Life Sciences 2024 Comparisons

Pharmaceuticals for human use are governed by the German Drug Act (Arzneimittelgesetz, or AMG), which primarily implements the Directive on the Community code relating to medicinal products for human use (Directive 2001/83/EC). In addition, several important German regulations govern the manufacture and distribution of pharmaceuticals and the pricing of prescription-only pharmaceuticals. Since 28 January 2022, pharmaceuticals for veterinary use have been governed by the Regulation on veterinary medicinal products (Regulation (EU) 2019/6), which is complemented by the German Veterinary Drug Act (Tierarzneimittelgesetz, or TAMG).

Since 26 May 2021, medical devices have been governed by the Regulation on medical devices (Regulation (EU) 2017/745) (MDR), which is complemented by the German Medical Device Law Implementation Act (Medizinprodukterecht-Durchführungsgesetz, or MPDG) as well as several further implementing German regulations. Since 26 May 2022, in vitro diagnostics have been governed by the Regulation on in vitro diagnostic medical devices (Regulation (EU) 2017/746) (IVDR), which is also complemented by the MPDG. For legacy medical devices and in vitro diagnostics, transitional provisions apply.

Regulatory oversight both of pharmaceuticals and medical devices is divided between federal authorities and state-level authorities.

With regard to pharmaceuticals, the federal regulatory authorities Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) and Paul-Ehrlich-Institut (PEI) are responsible for issuing national marketing authorisations (MAs), for approving clinical trials, and for pharmacovigilance. The PEI assumes these responsibilities for biological pharmaceuticals, such as vaccines and advanced therapy medicinal products (ATMP), whereas the BfArM is responsible for all other pharmaceuticals (centralised MAs are issued by the EC based on the evaluation of the European Medicines Agency (EMA) under the Regulation (EC) No 726/2004). The state-level authorities are responsible for issuing manufacturing, wholesale distribution and import licences, as well as for overseeing, ascertaining (through inspections) and enforcing compliance with applicable pharmaceutical laws.

As regards medical devices, the BfArM is responsible for classification decisions, clinical trial approvals and vigilance. Meanwhile, the state-level authorities are responsible for general oversight, inspections and enforcement.

The BfArM and the PEI are independent federal authorities within the portfolio of the Federal Ministry of Health and are subject to its oversight. The Federal Ministry of Health has the authority to issue directives to the BfArM and the PEI. The same applies mutatis mutandis to state-level authorities.

Enforceable decisions by regulatory bodies qualify as administrative acts, which can be challenged by the addressee (or by a third party with standing) by lodging an objection with the regulatory body that has issued the administrative act. By default, the objection has suspensory effect and impedes enforcement of the challenged administrative act. However, the regulatory body can order the immediate execution of the administrative act, notwithstanding the pending objection. In such case, the addressee of the administrative act (or a third party with standing) can submit a request to the competent administrative court to (re-)establish the suspensory effect of the objection, which (if successful) precludes enforcement until a final decision is obtained ‒ either the objection is sustained by the regulatory body or, upon filing a lawsuit against the administrative act and the unsuccessful objection proceeding, the administrative act is either confirmed or lifted by the administrative courts.

Objections against administrative acts, as well as requests for the (re-)establishment of suspensory effect and lawsuits, must be lodged in writing or electronically and within one month of notification of the decision to be challenged.

The aforementioned procedure applies to pharmaceuticals and medical devices as well as to other regulated products.

Pharmaceuticals may qualify as prescription-only, pharmacy-only, and freely sellable pharmaceuticals. Prescription-only medicinal products also qualify as pharmacy-only at the same time and may not be advertised to the public and, as with pharmacy-only pharmaceuticals, can only be dispensed by pharmacies (including online/mail-order pharmacies).

The same three-pronged distinction applies to medical devices. However, unlike pharmaceuticals, most medical devices are freely sellable and not qualified as prescription-only or pharmacy-only.

Since 31 January 2022, clinical trials of pharmaceuticals have been governed by the Regulation on clinical trials on medicinal products for human use (Regulation (EU) No 536/2014) (CTR) and new complementing provisions in the AMG. However, in certain scenarios, ongoing clinical trials of pharmaceuticals may continue to be conducted under the legacy national AMG rules during a three-year transition period that expires on 30 January 2025 (see 2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial).

Since May 2021, clinical trials of medical devices have been governed by the MDR and the MPDG. The same governance applies for clinical trials of in vitro diagnostics as of 26 May 2022.

Clinical trials require prior authorisation by the BfArM (or, in the case of biological pharmaceuticals such as vaccines, ATMPs and certain in vitro diagnostic medical devices, by the PEI) and – as part thereof or a prerequisite thereto – a positive opinion by the competent ethics committee. The focus of the authorisation procedure before the federal regulatory authority is the quality, efficacy/performance and safety of the investigational pharmaceutical or medical device. The focus of the review by the ethics committee is the ethical and scientific justification of the clinical trial – in particular, taking into account the rights of the trial participants.

Non-interventional clinical studies are excluded from the scope of the aforementioned regulations, but may, under the applicable state laws and regulations, require involvement of the ethics committee of the local physicians' association.

For clinical trials of pharmaceuticals under the CTR, the sponsor must – as of 31 January 2023 ‒ submit an application dossier electronically through the newly established Clinical Trials Information System (CTIS), which is the single-entry point for the submission of clinical trials under the CTR. Since 31 January 2023, clinical trials can no longer be commenced under the legacy AMG rules. Clinical trials authorised under the AMG rules that are expected to continue beyond 30 January 2025 need to be transitioned to the CTR/CTIS.

Applications through the CTIS will cover both the scientific review of the clinical trial by the competent federal regulatory authority (the BfArM or the PEI) as well as the ethical review by the competent ethics committee.

Applications for authorisation of clinical trials of medical devices by the BfArM, as well as for the prerequisite positive opinion by the competent ethics committee, must be submitted electronically through the German Medical Devices Information and Database System (Deutsches Medizinprodukte-Informations- und Datenbanksystem, or DMIDS) portal. The new application procedure established under the MDR and the IVDR is not yet applicable because the necessary new European Database on Medical Devices (Eudamed) is not yet fully functional and currently is not expected to become functional until 2027.

The competent federal regulatory authority (and, if applicable, the ethics committee) must acknowledge receipt within ten days and, in the case of formal deficiencies, request their remediation within ten days (14 days under the legacy AMG rules).

The assessment of formally completed applications for clinical trial authorisations will be completed by the competent federal regulatory authority within 45 days following the validation of the application (different timeframes apply under legacy AMG rules). Up to five days after the assessment phase, the decision on whether the clinical trial can be conducted will be issued. The relevant authority or ethics committee may request additional information from the applicant; until the receipt of any such information, the clock is stopped.

