American vs. European Medical Regulatory Systems Report

Introduction

Every year millions of patients flock in the American and the European healthcare facilities to seek for healthcare services. Both Europe and the US have their distinct regulations that govern the sale and use of drugs and medical devices. In the US, the Food and Drug Administration (FDA) is the body responsible for approving both the medicines and the medical devices (Basu and Hassenplug 485).

In Europe, medical device approval is the mandate of the Competent Authorities and the Notified bodies while drugs are approved by other agencies that will be discussed in this paper. There have been claims that the US regulatory system is slow, inefficient and expensive compared to that of Europe. Skeptics of the US system cite the fact that European patients get access to high-risk devices before their US counterparts.

For example, the American medical device regulatory system emphasizes efficiency checks while the European system only requires proof that the device is performing as expected. The strict procedures under the US system cause delays in approval denying patients access to certain high-risk devices in time. This paper shall compare and contrast the two countries’ regulatory systems in light of the drugs and medical devices approval.

Approval of medical devices

Similarities

One of the notable similarities between the two systems is that they are both designed to stimulate innovation. The European regulatory systems were established to encourage innovation to improve the quality of services in the European healthcare facilities (Curfman and Redberg 975).

The US system also encourages innovation by allowing the efficient devices into the healthcare market. Under the US system, efficiency checks are done to verify that the developed device improves patients’ outcome. The mentioned approach ensures that device manufacturers remain innovative to introduce improved contrivances for ease of approval.

The second similarity between the two systems is that they are both designed in such a way that they protect the patients from harm. Before the introduction of a new device for patient use, it has to be screened to ensure that patients’ safety is guaranteed. In Europe, the Competent Authorities handle safety checks processes before a device can be approved by the Notified Bodies (Kashyap, Gupta, and Raghunandan 123).

The FDA conducts safety checks in the US, and a machine is only approved if it satisfies the safety requirements. Under both systems, manufacturers are required to report any adverse results to mitigate the risks accruing to patients after treatment using such devices. The obligation is illustrative of the commitment by the duo systems to patients’ safety while at the same time allowing innovation.

The third similarity evident under the two systems is that the safety procedures increases with the risks involved. Manufacturers of low-risk devices (class 1) are only required to declare that the machine meets the set standards. The case is different for the high-risk devices that require more elaborate safety checks before approval. In the US, the high-risk devices are subject to strict clinical and safety trials before approval.

The approval process for the high-risk devices may take up to a year. Just like in the US, in Europe, the low-risk devices are approved upon declaration of conformity with the set standards by the manufacturers. However, the high-risk devices are subjected to more elaborate safety checks before their approval.

Differences

Centralization

In the US, the FDA is the sole approval body of all the medical devices before their introduction into the market. The FDA conducts both the safety and the efficiency checks before approving a certain device. In Europe, the approval process is a bit decentralized with the Competent Authorities having the mandate of conducting safety checks while the Notified Bodies handle the device approval procedures.

Data requirements

Manufacturers of medical devices in the US have to file a detailed report regarding both the safety and efficiency of the machine to the FDA. The FDA conducts both checks contemporaneously, and only machines that prove to be both safe and efficient are approved (Curfman and Redberg 977).

In Europe, the case is dissimilar since efficiency is not a requirement for approval of a medical device. Under the European system, only the safety checks are necessary for approval. The few approval requirements in Europe ensure that patients access high-risk devices promptly than in the US.

Access

The approval process of devices in the US is long and involves clinical trials to verify the efficiency of a machine. The clinical trials consume much time leading to delays in the introduction of the device to the market. The trials are stricter for high-risk devices such as heart surgical devices (Basu and Hassenplug 487).

In Europe, the approval process is not long and only involves the safety checks hence the devices reach the market in time. Statistics indicates that the European patients have wide access to high-risk machines than their US counterparts. The difference is attributable to the absence of clinical trials in the European system.

Transparency

The US legislations obligate the FDA to make full disclosure of the material facts that influence their decision to approve or disapprove a device. Information about the decision, as well as the evidence presented by the sponsors of the device, is readily accessible upon request by an interested party.

Besides, information regarding the approval criteria is available to manufacturers. The European legislations do not compel the Notified Bodies to give any information relating to the decision process. The ruling of the notified bodies is final, and thus it cannot be challenged due to the lack of such information.

Funding

The funding of the regulatory bodies is different in both the US and Europe. In the US, 80% of the approval funds come from the government, and only 20% is obtained from the manufacturers as approval fees (Kramer, Xu, and Kesselheim 850). This aspect ensures that the bodies remain independent, and the manufacturers cannot compromise the work.

