The Pharma Legal Handbook: Luxembourg

Cannabinoid drugs, medicinal cannabis and opioid drugs in Luxembourg - a comprehensive legal overview. Prepared in association with Emmanuelle Ragot, an independent firm anchored in Luxembourg, this is an extract from The Pharma Legal Handbook: Luxembourg, available to purchase here for GBP 99.

*Major changes are expected in 2022 on the use of cannabis which should impact its use for pharmaceutical purposes.

   

Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

The use of recreational cannabis is prohibited according to the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended.

The use of medicinal cannabis (cannabis used for pharmaceutical purposes) has recently been authorized by a law of 20 July 2018, introducing article 30-2 of the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended. See next section Medicinal Cannabis on this point.

According to the Grand-Ducal regulation of 26 March 1974 establishing the list of narcotic drugs, are not considered as narcotic drugs, under specific conditions related to their crop and their intended purposes, the varieties of hemp, provided that their concentration in delta-9-tetrahydrocannabinol (THC) is less than a specific rate. 

Furthermore, according to the Grand-Ducal Regulation of the 4 March 1974 relating to certain toxic substances, delta-9-tetrahydrocannabinol (THC), cannabidiol (CBD), cannabinol (CBN) and their isomers are considered as toxic substances, provided that they are incorporated in a medicinal product delivered in accordance with the Community acquis. They are classified as category “S” medicinal products in the Grand-Ducal regulation of 15 December 1992 relating to the marketing of medicinal products as amended, meaning that their deliverance is subject to a special medical prescription. As a consequence, their use is governed by the legislation applicable to medicinal products and the legislation applicable to toxic substances. For an easiest reading, such medicinal products will be referred as “Cannabinoid Drugs”.

 

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

Similarly to medicinal products, the regulatory authority in charge of Cannabinoid Drugs is the Ministry of Health (“Ministère de la Santé”), in particular the National Health Directorate (“Direction de la Santé”) and its department the Pharmacy and Medication Department (“Division de la Pharmacie et des Médicaments”).

Moreover, because Cannabinoid Drugs are also subject to the provisions of the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended, the following persons would be also competent:

• judicial police officers;
• officers of the gendarmerie, and police;
• the customs and excise administration; as well as
• the director, the deputy director, the medical inspectors and the pharmacist-inspectors of the National Health Directorate 

 

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

i. Authorization of Cannabinoid drugs

Cannabinoid Drugs in themselves are subject to the same provisions as medicinal products in this respect, so that there is not a specific regulatory framework for the authorization of Cannabinoid Drugs.

 

ii. Pricing, and reimbursement of Cannabinoid drugs

There is no specific regulatory framework for cannabinoid drugs but the general regulatory framework for medicinal products including the Social Security Code and the statutes of the National Health Fund (“Caisse Nationale De Santé” or “CNS”) apply also to cannabinoid drugs.

 

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

To our knowledge, the only Cannabinoid Drugs that has received a marketing authorization is Sativex®

 

5. Who can prescribe Cannabinoid Drugs?

All the doctors authorized to practice in Luxembourg can prescribe Cannabinoid Drugs.

 

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

No, there is no list of doctors authorized to prescribe Cannabinoid Drugs.

 

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

No approvals or notifications are required to prescribe Cannabinoid Drugs.

However, according to article 5 of the Grand Regulation of the Grand-Ducal regulation of 19 February 1974 implementing the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended, all those who hold Cannabinoid Drugs shall keep a specific register indicating the quantities they possess of said Cannabinoid Drugs. They shall enter in this register on a daily basis the quantities they acquire, produce, manufacture or debit and those they use for preparations or manufacturing. This register, as well as invoices or other supporting documents, must be kept for 10 years at the disposal of the judicial authorities and law enforcement officials.

 

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

According to article 2 of the Grand-Ducal regulation of 19 February 1974 implementing the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended, only those that have been subject to a prior authorization from the Minister of Health may deliver Cannabinoid Drugs, except the following category of persons and establishments:

• pharmacists holding a pharmacy which is open to the public;
• hospitals and specialized hospitals with a hospital pharmacy;
• doctors and veterinary doctors authorized to hold medicinal products within the limit of a provision for urgent care.

  Moreover, only pharmacists holding a pharmacy which is open to the public may sell or offer to sell Cannabinoid Drugs without the authorization of the Minister of Health.  

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

There is no list of retailers/distributors authorized to sell Cannabinoid Drugs.

 

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

No, there is no proposals for reform or significant change to the regulation of Cannabinoid Drugs.

 

11. When are they likely to come into force?

The question is not applicable.

   

Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the country?

Yes, medicinal cannabis is authorized since a law of 20 July 2018, introducing article 30-2 of the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended.

 

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

The regulatory authority with jurisdiction over medicinal cannabis in Luxembourg is the National Health Directorate under the authority of the Ministry of Health.

 

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

i. Authorization of medicinal cannabis

The authorization of medicinal cannabis is governed by article 30-2 of the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended.

 

ii. Pricing, and reimbursement of medicinal cannabis

There is no specific regulatory framework but the general regulatory framework for medicinal products including the Social Security Code and the statutes of the National Health Fund (“Caisse Nationale De Santé” or “CNS”) apply also to medicinal cannabis.

 

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

According to article 30-2 of the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended, the cannabis produced shall be subject to an approval from the National Health Directorate attesting their medical use.

According to article 1 of Grand-Ducal regulation of 19 February 1974 implementing the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended: 

• medicinal cannabis can only be imported with a prior authorization of the Minister of Health;
• the import authorization is delivered following a written application, stating the nature, quantity of the substances to import, as well as the alkaloid content of the substances. The importer can only take possession of the imported products after verification by the pharmacist-inspector of the Ministry of Health that may take samples. 

 

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

A prior authorization of the Minister of Health is necessary to import medicinal cannabis and the import is subject to a prior authorization of the Minister of Health.

 

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

The marketing and distribution of medicinal cannabis is governed by article 30-2 of the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended.

 

18. How can patients obtain Medicinal Cannabis?

According to article 30-2 of the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended, the patient having the following symptoms can obtain medicinal cannabis from a doctor authorized to practice in Luxembourg who had a previous special training about medicinal cannabis before:

• a serious illness, late stage or terminal illness, or
• a disease whose symptoms have a significant and lasting negative impact on its quality of life and which can be mitigated by the administration of medicinal cannabis.

 

19. Who can prescribe Medicinal Cannabis?

Doctors with a previously special training on the pharmacology of medicinal cannabis product, its presentation forms, therapeutic indications and side effects, as well as on the modalities and scientific bases of its prescription can prescribe medicinal cannabis, in accordance with article 30-2 of the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended.

 

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

There is no list of doctors authorized to prescribe medicinal cannabis.

 

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

No approvals or notifications are required to prescribe medicinal cannabis.

 

22. Where is Medicinal Cannabis available?

Medicinal cannabis can only be delivered in hospital pharmacies, in accordance with the above-mentioned article.

 

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

There is no list of retailers authorized to sell medicinal cannabis.