Subsequent significant changes to the approved clinical trial may only be implemented following prior approval by the federal regulatory authority (and/or the competent ethics committee, if applicable), depending on the subject matter of the change.

Clinical trial authorisations, as well as favourable ethics committee opinions, can be suspended or revoked if the conditions for approval of the clinical trial are no longer met.

In January 2024, the German Ministry of Health published a draft Act on Medical Research (Medizinforschungsgesetz) to strengthen the pharmaceutical industry in Germany. This provides for certain measures to streamline and accelerate the clinical trial authorisation procedure.

For pharmaceuticals, information on approved clinical trials performed under the legacy AMG rules are publicly accessible under the EU Clinical Trials Register. For clinical trials approved under the CTR, information is available on the CTIS platform.

Sponsors of clinical trials of pharmaceuticals must submit a report of the clinical trial results to the CTIS within one year of completion (or within six months for clinical trials governed by legacy AMG rules). This report is then published on the aforementioned databases.

In accordance with its Policy 0070, the EMA already publishes clinical data that pharmaceutical companies have submitted to support their centralised MA applications on its website.

Information on clinical trials of medical devices is currently not made available in free public databases. However, the MDR and the IVDR provide for the transparency of clinical trial information through the Eudamed database. The obligations of sponsors of clinical trials of medical devices to submit clinical trial results will come into force six months after publication of the EC notice that the clinical investigations and performance studies module of the Eudamed database has achieved full functionality. The EC recently announced the module will not be completed before the third quarter of 2026.

At the present time, there are no German regulations on the use of online tools to support clinical trials. However, in the light of experiences resulting from the hybrid clinical trial set-ups borne out of necessity during the COVID-19 lockdowns (and the emerging discussion on decentralised or entirely siteless clinical trials), guidance in this field can be expected in the future. Specifically, the recently proposed draft Act on Medical Research (see 2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial) explicitly allows that the consent of the trial participant may also be given electronically, provided it is signed through a qualified electronic signature. Generally, any use of clinical trials must comply with data protection requirements under the EU General Data Protection Regulation (GDPR) and applicable implementing and complementing German laws at federal and state level.

The clinical trial data directly generated in the trial – whether in “raw” form, as maintained at the clinical trial site, or in pseudonymised form, as subsequently transferred from the clinical trial centre to the sponsor – is considered “special category data”. Its processing is conditioned to higher requirements set out in Article 9(2) of the GDPR. Only anonymised data does not fall under the requirements of the GDPR, but anonymised clinical data is of limited use and the requirements for anonymisation are set at a high level. German law requires that clinical trial participants not only provide their informed consent to their participation in the clinical trial, but also provide their consent to the processing of their data by signing informed consents as approved by the competent ethics committee in the clinical trial authorisation procedure.

A transfer of clinical data that falls under the GDPR (ie, non-anonymised data) is generally only possible if covered by the informed consent of the trial participants. Whether – in the absence of express informed consent by the trial participants – the transfer of such data can also be justified by the purposes of scientific research under Article 9(2) lit. j of the GDPR depends on the specific situation.

The creation of a database containing personal data of trial subjects would need to comply with the requirements set out in the GDPR. Notably, the trial participants need to be informed about the use and storage of their data in such a database, and the database must meet applicable data security requirements. To the extent that the database is operated by a third party, that third party must itself comply with the GDPR. To the extent that the database is hosted outside the EU, or data are otherwise transferred outside the EU, the rules and ECJ case law regarding the transfer of personal data out of the EU must be complied with. Further data protection regulation is to be expected once the EC’s draft regulation to establish a European Health Data Space (EHDS), which includes the secondary use of data, comes into force.

German law defines pharmaceuticals as substances or preparations made from substances that are intended to treat, mitigate or prevent diseases or to restore, correct or modify physiological functions through a pharmacological, immunological or metabolic effect, or to make a medical diagnosis. Medical devices are defined as products – including devices, instruments, in vitro diagnostics, software, but also substances – that are intended for a medical use, but which achieve their principal intended action in or on the human body by means other than pharmacological, immunological or metabolic means.

Accordingly, the key criteria for classifying borderline products as either a pharmaceutical or a medical device relates to:

• identifying the principal intended purpose; and
• analysing whether such purpose is achieved by pharmacological, immunological or metabolic means.

Guidance on the interpretation of these terms has been published by the Medical Devices Co-ordination Group (MDCG), an EU expert body established under the MDR. The MDCG Guidance 2022–25 carries substantial weight and is available in its most current (April 2022) version via the EC website. Further guidance with specific examples can be found in the so-called “Borderline Manual” (current Version 3 of September 2023), also prepared by MDCG.

The responsibility for classifying a product appropriately lies with its manufacturer. If a product is granted an MA as a pharmaceutical, it will be considered as a pharmaceutical as long as the MA is in force. Conversely, however, Conformité Européenne (CE)-marking a product after conformity assessment in accordance with medical device law does not ensure that the implied classification as a medical device will be upheld if challenged by regulators or by competitors in court. Nevertheless, a manufacturer or the state supervisory authorities can apply to the BfArM for a binding decision as to whether the product in question qualifies as a medical device. The BfArM, in turn, may refer any such request to the EC for a decision by way of implementing the acts pursuant to Article 4 of the MDR.

German law does not, in principle, provide for different MA procedures for biological medicinal products (unlike, for example, the USA). However, the requirements regarding the contents of the dossier are different from those for biological medicinal products, owing to the importance of the manufacturing process of the biological medicinal product. Similarly, the MAs of biosimilars require substantially more documentation than MAs for generics of non-biological originator medicines.

Procedurally, MAs for biological medicinal products – provided they are not authorised by the EC under an EU-wide centralised MA – are granted by the PEI rather than the BfArM (see 1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices).

MAs are issued for an initial period of five years. If renewed upon request, at least nine months prior to the expiry of its initial term, the MA remains valid for an unlimited period of time. The MA may, upon renewal, be limited again for a five-year period only if the initial five-year period did not provide sufficient real-life data to guarantee the safety of the medicinal product.

An MA can be suspended or revoked if legal requirements for the MA ‒ for example, safety, efficacy and quality – are not met or are no longer met. Furthermore, an MA can be revoked under the “sunset clause” if the authorised pharmaceutical is not placed on the market within three years of the issuance of the MA or if the marketing of a pharmaceutical placed in the market is suspended for three successive years.

For medical devices, certificates issued by notified bodies that support the CE-marking of the medical device by the manufacturer are valid for up to five years. Certificates issued by notified bodies can be reduced in scope, suspended or revoked by the notified body if the requirements for issuance of the certificate are not met or are no longer met.

An MA for a pharmaceutical for human use can be obtained by the following means.

