The Pharma Legal Handbook: Germany

Want to know more about cannabinoid drugs, medicinal cannabis and opioid drugs in Germany? Read on! Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99.

 

Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

There is no uniform answer to this question.

In Germany, some Cannabinoid Drugs are subject to restrictions under the Narcotic Drugs Act (“BtMG”) or the New Psychoactive Substances Act (“NpSG”).

Tetrahydrocannabinol, for example, is classified in Germany as a marketable but non-prescription narcotic drug; Annex II to the Narcotic Drugs Act. On the other hand, Tetrahydrocannabinol (Dronabinol) used for medical purposes is marketable and a prescription drug under Annex III to the Narcotic Drugs Act. In turn, isomers of Tetrahydrocannabinol such as delta6a(10a)-THC are not marketable according to Annex I to the Narcotic Drugs Act.

Nabilone is marketable and a prescription drug in accordance with Annex III to the Narcotic Drugs Act.

On the other hand, products used as medicinal products and containing cannabidiol and having a THC content of less than 0.2% are classified as prescription drugs in Germany; Ordinance on the Prescription of Medicinal Products (“AMVV”), Annex 1 (to section 1(1) and section 5) Substances and preparations pursuant to section 1(1) intended for medical purposes. In addition, cannabidiol was granted the orphan drug status by the EU for the treatment of special forms of epilepsy; cf. Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products. In Germany, medicinal products may in general only be placed on the market if previously authorized or registered as such or if they have an appropriate authorization from the European Commission in accordance with Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.

 

2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?

Pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, the European Medicines Agency (“EMA”) is the competent body for the marketing authorization of medicinal products in the European Union and the EEA States on the basis of a centralized procedure. Orphan drugs, therefore, require mandatory authorization by the EMA in the centralized procedure.

In addition, solely national authorization in only one EU Member State is generally feasible unless – as is the case with orphan drugs – EMA’s exclusive competence is stipulated for. Moreover, national applications for authorization of the same product in more than one EU Member State are not admissible. In Germany, the Federal Institute for Drugs and Medical Devices (“BfArM”) is responsible for the approval of “normal” drugs. BfArM also performs the tasks of the Federal Opium Agency. The agency’s major tasks are the following:

• granting general licenses to trade in narcotic drugs, psychotropic substances and precursors,
• supervising the trade in narcotic drugs, psychotropic substances and precursors among license holders (manufacturers, traders, importers, exporters, cultivators and scientific institutions) by checking the reports submitted under Section 18 Narcotic Drugs Act and Article 9 of Commission Delegated Regulation (EU) 2015/1011 of 24 April 2015 supplementing Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Union and third countries in drug precursors, and repealing Commission Regulation (EC) No 1277/2005 and Article 10 of Commission Implementing Regulation (EU) 2015/1013 of 25 June 2015 laying down rules in respect of Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and of Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Union and third countries in drug precursors as well as inspecting manufacturing sites, trading enterprises, and storage facilities,
• issuing import and export authorizations for narcotic drugs and psychotropic substances
• granting import and export authorizations for precursors
• preparing and distributing special prescription forms for narcotic drugs.

 

3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?

There is no specific legal framework for and limited to Cannabinoid Drugs.

If Sativex® or Canemes® are prescribed in Germany within the approved indication areas (“in label”), the health insurance is obliged to cover the costs. If the physician prescribes one of the preparations in an indication that is not covered by the existing authorization (“off label”), however, patients must have their health insurance individually confirm in advance that the costs will be borne by the health insurance.

The situation is different for Dronabinol and Cannabidiol, however, which must also be prescribed by a physician, but the fact that these may or must be prescribed does not constitute a fundamental obligation for health insurance to bear the costs of the preparations. In these cases, separate declaration of coverage of the related costs by the health insurance is always required. It is thus at the discretion of the health insurance whether or not these costs will be covered. They may be obligated to bear the costs, however, if the patient suffers from a life-threatening or regularly fatal illness, if no other generally recognized treatment in accordance with the standard of care is available, and if there is a not entirely remote prospect of a cure or a noticeable positive effect on the course of the illness; cf. Federal Constitutional Court, December 6, 2005 – 1 BvR 347/98, NJW 2006, 891.

In order for Dronabinol or Cannabidiol to be included as a standard therapeutic agent in the health insurance’ catalogue of services, a recommendation of the Joint Federal Committee is required pursuant to Section 135 Social Code Book Five – Statutory Health Insurance, at the request of the Federal Association of Statutory Health Insurance Physicians, a Statutory Health Insurance Physicians’ Association, or of a Central Association of Statutory Health Insurances. To the best of our knowledge, neither Dronabinol nor Cannabidiol are currently the subject of any such request or recommendation.

 

4. Which are the cannabinoid drugs that have received market approval to date?

As narcotic drugs, Dronabinol and Nabilone are marketable and classified as prescription drugs in Germany. Cannabidiol is available as a prescription drug in Germany.

Sativex® Spray (Nabiximols: THC and CBD from Cannabis sativa extract) and Canemes® Capsules (Nabilone) have received market approval as proprietary medicinal products. Epidiolex® (Cannabidiol) has been submitted for market authorization. Pharmacies may also apply to BfArM for permission to import Marinol® (Dronabinol) or contact one of the importers who already hold an import license for this product.

 

5. Who can prescribe Cannabinoid Drugs?

Generally, licensed physicians of any specialty; for Dronabinol, this applies with the exception of dentists and veterinarians; cf. sections 2 et seqq. Ordinance on the Prescription, Dispensing, and Verification of Dispensing of Narcotic Drugs (Narcotic Drugs Prescription Ordinance – “BtMVV”).

 

6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?

A specific list does not exist. The Medical Associations of the German States are able to recommend a physician.

 

7. What approvals or notifications are required to prescribe Cannabinoid Drugs?

In cases of sufficient medical indication, there are no specific restrictions.

 

8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?

Sale is only possible through drug wholesalers and pharmacies.

 

9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?

The Pharmacist Chambers of the German States provide information about pharmacies. All full-supply pharmaceutical wholesalers are organized in the Federal Association of Pharmaceutical Wholesalers – PHAGRO e. V.

 

10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?

No.

 

11. When are they likely to come into force?

Not applicable.

 

Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the country?

Medicinal Cannabis is authorized in Germany.

 

13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?

In Germany, a government agency, the Cannabis Agency, has been established at the Federal Institute for Drugs and Medical Devices, which controls and monitors the cultivation of Medicinal Cannabis in Germany.

 

14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?

The quantities of Medicinal Cannabis that may be prescribed are governed by law. In accordance with section 2(1) Narcotic Drugs Prescription Ordinance, physicians must comply with the stipulated maximum quantities: within 30 days, they may prescribe up to 100,000 milligrams of Cannabis in the form of dried flowers or alternatively up to 1,000 milligrams of Cannabis extract (based on delta 9 THC content) per patient. Exceptions are possible in justified individual cases, if a patient is under permanent treatment and the necessary safety of narcotics trading is observed and maintained. The law does not govern the maximum active substance content in this respect, however.

Prior to starting a Cannabis therapy, the health insurance must approve the coverage of the related costs. In these cases, the health insurance usually consults the Medical Service of the Health Insurance Funds to obtain a professional assessment of the indication. A decision must be made within three weeks, and if an assessment is made by the Medical Service of the Health Insurance Funds, within five weeks. Health insurance may only reject an application in exceptional cases. If Cannabis therapy is to be carried out as part of specialized outpatient palliative care, the approval period is only three days.

Any therapy with Medicinal Cannabis must be documented for an accompanying study, which serves scientific purposes only. The physician transmits anonymized treatment data to BfArM. Without participation in the accompanying study, the costs will not be covered by the respective health insurance. The accompanying survey is intended to run until 2022.

Dried Cannabis flowers are about EUR 22.00 per gram. Costs of a therapy with Medicinal Cannabis are therefore in a range between EUR 300.00 and EUR 2,200.00 per month.

 

15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?

In the future, Cannabis will be grown in Germany exclusively for medical purposes. Cannabis is therefore a medicinal product. Consequently, only Cannabis grown in accordance with the Good Agricultural and Collection Practice (GACP) which specifically meets the requirements of the “Cannabis Flowers” monograph and also meets the requirements of the other relevant monographs and guidelines may be used. This is intended to ensure the availability of Cannabis in Germany for medical purposes in reproducible quality in accordance with any applicable drug law requirements. Medicinal Cannabis is therefore also subject to the statutory provisions of the Narcotic Drugs Act.

a) Demand is covered by imports, for which the Cannabis Agency as such is not responsible, but only until Medicinal Cannabis is available from German cultivation. The Federal Opium Agency at the Federal Institute for Drugs and Medical Devices issues the relevant authorizations.

b) The Cannabis Agency’s first cannabis tender process for cultivation of Cannabis in Germany was canceled by a court in March 2018. In July 2018, however, a new tender process was launched for the cultivation and harvesting of Medicinal Cannabis with a deadline for submission of bids at December 11, 2018. In April 2019, the first contracts were awarded for cultivation and harvesting for a total of 7,200 kg of Cannabis for a period of four years. BfArM expects that cannabis from cultivation in Germany will be available from 2020.

 

16. What approval or notifications are necessary to produce or import Medicinal Cannabis?

a) Anyone wishing to participate in trading, here the import of narcotic drugs, requires the general license of BfArM – Federal Opium Agency – in accordance with section 3 Narcotic Drugs Act. In addition, for each individual import transaction, the licensee will require a separate import permit from BfArM – Federal Opium Agency.

b) Anyone wishing to grow Cannabis in Germany in the future must take part in any future tender process initiated by BfArM – Cannabis Agency – and be awarded the relevant contract. Future tender offers will be published in the Official Journal of the European Union.

 

17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?

Trading in narcotics and psychotropics and precursors is comprehensively governed by the Narcotic Drugs Act and the relevant ordinances – Foreign Trade Ordinance on Narcotic Drugs, Internal Trade Ordinance on Narcotic Drugs, Prescription Ordinance on Narcotic Drugs – and by Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors and by Commission Delegated Regulation (EU) 2015/1011 of 24 April 2015 supplementing Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Union and third countries in drug precursors, and repealing Commission Regulation (EC) No 1277/2005 and Commission Implementing Regulation (EU) 2015/1013 of 25 June 2015 laying down rules in respect of Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and of Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Union and third countries in drug precursors and the Precursors Monitoring Act supplementing it.

In certain cases, physicians may prescribe pharmaceutical-quality Medicinal Cannabis on a narcotic drug prescription to patients with serious illnesses with the appropriate indication and in the absence of alternative therapies. According to Annex III to the Narcotic Drugs Act, Cannabis (marijuana, plants, and parts of plants belonging to the genus Cannabis) is only considered as marketable and prescription narcotic drug in Germany if grown for medical purposes under State control in accordance with Articles 23 and 28(1) of the Single Convention on Narcotic Drugs of 1961 and in preparations authorized as finished medicinal products.

 

18. How can patients obtain Medicinal Cannabis?

Patients need a narcotic drug prescription with which they may obtain Medicinal Cannabis in a pharmacy.

 

19. Who can prescribe Medicinal Cannabis?

Generally, licensed physicians of any specialty, with the exception of dentists and veterinarians; cf. sections 2 et seqq. Narcotic Drugs Prescription Ordinance.

 

20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?

A specific list does not exist. The Medical Associations of the German States are able to recommend a physician.

 

21. What approvals or notifications are required to prescribe Medicinal Cannabis?

In cases of a sufficient medical indication, there are no specific restrictions. It must be a serious disease with a corresponding indication and with no alternative therapies.

 

22. Where is Medicinal Cannabis available?

Sale is only possible through drug wholesalers and pharmacies.

 

23. Is there a list of retailers authorized to sell Medicinal Cannabis?

The Pharmacist Chambers of the German States provide information about pharmacies. All full-supply pharmaceutical wholesalers are organized in the Federal Association of Pharmaceutical Wholesalers – PHAGRO e. V.

 

24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?

No.

 

Opioid Drugs

25. Are Opioid Drugs authorized in your country?

There is no uniform answer to this question, as well. There are Opioid Drugs listed in Annex III to the Narcotic Drugs Act and therefore classified as marketable and prescription drug narcotics in Germany, such as Morphine, Sufentanil, Remifentanil, Fentanyl, Alfentanil. There are, however, also Opioid Drugs listed in Annex I to the Narcotic Drugs Act and therefore not marketable in Germany, such as Ohmefentanyl. There are also Opioid Drugs that are not relevant under the narcotic drugs laws, but are prescription drugs in Germany, such as Nalbuphin.

 

26. What are the regulatory authorities with jurisdiction over Opioid Drugs?

Where Opioid Drugs are medicinal products, the EMA and BfArM are the competent bodies. If the Opioid Drugs are narcotic drugs, the Federal Opium Agency of BfArM is competent.

 

27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?

