An increasing incidence of supply problems for essential and non-substitutable medicines in Slovakia, due to parallel exports – caused by the downward price spiral in the country – is compromising patient care, according to local reports.
IHS Global Insight perspective
Patient care is being put at risk in Slovakia, as the increased incidence of parallel exports of prescription medicines from the country is resulting in supply problems, even in the case of essential and non-substitutable medicines to treat serious conditions.
Changes in the system of international reference pricing in Slovakia in the past five years are being seen as one of the main causes of the current situation.
Parallel exports are becoming an important regional problem in central Europe, with governments in neighbouring countries following Slovakia in seeking to impose some restrictions on the practice. However, with the same governments equally keen to ensure that the public drug bill is kept low, it is hard to foresee any great improvement in the situation.
Parallel exports result in supply shortages
Falling prices of some expensive prescription medicines in Slovakia is resulting in supply shortages, as levels of parallel exports from the country increase, reports Slovak medical news provider Mediweb. As the source reports, there are shortages in the supply of medicines used in the treatment of psychiatric and neurological disorders, epilepsy and other serious conditions, for which patients would not otherwise switch treatments, and for which there are no substitutes on the market. Thus, patients are being put at risk due to the increased levels of parallel exports. With prices of medicines in Slovakia – particularly originators – considerably lower than in a number of European Union countries, it is a lucrative activity for wholesalers, especially in view of the low prices which they face within the country itself.
New parallel export bans may be on the way
The Slovak State Institute for Drug Control (ŠÚKL) has already instigated temporary bans on the export of medicines, imposing the bans in May and July this year, the source reports. According to Janka Rajnohová of the ŠÚKL, quoted by the source, bans are being prepared for five other drugs, with the institute having identified instances in which availability is being threatened for Slovak patients, although, as she emphasises, the final decision is yet to be made. Specifically, these are reported to be anti-epileptic, antipsychotic, antibiotic, and anticoagulant drugs.
The ŠÚKL reportedly remains in contact with specialists in particular therapeutic areas to assess the ongoing availability of treatments, and publishes notices of its intention to ban parallel exports, while also maintaining contact with pharmaceutical companies – discussions have been held with the Slovak Association of Research-based Pharmaceutical Companies, and the association of generics producers in the country, Genas. However, the Slovak Ministry of Health (MoH) is reported as stating that information about high levels of parallel exports are unfounded.
Shortages affect schizophrenia patients
Nevertheless, a psychiatrist from Bratislava, Barbora Vašecková, is quoted by Slovak newspaper Plus 7 Dni as saying that medicines for treating schizophrenia – in particular the long-acting Zypadhera (olanzapine; Eli Lilly, United States) and Xeplion (paliperidone palmitate; Johnson & Johnson, US) – are in short supply. This is in spite of the fact that, as the source states, the companies supplying these medicines have confirmed that they are delivering sufficient quantities. As Ms. Vašecková is reported as saying, this can create serious problems for schizophrenia, particularly since those drugs reported to be in short supply are long-acting versions of popular schizophrenia treatments, and are usually used in the treatment of patients with a problematic compliance history.
More drugs affected
Furthermore, Igor Minarovic, the vice-president of the Association of Slovak Pharmacists, is reported as saying that the anti-epileptic drug Lyrica (pregabalin; Pfizer, US) is in short supply, as well as anti-rheumatic and oncology drugs. Additionally, there is reported to be a shortage in the supply of Seretide (salmeterol; GlaxoSmithKline, UK) for the treatment of cystic fibrosis and other respiratory disorders, with serious problems for patients whose treatment is interrupted.
Pharmacies buy specific drugs in order to sell to distributors
As Mediweb reports, according to the Law on Medicines and Medical Devices introduced in December 2011, patients should not wait more than 24 hours before receiving any prescription medicines from a pharmacy. However, in the current situation, patients can reportedly be waiting for several weeks. A proportion of pharmacies operating in Slovakia – and in particular public pharmacies – purchase particular drugs and then sell them to distributors which then export them – specifically, to Germany, the Czech Republic, and Scandinavian countries, where they fetch a considerably higher price than in Slovakia. The source reports that out of the total Slovak pharmaceutical market – valued at around EUR1 billion (USD1.3 billion) annually – around 30% is accounted for by parallel exports. The declining prices of medicines in Slovakia, which is at the root of the problem, is blamed principally on the change in the regulations on international reference pricing (IRP) introduced in the aforementioned law, under which the price of medicines in Slovakia began to be calculated on the basis of the second-lowest price in the European Union.
Outlook and implications
Until the December 2011 change, the IRP system in Slovakia was based on referencing the average of the six lowest-priced countries in the EU, a system which came into force at the beginning of 2008. However, it was not fully and systematically applied until 2009, and it was then that the prices of medicines – and in particular originator medicines – started to decline in the country.
Until then, Slovakia had some of the highest prices in the EU for originators. The situation has become almost completely reversed now. Problems with parallel exports began to manifest themselves during 2012, when the price reductions for originators began to escalate with the change to the IRP system. In reaction, the Slovak MoH decided to introduce legal changes to give the ŠÚKL powers to regulate parallel exports (see Slovakia - Europe: 7 September 2012: Slovak Government's Plans to Restrict Parallel Exports of Medicines Have to Be Within EU's Rules).
Rising levels of parallel exports are an increasing problem across central Europe, with legislative measures being introduced or considered in Poland and Hungary to ensure that it does not interfere with the supply of medicines to patients in those countries. It is also detrimental for pharmaceutical companies, as their higher prices in the countries to which the pharmaceuticals are being parallel-exported are undermined. They also have the situation in the country from which their products are being exported of the authorities demanding increased supplies, even though they may be supplying at a normal level. However, as governments in these countries continue to seek more and more savings from the public drug bill, it is unlikely that these problems – and their associated impact on patients – will go away.