Małecka-Libera on additions to the law on the professions of nurses and midwives. The Secretary of State replies:

  • The regulation in question introduces changes to the law on the professions of nurses and midwives related to the need to implement the provisions of the EU directive into national law – stated Deputy Health Minister Piotr Bromber
  • However, the law does not only apply to amendments to the law on the profession of nurse and midwife, but also to the issues of clinical trials, the profession of doctor and dentist, physiotherapists and paramedics.
  • As the chairman of the Senate Health Committee said, the effects of public consultations on issues other than those related to the nursing and midwifery professions have not been recorded anywhere, which may indicate that the remaining provisions during the proceedings are in the bill.” thrown”.
  • As Deputy Minister Piotr Bromber explained – everything was consulted because “we talked about it with the community. Of course I will indicate in a relevant letter, at the request of the President, when and with whom we spoke”
  • In the end, the committee passed the proposed amendments to the bill pending in the Legislative Office of the Senate, objecting to the Ministry of Health, and passed the bill by 7 votes to one.

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One action, a wide range of changes

– The proposed regulation introduces an amendment to the law on the professions of nurses and midwives related to the need to transpose into national law the provisions of the EU Directive, which mainly concerns the temporary and occasional provision of cross-border services by nurses and midwives who will not be citizens of European Union countries – said the Deputy Prime Minister Piotr Bromber.

He added: First of all, it concerns the abolition of the obligation for these nurses or midwives to provide in the declaration information about the intention to practice the profession temporarily and occasionally, as well as the place and time of practice at the District Chamber of nurses and midwives, competent for the place of practice of the profession.

As Secretary of State Bromber explained, the pending law also includes significant changes to the law on the profession of doctor and dentist. Their goal is to specify the authority of competent institutions to evaluate clinical trials of drugs, including their ethical evaluation.

As explained by the Deputy Minister, in accordance with the regulation of the European Parliament, the chair of URPL is proposed as the competent authority responsible for licensing clinical trials, just like when preparing ethical reviews is proposed that these are prepared by bioethical committees working on the basis of the law on the profession of a doctor and dentist appointed by the Minister responsible for health.

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Amendments to the Medicines Act, the Act on the profession of physiotherapist and PRM

In addition, the law also makes changes to the Medicines Act, which relate, among other things, to:
establishing national rules of jurisdiction for the authorities competent in the field of marketing authorization and supervision of the manufacture, sale and use of medicinal products, and provisions allowing the collection of fees for activities.

As proposed by the State Secretary, the amendments proposed in the law also apply to the laws on the profession of physiotherapist and the National Medical Assistance in the field of examinations for paramedics and physiotherapists.

– In our opinion, the liquidation of these exams will allow faster access to the profession of physiotherapist and paramedic and significantly accelerate the entry of physiotherapists and paramedics into the labor market.

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Małecka-Libera: these are the additions to the bill

Senator Beata Małecka-Libera, who chaired the committee’s meeting, pointed out that the present law, entitled “Amendment to the Act on the Professions of Nurses and Midwives”, concerns many other provisions.

– I took a good look at the public consultations to which this project was subject and I was surprised to find that all the accusations and all the conclusions made by the public related only to the question of changing the regulation of the profession of nurse and midwife. It also turns out that on the RCL website, where all projects are publicly accessible, there is also no information on this topic – said Senator Małecka – Libera.

– Has the currently discussed bill changed its scope in the government during the legislative process? I have the impression that the original draft of this draft only related to the law on the profession of nurse and midwife, and only during, after social consultation, were new articles added to it, the chairman of the committee asked.

Doubts were also raised by the proposed regulations on clinical trials. Senator Wojciech Konieczny asked if the provision saying that the bioethics committee will be appointed by the Minister of Health is a result of the implementation of EU regulations or is it some other reason?

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The Minister of Health will decide

Lawyer Ewa Sobczak of the Supreme Medical Chamber pointed out that the draft, which was intended for public consultation of the law amending the law on nurses and midwives, obviously did not contain any changes to the law on the profession of doctor and dentist.

– We practically learned about this change when we received an invitation to the meeting of the parliamentary committee, where the first reading of the draft would take place. The Presidium of the Supreme Medical Council also issued a negative advice on the introduction of these changes, not only because of shortcomings in the scope of the procedure, but also because of the substantive solutions included therein, Sobczak said.

She also pointed out that the draft clinical trials law, which was in public consultations in 2021, intended to apply Polish law to EU regulations, also contained solutions that provided for the creation of a single bioethics committee, but it was predicted that it would be appointed from the committees, which will be placed on the list of authorized persons at their request.

– As far as I remember, the chairman of the High Commission on Bioethics, and not the Minister of Health, would define the conditions that the Commission on Bioethics must meet in order to be placed on such a list. Even then, the medical self-government expressed concern that the role of the bioethics committees operating in the district’s medical districts could be marginalized with this solution. In the current project there is complete discretion, freedom of regulation in this regard – added lawyer Sobczak, who represents NIL.

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The consultation was, but informal, explains the State Secretary

When asked by senators, Secretary of State Bromber explained whether there had been any public consultations on the law in question in the areas of clinical trials, professions of doctors and dentists, pharmaceutical law, explained that they were, but…informal.

– Everything has been consulted because we discussed it with the community. At the request of the Madam President, I will of course indicate in the relevant letter when and with whom we spoke. We also do not introduce anything by any regulation. After all, what we are doing now is only implementing the regulation, not ours, but the EU. And we implement it on a legal basis – said Deputy Minister Bromber.

In the end, the committee passed the proposed amendments to the bill pending in the Legislative Office of the Senate, objecting to the Ministry of Health, and passed the bill with 7 votes in favor and one abstention.

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