Any patient living in the European Union is entitled access to the best therapy available on the market for their particular disease. It is one of patients' basic rights. In February this year we broadcast a report on how Slovak patients have had issues finding some of their drugs in pharmacies.
Where are my pills Máte problém s prehrávaním? Nahláste nám chybu v prehrávači.
The State Agency for Drugs Control which is in charge of supervising and regulating the pharmaceutical market in Slovakia reported that the number of drug packages re-exported from Slovakia went up last year by 21% to 1.7 million packages. The most frequently re-exported drugs included psycholeptics, diuretics and anti-viral drugs. The medicines were most frequently exported to Germany, the United Kingdom, the Netherlands, Poland and Denmark. Currently companies which want to re-sell drugs abroad are obliged to notify the State Agency for Drugs Control of their intention and it can forbid the distributor to export a particular drug if this would endanger the health of Slovak patients. The practice has displeased the European Association of Euro-Pharmaceutical Companies, an organisation lobbying in favour of re-exports. It complained against the Slovak law to the European Commission shortly after it came into force arguing that it infringes the principle of the free movement of goods within the EU. The new team that took over the Slovak Health Ministry after the general elections in March has decided to change the law in order to fight against medicine shortages on the market and please the European Commission at the same time. Deputy Health Minister Andrea Kalavská explains how they plan to do it.
I think that there are multiple causes for the shortages of drugs on the Slovak market. It could be that producers have some outage or they can be caused by poor working relations between pharmaceutical companies, distributors and pharmacies. But I suspect you are more interested in the re-export business which is a big problem. The Health Ministry has prepared some changes with the law on medicines which aim at minimizing the effects of this business on Slovak patients and to improve their access to medicines. It will be the producer itself or the registration holder for a particular drug on the Slovak market that can re-export it. Distribution companies will be allowed to do it only with the specific permission of the producer or registration holder. This way we reduce the motivation for re-export because if you register a drug here where we have low prices it means that you want to put it on this market and sell it here.
Anca Dragu : But do you have any data on to what extent re-export is the root cause for the shortage and to what extent other factors play an important role, apart from what you have already mentioned, it could also happen that a pharmaceutical company decides to withdraw a particular drug from the market by not prolonging its registration for example?
Andrea Kalavská: No, I am not able to tell you concrete numbers because there are no such studies on this topic in Slovakia - but all we can do at the Health Ministry is try to limit the re-export business because I think that this has biggest contribution to the shortages of medicines.
AD: Currently, companies which want to re-sell drugs abroad are obliged to notify the State Agency for Drugs Control of their intention and it can forbid the distributor to export a particular drug if this would endanger the health of Slovak patients. The practice has displeased the European Association of Euro-Pharmaceutical Companies, an organisation lobbying in favour of re-exports which complained against the Slovak law to the European Commission arguing that it infringes the principle of the free movement of goods within the EU. What is the situation right now with that complaint?
AK: This complaint was made against the current legislation but the new law will change things because the producer itself or the registration holder for a particular drug on the Slovak market will be in control and will inform the State Agency for Drugs Control in seven days that a drug will be re-exported without the need to ask for permission. This way we try to please the European Commission and we will see if they will be satisfied with our solution or not.
AD: How have the distributors reacted to
this plan?
AK: I think that those which are directly targeted are obviously unhappy but this is not the Health Ministry‘s concern. Those companies which do conduct their business properly and fulfil their mission to sell medicines to Slovak pharmacies welcome such changes. When we began working on changing the law we created a big working group that included the representatives of distribution companies, those of the Association of Innovative Pharmaceutical Industry…
AD: Did you also have representatives of the producers of generics?
AK: We had only the Association of Innovative Pharmaceutical Industry because generics are already cheap so are not often re-exported.
AD: There are generic drugs which are cheaper in Slovakia than in other countries so they are re-exported to those countries in order to cash-in on the price difference.
AK: Yes, but the re-export mainly affects the originals.
AD: How do you know, if you don't have studies on re-export in Slovakia?
AK: We know this based on our discussions with both generic and innovative drug companies. At the beginning we had two meetings with these companies, distributors, pharmacies’ representatives, patients’ organisations and the State Agency for Drugs Control - and they chose whom to put in the working group that together with our experts from the Drug Policy Department have drafted the changes to the law. We called all of them on purpose, in order to avoid all sorts of complaints afterwards.
AD: There is no secret that the current model failed to achieve the expected results also because the State Agency for Drug Control does not have sufficient administrative capacity to conduct inspections on those companies involved in re-export. Some did not even bother to report their intention to do so. The Health Ministry which is in charge of licensing drug distribution companies has also limited capacity to control if these companies fulfil their obligations on paper only and a simple check in the available databases reveal that some are letter-box companies with no employees but millions of euro in turnover. The new law implies some controlling mechanisms too. How do you plan to fix this problem of lack of administrative capacity? How many extra people you plan to hire?
AK: We plan to make the whole distribution process more transparent from producer to distributor and pharmacy. It means more controls and done more often. Of course we will have to hire new people but I cannot tell you know how many but we should have an estimate in about two months.
AD: It’s widely known that the public administration in Slovakia does not offer good salaries and as you surely know there is a shortage of qualified people when it comes to healthcare policy expertise. Where do you plan to recruit these new employees from?
AK: I think that Slovakia is a country with a high unemployment rate so I think we can find employees. I can't perform miracles: I have to work with what I have in the specific conditions of this country.
AD: How will you motivate them to work for you given the fact that they have to be immune to corruption given that on the other side is big pharma with a lot of money to spend? How can you prevent them from switching sides after a while?
AK: The Slovak Health Ministry will never be able to offer salaries higher than the pharmaceutical companies. Is this what you wanted to hear? I appeal to the morality of our people because it is easy to complain that I can’t find my drug in the pharmacy but what do you do to fix this problem?
AD: Slovakia is a small market and it also lacks the administrative capacity to deal with the lobby of big pharmaceutical companies; mainly the innovative ones. Some new drugs are offered at such prices that it risks ruining the entire Slovak healthcare budget. Other countries in the region are in a similar situation and Slovakia has decided to join 10 of them Romania, Bulgaria, Hungary, the Baltic States, Croatia, Serbia and Macedonia and Poland in fighting in common for better access to medicines for their patients. At what stage is this project at the moment?
AK: Indeed we need to regulate the access to this innovative drugs in such a way that they would be available for our patients but will not ruin the budget. Of course you have a different position when you negotiate on behalf of patients from 11 countries instead of just 5 million Slovaks. We have already had two meetings in Sofia and Bucharest with another one scheduled for September and we have discussed how this cooperation could look like in concrete terms. We have created here in Slovakia our own working group and we have a liaison officer that communicates with partners from the other countries.
AD: One of the discussed proposals is to create a common agency that would hire good lawyers and lobby in favour of these countries at the EU level. How realistic is it?
AK: Yes, I think it is. All of us have problems with re-export on one hand and on the other we are all quite poor European countries so we realize that we have to find a solution to bring innovative therapies to our patients at affordable prices. We have to try it and we are all motivated to make it work. Now we have a draft agreement which each country has to work on in order to harmonize it with its own legislation and we will discuss the results in September.
Concludes Deputy Health Minister Andrea Kalavská. The Slovak Parliament is to discuss the changes to the Law on Medicines in autumn.
