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  • Writer's pictureHannah Copsey

Who regulates healthcare marketing? Things you need to know.

Updated: Apr 9

In healthcare marketing, there is a fine line between creativity and legal. 

Creativity can bring a campaign to life and help to build trust with your audience.

However, advertising regulations take away some of that creative freedom, and impose new challenges for healthcare marketers. 

This doesn’t mean that your marketing efforts are going to waste. As there are ways to overcome regulations and create campaigns that your audience will remember. 

In this article, we’ll give you a basic rundown of what you need to know to create compliant healthcare campaigns that make an impact. 

Why are regulations important in healthcare marketing? 

In healthcare, trust is everything. 

Advertising regulations help to ensure that there is trust between healthcare companies and their customers. 

When done correctly, marketing campaigns help to build credibility in a brand, its products and services. 

Here are some of the key reasons why healthcare advertising regulations should be considered: 

  1. To protect sensitive patient information and patient data

  2. To ensure that health claims are accurate and not misleading to consumers

  3. To ensure that all side effects of treatments are properly disclosed

What is healthcare marketing regulatory compliance? 

It comes as no surprise that any health-related marketing claims made must be truthful. 

In the UK, there are two regulatory agencies that set out rules for advertising:

  • The Committee of Advertising Practice (CAP) 

  • The Advertising Standards Association (ASA). 

The CAP is responsible for writing advertising codes. The ASA administers codes prepared by the CAP. 

These codes apply to all media as well as content on social media platforms.

Within the CAP code there are specific rules for health and nutritional claims, as well as rules for medical device companies

What are health claims? 

Health claims are any claims which link a relationship between a food, product, or ingredient to health benefits. 

Any health claims made must be accompanied by robust evidence. 

A recent ASA ruling on Willy’s Apple Cider Vinegar demonstrates how health claims are subject to strict requirements. 

Willy’s made a number of health-related claims about its new apple cider vinegar product. 

For example: “Speed up your metabolism” and “boost the immune system”. 

The ASA ruled that Willy’s had not included all the appropriate authorised evidence in their ads. 

They had therefore breached multiple rules in the CAP code, and so the ads could no longer be published in their existing format. 

What are the consequences of technical non-compliance? 

Whilst the ASA cannot impose fines on companies, it does publish public rulings which can result in reputational damage. 

Non-compliance with advertising codes can also create other logistical problems. 

For example, if a public body has ended a contract with a supplier of a medical product due to non-compliance. Other bodies can also exclude this company from future tenders. 

Similarly, if manufacturers are wanting to sell their products, non-compliance may come up in the due diligence process and stop any sales from going ahead. 

So while obtaining proper evidence can be a costly process. Adherence to truth in advertising laws may help save you from potential harm in the long run. 

How is healthcare marketing different from other industries? 

The CAP and the ASA regulate advertising for all industries in the UK. 

However, when it comes to  medicines and healthcare products, there are some additional rules that companies should be familiar with: 

  1. The Health Insurance Portability and Accountability Act (HIPAA) 

The HIPAA is a US law designed to protect sensitive patient information. In the UK it is known as the data protection act. 

These laws apply whenever you process protected health information. This includes any personal data linking to the physical or mental health of a person. 

There are many circumstances where you may need to process information about a person’s health. These include: 

  • Data collection via website forms 

  • Collection of patient testimonials 

  • The results from lab tests and product trials

Data protection laws ensure that patients’ information is handled sensitively and only used when necessary. 

  1. Food and drug administration (FDA)

The FDA is also based in the US. As the name suggests, the FDA sets rules and guidelines for food, medicines and medical devices. 

The UK equivalent to the FDA is the Medicines and Healthcare Products Regulatory Agency. 

When it comes to medicines, the FDA requires advertisers to disclose: 

  • The name of the drug (brand and generic) 

  • At least one FDA-approved use for the drug

  • The most significant risks of taking the drug 

Ads must essentially discuss the benefits and risks of a drug in a balanced fashion. 

The UK laws are somewhat similar. Advertisers must disclose the name and active ingredients in a product, as well as instructions on how to use it. 

In addition to this, advertisers must not: 

  • Make misleading claims about a drug or product

  • Suggest a medicine has no side effects

  • Quote recommendations by scientists, healthcare professionals or public figures

  • Suggest a medicine is the same or better than another named product

There are also different laws for prescription-only vs non-prescription drugs. 

For example, prescription-only drugs cannot be advertised to the general public. 

Organisations such as the Committee of Advertising Practice offer advice on adverts aimed at the public. The Medicines and Healthcare Products Regulatory Agency also provides advice on specific legal requirements. 

These regulations ensure that consumers and healthcare professionals have a true understanding of the medicines and healthcare products that they are using. 

The federal trade commission (FTC) act, or the office of fair trading, also help to protect consumers against unfair business practices. 

What about environmental claims? 

The Green Claims Code is a separate advertising code which relates only to environmental claims. 

The Green Claims Code aims to help businesses better understand the rules around environmental claims.

It also helps consumers to understand genuine environmental and sustainability efforts. 

The Advertising Standards Association is taking a firm stance on green claims to prevent greenwashing practices. 

It is essential that businesses ensure that all environmental claims can be fully substantiated. 

How can AGENCY help you? 

At AGENCY, our A-team comprises creatives, copywriters and legal professionals who can help you navigate the complexities of healthcare regulations.

We help deliver compelling and innovative healthcare campaigns that are both engaging and legally compliant. 

If you would like to hear more from us, and build your healthcare brand with confidence 

Get in touch here. 

If you would like to read more about our campaigns for growth, 

Visit our insight articles and case studies here. 

Frequently asked questions

  • What does MHRA regulate? 

The Medicines and Healthcare Products Regulatory Agency (MHRA) regulates medicines and medical devices to ensure that they are safe to use and effective. The MHRA helps to educate patients and healthcare professionals about the benefits and risks of medical products and services. This enables innovation in healthcare and ensures that medical research is beneficial to public health. 

  • What is the FDA equivalent in the UK?

The Medicines and Healthcare Products Regulatory Agency (MHRA) is the equivalent of the Food and drug administration (FDA) in the UK. The MHRA ensures that medical products are effective and safe to use. The MHRA also ensures that marketing of medicines and medical devices is truthful and not misleading to the public. 

  • Who regulates advertising in the UK? 

The Advertising standards agency (ASA) regulates advertising in the UK and ensures that all promotional materials adhere to a set of advertising guidelines. The Committee of Advertising practice (CAP) is closely associated with the ASA and is responsible for writing and maintaining the advertising codes and guidelines.


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