A recent amendment to the Czech Act on Pharmaceuticals created a new obligation on marketing authorisation holders to provide the State Institute for Drug Control ("SIDC") with reasons for interruptions to the supply of particular pharmaceutical products. The Czech market also realises that in practice, the limited availability of particular pharmaceutical products on the market is not always as a result of problems with their supply, but may also be associated with their exportation abroad. The market is therefore considering steps to try to limit such exportation and the Czech Ministry of Health has actually prohibited the export of a pharmaceutical product for the first time in modern history.
Obligation to report reasons for interruptions to drug supply
Marketing authorisation holders are required by law to report expected interruptions to the supply of pharmaceutical products on the Czech market to the SIDC at least two months before the interruption occurs. In exceptional circumstances, such notification to the SIDC can be made simultaneously with the commencement of the interruption, but no later than this point.
The industry is already familiar with this obligation since the rule has been in force for 5 years, however, as of 28 October 2013, marketing authorisation holders are also required to include reasons for the interruption, and may be subject to a fine of up to CZK 2,000,000 for failing to satisfy this requirement.
The aim of the amendment is to help pharmacists, doctors, and also the general public, to better estimate how long a particular drug may be unavailable to the market. Such a lack of availability could arise due to a simple delay in shipment lasting a matter of days, or could, in a more serious situation, last for a matter of weeks or months as a result of technical difficulties incurred during the manufacture. This amendment to the law aims to give pharmacists and doctors more advanced warning and an opportunity to assess the situation with respect to a particular drug and its availability and, if necessary, consider implementing changes, for example, to a patients' medication.
The first ban on drug export
According to some estimates, drugs worth CZK 5-10 billion disappear from the Czech market each year as a result of exportation, which in some cases leads to there being limited availability of that drug in the Czech market.
The Czech Act on Pharmaceuticals gives the Ministry of Health the power to take action in order to achieve access to medicines. However, there is no direct legal authorisation in the Act to justify a legal ban on exports. Although an amendment to the Act explicitly permitting the Ministry of Health to prohibit the export of drugs after consultation with the State Institute for Drug Control is being discussed, it is yet uncertain whether it will be adopted.
Nevertheless, the first drug export ban in the Czech Republic was imposed in October 2013 in relation to a particular batch of insulin pens. Although the Ministry of Health intends to continue using the export ban as a general measure, the Minister points out that it will only be used in exceptional circumstances as a temporary measure, and will only relate to a particular batch of medicines. The Minister of Health admits that the ban must be used with caution as there is a risk of conflict with EU law and the principle of free movement of goods.
This article is part of the International Life Sciences Update for February 2014