Advertising for pharmaceutical companies is subject to strict regulatory oversight governing the content, presentation and intended audience. These specific requirements are in addition to the country's general advertising laws.
Prescription-only products cannot be advertised in the EU or the UK. For other medicines, specific regulations are intended to prevent patients being misinformed about their illnesses or treatments for them. There are also regulations specific to the advertising of all types of medicines to doctors. They must also be able to trust that the marketing materials presented to them are reliable and accurate to ensure accurate prescribing.
Regulatory framework
The European Union (EU) provides a level of harmonisation of advertising laws under Directive 2001/83/EC. This is implemented on a national basis by each member state. In the UK, the Human Medicines Regulations 2012 govern medicines advertising.
In each EU member state national regulatory authorities are primarily responsible for enforcing medicines advertising regulations. These regulators have enforcement powers to impose sanctions which include fines, corrective advertising, and requiring the withdrawal of misleading advertisements. In many civil law countries competitors can make unfair competition claims for damages where they consider that they have suffered losses due to unlawful advertising. In addition to pharmaceutical-specific rules, medicines advertising must also comply with generally applicable national advertising laws.
Various industry-specific organisations (including the European Federation of Pharmaceutical Industries and Associations (EFPIA), and in the UK, The Association of the British Pharmaceuticals Industries (ABPI)) also have their own codes of practice. These codes are mandatory for members and in the case of the ABPI code, also for any company that opts to be regulated primarily by the ABPI (instead of the national regulator, the MHRA). These codes are viewed as an industry benchmark. Industry bodies have the authority to impose sanctions, including suspension of membership or public censure for non-compliance with their codes.
Key content of regulations and guidelines
Accuracy is paramount. All advertising must be accurate, balanced, and not misleading. Any claims made about a medicine must be substantiated by evidence (such as clinical trial data or peer-reviewed studies) and must reflect the product's Summary of Product Characteristics (SmPC).
Promote rational use. Advertisements must encourage the rational use of the medicine by presenting it objectively and without exaggeration. This includes providing clear information on the medicine's indications, contraindications, side effects, and proper usage.
Avoid prohibited claims. Advertisements must not suggest that a medicine's effects are guaranteed, that it has no side effects, or that it is better than or equivalent to another identifiable medicine. Claims of being "safe" are also prohibited.
Be fair and accurate in any comparisons. In countries in which comparative advertising is permitted, any comparisons must be accurate, fair, and substantiated. Comparisons should be based on relevant and comparable aspects of the medicines and should not mislead or otherwise disparage the competitor's product.
The same standards must be met when advertising online. Digital advertising, including websites, social media, and email marketing, must adhere to the same standards as analogue advertising.
Monitor social media. Companies must monitor and control their social media presence to ensure compliance. This includes managing user-generated content and ensuring that any promotional posts are clearly identified as such.
Do not advertise prescription only medicines (POMs) to the public. POMs are medicines that legally require a medical prescription from a licensed healthcare professional against which they are dispensed. Advertising of POMs to the general public is prohibited, though they can be advertised to healthcare professionals and others who are permitted to prescribe or supply the product.
Adverts for medicines must be clear and informative. Over the counter (OTC) medicines can be purchased without a prescription. They are classified into pharmacy medicines (P), which require a pharmacist's supervision, and general sales list medicines (G), which can be sold in general retail outlets. OTC medicines are typically used to treat common health issues that do not require direct supervision by a doctor. These medicines can be advertised to the public, subject to meeting all applicable advertising rules. Any advertising must include essential information such as the medicine's name, the common name of the active ingredient (if there is one), information necessary for the correct use of the medicinal product, and an express and clear invitation to carefully read the instructions on the package or the package leaflet. It is important to check national requirements for information that must be included in non-prescription only advertising as these details are not harmonised.
Further information is required if advertising to healthcare professionals. Advertisements directed at healthcare professionals must provide them with all the necessary information to make informed decisions. This includes specific information such as the marketing authorisation number, the name and address of the marketing authorisation holder, the medicine name and indications, product classification (eg POM, G or P) and a succinct statement of the SmPC. Again, national requirements for each country must be checked for mandatory content as this is not harmonised even in the EU.
Disease awareness campaigns must focus on education. Disease awareness campaigns that do not make product claims are not considered advertising. These campaigns should focus on educating the public about symptoms, risk factors, and the importance of seeking medical advice without promoting a specific product. Note that if a medicine is the only one available to treat the disease, then a disease awareness campaign by its manufacturer is likely to be considered advertising and to which all advertising laws will apply.
What compliance systems should pharmaceutical companies have in place?
Establish an internal scientific review process. Some countries require marketing authorisation holders to establish a scientific service to compile and collate all information relating to the product. Having such a service allows a dedicated scientific review team to gather and verify information related to the product, ensuring that all promotional materials are accurate and comply with regulations.
Establish a process for multiple stakeholder-review. When advertising across Europe it is particularly important to be aware of the rules applicable in each country, as they are not the same. Advertising will therefore need to be reviewed by lawyers in each country that is being targeted.
Develop a comprehensive training program. Ensure that all employees involved in the creation and dissemination of advertising materials are thoroughly trained on the relevant regulations and guidelines. This training should be ongoing to keep up with any changes in the regulatory landscape and labelling for the medicine.
Implement a robust compliance monitoring system. Establish a system to regularly review and monitor all advertising and promotional activities. This system should include periodic self-reviews and assessments to ensure ongoing compliance with both internal policies and external regulations.
Upcoming developments
EU pharmaceutical law is currently undergoing reform with a new directive proposed on 26 April 2023 to revise and replace the existing general pharmaceutical legislation. This directive introduces several changes in the regulation of medicines advertising in the EU. Further details of the expected changes are available here.
The UK may consider reviewing and potentially updating its own pharmaceutical advertising laws in response to these developments.
