The commercially approved medicines which are not available in-home country can be accessible by approaching a Named Patient Program (NPP). But NPP is applied only when the medicine is approved in at least one country so that the ordered medicine can be imported from that country to the patient’s country under the NPP.
Following are the circumstances which are responsible for the unavailability of medication in the home country:
- The medicine is approved but commercially not available in the patient’s country.
- Approved and commercially available in another country, but not yet approved and available in the patient’s home country.
- The patient’s home country discontinued the medication, but that not applicable to other countries
- The stock shortage of the particular medicine in the patient’s home country, but not in another country.
In general, pharmaceutical companies do not plan to make their product available for every country. The stringent regulatory approval process varies from country to country to make the product accessible to those countries. But that does not mean a physician will not prescribe the medication to their patient if he/she found that the particular medicine can treat, cure, or improve the quality of life of his or her patient. In such circumstances, patients are facing difficulty to get the prescribed medication in their home country. In other instances, patients do not obtain the prescribed medication due to a shortage of stock or discontinue the medication useability in their home country.
In such a condition, the application of Name Patient Program allows to access the required medicine by importing the medicine from another country. But for NPP application, proper prescription order made by an eligible physician is foremost important.
Clinical organizations with NPP have the authority to arrange such required medication for the patient by importing from another country where the medication is approved and available. Such organizations manage all the regulatory compliance and conduct logistical processing to deliver the medication to the patient. Moreover, they are also taking care of the safe use of the medication by taking assurance from the prescribed physician and patient. Therefore, patients need to apply for NPP to get unavailable medications in their home country. A clinical organization with NPP can source special medication from all around the globe and deliver the medication to the patient under the physician’s recommendations.
The target markets for the sponsors are the US, Europe, and Japan, or markets where larger demand arises due to a large number of patient populations. They primarily focus to get approval for the invented medications in such regions.
The sponsor can also get benefits through NPP application as they got the scope to expand their product availability apart from their commercialization plans. This will increase the scope of expanding the product market, as increase demand can help to commercialize the product in more regions. This will generate additional revenue. This can be beneficial for patients and physicians also as they readily get the prescribed medication in their own country in the future. Accessing the medication by applying NPP makes it ethical as the processing is conducted under a stringent regulatory controlled manner.
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