Sunday, July 6, 2025
  • News
  • Weather
    • Climate Business
    • Climate Change
    • Climate Solutions
    • Living Green
  • Business
  • Health
  • Opinion
  • Law & Order
  • Sports
  • Entertainment
  • Lifestyle
  • Sci-Tech
  • Behind The Brand
REGISTER
LOGIN
No Result
View All Result
The Kenya Times
  • News
    Uganda’s President Yoweri Museveni Photo/Museveni X

    Museveni Nominated to Seek Another Term, Highlights Six Priorities

    Chavakali High School Fees, KCSE Performance and Contacts

    Chavakali High School History, Fees, KCSE Performance and Key Contacts

    JKIA KAA

    KAA Issues Travel Advisory for Passengers Using JKIA and Wilson Airport

    CJ Koome Launches Mahakama Popote Virtual Court Guide. Robert Alai

    Judiciary Issues Statement After Police Fired Shots at Ruiru Law Courts

    Motorists Stranded for Hours Along Mombasa–Nairobi Highway

    Traffic Snarl-Up Leaves Motorists Stuck on Mombasa–Nairobi Highway

    Meru Governor Kawira Mwangaza. PHOTO/Governor Kawira Mwangaza

    Kawira Mwangaza Makes Comeback as New Party Leader After Ditching UDA

    National Treasury CS John Mbadi during a Senate Budget and Finance Committee meeting at County Hall, Parliament Buildings on March 18, 2025. PHOTO/Treasury X.

    Mbadi Appoints Former Governor to Replace Wangamati as CSs Make Changes

    IEBC Chairperson Erastus Ethekon appears before JLAC for vetting on May 31, 2025. PHOTO/National Assembly

    IEBC Addresses Reports of Removing 2 Million Voters from Register

    Kisii, Moi Among Universities with High 2025 Placements

    Kisii, Moi Among Universities with High 2025 KUCCPS Placements

  • Weather
    • Climate Business
    • Climate Change
    • Climate Solutions
    • Living Green
  • Business
    KRA Commissioner General Humphrey Wattanga speaking at a past event. PHOTO/KRA X

    KRA Issues Way Forward on Eldoret Congestion After Traders’ Outcry

    UK Leads in CBK Cross-Border Movement of Cash Survey

    Top Destinations Where Kenyans Are Wiring and Taking Physical Cash Abroad

    Co-op Partners with KTDA After Joining Africa's Top 25 List

    Co-op Bank to Invest Ksh1.2 Billion After Joining Africa’s Top 25 Largest Banks List

    EABL Names New Managing Director for Kenya in Major Leadership Shakeup

    EABL Names New Managing Director for KBL in Major Leadership Shakeup

    A person holding the Kenyan Shilling.

    Why Kenyan Shilling Has Strengthened in 2025 Compared to 2024

    Old Mutual offices

    Old Mutual to Cease Operations in South Sudan After Selling Tanzania Subsidiary

    Safaricom CEO Peter Ndegwa during the announcement of the company's 2425 Financial Year results. PHOTO/Safaricom PLC

    Safaricom Reports Ksh69.8 Billion Profit Ahead of 2025 AGM

    The Commercial International Bank (CIB) announced the acquisition of Mayfair Bank in Kenya in 2019. PHOTO/Daily News

    Commercial International Bank (CIB) Owners, Branches & Loans Offered

    KRA Announces Changes Affecting All Importers and Exporters

    KRA Announces Changes Affecting All Importers and Exporters

  • Health
    Medical examiner or forensic scientist with dead man's corpse in morgue. Photo/ Pexel

    Pneumonia and Cancer Emerge Among Lead Causes of Death in Kenya

    Aga Khan University Hospital Section Head, Nuclear Radiology and Chair, Department of Radiology

    Aga Khan Leads the Region in Advancing Prostrate Cancer Treatment

    Kenyatta National Hospital Gets EIB Global Boost for Energy Supply

    European Union Bank Intervenes to Help KNH Solve Frequent Blackout Challenge

    Govt Confirms Ksh 46,120 Monthly Pay for Intern Doctors

    Kenyan Govt Confirms Ksh46,120 Monthly Pay for Intern Doctors

    Tips on How to Navigate Raising Adolescents Teenagers

    One in Five Kenyan Teens at Risk of Mental Health Disorders – Report

    A first aid kit. PHOTO: Independence

    Basic First Aid Procedure For Injured

    Huduma Center Building, Kenya.

