Legislation & Regulation In The Americas
Keep up to date with legislation & regulation in the Americas.
The UK was the first country in the world to enforce specific restrictions and regulations on using animals for research. The Cruelty to Animals Act came into force in 1876, and made it an offence to perform experiments, on a living animal, that would cause pain, unless for advancing physiological knowledge, saving or prolonging life, or alleviating suffering. Other regulations included allowing only scientists to perform experiments, and requiring licences before experiments were permitted. This Act stood alone in regulating animal research in the UK until the Animals (Scientific Procedures) Act 1986 (ASPA) was introduced. ASPA was an extension and revision of the Cruelty to Animals Act 1876 with stricter regulations. ASPA continues to evolve. In 2013 cephalopods (octopus, squid, cuttlefish and nautilus) became protected species within UK and EU legislation.
The Animals (Scientific Procedures) Act 1986 (ASPA) currently regulates:
In March 2014, a document called the Guidance on the Operation of the Animals (Scientific Procedures) Act 1986 was produced after a public consultation. This document gives detailed guidance on how ASPA should be administered and enforced.
This includes further details on:
Under ASPA, a regulated procedure is defined as any procedure applied to a protected animal that will cause a level of pain, suffering, harm or distress, equivalent to or higher than that of a needle being inserted under good veterinary practice.
A protected animal, as defined by ASPA, is any living vertebrate other than man, and any living cephalopod. ASPA also extends protection to any vertebrate in foetal, larval or embryonic form, if, in the case of mammals, birds and reptiles, they are two thirds of the way through gestation or incubation period, or in other cases, when they become capable of independent feeding. Early life stage protection is not extended to cephalopods.
ASPA regulates animal experimentation through a three tier licensing system. This means that an establishment licence for the premises, a personal license for the person conducting the experiment, and a project licence for the specific programme of research that the project being carried out under, must all be in place. Licences are issued by the Home Office in England, Scotland and Wales, and by the Department of Health, Social Service and Public Safety in Northern Ireland.
ASPA was revised in 2013 to include the EU Directive 2010/63/EU – a directive that aimed to improve the welfare standards of animals in science across EU member states (Directive 2010/63/EU 2010). In January 2021 the UK officially left the European Union. As a result of this, most legislation, including amendments to ASPA from the EU directive, have been transposed from the EU back into domestic UK law.
In member states of the European Union, animal experimentation is controlled by the European Directive 2010/63/EU.
The directive sets out rules on:
Each Member State of the European Union had to revise or introduce new legislation in order to comply with this Directive.
The 3Rs are now an integral part of the Directive so Member States have to ensure:
The directive applies to all live vertebrates, namely all species of mammals, birds, amphibians and fish, and live cephalopods. Like ASPA, protection is also extended to specific early life-stages of some species.
Whilst ASPA regulates the use of animals for all scientific procedures in education, research and testing, other legislation dictates where animal tests may be required. This is known as regulatory testing and is often enforced by an overarching regulatory body. Examples include testing of new medicines, veterinary medicines, and chemical or environmental safety testing. Whilst subject to the 3Rs requirements of ASPA, these regulatory requirements must allow for efficient validation and adoption of alternative methods to replace animal tests wherever possible. Removing the requirement for animal tests can be achieved with the implementation of a legal ban.
Despite these bans there are still times where animal tests may occur on ingredients for cosmetics or household products under the requirements of UK REACH or EU REACH (registration, evaluation, authorisation, and restriction of chemicals) regulations.
Below is a brief overview of the existing legislative and regulatory frameworks where animal testing requirements still exist today in the UK.
REACH is a piece of legislation that exists independently in UK and EU law concerning the registration, evaluation, authorisation, and restriction of chemicals. The Health and Safety Executive in the UK is the regulator for REACH. Animal testing is still required under REACH to ensure the safety of people and the environment. However, to minimise the use of animals, REACH requires companies to share data to avoid unnecessary testing. Non-animal methods are the priority under REACH and tests involving animals can only be carried out when there is no other option.
Bans exist in the UK and EU to prevent the testing of finished cosmetic products, cosmetic ingredients, household products, and household ingredients on animals. However, previously REACH testing requirements overruled this ban. For example, when a chemical is produced in large amounts or a large percentage of the chemical will be used for other purposes that are not covered by the bans, REACH may require data from animal tests. We and many others believe, that this goes against the principles of the bans, and that data could be provided in alternative ways, avoiding animal use. In May 2023, the UK Government stopped providing licences for all animal tests for purely cosmetic ingredients under REACH, a change we hope to see reflected across the EU.