Compared to other drugs, there are no specific rules for authorization, pricing, and reimbursement of Opioid Drugs. It is a condition precedent to reimbursement that the drug is a prescription-only drug. Most of the Opioid Drugs used are standard therapeutics which are included in the service catalogue of the health insurance.

 

28. Which are the Opioid drugs that have received market approval to date?

A large number of Opioid Drugs have received market approval, including, but not limited to Codeine, Tilidine, Sufentanil, Remifentanil, Fentanyl, Alfentanil, Buprenorphine, Hydromorphone, Methadone, Oxycodone, Morphinesulphate-Pentahydrate or Morphinehydrochloride_Trihydrate (“morphine”), Piritramide, Tapentadol, Dihydrocodeine, Tramadol.

 

29. Who can prescribe Opioid Drugs?

Generally, any licensed physician. Special provisions are contained in sections 2 et seqq. Narcotic Drugs Prescription Ordinance. There is another restriction relating to Diacetylmorphine: prescribing physicians must be physicians qualified in addiction medicine and their qualification must extend to treatment with Diamorphine or they must have worked as physicians for at least six months as part of the “heroin-assisted treatment of opiate addicts” model project; section 5a Narcotic Drugs Prescription Ordinance.

 

30. Is there a list of doctors authorized to prescribe Opioid Drugs?

A specific list does not exist. The Medical Associations of the German States are able to recommend a physician.

 

31. What approvals or notifications are required to prescribe Opioid Drugs?

See above under item 29.

 

32. Which organizations are authorized to sell/distribute Opioid Drugs available?

Sale is only permitted via the wholesale trade in drugs and pharmacies.

 

33. Is there a list of retailers/distributors authorized to sell Opioid Drugs?

The Pharmacist Chambers of the German States provide information about pharmacies. All full-supply pharmaceutical wholesalers are organized in the Federal Association of Pharmaceutical Wholesalers – PHAGRO e. V.

 

34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?

No.

 

35. When are they likely to come into force?

Not applicable.

 

Also from this Legal Handbook

Dentons Germany’s Peter Homberg outlines the key requirements that companies need to fulfil in order to import medical cannabis into Germany and how attitudes and legislation on the topic are shifting across Europe.

 

In order to import medicinal cannabis from another country to Germany, like many other countries, the essential factor is that such medicinal cannabis has to be cultivated in a country compliant with Art. 23 and 28 para. 1 of the 1961 Single Convention on Narcotic Drugs

The European medicinal cannabis market is constantly changing these days. A number of new competitors are entering the market presenting business ideas of exporting medicinal cannabis from all over the world like Israel, Columbia, Malta, Macedonia or Australia to name just a few. Germany is Europe’s biggest medicinal cannabis market and therefore in the centre of attention of many in the business. But what exactly is the key requirement for importing medicinal cannabis to Germany?

 

In order to import medicinal cannabis from another country to Germany, like many other countries, the essential factor is that such medicinal cannabis has to be cultivated in a country compliant with Art. 23 and 28 para. 1 of the 1961 Single Convention on Narcotic Drugs. Accordingly, the respective exporter must carry out the cultivation of cannabis for medical purposes under state control and offer cannabis of medicinal quality. This means that the exporting country has to establish a government agency whose task is to license and monitor the cultivation and supply of cannabis. In Germany, this is the Cannabis Agency at the Federal Institute for Drugs and Medical Devices. This agency has the task to designate areas in which cultivation of medicinal cannabis shall be permitted, to give licenses to authorized cultivators and to purchase and take physical possession of the crops.

 

According to a statement by the Federal Institute of Drugs and Medical Devices of May 2019, imports to Germany are so far only being carried out from Canada and the Netherlands. Israel is said to fulfil the conditions as well. In January 2019, the Israeli government also admitted medical cannabis for export, but there are still a few hurdles in the way for exports from Israel.

 

For international trade in medical cannabis, the 1961 Convention stipulates further that every single import and export requires a license and that the export license may only be granted if the law of the recipient country permits the import and use of cannabis for medical purposes. In addition, the respective permits may only be granted within the framework of the recipient country’s forecasts of its needs.

 

The International Narcotics Control Board (INCB), an independent expert body established by the 1961 Single Convention, issues yearly estimates for each country’s demand in medicinal cannabis. In Germany, the estimated demand is around 15 tons for 2019. The trend is definitely rising. To stick with the German example, the cultivation of cannabis is also possible since the tendering procedure has ended this year and three companies have been awarded the cultivation licenses. The tender covers a total of 10,400 kg of cannabis, spread over four years with 2,600 Kg each year. The first harvest of medicinal cannabis from cultivation in Germany could take place in 2020. The rest of the demand is covered by imports. For the direct care of patients through pharmacies in Germany, a total of around 1200 kg of cannabis flowers was imported in 2017 and approx. 3000 kg in 2018, marking a significant undersupply of the market. As of May 2019, there were a total of 19 companies holding a permit to import medical cannabis to Germany.

 

The World Health Organization (WHO) has recently carried out an in-depth review of cannabis and cannabis products in which the positive and negative effects of these substances have been scientifically investigated. As a result, the WHO has formulated recommendations for a change in the classification of cannabis, which would also lead to a change in the respective control regime. The decision of the United Nations Commission on Narcotic Drugs has so far been postponed.

 

It is to be expected that in the near future more and more countries will legislate on cannabis for medical use. Part of this development is also the European Parliament resolution of February 2019 on the use of cannabis in medicine. It states that there is evidence that cannabis can have a therapeutic effect. The Parliament, however, stressed the importance of making a clear distinction between cannabis-based medicinal products and other forms of cannabis treatment and called for further scientific research in the therapeutic effects of cannabis.

Also from this Legal Handbook

All legal aspects surrounding regulatory reform in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99.

 

1. Are there proposals for reform or significant change to the healthcare system?

Two reforms came into law on January 1, 2019. The first one concerns the reduction of health insurance premiums for employees. It is named the “GKV-Versichertenentlastungsgesetz” (GKV-VEG) which provides the employers will again pay 50% of the health insurance contribution. The private health insurers are still permitted to require supplemental contributions from their members to meet the costs. The average supplement will be about 0.9% in 2019 so that the total contribution is 15.5% of the gross salary.

The second reform is referred to as the “Pflegepersonal-Stärkungsgesetz” (PpSG)” which concerns the nursing care insurance (Pflegepflichtversicherung). Due to the low pay and significant lack of nursing staff in geriatric care institutions, significant increases in pay and nursing staff are required and need to be funded. Nursing care insurance premiums are, therefore, expected to increase by at least 0.5% (max. cost 150 € per month).

 

2. When are they likely to come into force?

In an attempt to fund the system as a whole, further reforms can be expected which will probably mean that benefits will be further restricted and premiums will continue to increase.

 

Also from this Legal Handbook

The legal framework for patents and trademarks in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99.

 

1. What are the basic requirements to obtain patent and trademark protection?

1. In Germany, the Patent Act (Patentgesetz, PatG of 16 December 1980, as last amended on 8 October 2017 forms the legal basis for patents, while the Trade Mark Act (Act on the Protection of Trade Marks and other Signs, Markengesetz, MarkenG, of 25 October 1994, as last amended on 17 July 2017) is the legal basis for trademarks.

If one disregards the possibilities of a European patent, European Union trademark and/or international registrations, national German patents and trademarks will be granted by the German Patent and Trade Mark Office (DPMA) upon application if the respective requirements are fulfilled.

2. A patent is granted for a technical invention which (i) is new, (ii) is based on an inventive step and (iii) is susceptible of industrial application; if none of the statutory exclusions applies.

3. As for trademarks, basically, all signs, objects and designs, but also sounds, three-dimensional shapes, colours and theoretically also smells that are capable of distinguishing products and services from competitive offerings can be protected. In light of a recent change, German trademarks no longer have to be graphically representable. All trademarks which can be represented in the trademark register in such a way that the competent authorities and the public can clearly and unambiguously determine the subject-matter of trademark protection will be admitted for registration.

 

2. What agencies or bodies regulate patents and trademarks?

The German Patent and Trade Mark Office (DPMA) is the competence centre for all national intellectual property rights – patents, utility models, trademarks and designs.

More information can be found at: https://www.dpma.de/dpma/index.html

 

3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?

1. Patents can protect:

products (like devices or compounds used in surgery or therapy) or processes (like diagnostic methods, production processes, methods for obtaining known products, substances or compositions), or certain uses (like the use of compound X for the treatment of Y).

Certain categories of products and processes are expressly excluded from patent protection by law. The most relevant are:

• Mere discoveries, scientific theories and mathematical methods.
• Materials or substances already existing in nature and nuclear materials.
• Aesthetic creations.
• Schemes, rules or methods for intellectual acts, playing a game or doing business and computer programs.
• Presentations of information.
• Inventions whose commercial exploitation is contrary to the public interest or offends common decency, machines for forbidden gambling or for the production of clearly harmful or dangerous food or drinks.
• Plant varieties and animal breeds.
• The human body and the mere discovery of one of its components, including (partial) gene sequences.
• Processes for cloning or modifying the germinal genetic identity of human beings.
• The use of human embryos for industrial or commercial purposes.
• Methods of modifying the genetic identity of animals associated with the suffering of such animals without such methods being of significant medical benefit to humans.
• Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods.

2. The following can be registered as trademarks:

• a sign or set of signs which can be represented in such a way that the subject matter of the trademark protection can be clearly and unambiguously determined.

3. Something completely new under German law is the introduction of the certification mark. A certification mark is a mark which is designated as such at the time of application and for which the owner of the mark guarantees the material, the way in which the goods are manufactured or the services provided, the quality, accuracy or other characteristics. It must be capable of distinguishing itself from marks for which no such guarantee exists. With the certification mark, quality seals or test marks of neutral certification companies can thus obtain trademark protection.

A trademark can only be registered if there are no absolute grounds for refusal. These are, for example:

• Lack of distinctiveness.
• Descriptive indications to be kept free for general use.
• Apparent risk of misleading.
• Violation of public morality or public order.
• Emblem contained in the mark.

 

4. How can patents and trademarks be revoked?

1. Patents can be revoked in opposition proceedings and nullity actions. Anyone may oppose the grant of a patent within nine months of the publication of the grant of the patent (opposition period). After expiry of the opposition period, a patent can only be attacked in a nullity action before the Federal Patent Court.

Unless a patent is declared void or lapses due to non-payment of the annual renewal fee, the patent is then valid retroactively from the filing date for a maximum of twenty years.

2. In line with the various European Regulations it is possible to receive a supplementary protection certificate (SPC) for certain products, in particular medicinal products, which can, simply said, extend the term of protection for further five years. The Paediatric Medicinal Products Regulation (Kinderarzneimittel-Verordnung) also opens up the possibility of extending the term of protection of a supplementary protection certificate by a further (up to) six months. A prerequisite for this is that the application for the respective medicinal products contains results with regard to medicinal products studies conducted specifically on children that were conducted according to a previously approved paediatric investigation plan.

Grounds for nullity of a German patent may be:

• lack of patentability;
• lack of feasibility;
• inadmissible extension of the subject-matter of the patent compared to the original application as filed;
• unlawful withdrawal of the invention (can only be invoked by an infringer).

The Federal Patent Court will decide by judgment over a nullity action. The contested patent may be maintained (if the action is dismissed) or declared partially or wholly invalid (if the action is partially or wholly successful). If a patent is declared void, the proprietor retroactively loses all legal positions previously based on the application. Appeals against the decision of the Federal Patent Court will be heard by the Federal Court of Justice.

3. As regards German trademarks, proprietors of earlier trademarks have the opportunity to oppose a registration of a new mark in writing within a period of three month after publication of the newly registered trademark. The opposition must be filed with the German Patent and Trademark Office (DPMA). In principle, opposition can be filed if there is a fear that there is a likelihood of confusion between the earlier and newly registered mark. If successful, the newly registered mark will be cancelled.
During the term of the opposition period alternatively, thereafter exclusively, the proprietor of an earlier trademark may also file a cancellation action before the ordinary courts.

A trademark may be cancelled upon application if it has been registered contrary to § 3 or § 8 of the Trademark Act (absolute grounds for refusal):

• if it consists exclusively of a shape which results from the nature of the goods themselves, which is necessary to obtain a technical result, or which gives substantial value to the goods.
• if it is devoid of distinctive character for the goods or services; consists exclusively of signs or indications which have become customary in the current usage or in the bona fide and established practices of the trade to designate the goods or services; is of a nature to mislead the public; is contrary to public policy or to accepted principles of morality; contains certain state symbols or official certification marks which are excluded from trademark protection; has been applied for in bad faith.

In the case of relative grounds for refusal, it must be borne in mind that the likelihood of confusion must always be assessed from the point of view of the end consumer, who is less understanding than the person skilled in the art. In the case of absolute grounds for refusal, it is exactly the other way round: the skilled person is just as familiar with the special labelling habits in the medical sector as he is with the specialist medical vocabulary of the Latin and Greek languages.