However, the FDA at times suffers from the inadequacy of funds due to overreliance on government funding. In Europe, the regulatory bodies are funded by the manufacturers through the approval fees charged. This form of funding creates a client-customer relationship and may compromise the working of the boards leading to the approval of unsafe devices.

Approval of drugs

Similarities

Both the European and the US drug regulations are designed to ensure that only the safe drugs penetrate the market. The duo regulatory systems emphasize on the safety of patients as opposed to the existence of a variety of medicine in the market. Research indicates that the US and Europe have the most stringent safety check measures for approving drugs (Roberts, Allen, and Sigal 1378).

In the US, new drugs are subject to clinical trials and the approval process may take up to 18 months. In Europe, the average approval time is 12 months with numerous clinical trials conducted during the period to guarantee patients’ safety. In light of the elaborate approval procedures mentioned above, it is clear that the regulations are geared towards ensuring that the safety of patients is not compromised.

Another similarity worth mentioning is that the approval procedures for a particular drug, in both countries, mainly depend on the type of the drug. For drugs with similar characteristics, as the ones already in the market, less clinical trials are required. However, for new medicines, elaborate clinical trials are necessary to ascertain that the drug meets the safety criteria in place. Besides, the regulations are stricter for drugs meant for the treatment of acute illnesses such as cancer and diabetes.

Differences

Strictness

Much as the two countries share some similarities regarding the approval procedures, the US approval system is stricter than that of Europe. In the US, Every new drug must pass through the following five steps:

1. Pre-clinical Testing
2. The IND Application and FDA Review of the IND
3. Clinical Trials
4. The New Drug Application
5. The NDA Review Process

Each of the five steps involves serious screening to establish the safety and effectiveness of the drug (Stafford 1428). The European system is also strict but not as that of the US.

Centralization

In the US, the mandate of approving drugs lies with the FDA, which oversees the approval of all the drugs produced in the country. The FDA reviews and processes all the applications made by the drug manufacturers before approval. In Europe, the process of drug approval is somehow decentralized with various agencies having the mandate of conducting the approval procedures (Roberts, Allen, and Sigal 1380). The following agencies handle drug approval in Europe:

1. The European Medicines Evaluation Agency (EMEA)
2. Committee for Proprietary Medicinal Products (CPMP)
3. National Health Agencies
4. Registration process

In the US, drug manufacturers are only required to make a single application to the FDA requesting approval of their product. Once the approval certificate is granted, the manufacturer can introduce the drug to the American market without further registration requirements. In Europe, an approval given by a certain member state may not be valid in other member states (Kashyap, Gupta, and Raghunandan 107). Manufacturers are required to register with both the individual state agencies as well as with the regional agencies.

Conclusion

Drug and medical devices regulatory agencies have one thing in common, viz. they all seek to guarantee patients of their safety. The US and the European legislations share much in common ranging from the object to the safety procedures involved. However, there are sharp differences between the regulatory systems in the two countries regarding the approval procedures involved. Whereas the US requires that all the medical devices be screened for both safety and efficiency, Europe does not conduct efficiency checks.

Moreover, the US’s system of drug approval is far much stricter than that of Europe in that it involves serious scrutiny to ensure that the drugs are safe before their introduction into the market. Another notable difference in the two systems lies with the bodies responsible for overseeing the approval process. The US has a more centralized form of approval with the FDA being the sole approval body. On the other hand, Europe has several agencies that oversee the approval process for both the drugs and the medical devices.

Works Cited

Basu, Saptarshi, and John Hassenplug. “Patient access to medical devices—a comparison of US and European review processes.” New England Journal of Medicine 367.6 (2012): 485-488. Print.

Curfman, Gregory, and Rita Redberg. “Medical devices—balancing regulation and innovation.” New England Journal of Medicine 365.11 (2011): 975-977. Print.

Kashyap, Nitin, Vishal Gupta, and Vashti Raghunandan. “Comparison of Drug Approval Process in United States & Europe.” Journal of Pharmaceutical Sciences and Research 5.6 (2013): 107-164. Print.

Kramer, Daniel, Shuai Xu, and Aaron Kesselheim. “Regulation of medical devices in the United States and European Union.” New England Journal of Medicine 366.9 (2012): 848-855. Print.

Roberts, Samantha, Jeff Allen, and Ellen Sigal. “Despite criticism of the FDA review process, new cancer drugs reach patients sooner in the United States than in Europe.” Health Affairs 30.7 (2011): 1375-1381. Print.

Stafford, Randall. “Regulating off-label drug use—rethinking the role of the FDA.” New England Journal of Medicine 358.14 (2008): 1427-1429. Print.