 

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

There is no proposals for reform or significant change to the regulation of medicinal cannabis, but the legalization of medicinal cannabis in Luxembourg has been done recently by the law of 20 July 2018 amending the amended law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction.

   

Opioid Drugs

25. Are Opioid Drugs authorized in your country?

Opium and most opioid substances, such as fentanyl, oxycodone and piritramide are considered as narcotics according to the Grand-Ducal regulation of 26 March 1974 establishing the list of narcotic drugs and their recreational use is prohibited in accordance with the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended.

Other opioid substances, such as Buprenorphine, are considered as toxic substances in accordance with the Grand-Ducal regulation of 4 March 1974 concerning certain toxic substances as amended.

Opioid substances for medical use and medicinal products containing opioid substances are classified as category “S” medicinal products in the Grand-Ducal regulation of 15 December 1992 relating to the marketing of medicinal products as amended, meaning that their deliverance is subject to a special medical prescription. As a consequence, their use is governed by the legislation applicable to medicinal products and the legislation applicable to narcotics or toxic substances. For an easiest reading, such medicinal products will be referred as “Opioid Drugs”.

 

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

Similarly to medicinal products, the regulatory authority in charge of Opinoid Drugs is the Ministry of Health (“Ministère de la Santé”), in particular the National Health Directorate (“Direction de la Santé”) and its department the Pharmacy and Medication Department (“Division de la Pharmacie et des Médicaments”).

Moreover, because Opioid Drugs are also subject to the provisions of the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended, the following persons would be also competent:

• judicial police officers;
• officers of the gendarmerie, and police;
• the customs and excise administration; as well as
• the director, the deputy director, the medical inspectors and the pharmacist-inspectors of the National Health Directorate.

 

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

i. Authorization of opioid drugs

Opioid Drugs in themselves are subject to the same provisions as medicinal products in this respect, so that there is not a specific regulatory framework for the authorization of Opioid Drugs.

 

ii. Pricing, and reimbursement of opioid drugs

There is no specific regulatory framework for opioid drugs but the general regulatory framework for medicinal products including the Social Security Code and the statutes of the National Health Fund apply also to Opioid Drugs.

 

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

Based on the list of medicinal products marketed in Luxembourg (“Liste des médicaments commercialisés”), the Opioid Drugs which have received market approval to date include (without being exhaustive):

• Fentanyl (such Durogesic®)
• Piritramide (such as Dipidolor®)
• Buprenorphine (such as Temgesic® and Transtec®)

 

29. Who can prescribe Opioid Drugs?

All the doctors authorized to practice in Luxembourg can prescribe opioid drugs.

 

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

There is no list of doctors authorized to prescribe opioid drugs in Luxembourg.

 

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

No approvals or notifications are required to prescribe Opioid Drugs.

However, according to article 5 of the Grand Regulation of the Grand-Ducal regulation of 19 February 1974 implementing the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended, all those who hold Opioid Drugs shall keep a specific register indicating the quantities they possess of said Opioid Drugs. They shall enter in this register on a daily basis the quantities they acquire, produce, manufacture or debit and those they use for preparations or manufacturing. This register, as well as invoices or other supporting documents, must be kept for 10 years at the disposal of the judicial authorities and law enforcement officials.

 

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

According to article 2 of the Grand-Ducal regulation of 19 February 1974 implementing the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended, only those that have been subject to a prior authorization from the Minister of Health may deliver Opioid Drugs, except the following category of persons and establishments:

• pharmacists holding a pharmacy which is open to the public;
• hospitals and specialized hospitals with a hospital pharmacy;
• doctors and veterinary doctors authorized to hold medicinal products within the limit of a provision for urgent care

Moreover, only pharmacists holding a pharmacy which is open to the public may sell or offer to sell Opioid Drugs without the authorization of the Minister of Health.  

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

There is no list of retailers/distributors authorized to sell opioid drugs.

 

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

No, there is no such reform or significant change related to the regulation of opioid drugs.

 

35. When are they likely to come into force?

The question is not applicable.

   

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Click the following links to read more legal articles from Luxembourg:

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reform
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs

Also from this Legal Handbook

The key facts about regulatory reform in Luxembourg. Prepared in association with Emmanuelle Ragot, an independent firm anchored in Luxembourg, this is an extract from The Pharma Legal Handbook: Luxembourg, available to purchase here for GBP 99. *Many laws (11) have been published in Luxembourg in 2020, but 100% of them are in relation to the management of COVID 19.    

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

Yes, the ongoing draft law n°7383 which has been filed to the Chamber of Deputies on 25 October 2018 by the Minister of Health contains several proposals for reform that includes, without being exhaustive:

• allowing holders of a wholesale distribution authorization for medicinal products to supply directly certain medicinal products to the public, in particular for patients kept under oxygen at home (oxygen cylinder deliveries), or patients wishing to make dialysis at home (sachets of liquid dialysis) ;
• allowing state services to have access to medicinal products in the public health interest; 
• allowing doctors and dentists to have access to and be supplied with an emergency kit to meet the needs of their patients to whom they give care; as well as
• introducing a set of exceptional cases to the principle of a prior marketing authorization for medicinal products (such as for compassionate use or health emergency situations).

 

Furthermore, the European directives on medical devices on which Luxembourg legislation is currently based will be amended by two new European Regulations, directly applicable in the European Union: 

• Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC; and
• Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

 

2. When are they likely to come into force?

It is not possible to foresee the date of entry into force of the draft law n° 7383, as it is in an early stage of discussion.

The above-mentioned Regulations on medical devices will be fully applicable in May 2020 for medical devices and May 2022 for in vitro diagnostic medical devices.

   

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Click the following links to read more legal articles from Luxembourg:

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reform
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs

Also from this Legal Handbook

Patents and trademarks of drugs in Luxembourg - an overview. Prepared in association with Emmanuelle Ragot, an independent firm anchored in Luxembourg, this is an extract from The Pharma Legal Handbook: Luxembourg, available to purchase here for GBP 99. *Many laws (11) have been published in Luxembourg in 2020, but 100% of them are in relation to the management of COVID 19.    

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

I. THE MAIN LEGISLATIONS FOR PATENT AND TRADEMARK PROTECTION IN LUXEMBOURG ARE THE FOLLOWINGS:

• the law of 20 July 1992 amending the patent regime as amended;
• the Benelux Convention on Intellectual Property (trademarks and designs) as amended.

 

II. THE BASIC REQUIREMENTS TO OBTAIN PATENT PROTECTION ARE THE FOLLOWINGS: 

• the invention must be new; 
• the invention must involve an inventive activity; 
• the invention must be capable of being made or used in industry.

 

III. THE BASIC REQUIREMENTS TO OBTAIN TRADEMARK PROTECTION ARE THE FOLLOWINGS:

• For the registration of a trademark, the sign must:
  • be distinctive;
  • not descriptive;
  • not generic;
  • not deceptive.

• any sign that can be represented graphically and that serve to distinguish the goods or services of a company can be registered, and
• the trademark shall fulfill the condition of availability, that is to say the trademark had not been registered before by a third-party.

 

2. What agencies or bodies regulate patents and trademarks?

I. PATENTS

National patents are under the jurisdiction of the Office of Intellectual Property (“OPI”) of the Ministry of the Economy.

