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A pharmacy for a pharmacist. The decision of President Andrzej Duda and an important announcement from the Chancellery of the President of the Republic of Poland

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President Andrzej Duda signed an amendment to the Act on export insurance guaranteed by the State Treasury, the Chancellery of the President of the Republic of Poland announced on Friday. One of the elements of the regulation are changes in the regulations known as Pharmacy for pharmacists. However, this part of the amendment – in accordance with the announcement of the presidential minister Małgorzata Paprocka – will be referred to the Constitutional Tribunal under the post-control procedure.

This concerns the Act of July 13, 2023 amending the Act on export insurance guaranteed by the State Treasury and certain other acts. As the president’s office announced on Friday, the president signed the act on Thursday, September 7 this year. As reported by the president’s office, the solutions proposed in the act extend the statutory mandate of the Export Credit Insurance Corporation (KUKE) to include activities unrelated to exports.

A pharmacy for a pharmacist

At the same time, the amendment introduces changes to the Pharmaceutical Law – the so-called “Pharmacy for pharmacists” principle. In this respect, the amendment – according to a statement from the president’s office – “aims primarily to prevent the taking over of control within the meaning of the provisions on competition and consumer protection over an entity running a publicly available pharmacy by persons other than pharmacists or companies with their participation and by entities that already run, in directly or indirectly, at least four generally accessible pharmacies.

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“It will also be unacceptable for a person who is a member of the governing bodies of a company authorized to operate a pharmaceutical wholesale store or engaged in intermediation in the trade of medicinal products to take over control of an entity running a public pharmacy. The above restrictions will not apply to taking control as a result of an inheritance,” it said. the office of President.

As added, violating the ban on taking over control will result in the Voivodship Pharmaceutical Inspector withdrawing, by way of an administrative decision, the permit to run a public pharmacy for the entity over which control was taken over, and imposing a fine of PLN 50,000 by the pharmaceutical inspection authority. PLN up to PLN 5 million for the entity acquiring unauthorized control within the meaning of the Act.

Announcement of the application to the Constitutional Tribunal

The provisions relating to Pharmaceutical Law contained in the Export Insurance Act will be referred to the Constitutional Tribunal in the course of post-control, presidential minister Małgorzata Paprocka told PAP on Friday.

– Mr. President – due to the importance of regulations favorable to Polish entrepreneurs, in particular regarding conducting business activity in Poland Ukraine – decided to sign the act, which mainly concerns export insurance. Amendments to the Pharmaceutical Law were added in the course of work on the draft in the Sejm. The president decided that these provisions would be referred to the Constitutional Tribunal as a follow-up review, said Minister Paprocka.

As she pointed out, the office received a huge amount of correspondence on this matter, both expressing support for the solutions and pointing out reservations. She added that a meeting of the Health Protection Council was held at the Presidential Palace, devoted to changes in the Pharmaceutical Law, with broad participation of interested entities.

The president would like to Constitutional Court – as the only body authorized to do so – assessed the compliance of the act with the Constitution, in particular in terms of law-making standards – Paprocka said. She announced that details will be communicated when the application is submitted.

Amendment controversy

Change of regulations In the case of pharmacies, she previously criticized, among others, Lewiatan Confederation. Its position reads that “even though the project (on export insurance guaranteed by the State Treasury – ed.) has no connection with the regulation of the operation of pharmacies or broadly understood health care, provisions regarding pharmaceutical law were suddenly added to it without any consultations.”

“They radically change the rules governing the ownership and organization of the pharmacy market. They introduce a complete ban on ‘taking control’ over pharmacy entities by everyone except pharmacists and pharmacist companies,” the organization wrote.

According to the Lewiatan Confederation, “the amendment goes much further than the so-called ‘Pharmacy for Pharmacists’ adopted in 2017.” “Although this act also gave pharmacists and their companies the exclusive right to open pharmacies, its restrictions did not apply to pharmacies already operating,” the business organization notes. He adds that “the current amendment is different in this respect: it directly applies to all pharmacies currently operating on the market, prohibiting any activities related to the sale of pharmacy enterprises, and even the conclusion by pharmacy entities of certain agreements regulating economic cooperation, such as franchise or loans.”

“Fundamental changes introducing new rules of the game on the pharmacy market and interfering with the rights of hundreds of entrepreneurs, regardless of their substantive assessment, require a debate and a thorough assessment of the effects of introducing the new law,” it was emphasized in a position paper in mid-August.

This is another organization that openly criticized changes in pharmaceutical law. – Due to new regulations regarding pharmacies, drug prices may increase. Their availability will also decrease – Marzena Drela, Operations Director at the American Chamber of Commerce in Poland, said recently on TVN24 BiS. She added that the way the law is handled in Poland may discourage investors.

As “Puls Biznesu” reported at the beginning of August, large pharmacy chains with foreign capital informed the government and the president that tightening the regulations would result in arbitration. Claims can reach billions of dollars. According to “PB” to the Prime Minister, President and Deputy Prime Minister Jarosław Kaczyński The first letters informing about a potential dispute with Poland have already arrived. They were sent by Warburg Pincus, the American private equity fund that owns the Gemini network.

Read more: Claims can reach billions of dollars. Letters were sent to the government and the president

Main photo source: PAP/Marcin Obara

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