Recent News 35 : Following a public petition, Infarmed approves the use of phage therapy in Portugal

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Following a public petition, Infarmed approves the use of phage therapy in Portugal

It is the third European country to give the green light to this treatment for antibiotic-resistant infections.


On Saturday, November 23, the National Medicines Authority (Infarmed) approved the use of phage therapy. Portugal thus becomes the third European country, after Belgium and France, to define rules for the use of bacteriophages to treat antibiotic-resistant infections. 

The approval follows a petition created on August 2, 2023, which was signed by more than eight thousand people, enough to bring the proposal to the Assembly of the Republic for discussion. The petition called for the implementation of the Belgian model of phage therapy, given that Portugal has one of the highest prevalence rates of antibiotic-resistant infections in Europe.

The problem isn't new and has been worsening, hence the focus on alternatives such as phage therapy. This involves the use of bacteriophages, also known as phages—viruses that infect only bacteria. Phages attack specific bacterial agents without causing other damage to the body, resulting in fewer side effects than antibiotics. 

Following approval, Infarmed organized a webinar on Monday, November 25th, to mark Bacteriophage Day and to clarify any questions on the topic. "Recognizing the importance of creating a regulatory environment for the use of phage therapy, Infarmed approved the guideline on the use of compounded medicines for phage therapy in hospital settings—master preparations of bacteriophages—which authorizes them to be used in hospital settings for the treatment of individual patients under a single preparation and dispensed in pharmacies as a master formula," Infarmed reported on its website.

Recently, NiT reported the case of Eda Alves, a Portuguese woman suffering from cystic fibrosis who was one of the authors of the petition, along with Clara Casimiro, diagnosed with primary ciliary dyskinesia (a rare respiratory disease that causes frequent lung infections) and researcher Joana Azeredo, from the Center for Biological Engineering (CEB) at the University of Minho. 

Eda Alves told NiT that she was "very happy with the outcome" and "surprised by the speed of the process." "I congratulate Infarmed on its final decision and thank everyone who helped ensure our petition reached a successful conclusion. And I'm happy for everyone who can benefit from this therapy and that they won't be faced with barriers, as I was."

Diagnosed at three months old, Eda Alves reached 20 years of age without knowing anything other than dealing with the symptoms of a chronic genetic disease caused by the absence of the CFTR protein, which results in a buildup of secretions in the body. 

"All secretions from cystic fibrosis patients are thicker, making them difficult to eliminate," he explains. The fact that pulmonary secretions accumulate over time in a moist environment like the lungs "makes them a favorable environment for the growth of bacteria," he explains.

In the case of a bacterial infection, antibiotics are necessary, but when taken regularly, "bacteria develop defense mechanisms and become resistant to treatment," he explains with expertise. "In my case, because I've had a bacteria for several years, it became resistant."

However, the therapy doesn't just target pulmonary bacterial agents—it can act in a variety of situations, and each patient receives their own therapy, specific to the bacteria they need to eliminate. "Therefore, it can be more effective than antibiotics, which will target multiple bacteria."

Click here to learn about Eda Alves' story . 

Reference : https://www.nit.pt/fit/saude/apos-peticao-publica-terapia-fagica-e-aprovada-em-portugal

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