 

II. TRADEMARKS

There is no national trademark. The first level of protection consists of a Benelux trademark, covering the three territories of Belgium, Netherlands and Luxembourg.

The Benelux Office for Intellectual Property (BOIP) is in charge of the supervision of Benelux trademarks.

 

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

I. PATENTS 

Pursuant to the law of 20 July 1992 on the modifications of patents regime as amended, any invention which meet the requirements mentioned in question 1 can be protected by patents except, among others:

• discoveries, scientific theories and mathematical methods;
• purely aesthetic creations;
• plans, principles and methods in the course of intellectual activities, in the field of games or in the field of economic activities as well as computer programs;
• information presentations;
• methods of medical treatment for humans or animals (in contrast to medical products).

 

II. TRADEMARKS

Pursuant to the Benelux Convention on Intellectual Property as amended, any sign that can be represented graphically may be registered as a trademark. A trademark may therefore consist of one or a combination of characters, letters, words (including slogans) or figures. A trademark may consist of designs, symbols, and three-dimensional signs such as the shape or packaging of the product, sound marks such as musical or vocal sounds or colors.

However, ideas, concepts and scents cannot be registered as trademarks.

 

4. How can patents and trademarks be revoked?

I. PATENTS

According to article 73 of the law of 20 July 1992 on the modifications of patents regime as amended, a patent can be revoked by the Court of the patent owner’s elected domicile, following the request of any interested party based on one of the reasons below:

1. the subject matter of the patent is not patentable;
2. the patent does not expose the invention in a sufficient clearly and com-plete way so that a person skilled in the art can execute it;
3. the subject matter of the patent extends beyond the content of the patent’s application filed or, where the patent was issued on the basis of a divisional application or a new patent application filed, the subject-matter of the patent extends beyond the content of the original application filed;
4. the protection conferred by the patent has been extended;
5. the patentee is not entitled to obtain it.

 

II. TRADEMARKS

According to articles 2.26 and 2.27 of the Benelux Convention on Intellectual Property as amended, any interested party may invoke revocation of the right in a trademark before the competent court in the following cases:

1. within a continuous period of five years, it has not been put to genuine use on Benelux territory in connection with the goods or services in respect of which it is registered, and there are no proper reasons for non-use; in the event of litigation, the courts may place all or part of the burden of proof on the holder of the trademark;
2. in consequence of acts or inactivity of the holder, the trademark has become the common name in the trade for a product or service in respect of which it is registered;
3. in consequence of the use made of it by the holder of the trade mark or with his consent in respect of the goods or services for which it is registered, the trade mark is liable to mislead the public, particularly as to the nature, quality or geographical origin of those goods or services.

 

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

I. PATENTS

No, foreign patents do not have any legal effect in Luxembourg as it is.

However, Luxembourg is a signatory country of the European Patent Convention and it also signed the Patent Cooperation Treaty (“PCT”), so a European/international patent can be recognized provided the following conditions are fulfilled:

• European patents: an application covering Luxembourg for a European patent has been submitted to the European Patent Office (“EPO”) and validated. The European patent issued will have the same legal status as a national patent. 
• International patents: an application for an international patent covering Luxembourg has been submitted to the World Intellectual Property Organization in the context of the Patent Cooperation Treaty and the national stage of the PCT application has been completed in Luxembourg. 

 

II. TRADEMARKS

There is no national trademark. The first level of protection consists of a Benelux trademark, covering the three territories of Belgium, Netherlands and Luxembourg.

EU trademarks duly registered benefit from full protection in the European Union.

Regarding international trademarks, Luxembourg is a signatory country of the Madrid Agreement and Protocol concerning the International Registration of Marks, so an international trademark can be recognized in Luxembourg if the applicant has designated Luxembourg when applying for the trademark.

 

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

Within the framework of the relation between a reference medicinal product and its generic medicinal product, such barriers consist of the administrative protection of data relating to pharmaceutical, preclinical and clinical trials submitted in support of the marketing authorization of a reference medicinal product and the protection against the filing of a marketing authorization for a generic medicinal product, according to article 1-1 of the Grand-Ducal regulation of 15 December 1992 relating to the marketing of medicinal products as amended.

Pursuant to the above-mentioned article, the applicant for a marketing authorization related to a generic medicinal product may be exempted from providing the results of pharmaceutical, preclinical and clinical trials if it can prove that the concerned medicinal product is actually a generic medicinal product deriving from a reference medicinal product that has been authorized for at least 8 years in a Member State of the European Union

This means that the results of pharmaceutical, preclinical and clinical trials undertaken by the holder of a marketing authorization for a reference medicinal product is protected during 8 years from a transfer of such results to a competitor wishing to market a generic medicinal product deriving from said reference medicinal product.

Furthermore, no generic medicinal products can be marketed for a period of 10 years (11 years in specific cases) starting from the date of grant of the marketing authorization of the reference medicinal product from which it derives.

 

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

There is no particular restriction on the types of medicinal products or devices that can be granted patent and trademark protection provided that they fulfill relevant legal requirements.

 

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

The Luxembourgish law doesn’t make a difference between a national licensor and a foreign licensor, and there is no approval requirement about a patent or trademark license agreement. 

Below are some legal requirements related to a patent or trademark license:

 

I. PATENT

License agreement should be written in order to be valid and should be registered before the Office of Intellectual Property of the Ministry of the Economy in order to be enforceable against third parties, in accordance with articles 53 and 55 of the law of 20 July 1992 amending the patent regime as amended.

 

II. TRADEMARK

The license is effective against third parties only after the publication of a specific mention in the BOIP’s Trademarks Register, in the forms prescribed by regulations and against payment of the due, in accordance with article 2.33 of Benelux Convention on Intellectual Property as amended.

   

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Click the following links to read more legal articles from Luxembourg:

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reform
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs

Also from this Legal Handbook

An insight into product liability in Luxembourg. Prepared in association with Emmanuelle Ragot, an independent firm anchored in Luxembourg, this is an extract from The Pharma Legal Handbook: Luxembourg, available to purchase here for GBP 99. *Many laws (11) have been published in Luxembourg in 2020, but 100% of them are in relation to the management of COVID 19.    

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

There are four types of product liability recognized in Luxembourg:

• Liability for defective products, governed by the law of 21 April 1989 on the civil liability for defective products as amended;
• Contractual liability foreseen by articles 1603 seq of the Civil Code;
• Tort liability, foreseen by articles 1382 seq of the Civil Code;
• Liability regarding sale agreements concluded by consumers as foreseen by the Consumer Code.

 

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

Liability for defective products:

According to the definition of product provided by article 1 of the law of 21 April 1989 on the civil liability for defective products as amended, medicinal products and devices can be regarded as products and in case of defective medicinal products and devices, the manufacturers will be held responsible under the above-mentioned law.

 

Contractual and tort liability:

In addition, the manufacturers of medicinal products and devices are also responsible for providing, among others, specific information on medicinal products to users and doctors, in particular as to the possible harmful side effects. 

