New rules for life sciences industry against coronavirus in Poland

In preparation for situations of crisis caused by a potential spread of the coronavirus, the Polish Parliament has adopted a draft bill that introduces certain new obligations upon state-owned and private entities, including manufacturers and distributors of medicinal products and medical devices. The new bill applies to certain extent also to manufacturers of foodstuffs for particular nutritional uses. Whilst some provisions intend to apply only during a limited period of time when the danger of epidemic crisis can continue, certain provisions may turn to change the situation of pharmaceutical and medical devices companies for longer. The summary below will guide you through the amendments proposed in the draft bill. The draft is still pending parliamentary works. We will be updating you on the outcome so to assist you with timely preparation of relevant procedures in case of outbreak of the disease in Poland.

Draft of new bill on combating the coronavirus in Poland

On March 2, 2020 the Polish Parliament adopted a first draft of the bill on the prevention and combating COVID-19  ("coronavirus"), other infectious diseases and the situations of crisis caused by such diseases. Among other things, it intends to adapt the legal framework in which health care providers and manufacturers of medicinal products and medical devices operate to situations of crisis in which the Polish government will need to seek additional deliveries of drugs or provide medical care on a large scale.

Where to expect changes:

  • Public procurement

If it becomes probable that spread of the disease gets quick and out of control, or if such measures are needed for protection of health of many people, products and services can be ordered without applying the public procurement procedures.

As a result, if a health care practice will require additional deliveries of medicinal products, medical devices or food supplements, the purchases will be done based on direct sales.

  • Pricing

The Ministry of Health will be entitled to fix the maximum prices of the medicinal products (both OTC and prescription drugs) and medical devices that can be used in connection with treatment of the coronavirus disease, based on information obtained from the Chief Pharmaceutical Inspector.

  • Instructions of the Prime Minister and Chief Sanitary Inspector

The Prime Minister will be able to instruct private companies to perform certain tasks in form of a contract. The contract will be financed from the state budget.

The Chief Sanitary Inspector will be allowed to issue decisions addressed to private companies in certain cases, including decisions that impose an obligation on pharmaceutical wholesalers to distribute medicinal products or medical devices.

  • Life sciences companies to perform duties in the area of defence

Additional duties in the area of defence related to production or distribution of products might be imposed upon the manufacturers and distributors of drugs and medical devices in case of danger to life of health of people. This can include the necessity to set off additional production to satisfy the demand for certain products.

  • Reporting of the marketing volumes to the system

Entities currently obliged to report data in relation to certain products to the central system for drug marketing under article 72a of the Pharmaceutical Law (Zintegrowany System Monitorowania Obrotu Produktami Leczniczymi), as well as manufacturers and importers of medical devices might become required to report to the central system information in relation to all medicinal products and medical devices that are on the market. The Ministry of Health will have the right to limit the amount of products per patient. Companies that have not had the obligation to report to the central system so far will be obliged to make the necessary notifications within 24 hours from the Ministry's notice. Such companies will at the same time be required to report their individual opening balance.

  • Sales to wholesalers

Manufacturers and importers of medical devices will be obliged to sell the selected products only to pharmaceutical wholesalers. The pharmaceutical wholesalers will be obliged to sell the selected medicinal products and medical devices only to other wholesalers, pharmacies and health care practices in Poland.

Breach of the above duties may be fined up to PLN 5 mio.

  • Products available on stock of Material Reserves Agency

In case of deficiencies in the availability of critical drugs and medical devices on the market, deliveries of the products will be secured from the stock of the Agency of Material Reserves. However, the Agency may be ordered to purchase the necessary amounts of such products to refill the stock and if this turns impossible, the possession of such products will be seized in favour of the State Treasury. The seizure will be financed from the state budget based on average rates.

  • No compensation schemes

The new bill does not provide for any schemes of compensation to private entities in case damages are incurred as a result of exercising the above obligations.

Next steps

The draft bill is pending parliamentary works. There are many controversies about the current draft and its effect on the actual obligations of the private entities the bill comes into force as it is. Since the first patient infected with the coronavirus has been reported in Poland, it is expected that the new law can be adopted even by the end of the first week of March. If so, it will come into force immediately upon signing by the President and publication in the official journal.

Please reach out to us in case of any queries related to this topic.

 

 

Authored by Agnieszka Majka, Celina Bujalska and Anna Wiktorow

 

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