Re-export of drugs in the Slovak Republic
The Slovak Republic has a recurring problem with insufficiency of drug supply. Generally there are not enough vaccines for children, and cancer and heart disease medications are in short supply. Patients are very unhappy because of these shortages and are understandably upset when they are unable to purchase their medication at the pharmacy. Recently, in early January 2016, there was a shortage of heart disease medication in Handlová (located in the centre of Slovakia).
According to the State Institute for Drug Control (Štátny ústav pre kontrolu liečiv - SUKL), these are the main reasons for the drug shortages:
- (i) Re-exportation (the subject of this article);
- (ii) Poor logistics;
- (iii) Poor customer relations between pharmacies and distribution companies; or
- (iv) Other subjective factors, such as a growing number of patients and a lack of growth in supply.
Re-export mainly refers to drugs that are profitable for export. They are usually non-generic, relatively expensive drugs, such as cancer medication, vaccines, immunological medicinal products and osteoporosis medication sometimes used in rheumatology. In many cases the drugs are necessary for the treatment of serious and high-risk diseases which cannot otherwise be treated.
SUKL is trying to improve the situation by regularly monitoring the level of supplies of drugs. If there is a risk that certain drugs will not be available on the local market, requests for legal export of these drugs from Slovakia are denied. The list of drugs and human medical products with export permission denied from Slovakia is available on SUKL's official website and is regularly updated:
However, according to SUKL, non- availability of drugs is not always due to re-exportation. In most cases, it is caused by poor logistics and customer relations between pharmacies and distribution companies, or other subjective factors.
The Slovak Chamber of Pharmacies (Slovenská lekárenská komora – SLK) believes that some distribution companies and pharmacies are created solely for drug re-exportation from Slovakia. This has resulted in decreased prices. Drug prices in Slovakia are among the lowest in the European Union, and therefore re-exportation is lucrative to those countries where prices are higher.
The Association of Drug and Health Device Suppliers (Asociácia dodávateľov liekov a zdravotnícky pomôcok -ADLZP) also sees a problem in the illegal re-export and condemns this type of drug trade in official statements. They admit that there are certain drugs that are still not available and patients often have to wait a month or even longer for their medication. Even though manufacturers import medicines in quantities sufficient for the needs of the Slovak population, the drugs are not made available to patients due to re-exportation. According to the ADLZP, this problem cannot be solved by purchasing larger quantities of drugs as there is not enough supply on the market. Pharmaceutical companies plan their production quotas for each country six months in advance. They determine how much to produce by calculating the average number of people who have a certain disease.
The Ministry of Health in Slovakia (Ministerstvo zdravotníctva Slovenskej republiky) anticipated long term problems with the re-export of drugs. The ministry, under new administration, began regular monitoring of access to drugs, including vaccines. Since 2015 it has implemented more than thirty (30) new administrative procedures and instituted more than € 250,000 in fines for non-availability of drugs and medicines. At the latest meeting with SUKL and representatives of relevant groups and associations (which took place at the Ministry on January 20, 2016), the government proposed legislation that would strictly prohibit re-export of drugs. During its Presidency of the European Union, the Netherlands unequivocally declared that a priority in drug policy will be the re-export of drugs and how this contributes to a lack of available medication, not only in Slovakia, but in other European Union Member States as well.
Analysts disagree about a permanent prohibition of drug re-exportation. They believe that it is not possible, due to the existence of free trade laws between Member states of the European Union. A potential solution is to set a standard price for brand name drugs in the European Union, resulting in increased costs for health insurance companies. However, if this happens, they may continue to re-export medication in retaliation.
As the Ministry has not yet published their strategy to limit re-export, this issue is still under debate. Both industry professionals and the general public will have to wait and see what happens.
This article is part of the International Life Sciences Update for April 2016
