Domestic medicines vs imported ones. Debunking stereotypes

The war is changing the situation on the drug market: there is a certain shortage of imported medicines, and many of the Western pharmaceutical companies continue working in the market of the aggressor country. As a consequence, Ministry of Public Health in its appeal of March 8 calls on Ukrainians to buy medicines based on their active substance and availability in the pharmacy, and not on the trade name or brand of the drug. The information reports that all medicines of both domestic and foreign production pass the state registration procedure, therefore, all drugs are of the same quality.

Therefore, the war and the statement of the Ministry of Public Health do pushed us to take another look at the stereotypes "national producers cannot be of high quality", "imported products are always better" and "high price = high quality", which are sometimes still found in our society.* Let's try to get clear on the matter of Ukrainian medicines' quality and price.  Spoiler: buying Ukrainian medicines, you will get the same effectiveness and quality, supporting the Ukrainian economy, and saving your money.

94% of medicines in Ukraine are generic drugs (known as generics in various sources). A generic drug is a nonproprietary drug that reproduces the original drug for which the patent protection period has expired.

That is there exists an original innovative drug previously unknown, for the first time created and released on the pharmaceutical market, a drug that has patent protection for a certain period of time. In different countries, the period during which other manufacturers are not allowed to produce drugs containing its components lasts usually from 12 to 20 years . After the patent expires, generic analogues appear on the global market.

Their main advantage for the consumer is their lower price, because for the development of a completely new drug a pharma company needs about 10 years of research and approximately 1-2 billion USD .for the development of generics such period is 4-6 years and significantly less money required. A generic is a drug that has the same qualitative and quantitative active substances composition and the same dosage form as the reference drug, and most importantly, it's equivalence to the latter is proven. According to modern requirements, registration of a generic drug in the form of tablets, capsules or other so-called "Solid Dosage Forms" is impossible without a bioequivalence study. Bioequivalence studies prove that after taking the generic drug, the rate and volume of the active substance absorption into the blood are almost the same as after taking the original drug. Therefore, the therapeutic effect of the original drug and a generic drug with proven bioequivalence will be the same.

Approaches to proving generity and bioequivalence in our state do fully comply with EU legislation. Also, some domestic manufacturers, such as the pharmaceutical company Darnitsa, involve EU contract research organizations in these bioequivalence studies. At that the domestic pharmaceutical plants also meet international standards. For example, Darnitsa has been certified GMP (Good Manufacturing Practice) since 2002; and the GMP Certificate is the main document used to certify pharmaceutical industries around the world.

To summarize, let's debunk six myths about generic medicines:

• Generics are not as effective as the originals.

Generics, in order to be registered, must comply with all the legislative norms for registration and have the proven results of an equivalence study.

• Originals are produced in better factories than generics.

No at all factories must meet the same standard requirements to obtain a license. And abroad, generics can be produced in the same factories as the originals.

• Generics are cheaper, which means they are not high-quality products.

Generics are usually cheaper by 20-70% compared to the original. This is because creating an original (new) drug from scratch requires huge research funds. But thanks to certified production and research on equivalence to the original, generics have the same effect and quality.

• The generic drug does not look like the original drug, which means it does not have the same effect.

Sometimes the generic version of the drug may have a color or shape that differs from the original version, but these changes do not affect the result such drug produces. This means that a generic will involve the same therapeutic effects.

• Generic drugs take longer to take effect.

No, generics do "work" in the same way and in the same time period as the original drugs.

• Generic medicines are not as safe as the originals.

No at all Generics have the same active substance and produce their effect in the same way. So they have the same side effects as the originals.

What about abroad?

9 out of 10 recipes prescribed in the United States are generic medications. 23% of medicines in Europe, are generics.

Countries usually encourage the sale of generics and even conduct awareness-raising activities among the population about their safety and effectiveness. For example, the FDA (U.S. Food & Drug Administration) distributes booklets about generics and emphasizes that their consumption has saved the US health system up to 2.2 trillion USD over the last decade.

So, buying a drug from a domestic manufacturer, based on the same active substance as an imported analog, you not only get the same effectiveness/quality confirmed by law, and save your own money, but also support the Ukrainian economy development.

Moreover, domestic manufacturers continue their activity. Thus, Darnitsa, the largest manufacturer of packed** medicines in Ukraine, supports the country's pharmaceutical industry from the first days of the war. During the military aggression, Darnitsa handed over to medical institutions and volunteer organizations, free of charge more than 900 thousand packages of medicines for a total amount exceeding UAH 43 million.

Buy the domestic product!

Reference

PJSC pharmaceutical company "Darnitsa" was founded in 1930. Since 1998, Darnitsa is the leader in Ukrainian pharma industry in terms of drug production in kind. Strategic areas of products portfolio development include cardiology, neurology, and pain management.

* According to the GFK 2021 survey, the majority of Ukrainians consider domestic medicines to be of lower quality than imported ones. GfK Ukraine survey commissioned by the pharmaceutical company "Darnitsa", 2000 respondents, 18-55, Cities 100 thousand+, February 2021

**According to Proxima Research 2021-2022