Biocides are chemicals used to control harmful living organisms. An example of biocides include disinfectants and insect repellents. The GB Biocidal Product Regulations (GB BPR) cover the control of active substances used within these products, which falls under the regulatory body, the Health and Safety Executive. These regulations require that vertebrate testing should only be conducted as a last resort. If all other data sources have been exhausted, new vertebrate tests may be commissioned. It is recommended that the Health and Safety Executive is consulted with any new proposal for tests involving vertebrates.
Not following the correct procedure to conduct a test involving a vertebrate, or conducting a test when data already exists, can result in enforcement action due to a breach of the law. This can range from a fine to criminal prosecution.
Pesticides are chemicals intended to control organisms that are harmful to plants. Pesticide substances are evaluated by the Health and Safety Executive under Regulation (EC) 1107/2009. This regulation, also known as the plant protection product regulation, states that vertebrate animal tests must not be conducted when a validated non-animal method is available. The regulation also states that data from previous tests involving vertebrates should be shared to avoid repeating tests unnecessarily. The HSE defines a validated alternative method as an in vitro method which allows the prediction of animal-based endpoints and for which the Organisation for Economic Co-Operation and Development (OECD) test guidelines have been adopted.
The retained General Food Law Regulation (EC 178/2022), as amended by the General Food Law (Amendment etc) (EU Exit), regulates food to protect human health and consumer interest. This regulation covers food across production, processing, and distribution. These regulations also contain sections that may involve animal testing, including authorisation and registration for food additives, or testing of novel foods.
In England, Wales, and Northern Ireland, the Food Standards Agency is responsible for food safety and hygiene. The Food Standards Agency is a non-ministerial department and is supported by several advisory non-departmental public bodies that provide independent advice. These include:
The Organisation for Economic Co-Operation and Development produces guidelines for the testing of chemicals destined for use in many areas including industrial chemicals, pesticides, food additives, cosmetics, and pharmaceuticals. This is a set of internationally accepted guidelines outlining specific tests for assessing the potential effects of chemicals on human health and the environment. There are around 150 internationally agreed testing methods within them, both in vitro and animal–based. The guidelines are constantly under review so new in vitro tests can be adopted, and redundant animal-based methods can be withdrawn. Whilst many regulatory bodies implement these guidelines, they are not legally binding.
The Medicines Act 1968 is the legislation governing the manufacture and supply of all human and veterinary medicines across the UK. Medicines and medical devices legislation are regulated by the Medicines and Healthcare Products Regulatory Agency. This agency decides what medicines and devices should be granted marketing authorisation in the UK based on the safety, quality, and effectiveness data that is submitted to them under the Human Medicines Regulations 2012. The agency is also responsible for the UK Medical Device Vigilance System, which involves enforcing the legislation around medical devices, namely the Medical Devices Regulations 2002 (a safety regulation under the Consumer Protection Act 1987).
By law, all new drugs in the UK must be tested on two species during preclinical tests: a rodent (usually mice or rats), and a non-rodent (usually dogs, pigs, or non-human primates). This is based on safety guidelines produced by The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use and was implemented by the Medicines and Healthcare Products Regulatory Agency in 1995. The specific guideline that addresses the non-clinical testing requirements for both clinical trials and marketing authorisation applications is ICHM3. Despite animal testing laws being based on these guidelines, the guidelines themselves state ‘Since guidance is not legally binding, an applicant may submit justification for an alternative approach.’ Under circumstances like these in which the law and guidelines are unclear, we believe the regulations should be challenged and the law changed to allow for the reduction and replacement of animal tests. You can read more about this in our policy approach.
Alongside the Medicines and Healthcare Products Regulatory agency is the National Institute for Biological Standards and Control which conducts independent batch testing on all medicines in the UK. Whilst using animals is a legal requirement under the Human Medicines Regulations 2012, the UK batch testing policy, with the right agreements in place with other countries, may avoid using animals. The institute states that they are fully committed to the principles of the 3Rs and investigate potential non-animal methods, as required under the Animals (Scientific Procedures) Act 1986, although some of their work still requires the use of animals.
The Veterinary Medicines Regulations 2013 sets out legal requirements for the manufacture, authorisation, marketing, and distribution of veterinary medicines.
Like the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products fulfils a similar function for veterinary medicines in providing guidance on animal tests.
To manufacture veterinary medicines, manufacturing authorisation must be granted under the Veterinary Medicine Regulations. If the site of manufacture also manufactures human medicines, then the Medicines and Healthcare Products Agency guidance should also be followed.
To conduct clinical trials in animals for veterinary medicines, an animal test certificate must be held. Animal test certificates are issued by the Veterinary Medicines Directorate within the government, which assesses the application submitted for the certificate. There are several types of animal test certificates depending on the purpose of the clinical trial, though each type covers and permits the same things. Types include:
All clinical trials must be conducted in accordance with the guidelines produced by the International Cooperation.
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