They may be held liable to the extent the breach of their duty is directly linked to a damage suffered by the victim (either contractually or in tort according to the principle of non-accumulation of contractual and tort responsibilities).

 

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

Taken into consideration the principle of legal personality granted to each legal entity, as general principle, the legal entity should be the only one held liable regarding the manufacturing of medicinal products.

 

4. How can a liability claim be brought?

A liability claim can be brought by any interested party in judicial courts.

 

5. What defenses are available?

The defendant may invoke any defenses that are foreseen under common civil law, such as the fact that the defendant did not commit any breach of its duties or that there were circumstances constituting a force majeure.

For instance, according to article 4 of the law of 21 April 1989 on the civil liability for defective products as amended, the producer of a product can invoke the following defenses:

1. he did not put the product into circulation;
2. the defect which caused the damage did not exist at the moment when the product was put into circulation by him or that the defect was born subsequently;
3. the product has not been manufactured for sale or for any other form of distribution for the economic purpose of the producer, nor manufactured or distributed in the course of his professional activity;
4. the defect is due to the conformity of the product with mandatory rules emanating from public authorities;
5. regarding the manufacturer of a component of the product, that the defect is attributed to the conception of the product in which the component has been incorporated or the instructions given by the manufacturer of the product.

 

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Click the following links to read more legal articles from Luxembourg:

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reform
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs

Also from this Legal Handbook

All about traditional medicines and OTC products in Luxembourg. Prepared in association with Emmanuelle Ragot, an independent firm anchored in Luxembourg, this is an extract from The Pharma Legal Handbook: Luxembourg, available to purchase here for GBP 99. *Many laws (11) have been published in Luxembourg in 2020, but 100% of them are in relation to the management of COVID 19.    

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

According to article 52-2 of Grand-Ducal regulation of 15 December 1992 relating to the marketing of medicinal products as amended, traditional herbal medicinal products which meet the following requirements are registered through a simplified registration procedure, i.e. the application to be filed have less documents to annex than in case of the standard application related to medicinal products.:

• they have indications exclusively appropriate for traditional herbal medicinal products which, by their composition and their intended purpose, are designed for and intended for use without the monitoring of a doctor for diagnosis, prescription or follow-up of treatment;
• they are intended exclusively for use in a specified dosage and posology;
• they are preparations for oral, external and/or by inhalation use;
• the period of traditional use has expired;
• data on the traditional use of the medicinal product are sufficient; in particular, the safety of the product is demonstrated under the specified conditions of use and the pharmacological effects or efficacy of the medicinal product are plausible due to the longstanding use and experience.

However, when the Ministry of Health considers that a traditional herbal medicinal product meets the criteria for a prior marketing authorization, the simplified registration procedure shall not apply.

 

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

According to article 52-8 of the Grand-Ducal regulation of 15 December 1992 relating to the marketing of medicinal products as amended, advertising for traditional herbal medicinal products shall contain, in addition to the standard provisions governing the advertising of medicinal products, the specific mention “traditional herbal medicinal product to be used for one/several specified purpose(s) on the exclusive basis of the longstanding use”.

 

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

There is no specific regulation for traditional herbal products related to this subject, so the general regulatory framework for the advertising related to the medicinal products applies here.

 

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

There is no specific regulatory requirements for over-the-counter (non-prescription) medications, so the general regulatory framework for all medicinal products would apply.

Consequently, a marketing authorization is required before the launching of the OTC on the market.

 

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

According to article 3bis of the law of 25 November 1975 concerning the deliverance of medicinal products to the public as amended, OTC products are authorized to be sold on the internet in addition to the classical channels (please refer to question 18 in Marketing, Manufacturing, Packaging and labeling Advertising).

 

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

The general regulatory framework related to medicinal products applies.

 

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

Yes, pursuant to the general regulatory framework foreseen in article 19 of the Grand-Ducal regulation of 15 December 1992 relating to the marketing of medicinal products as amended, medicinal products except the following categories can be advertised directly to consumers:

• which can only be delivered on a medical prescription,
• which contain psychotropic substances or narcotics,
• which are reimbursable by social insurance.

As OTC products can be delivered without medical prescription, they can be marketed or advertised directly to the public if they fulfil the other requirements above.

 

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

Pursuant to article 30 of the Grand-Ducal regulation of 15 December 1992 relating to the marketing of medicinal products as amended, the Ministry of Health, when allowing the marketing authorization of the medicinal product, specifies if the medicinal product is part of the category of medicinal product subject to prescription or is part of the category of medicinal product not subject to prescription.

As a general principle, medicinal products subject to prescription are those likely presenting a danger either directly or indirectly, even when correctly used, if used without medical monitoring.

At the moment of the renewal of the marketing authorization, or in case of new circumstances, the Ministry of Health can re-examine the category under which the medicinal product is classified and can change its classification.

 

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

There is no specific requirements for the importation of either traditional medicinal products or OTC products. General framework should apply.

   

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Click the following links to read more legal articles from Luxembourg:

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reform
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs

Also from this Legal Handbook

An intro to the legal situation for marketing, manufacturing, packaging & labeling, and advertising in Luxembourg. Prepared in association with Emmanuelle Ragot, an independent firm anchored in Luxembourg, this is an extract from The Pharma Legal Handbook: Luxembourg, available to purchase here for GBP 99. *Many laws (11) have been published in Luxembourg in 2020, but 100% of them are in relation to the management of COVID 19.    

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

Please refer to question 3 in Chapter 1.  

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

Please refer to question 6 in Chapter1.  

3. What are the typical fees for marketing approval?

Please refer to question 4 in Chapter 1.  

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

Please refer to question 5 in Chapter 1.  

5. What are the requirements, if any, for post-approval pharmacovigilance?

According to Chapter 5-1 of the Grand-Ducal regulation of 15 December 1992 relating to the marketing of medicinal products as amended, a pharmacovigilance system has to be implemented and consists of the monitoring of unexpected side effects of medicinal products on humans or animals:

• on one part, by the Ministry of the Health: useful information are collected, that includes the risks of the medicinal products to the health of the patients or public health as well as undesirable effects on humans;
• on the other part, by the marketing authorization holder. The main requirements are the followings:
  • the marketing authorization holder should carry out a scientific evaluation of all relevant information, in order to consider options for preventing or minimizing risks and, if necessary, for taking appropriate measures;
  • the marketing authorization holder should carry out a periodic audit of his pharmacovigilance system. It records the main results of this audit in writing in the permanent file of the pharmacovigilance system and, based on these results, takes the necessary steps to develop and implement an appropriate action plan to solve the problems identified. Once the corrective measures fully implemented, the records may be deleted.

More detailed requirements related to the pharmacovigilance are available in articles 45-3 to 45-9 of the Grand-Ducal regulation of 15 December 1992 relating to the marketing of medicinal products as amended.

 

6. Are foreign marketing authorizations recognized?

In principle, foreign marketing authorization are not recognized in Luxembourg and all medicinal products for human use should be authorized by the Ministry of Health in order to marketed.

