×

Decisions and practices no. 4

30 July 2009

E-cigarettes containing nicotine are medicinal products
The European Court of Justice:  Third-party statements about medicines may be advertising
European Medicines Agency agrees to accept product numbers on inner packages
Delegation of the distribution of samples of medicinal products


E-cigarettes containing nicotine are medicinal products

In 2008, the Danish Medicines Agency determined that the product NyCigaret is a medicinal product, and that it must be licensed accordingly before it can be marketed in Denmark . The company behind the product filed a complaint with the Danish Ministry of Health and Prevention about the Danish Medicines Agency’s decision, and this decision has now been settled by the Ministry of Health and Prevention, which fully concurs with the decision of the Danish Medicines Agency.

In August 2008, the Danish Medicines Agency focused its attention on the product NyCigaret, a so-called tobacco-free e-cigarette (electronic cigarette) where the person smoking it inhales only vapour and nicotine, but neither tar nor the many other substances that are found in ordinary cigarettes.

The Danish Medicines Agency determined that NyCigaret is a medicinal product since the product can be used to modify physiological functions due to the pharmacological effect of nicotine, cf. section 2(2) of the Danish Medicines Act. A product that contains synthetic/extracted nicotine is considered a specialised product designed with the sole purpose of giving the user a dose of nicotine. (This would also be the case if the product, in addition to synthetic/extracted nicotine, contained a little raw tobacco).
The decision meant that NyCigaret had been placed illegally on the market because it had not been granted a marketing authorisation in accordance with section 7 of the Danish Medicines Act.

Complaint about the decision
The company complained about the Agency’s decision to the Danish Ministry of Health and Prevention, submitting that the fact that NyCigaret contained nicotine could not be the sole determining factor for classifying it as a medicinal product, adding that tomatoes, potatoes, etc., also contained nicotine like ordinary tobacco cigarettes.  
The company also pointed out that the product consisted of two parts: the battery and the cartridge refills. The battery and cartridge refills without nicotine could not constitute medicinal products in the opinion of the company.

The Ministry’s decision
In its decision of the complaint, the Ministry of Health and Prevention agrees with the Danish Medicines Agency that a product that contains synthetic/extracted nicotine is a specialised product designed with the sole purpose of giving the user a dose of nicotine. Consequently, the Ministry finds that NyCigaret must be classified as a medicinal product in accordance with section 2(2) of the Danish Medicines Act.

The Ministry further cited that NyCigaret is not comparable to tobacco products, which are stimulants that contain raw tobacco. Tobacco products release varying doses of nicotine in the body and do not appear as products designed with the sole intention of delivering nicotine in the body.

Furthermore, the Ministry finds that a distinction must be made between products containing extracted/processed nicotine and food such as tomatoes and potatoes, which serve a nutritional purpose and contain only little nicotine.
NyCigaret has been marketed in different packs containing an electronic smoking device, charger and cartridge refills.   The decision extends to all NyCigaret products that offer the user electronic smoking delivering nicotine in the body.

Karsten Jørgensen

Danish Medicines Act

2. In this Act a medicinal product means any product that

   (i) is presented as a suitable medicinal product for the treatment or prevention of diseases in humans or animals, or
(ii) may be used in or administered to humans or animals to restore, change or modify physiological functions by having a pharmacological, immunological or metabolic effect or to make a medical diagnosis.

7. A medicinal product may only be marketed or dispensed in Denmark when a marketing authorisation has been granted either by the Danish Medicines Agency pursuant to this Act or by the European Commission pursuant to the provisions of Community law laying down Community procedures for authorisation and pharmacovigilance of medicinal products for human and veterinary use etc. (Community marketing authorisation), cf., however, sections 11 and 29-32.

 

The European Court of Justice:  Third-party statements about medicines may be advertising

On 2 April 2009, the European Court of Justice delivered a judgment in a so-called reference for a preliminary ruling, determining that the positive statements made by a third party about a medicinal product may be regarded as advertising even though the third party in question is acting on his own initiative and independently of the manufacturer and the seller of the concerned medicinal product. It is for the national courts to assess the specific statements made.