• Centralised procedure ‒ through an application to the European Medicines Agency (EMA), with a view to obtaining a centralised MA valid in the entire EU/European Economic Area (EEA). The EMA shall give an opinion on the application within 210 days and the opinion is the basis for the decision by the EC to grant the centralised MA.
• National procedure ‒ through an application to the BfArM (or to the PEI for biological pharmaceuticals), with a view to obtaining a national MA valid in Germany. The statutory timeframe for issuing the MA is seven months upon receipt of a completed application. Where a national MA is to be applied for in several member states (decentralised procedure, or DCP), the reference member state will draw up a draft assessment report within 120 days and each member state shall take a decision within 90 days of receipt of these drafts. Where a national MA for the medicine has already been issued in another member state, that member state must submit an up-to-date assessment of the approved assessment to the German authority, which will make a decision on the application based on the other state՚s assessment within another 90 days (mutual recognition procedure, or MRP).

Changes to MAs for pharmaceuticals are submitted electronically to the competent regulatory authority (the EMA, the BfArM, or the PEI). Depending on their impact on the safety, quality and efficacy of the product, variations are classified as IA, IB or II. The former only require a notification, whereas the latter require prior approval.

Centralised MAs can be transferred following the procedure set out in Regulation (EC) No 2141/96. MAs issued by German authorities are transferred by contractual agreement between the current holder and future holder, and the new MA holder is subsequently notified to the competent federal regulatory authority (the BfArM or the PEI).

For medical devices, the CE mark may be affixed to the device once the manufacturer has conducted a conformity assessment. Depending on the risk-classification of the medical device, the conformity assessment requires the involvement of a notified body and the issuance of the certification by that notified body. A transfer of the CE mark is not possible legally; rather, the new manufacturer of the medical device must obtain and meet all the requirements necessary to CE-mark the medical device under their own name.

Besides clinical trials, pharmaceuticals that require an MA but are not authorised (yet) may only be supplied to patients in the following scenarios.

• Compassionate-use programmes ‒ for patients with a chronically or seriously debilitating disease (or whose disease is considered to be life-threatening) who cannot be treated satisfactorily by an authorised medicinal product. The pharmaceutical concerned must either be the subject of a pending MA application or must be undergoing clinical trials. In Germany, pharmaceuticals supplied under a compassionate-use programme may only be supplied free of charge.
• Named-patient programmes – upon prescription for a specific patient, pharmacies may import and dispense to that patient a limited quantity of medicinal products that are authorised in the country of export (but not in Germany) if no comparable medicines are available in Germany. A named-patient programme does not need to be authorised or notified to a regulatory authority.

German medical device law does not provide for compassionate-use programmes or named-patient exceptions for medical devices that need to bear a CE mark. However, the BfArM may ‒ upon request in individual cases – authorise the use of non-CE-marked devices under Section 7 of the MPDG (see Article 59 of the MDR) if their use is in the interest of public health or patient safety or health.

For pharmaceuticals, the MA holders must fulfil several ongoing obligations, including the following:

• to keep the dossier of the product up to date and notify, or submit variations to, the competent regulatory authority if the particulars set out in the MA change;
• to set up, maintain and audit a pharmacovigilance system, appoint a qualified person for pharmacovigilance (Stufenplanbeauftragter), maintain a pharmacovigilance master file, operate a risk management system for the pharmaceuticals, document and report suspected adverse reactions, monitor scientific literature for safety signals, prepare and submit periodic safety update reports;
• to appoint an information officer (Informationsbeauftragter) who is responsible for ensuring that the product labelling, package-insert leaflets, and summary of product characteristics, as well as all promotional material, is in line with the terms of the MA; and
• to take out and maintain product liability insurance that fully covers the specific statutory no-fault liability of the MA holder under the AMG.

Similarly, manufacturers of medical devices – ie, those who are indicated as the manufacturer in the labelling – are subject to a number of obligations under the MDR/IVDR, including the following:

• to keep the technical documentation of the device up to date;
• to appoint a person responsible for regulatory compliance (PRRC);
• to maintain and provide unique device identifier (UDI) information to improve the traceability of medical devices; and
• to comply with technovigilance reporting obligations, conduct post-market clinical follow-up (PMCF) activities, prepare post-market surveillance (PMS) reports or regular periodic safety update reports (PSUR), and prepare trend reports on safety signals. Further ongoing obligations for post-market surveillance can be derived from the manufacturer’s quality system, which typically implements the requirements of the harmonised technical standard ISO 13485:2016.

Although the EMA does publish a list of “medicines under evaluation”, the German federal regulators do not proactively publish pending MA applications under review. Details about approved pharmaceuticals are available in the public section of the database “AMIce” (Arzneimittel-Informationssystem).

Requests for information about pending, granted or rejected MA applications can be submitted to the BfArM or the PEI under the German Freedom of Information Act (Informationsfreiheitsgesetz, or IFG). However, to the extent that the requested information contains personal data, is protected by IP rights or constitutes confidential business information, that information will be redacted or will not be disclosed. The authority will typically ask the MA holder whether they consent to the requested disclosure and will allow for comment on the proposed redactions. Generally, the German regulatory authorities are more protective of the MA holder՚s information than the EMA.

As medical devices are not subject to a governmental approval process under current medical device law, any information about medical devices undergoing conformity assessment remains with the manufacturer and the notified body, who – as private parties – are not subject to the Freedom of Information Act. For medical devices placed on the market in Germany and notified to the BfArM, a limited set of information is available on the DMIDS database (accessible through the BfArM website). Under the MDR and the IVDR, certain information about medical devices is already made publicly available through the Eudamed database – namely, basic information about the economic operators (manufacturers, importers, distributors), about devices and about CE certificates issued by notified bodies. Eudamed will be expanded in the coming years to make certain clinical trial and performance evaluation data, PMS and vigilance information (such as field safety notices), and market surveillance information of the supervisory authorities publicly available also.

With regard to pharmaceuticals, the EU Falsified Medicines Directive (Directive 2011/62/EU) has been implemented into German drug law on the following basis.

• To prevent falsified prescription-only medicines entering the supply chain, prescription-only medicines must bear an anti-tampering device (eg, a sealing strip), which allows verification that the pack has not been opened, and a unique identifier to verify the authenticity of the pack (serialisation) – the details are set forth in the Delegated Regulation (EU) 2016/161.
• The import and distribution of falsified pharmaceuticals in Germany is expressly prohibited and is subject to penal sanctions. The regulatory authorities are authorised to take enforcement action against falsified medicines, including seizure.
• MA holders, wholesale distributors, and pharmacies are subject to increased control and notification obligations to identify and report falsified medicines.

Under the MDR and the IVDR, importers and distributors of medical devices have the obligation to inform the competent authorities of suspected falsified devices. The authorities may, where necessary to protect public health, confiscate, destroy or otherwise render inoperable any such falsified devices.

