How to Access New Medication – Legal Status and Practical Considerations (2022)


Every year, hundreds of thousands of patients around the world die because of suboptimal medical management. While some of these diseases genuinely have a high risk of mortality, many others can be treated with the right medications.


Unfortunately, many countries have strict and long approval processes to allow the use of a new drug. In some cases, these processes are controlled by bureaucratic and lobbying factors.


To solve this issue, named patient access was invented. It is a way to offer patients medications that may not be approved in their home country but have approval elsewhere.In this article, we will cover everything related to named patient access, including how it helps patients and the challenges it faces.




What is named patient access?

Each country in the world has an organization that regulates the approval, distribution, and commercialization of medications. In the United States, the Food and Drug Administration (FDA) is the responsible organization. In the United Kingdom, this role goes to the Medicines and Healthcare products Regulatory Agency (MHRA). Without approval by these organizations, the drug cannot get prescribed by physicians in that country. However, many people consider this process to be more administrative than medical. This stems from the fact the FDA is one of the best regulatory organizations in the world. Therefore, if the FDA approves a specific drug but the responsible entity in your country doesn’t approve it, does this mean that the drug is not safe?


In reality, every person on earth can confidently follow the regulations of the FDA without fear. Fortunately, you can do this legally thanks to something called “named patient access.”Named patient access allows physicians to prescribe certain medications because the patient has a special need.


Some of the reasons that meet the criteria of named patient access are:

· Drug shortages

· Temporary supply problems

· Special needs of an individual patient

· A license for the drug is not yet granted. This is due to ongoing clinical trials


Is named patient access legal?


Named patient access allows doctors and patients to use commercially approved medicines that are not available in the patient’s country. Thanks to this process, the medication can be imported on a per-case basis.


It should meet the following conditions:

· Approved but not commercially available in the patient’s country

· Approved in one country but not approved in the patient’s country

· Discontinued in the patient’s country

· In shortage in the patient’s country

This process is completely legal and most countries accept drug importation for special or urgent needs. In reality, we see the use of the drugs primarily in the case of critical conditions such as cancer and rare disease. Access to biological drugs approved in the US but absent in many countries can be life-saving for many struggling patients.If you need a specific medication from the United States and need more information about the Named Patient procedure, do not hesitate to contact us via the contact form below.


How does named patient access save patients


Patients with debilitating diseases need access to certain medications. This is especially true for cancer and rare disorders. While visiting a doctor in the US and getting treated remains the optimal choice, this is not viable for everyone. Learn more about the process of getting treated virtually or on-site in the US by clicking here.


For instance, patients with cystic fibrosis (CF) often suffer in their home country due to the shortage or complete absence of CF medications. One drug that meets the criteria of named patient access is Trixacar. It is a medication that treats CF with at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Without this medication, the risks of pulmonary infection and death become substantial.


Fyaro (sirolimus protein-bound particles) is another medication that meets the conditions of named patient access. It is a drug used to treat advanced cases of malignant perivascular epithelioid cell tumors. This cancer has a poor outcome, and this drug can help with that. We can give many other examples, especially in the oncology department but you get the gist of it.




What are the challenges that face named patient access?


Pandemic focused healthcare

COVID led most healthcare systems in the world to focus on this pandemic. As a result, medical practices were forced to limit the presence of patients, which severely damaged their profitability.The additional regulations in the field limited elective procedures and appointments, preventing patients from speaking to a doctor from the US and getting drugs that fall into the category of named patient access.


Delay in implementation of e-PA

Prior authorizations comprise a big challenge for patients to get treated. In 2020, the Trump administration launched a rule that streamlines communications for healthcare providers and payers. By requiring payers to use digital interfaces for data exchange and PA status, providers will learn whether a drug requires PA before prescription.Unfortunately, the Biden administration implemented a regulatory freeze to review all enacted policies. Therefore, the implementation of electronic prior authorization (PA) may get delayed.


How do we overcome these challenges


We partnered with the most successful doctors and prestigious hospitals in the country to give international patients the care they deserve. There are several challenges that face named patient access around the world. However, Medebound HEALTH can guide you through every step of the process. We will help you through the process of named patient access to provide the life-saving medication that you need.


Takeaway message


Named patient access is a legal way to overcome obstacles standing between patients and life-saving medications. This process allows people from all over the world to receive medicines approved outside the patient’s home country.

We hope that this article helped you understand the ins and outs of named patient access, including the challenges it currently faces.


If you have any questions or concerns about today’s topic, our comment section is open for discussion. You can also contact us via the contact form below for a private conversation.


Medebound HEALTH is an international healthcare company that is incorporated and headquartered in New York. It is dedicated to assisting patients across the globe with frustrating and devastating conditions, to gain easy access to top medical experts and advanced treatment methods in the US. Having signed up 1000+ specialists mainly affiliated to the Top 20 US hospitals, Medebound HEALTH has contracted with the world’s largest insurance firms, global Fortune 500 companies. Its services have covered worldwide members touching millions of lives, and bringing new hope to patients who would otherwise have limited options in their local countries. For more information visit us at https://www.medeboundHEALTH.com

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