The reference for a preliminary ruling was submitted by the Danish Western High Court (Vestre Landsret) in connection with the criminal proceedings against Mr Frede Damgaard. 
In 2003, Mr Damgaard stated on his website that Hyben Total could relieve the pain caused by various types of gout or arthrosis, and that the product was sold in Sweden and Norway.
Hyben Total was sold in Denmark by the company Natur-Drogeriet until 1999 at which time the information material was prepared by Mr Frede Damgaard.

The sale of the product was stopped in Denmark, because the Danish Medicines Agency classified the product as a medicinal product and because it had not been granted a marketing authorisation by the Danish Medicines Agency or the European Commission as required by the Danish Medicines Act.

Illegal advertising
Section 64(i) of the Danish Medicines Act prohibits the advertising of medicinal products that are not legally sold or dispensed in Denmark, implementing Article 87(1) of Directive 2001/83/EC on the Community code relating to medicinal products for human use. According to article 87(1), the Member States shall prohibit any advertising of a medicinal product in respect of which a marketing authorisation has not been granted.
Section 64(i) of the Danish Medicines Act was introduced on 17 December 2005, re-enacting the previous section 27b with no changes.

The Community law on advertising for medicinal products - and thus the corresponding Danish provisions - is to be interpreted based on the definition of advertising of medicinal products as provided by article 86: Any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products. This definition is implemented in Danish law by section 1 of the executive order on advertising for medicinal products (bekendtgørelse om reklame for lægemidler).

On these grounds, the Danish Medicines Agency assessed that Mr Frede Damgaard's statement on his website about Hyben Total was to be regarded as advertising, and since Hyben Total was not an authorised medicinal product, section 27b of the Danish Medicines Act had been violated.

Scope of concept of advertising
The Danish Medicines Agency reported Mr Frede Damgaard to the police, and in 2005 the Aarhus City Court (Retten i Aarhus) sentenced him to a fine for violation of section 27b of the Danish Medicines Act.
Mr Damgaard appealed against the judgment before the Danish Western High Court, submitting that he was not employed by Natur-Drogeriet and had not received any remuneration for writing about Hyben Total and that he had no interest in the company or in the sales of Hyben Total.

Mr Damgaard further argued that the information about Hyben Total published on his website did not constitute advertising as the concept, in his opinion, did not extend to information effected by an independent third party.
However, the prosecution service maintained that Mr Damgaard’s dissemination of information was aimed at encouraging consumers to buy Hyben Total, irrespective of whether there was a link between Mr Damgaard and the manufacturer or seller of that medicinal product.

Against this background, the Danish Western High Court decided to refer the following question to the European Court of Justice for a preliminary ruling: is the dissemination by a third party of information about a medicinal product to be understood as constituting advertising, even though the third party in question is acting on his own initiative and completely independently, de jure and de facto, of the manufacturer and the seller.

Review by the European Court of Justice 
The European Court of Justice states in its judgment that while the definition of advertising of Article 86(1) of Directive 2001/83/EC explicitly emphasises the purpose of the message, it does not provide any indication as to the people who disseminate that information. Thus, the wording of the definition does not rule out the possibility that a message originating from an independent third party may constitute advertising. Nor does the directive require a message to be disseminated in the context of commercial activity in order for it to be held to be advertising.

The European Court of Justice further states that even if the advertising is carried out by an independent third party outside any commercial activity, it is liable to harm public health, the safeguarding of which is the essential aim of Directive 2001/83/EC.

Finally, the European Court of Justice emphasised that it is for the national court to determine whether the actions of a third party constitute a form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of a medicinal product (and thus whether such actions are governed by the advertising rules).

Freedom of expression
Mr Damgaard also alleged before the European Court of Justice that his right to freedom of expression had been infringed as a result of his criminal conviction.
The Court replied that while the principle of freedom of expression is expressly recognised by Article 10 of the European Convention for the Protection of Human Rights and Fundamental Freedoms and constitutes one of the fundamental pillars of a democratic society, it nevertheless follows from Article 10(2) that freedom of expression is also subject to certain limitations justified by objectives in the public interest, in so far as those limitations are justified by a pressing social need and proportionate to the legitimate aim pursued.