The Federal Ministry of Finances and the customs authorities are responsible for enforcing German drug law with regard to pharmaceuticals imported from (or exported to) non-EU countries. The customs authorities will verify upon import the relevant import documentation, including whether a certificate attesting that the manufacture in the country of export complies with good manufacturing practices. If in doubt, the German customs authorities will liaise with the German regulatory authorities. German customs authorities regularly report on the numbers and types of intercepted counterfeit pharmaceuticals.

Similarly, the German customs authorities are responsible for enforcing compliance of imported medical devices with the applicable law, in accordance with Regulation (EC) No 765/2008. When determining further action, the German customs authorities will liaise with the competent German regulatory surveillance authorities if a medical device:

• displays characteristics that give cause to believe that the device presents a serious health or safety risk;
• is not accompanied by the required documentation or not marked as required; or
• has a CE mark that has been affixed to the device in a false or misleading manner.

In addition to the foregoing, border measures can be based on IP rights (see 10.1 Counterfeit Pharmaceuticals and Medical Devices).

The manufacture of pharmaceuticals (which also includes packaging, labelling and final release of the finished product) is subject to a manufacturing authorisation. The authorisation is granted by the competent authority of the federal state in which the manufacturing site is located. In order to obtain a manufacturing authorisation, the applicant must:

• appoint a Qualified Person (QP), as well as a Head of Production and a Head of Quality Control, each of whom must be appropriately qualified – the QP must also be experienced and reliable, to be evidenced through a clean criminal record certificate;
• have other appropriately qualified and trained personnel to conduct the manufacturing activities;
• have the appropriate premises for performing the manufacturing activities; and
• set up and maintain a quality system, consisting of standard operating procedures, which covers the manufacturing activities, and have the staff trained to its content.

The manufacturing licence will only be issued after a successful on-site inspection of the manufacturing premises by the regulatory authority. The statutory timeframe for issuing a manufacturing licence is three months from the submission of a complete application. However, follow-up requests by the authority or deficiencies identified in the inspection will stop the clock.

The manufacturing authorisation is granted for a specific site and typically for specific manufacturing activities and types of medicines – sometimes only covering individually specified medicinal products. It is issued for an unlimited time but remains subject to regular Good Manufacturing Practice (GMP) inspections by the competent authority.

The manufacture of medical devices is not subject to a governmental authorisation. The quality of the manufacturing processes is regulated indirectly through the conformity assessment of the respective device and the manufacturer՚s quality system, which supports the conformity assessment.

The wholesale distribution of pharmaceuticals is subject to a wholesale distribution licence (WDL). Wholesale distribution is not limited to the physical handling and storage of pharmaceuticals. A WDL is also needed for procuring, selling and supplying pharmaceuticals, even when the physical handling and logistics are outsourced to a third party. However, a manufacturer does not need a WDL for supplying and distributing pharmaceuticals that it has manufactured – any such supply and distribution is covered by the manufacturing licence.

The WDL is granted by the competent authority of the federal state in which the wholesale distribution site is located. In order to obtain a WDL, the applicant must:

• appoint a Responsible Person (RP) for wholesale distribution, who must be appropriately qualified, experienced and reliable – the latter to be evidenced through a clean criminal record certificate;
• have other appropriately qualified and trained personnel to conduct the wholesale distribution activities, as necessary;
• have the appropriate premises for performing the wholesale distribution activities; and
• set up and maintain a quality system, consisting of standard operating procedures, which covers the manufacturing activities, and have the staff trained to its content – this quality system shall in particular ensure that medicines are only sourced from (and supplied to) entities that are authorised to supply or procure such medicines, that all procurement and supply of pharmaceuticals is properly documented, and that recalls can be implemented.

The WDL will only be issued after a successful on-site inspection of the wholesale distribution site by the regulatory authority. The statutory timeframe for issuing a WDL is three months from the submission of a complete application. However, follow-up requests by the authority or deficiencies identified in the inspection will stop the clock.

As with a manufacturing authorisation, the WDL is granted for a specific site, for specific distribution activities and for specific types of medicines (including or excluding, for example, blood products, controlled substances, or temperature-controlled products). It is issued for an unlimited time, but remains subject to regular GDP inspections by the competent authority.

The distribution of medical devices is not subject to a governmental authorisation. However, under the MDR/IVDR, distributors are subject to certain obligations to ensure that only compliant medical devices are made available on the market (see Article 14 of the MDR/IVDR).

See 1.3 Different Categories of Pharmaceuticals and Medical Devices.

The import and export of pharmaceuticals is governed by the AMG – notably, its Sections 72 et seq.

The import of medical devices and in vitro diagnostics is regulated in the MDR and IVDR, respectively, by assigning regulatory responsibilities and duties to the importer where the manufacturer is not established in the EU and has not assigned an authorised EU representative (see 6.3 Prior Authorisations for the Importation of Pharmaceuticals and Medical Devices).

In order to import from outside the EU and EEA member states into Germany or to export from Germany outside the EU/EEA, an operator is required to have an EORI-number (EU-wide applicable customs registration number). Applying for a customs credit (deferred payment) and possibly providing a customs guarantee may allow the applicant to benefit from simplified customs operations (eg, electronic customs declarations, payment of duties online, simplified procedures). In addition, an operator may choose to apply for the status of Authorised Economic Operator (AEO), which should entail a pre-approval for most customs authorisations.

With regard to regulatory requirements, see 6.3 Prior Authorisations for the Importation of Pharmaceuticals and Medical Devices.

Pharmaceuticals may only be imported from outside the EU and the EEA member states (Norway, Iceland and Liechtenstein) into Germany if an MA for any such pharmaceutical is in place and if the importer holds an import authorisation. The issuance, scope and resulting obligations of an import authorisation are analogous to a manufacturing authorisation (see 4.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices). Exemptions from the requirements of an MA and an import authorisation requirement apply, inter alia, to:

• pharmaceuticals for the importer՚s own scientific use (except for clinical trials);
• pharmaceuticals imported in small quantities by the MA holder or an authorised manufacturer as samples or for analytical purposes;
• pharmaceuticals imported by an authorised manufacturer for further processing;
• pharmaceuticals imported by an MA holder, authorised manufacturer or wholesale distributor intended for further shipment into other EU member states;
• pharmaceuticals imported in small quantities for personal use;
• samples imported for use by regulatory authorities; and
• imports by pharmacies in connection with a “named-patient programme” (see 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations).

The import of medical devices from outside the EU and the EEA member states into Germany does not require a governmental authorisation. However, the imported medical devices must be lawfully CE-marked (based on a complete conformity assessment) and the importer will bear the regulatory responsibility for the device if the manufacturer is based outside the EU/EEA and has not appointed an authorised representative. Under the MDR/IVDR, the importer is subject to additional obligations to ensure that only compliant medical devices are imported and made available on the market (see Article 13 of the MDR/IVDR).