    Huduma Kenya Introduces Sign Language Interpreters

    BCG Vaccines Shortage Adressed as Kenya Receives 3M Doses

    Duale Says Ruto Signed Law Allowing SHIF Deductions in December 2024

    SHA headquarters in Nairobi

    High Court Judge Says SHIF Deductions Are Illegal

  • Opinion
    Kenya 2025/26 Budget Draws Criticism Over Tax Burden

    Demystifying Revenue Measures and Expenditure Outlook in Kenya – 2025/26

    Discipline Crisis: How Weak Parenting Shapes Our Youth

    The Crisis of Discipline: How Weak Parenting is Shaping a Bleak Future for Our Youth

    Nairobi Declaration on Climate Change and Call to Action

    Why African Higher Education Should Focus on Disaster Management & Climate Change

    Govt to Recognize Jobless Kenyans Without Certificates. Miguna Miguna Calls Out Ruto On Useless Degrees Remarks

    Kenya’s Universities Are Producing Graduates, But Is the Industry Ready to Receive Them?

    Why Gen Z protests are a threat to Kenya's politics and status quo

    Gen Z Is Not Passing Cloud But Seismic Change

    Donald

    At June’s NATO Summit, Just Keeping Donald Trump in the Room Will Be Seen as A Victory

    NPSC Selection Panel Shortlists Eric Kiraithe, Mwachanya

    How To Stop Kenya’s Police from Killing with Impunity

    Health Worker Handling Mpox Vaccine Vials PHOTO/KBC

    Understanding How Mpox Spreads, Symptoms, and How to Prevent

    Discipline Crisis: How Weak Parenting Shapes Our Youth

    Celebrating Father’s Day Unsung Heroes

  • Law & Order
    Sudan Army & Military soldiers patrol streets Juba PHOTO/UNICEF

    How Military Operations Get Their Codenames Around the World

    OCS Talaam

    Court Grants OCS Taalam Time in Albert Ojwang’ Death Inquest

    Guns recovered by police from civilians

    7 People Who Stole Guns During Gen Z Protests Arrested

    Aroko Turns to State Witness in Kasipul MP Murder Case

    New Twist as Businessman Aroko Turns to State Witness in Kasipul MP Murder Case

    LSK President Faith Odhiambo at a past function. PHOTO/Faith Odhiambo

    Faith Odhiambo Teaches Kenyans What to Do When Arrested During Protests

    NTSA on Road safety compliance checks at Luqman along the Nairobi-Mombasa Highway. Photo/NTSA

    NTSA Introduces New Traffic Rules for School Buses, Matatus and Trucks

    Babu Owino Slams Sakaja Over Goons Disrupting Protests

    Babu Owino’s Message to Sakaja After Expose of Goons Hired to Disrupt Protests

    Vocal Africa CEO, Hussein Khalid

    Hussein Khalid Profile: Background, Education and Career

    Dusit D2 Terror Attack Suspects Found Guilty Sentenced

    Court Sentences Duo Found Guilty of Funding Dusit D2 Terror Attack

  • Sports
    Gor Mahia's defender Rooney Onyango (left) and his teammate Benson Omalla celebrate in a past match.

    Gor Mahia, Club CEO Ray Oruo Split Amidst Ongoing Overhaul

    Kenya Morans Humiliate Nigeria in Rugby Africa Sevens

    Simbas Name Squad As 2027 RWC Qualifiers Begins Tomorrow

    Traffic Police officers in a past assignment.

    Motorists Association of Kenya Expose NPS Traffic Extortion

    Key Lessons from the Great Gor Mahia Trophyless Season

    Key Lessons from the Trophyless Season by Great Gor Mahia

    André Onana Free to Leave Manchester United on Loan

    André Onana Free to Leave Manchester United on Loan

    Chelsea Slam U.S. Club World Cup as “Unworthy & Shocking”

    Chelsea Slam U.S. Club World Cup as “Unworthy &Shocking”

    Rally Italia Sardegna_Hyundai Shell Mobis World Rally Team

    Hankook Tire Powers the WRC’s ‘EKO Acropolis Rally Greece’

    FIFA CLUB WORLD CUP

    FIFA Club World Cup Golden Boot Winners & All Time Top Scorers

    Michael Olunga Football Academy (MOFA) Complex 60% Complete

    Olunga Shares Video of His World-Class Complex Nearing Completion

  • Entertainment
    Elon Musk Father

    How Elon Musk’s Father Married His Stepdaughter

    Pastor Livingston Makali Sells Prayers for Ksh5,000

    Pastor Livingston Makali Sells Prayers for Ksh5,000

    Karangu Wa Muraya Criticised Over His SHA Praises.