When the exercise of the freedom of expression does not contribute to a discussion of public interest and, in addition, arises in a context in which the Member States have a certain amount of discretion, the court only examines the reasonableness and proportionality of the interference. This holds true for the commercial use of freedom of expression, particularly in a field as complex as advertising.

If the statements published on Mr Damgaard’s website are to be found to constitute advertising within the meaning of Directive 2001/83/EC, a conviction of Mr Damgaard could be considered reasonable and proportionate, in the light of the aim pursued, namely the protection of public health. In other words, Mr Damgaard cannot use his freedom of expression to have his case dismissed.

The European Court of Justice’s preliminary ruling 
The European Court of Justice's answer to the question referred to it therefore is, that Article 86 of Directive 2001/83/EC is to be interpreted as meaning that dissemination by a third party of information about a medicinal product, including its therapeutic or prophylactic properties, may be regarded as advertising… even though the third party in question is acting on his own initiative and completely independently, de jure and de facto, of the manufacturer and the seller of such a medicinal product.

The Danish Western High Court has not delivered its judgment yet. 

Karsten Jørgensen

Directive 2001/83/EC on the Community code relating to medicinal products for human use

Article 86
1. For the purposes of this Title, "advertising of medicinal products" shall include any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products; it shall include in particular:
- the advertising of medicinal products to the general public, 
- advertising of medicinal products to persons qualified to prescribe or supply them, 
- visits by medical sales representatives to persons qualified to prescribe medicinal products, 
- the supply of samples, 
- the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind, except when their intrinsic value is minimal, 
- sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products, 
- sponsorship of scientific congresses attended by persons qualified to prescribe or supply medicinal products and in particular payment of their travelling and accommodation expenses in connection therewith. 

2. The following are not covered by this Title:
- the labelling and the accompanying package leaflets, which are subject to the provisions of Title V,
- correspondence, possibly accompanied by material of a non-promotional nature, needed to answer a specific question about a particular medicinal product, 
- factual, informative announcements and reference material relating, for example, to pack changes, adverse-reaction warnings as part of general drug precautions, trade catalogues and price lists, provided they include no product claims, 
- statements relating to human health or diseases, provided there is no reference, even indirect, to medicinal products.


The European Convention for the protection of human rights and fundamental freedoms

Article 10 – Freedom of expression

1. Everyone has the right to freedom of expression. This right shall include freedom to hold opinions and to receive and impart information and ideas without interference by public authority and regardless of frontiers. This article shall not prevent States from requiring the licensing of broadcasting, television or cinema enterprises.

2. The exercise of these freedoms, since it carries with it duties and responsibilities, may be subject to such formalities, conditions, restrictions or penalties as are prescribed by law and are necessary in a democratic society, in the interests of national security, territorial integrity or public safety, for the prevention of disorder or crime, for the protection of health or morals, for the protection of the reputation or rights of others, for preventing the disclosure of information received in confidence, or for maintaining the authority and impartiality of the judiciary.


European Medicines Agency agrees to accept product numbers on inner packages

For a number of years, EMEA has questioned the legality of Denmark’s requirement for product numbers (in Danish 'Varenummer' or 'Vnr') to be placed on the inner packages enclosed in large packages of centrally authorised medicinal products. Now, EMEA has changed its course and has accepted the Danish requirement.

Pursuant to section 3 of the Danish executive order on product numbers, veterinary medicinal products that are enclosed in a so-called large package that is intended to be split up in several smaller packages must have a product number on the outside of the large package and a different product number on the individual inner packages. This requirement also applies to centrally authorised medicinal products.

Over many years, EMEA has raised its concern to the Danish Medicines Agency and the pharmaceutical industry about whether the special Danish requirement for product numbers to be placed on the inner packages is compliant with the current EU rules when it comes to centrally authorised medicinal products.

When the Danish Medicines Agency was drafting the amendment to the executive order on product numbers, it became necessary, once and for all, to clarify whether or not EMEA would accept the requirement for additional information on the inner packages in supplement to the EU requirement for information on the packages of centrally authorised medicinal products.

In January 2009, EMEA stated that it accepts the Danish requirement for product numbers. This ensures that medicine consumption can be registered as accurately as possible also when the inner packages of a large package are dispensed individually, which is essential for the correct monitoring of medicinal product use and consumption. 