European Union law has however introduced some specific procedure:

• Under the centralized procedure laid down in Regulation (EC) No 726/2004, a marketing authorization is granted by the European Commission which is valid for all the members of the EU ;
• Under the decentralized procedure introduced by Directive 2004/27/EC and implemented in Luxembourg law with article 5-1 of the Grand-Ducal regulation of 15 December 1992 relating to the marketing of medicinal products as amended, it is possible to submit an application simultaneously to several Member States that will be commonly assessed. One of the Member States will take the lead in evaluating the application as a “reference Member State”;
• Under the mutual recognition procedure laid down in Directive 2001/83/EC and implemented in Luxembourg law with article 5-1 of the Grand-Ducal regulation of 15 December 1992 relating to the marketing of medicinal products as amended, marketing authorizations from one EU Member State may be recognized in another EU Member State through a common assessment procedure.

 

7. Are parallel imports of medicines or devices allowed?

Yes, parallel imports of medicinal products or devices are allowed in accordance with the principle of free movement of goods within EU countries.

According to the guideline as provided for in European Commission Communication on parallel imports of proprietary medicinal products for which marketing authorizations have already been granted, parallel imports of medicinal products within EU countries should fulfil the following requirements: 

• the imported product has been granted a marketing authorization in the Member State of exportation;
• the imported product is sufficiently similar to a product that has already received marketing authorization in the Member State of destination even if there are differences relating to the excipients.

 

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?

According to article 25 of the Grand-Ducal regulation of 15 December 1992 relating to the marketing of medicinal products as amended:

• as part of the promotion of medicinal products to persons authorized to prescribe or to deliver them, it is prohibited to grant, offer or promise to such persons a bonus, monetary benefit or benefit in kind unless they are of negligible value and are related to the practice of medicine or pharmacy;
• however, the hospitality offered, directly or indirectly, at events of an exclusively professional and scientific nature is not prohibited. This hospitality must always be strictly limited to the main scientific purpose of the meeting and it should not be extended to people other than health professionals.

 

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

I. MANUFACTURING OF MEDICINAL PRODUCTS

Pursuant to the law of 4 August 1975 relating to manufacturing and import of medicinal products as amended, the manufacturing of medicinal products is regulated through prior manufacturing authorization by the Ministry of Health. To deliver a manufacturing and import authorization, the Pharmacy and Medication Department carries out inspections to verify the compliance with Good Manufacturing Practices (“GMP”).

 

II. MANUFACTURING OF MEDICAL DEVICES

No prior authorization is required for the manufacturing of the medical devices. 

However, the manufacturer should fulfill the requirements of the Grand-Ducal regulations related to medical devices, among which there are requirements related to conception and production of the device.

The Pharmacy and Medication Department / Ministry of Health is the competent authority for the surveillance of medical devices, among other duties.

 

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

Yes, local manufacturing requirements are compatible with the European Medicines Agency.

 

11. What is the inspection regime for manufacturing facilities?

The Pharmacy and Medication Department / Ministry of Health has authority over the manufacturing of medicinal products. Several pharmacist inspectors are designated by the Pharmacy and Medication Department to ensure that manufacturing facilities are in compliance with the laws and regulations. 

 

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

According to article 7-1 of the Grand-Ducal Regulation of 19 November 2004 relating to the manufacturing, the distribution and the brokerage of medicinal products, as amended, the Pharmacy and Medication Department is responsible for the inspection of manufacturing facilities located in Luxembourg which means that, as a principle, inspection by foreign inspectors or third-party inspectors is not allowed within the Luxembourg territory.

The Regulation (EC) No 726/2004 laying down a centralized Community procedures for the authorization and supervision of medicinal products for human use, foresees in its article 8 that the Committee for Medicinal Products for Human Use, part of the European Medicines Agency, may require an applicant for a marketing authorization based in Luxembourg to undergo a specific inspection of the manufacturing site. This inspection will be however carried out by the Luxembourg Pharmacy and Medication Department accompanied by a rapporteur, or an expert appointed by said Committee. 

 

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

I. MEDICINAL PRODUCTS

The conditions of storage of a medicinal product shall be mentioned on the leaflet and shall be complied with (temperature, humidity,…).

 

II. MEDICAL DEVICES

According to Annex I of the Grand-Ducal Regulation of 11 August 1996 concerning medical devices as amended, as general principle, medical devices shall be packaged in such a way that the characteristics and performances shall not be altered in the storage conditions and transport conditions as foreseen by the manufacturer (temperature, humidity, …)

 

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

I. MEDICINAL PRODUCTS

According to articles 10, 11 and 12 of the Grand-Ducal regulation of 15 December 1992 relating to the marketing of medicinal products as amended, the main requirements related to the packaging of medicinal products are the following:

• the outer packaging or, in the absence of an outer packaging, the immediate packaging of any medicinal product shall bear certain information as provided for in article 10 as for instance:
  • the name of the medicinal product followed by its dosage and pharmaceutical form and, where appropriate, the indication of the recipient (infants, children or adults); when the medicinal product contains up to three active substances, the international non-proprietary name (INN) or, if it does not exist, the common name;
  • the qualitative and quantitative composition of active ingredients per dosage unit or, depending on the form of administration, for a given volume or weight, using the common names;
  • the pharmaceutical form and the content by weight, by volume or in units per use;
• when the immediate packaging is contained in an outer packaging compliant with the requirements of the above-mentioned article 10, the immediate packaging, which is in a form of blister, must bear certain information as provided for in article 11, as for instance. the name of the medicinal product, the name of the marketing authorization holder, the expiration date, the manufacturer’s batch number;
• the information on the outer packaging or the immediate packaging must be written in an easily legible and in a clear comprehensible way. In addition, this information has to be written in at least one of the official languages (French, German, Luxembourgish).

 

II. MEDICAL DEVICES

According to Annex I of the Grand-Ducal Regulation of 11 August 1996 concerning medical devices as amended, the compulsory information on device labeling includes the following (without being exhaustive):

• the contact details of the manufacturer, and for devices imported into EU and to be distributed inside EU, the labeling, the outer packaging or the instructions for use should contain, in addition, the name and the address of the representative when the manufacturer is not established in EU;
• the indications strictly necessary to identify the device and the contents of the packaging in particular for users;
• special conditions of storage and/or handling;
• special instructions for use;
• warnings and/or precautions to take.

In addition, the device of the manufacturer should also put a “CE” mention on the labeling in accordance with the requirements of the conformity of “CE” mention as provided in Annex XII of the above-mentioned regulation.  

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

I. MEDICINAL PRODUCTS

According to article 10 of Grand-Ducal regulation of 15 December 1992 relating to the marketing of medicinal products as amended, the following additional information may be included in medicinal products labeling and packaging:

• the outer packaging may include signs or pictograms to clarify some of the mandatory information, and
• other information compatible with the summary of medicinal product characteristics, useful for health education, excluding any items that may be promotional in nature.

 

II. MEDICAL DEVICES

To our knowledge, there is no relevant regulation about additional information that may be included in labeling and packaging, except for specific medicinal devices regulated by specific laws/provisions...

 

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

General provisions related to advertising shall apply (prohibition of advertising regarding medicinal products which can only be issued on a medical prescription, …) as well as common rules regarding misleading information.