In addition to absolute and relative grounds for refusal which may be raised in a cancellation action, a trademark shall be cancelled upon application if, after registration, the trade mark has not been used within a period of five years. Proof of use of the trademark in dispute is then required.

Finally, the owner of a trademark may waive the trademark at any time, particularly by non-payment of the renewal fee. Until January 2019 registered trademarks were protected for a period of ten years until the end of the month in which the trade mark was applied for. For all new trademarks registered from 14 January 2019, the ten-year term will now expire exactly ten years after the filing date.

 

5. Are foreign patents and trademarks recognized and, if so, under what circumstances?

1. Because of the territoriality principle, patents and trademarks are valid only in the country for which they are granted. German patents and trademarks granted by the German Patent and Trademark Office (DPMA) are therefore valid for the Federal Republic of Germany only.

However, in addition to a German national application, patent protection can of course also be sought in several countries with one single application in case of European patent or an international registration. Moreover, it is possible to claim the priority of an earlier foreign patent application for the same invention within a period of 12 month following the filing date of the earlier application.

2. European patents are centrally filed and examined at the European Patent Office (EPO). They can be granted for the contracting states of the European Patent Organisation. The procedure is governed by the European Patent Convention (EPC). Once a European patent is granted, a “bundle patent” is created, which then breaks down into several individual national patents (e.g. in those countries where the applicant chose to validate the patent). Once granted, a European patent has the same effect in each contracting state for which it has been granted and is subject to the same regulations as a national patent granted in that state.

3. Trademark protection can also be extended to other countries. A trademark application can directly be filed in the countries where protection is sought.

If it is intended to label products uniformly throughout the EU, registration of a European Union trademark valid throughout the EU can be applied for.

 

6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?

Yes.

1. The Medicinal Products Act provides for a non-patent related way to extend an exclusive position for medicinal products vis-à-vis generics. Under the Medicinal Products Act, an application for marketing authorisation of a generic medicinal product can only refer to the data of the reference medicinal product if the reference medicinal product has been authorised for at least eight years (data exclusivity).

The generic medicinal product can then only be placed on the market after an additional period of two years (market exclusivity). In addition, market exclusivity can be extended by one more year if the marketing authorisation holder of the reference medicinal product, during the first eight years after marketing authorization, obtains authorisation for one or more new therapeutic indications with significant clinical benefit in comparison with existing therapies. Consequently, the maximum period for data and market exclusivity is eleven years (so-called “8+2+1 provision”).

2. Moreover, Regulation (EC) No 141/2000 on orphan medicinal products applies in Germany.

Therefore, orphan medicinal products enjoy market exclusivity for ten years. Orphan medicinal products are products intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition. During this period another application for a marketing authorisation will neither be accepted nor will a marketing authorisation for the same therapeutic indication be granted for a similar medicinal product. Moreover, an application to extend an existing marketing authorisation for such medicinal product will not be accepted. The period of market exclusivity can be reduced under certain circumstances. There are two exceptions to the exclusive position of the investor: The period can be shortened from ten to six years if the original designation criteria are no longer met after five years.

The purpose of this so-called shortening clause is in particular to regulate the case where, contrary to expectations, an orphan medicinal product develops into a “hit” due to changed circumstances, e.g. a sudden increase in the incidence of the disease in question, and thus the prerequisite for the special protection of competition of this medicinal product is no longer met due to sufficient profitability.

3. In addition, a similar medicinal product may exceptionally be approved before the expiry of the ten (or six) year period if the first holder of an orphan medicinal product license agrees to the second license, if the medicinal product itself cannot be supplied in sufficient quantities, or if the second applicant can prove in his application by means of clinical tests that his medicinal product is safer, more effective or otherwise clinically superior or at least makes a significant contribution to the diagnosis or treatment of patients.

4. On the other hand, for paediatric orphan medicinal products the total term of protection can be extended up to twelve years in accordance with Regulation (EC) 1901/2006 on medicinal products for paediatric use.

 

7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?

Other than the ones already described, there are no specific restrictions regarding the patent protection of medicines and/or devices.

 

8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?

No. There is no such requirement. An approval of a license and/or an entry of the license in the patent register is not necessary for the validity of the acquisition of the license.

However, it is possible to register the grant of an exclusive license under a patent in the German Patent and Trademark Register, but the entry of the license in the patent register has no material legal significance for the legal relations between the contracting parties and between the licensee and third parties. However, for evidence reasons it is recommendable to conclude license agreements in writing.

Moreover, there are some special rules that apply in the event that a patent or trademark is enforced by a licensee (e.g. standing to sue, entitlement to own damages claims, etc.). For trademarks, most of these rules are stipulated in § 30 of the Trademark Act, as for patents, most of these rules are based on case law.

 

Also from this Legal Handbook

An insight into product liability in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99.

 

1. What types of liability are recognized in your jurisdiction?

Under German law, liability can result from a culpable failure to comply with contractual or quasi-contractual obligations (contractual/quasi-contractual liability), or from a failure to comply with legal obligations which are not at the same time contractual or quasi-contractual obligations (statutory liability). Statutory liability can be further sub-classified as tortious liability (i.e. liability based on culpable illicit behavior) or absolute liability (i.e. liability regardless of default).

 

2. How do these types of liabilities apply to the manufacturers of medicines and devices?

1. Pursuant to § 84 of the Medicinal Products Act, manufacturers of medicinal products are (regardless of default, i.e. absolutely) liable in case of death or significant damage to the health of a person caused by the use of the medicinal product, provided that the designated use of the medicinal product has an adverse impact exceeding the scientifically justifiable extent, or provided the damage was caused by the fact that labelling, the application instructions or the summary of product characteristics were not in line with the state of the scientific knowledge.

2. If the damage matches the properties of the medicinal product, the causality between use of the product and damage is (rebuttably) presumed. The liability for damage is limited to EUR 600,000 (or instalments of up to EUR 36,000 per year) per person, with a maximum liability of EUR 120,000,000 or annual instalments of up to a total of EUR 7,200,000. If these maximum sums are exceeded by the claims of a multitude of persons, the liability per person is reduced pro rata.

3. A similar absolute liability applies to the manufacturer of medical devices, pursuant to § 1 of the Product Liability Act (Act on Liability for Defective Products, Product Liability Act of 15 December 1989, as last amended on 17 July 2017) if the product is defective in the sense of the law. Liability arises if the product is less safe than one is prompted to believe based on its presentation, its expectable application and the point in time when it has been brought into circulation. The absolute liability for damage caused by a product defect to the health of several persons is limited to a maximum total of EUR 85,000,000; if this sum is exceeded by the claims of a multitude of persons, the liability per person is reduced pro rata.

4. If a medicinal product or a medical device is defective, the manufacturer is in addition also (absolutely) liable for property damages according to the Product Liability Act, with a retention of EUR 500.

5. All aforementioned absolute liability claims are compulsory and cannot be waived in advance. The absolute liability described above does not exclude liability for tort (and/or, as the case may be, contractual/quasi-contractual liability) if the damage has been caused by culpable behavior, and these possible alternative liabilities are not subject to a limitation of liability.

6. Liability under German law aims primarily to compensate the material damage that has been caused, trying to avoid any over-compensation; in other words, there are no punitive damages under German law. In the case of damage to the health of a person, liability can also include a fair compensation for immaterial damages, in particular damages for pain and suffering.

 

3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?

Absolute liability as described in the answer to question 54 applies only to the manufacturer. If the damage has been caused by an act of negligence or even willful misconduct of a corporate executive, an employee or a representative, these may be held liable based on the general legal provisions on tort.

 

4. How can a liability claim be brought?

A liability claim can be brought by means of a regular complaint in civil procedure before a court of justice.

 

5. What defenses are available?

First of all, the manufacturer can try to argue that the prerequisites for his absolute liability as described in the answer to question 54 are not fulfilled; this includes the possibility to rebut the presumption of causality. In addition, the absolute liability for damages caused by medicinal products is excluded if it can be assumed, taking into account all relevant circumstances, that the root cause for the adverse effects of the medicinal product are not in the areas of product development or product manufacturing (e.g., rather caused by inappropriate storage in a pharmacy or the like). In the case of a defective medical device, the manufacturer’s absolute liability is excluded if he can show that the defectiveness of the product has been caused by the manufacturer’s obedience to compulsory legal provisions, or that even using the best available science and technology, the defectiveness of the product could not be noticed when the product was brought into circulation. If the aggrieved person has contributed to the damage by own culpable behavior, liability is reduced pro rata, regardless of whether the defective product is a medicinal product or a medical device. Of course, in both cases the general defenses against any kind of claim, like limitation of action etc., are available as well.

 

Also from this Legal Handbook

The low-down on the situation regarding traditional medicines and OTC products in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99.

 

1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?

The Medicinal Products Act contains special regulations governing Traditional Herbal Medicines and Homoeopathic Medicinal Products:

1. As per secc. 39a et seqq. of the Medicinal Products Act, Herbal Medicinal Products may be brought into market circulation as “Traditional Herbal Medicines” (i.e. herbal medicinal products the effectiveness of which is solely documented by their long-standing traditional use), provided the product has been registered as such with the competent federal authority, namely the Federal Agency for Medicinal Products and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM). In this case, no additional market authorization of § 25 of the Medicinal Products Act is required. Of course, a herbal medicinal product can also be marketed based on a regular market authorization, but in this case it may not be called “Traditional Herbal Medicine” and it cannot be registered as such. In the registration procedure, it must be shown that the Traditional Herbal Medicine has traditionally been in use for at least 30 years, at least 15 of which in the EU, that the product does not have harmful effects, and that the pharmacological effects of the product are plausible based on the long-term experience and use of the product.

2. Homoeopathic Medicinal Products must be registered with the BfArM instead of obtaining a regular market authorization in order for the Homeopathic Medicinal Product to be marketable as such (see secc. 39 et seq. of the Medicinal Products Act, also listing the possible reasons for refusal of registration). Like in the case of Traditional Herbal Medicines, an existing market authorization hinders a registration of the Homoeopathic Medicinal Product as such. The market authorization can be waived by its holder, though.

 

2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?

In general, advertising for such medicinal products is subject to the same legal provisions (in particular as set forth in the Health Advertising Law) like advertising for regular medicinal products (for details, see the answer to question 38 above). Advertisements for traditional herbal medicines must include the statement “Traditional herbal medicine to be applied for [specific field of application] exclusively based on long-time application” (§ 4 par. 1 sentence 2 of the Health Advertising Law), whereas advertisements for homoeopathic medicinal products may not contain an indication of the field of application (§ 5 of the Health Advertising Law).

 

3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?

See the answers to questions 45 and 38 above.

 

4. What are the regulatory requirements for over-the-counter (non-prescription) medications?

Concerning the authorization process, see the answer to question 22, regarding pricing, see the answer to question 12 above.

 

5. Are there any limitations on locations or channels through which OTC products may be sold?

1. Non-prescription medicinal products can be further sub-classified as pharmacy-only or general-sale products. Most medicinal products and some medical devices may only be sold in pharmacies; this is the general rule for medicinal products set forth in § 43 of the Medicinal Products Act (see answers to question 14 and 39/49 above).

2. Exceptions from this rule can be found in §§ 44 et seqq. of the Medicinal Products Act and in the Ordinance on Pharmacy-Only and General-Sale Products (Verordnung über apothekenpflichtige und freiverkäufliche Arzneimittel (AMVerkRV) of 24. November 1988, most recent amendment of 26. September 2018).

3. Regarding medical devices, details on their classification as prescription-only and pharmacy-only products are set forth in the Ordinance on the Dispensing of Medical Devices (Verordnung zur Regelung der Abgabe von Medizinprodukten (Medizinprodukte-Abgabeverordnung – MPAV), dated 25 July 2014, most recent amendment of 21 September 2018.

4. If a medicinal product is classified as a general-sale product, it still may not be sold through vending machines or other self-service sale channels but only through shops where at least one qualified person is available to give advice. The aforementioned restrictions do not apply to very few, very specific products like plant parts, plant juices, curative waters, contraceptives, medicinal products designated to prevent sexually transmitted diseases, disinfectants for outward application, or oxygen (see secc. 50 et seqq. of the Medicinal Products Act).

 

6. What health, advertising, and marketing claims may be made for OTC products?

Advertising of OTC medicinal products is governed by specific provisions in the Health Advertising Law (for further details, see the answer to question 38 above). OTC products which are a prescription-only medicinal product may not be advertised to the general public but to members of the medical professions and medic trade, only (sec 10 of the Health Advertising Law).

 

7. Can OTC products be marketed or advertised directly to the public?

Yes, provided the applicable restrictions (in particular those set forth in the Health Advertising Law and the Unfair Competition Act) are observed.

