Last update: 7 March 2016
What is health?
‘Health’ can mean different things to different people. As the idea of ‘population health’ has become more influential over the last decade, ‘health’ no longer refers merely to the sum of the health of individuals.
The World Health Organisation’s (WHO) definition of health is among the more comprehensive definitions and is widely known, if not always accepted. According to WHO, health is:
‘A state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity.’1
This definition is attractive, because it does not define health as an absence of disease or through negative references. It is important to remember, however, that not all healthcare systems agree with this definition.
Health system decision makers generally measure health and the performance of health systems in terms of goodness and fairness:2
- Goodness means a health system responding well to what people expect of it
- Fairness means it responds equally well to everyone, without discrimination
What are health systems?
Health systems differ between countries and sometimes between regions within countries. Health systems seek to deliver high-quality health services to their members (or population). Some health systems:
- provide hospital services only
- provide community and primary care
- are responsible for prevention of disease and promotion of health.
Most health systems have responsibility for all of these.
In virtually every health system in the world, governments play a key role. However, the role of different governments are not all the same. In some cases, for instance, the government’s role is only to create the legal rules that govern the system which is provided by independent bodies. In other cases, governments may fund the health system and organise the delivery of health services.
Funding structures for health systems differ substantially. For instance, some systems are funded through taxes, while others are insurance-based schemes. Co-payments by the individuals may or may not be included.
While it is common to speak of public, private, and mixed systems, these descriptions may be misleadingly simple. For instance, a publicly-financed system (paid for by the public through taxes or social insurance such as in the UK) may in fact rely on non-public entities (such as for-profit or not-for-profit institutions and providers funded by investors or charitable donations) to deliver services.
What is a health technology?
Technology can be defined as the application of a branch of knowledge for practical purposes. Health technology can therefore be defined as any ‘intervention that may be used to promote health, prevent, diagnose or treat disease, or for rehabilitation or long-term care. This includes pharmaceuticals, devices, procedures, and organisational systems used in health care.’3
The term ‘health technology’, therefore, can be used to refer to many different interventions in a healthcare system. Examples include:
- Programmes to prevent ill-health (for example, childhood vaccination programmes)
- Procedures (such as surgery)
- Medicines
- Devices (equipment or machinery that deliver healthcare interventions or assist with activities of daily living, such as an insulin pump or an epinephrine auto-injector)
What is Health Technology Assessment (HTA)?
Health Technology Assessment (HTA) is a form of policy research that examines the short- and long-term consequences of using a health technology. It is a multidisciplinary process that attempts to summarise information about the medical, social, economic, and ethical issues related to the use of a health technology. It aims to do this in a systematic, transparent, unbiased, robust manner. The purpose of HTA is to aid decision-making by providing information about the impact of those decisions.
HTA is used by many health systems across the world, and its use is becoming more widespread. However, HTA may be defined in different ways in different systems, sometimes broadly and sometimes more narrowly.
The European Union Network of Health Technology Assessment organisations (EUnetHTA) has defined health technology assessment as:
‘…a multidisciplinary process that summarises information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner. Its aim is to inform the formulation of safe, effective health policies that are patient-focused and seek to achieve best value.’4
Despite its policy goals, HTA must always be firmly rooted in research and the scientific method.
Generally speaking, HTA aims to inform decisions made in health systems about which health technologies are of most value and should be invested in. This determination of value is complex and must take policy and social context into account.
What is the difference between HTA and regulatory affairs?
Some may question why HTA bodies are needed, given the existence of regulatory agencies that approve medicinal products for sale (issue Marketing Authorisations), monitor their (safe) use (pharmacovigilance), and take appropriate measures. However, regulatory agencies and HTA bodies have different mandates.
Typically, regulatory authorities base their authorisation decisions on the objective scientific criteria of quality, safety and efficacy of the medicinal product concerned, to the exclusion of economic and other considerations.5 Clinical data that form the basis for the decision about marketing authorisation, in most cases, originate from randomised controlled clinical trials where the medicinal product is tested against a placebo or comparator under tightly controlled conditions.
HTA bodies, on the other hand, concentrate on evidence regarding clinical effectiveness, safety, cost-effectiveness and, when broadly applied, include consideration of the social, ethical, and legal aspects of the use of health technologies. A major use of health technology assessment is informing reimbursement and coverage decisions, in which case HTAs should include benefit-harm assessment and economic evaluation. Such assessment is required because while patients should be able to access effective treatment and care, resources may be limited and must be allocated appropriately.
These decisions should be made in light of public values and those of the patients served by the health system.
Further Resources
- International Network of Agencies for Health Technology Assessment (INAHTA): http://www.inahta.org/
- European Network for Health Technology Assessment (EUnetHTA): http://www.eunethta.eu/
- Health Equality Europe (2008). Understanding Health Technology Assessment. Retrieved 4 July, from https://htai.org/wp-content/uploads/2018/02/PCISG-Resource-HEE_ENGLISH_PatientGuidetoHTA_Jun14.pdf
Attachments
- Fact Sheet: Examining the differences between regulatory and Health Technology Assessment (HTA) decision-making
Size: 105,196 bytes, Format: .docx
This fact sheet compares Regulatory Approval with HTA
References
- World Health Organisation (2016). ‘Constitution of WHO: principles’. Retrieved 4 July 2021, from https://www.who.int/governance/eb/who_constitution_en.pdf
- World Health Organisation (2000). The World Health Report 2000. Health Systems: Improving Performance. Geneva: World Health Organisation. Retrieved 11 February, 2016, from https://www.who.int/whr/2000/en/whr00_en.pdf
- INAHTA (2016). ‘What is Health Technology Assessment (HTA)?’ Retrieved 11 February, 2016, from http://www.inahta.org/
- ‘What is Health Technology Assessment (HTA)?’ Common Questions. Retrieved 8 August, 2021, from https://www.eunethta.eu/about-eunethta/
- European Commission (2004). ‘Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.’ Retrieved 11 February, 2016, from http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32004R0726
A2-6.01.1-v1.1
- Fact Sheet: Examining the differences between regulatory and Health Technology Assessment (HTA) decision-making