The applicable non-tariff regulations depend on whether an imported product qualifies as a pharmaceutical, a medical device or another type of product. This in turn depends on whether that product meets the statutory product definition under the AMG or the applicable medical device regulations (for details, see 1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices and 3.1 Product Classification: Pharmaceuticals or Medical Devices).

Germany is a member of the EU and thus participates in the free trade arrangements concluded by the EU. It is also a member of the World Trade Organization (WTO).

Pharmaceuticals

The AMG (notably, its Section 78) and the German Drug Pricing Regulation (Arzneimittelpreisverordnung, or AMPreisV) set out whether pharmaceuticals are subject to price controls and, if so, also set out the price margins of wholesalers and pharmacies. Generally, only prescription-only pharmaceuticals that are dispensed in pharmacies are subject to price controls and fixed margins. Non-prescription pharmaceuticals, as well as prescription-only pharmaceuticals dispensed directly to hospitals, are exempt from the general statutory price controls.

Under German constitutional law, the pharmaceutical company is free to set its sales price. However, the public health insurance funds are not obliged to reimburse such prices in full. Rather, for pharmaceuticals that are subject to price control under the German AMG and German AMPreisV, the German Social Code V (Sozialgesetzbuch V, or SGB V) – which regulates the public health service and the public health insurance system that covers approximately 90% of the German population – provides for several price control mechanisms.

Early benefit assessment and reimbursement price negotiations (AMNOG)

As of 1 January 2011, the so-called AMNOG Act has introduced a price control mechanism for pharmaceuticals with a new active substance. Reimbursement prices for such innovative pharmaceuticals are negotiated between the MA holder and the Central Federal Association of Health Insurance Funds (GKV-Spitzenverband) on the basis of a so-called “benefit assessment”. As of 12 November 2022, the Act to Stabilise the Financing of the Public Health Insurance (GKV-FinStG) has materially tightened the AMNOG rules with an effort to curb public prescription-drug spending.

The process has two consecutive preparatory phases of six months each, as follows.

• Phase 1 (one to six months after product launch in Germany) – upon the launch of the medicine on the German market, the MA holder must submit a dossier demonstrating (through clinical evidence) the additional therapeutic benefit of the new medicinal product in comparison with the so-called appropriate comparator therapy, ie current standard treatment. Orphan drugs enjoy certain exemptions from this requirement if the annual outpatient turnover in Germany does not exceed EUR30 million (EUR50 million prior to the GKV-FinStG). Based on the assessment of the data in the submitted dossier, the Federal Joint Committee of the German public health insurance system (Gemeinsamer Bundesausschuss, or GBA) determines the scope and degree of the additional therapeutic benefit of the new medicine.
• Phase 2 (seven to 12 months after product launch in Germany) – the additional therapeutic benefit determined by the GBA is a key factor for subsequent reimbursement price negotiations between the MA holder and GKV-Spitzenverband during the seven to 12 months following the launch. The GKV-FinStG has emphasised the prejudicial nature of the additional therapeutic benefit assessment on the negotiable reimbursement price by establishing several mandatory price ceilings linked to certain assessment outcomes. By way of example, if no additional therapeutic benefit is found and the comparator therapy is still patent-protected, the negotiated reimbursement price for the new medicinal product must result in annual therapy cost that is at least 10% lower than the patent-protected comparator therapy, effectively penalising the new medicinal product. The agreed reimbursement price will apply retroactively for all patients in Germany (including those privately insured) from the seventh month of the market launch onwards (before the GKV-FinStG: only from the 13th month onwards). If the MA holder and GKV-Spitzenverband fail to agree on a reimbursement price for the new medicine, a reimbursement price will be unilaterally set by an arbitration board, with retroactive effect to the seventh month since the market launch.

In the first year of the marketing, and until the reimbursement price kicks in at the beginning of the seventh month following the market launch, the new medicinal product will by default be reimbursed at the price set by the MA holder. With the new EU Health Technology Assessment (HTA) Regulation (EU) 2021/2282, the benefit assessment of new therapies will gradually be regulated for the first time at an EU level. Starting with new oncology pharmaceuticals and ATMPs only in January 2025, the assessment will take place in parallel with the EU regulatory MA process. The scope of the EU HTA process will be expanded to orphan drugs in January 2028 and to all other medicines in January 2030. As a result, the German AMNOG assessment procedures are expected to be adjusted to ensure a seamless link of the EU and national assessment procedures.

Reimbursement price caps for established therapeutic classes

The GBA can establish therapeutic classes of pharmaceuticals that cover a group of pharmaceuticals of similar or comparable active substance and comparable therapeutic effect. For each class, the GBA will set (and review annually) reimbursement price caps, which generally lie in the lower third of the range between the lowest price and the highest price of all pharmaceuticals in that class. Public health insurance will only reimburse these pharmaceuticals up to the cap; if the MA holder sets a higher price, the patient will need to pay the difference. This price control primarily, but not exclusively, affects generics.

Statutory rebates

MA holders must reimburse a statutory rebate of 7%, temporarily raised to 12% for the 2023 calendar year by the GKV-FinStG, (for patent-protected pharmaceuticals) and 16% (for generics and the corresponding off-patent reference pharmaceuticals) to public health insurance funds. Statutory rebates do not apply for pharmaceuticals in established therapeutic classes subject to the reimbursement price caps.

Price freeze

Since 1 August 2010, MA holders must pay back to public health insurance funds any increase in price beyond the price effective on 1 August 2009. Since 1 August 2018, the reference price level is adjusted annually for inflation. The price freeze, which has been prolonged until end of 2026 by the GKV-FinStG, does not apply where a reimbursement price is set based on the early benefit assessment or capped for an established therapeutic class. Current legislative initiatives seek to exempt supply-critical, off-patent pharmaceuticals without a therapeutic alternative from the price freeze.

The prices for pharmaceuticals that are not covered by Section 78 of the AMG and AMPreisV (mainly non-reimbursable medicines) can be set or negotiated freely.

Medical Devices

German medical device law does not provide for price controls. German public healthcare law, in turn, does not provide for a common reimbursement and pricing mechanism for all medical devices. Rather:

• where medical devices are part of the outpatient medical therapy (eg, ophthalmic medical devices that can be implanted in an outpatient setting), the healthcare provider is generally reimbursed for the purchase price by the public health insurance fund ‒ however, regional collective agreements may provide for particular reimbursement requirements and price caps; and
• medical devices prescribed by a healthcare provider that serve to secure the medical therapy, or mitigate or compensate the effects of injuries, are qualified as auxiliary devices (Hilfsmittel). Suppliers of auxiliary devices must meet pre-qualification requirements and enter into supply agreements with public health insurance funds in order to be entitled to supply (and be reimbursed for) auxiliary devices to insured patients. Furthermore, auxiliary devices may be grouped in established therapeutic classes similarly to pharmaceuticals, with a view to capping the reimbursement price.