Advertising to the general public is not permitted for prescription medicinal products. For details, see the answers to questions 49 and 38 above.

 

8. What is the mechanism by which a prescription-only product can be converted to an OTC product?

1. In general, such conversion is not possible unless the composition of the medicinal product is changed and a new market license is obtained. The question of whether a product is classified as a prescription-only product depends on the active pharmaceutical ingredients used in the product. The mere presence of certain active substances listed in the Ordinance on Prescription Drugs (Verordnung über die Verschreibungspflicht von Arzneimitteln, (Arzneimittelverschreibungsverordnung – AMVV) of 21. December 2005, most recently amended on 26. September 2018), or the use of substances the effects of which are not commonly known in medical science (§ 48 par. 1 no. 3 of the Medicinal Products Act) results in the product’s classification as prescription-only drug.

2. Exeptions apply in case the relevant active substance is used in a homoeopathic dose (§ 5 of the Ordinance on Prescriptive Drugs). In certain special cases (such as with medicinal products intended for animal use if the animal is raised for food production (see § 48 par. 1 no. 2 of the Medicinal Products Act), a specific indication or purpose of the product can result in a prescription-only classification. If that purpose falls away, the prescription-only classification may fall away as well. However, it is mandatory in all of these cases that a new market authorization and classification is obtained.

 

9. What are the requirements for the importation of either traditional medicines or OTC products?

Importation regulations for traditional herbal medicines, OTC medicinal products and prescription drugs are essentially similar. In a nutshell, the importation of medicinal products generally requires a valid market authorization or product registration for Germany. In addition, pursuant to § 73 par. 1 of the Medicinal Products Act, if the medicinal product is imported from an EU or EEA member state, the (professional) recipient in Germany must be a licensed pharmaceutical business, a wholesaler or a veterinarian, or it must run a pharmacy or a hospital. If the medicinal product is imported from a country outside the EU and the EEA, the recepient must be a holder of an importation license according to secc. 72, 72b or 72c of the Medicinal Products Act. If the medicinal product is sent directly to a consumer from abroad, the sender must be an EU or EEA based pharmacy holding a permission to perform mail-order trade with medicinal products according to § 11a of the Pharmacy Law, or according to the equivalent national law of the EU or EEA member state where the sender is seated, provided the German regulations on mail-order trade with medicinal products (in particular, §17 par. 2a and par. 2b of the Ordinance on the Operation of Pharmacies (Verordnung über den Betrieb von Apotheken (Apothekenbetriebsordnung – ApBetrO) of 09 February1987, most recent amendment of 2 July 2018) are observed.

 

Also from this Legal Handbook

All about marketing, manufacturing, packaging & labeling, and advertising in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99.

 

1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?

1. The Third Chapter of the Medicinal Products Act sets forth the rules relating to the manufacture of medicinal products (including new drugs, biologics, over-the-counter medications and medicinal products in general), particularly the manufacturing authorisation and its limits in §§ 13 and 15, the process leading up to the decision on the manufacturing authorisation in § 14, the required expert knowledge in § 15, relevant deadlines in § 17, the withdrawal, revocation and suspension processes, the areas of responsibility in § 19, Notification obligations in § 20, a definition of the active substances and other substances governed by these rules in § 20a, special provisions on the sourcing of tissues and tissue preparations, pertinent laboratory testing, processing, perservation, storage and placing in the market in §§ 20b and 20c, as well as certain exceptions from these tissue-related rules.

2. Concerning medical devices, the corresponding rules of the Medical Devices Act apply.

 

2. What is the authorization process for the marketing of generic versions of these products?

Generic versions of medicinal products and medical devices are subject to essentially the same authorization rules, except that certain exemptions may apply regarding the submission of documentation.

 

3. What are the typical fees for marketing approval?

See the information provided to Question 4 of Regulatory, Pricing, and Reimbursement.

 

4. What is the period of authorization and the renewal process?

1. See Question 5 above: Pursuant § 31 of the German Medicinal Products Act, the marketing authorisation expires (i) if the authorised medicinal product is not placed on the market within three years from marketing authorisation, or if it was placed on the market, the market presence is interrupted for three successive years; (ii) when waived in writing; (iii) five years after it was granted, unless a timely application for prolongation is filed nine months prior to the expiry date; (iv) if the prolongation of the marketing authorisation is refused. Prolonged marketing authorizations are valid for an unspecified period, subject to detailed conditions.

2. Pusuant § 31 (2) of the German Medicinal Products Act, the application for prolongation shall be supplemented by a report giving details of whether, and to what extent, the criteria by which the medicinal product is assessed have altered over the previous five years. Updates of the quality, safety and efficacy documents must be filed.

Further details apply as set forth in § 31 of the German Medicinal Products Act.

 

5. What are the requirements, if any, for postapproval pharmacovigilance?

1. Pharmacovigilance is aiming at drug safety and involves the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.

The legal framework of pharmacovigilance is set forth in the Thenth Chapter of the Medicinal Products Act, comprising the organisation of the pharmacovigilance system (§§ 62 to 63a), the pharmacovigilance obligations of the marketing authorisation holder (§ 63b), involving documentation and reporting obligations (§§ 63c and 63 i), periodic safety update reports (§ 63 d), prerequisites for non-interventional post-authorisation safety studies (§§ 63f and 63g).

2. All events of pharmacovigilance are centrally recorded and evaluated, in particularly any adverse reactions, interactions with other products, adulterations as well as potential risks to the environment, all in in co-operation with the agencies of the World Health Organization, the European Medicines Agency, the medicinal product authorities of other countries, the health and veterinary authorities of the federal Laender, the medicinal product commissions of the chambers of the health professions and national pharmacovigilance centres. The competent authority monitors the outcome of the risk minimisation measures contained in risk management plans and evaluates the data in the EudraVigilance database. It can inspect the collection and evaluation of medicinal product risks and the co-ordination of necessary measures in enterprises and facilities that manufacture, place on the market or clinically test medicinal products. To this end, the representatives of the competent authorities can enter the production areas and business premises during regular working hours, inspect documents including the pharmacovigilance master file and request information.

If an inspection results in the conclusion that the marketing authorisation holder fails to meet the requirements of the pharmacovigilance system, the authority shall notify the marketing authorisation holder of the detected deficiencies and notify other authorities involved.

3. Pharmaceutical entrepreneurs must appoint a graduated plan officer which is a qualified person who is resident in a Member State of the European Union having the required expert knowledge and the reliability necessary for exercising the assigned function of setting up and managing a pharmacovigilance system and to collect and evaluate notifications on medicinal product risks. The graduated plan officer is responsible to meet all notification and risks response requirmements.

4. The marketing authorisation holder is obligated to set up, operate and update, for every medicinal product, the prescribed pharmacovigilance system in order to scientifically evaluate all information on risks, examine risk minimisation and prevention measures and, if necessary, take risk minimisation and prevention measures immediately. To that end it must maintain and disclose when requested the pharmacovigilance master file. Pharmacovigilance information may not be published unless the competent German authority, the European Medicines Agency and the European Commission have first been notified in accordance with the prescribed procedures.

Other statutory duties and obligations apply as set forth in the Thenth Chapter of the Medicinal Products Act and supplementing provisions.

These rules do not apply to medicinal products that are used as investigational medicinal products within the framework of a clinical trial.

 

6. Are foreign marketing authorizations recognized?

Yes, subject to EMA and German regulations.

 

7. Are parallel imports of medicines or devices allowed?

Yes, subject to German and EMA import regulations.

 

8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?

1. The marketing practices for medicinal products and medical devices are governed by (i) the Health Advertsing Law (Gesetz über die Werbung auf dem Gebiete des Heilwesens (Heilmittelwerbegesetz – HWG) of 11 July1965, most recent amendment of 20 December 2016) and (ii) the Act Against Unfair Trade Practices in the versions of 3 March 2010, as last amended on 17 February 2016 (http://www.gesetze-im-internet.de/englisch_uwg/englisch_uwg.html), as well as a number of Codes of Conduct which are regularly applied by the courts as generally applicable rules of trade practice. For further details see answers to Question 38 below.

2. By way of general background regarding sweepstakes incentives, the following principal rules apply:

Subject to restrictions set forth in the Health Advertising Law, random draw promotions, instant win games are permissible provided the entrant is not required to pay a stake. There is no bonding, prize deposit or license required for promotional chance or skill based games or contests. No purchase is required. Restrictions of German and any other applicable (EU) data protection laws apply.

3. Unless the entrant (data subject) has expressly consented to the use of its personal data (or unless that consent is implied as part of the legal relationship entered under the Official Rules), personal data may not be collected, processed or used. Data transfer to a jurisdiction outside the European data protection regime requires special consent. The EU Commission has adopted in 2016 its decision on the EU / U.S. Privacy Shield which protects the fundamental rights of individuals in the EU whose personal data is transferred to the United States. It regulates transatlantic data transfers.

4. If a promotion is directed to German entrants, foreign sweepstakes sponsor should have the official sweepstakes rules reviewed in respect of compulsory German local law. Sponsors should be aware that the enforcement of German fair trade laws is mainly a matter of enforcement by competitors or trade associations by means of cease and desist requests and complaints to the courts (including quick and effective preliminary injunction proceedings). Government agencies or regulatory bodies get rarely involved.

See question 17 below for enforcement rules.

 

9. How is the manufacturing of medicines and devices regulated and by which agencies?

1. The Eighth Chapter of the Medicinal Products Act governs safety and control measures by means of regulations for enterprises and facilities which develop, manufacture, test, store, package or place on the market medicinal products.

This applies to active substances and other substances as well as tissues intended for the manufacture of medicinal products. The regulations govern the development, manufacture, testing, storage, packaging, quality assurance, acquisition, supply, stockpiling and marketing of medicinal products, the maintaining and keeping of records on the operational processes, the keeping and monitoring of the animals used in the manufacture and testing of medicinal products and the records kept on them, staffing requirements, the nature, size and equipment of the premises, sanitation requirements, the nature of containers and other packaging, the labelling of containers and packaging in which medicinal products and their starting materials are stored, the stand-by obligation for medicinal product wholesalers, the retention of batch samples including quantities and duration of storage, the labelling, separation or destruction of medicinal products which are unfit for marketing etc.

2. The framework is laid down in the “Pharmacopoeia“ which is a collection of recognized pharmaceutical rules regarding the quality, testing, storage, dispensing and designation of medicinal products and the substances used in their manufacture as developed by the German Pharmacopoeia Commission (set up at the Federal Institute for Drugs and Medical Devices) or by the European Pharmacopoeia Commission. It is published by the Federal Institute for Drugs and Medical Devices in co-ordination with the Paul Ehrlich Institute and the Federal Agency for Consumer Protection and Food Safety.

The Pharmacopoeia also contains requirements regarding the nature of containers and outer packaging.

In a nutshell, only substances and packaging (containers) coming into contact with a medicinal product, and only the pharmaceutical forms compliant with recognised pharmaceutical rules, may be used in the manufacture of medicinal products. There is an official compilation of test procedures for the sampling and testing of medicinal products and their starting materials.

 

10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the US Food & Drug Administration (US FDA) and/or the European Medicines Agency (EMA)?

The answer is generally yes, subject to specific requirements of German law.

 

11. What is the inspection regime for manufacturing facilities?

The compentent authorities can inspect manufacturing enterprises and facilities marketing or clinically testing medicinal products. To this end, the authorities can enter the production areas and business premises during regular working hours, inspect documents including the pharmacovigilance master file and request information.

 

12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?

Yes, by means of judicial and administrative assistance procedures and subject to co-ordination with the relevant German authorities.

 

13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?

There is a general duty to affix on the outside of the packaging the full name and postal address (not the PO Box) of the manufacturer or the importer. Certain exceptions apply, see also the details provided in response to question35 below.

Packaging misleading anyone as to the size, content or quality of the product is prohibited.
There are also many rules regulating certain mandatory disclosures and indications, including the language to be used, which must be affixed to the packaging, depending on the type of the product (see question 14 below).

 

14. What information must be included in medicine and device labeling?

1. § 10 of the Medicinal Products Act governs essentially all labelling requirements regarding medicinal products. Finished medicinal products not intended for clinical trials or exempted from marketing authorisation requirements must be labelled with (i) the name and address of the manufacturer and local representative if appointed, (ii) the name of the medicinal product, (iii) details of the strength and pharmaceutical form, (iv) any applicable information regarding administration to babies, children or adults, (v) if the medicinal product contains up to three active substances, the international non-proprietary name (INN) or, if the latter does not exist, the common non-proprietary name, (vi) the marketing authorisation number (vii) the batch identification or (if not distributed by batch) the date of manufacture, (viii) pharmaceutical form, (iix) the content by weight, volume or number of items, (ix) the method of administration, (x) the active substances by type and quantity and other constituents by type as required by the market authorization, (xi) in the case of genetic engineering, the active substance and the name of the genetically modified micro-organism or cell line used in its manufacture, (xii) the expiry date with the instruction ‘verwendbar bis’ (to be used by), (xiii) in the case of a prescription drug the indication ‘Verschreibungspflichtig’ (prescription-only), (xiv) in the case of other medicinal products that may only be dispensed to consumers in pharmacies, the indication ‘Apothekenpflichtig’ (pharmacy-only), (xv) in the case of samples, the indication ‘unverkäufliches Muster’ (sample – not for sale), (xvi) the indication that medicinal products are to be kept out of the reach of children (unless they are curative waters), (xvii) where necessary, special precautions for the disposal of unused medicinal products or other special precautions to avoid hazards to the environment, (xviii) the intended use in the case of non-prescription medicinal products. Other requirements apply (such as the name of the medicinal product in Braille language, warnings, specific storage instructions etc).

