In 2022, more than 200 Indonesian children have died from using a cough syrup from the company Afi Farma. The cough syrup contained poisonous ethylene glycol. This substance can cause kidney and liver problems and is also used in paint and brake fluid. This can be fatal, especially for young children.
The director and three other executives of a drug company from Indonesia have been sentenced to two years in prison. Afi Farma pointed the finger at its supplier. They had delivered the toxic substance, while the safe propylene glycol had been ordered. But because the company had not tested the ingredients itself and relied on the information from the supplier, the toxic substance ended up in the cough syrup. Afi Farma's lawyer told BBC News that the regulator in Indonesia does not require drug factories to test the ingredients themselves, but the judge did not think that was a good argument. The judge in East Java convicted the four for deliberately making a product that did not meet safety requirements. They must also each pay a fine of 60,000 euros. According to André den Exter, associate professor of Health Law at Erasmus School of Law, Afi Farma in the Netherlands would not end without a hitch by pointing the finger at its supplier.
Legal requirements for medicine
What is meant by a medicine is stated in Article 1 sub b of the Medicines Act. This states that it must concern a substance or combination of substances that is intended to be administered or used as being suitable for certain medical purposes. The drug must be able to cure or prevent human diseases, contribute to the diagnosis or contribute to the restoration, improvement or modification of physiological functions.
The Medicines Act states how a medicine may be produced and traded. This law is based on a European directive 2001/83/EC. Den Exter explains that the entire production, sales, import, export and resale process is regulated via a licensing system. The guideline also contains the rules of 'good manufacturing practices (GMP)'. Den Exter: “GMP rules: a quality assurance system for the pharmaceutical industry.” These are the international and European professional standards that apply.
European or national permit
If a permit is granted by the Dutch State, it only applies in the Netherlands. When a permit is granted by the European Union, it applies to all countries of the European Union. “An EU authorization is only possible for specific medicines, a national authorization for other medicines. Sometimes a pharmaceutical company wants a medicine to only be available in a few countries”, says Den Exter.
Den Exter explains that a medicine must meet various conditions. Article 40 of the Medicines Act states that it is prohibited to place a medicine on the market without a marketing authorization from the European Union.
Such a marketing authorization is granted if the requirements of Article 45 of the Medicines Act are met. It states that research must be conducted into the benefits and risks of the drug, whether the drug has the desired effect, whether the composition is correct and whether the drug is not contrary to the law.
Liability
If a medicine is placed on the market without a permit, this constitutes a criminal offense under Article 45. Den Exter adds that by violating this rule, civil claims can also be filed. This includes the well-known 'wrongful act' and 'breach of contract'. In short, both provisions mean that damage caused by the drug must be compensated by the person who can be held liable for it. Product liability, a European directive that explicitly focuses on the producer, is also part of Dutch civil law through which compensation can be awarded.
Afi Farma has indicated that it knew nothing about the toxic substance in the cough syrup and that the error was due to their supplier. Under Dutch law and the European directive, Afi Rarma, just like in East Java, cannot get away with this. The supplier and the buyer can both be held liable for the consequences of a poisonous cough syrup.
- Associate professor