    Karangu Muraya Faces Backlash After Appealing for Medical Support

    American Mogul Tyler Perry

    Tyler Perry Sued for Sexual Assault by Actor Derek Dixon

    A photo of phone screens with the WhatsApp app. PHOTO/Nextpit.

    WhatsApp to Introduce Ads on Status & Channels

    Senator Hezena Lemaletian

    Senator Says Her Life Is in Danger After Rejecting Marriage Proposal

  • Lifestyle
    Elon Musk Father

    How Elon Musk’s Father Married His Stepdaughter

    Murphy

    From Co-Stars to Family: Eddie Murphy and Martin Lawrence Children Get Married

    Robbie Lyle, the Arsenal Superfan Who Revolutionised Football Media

    Meet Robbie Lyle: The Arsenal Superfan Who Revolutionized Football Media

    Ida Odinga and her husband Raila cut a cake at Villa Rosa Kempinski in Nairobi on August 24, 2023 at a party to celebrate her birthday and their anniversary.

    Raila Shares One Secret of a Lasting Marriage as He Graces Glamorous Wedding 

    Thriving business of Second-Hand Clothes PHOTO/Nation

    Leading Sources of Kenya’s Mitumba

    Cleaning a dirty fridge PHOTO/The Spruce

    Step-by-Step Process for Cleaning Your Fridge

  • Sci-Tech
    First Kenyan-Owned Aircraft to Land on Australian Soil

    First Kenyan-Owned Aircraft to Land on Australian Soil

    Step by Step Guide to Managing Your Google Account Storage.

    Out of Google Storage? Here’s How to Free Up Space Without Deleting Important Data

    President William Ruto inspecting ongoing Affordable Housing Project. PHOTO/PCS.

    Zuku Launches Ksh10 Per Day Wi-Fi

    Microsoft Headquarters. PHOTO/ Microsft

    Why Microsoft is Firing 6,000 Employees After Sacking 10,000 Two Years Ago

    A collage of AI photo and an English love poem that has been translated into a local language by Simba AI PHOTO/CLA/Simba AI Launch

    Simba AI: Kenya’s First AI That Understands & Translates English into Local Language

    properties of AICAR and its possible impact on different research domains.

    AICAR Peptide: Insights into Its Possible Role in Research and Future Implications

  • Behind The Brand
  • News
    Uganda’s President Yoweri Museveni Photo/Museveni X

    Museveni Nominated to Seek Another Term, Highlights Six Priorities

    Chavakali High School Fees, KCSE Performance and Contacts

    Chavakali High School History, Fees, KCSE Performance and Key Contacts

    JKIA KAA

    KAA Issues Travel Advisory for Passengers Using JKIA and Wilson Airport

    CJ Koome Launches Mahakama Popote Virtual Court Guide. Robert Alai

    Judiciary Issues Statement After Police Fired Shots at Ruiru Law Courts

    Motorists Stranded for Hours Along Mombasa–Nairobi Highway

    Traffic Snarl-Up Leaves Motorists Stuck on Mombasa–Nairobi Highway

    Meru Governor Kawira Mwangaza. PHOTO/Governor Kawira Mwangaza

    Kawira Mwangaza Makes Comeback as New Party Leader After Ditching UDA

    National Treasury CS John Mbadi during a Senate Budget and Finance Committee meeting at County Hall, Parliament Buildings on March 18, 2025. PHOTO/Treasury X.

    Mbadi Appoints Former Governor to Replace Wangamati as CSs Make Changes

    IEBC Chairperson Erastus Ethekon appears before JLAC for vetting on May 31, 2025. PHOTO/National Assembly

    IEBC Addresses Reports of Removing 2 Million Voters from Register

    Kisii, Moi Among Universities with High 2025 Placements

    Kisii, Moi Among Universities with High 2025 KUCCPS Placements

  • Weather
    • Climate Business
    • Climate Change
    • Climate Solutions
    • Living Green
  • Business
    KRA Commissioner General Humphrey Wattanga speaking at a past event. PHOTO/KRA X

    KRA Issues Way Forward on Eldoret Congestion After Traders’ Outcry

    UK Leads in CBK Cross-Border Movement of Cash Survey

    Top Destinations Where Kenyans Are Wiring and Taking Physical Cash Abroad

    Co-op Partners with KTDA After Joining Africa's Top 25 List

    Co-op Bank to Invest Ksh1.2 Billion After Joining Africa’s Top 25 Largest Banks List

    EABL Names New Managing Director for Kenya in Major Leadership Shakeup

    EABL Names New Managing Director for KBL in Major Leadership Shakeup

    A person holding the Kenyan Shilling.

