The coronavirus pandemic has put the entire economic system, especially the healthcare sector, to the difficult test. A sudden increase in infected patients and a huge demand for medicines, personal protective equipment, medical equipment and devices are only few of challenges currently faced by healthcare providers, pharmaceutical companies and medical equipment manufacturers. At the same time, the fight against the pandemic with administrative measures means facing limitations in the transport of goods, movement of persons and, consequently, limitation of available resources.
From 14 March 2020 until further notice, the state of epidemiological emergency was introduced due to SARS-CoV-2 virus infections.
The state of epidemiological emergency necessitated introduction of restrictions on the movement of persons, bans and restrictions on the export/sale of certain medical equipment and personal protective equipment outside of the country. Limitations and restrictions have been extended also to certain types of business activity. However, since the situation is evolving, further restrictions and bans may be introduced over time.
Pharmaceutical companies and entities active on the medical devices market should be aware that administrative bodies may take up various activities, which may affect their business, such activities including in particular:
- setting maximum prices for products,
- imposing restrictions on the sale / transport of products,
- imposing additional reporting obligations on product trading,
- obligations to manufacture and distribute certain products,
- confiscation of products for state reserves.
The Act on Extraordinary Measures for Preventing, Counteracting and Combating COVID-19, Other Infectious Diseases and Emergencies Caused by Them (“Special-Purpose Act”) gives the Minister of Health the right to set maximum prices for medicinal products (both OTC and Rx), medical devices, foodstuffs for special nutritional purposes, which may be used in connection with COVID-19 counteraction. These regulations are separate from the rules of setting official prices for these products in the case of their reimbursement from public funds.
Restrictions on sale / transport
Along with the introduction of the state of epidemiological emergency, the export / disposal of respirators and patient monitors outside Poland was prohibited. In addition, the sale and export of certain protective and disinfecting measures was made conditional upon a prior notification of such intention to the competent voivode.
The Minister of Health was also empowered to determine a list of medicinal products, medical devices and foodstuffs for special nutritional purposes, the trade of which will be possible only within the territory of Poland. These are also new regulations independent of the existing provisions on counteracting the export of products at risk of unavailability in Poland.
Moreover, the sale of products within the territory of Poland may be limited by determining the quantity of products per one patient in a certain period.
Additional reporting obligations
The Special-Purpose Act allows the Minister of Health to extend the obligation to report trading through the Integrated Monitoring System for Trading in Medicinal Products (the “Monitoring System”). This obligation may be imposed on manufacturers and importers of medical devices in addition to entities currently required to report via the Monitoring System. Importantly, all medicinal products, foodstuffs for nutritional purposes and medical devices on the market may be subject to the reporting obligation.
Manufacturing and distribution obligation
For the purpose of ensuring the appropriate amount of medicines, personal protective equipment and medical devices, the Special-Purpose Act enabled the Minister of Health to create strategic reserves based on single-source contracts with the priority of purchase.
At the same time, entrepreneurs involved in the manufacture and distribution of medicinal products, foodstuffs for special nutritional purposes, personal protective equipment and medical devices, as well as in the provision of health care services were covered by the regime of regulations on the organisation of tasks for the benefit of the state defence. Thus, these entities may be covered by mobilisation programmes under which they will be required to manufacture and distribute their products at a request of the State.
Seizure of products for strategic reserves
In emergency, when replenishment of strategic reserves by purchasing products proves impossible, the Special-Purpose Act entitles the Minister of Health (and other competent ministers) to order the seizure of medicinal products, foodstuffs for special nutritional purposes, medical devices, personal protective equipment or apparatus for the benefit of the State Treasury. The seizure is based on average rates applied in economic relations of a certain type.
How can we be of help?
Our Law Firm offers complex advice in the field of health protection and pharmaceutical law. We have long track record of providing professional legal advisory services in that area to biggest Polish and foreign entrepreneurs.
In view of the introduced state of epidemiological emergency, entrepreneurs operating in the healthcare sector should take appropriate measures to prepare for additional administrative obligations that may be imposed on them. It is important to monitor the legislation in this area and to react to changes.
Please contact us if you require legal advice or have questions with reference to the above.
Information contained in this publication is of general nature and does not relate to the situation of a particular company. Due to frequent changes in Polish legislation, we kindly request that you make sure that on the day you are reading this publication the information contained therein is still up to date. We suggest that you consult our advisers before making any decisions.