Internet Advertising & Sales of Non-prescription Medicines Permitted Under EU Law

The European Court of Justice ("ECJ") has held that EU member states cannot prohibit non-prescription medicines from being advertised and sold over the internet. However, EU member states are able to ban the internet advertising and sale of prescription medicines.

Background

The case (C-322/01) involved the sale of prescription only ("POM") and non-prescription medicines to patients in Germany by an internet pharmacy called 0800DocMorris NV based in Holland ("DocMorris"). DocMorris is licensed by the Dutch authorities to run a pharmaceutical business including its internet website. The case was bought against DocMorris by an association representing the interests of German pharmacists.

At issue was whether various EU directives and German national law prohibited the sale of medicines over the internet, and if they did, whether they were in breach of Articles 28 and 30 of the Treaty of Rome permitting the free movement of goods.

No medicine can be legitimately sold or advertised for sale in any EU member state without that member state having granted a marketing authorisation in respect of that medicine. In addition, the marketing authorisation must specify whether or not the medicine is subject to a medical prescription. POMs are those that can be dangerous, even if used correctly, without medical supervision. Non-prescription medicines include those that can only be sold in a pharmacy ("P") or those that can be sold in virtually any other type of shop (General Sales List; "GSL").

Under German law (which is similar in many ways to the UK) a pharmacist must supervise sales by the pharmacy in person. In addition, the pharmacist must examine a medicine before selling it, oversee the handing of the medicine to the customer, advise and consult customers, ensure that errors are spotted in prescriptions and prevent the intentional misuse of prescriptions.

German national law prohibits the sale by mail order of medicine for medical products that may be sold only in pharmacies (i.e. P medicines).

The ECJ was asked a number of questions by the German court. Its conclusions were as follows:

1. Laws of an member state that ban the sale of medicines which are not authorised in that member state are not contrary to EU law.
2. German national law prohibits sales by mail order of medicines that can only be sold in pharmacies. Although this restriction applies to all pharmacies, whether or not German, it has a greater effect on pharmacies established outside Germany. This is because the internet is a more significant way of gaining access to the German market for non-German businesses. There was therefore a quantitive restriction on the free movement of these goods into Germany that would only be acceptable if it could be justified.
   DocMorris argued that a ban on the internet sale of both POM and P medicines could not be justified. It said that it complied with the Dutch regulations for sales in pharmacies, including only selling POMs on receipt of original prescriptions. The only difference was that the customer did not come into the pharmacy. The ECJ agreed that there was no justification to ban the sale of non-prescription medicines by mail order (including P’s). However, stricter controls on POMs may be justified. The authenticity of prescriptions needs to be checked and it is important to ensure that such a medicine is handed over to the customer himself, or to the person to whom collection has been entrusted by him. This is enough to justify a ban on sales by mail order (including via the internet).
3. As to whether the German law on advertising medicines was in accordance with Community law, bans on advertising medicines that do not have marketing authorisations in Germany and on the advertising of prescription medicines to the public were fully in accordance with Community law. However a German ban on the advertising of medicines that can only be supplied in pharmacies was contrary to Community law to the extent it encompassed more than prescription only medicines.

This decision allows EU member states to prohibit the sale and advertising of prescription medicines to patients over the Internet, but leaves internet pharmacies free to sell non-prescription pharmacy and general sales medicines. In Germany the effect of this judgment will be limited as from the beginning of 2004 the German government has lifted the ban on all mail order sales of medicines, including prescription medicines, provided that certain stringent requirements are met.

In the UK the current position is different. Although there is no express ban on sales of POM and P medicines by mail order or over the Internet, they can only be sold or supplied at registered pharmacy premises by, or under the supervision of, a pharmacist, and POM’s can only be sold in accordance with a prescription. Additionally, advertisements for POMs are not acceptable on web sites other than those whose nature and content is directed at health professionals.

However, in the UK there is also currently a ban on advertising to the general public of non-prescription medicines to treat certain diseases (such as bone diseases and cardiovascular diseases). Following the DocMorris judgment it appears that this ban may breach EU rules on free movement of goods. This may soon be resolved as the UK government indicated in August last year that this ban will be lifted sometime in 2004, although EU wide bans on non prescription medicines for treating certain other diseases (e.g. malignant diseases and HIV related diseases) will be retained.

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