EU pharma package: new rules on advertising medicinal products

The EU pharma package is set to bring about changes in the area of pharmaceutical advertising. Admittedly, the draft of the new European directive on medicinal products ("New Medicinal Products Directive") is largely based on the existing legal framework, which is transposed in Germany in particular in the German Act on Advertising in the Field of Health ("HWG") and the German Unfair Competition Act ("UWG"). A fundamental overhaul of the rules on advertising is therefore not expected. Nevertheless, the European legislator has introduced a number of changes that could have a significant impact on the communications from pharmaceutical companies. The focus is on the planned broadening of the definition of "healthcare professionals", stricter guidelines for comparative advertising and expanding the definition of "advertising". For pharmaceutical companies, drug manufacturers, compliance officers and marketing departments, this may have significant implications for advertising activities, approval processes and communications with healthcare professionals. This article outlines the changes the EU pharma package envisages for the advertising of medicinal products and the practical implications the new regulations may have for the pharmaceutical industry.

EU pharma package: Expanding the definition of "healthcare professionals" in pharmaceutical advertising

In future, not only those authorised to prescribe or dispense medicinal products will be regarded as "healthcare professionals", but also those who are authorised and qualified to administer medicinal products. From a national perspective, this could, in any case, significantly broaden the current narrow definition of "medical professionals" in section 10 (1) HWG and make it easier to target advertising at other professional groups beyond doctors and pharmacists.

This is because, pursuant to section 10 (1) HWG, advertising for medicinal products for which a prescription is required may only be directed at persons authorised to prescribe medicinal products (doctors, dentists, veterinarians) or to dispense them (pharmacists), or at persons who are licensed to sell medicinal products. A large group of qualified professionals who are also in direct contact with patients has not yet been included, i.e. the individuals who coordinate complex treatment plans and provide training in specialist therapies. This includes nursing staff and other qualified professionals, particularly in specialised medical practices, such as diabetes consultants or rheumatology assistants. 

Although it is not currently permissible under German law to advertise prescription medicine to these professional groups, this could change soon. This is because Article 175 (1) (b) New Medicinal Products Directive also seeks to include those persons who are authorised and qualified to administer medicinal products in the definition of "healthcare professionals". The reasoning behind this is that they are also capable of correctly assessing the information contained in the advertising for a prescription medicine on the basis of their knowledge, training and experience. This would expand the opportunities for pharmaceutical companies to target these individuals specifically in doctors' offices.

The group of persons authorised to dispense free samples of non-prescription medicines will also be expanded; from now on, it will include not only those authorised to prescribe but also those authorised to administer such medicines (Article 185 (2) New Medicinal Products Directive).

Stricter rules on comparative advertising for medicinal products

According to the legislators involved in revising the Directive, the rules on comparative advertising will also be tightened (Article 176 (4) New Medicinal Products Directive). This will not be limited to an explicit ban against highlighting the negative aspects of other medicinal products. Advertising claims stating that a product is "safer" or "more effective" than another medicinal product will only be permitted if the claim can be explicitly substantiated on the basis of the relevant summaries of product characteristics (SmPCs). This would mean that the SmPCs will become even more important as a legal reference point for advertising claims. This is because comparative advertising claims would be prohibited unless they can be explicitly substantiated by the respective SmPCs. This would be particularly relevant in practice for medicinal products for which direct comparative studies with competing products (so-called head-to-head studies) are only completed after marketing authorisation has been granted. To date, comparative advertising claims can also be based on such direct comparative data which has not yet been incorporated into the relevant SmPCs – provided that the new findings do not contradict the information contained in the relevant SmPCs. The European legislators intend to change this. It will no longer be permitted to advertise using new head-to-head data that has not yet been incorporated into the text of the relevant SmPCs, regardless of whether or not the data are scientifically sufficiently valid. This would significantly limit the scope for advertising using newly published data in future.

New definition of the term "advertising" in EU pharma package: implications for pharmaceutical companies

In future, "advertising" will also mean advertising that does not relate to specific medicinal products (Article 175 (1) (h) New Medicinal Products Directive). This includes, in particular, the advertising by a pharmacy of its entire range of prescription and non-prescription medicinal products, an issue which has repeatedly been the subject of legal proceedings in recent years, notably before the Court of Justice of the European Union. In 2021, the Court of Justice of the European Union (judgment of 15 July 2021, Case C-190/20 – DocMorris) held that such product range advertising for prescription medicine should not constitute advertising within the meaning of Directive 2001/83/EC. It remains to be seen whether disease awareness campaigns, insofar as they refer directly or indirectly to prescription medicine, might also be covered by this in future. Pharmacological treatment options often play a role in this context as well, without the focus being on any particular medicine.

All of this shows that the EU pharma package not only concerns issues of market access and regulation in the strict sense, but may also have implications for the way pharmaceutical companies communicate. It remains to be seen how the Member States will transpose these regulations. Companies should therefore closely monitor further legislative developments in Germany and prepare their review and approval processes at an early stage in light of potential changes. 

In short: the key changes to the rules on the advertising of medicinal products

The EU pharma package introduces new rules for advertising of medicinal products in Europe.

• The definition of healthcare professionals will be broadened to include other qualified occupational groups in future.
• Comparative advertising could be subject to significantly stricter requirements and more closely aligned with the SmPC. In particular, the use of new scientific data to support advertising claims may be restricted in this respect in future.
• The European definition of the term "advertising" will be broadened to potentially cover additional forms of communication.
• Pharmaceutical companies should prepare their compliance, review and approval processes at an early stage for any potential changes.
• Further legislative developments and how they are transposed at national level in Germany will be crucial.