The administrative price cap proposed by the new rules for regulating the pharmaceutical market may lead to the disappearance of important drugs, especially imported ones, which will reduce patients' access to quality medicines. This opinion was expressed in an interview with UNN by the executive director of the Tabletochki Foundation Vyacheslav Bykov. According to him, this may provoke a switch to cheaper analogs with lower efficacy, which will negatively affect the quality of treatment in Ukraine. As an alternative, he suggests deregulation, simplification of market entry for new drugs, and the introduction of the Track&Trace system to combat counterfeiting.
- How do you think the new price regulation will 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?
It is difficult to make predictions. Deep inside me, I still have a hope that the NSDC knows something that I do not know and do not understand, and therefore has mechanisms and levers to compensate for the negative effects of administrative regulation of the market. But the realist in me recalls how difficult it can be for the State Enterprise "Medical Procurement of Ukraine" to persuade a supplier to participate in a tender because the latter is not comfortable with the ratio of the expected price and the strict terms of government contracts, and how the Tabletochki Foundation has to buy what the state does not want to sell.
- If the state policy provides only for administrative price reductions without compensatory mechanisms, the probability of gradual withdrawal of certain drugs from the market is quite high.
We shouldn't forget that there is no restriction that our market can't find a creative way to meet. I am waiting for new "schemes" to appear.
- 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?
They won't, because there are no protocols ("national standards" in regulatory language). And they do not exist, in particular, because they are afraid to adopt them in the form they are used in Europe, because it is impossible to fulfill them - we simply do not have certain drugs or procedures. And it seems that manufacturers have now received a warning rather than a signal of comfortable conditions for entering the market, which suggests that neither new drugs nor new protocols will appear in the near future.
- Will the innovations affect the physical availability of medicines, including imported ones? After all, associations such as the European Business Association have already stated their concerns about foreign companies.
Time will tell. Only one thing is certain - our market will become less interesting for most reputable pharmaceutical companies.
- Is there a danger that some patients will be forced to switch to less effective or cheaper analogues? Could this worsen the quality of treatment and cause additional health risks?
In the context of medicines, analog does not always mean the same. Sometimes, even the same substance, in the same dosage and form, but from a different manufacturer, can work worse than the original drug. The content of impurities and excipients should be noted separately. Cheaper drugs may mean a higher risk of intolerance or allergic reactions. I know of several cases where doctors massively refused to use cheap drugs that came through public procurement because of this. If cheap generics take the place of original drugs in Ukraine, we can expect a decline in the quality of life during and after treatment.
- 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 ongoing treatment do not suffer? Is there a risk that vital medicines that are needed by patients in your organization will disappear from the market? Please tell us more about this.
There are two paradoxical risks that the President's initiative will have the opposite effect. It seems that medicines should become more accessible and cheaper, but in practice, this may lead to the disappearance of expensive drugs from the official Ukrainian market (unavailability) and their rise in price on the black market.
The alternative solution that I see is also paradoxical - deregulation instead of administrative influence.
I would suggest simplifying market entry for new companies and drugs, not requiring registration in Ukraine if there is a registration in the EU. The packaging should remain in English, and the importer should be obliged to translate the instructions for medical use. At the same time, implement the Track&Trace system at the state level to combat counterfeiting and illegal imports. This will increase supply, which will stimulate competition and thus lower prices.
In parallel, we must work to increase the real purchasing power of the population. With a pension of UAH 2,800, any price for medicines will be too high.
These are slow and unpopular solutions that require even more difficult and unpopular measures, but not everything that is popular is right.
Recall
The Verkhovna Rada passed in the second reading the draft law No. 11493 on the regulation of the pharmaceutical market. In particular, one of the provisions is the establishment of a margin of 8% for distributors and representative offices of foreign pharmaceutical companies.
The European Business Association has previously called on the President of Ukraine to veto the draft law passed by the Parliament due to concerns that the innovations may negatively affect the health of patients.
Add
Health Minister Viktor Lyashko did not rule out a possible reduction in the range of medicines in pharmacies after the law comes into force, which could affect the availability of medicines for Ukrainians.