The actual sales price in other EU countries will be taken into account in the AMNOG reimbursement price negotiations for innovative pharmaceuticals (see 7.1 Price Control for Pharmaceuticals and Medical Devices).

90% of the German population is enrolled in the statutory health system. These patients have a right to be provided with all treatments (including pharmaceuticals and medical devices), which are medically necessary, sufficient and cost-effective. This means that the coverage of pharmaceuticals is generally limited to prescription-only medicines, and the cost is controlled through various statutory price control mechanisms (see 7.1 Price Control for Pharmaceuticals and Medical Devices) and by tenders of the statutory health insurance funds.

The additional benefit of novel pharmaceuticals by comparison to the standard therapy is a key factor in negotiating the reimbursement price (see 7.1 Price Control for Pharmaceuticals and Medical Devices).

Physicians are subject to various mechanisms to ensure that their prescribing of pharmaceuticals is cost-efficient. Physicians who prescribe excessively may be required to pay damages to the public healthcare system.

In order to curb pharmaceutical spending, pharmacies must observe several substitution rules designed to increase the dispensing of generics or cheaper parallel-imported pharmaceuticals rather than originator products. A pharmacist who fails to comply with those substitution rules must pay back to the public healthcare system the full price of the dispensed product, without the option to offset the theoretical cost of the cheaper alternative that should have been dispensed under the substitution rules.

Medical apps may qualify as medical devices if the app meets the definition of a medical device (see 3.1 Product Classification: Pharmaceuticals or Medical Devices). The MDCG Guidance 2019-11 on the qualification and classification of software offers additional criteria to operationalise the general medical device definition for software. A key criterion within the five-step decision tree proposed by the MDCG Guidance 2019-11 is whether the app performs actions on data for a specific patient that go beyond mere storage, archival, lossless compression, communication, or simple search. One test is whether the app creates or modifies medical information through its own algorithm.

Many medical apps that were classified as risk class I before the MDR may classify as class IIa or higher under the MDR. As a result, their re-certification under the MDR will require the involvement of a notified body (see 3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices). Until (re-)certification under the MDR, such apps may continue to be marketed under their pre-MDR certification until 31 December 2028 – subject to several conditions, including that their design and intended purpose are not significantly changed.

If a medical app qualifies as a medical device of class I, IIa or IIb, that medical app can qualify as a Digital Health Application (DiGA) and be eligible for prescription by physicians and reimbursement by the public health insurance system (“app on prescription”). This reimbursement mechanism for medical apps was introduced in late 2019 and is the first statutory reimbursement mechanism for medical apps in the world. In order to be included in the DiGA Directory of reimbursable apps, the manufacturer of the DiGA must submit an application to the BfArM, showing that:

• the main function and medical purpose of the DiGA is based on digital technologies and functions;
• beyond security and functionality (evidenced through the CE mark), quality, data protection, data security and inter-operability requirements are met; and
• the use of the DiGA provides positive healthcare effects (patient-relevant medical benefit, structural and procedural improvements in healthcare) – as to medical devices of class IIb, the use must provide a medical benefit.

If positive care effects are not excluded, but supporting data is not yet available, DiGAs can be temporarily admitted to the DiGA Directory for up to 12 months (in exceptional cases, 24 months) to generate that data. Once the data is available, the reimbursement price for the DiGA will be negotiated in a process that is comparable to the AMNOG procedure for novel pharmaceuticals (see 7.1 Price Control for Pharmaceuticals and Medical Devices). In 2021, the DiGA concept was extended to Digital Nursing Apps (DiPA), such as fall prevention apps or personalised memory games for people with dementia.

German doctors may provide telemedicine services where face-to-face patient contact is not medically required. In 2019, the anachronistic prohibitions to advertise for such telemedicine services and to dispense medicines prescribed through a telemedicine service have been lifted. However, the promotion of telemedicine services remains challenging because new case law only allows the promotion of telemedicine services to the extent that it is proven that the promoted service complies with generally accepted professional standards.

In the public healthcare system, the telemedicine services that are reimbursed to the doctors are growing. Pushed forward with the recently passed Digital Act, telemedicine will become an integral part of statutory healthcare. To this end, the previous quantity restriction on video consultations (previously a maximum 30% of all treatment cases) has been lifted. At the same time, medical remuneration is more strongly oriented towards quality features. The collective agreement between GKV-Spitzenverband and the doctors՚ head association sets out requirements on patient authentication, data privacy and quality requirements for the telemedicine service provider that must be complied with in the public healthcare system.

There are no special rules for the online promotion and/or advertising of medicines and medical devices. Rather, companies promoting their medicines or medical devices online must comply with all applicable requirements, including advertising limitations set forth in the Health Product Advertising Act (Heilmittelwerbegesetz, or HWG), pharmacovigilance obligations, and data privacy and telecommunications laws.

From a regulatory perspective, German drug law (the German Drug Prescription Regulation (Arzneimittelverschreibungsverordnung, or AMVV)) and German medical device law (the German Medical Device Dispensing Regulation (Medizinprodukte-Abgabeverordnung, or MPAV)) already allow prescriptions to be issued electronically and be signed by electronic qualified signature.

For patients insured in the public health insurance system (see 7.3 Pharmaceuticals and Medical Devices: Reimbursement From Public Funds), the issuance of e-prescriptions for prescription-only drugs is obligatory as of January 2024. The e-prescription issued by the physician is stored and encrypted in a central database of the federal government’s telematics infrastructure provided by the National Agency for Digital Medicine (gematic), which pharmacies can access. Patients can thus redeem their e-prescription (consisting of a token) either via app, electronic health card or via paper printout at their preferred pharmacy. It is also possible to integrate e-prescriptions into the electronic patient record. The scope is likely to be gradually expanded to all pharmaceuticals.

Medicines and medical devices may be sold online. German pharmacies may also sell both prescription-only and pharmacy-only medicines online if:

• the pharmacist also holds a mail order pharmacy permit (Versandhandelserlaubnis); and
• the mail order business is conducted “out of the pharmacy” in addition to the retail pharmacy business.

Mail order pharmacy activities are not permitted in Germany without running a “bricks-and-mortar” pharmacy.

In addition to German pharmacies, several Dutch online pharmacies located at the Dutch/German border supply the German market, leveraging the free movement of goods within the EU.

In the public health system, which covers approximately 90% of the German population, the electronic patient record (ePA) is currently being rolled out and will be implemented nationwide and automatically for all publicly insured persons by 2025. The Digital Act provides for an opt-out procedure to enhance the amount of users. The ePA is regulated in the Social Code V (see 7.1 Price Control for Pharmaceuticals and Medical Devices). In addition to the German legislation, the digitalisation of health records is currently enhanced by the EC’s proposal for the EHDS, which primarily aims to facilitate cross-border access to and exchange of health data (so-called primary use of data).

As electronic health records qualify as “special category data” under the GDPR, the considerations on clinical trial data in 2.5 Use of Resulting Data From Clinical Trials apply mutatis mutandis to electronic health records.

In Germany, the Patent Act contains the relevant provisions for patents.

There is a huge variety of general patent law issues that can become relevant for pharmaceuticals and medical device products, ranging from the determination of the widest possible scope when applying for a patent to a potential infringement under the doctrine of equivalents in infringement proceedings. In addition, the specific provisions regarding a second and subsequent medical use – as well as the extension of the patent term by way of a supplementary protection certificate set out in 9.3 Patent Term Extension for Pharmaceuticals – often play an important role. Not strictly resulting from patent law provisions, yet of great relevance in patent strategies and litigation, agreements between originators and generic entrants may also be considered as anti-competitive.

There are no specific patentability requirements for pharmaceuticals or medical devices as such. Even though methods for treatment by surgery or therapy and diagnostic methods are not patentable, the use of substances in these methods is explicitly not covered and thus patentable. Further restrictions regarding patentability relate to processes for cloning human beings and for modifying the germinal genetic identity of human beings.

A second or subsequent medical use is patentable if the medical indication is new. Therefore, the type of application or the area of use must not be previously known.

However, generally, it is not sufficient to modify the dosage regime even if this improves the effectiveness of the drug. Notwithstanding, the discovery of the use for new patient populations is patentable if the new patient group can be clearly distinguished from the previously known group.

The preparation and use of the drug for the claimed (second or subsequent) use constitutes patent infringement regarding the (new) patent. Preparation for such use can result from instructions for use delivered with the drug. Nevertheless, the drug can be used in a non-infringing manner for the previously known purpose, provided that this application is not protected (anymore). If there is a prior product patent with broad claims, the patent covering a second or subsequent use may be a dependent invention.

The patent holder of an authorised medicinal product can apply for a supplementary protection certificate (SPC) within six months following the grant of the MA. The SPC can extend the protection term by the time that elapsed between the application for the patent and the MA, reduced by five years. This potential extension is limited to five years, plus six months in cases with completed studies in compliance with an agreed paediatric investigation plan. For each medicinal product, only one SPC can be granted, and the product must be covered by a first MA.

Generally, the certificate confers the same rights as the basic patent, with certain limitations regarding the intended export of the products.

Any third party can bring an action for declaration of invalidity of the certificate before the German Federal Patent Court, according to Section 81 of the German Patent Act.

As for any product patent, infringing actions include the manufacturing, offering, placing on the market or use of a product, as well as importing or possessing it to these ends. Advertising a product may also infringe a patent, even if the advertising only relates to subsequent distribution after the lapsing of the patent.

In order to get injunctive relief, the infringement must be (at least) imminent. The application for an MA is not considered to fulfil the requirement of imminent infringement.

In the case of a medical product that has been authorised more than a year before the term of the patent, but which has not been brought on to the market since, the Higher Regional Court of Düsseldorf found that the grant of the authorisation was generally not sufficient to show that infringement was imminent. Thus, the court rejected imminent infringement, provided that the authorisation would not be withdrawn if it were not used until the end of the patent term.

The German Patent Act provides for an experimental use exemption and, in particular, for the “Roche-Bolar” exemption, which allows the generic entrant to proceed with the application for an MA before the expiry of the patent. The exemption covers all actions that are necessary in order to receive the MA.

Furthermore, there is a (theoretical) option for compulsory licences based on Section 24 of the German Patent Act. Even though this option is not strictly limited to pharmaceuticals or medical devices, the only case in which such a compulsory licence has been granted by the Federal Patent Court (upheld by the Federal Court of Justice) was related to a pharmaceutical product (an anti-retroviral HIV/AIDS medicinal product called “Isentress”). The interested licensee must apply for the grant of the compulsory licence and demonstrate:

• that they failed to receive a licence in compliance with reasonable and common business practices after having tried to receive that licence throughout a reasonable period of time; and
• that the public interest requires the granting of a compulsory licence.

Typically, the patent holder and the exclusive licensee can bring proceedings for patent infringement. The action can include claims for injunctive relief, rendering of accounts, and recall and destruction of infringing products, as well as damages.

The typical procedure begins at one of the most commonly used regional courts for patent litigation, which are Düsseldorf, Mannheim and Munich. The first-instance decision, which is provisionally enforceable, will be reached within eight to 15 months, depending on the court. This decision can be appealed before the higher regional court.

These actions can be requested as preliminary measures ‒ in which case, the courts would generally require that the patent in suit has survived an inter partes validity attack. However, this requirement is often not applied to preliminary measures against generic entrants, meaning preliminary injunctions can be granted. In spring 2021, the Higher Regional Court of Munich requested a preliminary ruling of the ECJ on whether the general requirement of inter partes validity proceedings in order to grant a preliminary injunction is compliant with the IP Enforcement Directive.

Given that Germany has a bifurcated patent system, invalidity is not available as a defence in infringement proceedings on the merits. The alleged infringer must bring a separate nullity action before the Federal Patent Court to invalidate the patent. This nullity action usually takes more than two years, resulting in a so-called injunction gap between the (provisionally) enforceable infringement decision containing injunctive relief and the potential declaration of nullity of the patent in suit. A legislative reform in summer 2021 tightened procedural timelines to close this injunction gap – the statement of defence against a nullity action must now be filed within two months and, as of spring 2022, the German Federal Patent Court will provide a “qualified notice” containing its preliminary assessment of a pending nullity action within six months from filing the action.

Even though German courts tend to be strict when granting preliminary injunctions if the patent has not been confirmed in inter partes validity proceedings, they often make an exception for cases against generic entrants. Therefore, if a generic entrant wishes to enter the market before the expiry of the originator՚s patent, they could file a nullity action before the Federal Patent Court in order to make sure that the potentially infringed patent will be invalidated before market entry. However, this option is very expensive and time-consuming.

There is no patent linkage system in place. Patent law and the laws governing the MA of a generic drug are separate in Germany.

Other than using patent law, an IP rights holder can take action against counterfeit pharmaceuticals and medical devices primarily based on trade mark law.

Trade mark infringement grants the rights holder various remedies, including claims against the counterfeiter to cease and desist infringing the trade mark, claims for damages and siphoning off the profits, and claims for destruction of the infringing products. In order to prevent counterfeit medicines from being imported, the rights holder can also (under Regulation (EU) No 608/2013) request the customs authorities to detain products suspected of infringing the holder՚s trade marks for further determination. Furthermore, trade mark infringement can be criminally sanctioned and expose the counterfeiter to imprisonment of up to three years or to monetary fines.

