The complex path to meeting promotional materials requirements in Europe

For companies promoting medicines in the UK, there are two routes of regulation: through a self-regulated system or through the MHRA. Additionally, before even starting a promotional materials campaign in the UK, companies must ensure the information has been approved by a qualified signatory and that the material is in its final form.¹

The Medicines and Healthcare products Regulatory Agency (MHRA) has committed to vetting any initial advertising for new active substances. Vetting by MHRA may also be required where a product is reclassified or where previous advertising has breached the regulations. Companies that are self-regulating must comply with the Association of the British Pharmaceutical Industry (ABPI) Code of Practice, which is administered by the Prescription Medicines Code of Practice Authority (PMCPA).^2,3 Companies found in breach of the ABPI Code must undertake to cease the practice and must pay an administrative charge. Other more serious actions may be taken if the PMCPA deems it necessary.⁴ 

Those who are not ABPI members or who have not provided written confirmation that they will abide by the jurisdiction of the PMCPA will be dealt with by MHRA if there is a complaint about any misleading advertising for a medicine.⁵ Additionally, the MHRA will deal with repeated breaches or where self-regulation fails. The sanctions available to the MHRA vary but can be legally based and company directors may incur personal liability.⁶

While self-regulation is widely accepted, there are processes that need to be followed, including legal liability for company directors, and so it might not always make sense for small companies that are new to the market. Another code requirement for companies operating in the UK is to ensure their sales representatives are properly trained and, if they are new to the industry, require them to sit an examination within a year, and pass it within two years.⁷ To navigate these complexities, companies may choose to seek a partner to provide standard operating procedures and to train representatives in the ABPI requirements. 

As with all the other European countries, Nordic countries require that all materials are in accordance with the latest summary of product characteristics (SPC). However, the nuances as to what this means in practice causes confusion for many companies. Sweden has been particularly strict on this issue and has long prevented companies from including much additional information, though we are starting to see a shift to a less rigid approach and more in keeping with other Nordic markets, such as including long-term treatment results. 

Other complexities facing companies new to the Nordics are differences between which countries will accept abstracts and posters in substantiating claims and which won’t, and in what circumstances. 

Regulatory oversight again varies by market. In Finland, for example, members of Pharma Industry Finland (PIF) are self-regulated and those that breach the local code may face fines. Companies that are not members of the local industry bodies will be regulated by the regulatory authorities, such as Fimea in Finland.¹¹

Given these complexities, companies need to consider their Nordic launch very carefully and seek advice if they are new to these markets. 

Companies that are not members of either must follow the compliance process for review and oversight of their promotional materials and communications with HCPs as outlined in the local regulation.  

One of the challenges for companies with medicinal products on the market in Germany is that the advertising regulation is not specific, which puts the onus on the Information Officer to understand and interpret the regulations, ensuring materials are in compliance with the laws and the codes. There are no specific qualifications written in the law for the Information Officer. It is up to the company to ensure the person has the right knowledge and reliability required to perform their duties.¹³ Since no one person can have insight and oversight of all activities, it is the responsibility of the Information Officer to ensure there are processes in place to manage oversight of relevant company activities. 

Further complicating the landscape is that Germany has a federal system with 16 federal states. For example, some local (federal) authorities may require companies to provide an explanation as to why they deem the Information Officer to be suitable for the role. 

Given the highly complex and heterogeneous nature of the German market, it is important that companies have local knowledge and expertise to navigate the different codes and requirements. 

The country-specific nature of promotional materials compliance requirements makes it very difficult for companies new to Europe to navigate the process on their own. Without local presence, it is next to impossible to understand the nuances of each market, even with a deep understanding of the EFPIA code. 

Unlike the United States, Europe does not have a single approach to promotional materials, even within the European Union. There are numerous examples of companies that have fallen foul of local requirements and the consequences can be dire, including extensive audit by the self-regulatory body or vetting of materials by the health authorities. Having local support in Europe and ensuring rigorous training of your local representatives is therefore vital.