How Ukraine is strengthening the quality control of medicines
Ukrainian MPs are changing the healthcare system step by step. We continue to implement the health care reform and address the problems facing the industry.
One of them is the quality of medicines. Due to the imperfect legal framework, Ukrainians often buy expensive imported medicines of dubious origin. We want to supply Ukraine with medicines the same quality and effectiveness as in the EU and the US. I will explain what caused this problem.
Today, in Ukraine, there is no strict control over medicines. There are several reasons why a medicine purchased at a pharmacy may be ineffective: improper storage and transportation, the manufacturer’s desire to save on components, equipment, technology. As a result, the medicine which was registered in Ukraine formally corresponds its characteristics. However, the medicine that citizens buy in a pharmacy do not correspond the stated quality. In fact, it is a fake but legal, has branded packaging and all the necessary documents.
I will note that the inconsistency of the declared quality of medicines is a problem faced also in the countries of the European Union. In the EU, this issue is resolved as follows: full responsibility for the characteristics of a medicinal product during its “life cycle” rests with the holder of a trade license (in Ukraine — it is called a “registration certificate”).
According to the EU laws, it is the holder of the registration certificate who is responsible for the safety, efficacy and quality of the medicinal product, who performs pharmacovigilance and has responsibilities related to compliance with the requirements of good manufacturing practice (GMP). Importantly, the owner cannot be a non-resident company. And this is quite understandable, because it is more realistic to prosecute a resident if a batch of their medicine which entered the EU market turns out to be of poor quality.
Ukrainian law does not currently clearly define who can be the holder of a registration certificate for a medicinal product, what their functions are, and what their responsibility is in the event of a breach of the law. Therefore, even after detecting a systematic defect, regulatory authorities do not have a real opportunity to bring the owner of the medicine to justice.
After all, the owner can be located in another country, outside the Ukrainian legal field, and ignore the requirements of the Ukrainian regulatory authorities. This situation provokes the active distribution of low-quality medicines in Ukraine: some Asian manufacturers understand that in the absence of strict controls such as those in the EU, they can supply lower quality products to Ukraine.
The Committee on Public Health of the Verkhovna Rada, which I am the chair of, has clearly formulated the requirements for the holder of a registration certificate, by analogy with the EU law.
The holder of the registration certificate must be responsible for the safety, efficacy and quality of the medicinal product, the accuracy of the information provided, and pharmacovigilance. It is obvious that the control will be effective only if the owner is a legal entity registered in Ukraine. In this case, it is much easier not only to find the officials of the registration certificate holder, but also to bring them to justice.
The relevant bill has already been submitted to the Verkhovna Rada. It introduces a long transition period, during which certificate holders must bring their documents in line with the law.
Another initiative is the draft law “On Medicines”. It is a systematic, comprehensive bill that will allow us to adapt our legislation to the European one. It will also strengthen laboratory quality control of medicines. This code provides the regulatory body and the consumer with complete information about the medicine and its origin, preventing counterfeits from entering the market.
The third change we propose concerns the online trade in medicines. Online selling of medicines is evolving around the world and becoming more popular every year. Today, in Ukraine, this sphere is semi-legal: the consumer has no guarantee that they will receive a quality medicine and not a counterfeit. Therefore, we have prescribed a clear mechanism on how to protect citizens and make the sale of medicines online legal.
Licensing of market operators engaged in distance trade in medicines is being introduced. The license must be placed on the main page of the site which sells medicines. Thus, each of us will be able to immediately understand whether the site is official or not. There will also be clear rules for the delivery of medicines through courier services or by post.
Online trade almost always reduces the cost of goods. The issue of more affordable medicines is very relevant for Ukraine due to low incomes of citizens. For example, according to official statistics in June, the average salary of a Ukrainian citizen was $ 410.
Thus, the changes in the legislation that I mentioned above will allow the state to better control the quality of medicines, reduce their cost and bring the legislation in line with EU requirements.