Localization
DLA Piper / Poland
All legal aspects surrounding localization in the Polish pharma market. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 75.
1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies?
No, there are no rules or regulations requiring or encouraging localisation in Poland. However, certain activities are subject to authorisation by Polish authorities.
For example, placing medicinal products on the Polish market is subject to an authorisation by the President of the Office for the Registration of Medicinal Products or the European Medicines Agency. Some entities must have to have their seat in an EU/EEA member state, e.g. the representative of a sponsor of a clinical trial.
2. Have there been any recent significant changes involving localization rules? If yes, when did they take place and what did they involve?
There have not been any recent significant changes involving localisation rules.
3. Is the process of obtaining a marketing authorization impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?
No, the process of obtaining a marketing authorisation is not impacted by localisation policies. However, as mentioned in the answer to Question 114, placing a medicinal product on the Polish market is subject to authorisation by local authorities.
4. Is the pricing process for pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?
No, the pricing process for pharmaceutical products is not impacted by localisation policies.
5. Is the reimbursement of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?
No, the reimbursement of pharmaceutical products is not impacted by localisation policies.
6. Is the access to public or public tenders of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?
No, access to public tenders of pharmaceutical products is not impacted by localisation policies. The contracting entity cannot require the tenderer to be a company registered in Poland, hence, any company may submit offers for public tenders.
7. Are import tariffs, importation and/or exportation permits, trade and/or taxation of pharmaceutical products impacted by localization policies in your country? If yes, how so?
In general, import tariffs, importation and/or exportation permits, trade and/or taxation of pharmaceutical products are not impacted by localisation policies. However, as mentioned in the answer to Question 1, importation is subject to authorisation by local authorities.
In terms of taxation, PIT and CIT payers can benefit from an R&D tax credit allowing them to deduct up to 100% of the amount of so-called qualified expenses.
8. Are there any other incentives or advantages offered by the current local localization rules in your country? If yes, what are they?
No, there are currently no other incentives or advantages offered by localisation rules.
9. Are there discussions about the possibility of implementing localization policies in your country? If yes, what are the proposed reforms and when should they come into place?
No, there are currently no discussions about the possibility of implementing localisation policies in Poland. However, one of the strategic goals defined in the Medicines Policy 2018 – 2022 is strengthening and developing the potential of the pharmaceutical sector located in Poland. It is emphasised that national medicines policies should put in place mechanisms encouraging investments in the pharmaceutical sector in Poland. Nonetheless, there are no specific plans to regulate this by way of localisation requirements or advantages.