 

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

I. MEDICINAL PRODUCTS

According to article 19 of the law of 11 April 1983 on the regulation of the marketing authorization and advertising of medicinal products as amended, states, as general rule, that any advertising to the general public is prohibited except:

• with a prior authorization granted by Ministry of Health; or
• where it is limited to general advertising, only mentioning the name and the composition of the medicinal product, the name and address of the manufacturer.

A prior tax has to be paid.

More detailed restrictions and requirements for the advertising of medicinal products to the general public and to the healthcare professionals are foreseen in the Grand-Ducal regulation of 15 December 1992 relating to the marketing of medicinal products as amended.

 

II. MEDICAL DEVICES:

General rules apply and it is forbidden to advertise medical devices which are not compliant with the applicable laws and regulations.

 

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

I. THE SALE AND DELIVERY OF MEDICINAL PRODUCTS

According to articles 3 of the law of 25 November 1975 concerning the deliverance of medicinal products to the public as amended, medicinal products can only be dispensed to the public in pharmacies, except in cases where they can also be delivered by the pharmacist, under specific conditions, to patients accommodated in the following establishments: 

• centers, homes and services for the elderly; 
• geriatric or accommodation centers of services for authorized people according to the law of 8 September 1998 regulating relations between the State and organisations working in the domain of social, family and therapeutic as amended.

Pursuant to the law of 4 August 1975 relating to manufacturing and import of medicinal products as amended, OTC medicinal products can be sold on the internet, through a dedicated website created and managed by a pharmacist having made a prior notification to the Ministry of Health, and send from the pharmacy.

 

II. THE SALE AND DELIVERY OF MEDICAL DEVICES:

Pursuant to article 2-1 of the law of 16 January 1990 on medical devices as amended, which constitutes the main regulation for medical devices, medical devices can be delivered by pharmacists or other authorized persons in accordance with the Luxembourgish legislation in force.

 

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

There is no specific regulation about electronic marketing and advertising of medicinal products, so the general regulation framework as provided for in the law of 11 April 1983 on the regulation of the marketing authorization and advertising of medicinal products as amended would apply.

 

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

According to article 19 of the Grand-Ducal regulation of 15 December 1992 relating to the marketing of medicinal products as amended, medicinal products except the following categories can be advertised directly to consumers:

• which can only be issued on a medical prescription,
• which contain psychotropic substances or narcotics,
• which are reimbursable by social insurance.

 

21. How is compliance monitored?

According to articles 28 and 29 of Grand-Ducal regulation of 15 December 1992 relating to the marketing of medicinal products as amended:

1. compliance with advertising regulation is monitored and evaluated by the Pharmacy and Medication Department / Ministry of Health;
2. the person responsible for marketing authorization should establish within his company a scientific service responsible for the information relating to the medicinal products he introduces on the market, and

• • keep at the disposal of the authorities or bodies responsible for the control of pharmaceutical advertising or communicate them a copy of any advertisement issued by his company, accompanied by a notice indicating the recipients, the way of diffusion and date of first diffusion;
  • ensure that the pharmaceutical advertising made by his company complies with the legal requirements that apply;
  • verify that the medical representatives employed by his company are adequately trained and respect their legal obligations;
  • provide the authorities or bodies responsible for the control of pharmaceutical advertising with the information and assistance required;
  • ensure that decisions taken by the authorities or bodies responsible for the control of pharmaceutical advertising are immediately and completely respected.

 

22. What are the potential penalties for noncompliance?

According to article 20 of the law of 11 April 1983 on the regulation of the marketing authorization and advertising of medicinal product as amended, the potential penalties for non-compliance are the following:

• 8 days to 6 months of imprisonment and/or
• a fine of 251 to 10,000 euros.

   

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Click the following links to read more legal articles from Luxembourg:

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reform
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs

Also from this Legal Handbook

Preclinical and clinical trial requirements in Luxembourg - a legal guide. Prepared in association with Emmanuelle Ragot, an independent firm anchored in Luxembourg, this is an extract from The Pharma Legal Handbook: Luxembourg, available to purchase here for GBP 99.

*Many laws (11) have been published in Luxembourg in 2020, but 100% of them are in relation to the management of COVID 19. 

   

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

Pursuant to the Grand-Ducal regulation of 15 December 1992 relating to the marketing of medicinal products as amended, clinical trials are not required to be conducted locally as a condition (stated or implicit) for marketing approval.

For trials conducted without the EU, it is required to include a declaration which certifies that the clinical trials conducted meet the requirements of the Directive 2001/20/CE with the application for marketing authorization.

 

2. How are clinical trials funded?

To our knowledge, most clinical trials are funded by the pharmaceutical industry as well as sponsoring companies.

 

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

It is required by the Grand-Ducal regulation of 30 May 2005 on the application of good clinical practice in conducting clinical trials of medicinal products for human use as amended, that the clinical trial protocols should contain the objective(s), conception, method, statistical aspects and organization of the clinical trial (article 28(h)).

The National Research Ethics Committee (“Comité National d’Ethique de Recherche”, or “CNER”) issue an opinion before the start of the clinical test for which the CNER has been consulted.

 

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

According to article 3 of the Grand-Ducal regulation of 30 May 2005 on the application of good clinical practice in conducting clinical trials of medicinal products for human use as amended, the requirements for consent by participants in clinical trials are the followings:

• the participant to the trial or, where that person is not able to give his informed consent, his legal representative, must have had the opportunity, by an interview with the investigator (the responsible person of the clinical trial) or a member of the group in charge of the trial to understand the objectives of the trial, its risks and drawbacks as well as the conditions in which it will be realized;
• the participant has been informed of his right to withdraw from the trial at any time;
• the consent should be written; if the person concerned is not able to write, in exceptional cases foreseen by the law, he can give oral consent in the presence of at least one witness.

 

5. May participants in clinical trials be compensated?

Pursuant to articles 4 and 5 of Grand-Ducal regulation of 30 May 2005 on the application of good clinical practice in conducting clinical trials of drugs for human use as amended, compensation for minor participants and incapable adults in clinical trials are allowed.

 

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

According to article 3 of Grand-Ducal regulation of 30 May 2005 on the application of good clinical practice in conducting clinical trials of medicinal products for human use as amended, the participants in clinical trials are protected and indemnified against any harm that arises as a result of participation in the trial trough three measures:

• a list of prior conditions that a clinical trial must fulfil in order to be undertaken:

1. 1. the foreseeable risks and disadvantages were weighed against the expected benefit for the subject participating in the trial and for other current and future patients. A clinical trial can only begin if the Minister of Health concludes that the therapeutic benefits and in the domain of public health justify the risks and can only continue if compliance with this requirement is constantly monitored;
   2. the participant to the trial or, where that person is not able to give his informed consent, his legal representative, must have had the opportunity, by a prior interview with the investigator (the responsible person of the clinical trial) or a member of the group in charge of the investigation to understand the objectives of the clinical trial, its risks and drawbacks as well as the conditions in which it will be realized, and has been informed of his right to withdraw from the clinical trial at any time;
   3. the participant’s right for the respect of her/his physical and mental integrity, the participant’s right to privacy shall be respected, as well as the protection of personal data according to the relevant regulations;
   4. the participant or, where that person is not able to give his informed consent, his legal representative, has given written consent after being informed of the nature, scope, consequences and the risks of the clinical trial; if the person concerned is not able to write, in exceptional cases provided by law, he can give oral consent in the presence of at least one witness;
   5. the participant may withdraw from the clinical trial at any time and without incurring any prejudice;
   6. provisions for insurance or indemnity covering the liability of the investigator (the responsible person of the clinical trial) and the sponsor (any person, company, institution or organization responsible for the launching, the management and/ or the funding of the clinical trial) are foreseen.