2. Special rules apply to medical devices in accordance with the Medical Devices Act (Medizinproduktegesetz, MPG) of 2 August 1994, as amended, as well as supplementary laws and regulations governing the marketing of medical devices.

 

15. What additional information may be included in labeling and packaging?

1. § 11 of the Medicinal Products Act governs the rules applicable to information leaflets to be placed in the package of finished medicinal products (not applicable to products intended for clinical trials, residue testing, or products which do not need a marketing authorisation. The heading oft he leaflet must be ‘Gebrauchsinformation’ (Instructions for Use). It must contain, in the order prescribed by the Act, in easily legible, readily comprehensible German and in conformity with the product information required for members of the medical professions and trade (§ 11a): (i) the name of the medicinal product (§ 10), (ii) the substance or indication group or the mode of action, (iii) the therapeutic indications, (iv) a list of information that must be read before taking the medicinal product, namely contra-indications, corresponding precautions for use, interactions with other medicinal products or other products, warnings, (v) the instructions under normal conditions of use, relating to posology, method of administration, frequency and, if necessary, time of administration, if required, duration of treatment, (vi) warnings in the event of an overdose, forgotten doses or warnings on the risk of adverse consequences if the treatment is stopped, (vii) the specific recommendation that a doctor or pharmacist should be consulted in the event of queries relating to the use, (viii) a description of adverse reactions, counter measures and an additional standard text which explicitly instructs the patient to inform their physicians, pharmacists, health professionals or the competent authority directly of every suspected adverse reaction, (iix) the expiry date stated on the packaging with a warning that the medicinal product may not be used after the expiry date, required special precautions for storage and information on shelf life after opening of the container or after preparation of the ready-to-use preparation by the user, (ix) if required, a warning about specific visible signs indicating that the medicinal product may no longer be used, (x) complete qualitative composition in terms of active substances and other constituents and quantitative composition in terms of the active substances, (xi) the pharmaceutical form and content by weight, volume or number of items for each of the medicinal product’s pharmaceutical forms, (xii) the name and address of the pharmaceutical entrepreneur and, where applicable, of his/her local representative, (xiii) the name and address of the manufacturer or importer who released the finished medicinal product for placing on the market. In case other product names are used in other EU Member States, a list of these other names must be stated, (xv) the date of the most recent revision of the package leaflet.

2. Other information may be required and special rules apply to living organism in the case of virus vaccines, human blood plasma, traditional herbal medicinal products and other products as well as products for animal use. At the request of patient organisations, the package leaflet must be made available in formats appropriate for the blind and and partially-blind persons.

3. Pusuant to § 11a of the Medicinal Products Act, members of the medical profession may ask for instructions for use by experts (expert information) for finished medicinal products which are subject to or exempted from the obligation to obtain a marketing authorisation. The instructions must bear the heading ‘Fachinformation’ (expert information) and must include the information set forth in § 11a of the Act, including but not limited to the name of the medicinal product, followed by the strength and the pharmaceutical use form, information on the qualitative and quantitative composition in terms of active substance and other constituents, knowledge required for proper administration of the product, the pharmaceutical form, clinical information, therapeutic indications, posology and method of administration, contra-indications, special warnings and precautions for use, precautions to be taken by the patient, interaction with other medicinal products or other products if this is likely to influence the effect of the medicinal product, use during pregnancy and lactation, effects on the ability to drive or operate machinery, adverse reactions when used as intended, overdosage symptoms, emergency procedures, antidotes, pharmacological properties, pharmaceutical information, the date of first authorisation or prolongation of the authorisation, the date of revision of the expert information, as well as a certain uniform instruction that explicitly calls upon health professionals to report suspected adverse reactions.

Other provisions: The German Federal Ministry of Health may issue additional regulations.

 

16. What items may not be included in labeling and packaging?

On or in the package of a medicinal product there may be no advertising (of any product). It is important to make a difference between required product information and prohibited promotional content.

Certain additional product information which is not otherwise governed by a regulation of the European Community or the European Union, or which is already permissible pursuant to such a regulation, shall be permitted if it relates to the use of the medicinal product and is not inconsistent with other required information. Such information must be clearly separate and distinct from the information required in the package information.

 

17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?

1. By way of general background information, all advertising (print, billboard, radio; broadcast, TV, movie, and online media) is governed by German statutory law, administrative regulations and industry self-regulation. Relevant advertising rules relate to fair trade, consumer protection, distance (electronic) contracting, data protection, privacy, industrial and intellectual property, the antitrust laws, regulations governing audio-visual media services, youth protection as well as regulations concerning particular products and services (such as medicinal products and medical products, food, tobacco, alcohol etc).

2. The primary source of advertising regulation are the German Law Against Unfair Trade Practices of 3 March 2010, last modified 17 February 2016, implementing the EU Unfair Commercial Practices Directive (Directive 2005/29/EC of 11 May 2005), the Privacy and Electronic Communications Directive (Directive 2002/58/EC of 31 July 2002) and the Technical Standards and Regulations Directive (Directive 98/34/EC of 22 June 1998, now replaced by Directive 2015/1535/EU). Other EU sources applicable in Germany are the Regulation No 1924/2006/EC of 20 December 2006 on nutrition and health claims made on foods. Further relevant sources are the Law Relating to the Enforcement of EU Consumer Protection of 21 December 2006 and the Price Declaration Regulation (as revised on 17 July 2017).

3. Procedurally, the German Law Relating to Cease and Desist Claims regarding Consumer Law and Other Violations (as revised 17 July 2017) regulates special issues of unfair advertising prosecution.

4. Health-related advertising (i.e. advertising relating to pharmaceutical/medicinal products (drugs), medical devices and other products where the advertising concerns the diagnosis, cure, relief or abatement of a medical condition of human beings or animals, as well as advertising relating to plastic surgery without medical indication) is regulated by the Health Advertising Law (Heilmittelwerbegesetz) of 19 October 1994, amended most recently on 20 December 2016 (for further details see also answer to question 29 above).

In terms of the Law’s basic rules, health advertising is considered misleading and is prohibited if: (i) the advertised product has not been approved for marketing; (ii) it claims, in particular, an efficacy or effect which does not exist; (iii) it advertises a guaranteed success or the absence of detrimental effects in case of long term use; (iv) it conceals the intent of advertising; (v) it contains untrue or misleading statements regarding the composition or property of a medicinal product, medical device or other product or treatment; or (vi) it contains incorrect information on the identity, education, ability or records of the manufacturer, inventor or related persons.

5. The German Health Advertising Law prescribes legible doctor and patient information (subject to the rules of the Medicinal Products Act described above).

Advertising to the public (as opposed to members or institutions of the medical or veterinarian professions, or parties permitted to trade with relevant products) is restricted and must bear special warnings. Any such advertising may not be directed to children below the age of 14 and may not be connected with promotional contests or sweepstakes promoting excessive use of medicinal products or medical devices. Prescription drugs may not be advertised except to doctors, dentists, veterinarians, pharmacists and persons permitted to trade in such products.

6. The law regulates the extent to which members or institutions of the medical or veterinarian professions, or parties permitted to trade relevant products may be offered, or may accept, a benefit, gift or other promotional item (see the summary of compliance rules in answer to question 29.)

7. German law does not require government pre-approvals of advertising (certain exceptions apply in the sector of youth protection). On a voluntary, self-regulatory basis, the Central Association of the German Advertising Industry (Zentralverband der Deutschen Werbewirtschaft—http://www.zaw.de) offers certain pre-clearance and advisory services to its members. A membership list is available at http://www.zaw.de/index.php?menuid=87.

8. For their own protection against cease and desist claims, advertisers do normally pre-clear advertising (by in-house or external cousel).

In Germany, advertising regulations are not normally enforced by government bodies, but rather by competitors, consumer protection agencies, or industry trade associations, in each case requesting enforcement of applicable German law. These organizations include, for instance, the Centre of Protection against Unfair Competition (Wettbewerbszentrale) in Bad Homburg, or Integritas (the self-regulatory body for pharmaceutical advertising) in Bonn. As concerns drug, medical device and food advertising, product labeling etc, relevant public institutions (agencies and regulatory bodies) monitor the market and enforce fair competition and fair trade rules, as well as regulations pertaining to their specific competencies.

9. To prosecute a violation, a competitor or qualifying consumer or industry association claiming a violation would, as a first step, send a formal cease and desist request to the violating party. The defendant party may either refuse to comply with the request or accept the request by issuing a formal cease and desist undertaking, including a penalty clause stating that any future violations will be subject to a penalty payment. If a cease and desist request is refused, the complaining party may ask a court to issue a cease and desist order by preliminary injunction (even without notice or hearing). A decision on such a motion is normally available in a matter of hours or days. The defendant party may contest the injunction order by a filing an ‘objection’. Any resulting court judgment is subject to appeal to the appellate court.

10. In practice, claimants would not normally pursue claims for damages in unfair advertising cases because the required proof and quantification of damages is generally difficult to establish in court. In theory, it is possible to ask that profits gained through an illegal trade practice should be surrendered to the government. In practice, however, this sanction has little relevance in unfair trade disputes.

11. Apart from administrative sanctions, there are not normally criminal sanctions, except in cases of intentional, fraudulent misleading of the public, for instance in violation of § 16 of the German Law Against Unfair Trade Practices which prohibits misleading advertising.

12. Consumers may indirectly prosecute violations of fair trade laws aiming at the protection of consumers, by asking a qualifying fair trade protection association (see answer to question 8 above) to take appropriate action against the advertiser.

13. Advertising self-regulation is becoming increasingly customary in Germany. The German Advertising Council (Deutscher Werberat—see http://www.werberat.de/keyfacts) and, for instance, pharmaceutical industry organizations operating on a membership basis have gained significant authority (by example, the Association on Self-Regulation in the Pharmaceutical Industry (“FS-Arzneimittelindustrie”, https://www.fsa-pharma.de/ and www.pharma-transparency.eu/).

The German Advertising Council is a founding member of the European Advertising Standards Alliance (EASA), and co-operates closely in this sector with the International Chamber of Commerce (ICC).

14. These bodies create ‘best practice’ rules (codes of conduct) which influence the interpretation of statutory and regulatory law by the courts. All self-regulatory bodies have adopted advertising codes which are often available in the English language.

15. If drug advertisement contains a specific claim relating to the properties or characteristics of an advertised product or service, the advertiser may be required, by relevant statutory or case law, to substantiate such claim. Substantiation requirements are contained in a number of laws and case law relating to specific products and services, particularly health and environmental (green) advertising. Even if there is no specific substantiation requirement, if a competitor, or competent fair trade association, challenges the accuracy of a given claim, the advertiser must prove the accuracy of its claim by substantiation of the alleged facts. This also applies for study results referenced by the advertiser.

16. Endorsements and testimonials must be truthful and may not be misleading. For instance, a testimonial can be misleading if the influencer is not qualified to comment on the endorsed product. In German health advertising law, it is not permitted to advertise, to consumers, an endorsement and testimonial by a persons practicing in the health sector or as an academic if such endorsement or testimonial is likely to increase the use of the advertised drug.

17. The European Directive 97/55/EC dated 6 October 1997 regulating comparative advertising in Europe has been adopted into German fair trade legislation. Comparative advertising is permitted subject to certain restrictions. Comparative advertising is permissible if it concerns products or services serving the same purpose and relates objectively to one or more features of a product or service which are essential relevant verifiable typical for the product or service. Comparative advertising is illegal if it diminishes, in an unfair manner, the reputation of a competitor or unfairly disparages or degrades the products or services of a competitor or its personal or business affairs. As applies to any other advertising, comparative advertising must be true and accurate.

18. Advertising involving the price of a product or service must comply with the Price Declaration Regulation (Preisangabenverordnung). Prices advertised to consumers must include the Value Added Tax (VAT) and any other price components. Special rules apply in distance sales, eg the obligation to disclose additional packaging or mailing charges. Price change conditions are subject to restrictions. Products shown in shops, displayed in shop windows or in catalogues must clearly state the price, either on or near the product. Prices of products sold by weight, volume or size, must be stated with their unit price and their price by a stated standard weight, volume or size.

19. ‘Special Sales’, ‘Off Season Sales’, ‘Below Cost Sales’, ‘Clearances’ or special promotional periods during which goods or services are offered on special terms for a limited period of time are permitted, provided that any offered price reduction is a true price reduction that applies for a considerable period of time (no short-term price swinging). Announcements must not be misleading regarding the original or reduced price. Offers must comply with the Price Declaration Regulation. Conditions for special offers must be clear and unambiguous as to their scope (eg clear indication of any exceptions) and, if limited in time, state the period during which it is applicable. A ‘discount’ is a price reduction offer, an additional quantity of an identical product or service purchased, or a cash value offered by means of a coupon or voucher which can be applied against the purchase price of an identical product or service. Discounts are permissible, but subject to fair trade limitations relating to advertising that is misleading, or exerts undue influence.

20. The full name and address of the online advertiser must be disclosed in all advertising and offers which promote the properties and price of a product or service in a manner which enables the average consumer to make a purchase decision. The mere indication of an internet address is not sufficient.

21. As a rule, advertising content must be separate from editorial content. Advertising must be clearly recognizable as advertising, eg there must be a mark stating that the content is an advertisement. Advertising in an editorial context must be marked ‘advertising’ (‘Anzeige’).

 

18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?

1. Medicinal products and devices are sold by pharmacies (Apotheken), drugstores (Drogerien), medical supply stores (Sanitätshäuser) and other stores, depending on the kind of medicinal product and device. The sale of pharmacy-only and prescription medicinal products is restricted to pharmacies.

2. Online purchases and delivery of medicinal products by mail are permitted for pharmacies carrying a special license for “shipping pharmacies”(”Versandapotheken”) pursuant to § 11a Pharmacy Law. The shipping pharmacy sector is subject to the regulations applicable to regular local pharmacies, plus a number of special rules relating to online sales pusuant to the license conditions. Shipping of medicinal products by pharmacies is permitted since 2004 (§ 43, paragraph 1 of the Medicinal Products Act). In Germany, well over 3,000 of the 21,000 pharmacies do have the required medicinal products shipping license as an additional (side) distribution channel of the pharmacy. Licensed shipping pharmacies are listed on the website of the German Institute for Medicinal Information and Documentation (DIMDI) www.dimdi.de, together with additional information on this subject matter.

3. The Seventh Chapter of the Medicinal Products Act (§§ 43 to 53) governs the sale of medicinal prodcucts, in particular the Pharmacy-only requirement, (§§ 43 to 46), rules regarding the medicinal products distribution channels (§§ 47 to 47 b), prescription requirements (§ 48), Retail trading of over-the-counter medicinal products (§ 50), Sale by itinerant traders (§ 51), self-service restrictions (§ 52), Wholesale trading of medicinal products (§ 52 a) and other details regarding brokering and consultation requirements.

 

19. What are the restrictions and requirements for electronic marketing and advertising via email, by internet, social media, and other channels?

1. § 7 of the German Law Against Unfair Trade Practices regulates certain forms of advertising and promotion by means of electronic messages (based on the European E-Commerce Directive of 8 June 2000). It is illegal to unreasonably direct advertising to someone who does not wish to receive advertising. Marketing/advertising by telephone (‘cold calls’) directly to consumers is illegal, unless the consumer has given express consent. If the marketing/advertising is directed to any party other than a consumer who has not expressly consented, it is illegal unless there is express or implied consent. Advertising through automatic calling machines, telefax or electronic mail is illegal if the receiving party has not expressly consented to such advertising. Very narrow exceptions apply.

2. On publicly-available online advertising, an advertiser has to provide specific identifying information that is easily recognizable, directly accessible and consistently available. These criteria are met when it can be found under a clear headline such as ‘contact’ or ‘imprint’ on the homepage or not more than two clicks away from the homepage. The imprint must include (i) the full (company) name, postal address (not PO Box), and contact email address of advertiser, and, if the advertiser is a legal entity, the form of organization and the full name of the legal representative (CEO, Managing Director), (ii) the location of the commercial register in which the advertiser is registered, including its registration number, (iii) the VAT Identification number, if applicable. Additional requirements apply in certain circumstances.

3. Advertising in social networks (eg posts by influencers) needs to be marked as such, if the person posting the messages receives compensation for its participation in the ad. References such as ‘#ad’ or ‘#sponsored’ would not be sufficient, #werbung (English = advertisement) is normally ok. Social media advertisements must comply with all general advertising rules.

4. The liability of internet advertisers offering promotions is regulated by the Telemedia Act (Telemediengesetz of 26 February 2007, mosst recent amendment of 28 September 2017) implementing he EU Directive on E-Commerce. Service providers are not liable for the information transmitted if the provider has not initiated the transmission, selected the receiver of the transmission, or selected or modified the content contained in the transmission. There is service provider liability in all other cases.

The scope of liability is quite broad, including responsibility to take steps to avoid and prevent illegal acts. Service providers are not generally obliged to monitor their websites, but must act if made aware of a breach on their website.

 

20. May medicines and devices be advertised or sold directly to consumers?

Non-prescription medicines and devices may be advertised and sold directly consumers, subject to the restrictions of the German Health Advertising Law Heilmittelwerbegesetz) of 19 October 1994, amended most recently on 20 December 2016. For details of the laws governing advertising and sales of medicinal products and medical devices see the responses to question 38 above.

 

21. How is compliance monitored?

1. Compliance with sales and advertising restictions is monitored, and infringements prosecuted, by (i) competitors, (i) industry associations and (iii) to a limited extent by government authorities.

2. The main sector of governmental supervision relates to the manufacture and marketing of medicinal products. The competent authorities can inspect the manufacture, distribution and evaluation of medicinal product risks. In order to reduce risks, the authorities are involved in the co-ordination of necessary measures in enterprises and facilities that manufacture, place on the market or clinically test medicinal products. To this end, the representatives of the competent higher federal authority, in consultation with the competent authority, can enter the production areas and business premises during regular working hours, inspect documents including the pharmacovigilance master file and request information.

 

22. What are the potential penalties for noncompliance?

1. § 17 of the German Medicinal Products Act governs the criminal sanctions, penalties and fines in the case of a criminal violation of the medicinal products laws. Depending on the kind and circumstances of such criminal violation, the scope of sanctions ranges from imprisonment up to three years to monetary fines. As concerns criminal monetary fines, the court can impose a fine up to EUR 30.000 per day for the number of days determined by the court (max. 360 days) – „daily rate“, pursuant to § 40 of the German Criminal Code of 15 May 1871, as amended (most recent amendment of 30 October 2017). If a criminal violation (offense) is committed by a legal representative of a business, the company fine can be up to 10 million EUR (see paragraph 3 below).

2. Pursuant to the Act on Regulatory Offences of 24 May 1968, as amended (most recent amendment of 17 December 2018), an administrative fine for a regulatory violation can be a maximum of EUR 1,000.00, except where a higher amount is stated in a relevant law. The administrative fine shall in any case exceed the financial benefit which the perpetrator or the company has obtained from the offense (§ 17 para 4 Administrative Offenses Act).

3. Where an administrative or criminal offense, pursuant to one of the statutes regulating the manufacture and sale of a medicinal product, is committed by an individual acting as a legal representative of a company, the administrative fine can imposed on the company (§ 30 Administrative Offenses Act,
see http://www.gesetze-im-internet.de/englisch_owig/englisch_owig.html#p0156.

Such corporate money fine pusuant § 30 of the Regulatory Offences Act can be imposed in case of an offence commited by a management individual by which the company violates its obligations, or from which the company benefits or was intended to benefit. This applies to any regulatory offence, regardless of what the offence concerned (it can be any offence within the sector of medicinal products, medical devices, food safety or CLP Regulations). In case of an intentional offence, the maximum amount of a fine is € 10 million, plus the absorption/skimming off of profits derived from the violation. In case of a negligent offence, the maximum amount of a fine is € 5 million, plus said absorption of profits.

Limited or permanent revocation of regulatory and/or professional licenses is also possibility.

 

Also from this Legal Handbook

A brief overview of the situation regarding preclinical and clinical trial requirements in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99.

 

1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?

1. In principle, pre-clinical and clinical studies and trials can be obtained from regulated and approved providers in Germany or abroad. Conditions apply. Pursuant § 40 of the German Medicinal Products Act, a sponsor or a representative of the sponsor whose registered place of business is situated in a Member State of the European Union or in another State that is a party to the Agreement on the European Economic Area, must be available. See also the summary of the Federal Agency for Medicinal Products and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) at https://www.bfarm.de/EN/MedicalDevices/ClinicalTrials-MD/Authorisation/_node.html

2. The sixth chapter of the German Medicinal Products Act sets some of the relevant rules for clinical trials and the protection of human subjects in clinical trials (§ 40: General conditions for clinical trials (acceptable risks, informed consent of subjects following comprehensive disclosure and risk information, risk insurance purchased for the benefit of subjects, protection of minors, completion of prior toxicological and animal testing, minimum of two years professional experience of supervising physician (principal investigator), independent ethics committee evaluation with consent), § 41: Other special pre-conditions for clinical trials, § 42: Ethics committee procedures, procedure for authorisation by the German federal authority, § 42a: Withdrawal, revocation and suspension of the authorisation or of the favourable opinion, and § 42b: Publication of the results of clinical trials.

 

2. How are clinical trials funded?

Funding is generally provided by the medicinal product developer or manufacturer (sponsor and co-sponsors).

 

3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?

1. The protocol describing all details of the study terms is prepared by the study sponsor and submitted, with supporting documentation (active ingredient dossier, proof of insurance, consent forms, sponsor/investigator/institution details, study subject inclusion scheme etc.) to the relevant ethics committee (§ 42 (1), (2) of the Medicinal Products Act) and the relevant approval authority (Federal Institute for Drugs and Medical Devices (BfArM) or the Federal Institute for Vaccines and Biomedicines (PEI), as applicable). Thereafter, the competent local supervising authority is notified of the intended clinical trial (§ 67 (1), (1), (5) of the Medicinal Products Act).

2. A changed approval procedure is expected in 2019 under EU Regulation on Clinical Trials (536/2014, CTR) and pertinent German law, providing for a single application to the EU-Portal. That will be accessible via the EU-Database from all EU member states in which an applicant plans a clinical trial.

 

4. What are the requirements for consent by participants in clinical trials?

Pursuant § 40 of the German Medicinal Products Act, the study subject must be of age and capable of understanding the nature, significance and implications of the clinical trial and able to form a rational intention in the light of the facts. It must have been fully informed and given written consent which consent must also refer specifically to the collection and processing of health-related data.

 

5. May participants in clinical trials be compensated?

Yes, compensation is permitted and customary.

 

6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?

Pursuant § 40 of the German Medicinal Products Act, an insurance policy covering risks of death and body or health injury must be in place which provides benefits to the study subject even when no one else is liable for the damage. The insurance must be taken out in favour of the study subject with an insurance carrier authorised to conduct business in a Member State of the European Union or another State Party to the Agreement on the European Economic Area. Its scope must be reasonably commensurate with the risks involved in the clinical trial and determined on the basis of the risk assessment in such a way as to ensure that for every case of the death or permanent occupational disability of a study subject, at least 500,000 € will be available. In so far as benefits are paid by the insurance, all claims to damages shall be extinguished.

 

Also from this Legal Handbook

An intro to the legal situation for regulatory, pricing, and reimbursement of drugs in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99.

 

1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?

• Federal Ministry for Health (Bundesministerium für Gesundheit (BMG), Berlin and Bonn). https://www.bundesgesundheitsministerium.de/
  Drafting legislation, regulations and ordinances in all sectors of health care and social insurance, regarding admission of health care professionals, manufacturing and market licenses for medicinal products and medical devices.
• Federal Agency for Medicinal Products and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Bonn. www.bfarm.de/EN/BfArM
  National manufacturing and market licenses for medicinal products and medical devices, authorization of clinical studies for medicinal products and medical devices, risk supervision, supervision of drug traffic.
• Robert Koch-Institut (RKI) https://www.rki.de/EN/Home/homepage_node.html
  The Robert Koch Institute (RKI) is the government’s central scientific institution in the field of biomedicine. It is one of the most important administrative bodies for the safeguarding of public health in Germany. Intelligence, prevention, abatement and control of diseases, in particular infectious diseases.
• Paul-Ehrlich-Institut (PEI) https://www.pei.de/EN/home/node.html
  The Paul-Ehrlich-Institute is another Agency of the German Federal Ministry of Health. Its research and control activities promote the quality, efficacy and safety of biological medicinal products. It is in charge of national market licenses for biomedical medicinal products such as vaccines, authorization of clinical studies and risk supervision regarding medicinal products.
• Federal Insurance Agency (Bundesversicherungsamt, BVA)
  Supervision of federal public health insurers, administration of structural risk equalization between health insurers, health fonds.
• Federal Center for Health Education (Bundeszentrale für gesundheitliche Aufklärung (BZgA)
  Prevention campaigns, education measures, model projects for child and youth health, aids, addiction.
• Institute for Quality and Commercial Feasibility in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG)
  Evaluation of diagnosis and therapy methods, cost and benefit evaluations for medicinal products. review of structured therapy programmes, high quality patient information.
• Institute for Quality Security and Transparency in Health Care (Institut für Qualitätssicherung und Transparenz im Gesundheitswesen, IQTIG))
  Development and implementation of measures for quality enforcement and transparent reporting in health care.

