Is that even legal? Human and animal bits and bobs and other weird things

There are certain materials that capture attention and the imagination. It is often said that the law struggles to keep up with the pace of development, but let's give it a chance. In this blog, I take a quick look at the laws that apply to specific materials.

If you were wanting to read about some of the strange and wonderful things going in the world, urine luck.

In the UK, the main legislation governing the use and storage of human tissue is the Human Tissue Act 2004 ("HT Act"). The key definition is "relevant material", which means material, other than gametes, which consists of or includes human cells. Even a single cell can cause material to be covered by the HT Act. Otherwise, I have set out below some laws and regulatory regimes that will or may apply to specific products. But beware the devil in the detail, particularly if multiple regulatory regimes are likely to apply!

There are two other types of law that are relevant:

• Consumer laws relating to defective products derived from these materials (Consumer Protection Act 1967).

• Data privacy laws relating to information within these materials, such as genetic information, or information about donors.

Urine

The Human Tissue Authority ("HT Authority") specifically identifies urine as being considered to be relevant material under the HT Act. Otherwise, consider the application of healthcare law to the collection and use of urine and medical device regulation if it is being investigated with an in vitro diagnostic device.

Stem cells

According to the HT Authority, stem cells derived from the body (not the blood) and umbilical cord blood stem cells are relevant material under the HT Act. However, stem cells derived from an embryo are not considered relevant material.

Cell lines

If the material contains cells, but they have divided or been created outside the human body, then it is not subject to the HT Act. The HT Authority specifically identifies cell lines and cells that have divided in culture as not being relevant material under the HT Act.

If cells from a cell line are intended for human application, then they are subject to the Human Tissue (Quality and Safety for Human Application) Regulations 2007. The definition of "cells" in that regulation specifically includes "cell lines grown outside the human body" (so it is wider than the same concept in the HT Act).

Gametes and embryos

Gametes, eggs (ova) and sperm cells (spermatozoa) are all identified by the HT Authority as not being relevant material.

Embryos and gametes are subject to the Human Fertilisation and Embryology Act 1990. There are many provisions clarifying what is meant by these terms and specifying materials and activities that are covered by the Act, so it is best to check carefully.

Breast milk

According to the HT Authority, breast milk is relevant material. It also may be subject to food law or medicines regulation depending on the intended use.

Placenta

According to the HT Authority, non-fetal products of conception, such as amniotic fluid, umbilical cord, placenta and membranes, are all relevant material.

Blood and related products

According to the HT Authority, blood is relevant material.

Also, blood and blood components are subject to the Blood Safety and Quality Regulations 2005 if intended for transfusion or manufacture of therapeutic products. Those therapeutic products would then be subject to medicines regulation.

Teeth

According to the HT Authority, teeth are relevant material. Dentists take note.

Exosomes

Exosomes are not specifically mentioned in the HT Act or by the HT Authority. However, the HT Authority does specifically state that the following are not considered relevant material: "Extracted material from cells e.g. nucleic acids, cytoplasmic fractions, cell lysates, organelles, proteins, carbohydrates and lipids". They are likely not subject to the HT Act, unless someone argues successfully that they are cells (because they have a cell membrane).

Plasma

The HT Authority specifically identifies plasma as not being considered to be relevant material. However, it notes that plasma may be prepared or processed in a manner that leaves small numbers of platelets and other blood cells in the material, in which case it would be relevant material.

Plasma is a blood component under the Blood Safety and Quality Regulations 2005. In some circumstances plasma may be considered a medicine and therefore subject to medicines regulations.

Faeces

The HT Authority specifically identifies faeces as being considered to be relevant material under the HT Act.

Faecal Microbiota Transplant (FMT) products are regulated by the MHRA as medicines. The HT Authority has specifically stated that FMT products are not subject to the Human Tissue (Quality and Safety for Human Application) Regulations 2007.

Hair and nails

The HT Authority specifically identifies hair and nails from living donors as not being considered to be relevant material. However, it is not hard to imagine human cells being included in samples of hair and nails. In addition, the HT Authority specifically identifies hair and nails from deceased donors as being considered to be relevant material.

Orthotics

Depending on the exact product and its use, orthotics are generally considered to be medical devices and therefore subject to the Medical Device Regulation 2002.

Human DNA

The HT Act makes reference to DNA many times. The main thing to remember is that non-consensual analysis of DNA is a criminal office. You must get "qualifying consent" and only use the DNA for an "excepted purpose". See Schedule 4 of the HT Act to get to grips with those concepts. Otherwise, since they are not cells, the HT Authority specifically identifies DNA, RNA and nucleic acids extracted from cells as not being relevant material. Assuming thhat you are not unlawfully analysing DNA, then your main concern is about data privacy compliance. Also, devices used to analyse DNA may be subject to medical device regulation.

Live animals

If you are using animals in research, then you will need to comply with the Animals (Scientific Procedures) Act 1986. Licences are required from the Animals in Science Regulation Unit (ASRU) of the Home Office.

Animal products (such as gelatin)

If animal products are used in your product, they may be subject to the laws relating to Products of Animal Origin (POAO) or Animal By-Products (ABP). Essentially, this is mainly about controlling the spread of infectious diseases and is a touchy subject at the international level. Animal products that are included in products regulated under other regimes (such as medicines) may trigger specific additional requirements under those regimes.

Cosmetics

Cosmetics are also regulated in the UK under the Cosmetic Products Enforcement Regulations 2013 and the post-Brexit UK amended version of the EU Cosmetics Regulation (Regulation (EC) No 1223/2009). If your product is intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity, and the purpose of doing so is about cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours, then, in principle, you need to comply with cosmetics regulation. Note that a suppository could not be a cosmetic. Also, it is not lawful to use human stem cells or materials of human origin in UK cosmetics. Cosmetic products often stray close to the borderline with medicines regulation.

Biocides

If your products contains an active substance (including a micro-organism) and is intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on, any harmful organism by chemical or biological means, then, in principle, it will be regulated under the Biocidal Product Regulations 2001. The rules are different in Northern Ireland (there is an equivalent EU regulation), and there is often overlap with other regulatory regimes.

Is your material on the list above? Whatever your materials or products contain, have you identified the laws that apply specifically to each component? This might vary depending on what activities you undertake and where the component in question ends up. Contact harry@hamiltonlawscientific.com to have an initial chat and arrange for a free preliminary view and a quote for legal support on regulatory compliance and dealing with product-related risks in contracts.

More funky materials to be added. Feel free to make suggestions!