Phage therapy in the US and EU – Compassionate Use
Phage therapy has been open to patients at the Eliava Institute in Georgia since the 1920s, and in Poland since 2005 (accepting patients that meet their criteria). Other countries such as Russia and Ukraine allow the open use of phage therapy, but do not have specific phage centers. Any patient can have a sensitivity test performed in a microbiological laboratory. The results of this test will indicate which phage products, that are available in the open market, should be used against their condition.
In the US and EU, phage therapy is considered to be experimental. Treatments are only given to patients that qualify for compassionate use. Compassion use is also known as an expanded access programme, name patient programme or patient named product. The terminology differs but the terms point towards a treatment of an unauthorized treatment, or an experimental product or products in development that are unauthorised. The main factor for compassionate use is for patients who have tried all other methods of treatments, which have failed, leaving phage therapy as a last resort.
Phage therapy in the US
Phage therapy in the US is currently seen as experimental and treatment with bacteriophages is allowed if a patient meets the criteria for compassionate use.
Criteria for compassionate use or expanded access treatment in the US:
- Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition.
- There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
- Patient enrollment in a clinical trial is not possible.
- Potential patient benefit justifies the potential risks of treatment.
- Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
You can find out more information on compassionate use in the US here.
Regulations on the use of phage therapy for compassionate use in the US
FDA - Emergency Investigational New Drug (EIND) Applications for Antiviral Products
Phage therapy in the US – San Diego, California
IPATH - The Center for Innovative Phage Applications and Therapeutics at UC San Diego, California opened in 2018. To find out if you are eligible for phage therapy, you can view the center’s FAQs here.
Phage therapy in the EU
In Europe, regulations for unauthorized medication for compassionate use therapies and are set individually by every Member State. Compassionate use programs are implemented and coordinated by every individual Member State, which sets its own rules, conditions and procedures to meet the national legislation. These programmes are only put in place if the medicine is expected to help patients with life-threatening, long-lasting or seriously debilitating illnesses, which cannot be treated satisfactorily with any currently authorised medicine.
Doctors who would wish to receive medication under the compassion use for their patient, can contact the appropriate national authority in their country. The European Medicines Agency (EMA) provides all European Member States with recommendations, through the Committee for Medicinal Products for Human Use (CHMP). Such recommendations can be submitted by the Committee at the request of one Member State. The EMA does not create a legal framework, but provides recommendations on how to administer, distribute and use the medication for compassionate use.
You can find out more information on compassionate use in the EU here.
Regulations on the use of phage therapy for compassionate use in the EU
WMA declaration of Helsinki – Ethical Principles for Medical Research involving human subjects
Phage therapy in the EU – Brussels, Belgium
The Queen Astrid Military Hospital in Brussels, Belgium makes use of phage therapy and is open to receiving requests from patients. There are certain requirements by which patients may be eligible to receive phage therapy. In order to check if you qualify for phage therapy in Belgium, you can send an email to pt@mil.be.Should you know of any centers or institutes, not mentioned above, that provide phage therapy to patients, feel free to contact us directly by sending an email to contact@bacteriophage.news.
Posted from my blog: https://www.bacteriophage.news/phage-therapy-in-the-us-eu-compassionate-use/