A simple definition of regulations for IVF units are ‘rules that are mandatory because they can be enforced by law’.
Broadly speaking, the purpose of any regulation is to:
- Create limits: what can be done and more importantly what can’t be done
- Constrain/define rights: the rights of patients
- Create duties: the duty of care
- Allocate responsibilities: who is qualified to do what.
In many countries the practice of Assisted Reproductive Technology (ART) in a clinic setting is controlled by acts of government. In the UK, ART is governed by the Human Fertilisation and Embryology Act 2008. This Act of Parliament established the Human Fertilisation and Embryology Authority (HFEA). They publish a Code of Practice1 and inspect IVF clinics to ensure that they are compliant with the code.
In some areas of the world the link between the law and regulations is less obvious. However, generally speaking, government administrations within a country will recognise a body specifically tasked with accrediting ART facilities. They make sure that they adhere to some form of recognized code. In Australia the equivalent of the UK’s HFEA is the Reproductive Technology Accreditation Committee.
Self-regulation can also run alongside legal regulation through trade associations and national or regional medical councils. Staff may be members of healthcare professional organisations such as the UK’s British Medical Association and Royal College of Nursing. Often, law requires health care professionals to register with recognised professional bodies in order to practice.
Regulations should not be confused with guidelines. Guidelines are not mandatory, but they can when the law is lacking substitute for regulations.
The range of the regulatory field
In general, there are two categories of regulation, which are applicable to the field of IVF:
- Regulations pertaining specifically to ART, which are linked to national laws: These might be fairly general, or extremely detailed such as the New Zealand Fertility Standard NZS81812
- Regulations that are not specific to ART but still apply to running an IVF unit: the requirement that health care professionals are registered with appropriate professional bodies. This category also includes all the regulations pertaining to occupational health, building safety and fire regulations
- Regulations pertaining to statutory laws and rights regarding transactions: these relate to things like contractual obligations between paying customers and organisations providing the paid-for services. These apply as much to the provision of ART services as to the provision of any goods including second-hand cars and televisions! These can have important real-world consequences in their practical application. In New Zealand it means that IVF clinics cannot discriminate against customers. This means they cannot put a limit on the upper age of a potential patient in terms of access to treatment. In other locations, it means IVF clinics cannot discriminate against potential customers in terms of marital status of sexual orientation.
Hints and Tips – using non-ART regulations to manage risk
Make a list of non-ART regulations, standards and regulations in your country that apply to your IVF clinic. These can be allocated in categories:
- Medical safety: infection control, medicines regulations, medical device procedures and safety protocols, management of healthcare waste
- Patients: international/national legislation (e.g. Human Rights Act in specific country location), data and privacy, consumer protections
- Staff/Team: employment relations, occupational health, injury prevention
- Organisation: risk management, business continuity plan, resource management.
ART regulation – the what and the how
In terms of ART regulation, most authorities agree on the categories, topics and issues. These will include:
- required competencies of staff
- patient information
- patient counselling
- safe handling of gametes and embryos
- storage
- patient and sample identification
- informed consent procedures.
This is the ‘what’ of the regulations.
However, the level of detail the various authorities provide in ‘how’ to adhere to the regulations differs.
For instance, the UK’s HFEA is very detailed in describing what to do and how to do it. It is about 230 pages long! Whereas the Australian RTAC Code of Practice describes what has to be achieved but lacks detail on how to do this. Consequently, it is only 24 pages long.
There are pros and cons to both approaches. The main criticism of the more detailed approach is it that it limits flexibility. It also puts too much of a premium on the means rather than the end.
The limitations of regulations
The main limit of regulations is that they don’t provide solutions to the problems that clinics encounter. It’s challenging for clinics to deliver their service within the regulations! Regulations seldom address how to react to unusual events.
Regulations are not in place to ensure the success of ART clinics. They mainly exist to protect society from bad behaviour, incompetence and bad practice. Adherence to regulations is also not necessarily a measure of quality. For instance, regulations might insist that IVF Clinics have a Quality Management System (QMS) in place. But the regulations may only be marginal in stipulating the quality parameters of the required QMS.
It is best to think of the ART regulations as being a little like the Highway Code. Yes, there are rules to be observed in any car journey, but there are always more ways than one to get from A to B! The Highway Code does not guarantee that you won’t have an accident or that all drivers and cars of the same quality!
The regulations on their own are a good thing, and adherence to them will make accidental failure less likely. But they have to be applied together with good governance, and risk mitigation via an effective Quality Management System. This minimises risk and helps pave the way to success.
Neil Madden, Editor
The Fertility Hub
References
- Human Fertilisation and Embryology Authority. 2015. Code of Practice. http://www.hfea.gov.uk
- Fertility Services Standard Handbook. 2007. NZS 8181: 2007. Wellington, New Zealand. 2007.