• the medical care provided to participants and the medical decisions made about them are the responsibility of a qualified medical practitioner or, where appropriate, a qualified dentist;
• the participant has a contact point with whom he can obtain additional information.

In any case, the common civil liability for misconduct will be applicable to the investigator and the sponsor.

   

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Click the following links to read more legal articles from Luxembourg:

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reform
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs

Also from this Legal Handbook

A brief overview of the situation regarding regulatory, pricing and reimbursement of drugs in Luxembourg. Prepared in association with Emmanuelle Ragot, an independent firm anchored in Luxembourg, this is an extract from The Pharma Legal Handbook: Luxembourg, available to purchase here for GBP 99. *Many laws (11) have been published in Luxembourg in 2020, but 100% of them are in relation to the management of COVID 19.    

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

Within Luxembourg, the regulatory authority in charge of the matter of drugs, biologicals, and medical devices is the Ministry of Health (“Ministère de la Santé”), in particular the National Health Directorate (“Direction de la Santé”), composed of six departments among which:

• the Pharmacy and Medication Department (“Division de la Pharmacie et des Médicaments”) is in charge of the regulatory framework concerning drugs and biologicals; and
• the Curative Care and Healthcare Quality Department (“Division de la Médecine curative et de la Qualité en santé”) is in charge of the regulatory framework concerning medical devices.

 

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

For easier reading, drugs and biological will be referred hereafter as “medicinal products” except when otherwise mentioned.

I. MEDICINAL PRODUCTS

The main regulations governing the authorization of medicinal products, compiled in the Health Code (“Code de la Santé”) are:

• the law of 4 August 1975 relating to manufacturing and import of medicinal products as amended;
• the law of 25 November 1975 relating to the delivery to the public of medicinal products, as amended;
• the law of 11 April 1983 on the regulation of the marketing authorization and advertising of medicinal products as amended;
• the law of 6 January 1995 relating to the wholesale distribution of medicinal products as amended;
• the Grand-Ducal regulation of 15 December 1992 relating to the marketing of medicinal products as amended; and
• the Grand-Ducal regulation of 19 November 2004 relating to the manufacturing, the distribution and the brokerage of medicinal products, as amended.

Regarding the pricing, and reimbursement of medicinal products, the Social Security Code (“Code de la Sécurité Sociale”) and the statutes of the National Health Fund (“Caisse Nationale De Santé” or “CNS”) would apply.

 

II. MEDICAL DEVICES 

The regulatory framework for the authorization, pricing, and reimbursement of medical devices is:

• the law of 16 January 1990 on medical devices as amended, which constitutes the main regulation for medical devices and the Grand-Ducal regulations related thereto.
• the Social Security Code and the statutes of the CNS for pricing and reimbursement.

   

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

I. MEDICINAL PRODUCTS

Manufacturing authorization: 

Pursuant to the law of 4 August 1975 relating to manufacturing and import of medicinal products as amended, in order to obtain authorization to develop and test new medicinal products, the manufacturer should apply and obtain a prior authorization of manufacturing from the Ministry of Health, except if there is specific exemptions in the law. 

The application for the granting of the authorization is subject to investigations and a report established by the relevant authority (“Inspection des Pharmacies”).

The decision taken by the Ministry is notified to the applicant and must contain the grounds of the decision.

As foreseen in the Grand-Ducal regulation of 19 November 2004 relating to the manufacturing, the distribution and the brokerage of medicinal products as amended, the application for a prior authorization of manufacturing must contain information such as the contact details of the applicant, the place where manufacturing operations are performed, list of medicinal products manufactured.

According to article 4 of the law of 4 August 1975 relating to manufacturing and import of medicinal products as amended, the manufacturing of the medicinal products is made under the supervision of a pharmacist duly agreed by the Ministry of Health.

 

Marketing authorization: 

Before the launching of a new medicinal product on the market, the manufacturer must have obtained a marketing authorization.

• In case of a national marketing authorization, the manufacturer should apply for a prior authorization from the Ministry of Health. According to article 2 of the Grand-Ducal regulation of 15 December 1992 related to the marketing of medicinal products as amended, the complete application must be submitted to the Ministry of Health in electronic format in accordance with the requirements of the European file format. 

Details regarding the medicinal product and the applicant should be included in the application, including (without being exhaustive) the name or company name and the domicile or the registered office of the person responsible for the marketing and name of the medicinal products.

• In case of the filing of an application for an EU marketing authorization from the European Medicines Agency (“EMA”), several steps regulated at the EU level have to be duly followed.

In this case, there is no need for a marketing authorization within Luxembourg. However, prior to the sale of the medicinal product, a file has to be provided to the Ministry Health containing a copy of the European Commission’s decision with all the annexes.

In addition, a request for the price to the public of the medicinal product has to be filed at the Ministry of Social Security.

Lastly, for the potential reimbursement of the medicinal product, if any, a request to the CNS has to be filed in order to be mentioned on a list called “liste positive”, i.e. the list of the medicinal products for which a part of the price to the public will be reimbursed by the CNS, the rate of the reimbursement depending on the type of medicinal product.

 

II. MEDICAL DEVICES

Manufacturing authorization: 

No prior authorization is required for the manufacturing of medical devices. 

However, the manufacturer should fulfill the requirements related to the manufacturing provided for under the different Grand-Ducal regulations related to medical devices, among which there are requirements related to conception and production of the device.

 

Marketing authorization:

No prior authorization is required for the marketing of the medical devices.

However, the manufacturer should fulfil two conditions foreseen under the different Grand-Ducal regulations related to medical devices:

• the medical devices may only be marketed and/or put into service provided that they are duly supplied and are correctly installed, maintained and used according to their intended purpose; and
• the medical devices may only be marketed and/or put into service provided that the label EC is mentioned, this label indicating that their conformity with EC requirements has been validat

   

4. What are the approximate fees for each authorization?

I. MANUFACTURE AUTHORIZATION: 

For a new medicinal product, the manufacture authorization fee is determined on a case by case basis depending on the scope of the investigations carried out by the Inspection des Pharmacies.

 

II. MARKETING AUTHORIZATION:

Pursuant to the Grand-Ducal regulation of 24 December 1993 fixing the fees due for the marketing authorization of medicinal products as amended, the marketing authorization fee amounts:

• to 600.€ (six hundred euros), when the medicinal product has already been granted with an authorization delivered in a Member State of the European Union, in accordance with the relevant directives; 
• to 12,500.€ (twelve thousand five hundred euros), when such authorization is lacking. 

The fee has to be paid per form and dosage.