Note on English language citations and summaries of German laws, statutes and regulations: As concerns English versions of the laws, statutes and regulations referred to in this publication, please refer to the translations made available on the following website of the Federal Ministry of Justice and Consumer Protection:

http://www.gesetze-im-internet.de/Teilliste_translations.html

References in this publication to English versions and summaries of German laws, statutes and regulations are partly based on the translations made available on above website.

 

2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?

1. Medicinal Products, Biologicals:

The regulatory framework for German manufacturing and market authorizations of medicinal products and biologicals is set forth in the German Medicinal Products Act (also referred to as the Pharmaceuticals Act or Drug Act, Arzneimittelgesetz, “AMG”) of 12 December 2005 as amended, as well as a number of supplementary laws and regulations governing the implementation of the rules set forth in the Act. An English translation of the AMG is available on the following website of the Federal Ministry for Justice and Consumer Affairs: http://www.gesetze-im-internet.de/englisch_amg/index.html.

European manufacturing and market authorizations by EMA, London, are regulated by EU Regulations, notably Regulation (EC) No 726/2004.

Definition of Medicinal Products: Pursuant to § 2 (1) of the Medicinal Products Act, all “substances and preparations made from substances which are intended for use on or in the human or animal body and are intended for use, based on their properties, as remedies for the curing, alleviating or preventing of human or animal diseases or disease symptoms’ are medicinal products (Medicinal Products), unless they are foods, cosmetics, tobacco products or medical devices. The rules of the German AMG are essentially based on EU Directive 2001/83 (Code of Human Medicines Directive), EU Regulation 536/2014 and many others.

2. Medical Devices:

The regulatory framework for the manufacture and authorization of medical devices is set forth in the Medical Devices Act (Medizinproduktegesetz, “MPG”) of 2 August 1994, as amended, as well as supplementary laws and regulations governing the marketing of medical devices.

3. The regulatory framework of pricing of medicinal products and medical devices was reformed in 2011 and is essentially governed by the Law Reforming the Pharmaceutical Market generally referred to as “AMNOG” (Arzneimittelmarkt-Neuordnungsgesetz of 2011), as well as a number of other and supplementary laws and regulations. Up to 2011, the wholesale sale price of a new, patent protected prescription drug was determined by the manufacturer, except where such drug was assigned to a group of fixed price drugs. Since 2011, this applies only to the first year following market authorization. During that first year, any such medicinal product prescribed within the public health insurance system (Gesetzliche Krankenversicherung (GKV)) is evaluated as to its additional benefits as compared to other current standard therapies of the same indication (early benefit evaluation, „Frühe Nutzenbewertung“). If an additional benefit has been determined, the representatives of the GVK and of the manufacturer negotiate a reimbursement amount which is usually lower than the original manufacturer asking price. If there is no such additional benefit, the new drug is subject to a determined fixed price.

Wholesale adds a wholesale margin within a statutory maximum. That wholesale price is the nationwide uniform price charged to drug stores (pharmacies). The pharmacy sales price for prescription drugs (also uniform in Germany) is determined by adding a margin of 3 percent to the wholesale price, plus a fixed pharmacy service compensation of 8.35 Euros, and the value added tax. If the sale is charged to a public heath insurance, the price is reduced by a fixed deduction which is, since 2015, an amount of 1.77 Euros per unit.

The price of freely sellable medicinal products soled in pharmacies or elsewhere is determined by each pertinent seller (for example, herbal teas, plant extracts, vitamines, minerals etc.).

The price of the large number of generica is relatively moderate in Germany, whereas the prices for patent protected medicinal products is relatively high compared to other markets (where lower or no value added tax or different price regulation systems apply). The price difference prompts some German wholsale businesses to import from abroad (parallel imports).

4. The reimbursement of the cost of medicinal products and medical devices is regulated in laws and regulations regarding public health insurance and private health insurance. Details will be outlined in the answers to questions 10 to 13 below.

 

3. What are the steps to obtaining authorization to develop, test, and market a product?

1. The third section of the Medicinal Products Act (governing manufacturing licenses in §§ 13 to 20d), the fourth section (governing market license in §§ 21 to 37) as well as the sixth section (governing the protection of human subjects and ethincs in clinical testing in §§ 40 to 42b of the Medicinal Products Act) regulate the development, testing and marketing of medicinal products. The Medical Devices Act provides the corresponding background for medical devices. These statutes describe in detail the application and authorization process, withdrawals, revocations and the resting of the authorization. A “qualified person” must be available to the medicinal product manufacturing facility.

2. Any medicinal product placed on the German market following a marketing authorization from the German authorities or from the European Medicines Agency (EMA) must have successfully completed clinical trials substantiating the efficacy and safety. “Finished medicinal products” are manufactured in advance and placed on the market in packaging intended for distribution to the consumer (as defined in § 4 (1) of the German Medicinal Products Act),

Two kinds of medicinal products do not require marketing authorizations (§ 21 (2) of the German Medicinal Products Act), namely (i) medicinal products manufactured in a under a licensed pharmacy (no more than 100 packages per day) and (ii) medicinal products that are intended for use in clinical trials on humans.

Further, pursuant to § 21 (2) No. 6 of the Medicinal Products Act, an exception applies to medicinal products applied to a patient, free of charge, as a matter of compassionate use (to treat a life-threatening disease that cannot be treated satisfactorily with an authorised medicinal product), subject to the rules of the Ordinance for Compassionate Use (Verordnung über das Inverkehrbringen von Arzneimitteln ohne Genehmigung oder ohne Zulassung in Härtefällen (Arzneimittel-Härtefall-Verordnung – “AMHV”) of 14. July 2010 issued by the Federal Ministry of Health (Bundesgesundheitsministerium).

3. As concerns medical devices, §§ 4 to 14 of the Medical Devices Act regulate the required properties of medical devices, §§ 15 to 18 govern the role of supervisory authorities and certifications, §§ 19 to 24 concern clinical testing and market authorizations, and §§ 25 to 31 regulate the supervision and risk reporting.

 

4. What are the approximate fees for each authorization?

1. Depending on the nature of the product, fees and expenses are charged for the decision on the marketing authorization, on the authorization of tissue preparations, on the authorization of medicinal products for advanced therapies, batch releases, the processing of applications, activities in the context of the compilation and evaluation of risks of medicinal products, for the protest procedure against an administrative act issued on the basis of the Act or other services, including independent consulting and information services. The maximum fee for the market authorization as such of medicinal products is EUR 57,500.

2. Regarding the cost charged by the Paul-Ehrlich-Institute for market authorizations of biomedical medicinal products (such as vaccines), detailed information is available on the Institute’s website https://www.pei.de/EN/home/node.html.

 

5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?

1. Pursuant § 31 of the Medicinal Products Act, a marketing authorisation expires (i) if the authorised medicinal product is not placed on the market within three years from marketing authorisation, or if it was placed on the market but the market presence is interrupted for three successive years; (ii) when waived in writing; (iii) five years after it was granted, unless a timely application for prolongation is filed nine months prior to the expiry date; (iv) if the prolongation of the marketing authorisation is refused. Prolonged marketing authorizations are valid for an unspecified period, subject to detailed conditions.

2. Pusuant § 31 (2) of the Medicinal Products Act, the application for prolongation shall be supplemented by a report giving details of whether, and to what extent, the criteria by which the medicinal product is assessed have altered over the previous five years. Updates of the quality, safety and efficacy documents must be filed.

Further details apply as set forth in § 31 of the Medicinal Products Act.

 

6. How does the authorization process differ between brand-name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?

1. As concerns German manufacturing and market authorizations, there are no differences in the authorization process for local versus foreign manufacturer, provided all regulatory requirements are fulfilled.

2. Regarding the market authorization of generic medicinal products, § 42 b of the German Medicinal Products Act provides for certain limited benefits regarding support document filing requirements. The Act permits the applicant to reference, without a previous applicant’s agreement, certain documentation, including the expert report, already filed in support of a previous applicant’s medicinal product („Reference Medicinal Product“), provided the Reference Medicinal Product has been authorised for at least eight years. This also applies to filings for authorisations in another Member State of the European Union. However, a generic medicinal product authorised pursuant to this provision facilitating the documentation process may not be placed on the market until ten years have elapsed following the first authorisation of the Reference Medicinal Product (subject to further details). An authorisation pursuant to the above rules requires that the medicinal product in question has the same qualitative and quantitative composition of active substances and the same pharmaceutical form as the Reference Medicinal Product, and that the bioequivalence has been demonstrated in bioavailability studies (details apply). The applicant is not required to submit bioavailability studies if it can otherwise demonstrate that the generic medicinal product meets the relevant bioequivalence criteria in accordance with current scientific knowledge.

 

7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated?

Combination products are usually innovative medicinal products and medical devices featuring the benefits of a medical device in combination with a pharmacological component (based on coating, impregnation or otherwise). The evaluation of a combination product for the regulatory market authorization process of § 25 of the Medicinal Products Act is obviously more complex than the process applicable to a medical device, only. The relevant German authority will require extra time to determine the necessary scope of evaluation and to conduct required examinations. Manufacturers of combination products should, therefore, seek early advice and instructions from the authority to determine the extent of documentation and supplementary approvals or certifications (such as a CE certification).

 

8. How is compliance with regulation monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?

1. The eighth Chapter of the Medicinal Products Act contains rules pertaining to safety and quality control, notably § 54 on internal regulations, § 55 on Pharmacopoeia and § 55a containing the rules for official compilation of test procedures. Securing, monitoring and enforcing the quality of medicinal product manufacturing is primarily based on § 54 in combination with the Regulation Replacing the Operation Ordinance for Pharmaceuticals Manufacturers (Verordnung zur Ablösung der Betriebsverordnung für pharmazeutische Unternehmer) of 3 November 2006.

2. The German Medicinal Products Book (Arzneibuch) referenced in aforementioned Regulation consists of several volumes of rules and regulations which also include the European Medicinal Products Book. It represents a binding regulatory collection of recognized pharmaceutical rules regarding the quality, examination, storage, distribution and labeling of medicinal products. On the European level, these requirements and procedures for marketing authorisations, as well as the rules for monitoring any authorised products, are primarily laid down in Directive 2001/83/EC and in Regulation (EC) No 726/2004. In addition, the rules of Good Manifacturing Practices (and similar Good Practices rules in other sectors) apply.

3. In essence, the safety regime applicable in Germany corresponds to the rules of the European Medicines Agency EMA, it is highly complex and comparable to the regulations applied by the U.S. Food and Drug Administration.

 

9. What is the potential range of penalties for noncompliance?

1. § 17 of the Medicinal Products Act governs comprehensively the criminal sanctions, penalties and fines in the case of violations of regulatory law. Depending on the kind and circumstances of a violation the scope of sanctions ranges from imprisonment up to three years or monetary fines. Pursuant to § 40 of the German Criminal Code (Strafgesetzbuch „StGB) of 15 May 1871, as amended (most recent amendment of 30 October 2017), a monetary fine can be a maximum of EUR 30.000 per day for the number of days to be determined by the court (max. 360 days) – „daily rate“). In case of a criminal offense committed by a legal representative pursuant to the German Criminal Code, or pursuant to one oft he statutes relating to medicinal products or medical devices, the company fine can be up to 10 million EUR.

2. Pursuant to the Act on Regulatory Offences (Bußgeldgesetz) of 24 May 1968, as amended (most recent amendment of 17 December 2018), an administrative fine can be a maximum of EUR 1,000.00, except where a higher amount is stated in a relevant law. The administrative fine shall in any case exceed the financial benefit the perpetrator or the company obtained by the offense (§ 17 para 4 Administrative Offenses Act).

Where an administrative or penal offense, pursuant to one of the statutes named herein, is committed by an individual acting as a legal representative of a company, the administrative fine can imposed on the company (§ 30 Administrative Offenses Act, see http://www.gesetze-im-internet.de/englisch_owig/englisch_owig.html#p0156. Such corporate money fine pusuant § 30 of the Regulatory Offences Act can be imposed in case of an offence commited by a management individual by which the company violates its obligations, or from which the company benefits or was intended to benefit. This applies to any regulatory offence, regardless of what the offence concerned (it can be any offence within the sector of medicinal products, medical devices, food safety or CLP Regulations. In case of an intentional offence, the maximum amount of a fine is € 10 million, plus the absorption/skimming off of profits derived from the violation. In case of a negligent offence, the maximum amount of a fine is € 5 million, plus said absorption of profits.