    Why Kenyan Shilling Has Strengthened in 2025 Compared to 2024

    Old Mutual offices

    Old Mutual to Cease Operations in South Sudan After Selling Tanzania Subsidiary

    Safaricom CEO Peter Ndegwa during the announcement of the company's 2425 Financial Year results. PHOTO/Safaricom PLC

    Safaricom Reports Ksh69.8 Billion Profit Ahead of 2025 AGM

    The Commercial International Bank (CIB) announced the acquisition of Mayfair Bank in Kenya in 2019. PHOTO/Daily News

    Commercial International Bank (CIB) Owners, Branches & Loans Offered

    KRA Announces Changes Affecting All Importers and Exporters

    KRA Announces Changes Affecting All Importers and Exporters

  • Health
    Medical examiner or forensic scientist with dead man's corpse in morgue. Photo/ Pexel

    Pneumonia and Cancer Emerge Among Lead Causes of Death in Kenya

    Aga Khan University Hospital Section Head, Nuclear Radiology and Chair, Department of Radiology

    Aga Khan Leads the Region in Advancing Prostrate Cancer Treatment

    Kenyatta National Hospital Gets EIB Global Boost for Energy Supply

    European Union Bank Intervenes to Help KNH Solve Frequent Blackout Challenge

    Govt Confirms Ksh 46,120 Monthly Pay for Intern Doctors

    Kenyan Govt Confirms Ksh46,120 Monthly Pay for Intern Doctors

    Tips on How to Navigate Raising Adolescents Teenagers

    One in Five Kenyan Teens at Risk of Mental Health Disorders – Report

    A first aid kit. PHOTO: Independence

    Basic First Aid Procedure For Injured

    Huduma Center Building, Kenya.

    Huduma Kenya Introduces Sign Language Interpreters

    BCG Vaccines Shortage Adressed as Kenya Receives 3M Doses

    Duale Says Ruto Signed Law Allowing SHIF Deductions in December 2024

    SHA headquarters in Nairobi

    High Court Judge Says SHIF Deductions Are Illegal

  • Opinion
    Kenya 2025/26 Budget Draws Criticism Over Tax Burden

    Demystifying Revenue Measures and Expenditure Outlook in Kenya – 2025/26

    Discipline Crisis: How Weak Parenting Shapes Our Youth

    The Crisis of Discipline: How Weak Parenting is Shaping a Bleak Future for Our Youth

    Nairobi Declaration on Climate Change and Call to Action

    Why African Higher Education Should Focus on Disaster Management & Climate Change

    Govt to Recognize Jobless Kenyans Without Certificates. Miguna Miguna Calls Out Ruto On Useless Degrees Remarks

    Kenya’s Universities Are Producing Graduates, But Is the Industry Ready to Receive Them?

    Why Gen Z protests are a threat to Kenya's politics and status quo

    Gen Z Is Not Passing Cloud But Seismic Change

    Donald

    At June’s NATO Summit, Just Keeping Donald Trump in the Room Will Be Seen as A Victory

    NPSC Selection Panel Shortlists Eric Kiraithe, Mwachanya

    How To Stop Kenya’s Police from Killing with Impunity

    Health Worker Handling Mpox Vaccine Vials PHOTO/KBC

    Understanding How Mpox Spreads, Symptoms, and How to Prevent

    Discipline Crisis: How Weak Parenting Shapes Our Youth

    Celebrating Father’s Day Unsung Heroes

  • Law & Order
    Sudan Army & Military soldiers patrol streets Juba PHOTO/UNICEF

    How Military Operations Get Their Codenames Around the World

    OCS Talaam

    Court Grants OCS Taalam Time in Albert Ojwang’ Death Inquest

    Guns recovered by police from civilians

    7 People Who Stole Guns During Gen Z Protests Arrested

    Aroko Turns to State Witness in Kasipul MP Murder Case

    New Twist as Businessman Aroko Turns to State Witness in Kasipul MP Murder Case

    LSK President Faith Odhiambo at a past function. PHOTO/Faith Odhiambo

    Faith Odhiambo Teaches Kenyans What to Do When Arrested During Protests

    NTSA on Road safety compliance checks at Luqman along the Nairobi-Mombasa Highway. Photo/NTSA

    NTSA Introduces New Traffic Rules for School Buses, Matatus and Trucks

    Babu Owino Slams Sakaja Over Goons Disrupting Protests

    Babu Owino’s Message to Sakaja After Expose of Goons Hired to Disrupt Protests

    Vocal Africa CEO, Hussein Khalid

    Hussein Khalid Profile: Background, Education and Career

    Dusit D2 Terror Attack Suspects Found Guilty Sentenced

    Court Sentences Duo Found Guilty of Funding Dusit D2 Terror Attack

  • Sports
    Gor Mahia's defender Rooney Onyango (left) and his teammate Benson Omalla celebrate in a past match.

