United states spend more on healthcare services than any other nation in the world. In year 2007, USA spent around 16% of investment per years in healthcare sector, and UK spent something around 8.4% of its GDP. So, healthcare expenditure of United states is almost twice if compared with UK healthcare expenditure.
Private vs public sector
US healthcare sector is the world’s largest private sector system. Similarly, UK healthcare is one of the largest public healthcare systems on the globe.
The US health care system can be considered as a hybrid system. US healthcare is offered by many organisations with different characteristics. In US health care is delivered by the private sector providers almost exclusively. Hospitals are owned by different profit, non-profit and charitable organizations. It is estimated that around 58% of the community hospitals are owned by non-profit organisations, 21% are private companies and remaining 21% are funded by the US government.
Medicare, Medicaid and other insurance programs give access to around 84% of whole US population. The remaining population needs to pay for these medical care services by their own or may depends on other charity care organizations. UK healthcare system has far lesser variation regarding the healthcare outcomes and patient access schemes among its citizens. So, in terms of financial fairness UK healthcare system is ranked higher compared to the US healthcare system.
Responsiveness to the healthcare systems
According to WHO survey, US ranks number one in the responsiveness to its citizen’s healthcare requirements. On the other hand, UK is very less responsive and mostly financially constrained. UK healthcare system is driven by an extremely tightly funded healthcare budgeting system. Funding is mostly raised only for the most essential healthcare services which is based on a explicit cost-effective analysis of the medical care. This leads to a long waiting list for the newly developed and potentially less essential healthcare services and therapies.
Difference in the drug approval system
The drug approval process of the U.S. and EU don’t resemble. Most of the regulatory steps adopted are similar but still have a huge difference regarding the overall process, approval time, and costs.
FDA drug approval process is more costly and time-consuming. In spite of that, it is more risk-averse and less robust.
Let’s talk about the drug approval process of US and UK
The key steps involved in drug or medical device in the U.S. and EU are as follows:
IND application
Clinical investigation needs approval for starting all planned clinical trials. The application named as Investigational New Drug, is filled to the relevant regulatory authorities.
1. Application submission process in the U.S. compared to EU
Drug investigators across all states in the U.S. fill an application in FDA for the drugs under investigation.
U.S. has a single regulatory body across all states whereas EU countries designate their own regulatory bodies assisting approval for new clinical trials. Drug investigators can apply in one or more countries.
2. Clinical trial phases
U.S. and EU both share the same regulatory requirements for clinical data evaluation. Clinical trials are completed in mainly three phases including one additional pilot trial (known as Phase 0).
Data evaluation from different phases are mentioned below:
A. Phase 0 and Phase I
These are performed to generate data regarding pharmacology and dose rage of the drug under clinical investigation. It includes very small numbers of healthy persons with the exception of some specific indications where people with the disease are enrolled. For example- cancer and AIDS.
B. Phase II
It is performed to get a dose-response relationship of the interventional drugs. This phase may require data from several hundreds of the participants. Dose-response is observed in terms of safety and efficacy.
C. Phase III
This phase is considered as pivotal (with few exceptions) to generate safety and efficacy data with strong statistical significance. Participants involved are several hundreds to thousands, so that power of studies can show high statistical significance.
3. Orphan drugs application
Orphan drug designation is a special approval of a drug showing promising treatment effects for the rare diseases. If a disease affects lesser than 200,000 people in the U.S. and ≤1/50,000 in the EU, it is considered a rare disease.
4. Emergency drug application (EIND) process
An emergency drug application is filed for the life-threatening situations where treatment can be started just after EIND approval. In spite of EIND application approval, the conventional IND application process is required and must be initiated parallelly.
In U.S. treatment can be just after approval of EIND but in EU drug must be already under clinical trial investigation.
5. Pathway to drug approval
In U.S. all drug approval is done by a single regulatory body named as FDA.
If we understand drug approval in various EU countries, there is no single regulatory body. However, EU countries follow a centralized process where all drugs get its approval from ultimately a single regulatory body called as EMA.
The application for drug approval can be submitted to the single state regulatory body or in multiple states via EMA. The possible ways are as follows:
i) Application to a single state: The application is submitted in a single state and approval in the same.
ii) Application for mutual recognition: if a drug gets approval in a single state it can fill application for mutual understanding with the other EU countries.
iii) Decentralized approach of approval: The investigators can fill simultaneous applications to all EU states.