A Named Patient Program (NPP) provides patients and physicians access to commercially approved medicines that are not available to them in their own country. These drugs must be approved in at least one country, from which it can be imported into the patient’s country under a NPP.

These may be drugs that are:

  • Approved but not yet commercially available to be prescribed in the patient’s country

  • Approved and available in one country but not approved and available in the patient’s country
  • Discontinued in the patient’s country but not another

  • In shortage in the patient’s country but not another

Please refer to either our Patient and Physicians or Sponsors section below for further information related to your NPP needs.

A Named Patient Program (NPP) provides patients and physicians access to commercially approved medicines that are not available to them in their own country. These drugs must be approved in at least one country, from which it can be imported into the patient’s country under a NPP.

These may be drugs that are:

  • Approved but not yet commercially available to be prescribed in the patient’s country

  • Approved and available in one country but not approved and available in the patient’s country
  • Discontinued in the patient’s country but not another

  • In shortage in the patient’s country but not another

Please refer to either our Patient and Physicians or Sponsors section below for further information related to your NPP needs.

Patients & Physicians

Because drug companies rarely plan to make their products available in every region of the world, patients sometimes find they are unable to access certain approved medicines in their own country. Other times, patients may find that a drug they have been using is discontinued or is in shortage.

In these circumstances, patients may be able access needed drugs from another country through a NPP. To be eligible for a NPP, a patient must have a physician who is willing to prescribe the medicine on their behalf.

WEP Clinical can source products from all regions of the world and deliver them to patients and physicians in need. WEP Clinical handles all the regulatory and logistical processes involved in drug delivery and works with the patient’s physician to ensure appropriate and safe use of the drug.

If you are a patient, and you and your physician wish to gain access to an unavailable medication, please contact us at:

SPONSORS

Sponsors may only be able to focus on specific key markets when seeking approval for their drugs. Often these are well-established markets, like Europe, the US and Japan, as well as other markets which provide large patient populations.

However, sponsors could benefit from allowing access to their products in markets outside of their commercialization plans. This would allow companies to:

  • Deal with unsolicited patient request for drug in an ethical and regulatory controlled manner

  • Provide exposure to, and experience with, company products to physicians in additional countries and build a larger KOL network and future advocates

  • Provide new products to patients who would move to commercial drug when it becomes available in these countries

  • Generate additional revenues

Because there are numerous restrictions and regulations that apply on a country by country basis, providing access to medicine can be a very complex and daunting task. WEP Clinical has many years of experience helping sponsors supply their products in new regions.

If you are a sponsor and want to make your drugs available in countries where they are currently unavailable or not yet approved, please contact us at:

SPONSORS

Sponsors may only be able to focus on specific key markets when seeking approval for their drugs. Often these are well-established markets, like Europe, the US and Japan, as well as other markets which provide large patient populations.

However, sponsors could benefit from allowing access to their products in markets outside of their commercialization plans. This would allow companies to:

  • Deal with unsolicited patient request for drug in an ethical and regulatory controlled manner

  • Provide exposure to, and experience with, company products to physicians in additional countries and build a larger KOL network and future advocates

  • Provide new products to patients who would move to commercial drug when it becomes available in these countries

  • Generate additional revenues

Because there are numerous restrictions and regulations that apply on a country by country basis, providing access to medicine can be a very complex and daunting task. WEP Clinical has many years of experience helping sponsors supply their products in new regions.

If you are a sponsor and want to make your drugs available in countries where they are currently unavailable or not yet approved, please contact us at:

FAQ’S

The difference between these two programs is that an EAP provides access to pre-approval, investigational drugs that are still being studied/tested in clinical trials. A NPP provides access to post-approval drugs that are no longer in clinical trial and are commercially available in one or more country.

Pharmaceutical companies are not required to provide their products through a formal NPP. However, there are several benefits associated with named patient drug supply that may be of interest to companies. See the Sponsors NPP section for more information.

Companies do not have to wait for commercialization to provide their products through a NPP. Following marketing approval (occurs prior to commercialization), companies can use a NPP to continue supplying their drug to clinical trial patients, or any additional patients, before it becomes commercially available to them. This allows companies to begin generating revenue and serves as a cost-effective alternative to an open-label extension study.

Companies can provide drug to patients in any country in which they have not yet received marketing approval. This includes countries in which a company plans to seek marketing approval, as well as those countries in which a company does not plan to seek marketing approval.

To import a drug into a patient’s home country through a NPP, the patient’s physician will have to complete the necessary importation documentation. This documentation will be reviewed by the FDA, or the equivalent regulatory body, when the drug arrives in the patient’s home country. Without this documentation, the drug will not be allowed to pass through customs and will most likely be sent back to the origin country.

WEP Clinical can help provide support in obtaining the right permits and can assist physicians with the completion of the right documentation.

Information can usually be found on manufacturer websites if they have an approved NPP. Additionally, WEP Clinical is always happy to help research potential options on your behalf, and even beginning a dialogue with the manufacturer.

At WEP Clinical, we take product visibility and custody very seriously. Deploying a controlled NPP program can improve a sponsor’s compliance profile which ensures product integrity and avoids diversion. Patients benefit because they have access to authentic and correctly handled products at a price approved by the sponsor.

There are two critical factors to executing exceptional compliance for NPPs which minimizes reputational and legal risks with the aim of a positive patient experience:

1. The distributor is fully compliant and audited to EU, US and World Health Organization (WHO) guidelines for Good Distribution Practices

2. Supply is in compliance with any local country specific regulations

Working alongside our distribution partners, we can provide visibility into a product status throughout its journey “end to end”. Your product will not leave our control at any stage, nor will it enter the hands of any unknown supply chains

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