The inclusion of a wide range of important medicines on the reimbursement list and the related drop in their prices has led to the uncontrolled export of medicines outside Poland. Wholesalers tempted by this attractive market situation have been selling these medicines on more lucrative markets, not taking into account the shortage of important medicines in Polish pharmacies which may threaten public health.
The general provision under Polish law requiring marketing authorization holders and pharmaceutical wholesalers to maintain a supply of medicines in quantities corresponding to patients' needs in Poland was ineffective. Therefore, on 21 May 2015, the President of Poland signed an amendment to the Polish Pharmaceutical Law. The new law aims to monitor the distribution of medicines falling within a determined category of availability, foodstuffs intended for particular nutritional uses, and medical devices subject to refunds (collectively, "Products"). All participants in this distribution chain will be obliged to inform the relevant authority about their stocks on a regular basis. Moreover, the export of Products will be restricted up to a certain threshold to ensure Polish citizens receive guaranteed health safety.
As this amendment may influence trade within the EU, it has to be in conformity with EU law, in particular with Articles 35 and 36 of the Treaty on the Functioning of the European Union, which establish the free movement of goods within the EU. However, quantitative restrictions may be justified inter alia on grounds of the protection of health and life of humans. Restricting the export of medicines should therefore be regarded as proportionate as it will improve the availability of medicines on the Polish market and the restriction only applies to the Products which are in short supply on the Polish market.
Poland notified this change in law to the European Commission on 26 March 2015 under the number 2015/144/PL. The Commission has not raised any objections. The amendment will come into force within 30 days from its publication, except for the provision providing for a new electronic system of monitoring the distribution of medicines that will be functioning from 1 January 2017.
A list of the Products will be published in a notice by the Ministry of Health at least once every two months.
Obligations of wholesalers
Pharmaceutical wholesalers will be obliged to notify the General Pharmaceutical Inspector ("GIF") of their intention to export or sell Products outside Poland. The notification should include inter alia the quantity of the Product to be exported or sold. The GIF may oppose this in the form of a decision within 30 days from the notification taking into account the threat of a shortage of a particular Product and the importance of the Product for public health in Poland. Such a decision is enforceable immediately. The GIF's opposition will be published in the GIF Bulletin, and information about the opposition will be passed to the relevant customs authorities. The wholesaler concerned may submit a motion for reconsideration to the GIF within seven days from publication. Otherwise, upon the GIF's opposition the wholesaler will be obliged to sell the Products in Poland in the quantity indicated in the original notification. After 30 days from the publication of the opposition, the wholesaler may submit a new notification of its intention to export or sell further of the Products outside Poland.
If the GIF fails to oppose the notification within 30 days then pharmaceutical wholesalers may export or sell the Products outside Poland. However they still have to inform the GIF of this within seven days of export/sale.
If a wholesaler exports or sells Products without notifying the GIF, or despite a GIF opposition, it will be liable to a penalty of up to 5% of its annual net turnover, but not less than double the value of the Products intended for export or sale outside Poland.
Obligations of pharmacies
Pharmacies that cannot fulfil their duty to provide Products to Polish patients are obliged to notify the relevant regional pharmaceutical inspector (WIF) about this issue within 24 hours of becoming aware of it. If 5% of pharmacies in the region, or any hospital pharmacy, cannot ensure access to a particular Product, the WIF informs the GIF. The GIF then determines the Products' availability in the wholesale market in order to consider what action may be necessary.
It seems that the new remedies set forth in this amendment to the Polish Pharmaceutical Law, including new duties of wholesalers and pharmacies, new rights of pharmaceutical inspectors and serious sanctions for disobedience, will serve as an additional tool to guarantee health safety to Polish citizens.
This article is part of the International Life Sciences Update for July 2015.