Changes to Poland's pharmaceutical law, which include a mechanism to restrict parallel exports of drugs in short supply, are close to implementation, with presidential ratification expected soon.
IHS Life Sciences perspective | |
Significance | Following the Polish Senate's passage of changes to the pharmaceutical law, including a new mechanism to restrict parallel exports of drugs in short supply, only ratification by the president now remains. |
Implications | The passage of the measures relating to the restriction of parallel exports has been long and complex, but it appears that increasing concerns about drug shortages have been instrumental in accelerating the legislative process. |
Outlook | The Polish authorities will have to be careful not to apply bans on parallel exports too generally, with the European Commission ready to intervene if it perceives that rules on free movement of goods are being violated – in view of recent experiences in Slovakia. |
Poland's Senate, the upper house of the Polish parliament, passed a package of amendments to the country's pharmaceutical law on 7 May, which includes measures intended to restrict the parallel export of medicines. According to the website of the lower house, the Sejm, the package of amendments has now been passed to the president (currently Bronislaw Komorowski, although a two-round presidential election is currently under way in Poland) for ratification.
The main aspects of the regulations designed to restrict parallel exports of medicines are outlined below:
- Organisations wishing to carry out parallel exports of medicines outside Poland, or the sale of medicines to organisations outside the country, will have to inform the Main Pharmaceutical Inspectorate (GIF) before doing so.
- The GIF will be able to issue a decision preventing the parallel export of medicines that are in short supply or lacking in the Polish market within 30 days of the notification from the organisation carrying out parallel exporting or selling medicines to organisations outside Poland.
- A list of medicines with supply problems leading to a possible absence in the market will be published at least every two months by the health minister – it will be made public in the official gazette of the minister.
- Organisations intending to parallel export medicines that have received a refusal from the GIF are entitled to request that their application be reconsidered – they are required to request such reconsideration within seven days of receiving the refusal from the GIF.
- If the GIF does not refuse the parallel export of particular medicines, organisations involved in parallel exporting must carry out the exports (or sales) for which they applied to the GIF within 30 days of the GIF's decision.
- Organisations involved in parallel exports of medicines in Poland will be required to inform the GIF within seven days of their completion of the parallel export/sale of medicines outside Poland.
- The organization that applies to the GIF to carry out the parallel export of particular medicines may apply again to carry out parallel exports within 30 days after any refusal by the GIF to allow such export/sale.
The full text of the amendments can be found at the website of the Sejm, in Polish, here.
Outlook and implications
It would appear that despite concerns that opposition from other EU member states and the impending parliamentary election in September could prevent the implementation of the changes to the pharmaceutical law, the changes are now highly likely to be introduced. The issue of missing medicines in Polish pharmacies has been rising up the agenda of public interest in recent months, and this has been matched by the determination to see the legislation through.
Many kinds of medicines are reportedly involved, including insulins, antithrombotic, and oncology medicines. Since 2012, when the Reimbursement Act came into effect in Poland, there has been a steady drop in the prices of medicines in the country, with larger internal reference-pricing groups and more frequent price changes helping to make the prices of many drugs in the country among Europe's lowest. The inevitable consequence of this has been that the profitability of selling medicines bought in Poland in countries where medicine prices are higher has grown to such an extent that parallel exporting has apparently boomed. Another issue is that some pharmacies in Poland have been allegedly illegally selling medicines back to wholesalers, which then sell them abroad – one cause for this is the fixed margins that pharmacies must charge for prescription medicines, which severely limits their competitive possibilities.
Many other countries in central and southeastern Europe have already introduced restrictions on parallel exports. It remains to be seen how strictly these regulations will be applied in Poland. In neighbouring Slovakia, the country's government has been forced to agree to changes to its legal provisions intended to rein in parallel exports (see Slovakia: 22 December 2014: Slovak government plans changes to law restricting parallel drug exports after negotiations with European Commission). The Polish authorities will have to tread carefully in respect of the European Commission's rules only allowing a very limited restriction of parallel drug exports.