The requirement for product numbers on inner packages was recently modified through an amendment of the executive order on product numbers, specifying that a product number is only required on the inner packages if it should be possible to split up the large package. Consequently, companies are free to choose whether or not to print product numbers on the inner packages, but must bear in mind that the large package can only be split up if the inner packages have a product code.

Karen Jensen


Delegation of the distribution of samples of medicinal products

A company who holds the marketing authorisation for a medicinal product may enter into an agreement with a wholesale distributor, detailing that the wholesaler is to distribute medicinal product samples and keep a record of the number of samples supplied on behalf of the company.

Pursuant to section 1(vi) of the executive order on distribution of samples of medicinal products, only the marketing authorisation holder or his representative may distribute medicinal product samples to doctors, dentists and veterinarians. 
Similarly, it is only the marketing authorisation holder or his representative that may keep a record of the number of medicinal product samples supplied. This appears from section 2 of the executive order.

Changed rules and new practice
So far, the practice of the Danish Medicines Agency has been to interpret representative as the representative written in the summary of product characteristics who also appears on the medicine package. Therefore, it has not been allowed to contract out to a third party the activity of distributing medicinal product samples to doctors, etc. Nor has it been permitted to contract out to a third party the record-keeping of distributed samples, not even in those cases where the distribution of samples has taken place from a consultant comprised by the marketing authorisation holder’s section 39 authorisation (authorisation to handle medicinal products) .

An amendment of the executive order on good distribution practice (the GDP executive order) has now made it possible for a wholesale distributor who does not hold the marketing authorisation to distribute medicinal product samples to doctors, dentists and veterinarians when the wholesale distributor has been granted a special authorisation by the Danish Medicines Agency. This appears from a new subsection 20(4) of the GDP executive order, which entered into force on 25 November 2008. 

As a result of the amendment, the Danish Medicines Agency has changed its practice pursuant to the executive order on distribution of medicinal product samples according to which it is now possible for the marketing authorisation holder of a medicinal product to contract out to a third party both the distribution of medicinal product samples and the record-keeping of the number of samples distributed.

Requirements for the distribution and record-keeping of samples
It is assumed that the distribution and record-keeping take place in compliance with the applicable rules. If the marketing authorisation holder also has a section 39 authorisation for wholesale distribution, this must appear from the contract between the marketing authorisation holder and the wholesale distributor who is to distribute the medicinal product samples on behalf of the marketing authorisation holder. The requirement for such a contract appears from section 27 of the GDP executive order.

In special cases where the marketing authorisation holder does not also have a section 39 authorisation for wholesale distribution, the requirement for compliance with the applicable rules imposed on the wholesale distributor who is to distribute the medicinal product samples on behalf of the marketing authorisation holder, will appear from the terms and conditions of the special authorisation granted by the Danish Medicines Agency to the wholesale distributor pursuant to section 20(4) of the GDP executive order.

This change of practice has no impact on sales representatives’ (consultants’) access to distribution of medicinal product samples to doctors, etc. Such distribution is still subject to the requirement that the representative or consultant must be comprised by a section 39 authorisation of either the marketing authorisation holder his representative. Alternatively, the sales representative must hold such authorisation himself. 

Inger Marie Conradsen

Executive order on the distribution of medicinal products
Section 20.-(1) Wholesale distributors must ensure that any distribution within the EU/EEA  ... takes place only to companies or persons holding an authorisation for manufacture, import, wholesale or retail distribution or to pharmacies, cf., however, subsections (2)-(6).
(4) In addition to the recipients of subsection (1), the marketing authorisation holder or his representative may, upon agreement with the Danish Medicines Agency, distribute medicinal product samples to doctors, dentists and veterinarians, cf. the executive order on distribution of samples of medicinal products. The Danish Medicines Agency may lay down the terms and conditions of such authorisation.


As at 9 July 2009, 10 companies benefit from the new possibilities:

Three wholesalers have been granted authorisation to distribute medicinal product samples to doctors

Seven pharmaceutical companies have contracted out to a wholesaler the distribution of medicinal product samples to doctors