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Law Market News

False Directive: Accessibility problems and price increases

As we have already informed, the so-called False Directive came into force on February 9th. Its main objective is to seal the distribution chain by serializing the packaging. However, the first month of its operation brought a lot of confusion on the market.

As reported by “Dziennik Gazeta Prawna”, the problem in Poland is more serious than in other countries. All because the preparations for the entry into force of the system were postponed until the last minute. Many pharmacies received access data to the system only after 9 February. In addition, unlike some other countries, Poland did not decide to introduce a transitional period for the implementation of the directive.

One of the effects of the false directive, according to the mgr.farm portal, are problems with the availability of cephalosporins. These are the key antibiotics in the treatment of hospital infections.  The main supplier of this group of drugs to the Polish market is Polpharma. The company, which in 2018 modernized its machine park and increased its production capacity, has a problem with the serialization of its optics. They result from errors in operation and the inefficiency of the data hub at the European level. The system does not properly read serialization data, which makes it impossible to release already produced series. The problem with adding codes to the European database occurs also in other manufacturers.

The second effect of the directive may be an increase in the price of medicines. According to mgr.farm, it is already visible in the tender procedures announced by hospitals. And soon it may also affect medicines in public pharmacies.  In this way, manufacturers will try to compensate for the costs associated with the introduction of the system and the serialisation of packaging. In the case of Polpharma, the investments in fixed assets alone amounted to about PLN 40 million.

According to PMR information, problems after the entry into force of the false directive also occur in other countries in the region. For example, in Bulgaria, packaging with or without serialisation codes is in circulation. The implementation of the system is hindered by the fact that many pharmacies in this country do not have access to the Internet, and sometimes also to electricity. The system will not be fully operational until 2021.

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