At least 16 hospitals in Italy have been found to be using a cancer drug imported from India that is not approved by the European Union. According to an investigation conducted by the Bureau of Investigative Journalism and the media organisation Politico, Celginase, which was not approved due to poor quality, has been imported into Italy for the past seven years by exploiting a legal loophole. These drugs are imported because they are inexpensive.
Before reaching hospitals, medicines are not checked for quality, safety, or efficacy by Italy’s Medicines Control Board or the Ministry of Health. The fact that these tests are beyond the scope of the European Medicines Agency also allows hospitals to import them voluntarily.
According to the report, much of the drug is still in various hospitals, and it is unclear how many patients who used it experienced side effects and had their disease worsen.
Celginase, an asparaginase-class drug, is used to treat acute lymphoblastic leukaemia (blood cancer). It is one of the most common cancers in children.
Celginase, which is manufactured and approved in India, is significantly less expensive than Oncaspar, the best cancer drug currently available in Italy. A bottle of the approved medication costs €2,500, whereas Celginase costs only €13. However, studies show that this drug is not of high enough quality or effectiveness to cure cancer.
Celginase has been reported to have been exported to 90 countries worldwide since 2016. It threatens the health of 70,000 children worldwide.
In 2018, when the availability of Oncaspar fell short in the country, the Italian drug regulatory body allowed the importation of another low-quality drug, Aspatero. This was because the children might not get cured if the medicine was not given correctly.
Even after Oncaspar became available, many hospitals continued to import the less expensive cancer drug Celginas. According to the report, Celginas has been imported into the country this year as well. Celginas is likely to be used in more hospitals than expected, as the drug has been imported by all seven regional health departments in Italy.
The patient does not understand what medicine is being given to the patient from the normal records provided by the hospital. There is no way to know where these drugs are manufactured or approved.
Celginas is made by transforming E. coli bacteria into medicine. This procedure can be extremely painful, and the drug may cause allergic reactions in some people. That is why doctors recommend Oncaspar, which is of the highest quality. Since 2016, Oncaspar has been the first treatment option for children with blood cancer in Europe.
Under Italian law, if a drug is in short supply, the same drug can be imported from another country with the permission of the Medicines Control Board.
Meanwhile, the law also allows drugs like Celginas to be imported if the drug is not approved in the EU and there is no other drug to give a patient. However, a legal loophole allows doctors to request permission to import unlicensed medicine when quality medicine is available. Hospitals and doctors take advantage of this. This is the reason why Celginas is imported while Oncaspar is available in abundance. At the same time, the law requires that the name and other information of the patient who is given a drug without EU approval be kept accurate.
The Italian Ministry of Health’s customs department has the authority to authorise the importation of unlicensed drugs. There, it is only checked that the paper provided by the hospital contains all the information and that the medicine imported is the same as the medicine on the paper. That is, there is no way to test their quality. Doctors will decide whether this medication can be used instead. But first, the patient must be informed about the medication and provide informed consent. But it is clear from the report that none of this is being implemented here, and patients are being forced to use substandard medicine instead.
According to documents obtained under the Freedom of Information Act by the health ministry’s customs department, celginase is used by 16 hospitals in Italy. Over the last seven years, hospitals such as the Istituto Nazionale dei Tumori in Milan and San Camillo Forlanini in Rome have imported hundreds of bottles of this substandard drug.
The Istituto Nazionale Tumori says that Celginase has to be used because of the lack of access to a quality drug. They also say that patients who have been given it are getting better. The hospital says that the Italian Medicines Control Board has not given any warning that the drug is dangerous.
In the event of a shortage, there are no specific guidelines for using Celginase as a substitute for Oncaspar. It is also problematic that the European Medicines Agency and the Italian Medicines Control Board currently have no mechanisms to check or take action against the importation of drugs approved in non-EU countries without EU approval. According to the Italian Medicines Control Board, they are not liable if they do not obtain results with drugs not approved by the EU.
Celginase from India is mostly transported via Switzerland. This drug, however, is not used in Switzerland. Swiss customs are also unaware that Celginase has been shipped to any EU country other than Italy.
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