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29-01-2025

Generic medicines – what do you know about them and what is good to know?

Iliustracija

Many people have probably heard this name, but not everyone can explain what it is. Some have heard it from doctors, others from neighbours or from myths in society. So, what are generic medicines, how do they come about and what is important for every patient to know about them?

Verified alternative

A survey carried out by 15min.lt showed that almost half of the residents is not familiar with the concept of generic medicines. In response to the question “Do you know what generic medicines are?” 49% answered yes, but 38% said they did not know and another 13% were not sure about their knowledge.

According to Lina Škiudaitė, Adviser of the Pharmaceuticals Reimbursement Division of the National Health Inisruance Funds (NHIF), medicines may be subdivided into three groups. “The first group – original medicines, those protected by a patent. The second – referential medicines, former original medicines, for which patent protection has already expired. The third group – generic medicines, which are the copies of original medicines, so-called alternatives, corresponding to the dose and active substance of the original and indications for prescribing. The latter are introduced into the market when the patent for the original medicine expires,” the specialist explained.

The patent for original medicines is valid for 20 years in the EU. Under certain conditions, manufacturers can extend this period by 5 years, which they usually do, so that maximum patent protection for an original medicine is usually 25 years.

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Lina Škiudaitė, Adviser of the Pharmaceuticals Reimbursement Division of the National Health Inisruance Funds (NHIF photo)

Generic medicines – driving force

Original medicines are produced by companies that have to carry out a series of pre-clinical studies, first in cell and tissue cultures, animals, and finally in human clinical trials, in order to develop the medicine and bring it to market. The World Health Organisation (WHO) recognizes that these stages are very expensive, cost millions and sometimes billions of euros. However, WHO analyses show that pharmaceutical companies, that produce original medicines, do not only set the prices of the medicines based on the cost of research and development, but also on commercial purposes to obtain the maximum amount that the customer is willing to pay for the medicine. This makes, for example, cancer drugs unaffordable not only for patients, but often also for countries. WHO recommends pharmaceutical manufacturers to increase transparency of corporate pricing methods.

Generic medicines are cheaper because pre-clinical and clinical trials have already been carried out to develop the original medicine. When a pharmaceutical company develops a generic medicine, it must carry out bio-absorption studies to prove the efficacy of the medicine compared to the original.

According to L. Škiudaitė, generic medicines are a driving force that reduces the prices of original medicines, which means that patients find these medicines more affordable and there are more opportunities for reimbursement. Saving money allows new innovative medicines to be added to the list of reimbursed medicines and to provide more patients with the treatment they need.

Very strict control

Sometimes you may hear doubts that generic medicines are less effective and safe. Is that fear justified?

Eglė Karinauskė, a clinical pharmacologist at Kaunas Clinics of the Hospital of Lithuanian University of Health Sciences, says that the doctor usually writes the name of the active substance in the prescription, and it is up to the person to decide which medicine to buy – the original or the generic.

“The quality of all medicines is regulated by the State Medicines Control Agency, the European Medicines Agency and other responsible authorities. In the event of any deviation, such a “batch” of medicines could not be sold. There are very strict controls. Both original and generic medicines comply with the principles of rational use of medicines and are therefore equally effective and safe,” E. Karinauskė highlights.

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Eglė Karinauskė, a clinical pharmacologist at Kaunas Clinics of the Hospital of Lithuanian University of Health Sciences

A person’s attitude can make a difference to the treatment itself, she says. “Beliefs can also lead to placebo – ‘I'm taking the original, it will make me feel better’ - and nocebo – ‘I've got the generic, it won't work’ - effects. This is why attitudes towards taking medicines are very important, and public education is very needed and can make a big difference.”

E. Karinauskė believes that the introduction of generic medicines on the market benefits both individual patients and society – competition not only makes medicines available at a lower price, but also means that they no longer depend on a single manufacturer to supply the market.

This article is a part of the pharmacy literacy campaign “Medicines don't speak”, run by the NHIF.

(Getty Image photo)

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Last updated: 24-02-2025

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