    Gor Mahia, Club CEO Ray Oruo Split Amidst Ongoing Overhaul

    Kenya Morans Humiliate Nigeria in Rugby Africa Sevens

    Simbas Name Squad As 2027 RWC Qualifiers Begins Tomorrow

    Traffic Police officers in a past assignment.

    Motorists Association of Kenya Expose NPS Traffic Extortion

    Key Lessons from the Great Gor Mahia Trophyless Season

    Key Lessons from the Trophyless Season by Great Gor Mahia

    André Onana Free to Leave Manchester United on Loan

    André Onana Free to Leave Manchester United on Loan

    Chelsea Slam U.S. Club World Cup as “Unworthy & Shocking”

    Chelsea Slam U.S. Club World Cup as “Unworthy &Shocking”

    Rally Italia Sardegna_Hyundai Shell Mobis World Rally Team

    Hankook Tire Powers the WRC’s ‘EKO Acropolis Rally Greece’

    FIFA CLUB WORLD CUP

    FIFA Club World Cup Golden Boot Winners & All Time Top Scorers

    Michael Olunga Football Academy (MOFA) Complex 60% Complete

    Olunga Shares Video of His World-Class Complex Nearing Completion

  • Entertainment
    Elon Musk Father

    How Elon Musk’s Father Married His Stepdaughter

    Pastor Livingston Makali Sells Prayers for Ksh5,000

    Pastor Livingston Makali Sells Prayers for Ksh5,000

    Karangu Wa Muraya Criticised Over His SHA Praises.

    Karangu Muraya Faces Backlash After Appealing for Medical Support

    American Mogul Tyler Perry

    Tyler Perry Sued for Sexual Assault by Actor Derek Dixon

    A photo of phone screens with the WhatsApp app. PHOTO/Nextpit.

    WhatsApp to Introduce Ads on Status & Channels

    Senator Hezena Lemaletian

    Senator Says Her Life Is in Danger After Rejecting Marriage Proposal

  • Lifestyle
    Elon Musk Father

    How Elon Musk’s Father Married His Stepdaughter

    Murphy

    From Co-Stars to Family: Eddie Murphy and Martin Lawrence Children Get Married

    Robbie Lyle, the Arsenal Superfan Who Revolutionised Football Media

    Meet Robbie Lyle: The Arsenal Superfan Who Revolutionized Football Media

    Ida Odinga and her husband Raila cut a cake at Villa Rosa Kempinski in Nairobi on August 24, 2023 at a party to celebrate her birthday and their anniversary.

    Raila Shares One Secret of a Lasting Marriage as He Graces Glamorous Wedding 

    Thriving business of Second-Hand Clothes PHOTO/Nation

    Leading Sources of Kenya’s Mitumba

    Cleaning a dirty fridge PHOTO/The Spruce

    Step-by-Step Process for Cleaning Your Fridge

  • Sci-Tech
    First Kenyan-Owned Aircraft to Land on Australian Soil

    First Kenyan-Owned Aircraft to Land on Australian Soil

    Step by Step Guide to Managing Your Google Account Storage.

    Out of Google Storage? Here’s How to Free Up Space Without Deleting Important Data

    President William Ruto inspecting ongoing Affordable Housing Project. PHOTO/PCS.

    Zuku Launches Ksh10 Per Day Wi-Fi

    Microsoft Headquarters. PHOTO/ Microsft

    Why Microsoft is Firing 6,000 Employees After Sacking 10,000 Two Years Ago

    A collage of AI photo and an English love poem that has been translated into a local language by Simba AI PHOTO/CLA/Simba AI Launch

    Simba AI: Kenya’s First AI That Understands & Translates English into Local Language

    properties of AICAR and its possible impact on different research domains.

    AICAR Peptide: Insights into Its Possible Role in Research and Future Implications

  • Behind The Brand
No Result
View All Result
The Kenya Times ~ Trending, Breaking News and Videos
No Result
View All Result
ADVERTISEMENT

Italian Hospitals Imported Unapproved, Substandard Cancer Drug

by Laura Margottini
July 2, 2023
Reading Time: 10 mins read
FacebookTwitterLinkedInRedditWhatsApp

At least 16 hospitals in Italy have been treating cancer patients with a poor-quality imported drug that is not approved for use in the EU, the Bureau of Investigative Journalism (TBIJ) and POLITICO can reveal.