Pharmaceuticals may not use names which are misleading, particularly regarding the efficacy and safety of the product (Section 8 of the AMG). Similarly, Article 7 of the MDR and the IVDR prohibit the use of any trade mark, name or text in the labelling, instructions claims, marketing and promotion that may mislead the patient regarding the device՚s intended purpose, safety or performance.

The regulatory authorities have issued guidelines specifically in relation to pharmaceuticals on the acceptability of names or human medicinal products. For pharmaceuticals to be authorised centrally by the EC, the guideline by the EMA applies. For pharmaceuticals to be approved nationally, the guideline by the BfArM and the PEI applies. Both guidelines set out further requirements and recommendations for developing an invented name for the pharmaceutical. The German guideline also addresses under which conditions one brand name can be used as an umbrella brand for several products of a product family.

The trade dress and design of pharmaceuticals, medical devices and their packaging may be protected by design rights and by copyright (and potentially also by trade marks). This protection will depend on whether the trade dress or design in question meets the criteria for any such protection. Registering design rights may present a relatively inexpensive way to protect the design of pharmaceuticals and particularly medical devices. Furthermore, the Act against Unfair Trade Practices (Gesetz gegen den unlauteren Wettbewerb, orUWG) may afford the product owner claims against competitors who pass off their products as the original products.

For pharmaceuticals, the data provided by the MA holder in support of the MA application is protected by regulatory data exclusivity for eight years following the granting of the MA. For this eight-year period, other applicants may not cross-refer to the original clinical and pre-clinical data in support of an MA application for a generic copy of the pharmaceutical.

Furthermore, a generic product for which an MA has been granted through reference to the originator MA data may only be placed on the market ten years after the granting of the original MA. If, during the first eight years, a new therapeutic indication has been added to the original MA that brings a major clinical advantage in comparison to existing therapies, the marketing exclusivity can be extended by up to one more year to 11 years (this is known as the “8+2+1” rule). These rules apply equally to chemical drugs and biologics.

This regulatory data protection and marketing exclusivity periods are expected to be reduced – or conditioned on additional requirements ‒ in the future, as part of the EU՚s proposed revision of its general pharmaceutical legislation (the so-called EU Pharma Package). In order to promote the availability of pharmaceuticals across the EU, the proposal of the EC conditions the eight-year regulatory data protection period to the pharmaceutical being made available in all EU members states within the first 24 months of launch, lest the regulatory data protection period be reduced to six years. Counter-proposals by the EU Parliament point in opposite directions. The ultimate impact of the EU Pharma Package on data and market exclusivity periods will depend on the outcome of the upcoming political negotiations in the EU.

For medical devices, no data exclusivity rules apply because medical devices do not require an MA.

On the basis of the amended German Protection Infection Act, the BfArM has been granted authority to grant exemptions from various requirements of German drug law. This included, where necessary, granting:

• exemptions from requirements applicable to clinical trials, MA applications, import of medicines, and compassionate-use programmes; and
• permissions to distribute medicines:
1. with non-compliant labelling;
2. that had not been manufactured in full compliance with GMP; or
3. that were past their expiry date.

This authority expired on 31 December 2023.

As regards medical devices, based on the Commission Recommendation 2020/403, special temporary regimes allowing for the placing on the market of face masks that were not CE-marked were in place until late summer 2020 and enforcement against non-compliant face masks was limited to those presenting a health hazard. Since face masks are no longer in short supply, regulatory enforcement against non-CE-marked face masks has increased (see also the updated Commission Recommendation (EU) 2021/1433).

The EMA issued guidance on the management of clinical trials during the COVID-19 pandemic, to which the BfArM issued complementing guidance. The EMA guidance provided that, subject to a number of specific circumstances, patients participating in clinical trials may have investigational medicines delivered to their homes ‒ with that delivery to be carried out by the trial sites or hospital pharmacies or, exceptionally, through distributors.

As a result of the COVID-19 pandemic, decentralised clinical trials have become more and more relevant. To facilitate the conduct of such clinical trials, the current draft Act on Medical Research (Medizinforschungsgesetz) foresees the direct dispensing of pharmaceuticals by doctors to participants in clinical trials, provided that the safety and pseudonymisation of the participants and the validity of collected data are guaranteed and approval has been granted by the competent higher federal authority. 

In 2022, importers and manufacturers of face masks requested that the BfArM exempt them from performing a full conformity assessment for non-CE-marked imported masks under the legacy medical devices rules applicable before 26 May 2021 (see Article 59 of the MDR, which is currently applicable) and permit them to rely on a fast-track assessment by certain notified bodies. Given that face masks are no longer in short supply, this pathway is no longer permitted.

Generally, GMP certificates for manufacturing and importing sites in the EEA have been automatically extended until the end of 2024.

In March 2020, the German government issued a temporary decree imposing an export ban on certain personal protective equipment such as protective masks. Subsequently, the enforcement of the regulations applicable to face masks imported into the EU and Germany was temporarily halted but has resumed since (see 11.1 Special Regulation for Commercialisation or Distribution of Medicines and Medical Devices).

The German healthcare system is undergoing a concerted digitalisation effort, including the wider use of telemedicine (enhanced by the recently passed Digital Act), which had been initiated before and independently of COVID-19. According to public polls, however, COVID-19 has sparked both more doctors to provide – and more patients to use ‒ telemedicine services.

The German government has not announced any intention to issue compulsory licences for treatments or vaccines related to COVID-19. However, the German Infection Protection Act states that the Federal Ministry of Health is entitled to issue an order whereby an invention is to be used in the interest of the public welfare (Section 13 of German Patent Act). Revisions on the compulsory licensing of IP rights at an EU level can be expected – initiated by the EC’s EU patent reform proposal (the so-called EU Patent Package), which aims to tackle cross-border crises within the EU, including public health emergencies.

No liability exemptions have been introduced for COVID-19 treatments or vaccines. The general liability rules for pharmaceuticals apply. As an exception thereto, liability exemptions applied to pharmaceutical companies whose COVID-19 treatments or vaccines had been procured and supplied by the Germany government despite not meeting certain requirements of applicable drug law; those liability exemptions expired on 31 December 2023.

No manufacturing sites in Germany have been requisitioned or converted due to COVID-19.

The general rules governing public procurement have not been changed owing to COVID-19. Based on the amendments to the German Infection Protection Act in response to the COVID-19 pandemic, the federal government can promulgate regulations allowing the government to take measures for procuring and stockpiling drugs and other necessary products should an epidemic situation of national scope be announced by the German Parliament.

In May 2020, the German Parliament passed a regulation permitting the central procurement of certain medical products (including pharmaceuticals, medical devices, and laboratory diagnostics) by the Federal Ministry of Health. The regulation expired on 31 December 2023. A number of tenders suggest that public purchases are increasingly placing stronger emphasis on more local manufacture and supply chain resilience.