Australia has apologized to thalidomide survivors. What about Europe?

Irish survivors of thalidomide, a drug prescribed around the world in the 1950s and 1960s, on Wednesday asked the victims for a government apology after one was issued by Australia.

“We dare to dream that Ireland will follow suit and allow us to bring long-term closure to a tragedy we did not commit, allowing the small group of previously unrecognized survivors to be brought in from the cold,” Finola Cassidy, spokeswoman for the Irish Thalidomide Association, told the newspaper. Irish independence.

The estimated 40 countries that survived — she said — failed to withdraw in 1961 after concerns were raised about its effects.

Euronews Next has contacted the Irish government for comment.

The move follows Australia’s historic decision to apologize for the scandal, which affected an estimated 20,000 people worldwide in the mid-20th century.

“We apologize to Australians who were harmed by thalidomide,” Prime Minister Anthony Albanese told survivors in Australia’s House of Representatives on the 62nd anniversary of its withdrawal from the market.

“At the end of the day, Australia is apologizing,” he added. “These apologies relate to the darkest chapters in our history”.

In Europe, the thalidomide scandal led to major changes in drug regulation.

But how deep is the drug’s impact on European women and children and where do countries stand on official recognition of the damage it has done to people’s lives?

Babies with severe limb deformities

Developed by the Swiss pharmaceutical company CIBA in 1953, thalidomide was presented as a harmless alternative to barbiturates.

Originally created as a sedative or tranquilliser, its use soon expanded to treat a variety of ailments in pregnant women, including colds, fevers, nausea, and morning sickness.

It was distributed in 46 countries in the 1950s and 1960s, with the notable exception of the United States, as the FDA never approved it.

Pat Sparrow, a midwife in Australia, had trouble. She and her superior – Dr William McBride – wrote to the scientific journal The Lancet in 1961 that pregnant women who received the drug had high rates of birth defects.

Their observations were soon confirmed by other reports of children born with phocomelia, characterized by missing or severely deformed limbs, and the drug was soon withdrawn.

10,000 to 20,000 patients worldwide

According to estimates, globally, between 10,000 and 20,000 babies have been exposed to the drug. Moreover, the drug caused miscarriages, stillbirths and infant deaths, which have become more difficult to quantify.

In pre-reunification Germany, the drug was only permitted in the West. Pharmaceutical company Grnenthal bought the product from CIBA and sold thalidomide under the brand name Contergan. It is sold over the counter.

More than 5,000 German children were affected. Grünenthal executives faced legal challenges in 1968. The company apologized in 2012.

“We apologize for not being able to find your way person to person for nearly 50 years. Instead, we have been silent. We are very sorry about that,” said Harald Stock, chief executive of Grunenthal at the time.

In 2010, Britain officially apologized for the scandal and the Thalidomide Trust has financially supported 543 people.

Although the drug was withdrawn from other European markets in 1961, thalidomide was sold in Spain until the early 1980s.

Due to regulatory failures and delayed recognition of the drug’s teratogenic effects, many victims did not receive proper support and compensation.

Only two dozen have received compensation from the Spanish government.

A survivor’s group initially won a legal battle against Grnenthal, but later overturned the decision on appeal in 2013, saying it lacked control over national distributors illegally distributing drugs containing thalidomide.

One notable outlier in Europe is France, where thalidomide was never distributed.

Drug approval changes

Following the scandal, governments across Europe implemented stricter regulatory frameworks for drug development and testing.

For example, post-market surveillance systems were strengthened to continuously monitor drug safety and detect potential adverse effects even after a drug has been approved.

The Swedish government, in partnership with the World Health Organization (WHO), created the Uppsala Observatory in 1978.

The institute said its foundation was rooted in the international outcry that followed the tragedy

Birth defects caused by thalidomide.

those European Medicines Agency (EMA) It was also established in 1993 to provide a centralized drug approval and safety monitoring system.

EMA now monitors EudraVigilance, a database that collects and stores reports of suspected adverse reactions to medicines from healthcare professionals, patients and pharmaceutical companies.