Gaps in national and EU regulation have allowed Italian hospitals to legally request shipments of Celginase, a low-cost cancer medicine shown to be substandard, even when better alternatives have been available.

Neither Italy’s drugs regulator nor the country’s ministry of health are responsible for checking the quality, efficacy or safety of this drug before allowing it into Italian hospitals. Nor does this fall within the remit of the European Medicines Agency (EMA).

Hundreds of vials of the drug have arrived from India over the last seven years. It is unknown how many cancer patients could have experienced adverse side effects or lower chances of remission as a result. Many vials still sit on hospital shelves today.

Celginase is a brand of asparaginase, a drug used to treat acute lymphoblastic leukemia, the most common form of childhood cancer. Celginase is made and approved in India, and costs a tiny fraction of the price of the “gold-standard” brand: as little as €13 a vial compared with about €2,500. Published academic studies have found it did not meet minimum manufacturing standards or consistently reach the clinical activity threshold to treat cancer.

In January, TBIJ and STAT revealed that poor-quality brands of asparaginase, including Celginase, have been shipped to more than 90 countries since 2016, putting an estimated 70,000 children around the world at risk.

In 2018, an apparent nationwide shortage of Oncaspar, the “gold-standard” asparaginase, led to children in Italy receiving another brand, Aspatero, which was later found to be substandard. (The hospital concerned said its request to import Aspatero was authorized by the Italian drugs regulator, and that not doing this would have “reduced the chances of children’s recovery.” The drugs regulator confirmed it had authorized the import.)

But TBIJ and POLITICO can now reveal that Celginase has been purchased by Italian hospitals even when the gold-standard product has been available – in some cases as recently as this year. Further records show that Celginase was also imported by seven Italian regional health departments, suggesting that the actual number of hospitals using the drug could be far higher.

Informed consent paperwork does not detail the brand of the drug that patients will be given nor the countries in which it is approved. Patients are being left in the dark.

Lack of liability

There are several different types of asparaginase. “Native” asparaginase is made from Escherichia coli (E. coli). Turning this bacterium into medicine is complicated and even good-quality native asparaginase can cause side effects, including severe allergic reactions.

For this reason, doctors prefer to use modified versions of asparaginase. These are less likely to cause allergic reactions but are much more expensive up front.

Although Celginase and Oncaspar are both asparaginases, they are different: Celginase is native, Oncaspar is modified. Oncaspar has been approved for use in Europe since 2016 and is the brand of asparaginase recommended as first-choice treatment for acute lymphoblastic leukemia.

In Italy, if a drug is in shortage, doctors and pharmacists can ask the Italian drugs regulator to greenlight the import of that same drug from another country.


Also Read: Gov’t too broke to remit NHIF money – Health CS Nakhumicha


A different law permits a drug that is not approved in the EU but is elsewhere in the world – such as Celginase – to be imported for an individual named patient if a doctor deems there is “no valid alternative therapy available”. As Celginase and Oncaspar are not exact equivalents, doctors have been able to request Celginase imports even if Oncaspar is available.

Crucially, this process bypasses the country’s drugs regulator. In Italy, permission is instead given by the ministry of health’s customs agency, which is required only to check that the paperwork has been correctly filled out by the hospital and the drug arriving is the one requested.

It is not required by law to check the quality of imported drugs nor ask for data from the overseas regulators that approved them.

The drug was meant to save children’s lives. Instead, they’re dying

Instead, the responsibility for these drugs lies with the individual doctor who requests them. The Italian drugs regulatory agency said that doctors should use qualified and reliable import intermediaries who can guarantee the quality and safety of the drug, particularly with suppliers in non-EU countries, and that doctors should get informed consent by giving the patient complete, transparent and exhaustive information on the drug.

Through freedom of information requests to the Italian customs agency of the ministry of health, TBIJ and POLITICO found that at least 16 hospitals, including the Istituto Nazionale Tumori in Milan and San Camillo Forlanini in Rome, imported hundreds of vials of Celginase into the country over a seven-year period. (The Istituto Nazionale Tumori said that shortages required them to source Celginase. It added that the patients who received the drug are either responding to it or are in remission, and that the Italian drugs regulator has never provided information showing that Celginase could be harmful. San Camillo Forlanini did not respond to a request for comment.)

Attilio Guarini, a doctor who treats patients with acute lymphoblastic leukemia at Policlinico di Bari hospital, says there is no clinical guidance recommending doctors turn to a native asparaginase – such as Celginase – if Oncaspar is available.

The Italian drugs regulator told TBIJ that it denies any responsibility for the “efficacy and safety” of medicines imported from non-EU countries that are not authorized in accordance with EU regulations.

The European Medicines Agency (EMA) also has no power over imports of unapproved drugs from non-EU countries, according to its former head Guido Rasi.

Most of the Celginase imported into Italy from India came via Switzerland. The Swiss customs agency said it does not have specific data on the products we asked about. It did not know if Indian asparaginase imported via Switzerland may have gone to any other EU countries besides Italy, but it is understood that Celginase was not used in Swiss hospitals.

The EU issue

In certain situations, such as drug shortages, it is vital for European countries to be able to import medicines that may not be approved in the EU.

In 2001, the EU published new bloc-wide legislation allowing medicines that “fulfil special needs” to be excluded from the standard European rules around quality, safety, efficacy and manufacturing. But only under strict conditions.

“There are loopholes in the system and we are working to fix them” – Ulrico Angeloni, Italian customs agency

Any such medicines (which may include those not approved in the EU) need to be formulated according to the specifications of an authorized healthcare professional – such as a doctor or a pharmacist – and given to an individual patient under this worker’s “direct personal responsibility”.

Each country has incorporated this into its own national law in different ways.

In Italy, the prescribing doctor must justify the exceptional use, which is then checked by the customs agency of the ministry of health. In Spain, the hospital or health department must request access to the unlicensed drug from the regulator. In Ireland, the doctor issues the prescription and the wholesaler or manufacturer is required to notify the regulator of the import.

And while the EU law was meant to be applied to individual patients, in practice this is not always the case. In Germany and Italy, for instance, there are provisions for orders large enough to temporarily stock a hospital pharmacy. In Ireland, the law has been used so extensively that in 2020 more than 1.5 million packs of the 50 most popular drugs were brought into the country under the rules.

“If products for commercial sale are routinely entering the EU as unlicensed medicines and they’ve been supplied under the named-patient […] regime then that’s an issue,” says Grant Castle, partner at Covington law firm.

He said these rules allow patients to access medicines where there is a bona fide medical need and are “not a suitable basis” to import medicines for other reasons. “If that is happening, it’s a loophole.”

While it is down to member states to put rules in place for named-patient supplies of unlicensed medicines, Castle added, national rules “generally do not provide the same safeguards”.

Gilles Vassal, a pediatric oncologist and board member of the European Society for Pediatric Oncology, agreed. When addressing shortages by importing medicines unauthorized in the EU, he asks: “What are the measures set up at [the national] level to control the quality of the medicine they are importing?”


Also Read: Health Cs Nakhumicha on How Small Hospitals Defraud NHIF


The Italian drugs regulator said that in February 2023, it exchanged information with WHO on data around a potential lack of efficacy of the Indian-sourced drug Aspatero provided by the study highlighted in TBIJ’s first story. It added that there appears to be no evidence from the WHO or national regulatory authorities of low-quality, dangerous or ineffective asparaginases imported from India.

However, a European Commission spokesperson said that the Italian drugs regulator and other Italian authorities have been investigating this issue, which involves some specific Italian hospitals. A WHO spokesperson said it had contacted the countries reported in TBIJ’s original investigation into asparaginase, but that no “actionable information” had been received.

Changes to the EU law are also in the works to attempt to address some of these concerns. A planned revision of the bloc’s pharmaceutical legislation would include a line stipulating that countries “shall encourage” doctors and patients to report data on the safety of the use of unlicensed medicines to their own regulator. 

It would also oblige drugmakers to flag any potential shortages six months in advance – up from two months – and it could require companies or wholesalers to keep larger stockpiles.

In Italy, the customs agency has responded to TBIJ’s enquiries by working to modify its forms so doctors must give more detail about clinical reasons for the import. “We realized that there are loopholes in the system, so we are now working to fix them,” said Ulrico Angeloni, one of the agency’s coordinators.

Doctors that TBIJ and POLITICO spoke to would like to see national measures to verify the quality of unlicensed drugs accessed via these loopholes, as well as more transparency on their use, effectiveness and safety.

For now, the paradox remains that while Europe’s medicines are among the most highly regulated in the world, drugs that are shipped in from abroad can fail to meet even minimum standards.

The manufacturer of Celginase did not respond to a request for comment.

