Products and services that keep people healthy – what are you promising exactly?

Health, the biggest challenge. (Well, let's put climate change to one side for a moment.)

We all want to be as healthy as possible, stay healthy for as long as possible, and, if needed, restore ourselves to good health quickly following injury or sickness. It's a constant. And it doesn't always feel like modern life promotes health and wellbeing as it should.

More and more we are made aware of what we can do to take our health into our own hands, and there are plenty of businesses that are positioning themselves to help us. So, what do those businesses need to think about.

1. What is the intended purpose of the product or service and is it safe?

   Most of the laws relating to health and wellbeing products and services are about protecting people from unfair business practices and unsafe products. So, the focus of your initial questions should be about whether: (a) the ultimate customers will understand and get what they have paid for; and (b) there is any risk that people could be injured or property could be damaged by the product or service.

2. What claims are being made and what will users and recipients think of those claims?

   The health and wellbeing sector is full of hope, which is inspiring for the health conscious. However, it also provides an opportunity to go too far. The Advertising Standard Agency (ASA) regulates advertisements and provides detailed guidance on the types of claims that can be made lawfully in the marketing of products and services. A claim about positive health effects might breach advertising laws if it is unsubstantiated or misleading. In the worst case scenario, a bad claim might stop a person getting the clinical treatment they actually need, which could lead to liability for the business making that claim.

3. Is the service a regulated care activity?

   Certain activities involving the provision of care are regulated. If you are providing regulated healthcare, then you will need to register with the Care Quality Commission (CQC). Take care not to underestimate that as a job to do.

4. Is the product regulated, for example as a medicine?

   Sometime this is far less than clear, and the actual determination of a product's regulatory status is a complex matter. Tread carefully. It is better to explore early and even engage in the discussion with regulators before you go too far. Regulatory regimes normally make it an offence to go to market without taking the required pre-market steps.

   There are aspects of product regulation that are affected by the claims made about products. Presenting a product as being effective at treating a medical condition might cause that product to be regulated as a medicine, for example.

5. Does the contract actually protect me?

   The legal terms that apply to the supply of goods or services to consumers are subject to the Consumer Rights act 2015. In short, as a result of that Act it is difficult to limit or exclude liability or transfer risk or responsibility onto the consumer. Contractual approaches to risk and liability require careful drafting and the application of principles found in detailed law and guidance. In addition, there are specific rules relating to information and cancellation, which need to be complied with.

6. If a risk has been identified, what mitigating measures have been implemented?

   It may be best to focus on how you can avoid problems in the first place, rather than build up lots of defensive mechanisms to lean on in the event of a disaster or claim. Those types of measures can form a part of the contracting approach, such as encouraging consumers to think carefully about other options. Disclaimers and warning notices can be designed with this purpose in mind.

7. Got insurance and a good complaints policy?

   No need to labour the point. They can help make problems smaller than they otherwise could be.

Are you a health or wellbeing business providing services (such as online consultations) or products (such as supplements or relaxation devices)? Have you asked yourself these questions and developed measures to mitigate your specific risks? Contact harry@hamiltonlawscientific.com to discuss cost-effective legal support in relation to contracts, regulatory matters and commercial practices.