NHS: the UK Healthcare System
While the UK healthcare system has both a private and a public component, only 11% of the population has private health insurance and most policies have upper spending limits or only cover specific medical conditions.
Which makes the public sector by far the most important. The organization managing the provision of public healthcare is called the National Healthcare System (the NHS) and is financed through taxation. Services are provided free of charge at the point of delivery. Dental services and prescription drugs are charged to the patient.
Some, including the US based Commonwealth Fund rated the NHS as the best healthcare system in the world: https://interactives.commonwealthfund.org/2017/july/mirror-mirror/
Regional NHS systems
The NHS consists of four separate Regional Systems: NHS England, NHS Scotland, NHS Wales and HSC Northern Ireland.
Each system can make certain decisions. I’ll take NHS England to illustrate how the system works and provide a hint of the underlying structure of the organization.
Patients who need care visit a General Practitioner or primary care physician.
All GP’s in a specific region are members of a regional “Clinical Commissioning Group” (CCG). There exist 207 CCG’s within This particular Regional System. The regional Clinical Commissioning Group decides what organizations will provide secondary care to the patients in the region. The secondary care organizations are organized as Trusts.
When a GP sees a patient and decides on next steps if needed, the primary physician will forward the patient for further care to one of the secondary-care providers, one of the Trusts. There are 470 such trusts in this Regional System.
Healthcare expenditures
Healthcare expenditure in 2017 was $249 billion. The public sector is accountable for around 80% of the total and serves 84% of the population.
Amazing to know is that in 2017, public healthcare expenditures grew by only 0.3%, despite serving an ever-aging population with growing medical needs. Obviously, for the NHS cost control is a major priority.
Medical Device companies should not be surprised to learn that financial pressures influence purchasing decisions by healthcare providers.
NICE: the UK’s Health Technology Assessment body
While each of the country’s four NHS systems decides how money will be spend, they are assisted on the National Level by a process of Health Technology Assessment. The HTA body determines the value of your technology to the local healthcare system. Based on cost and benefits to the healthcare system, the individual patient and national health.
You may think that because your technology has added value within the US, and because CMS or one or another insurance company has accepted your technology and has issued reimbursement for it, that you will receive similar positive reimbursement decision in another country. That may or may not be the case.
The National Institute for Health and Clinical Excellence (NICE) is one of the key national HTA organizations for England, Wales and Northern Ireland. A separate organization performs the health technology assessment for Scotland (Scottish Health Technologies Group).
In that role, NICE evaluates medical technologies.
There are three possible scenarios:
- Your product is me too: it can be added to an existing NHS Supply chain framework as a range extension, you do so directly with NHS Supply Chain.
- Your product is me too, with added benefits: it is recommended that you submit your product to NICE for evaluation. If the additional benefits justify making the technology available, NHS Supply Chain will add it to the existing framework.
- If the product does not fit within an existing framework (e.g. a first of its kind): then you must submit your product for evaluation. If the technology offers additional benefit and is in the scope of NHS Supply Chain, NHS Supply Chain will provide a fast track route to market for your technology.
MHRA: The UK Regulatory body for Medical Devices
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring that medical devices work and are acceptably safe. because the UK up till recently was part of the EU, the EU MDD, AIMD and IVDD directives had been implemented in UK law. After the issues encountered in the late 2000’s, the EU Commision set out to replace these directives withe the Medical Device Regulations (MDR).
MHRA has been very instrumental in developing the new EU MDR. As a result, even though the UK is now going its separate way from Europe, the regulatory environment in the UK is not expected to deviate much from the one in Europe. That is of course if MHRA has anything to say about it.
UK Market Potential
There are several ways to learn more about the potential for your product in the UK market. One of which is to find out what products are currently used and what prices your competitors are able to charge.
GB5D can help you explore whether or not the UK market is worth entering.
BTW: Did you know that the British consider the NHS, the UK Healthcare System, a British Icon on par with the Monarchy?