This article is republished from The Bureau of Investigative Journalism under a Creative Commons license. Read the original article

Reporters: Laura Margottini and Rosa Furneaux
Additional reporting: Maria Cristina Fraddosio
Illustration: Evangeline Gallagher
Deputy editor: Chrissie Giles
Editor: Meirion Jones
Production editor: Alex Hess
Fact checkers: Alice Milliken and Meriem Mahdhi
Impact producer: Paul Eccles

Tags: CancerCelginaseFood and DrugsHealthItalian Hospitals
Laura Margottini

Laura Margottini

Laura is an award-winning investigative journalist exploring health, environment and science policy. She was a contributor for Science magazine for a decade and has extensively worked for the Italian national daily il Fatto Quotidiano.

Related Posts

Sudan Army & Military soldiers patrol streets Juba PHOTO/UNICEF

How Military Operations Get Their Codenames Around the World

July 2, 2025
OCS Talaam

Court Grants OCS Taalam Time in Albert Ojwang’ Death Inquest

July 2, 2025
Guns recovered by police from civilians

7 People Who Stole Guns During Gen Z Protests Arrested

June 29, 2025
Aroko Turns to State Witness in Kasipul MP Murder Case

New Twist as Businessman Aroko Turns to State Witness in Kasipul MP Murder Case

June 26, 2025
Advertisement

LATEST ARTICLES

  • Museveni Nominated to Seek Another Term, Highlights Six Priorities
  • Gladys Boss Profile: Educational Background, Career, and Family
  • David Kangogo Profile: Educational Background , Career, Family and Networth
  • Chavakali High School History, Fees, KCSE Performance and Key Contacts
  • KAA Issues Travel Advisory for Passengers Using JKIA and Wilson Airport
  • Demystifying Revenue Measures and Expenditure Outlook in Kenya – 2025/26
  • Judiciary Issues Statement After Police Fired Shots at Ruiru Law Courts
  • Traffic Snarl-Up Leaves Motorists Stuck on Mombasa–Nairobi Highway
  • Traffic Disruption on Southern Bypass as Oil Tanker Overturns
  • List of Countries with Official State Religions Around the World
  • Kawira Mwangaza Makes Comeback as New Party Leader After Ditching UDA
  • Mbadi Appoints Former Governor to Replace Wangamati as CSs Make Changes
  • IEBC Addresses Reports of Removing 2 Million Voters from Register
  • Kisii, Moi Among Universities with High 2025 KUCCPS Placements
  • KRA Issues Way Forward on Eldoret Congestion After Traders’ Outcry
Advertisement

Company

About Us

Our Authors

Our Experts

Social Media

Policies

Privacy Policy

House Rules

Standards and Policies

Terms and Conditions

Subscription

My Account

Contact Us

Contact Us

Join Our Team

Advertise With Us

© Copyright 2025 | The Kenya Times | All Rights Reserved

Welcome Back!

Sign In with Facebook
Sign In with Google
Sign In with Linked In
OR

Login to your account below

Forgotten Password? Sign Up

Create New Account!

Sign Up with Facebook
Sign Up with Google
Sign Up with Linked In
OR

Fill the forms below to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In
Your Privacy and Cookies
We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept”, you consent to the use of ALL the cookies.
Do not sell my personal information.
Cookie settingsACCEPT
Privacy & Cookies Policy

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may have an effect on your browsing experience.
Necessary
Always Enabled
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
Functional
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytics
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
Others
Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet.
SAVE & ACCEPT
LOGIN | REGISTER
  • Login
  • Sign Up
  • Cart
No Result
View All Result
  • News
    • Diaspora News
    • National News
    • World News
  • Weather
  • Climate
    • Climate Business
    • Climate Change
    • Climate Solutions
    • Environment
  • Business
    • Banking
    • Cryptocurrency
    • Money Markets
    • Real Estate
    • Startups
  • Health
    • Mens Health
    • Mental Health
    • Wellness
    • Womens Health
  • Law & Order
    • Cyber Crime
    • Courts
    • Financial Fraud
    • Missing Persons
  • Sports
    • Athletics
    • Basketball
    • Boxing
    • Cricket
    • Football
    • Formula 1
    • Golf
    • Rugby
  • Entertainment
    • Music
    • Movies
  • Lifestyle
    • Arts & Culture
    • Disabilities Matters
    • Family
    • Fashion
    • Food
    • Human Interest
    • Travel & Tourism
  • Opinion
    • Editorials
    • Letters to Editor
    • John Mukum Mbaku
    • Makau Mutua
    • Peter Ongera
    • Salim Lone
    • XN Iraki
  • Sci-Tech
  • Behind The Brand
  • Contact Us

© 2024 The Kenya Times | Our Privacy Policy | Standards and Policies | House Rules