 

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

Pursuant to the law of 11 April 1983 on the regulation of the marketing authorization and advertising of medicinal products as amended, the marketing authorization is valid for 5 years. 

It can be renewed every 5 years by a request of the authorization’s holder, presented within 3 months before the expiration of the marketing authorization.

 

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

According to article 1-1 of Grand-Ducal regulation of 15 December 1992 relating to the marketing of medicinal products as amended, for generic versions of medicinal products, the applicant shall follow the general authorization process. 

Nevertheless, the applicant doesn’t need to provide the results of the pharmaceutical, preclinical and clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product that is or has been authorized for eight years. 

Instead, he can provide an appropriate scientific bibliographical documentation concerning the above tests.

There is no difference for local manufacturers versus foreign-owned manufacturers.

 

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

There is no special regulation about combination products between several medicinal products.

In case of combination products between medicinal products and devices, according to article 1 (3) of Grand-Ducal regulation of 11 August 1996 on medical device as amended, if a device is marketed in such a way that the device and the medicinal product form a single integrated product that is intended to be used exclusively in the association given and which is not reusable, this product is regulated by EU Directive 2001/83/EC as a medicinal product.

 

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?

Compliance with regulations is monitored and evaluated by the Pharmacy and Medication Department / Ministry of Health. 

It has authority over questions related to medicinal products and it controls the manufacturing, marketing, advertising, distribution, import and export of these products. 

The Pharmacy and Medication Department / Ministry of Health also carries out inspections to make sure that the distribution sites are compliant with the requirements of good practices. 

The regulatory regime is comparable with EMA expectations and requirements.

 

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

For non-compliance:

• with the provisions related to the manufacturing and import of medicinal products (article 14 of the law of 4 August 1975 relating to manufacturing and import of medicinal products as amended): 

• • 8 days to 6 months of imprisonment and/or
  • a fine of 251 to 10,000 euros.

• with the provisions related to the marketing authorization and advertising of medicinal product (article 20 of the law of 11 April 1983 on the regulation of the marketing authorization and advertising of medicinal product as amended):
• • 8 days to 6 months of imprisonment and/or
  • a fine of 251 to 10,000 euros.

• with the provisions related to medical devices (article 4 of the law of 16 January 1990 on medical devices as amended):

• • 8 days to 1 month of imprisonment and/or
  • a fine of 2,501.- to 1,000,000.- Luxembourgish Francs (to be converted into euro / no updated version of the article available in the Code de la Santé).

 

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

The national health care system is administered by the National Health Fund (“Caisse nationale de santé” or “CNS”).

The CNS is a public institution endowed with the civil personality and placed under the supervision of the Ministry of Social Security, acting through the General Inspectorate of the Social Security (“Inspection générale de la sécurité sociale” or “IGSS”).

It is managed by a Council of Administration with a tripartite organisation comprised of representatives of the workforce, the employers and a State representative as chairman of the Committee.

Funds come from the payment of the mandatory social contributions (the general principle is that one part of these social contributions is paid by the employers and one part is paid by the employees).

 

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

Many people subscribe to a private health insurance with a professional company affiliated with the Ministry of Social Security. The advantage of having an additional insurance is to cover unforeseen medical costs and/or unexpected hospitalization not covered by the CNS.

 

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

In addition, many employers offer supplementary coverage as a benefit of employment. This additional coverage pays the portion of medical fees that isn’t covered by the CNS and may offer extended coverage. 

I. MEDICINAL PRODUCTS

Prices of medicinal products are regulated by the Ministry of Social Security, according to article 22ter of the Security Social Code and the Grand-Ducal regulation of 1 December 2011 determining the criteria, conditions and procedure relating to the pricing of medicinal products for human use as amended.

As mentioned above, a request for the price to the public of a medicinal product has to be filed to the Ministry of Social Security before the launching of the product on the market.

According to article 4 of the Grand-Ducal regulation of 1 December 2011 determining the criteria, conditions and procedures relating to the pricing of medicines for human use as amended, the prices of medicinal products approved by the Minister of Social Security are published in the official Gazette (the “Memorial”) each year in January on the list of prices of commercialized medicinal products (“Liste des médicaments commercialisés”). Changes of price during the year are published monthly at the Memorial.

 

II. MEDICAL DEVICES

To our knowledge, prices of medical devices are freely determined.

 

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

I. MEDICINAL PRODUCTS

There is a third-party payment system for medicinal products. The CNS is in charge of the national reimbursement system for medicinal products. 

As mentioned above, before the launching of a medicinal product on the market, for the potential reimbursement of the medicinal product, if any, a request to the CNS has to be filed in order to be mentioned on a list called “liste positive”, i.e. the list of the medicinal products for which a part of the price to the public will be reimbursed by the CNS, the rate of the reimbursement depending on the type of medicinal product (there are three rates of reimbursement, depending on the category of the medicinal product: 40%, 80% and 100%).

As a result, the CNS will cover the reimbursable part of a medicinal product according to this list, and the patient will pay for the rest of the price, if any.

 

II. MEDICAL DEVICES

The CNS is also in charge of the reimbursement of medical devices.

Similarly, before the launching of a medical device on the market, for the potential reimbursement of the medical devices, if any, a request to the CNS has to be made in order to be grouped into specific files from “Fichier B1” to “Fichier B7” in CNS Statutes, i.e. the files of the medical devices for which a part of the reference price will be reimbursed by the CNS, the rate of the reimbursement depending on the type of medical devices (there are three rates of reimbursement, depending on the category of the medical devices: 40%, 80% and 100%).

Therefore, the CNS will cover the reimbursable part of a medical device according to the files, and the patient will pay for the rest of the price, if any.

 

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

According to articles 3 of the law of 25 November 1975 concerning the deliverance of medicinal products to the public as amended, medicinal products can only be dispensed to the public in pharmacies, except in cases where they can also be delivered by the pharmacist, under specific conditions, to patients accommodated in the following establishments: 

• centers, homes and services for the elderly; 
• geriatric or accommodation centers of services for authorized people according to the law of 8 September 1998 regulating relations between the State and organisations working in the domain of social, family and therapeutic as amended.

Pursuant to the statutes of the CNS, the CNS is in charge of the payment of the fees due to the pharmacists according to the reference tariff and the rate (80% or 100%) as provided for in list n° 11, appendix D of the statutes of the CNS. In case the fees due to the pharmacists exceed the part taken in charge by the CNS, the remaining part of the fees is paid by the patients.

 

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?

Pursuant to the law of 28 October 2016 on the recognition of professional qualifications, pharmacists who dispense medicinal products and devices have the obligation to dispense safe and effective medicinal products of the required quality and to provide information and advice on medicines including their proper use.

In addition, they have also ethical obligations towards other healthcare profession and the public as provided for in the Code of Ethics of Pharmacists, such as the obligation of professional secrecy.

Any breach of these obligations might lead to their common civil liability and/or disciplinary penalties such as warning, reprimand and fine, in accordance with article 20 of the law of 8 June 1999 on the Medical College (“Collège médical”)

   

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Click the following links to read more legal articles from Luxembourg:

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reform
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs