In Slovakia, we have a problem with the availability of innovative medicines, in this respect we lag behind not only the neighboring countries - the Czech Republic or Poland, but also Slovenia, Croatia and Bulgaria. "Pharmaceutical companies do not rank Slovakia among attractive markets. Our market is small and at the same time we have strict and complicated price regulation," explains Peter Marenčák, specialist in health law from L/R/P advokáti, s.r.o.

In Slovakia, unfortunately, the fates of terminally ill people who are forced to organize collections because the insurance company refuses to reimburse them for the necessary medicine resonate. Why is this happening?

Unfortunately, situations where patients are forced to look for alternative ways of financing treatment tend to be the result of several factors. A common problem is that the drug in question is not categorized in Slovakia, i.e. included in the list of drugs covered by public health insurance by default. If the drug is not categorized, the health insurance company does not have to reimburse the insured, but can only - on the so-called exception. In addition, insurance companies have a limit set by law on the amount of money they can spend in a calendar year to pay for medicines for an exception, while the law also orders them not to agree to an exception that would exceed the given limit. As the limit is used up during the year, at the end of the year, patients have, logically, less chance that the insurance company will approve the exception than at the beginning of the year, when the limit has not yet been used up.

Do innovative medicines reach the Slovak market later than in other EU countries?

Yes, that's right. In Slovakia, we have a long-term problem with the availability of innovative medicines, and in this respect we lag behind not only neighboring countries - the Czech Republic or Poland, but also countries such as Slovenia, Croatia or Bulgaria. After the legislative change in 2022, there was a certain shift and increase in the entry of new drugs and indications into the categorization, but often, especially in oncology, these are drugs and indications that were registered at the European level long ago and are in other member states already a therapeutic standard. We still have reserves in the inclusion of the absolutely newest innovative drugs and indications. According to the latest analysis of the Association of Innovative Pharmaceutical Industry, 59 modern oncology drugs were registered by the European Medicines Agency between 2020 and 2023, of which 7 were covered by public health insurance in Slovakia at the beginning of this year, while 13 in the Czech Republic, 19 in Poland and Slovenia, and Bulgaria even up to 22 medicines.

How can medicines enter the Slovak market?

Mass-produced medicines can enter our market immediately after they are registered. Drug registration means the process in which the effectiveness, safety and quality of the drug is scientifically verified and a decision is made on granting permission to market the drug. If a medicine is registered, it means that it is effective, safe and can be used in the provision of health care. Medicines are registered in our country by the State Institute for Drug Control, but not always. According to European legislation, many new medicines must be registered through a centralized procedure at the EU level, when the European Commission issues a decision on their registration based on the evaluation of the European Medicines Agency. Such registration is valid throughout the EU. However, the registration of the drug itself does not guarantee that the drug will be covered by health insurance companies on our market. This is precisely what the categorization is for, which represents a separate process led by the Ministry of Health, in which it is decided which registered medicines, in what amount and under what conditions, will be covered by public health insurance by default. Therefore, expensive innovative medicines do not actually enter our market immediately after registration, but only after they have been classified and reimbursed by the public health insurance. Until then, they are unaffordable for patients and therefore unsellable on the market. At the same time, it is true that only by including the drug in the categorization does the pharmaceutical company have the obligation to ensure its availability on our market in sufficient quantity.

What is the reason for the slower entry of innovative drugs into our market?

First of all, the pharmaceutical company itself must be interested in the categorization of its medicine in Slovakia and submit the relevant application. Without this, the ministry cannot include any medicine in the categorization. I am pointing out this, at first glance, banal fact for the reason that pharmaceutical companies do not rank Slovakia among attractive markets. Our market is both small and at the same time we have strict and complicated price regulation. Another possible factor is the length of the categorization procedure. According to the law, the ministry should make a decision within 180 days from the receipt of a complete application, but the entire process of listing the drug often takes a year, sometimes even more. Bureaucratic obstacles are also a problem. For example, the requirement to submit at least five officially determined drug prices from other EU states when categorizing a new original drug, otherwise the ministry will not be able to grant it more than a 20 percent reimbursement. Such a requirement de facto forces companies to wait with the categorization of the drug in Slovakia until they undergo price regulation in at least five other member states. A practical problem for innovative medicines is also the absence of older comparable medicines in our categorization, with which they could be compared for the purpose of proving their cost-effectiveness.

You mention that we have strict and complicated price regulation. In what specifically?

According to the law, the officially determined price of a categorized drug, i.e. the manufacturer's maximum price, must not be higher than the average of the three lowest prices of the drug from other member states. For this purpose, the prices of categorized medicines in our country are regularly referenced, that is, they are compared with the prices in the EU. This happens up to twice a year for the latest categorized medicines. For the second year in the law, there is also an institute of special price regulation, allowing to temporarily avoid referencing and to have a higher price than the average of the three lowest in the EU, but only if there are circumstances worthy of special attention, precisely defined by the decree. Another pressure to reduce prices is brought by the regular quarterly review of reimbursements by health insurance companies. All these measures result in the prices of categorized medicines in Slovakia being among the lowest in the EU. On the one hand, this helps to save public resources, but on the other hand, it does not act as a motivating factor for companies, taking into account the fact that the possible low regulated price of the drug in Slovakia may affect their pricing in markets in much larger member states than ours. At the same time, the low prices of medicines motivate various speculative traders to illegally re-export them from Slovakia abroad, which in turn causes problems for our patients and the pharmaceutical companies themselves.

As part of LRP lawyers, you represent various pharmaceutical companies, what problems do they most often contact you with?

Clients from the pharmaceutical sector turn to us with problems from all areas of pharmaceutical legislation and legal and ethical regulation of their sector as such. The above also applies to clients operating in the medical devices sector. For a long time, I have specialized in solving various problems and disputes, including legal ones, in the field of categorization, whether in matters of classifying medicines and medical devices, changes in their officially determined prices, reimbursement by health insurance companies, indication restrictions and many others.