Manual regulation of prices for medicines will lead to delays in the supply of imported drugs, their shortage and rise in price - Patients of Ukraine

The government's proposed restrictions on markups on medicines may lead to a reduction in supplies and the withdrawal of international companies from the Ukrainian market . UNN asked Inna Ivanenko, Executive Director of the CF "Patients of Ukraine", what this means for Ukrainian patients, how it will affect treatment protocols, and whether it is possible to reduce prices without compromising the availability of drugs .

• In your opinion, how will the new price regulation affect the availability of medicines for patients? Do you see a risk that manufacturers will reduce supply or withdraw certain medicines from the market due to the restrictions?

In our opinion, the new manual regulation of drug prices, which was prescribed and adopted in a hurry in the draft law 11493, offers almost no effective tools and will not lead to a real reduction in the cost of medicines in Ukrainian pharmacies. Moreover, it is likely to provoke significant delays in deliveries, shortages of medicines in pharmacies and higher prices for medicines, which will worsen patients' access to treatment.  The NSDC's decision also contained few provisions that could destabilize the market, but the emphasis on expanding reimbursement and the need to implement the provisions of the Bolar is positive.

("Bolar Rule" is a provision according to which actions taken by the applicant of a generic drug (analog) to conduct trials and state registration of such a drug before the expiration of the patent are not recognized as infringement of the patent for an original drug - ed.)

• Will the innovations affect the implementation of treatment protocols, since they contain certain drugs, including imported ones, which, according to the professional community, may disappear?

It is still difficult to predict what impact this will have.

• Will the innovations affect the physical availability of medicines, including imported ones? After all, associations such as the European Business Association and the European Business Association have already expressed concerns from foreign companies.

Indeed, Law No. 11493 contains a requirement proposed by Yulia Tymoshenko that a manufacturer must supply one distributor with no more than 20% of the net income from the sale of a drug for the previous year. In this way, the market will be artificially regulated, with 1 distributor able to supply up to 1/5 of the total volume of the drug on the market. If the other distributors do not purchase the entire volume of medicines from the manufacturer (up to 20% each), the manufacturer is given the right to supply distributors with more than 20% of the volume of medicines. 

This means that foreign  drug manufacturers must now look for new distributors to supply their drugs to Ukraine and have the capacity to properly distribute them to pharmacies. For patients, this is a risk that new players will not have the necessary logistics and operational capacities to ensure transportation, storage of medicines in appropriate conditions, and delivery, especially to remote communities. It is also unclear how new drugs that have never been sold on our market will enter the Ukrainian market. It is unclear how 20% of sales revenue for the previous year will be calculated. These innovations will create a lot of bureaucratic obstacles for manufacturers and may cause a shortage of medicines. 

• Is there a danger that some patients will be forced to switch to less effective or cheaper analogs? Could this worsen the quality of treatment and cause additional health risks?

The shortage of medicines that may result from a number of changes may lead to the suspension of treatment for patients when Ukrainians simply cannot buy medicines due to their unavailability or overpriced prices. Therefore, patients will start switching to other medications not because of the doctor's decision, but because the drug is not available in the pharmacy. In addition, this may lead to an increase in "gray" procurement  of medicines from the EU, Turkey and other countries where medicines can be purchased at lower prices. These are illegally imported medicines, which the patient cannot be sure that the storage and transportation conditions have been met. 

• What other risks do you see in the new regulation of the pharmaceutical market for patients? What changes, in your opinion, can make the situation more balanced so that those who need constant treatment do not suffer?

The main concern from the patient community is that medicines may disappear from pharmacy shelves, and those that do reach them may increase in price. This is a very dangerous situation for Ukrainian patients, who may not be able to buy the necessary medicines even at their own expense. 

We are convinced that in order to improve patients' access to medicines and reduce their prices, it is necessary to promote natural competition in the market. In particular, one of the few positive points approved in the NSDC decision is the expansion of the list of reimbursement of medicines, which will reduce the price of these medicines and out-of-pocket expenses for patients, as such drugs are fully or partially covered by the state. In neighboring countries such as the Czech Republic, Latvia, and Poland, more than 70% of medicines are reimbursed to patients. 

• Can reference pricing lead to higher prices for imported drugs and does this mean that Ukrainian patients will be deprived of access to the best international medical developments?

In general, price reimbursement should lead to lower prices for medicines. This is how the Affordable Medicines reimbursement program works. However, it is still unclear how the government officials plan to administer the process, from which countries prices will be taken for comparison, and for which medicines this approach will be applied. It is still difficult to talk about the consequences of reference pricing for patients, because it is very important how the bylaws will be written. In addition to the above, there are 17 thousand medicines registered in Ukraine. It is not known how to carry out the  referencing procedure in 2 months. Market players claim that even this technical issue may lead to a market collapse within the next 2-3 months.  

• What alternative solutions would you suggest to reduce the cost of medicines without the risk of their shortage or disappearance from the market?

Our patients' community believes that only by promoting natural competition in the pharmaceutical market can prices for medicines be reduced. In particular, for 7 years now, we have been emphasizing the need to introduce a parallel import mechanism for all drug sales channels  in Ukraine (public, hospital and pharmacy). This is a mechanism in which  medicines are imported from other countries (where these medicines are sold at lower prices) by legally independent suppliers, without the participation of the official representative of the manufacturer, but in compliance with all quality and safety standards. This way, the monopoly of distributors is overcome. And patients who need expensive and long-term treatment can buy quality medicines at market prices in the EU. 

The parallel import mechanism has been in place in the EU for over 20 years and has helped reduce drug prices by 20%. As a result, Germany saves €202 million annually, Sweden saves €60 million, and Poland saves €67 million per year. Since 2025, the parallel import mechanism has been allowed in Ukraine for public and hospital procurement. However, this does not solve the problem of inflated drug prices, and the state does not cover all patients with the necessary treatment. Therefore, we call for the introduction of parallel imports for pharmacies. This will expand the range of products and increase competition. It is also important to expand the list of Affordable Medicines and fill it with evidence-based effective molecules.

• Has your foundation addressed the government or specialized authorities with proposals for more balanced regulation of drug prices?

Thus, our Foundation has repeatedly raised the issue of introducing parallel imports for pharmacy procurement. In particular, recently we addressed the President of Ukraine with a letter from the patients' community calling to promote the introduction of parallel imports as an effective tool to reduce the prices of medicines in pharmacies.