Limited or permanent revocation of regulatory and/or professional licenses is also possibility.

See also responses to question 22 of Marketing, Manufacturing, Packaging & Labeling, Advertising.

 

10. Is there a national healthcare system? If so, how is it administered and funded?

Germany has a highly developed and comprehensive national healthcare system composed of a combination of public health insurance (sickness funds or gesetzliche Krankenkassen) and private health insurance (Private Krankenversicherung). The system is administered by the administrations and institutions named in the answer to question 1 above and the Federal Joint Committee (Gemeinsamer Bundesausschuss, „G-BA“) which is a central body of self-regulation for the steering of medical care and implementation of statutory rules. It is a public health organization issuing regulations implementing the legislative health laws and reforms. About 85% of the population are mandatory or voluntary members of the public health insurance, the rest has private health insurance.

The funding is in the hands of the public health care insurances or private insurers.

 

11. How does the government (or public) healthcare system function with private sector healthcare?

1. All active and retired workers, and employees earning up to about EUR 60,000 annually are automatically signed up to one of the public non-profit sickness funds. The contributions are paid equally by employers and employees. Membership cannot be refused.

In parallel, there are private health insurances which can be used by individuals with higher income, students and civil servants, and anyone else for complementary coverage.

2. Long-term care (Pflegeversicherung) is paid for half and half by the employer and the employee. It covers cases of necessary care requirements (individuals not being able to manage their daily routine such as eating, cleaning, personal hygiene, etc.). The contribution is about 2% of the income or pension plus the employer’s one half share.

3. The contributions to the public health insurance are determined by the Federal Ministry of Health, covering a fixed set of healh-related services regulated in the German Social Law Book (Sozialgesetzbuch – SGB). The health services must be economically viable, sufficient, necessary and meaningful. Contributions do not dependent on an individual’s health condition but are a percentage of the salary under about EUR 60.000 per year (currently 15.5%, 7.3% of which is covered by the employer). Family members are insured.

4. In the Private health insurance system, the premium is individually agreed on the basis of the insurer’s terms, defining the set of covered services and the degree of coverage. The amount depends on the scope of purchased services and the insured’s risk (health, age of entry etc). The contributions are used to accumulate savings for rising health costs at higher age (required by law).

The private health care organizations supplement the public system and operate independently, subject to the regulatory rules governing safety and consumer protection.

 

12. Are prices of drugs and devices regulated and, if so, how?

1. Within the framework of the Law Reforming the Pharmaceutical Market of 2011 (AMNOG, see introductory information in the answer to question 2 above) and the German Social Security Laws, the sale of medicinal products and certain medical devices marketed in Germany benefits from the general principle of cost reimbursement by the public (or private, as the case may be) health insurers, except products falling into a category excluded by law (such as OTC products), or excluded by a decision of the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA). This general rule is subject to certain exceptions. A non-prescription product (over-the-counter product, “OTC”) can be purchased without a physician’s prescription. Pursuant to § 48 of the German Medicinal Products Act, the German Ministry of Heath can determine that a medicinal product can be sold without prescription if the properly applied or used product does not endanger the user’s health even if the use is not supervised by a physician. OTC products can be products which are available in pharmacies, only, or products available outside a pharmacy.

OTC products play a major role in the sector of self-medication. With a view to the fact that most OTC products do not qualify for reimbursement, they are not relevant for public health insurers. They are more important for private insurers („PKV“) which, in certain circumstances, reimburse the costs of OTC medicinal products recognized by evidence based medical practice or which are a well-proven medicinal alternative.

2. There is, in principle, free manufacturer pricing for a year after a medicinal product is first placed on the market. There is a formal assessment of the “added therapeutic effect” of a new pharmaceutical product which then forms the basis of the price determination. Products are often combined (clustered) in groups of therapeutically similar products which qualify for maximum reimbursement amounts. The prices of innovative medicinal products are normally negotiated. In principle, prescription drugs are reimbursed by the health insurances (with certain exceptions set out in the so-called “negative list” maintained by the G-BA.

3. The process of evaluation and price negotiation extends to new and patented medicinal products (except products which generate public health insurance expenditures of less than 1 million EUR). Based on their marketing authorization, orphan drugs are normally deemed to have excess therapeutic benefit without reference to comparing products in Germany (subject to certain limitations). For details see the extensive AMNOG-related literature.

 

13. How are drugs and devices used by patients paid for? What roles do public and private payers play?

1. Prices of drugs dispensed to hospital patients are negotiated between pharmaceutical manufacturers and hospitals or organizations purchasing for hospitals, subject to certain limits. They are paid for either by the public health insurance or, where private insurance applies, by the patient who would apply for reimbursement by its private insurer.

2. Regarding other patients not treated in a hospital, pharmaceutical manufacturers are required to apply a 7% discount off the ex-factory price for the benefit of sickness funds and other health insurers on patented medicinal products not allocated to a price group (Social Security Act SGB V, § 130a). For generics not clustered in a price groups, the discount is 6%, plus a further discount not exceeding 10%. Again, purchases and services are paid for either by the public health insurance or, where private insurance applies, by the patient who would then apply for reimbursement by its private insurer.

 

14. Who dispenses drugs and devices to patients and how are those dispensers compensated?

1. Medicinal Products and medical devices the sale of which is restricted to pharmacies (can be prescription or non-prescription products) may be purchased and sold by licensed pharmacies or drug wholesale entities, only (pharmacies in the case of retail (§ 17 of the Pharmacy Act, Gesetz über das Apothekenwesen (Apothekengesetz – ApoG) of 20. August 1960 in the version of 15. Oktober 1980, most recent amendment of 29. März 2017) or licensed medicinal products wholesale entities in the case of wholesale.

2. The seventh chapter of the Medicinal Products Act (§§ 43 to 53) regulates the sale of medicinal products, addressing in §§ 43 to 45 the pharmacy-only requirement and its exceptions and extensions, in § 47 the permitted distribution channels, in § 47a the obligation to keep records, in § 47b certain special distribution channels (diamorphine), in § 48 the prescription requirement, in § 51 the sale by itinerant traders, in § 52 the prohibition of self-service, in § 52a the wholesale trading of medicinal products, in §§ 52b and 52c the supply and brokering of medicinal products and in § 53 the expert consultation obligations.

3. Summarizing some of the more essential rules, it should be noted that all retail of medicinal products and medical devices restricted to pharmacies must take place within the authorized pharmacy’s premises. Self-service is not permitted in pharmacies for products the sale of which is restricted to pharmacies. Drive-in Pharmacies are permitted, subject to certain rules. Delivery may be arranged by means of reliable messengers, subject to the rules of § 11a of the Pharmacy Act. Distant sales of medicinal products is also permitted in accordance with and subject to the restrictions of the rules of § 11a of the Pharmacy Act. Other products not restricted to pharmacy sale can be sold by drugstores (Drogerien) or otherwise.

4. The sale of prescription medicinal products (§ 3 of the Prescription Drug Regulation) is subject to detailed recording and monitoring requirements of the pharmacist.

5. Medical devices not restricted to the sale in pharmacies are sold in medical supply stores.

6. Retail purchases must be paid for by the purchasing party which in turn can arrange for reimbursement by the relevant public or private health insurer (subject to the relevant conditions).

 

15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?

The Pharmacy Act, the Prescription Drug Regulation and other rules and regulations provide for detailed professional consulting, advice, monitoring, supervision, recording and documentation responsibilities. Safety and security rules ensure the safeguarding of harmful substances. The identification of medicinal products is regulated in § 300 III No 1 of the Fifth Book of the Social Security Act, based on the uniform Identification Number for Medicinal Products (Pharmazentralnummer “PZN”). Pharmacies are subject to service obligations, prescribed opening hours, access regulations, night and emergency service obligations and the obligation to provide pharmaceutical counselling to customers.

 

Also from this Legal Handbook

Peter Homberg of Dentons Germany examines the regulatory status quo around the free sale of products containing cannabidiol (CBD) across Europe. Although deregulation efforts are underway, Homberg argues that the trade in these products is not as free and unregulated as it may initially seem.

 

CBD products that are marketed in Gemany as pharmaceutical products must comply with the strict provisions of the Medicinal Products Act of Germany (Arzneimittelgesetz), as a CBD pharmaceutical product is categorized as a prescription drug

Products containing cannabidiol (CBD) are in high demand throughout Europe. An increasing number of suppliers are trying to satisfy customer demand in all product categories. In any case, these are CBD products with a tetrahydrocannabinol (THC) content below 0.2 percent.

 

In Europe, CBD products are governed by various laws, both European and national. The applicable law depends on the respective final product containing CBD and its categorization. CBD products may be categorized as medicine, food supplements or cosmetics, depending on how the product is marketed.

 

In order to place CBD products legally on the European market, they must comply with the applicable European and national legislation.

 

In Germany, CBD products containing a concentration of THC of less than 0.2 percent are generally not subject to the Narcotic Drugs Act (Betäubungsmittelgesetz), due to the fact that it has no psychoactive effect in comparison to a product containing more than 0.2 percent THC, provided that trading is exclusively for commercial or scientific purposes, which precludes any misuse for intoxication purposes. CBD products that are marketed in Gemany as pharmaceutical products must, however, comply with the strict provisions of the Medicinal Products Act of Germany (Arzneimittelgesetz), as a CBD pharmaceutical product is categorized as a prescription drug.

 

In addition, there are various European regulations that standardize the handling of CBD products throughout Europe. This applies in particular to the area of food supplements and cosmetics.

 

Regarding food supplements containing CBD, the Novel Food Regulation has to be taken into account. Novel foods are subject to harmonized rules throughout the European Union (EU) in order to achieve a high level of protection of human health on the one hand and to ensure the functioning of the internal market on the other. Therefore, novel foods must undergo a risk assessment before they can be placed on the market. This is regulated in Regulation (EU) 2015/2283 (Novel Food Regulation).

 

CBD is currently not included in the EU Community list, which positively lists such foods that are already authorized to be placed on the European market without prior additional examination.

 

Information on whether a product might need an authorization under the Novel Food Regulation can be found in the Novel Food catalogue of the European Commission, available online. In the past, the classification of CBD was initially not clearly assessable for market participants, as the entry of CBD in the Novel Food catalogue only classified as Novel Foods those CBD products “in which CBD levels are higher than the CBD levels in the source Cannabis sativa L”. However, due to recent changes of the Novel Food catalogue, the entry for CBD now states “extracts of Cannabis sativa L and derived products containing cannabinoids are considered novel foods as a history of consumption has not been demonstrated. This applies to both the extracts themselves and any products to which they are added as an ingredient (such as hemp seed oil). This also applies to extracts of other plants containing cannabinoids. Synthetically obtained cannabinoids are considered as novel.” By now, the Novel Food Catalogue explicitly states that all food supplements containing CBD are subject to an approval even with a THC content of less than 0.2 percent.

 

There is currently one novel food application for CBD under consideration with the European Food Safety Authority (EFSA), to authorize the use of CBD in food supplements for adults with a daily intake of up to 130 mg. In case the application is successful, the European Commission must draft an implementing act authorizing the use of the product within seven months. However, the opinion of EFSA has not yet been published.

 

The essential requirements and obligations for cosmetics containing CBD are governed by Regulation (EC) 1223/2009 (“Cosmetics Regulation”). According to Article 14 in conjunction with Annex II of the Cosmetics Regulation, cosmetic products may not, in principle, contain prohibited substances, including in particular, according to Table I of the Single Convention on Narcotic Drugs of 1961, the flower and fruit buds of the cannabis plant from which the resin has not been removed. Seeds and leaves not mixed with such strands are excluded. Consequently, the prohibition does not cover CBD obtained from the seeds and leaves of the cannabis plant which have not been mixed with the flowers or fruit from which the resin has not been removed. CBD, which is synthetically produced, is also not prohibited in cosmetics. Hence, it is essential for the retailer to have precise knowledge of the exact production of the respective CBD and the harmlessness of the product before selling cosmetics containing CBD.

 

The Austrian authorities have adopted an even stricter position. The Austrian Ministry of Health has issued a decree banning the sale of food and cosmetic products containing the cannabis ingredient CBD. The prohibition does not apply to pharmacies if CBD products are offered as so-called “presentation drugs” which are subject to strict controls and may only be sold in pharmacies.

 

In conclusion, the trade of CBD is not as free and unregulated as it seemed at the beginning. The regulations around CBD have always been quite strict. Moreover, they are handled and enforced more restrictively from time to time. It remains to be seen whether deregulation efforts, such as the attempt to include CBD in the list of approved novel foods, will be successful.