
The information on the package must be generally understandable and in German. A patient information leaflet is mandatory.
How is the promotion of off-label use regulated?
According to Section 3a of the Advertising in the Healthcare System Act, medicinal products must not be advertised outside the scope or indication of the obtained marketing authorisation (ie, off-label use), regardless of whether the product is effective in the non-authorised field.
However, Section 3a does require a product reference. Therefore, the pharmaceutical entrepreneur is permitted to report about the stage of development of any active ingredient. In addition, contributions to scientific journals or congresses which are objective, competent and with no advertising surplus need not be a product-related promotional advertisement (this is a case-by-case decision).
Relations with healthcare professionals
Gifts and incentives
What rules apply to the provision of gifts, discounts and other incentives to healthcare professionals?
Gifts, discounts and incentives are prohibited by certain industry codes and several provisions governing the healthcare profession (in particular regarding public healthcare professionals), unless the healthcare professional’s employer gives prior approval.
Regarding general interactions with healthcare professionals, several provisions must be taken into account, including:
- rules governing the healthcare profession;
- the Fifth Social Security Code (Section 128);
- the Criminal Code;
- the Common Position on the Assessment in Criminal Law of the Cooperation between Industry, Medical Institutions and their Employees, issued by the leading trade associations; and
- the industry codes of several German and European pharmaceutical associations (eg, the European Federation of Pharmaceutical Industries and Associations, the Association of Voluntary Self-regulation for the Pharmaceutical Industry and the association Arzneimittel und Kooperation im Gesundheitswesen eV).
Although they apply only to their respective members, the industry codes for these pharmaceutical associations act as guidelines for the entire industry. Thus, it is recommended that all pharmaceutical companies implement the principles and measures contained in the codes and the common position, with particular regard to the anti-corruption and bribery provisions.
How can a liability claim for a defective medicinal product be brought?
The injured party must bring an action before the court.
Civil law procedures allow a number of individual claimants to combine their claims if they share the same factual and legal background (Section 59 of the Civil Procedure Code). The court may also merge two separate claims under certain circumstances (Section 147 of the Civil Procedure Code).
However, even in a joint action, each claimant remains a fully independent party.
Which parties can be held liable for a defective medicinal product?
The Medicinal Products Act (Section 84) provides for the strict liability of the marketing authorisation holder and/or the pharmaceutical entrepreneur, regardless of fault. As the entity named on the packaging (for the German market) is also held liable for any damages that arise from the product, importers or re-importers are also liable if the product is sold under their name.
Manufacturers, suppliers, spare part suppliers and domestic importers can also be held liable under tort law.
Where multiple parties are responsible, each party is jointly and severally liable.
The pharmaceutical entrepreneur may be excluded from liability in the case of off-label use – as the product is not used according to its defined application – unless it was aware of the off-label use (this is determined on a case-by-case basis). Depending on the informed consent of the patient, the treating physician may also be excluded from liability.
What remedies are available to successful claimants?
In case of death, several remedies are available (Section 86 of the Medicinal Products Act), including:
- the costs of an attempted cure;
- financial losses incurred by the deceased party as a result of the suspension or reduction of his or her earning capacity;
- the resulting increase in need during the course of the disease;
- funeral costs; and
- the legal obligation to support third parties with maintenance claims against the deceased.
In case of an injury to the body or to health (Section 87 of the Medicinal Products Act), the following remedies are available:
- treatment costs;
- financial losses incurred as a result of the temporary or permanent suspension of or reduction in earning capacity;
- the resulting increase in the person’s needs; and
- compensation for personal suffering.
However, liability is limited as follows (Section 88 of the Medicinal Products Act):
- €600,000 or a yearly payment of €36,000 for each death or injury; and
- in case of death or injury of several persons, €120 million or a yearly payment of €7.2 million.
Exclusion and limitation
On what grounds can liability be excluded?
Exclusion of liability under Section 84 of the Medicinal Products Act is not permitted.
What preventive steps can be taken to limit liability?
Liability under Section 84 of the Medicinal Products Act cannot be restricted.
Compliance and enforcement
What measures are in place to enforce the laws governing medicinal products?
In order to enforce such laws, the Medicinal Products Act itself (Sections 95 to 97) provides a legal regime of punishments for infringement of laws governing medicinal products. According to these regulations, fines and prison terms of up to 10 years can be imposed.
After granting the relevant authorisations, the competent authorities monitor manufacturers and marketing authorisation holders to ensure compliance with the respective provisions. Where any infringements or defects are detected, the relevant authorisation may be revoked or withdrawn and the authority may request further measures.
What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?
There are self-regulating measures as well as measures issued by the authorities.
The Criminal Code imposes fines or imprisonment for bribery of healthcare professionals, on both the briber and the bribed healthcare professional.
The implementation of and adherence to industry codes is a self-regulating measure. For any infringement of an applicable industry code, the relevant decision-making body may impose fines and take further measures (eg, publication of the case). For example, potential penalties for non-compliance with the Association of Voluntary Self-regulation for the Pharmaceutical Industry Transparency Code include fines of up to €400,000.
For compliance reasons, it is recommended that pharmaceutical companies apply and adhere to the so-called ‘golden rules’:
- The principle of documentation – all documents and potentially important circumstances should be in writing and recorded accordingly (eg, contract management).
- The principle of transparency – all transfer of values to healthcare professionals should be disclosed to the competent institution or employer of the healthcare professional.
- The principle of separation – maintain a distinction between all activities by healthcare professionals and organisations and procurement decision-making activities in respect of medicinal products.
- The principle of equivalence – remuneration paid to healthcare professionals and organisations for services provided should reflect the fair market value of the service.