The introduction of strict administrative regulation of drug prices could lead to a shortage of high-quality European drugs and their replacement with cheaper analogues from India and other countries . This is warned by Ivan Zelensky, director of the Drop of Blood Charity Foundation .
- How do you think the new price regulation will affect the availability of medicines for patients? Do you see a risk that due to the introduction of restrictions, manufacturers will reduce supply or withdraw certain drugs from the market?
This is a very risky bill. In general, if we have a market economy in the country, and the state begins to interfere in the market, introducing additional regulations, then this is not very good. Some drugs may, on the contrary, become more expensive, not cheaper, and some drugs may disappear from the market altogether . That is, it will become unprofitable for them to sell their goods in Ukraine, and they will leave.
- Will the innovations affect the implementation of treatment protocols, since they prescribe certain drugs, including imported ones, which, according to the warnings of the professional community, may disappear?
I can comment on my field, oncology. The main molecules are purchased through the nomenclature of government procurement. And there it is more or less normal, there are long-term contracts and the risk is small.
The risk is where the pharmacy segment is, where retail is. In retail, every drug competes with each other on the shelf.
- Will the innovations affect the physical availability of medicines, including imported ones? After all, associations such as the European Business Association have already expressed concern on the part of foreign companies.
They are right. In fact, in our country, what a story: the market can be conditionally divided into three parts. One part is European manufacturers, there are generic or original. Another part is our Ukrainian manufacturers, we have quite powerful pharmacology. And the third part is Indian manufacturers, whom we, unfortunately, let into our market very much. And they put a lot of pressure on our manufacturer, and especially on the European, with their low prices. Therefore, this law risks leading to the fact that the Europeans will leave, and the Indians will survive. And this will hit our manufacturers a lot. And there are problems with Indian manufacturers. First, because of the quality, and secondly, they may not deliver the drug on time.
Therefore, I share the concerns of the European Business Association.
- Is there a risk 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?
Yes, and it is possible. That is, if brands are leaving the market, conditionally, and only cheaper options remain, then in the cheaper options there is always a risk that they will be of poor quality. This is how it works with everything. It is one thing to buy a branded car, and another - some kind of fake. It is the same with medicines.
- 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?
The very first thing I would do is ban access to our market for cheap Indian manufacturers. That is, we cannot completely abandon Indians. Good Indians, those registered in Europe, must be left. All the others must be removed from the market. Moreover, we are now working very closely in unison with Europe. Sooner or later we will get into the European Union. And Europe does not let cheap and low-quality Indians into its market.
Second, we need to expand the “Affordable Medicines” program as much as possible and cover the main areas of treatment for Ukrainian patients with it. In this way, we will preserve the market and give the patient the opportunity to choose whether to take a cheap option for free or pay extra and take an expensive option. This is how European markets work.
Reimbursement is a chance to avoid a shortage of precisely those drugs that actually treat . Because if all sorts of hepatoprotectors, neuroprotectors, or antivirals disappear from the market, conditionally, no one will die from it. This is fuflomecin. Ukrainians actually buy fuflomecin. If they disappear, nothing terrible will happen. And if antibiotics, conditionally, original ones disappear, it will be such a serious shock.
Of course, we still need to look at that collusion. My understanding is that this bill is designed to break the collusion of two distributors. We can't say that it doesn't exist, but it most likely arose historically, not because of collusion. That is, the others simply worked worse, and in the end, these two distributors - Optima and BaDM - survived in the competitive market. So, they survived, and the smaller ones died. Perhaps we should let two or three more distributors work in this market. But these are very subtle tools. The Americans know how to do it somehow. And here they stupidly flouted the law, made this 20%, and it's not a very good story.
- Has your foundation contacted the government or relevant authorities with proposals for more balanced regulation of drug prices?
We are currently considering a petition to the President to veto this law. But we do not yet have a consensus.
We are now advocating, firstly, a law on parallel imports, because it will not fundamentally solve the problem, but it will give the market a little more air. It will be possible to import drugs from Europe through parallel imports, and not only from Europe. And secondly, we propose to the Ministry of Health to expand the reimbursement program. We, from our oncology community, have proposed several molecules that should be included in the reimbursement program, and thereby prevent their disappearance from the market, and vice versa, leave competition on the market.
